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As filed with the Securities and Exchange Commission on April 21, 2023
Registration No. 333-269741
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 3
TO
FORM S-4
REGISTRATION STATEMENT
Under
The Securities Act of 1933
Angion Biomedica Corp.
(Exact name of Registrant as specified in its charter)
Delaware
2834
11-3430072
(State or Other Jurisdiction of
Incorporation or Organization)
(Primary Standard Industrial
Classification Code Number)
(I.R.S. Employer
Identification Number)
7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
Jay R. Venkatesan, M.D.
President and Chief Executive Officer
Angion Biomedica Corp.
7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Please send copies of all communications to:
Kenneth L. Guernsey
Brett D. White
Anitha Anne
Cooley LLP
Three Embarcadero Center,
20th Floor
San Francisco, CA 94111
(650) 843-5000
Jennifer J. Rhodes
General Counsel
Angion Biomedica Corp.
7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
Kristen Ferris
Goulston & Storrs PC
400 Atlantic Ave
Boston, MA 02110
(617) 482-1776
William C. Hicks
Daniel A. Bagliebter
Mintz Levin Cohn Ferris
Glovsky & Popeo, P.C.
One Financial Center
Boston, MA 02111
(617) 542-6000
Approximate date of commencement of proposed sale to the public: As soon as practicable after the effectiveness of this registration statement and the satisfaction or waiver of all other conditions under the Merger Agreement described herein.
If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, please check the following box.
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
Accelerated filer
Non-accelerated filer
Smaller reporting company
 
 
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.
If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:
Exchange Act Rule 13(e)-4(i) (Cross-Border Issuer Tender Offer)
Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender Offer)
The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment that specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

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The information in this proxy statement/prospectus/information statement is not complete and may be changed. Angion may not sell its securities pursuant to the proposed transactions until the registration statement filed with the Securities and Exchange Commission is effective. This proxy statement/prospectus/information statement is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
PRELIMINARY—SUBJECT TO COMPLETION—DATED APRIL 21, 2023
PROPOSED MERGER
YOUR VOTE IS VERY IMPORTANT
To the Stockholders of Angion Biomedica Corp. and Elicio Therapeutics, Inc.:
Angion Biomedica Corp. (Angion) and Elicio Therapeutics, Inc. (Elicio) have entered into an Agreement and Plan of Merger and Reorganization, dated January 17, 2023, as may be amended from time to time (Merger Agreement), pursuant to which Arkham Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of Angion (Merger Sub), will merge with and into Elicio, with Elicio surviving as a wholly owned subsidiary of Angion (Merger). The Merger will result in a clinical-stage biopharmaceutical company advancing Elicio’s proprietary lymph node-targeting Amphiphile (AMP) technology to develop immunotherapies, with a focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors.
The Merger will become effective at the time the Certificate of Merger has been duly filed with the Secretary of State of the State of Delaware or such other date and time as is agreed upon by Angion and Elicio and specified in the Certificate of Merger in accordance with the General Corporation Law of the State of Delaware (DGCL) (such date, the Closing Date, and such time, the Effective Time). At the Effective Time, each outstanding share of common stock of Elicio (including the shares of common stock issuable upon conversion of all shares of preferred stock of Elicio prior to the Merger) $0.01 par value per share (Elicio common stock), will be converted into the right to receive approximately 5,719,223 shares of common stock of Angion, $0.01 par value per share (Angion common stock), based on an assumed exchange ratio of 0.0164, assuming a reverse stock split of Angion common stock at a ratio of 10-for-1 to be implemented prior to the consummation of the Merger as may be adjusted and as discussed in this proxy statement/prospectus/information statement, and further adjusted based on Angion’s net cash in connection with the closing of the Merger (which net cash is expected to be between $26.5 million and $31.5 million). Angion will assume outstanding and unexercised options to purchase shares of Elicio common stock, and in connection with the Merger they will be converted into options to purchase shares of Angion common stock based on the agreed upon exchange ratio. At the Effective Time, Angion’s stockholders will continue to own and hold their then existing shares of Angion common stock, subject to adjustment for the reverse stock split. Each warrant to purchase Elicio common stock outstanding and unexercised immediately prior to the Effective Time of the Merger will be assumed by Angion and will become a warrant to purchase shares of Angion common stock, with the number of shares and exercise price being adjusted by the same exchange ratio. All outstanding and unexercised options to purchase shares of Angion common stock will remain effective and outstanding.
Immediately following the Merger, the pre-Merger equity holders of Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million.
The shares of Angion common stock are currently listed on The Nasdaq Global Select Market under the symbol “ANGN” although Angion plans to transfer its listing to The Nasdaq Global Market prior to completion of the Merger and Elicio has filed an initial listing application with The Nasdaq Stock Market LLC (Nasdaq) pursuant to Nasdaq’s “reverse merger” rules. Substantially concurrent with the completion of the Merger, Angion will be renamed “Elicio Therapeutics, Inc.” and expects to trade on The Nasdaq Global Market under the symbol “ELTX”. On    , 2023, the last trading day before the date of this proxy statement/prospectus/information statement, the closing sale price of Angion common stock was $     per share.
Angion is holding a special meeting of stockholders in order to obtain the stockholder approvals necessary to complete the Merger and other matters. At the Angion annual meeting, which will be held exclusively online via live audio-only webcast on    , 2023, at 9:00 a.m. Pacific Time, unless postponed or adjourned to a later date, Angion will ask its stockholders, among other things, to (i) approve the issuance of shares of Angion common stock as consideration in the Merger and (ii) to approve an amendment to Angion’s certificate of incorporation effecting a reverse stock split of Angion common stock at a ratio in the range from 5 -for-1 to 30 -for-1, with such specific ratio to be mutually agreed upon by the respective Angion and Elicio boards of directors or, if the issuance of shares of Angion common stock as consideration in the Merger is not approved by Angion stockholders, at a ratio determined solely by the Angion board of directors (Angion’s Board or the Angion Board) following the special meeting, each as described in this proxy statement/prospectus/information statement.
Please refer to the various provisions of this proxy statement/prospectus/information statement for further information with respect to the business to be transacted at the Angion special meeting. As described in this proxy statement/prospectus/information statement, certain of Elicio’s stockholders are parties to Support Agreements with Angion and Elicio, whereby such stockholders have agreed to vote their shares in favor of the adoption or approval, among other things, of the Merger Agreement and the approval of the transactions contemplated therein, including the Merger, the issuance of shares of Angion common stock to Elicio’s stockholders, and the change of control resulting from the Merger, subject to the terms of the Support Agreements.
In addition, following the effectiveness of the registration statement on Form S-4 (Registration Statement), of which this proxy statement/prospectus/ information statement is a part, and pursuant to the conditions of the Merger Agreement and the Support Agreements, Elicio’s stockholders who are party to the Support Agreements will each execute an action by written consent of Elicio’s stockholders, referred to as the written consent, adopting and approving the Merger Agreement, thereby approving the transactions contemplated therein, including the Merger. No meeting of Elicio’s stockholders will be held; all of Elicio’s stockholders will have the opportunity to elect to adopt the Merger Agreement, thereby approving the Merger and related transactions, by signing and returning to Elicio a written consent once this Registration Statement is declared effective by the Securities and Exchange Commission (SEC).
After careful consideration, Angion’s Board has unanimously: (i) determined that the Merger and the transactions and actions contemplated by the Merger Agreement are fair to, advisable and in the best interests of Angion and its stockholders; (ii) authorized, approved and declared advisable the Merger Agreement and the transactions contemplated therein, including the Merger, the issuance of shares of Angion common stock to the stockholders of Elicio capital stock pursuant to the terms of Merger Agreement and the treatment of the options and warrants to purchase Elicio capital stock pursuant to the Merger Agreement; and (iii) determined to recommend, upon the terms and subject to the conditions set forth in the Merger Agreement, that the stockholders of Angion vote “FOR” each of the proposals set forth in this proxy statement/prospectus/information statement.
After careful consideration, Elicio’s board of directors (Elicio’s Board or the Elicio Board) has unanimously (i) determined that the Merger and the transactions and actions contemplated by the Merger Agreement are fair to, advisable and in the best interests of Elicio and its stockholders, (ii) authorized, and declared advisable the Merger Agreement and the transactions contemplated therein, including the Merger and (iii) determined to recommend, upon the terms and subject to the conditions set forth in the Merger Agreement, that each Elicio stockholder sign and return the written consent, indicating its (a) adoption of the Merger Agreement and approval of the transactions contemplated therein, including the Merger, (b) acknowledgement that the approval given is irrevocable and that such stockholder is aware of its rights to demand appraisal for its shares pursuant to Section 262 of the DGCL and that such stockholder has received and read a copy of Section 262 of the DGCL, (c) consent to conversion of Elicio’s preferred stock to Elicio common stock immediately prior to the closing of the Merger, for Elicio’s preferred stockholders, and (d) acknowledgement that by its approval of the Merger such stockholder is not entitled to appraisal rights or dissenters’ rights with respect to its shares in connection with the Merger and thereby waives any rights to receive payment of the fair value of its capital stock under the DGCL.
More information about Angion, Elicio and the proposed transaction is contained in this proxy statement/prospectus/information statement. Angion and Elicio urge you to read this proxy statement/prospectus/information statement carefully and in its entirety. In particular, you should carefully consider the matters discussed under “Risk Factors” beginning on page 20.
Angion and Elicio are excited about the opportunities the Merger brings to Angion’s and Elicio’s stockholders, and thank you for your consideration and continued support.
Jay R. Venkatesan, M.D.
President and Chief Executive Officer
Angion Biomedica Corp.
Robert Connelly
Chief Executive Officer
Elicio Therapeutics, Inc.
Neither the SEC nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this proxy statement/prospectus/information statement. Any representation to the contrary is a criminal offense.
This proxy statement/prospectus/information statement is dated     , 2023, and is first being mailed to Angion’s and Elicio’s stockholders on or about     , 2023.

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graphic
7-57 Wells Avenue, Newton, Massachusetts 02459
NOTICE OF SPECIAL MEETING OF STOCKHOLDERS
To Be Held On    , 2023
Dear Stockholder of Angion:
The board of directors of Angion is pleased to deliver this proxy statement/prospectus/information statement for the proposed merger between Angion and Elicio, for the purpose of, among other things, considering the approval of the issuance of Angion common stock pursuant to the Merger Agreement, between Angion and Elicio, pursuant to the Merger.
There will not be a physical meeting location. The special meeting (which will also serve as Angion’s 2023 annual meeting of stockholders) (Angion special meeting) will be held exclusively online via live audio-only webcast on    , 2023, at 9:00 a.m. Pacific Time, and can be accessed by visiting www.virtualshareholdermeeting.com/ANGN2023SM, where you will be able to attend the Angion special meeting via live audio-only webcast. You will be able to vote your shares and submit questions during the Angion special meeting webcast by logging in to the website listed above using the 16-digit control number included in your proxy card. Online check-in will begin at 8:45 a.m. Pacific Time, and Angion encourages you to allow ample time for the online check-in procedures. Please note that you will not be able to attend the Angion special meeting in person. Angion is holding the Angion special meeting to consider the following proposals:
1.
Approve the issuance of shares of Angion capital stock pursuant to the Merger, which will represent more than 20% of the shares of Angion common stock outstanding immediately prior to the Merger and result in a change of control of Angion, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), referred to as the Stock Issuance Proposal;
2.
Approve an amendment to the amended and restated certificate of incorporation of Angion to effect a reverse stock split of Angion common stock at a ratio within the range between 5-for-1 to 30-for-1 (with such ratio to be mutually agreed upon by Angion and Elicio prior to the effectiveness of the Merger or, if the Stock Issuance Proposal is not approved by Angion stockholders, determined solely by the Angion Board), referred to as the Reverse Stock Split Proposal;
3.
Approve an amendment to the Angion amended and restated certificate of incorporation to provide for the exculpation of officers, referred to as the Exculpation Proposal;
4.
Elect the Angion Board nominees, Itzhak Goldberg, M.D., F.A.C.R. and Allen R. Nissenson, M.D., to the Angion Board in the class of directors to hold office until the 2026 Annual Meeting of Stockholders, referred to as the Director Election Proposal;
5.
Ratify the selection of Moss Adams LLP as Angion’s independent registered public accounting firm for the fiscal year ending December 31, 2023, referred to as the Accounting Firm Proposal; and
6.
Approve a postponement or adjournment of the Angion special meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Stock Issuance Proposal and/or the Reverse Stock Split Proposal, referred to as the Adjournment Proposal.
These six proposals are referred to collectively as the Angion Proposals.
Please read this proxy statement/prospectus/information statement for further information with respect to the business to be transacted at the Angion special meeting. The Angion board of directors (Angion Board) has fixed April 17, 2023, as the record date for the determination of stockholders entitled to notice of, and to vote at, the Angion special meeting and any adjournment or postponement thereof. Only holders of record of shares of Angion common stock at the close of business on the record date are entitled to notice of, and to vote at, the Angion special meeting.

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At the close of business on the record date, Angion had 30,114,190 shares of common stock outstanding and entitled to vote. A complete list of such stockholders entitled to vote at the Angion special meeting will be available for examination at the Angion offices in Newton, Massachusetts during normal business hours for a period of ten days prior to the Angion special meeting.
Your vote is important. Approval of each of the Stock Issuance Proposal, the Accounting Firm Proposal and the Adjournment Proposal requires the affirmative vote of a majority of the voting power of the shares of common stock present in person, by remote communication, or represented by proxy at the Angion special meeting and voting affirmatively or negatively (excluding abstentions and broker non-votes) on the matter. The affirmative vote of the holders of a majority of the Angion common stock outstanding on the record date for the Angion special meeting is required for the approval of the Reverse Stock Split Proposal and the Exculpation Proposal. With respect to the Director Election Proposal, directors are elected by a plurality of the affirmative votes cast in person or by proxy at the Angion special meeting, and the nominees for director receiving the highest number of affirmative votes will be elected. No Angion Proposal is conditioned upon any other Angion Proposal. However, each of the Stock Issuance Proposal and the Reverse Stock Split Proposal is a condition to the consummation of the Merger. Therefore, the Merger cannot be consummated without the approval of the Stock Issuance Proposal and the Reverse Stock Split Proposal.
You are cordially invited to attend the Angion special meeting. The Angion special meeting can be accessed by visiting www.virtualshareholdermeeting.com/ANGN2023SM, where you will be able to attend the Angion special meeting via live audio-only webcast. You will be able to vote your shares and submit questions during the Angion special meeting webcast by logging in to the website listed above using the 16-digit control number included in your proxy card. Whether or not you expect to attend the Angion special meeting, to ensure your representation at the Angion special meeting, Angion urges you to submit a proxy to vote your shares as promptly as possible by (1) visiting the Internet site listed on the enclosed Angion proxy card, (2) calling the toll-free number listed on the enclosed Angion proxy card or (3) submitting your enclosed Angion proxy card by mail by using the provided self-addressed, stamped envelope. Submitting a proxy will not prevent you from attending by means of remote communication the Angion special meeting and voting at the Angion special meeting, but it will help to ensure that a quorum is present and avoid added solicitation costs. Any holder of record of Angion common stock as of the record date who attends the Angion special meeting may vote at the Angion special meeting, thereby revoking any previous proxy. In addition, a proxy may also be revoked in writing before the Angion special meeting in the manner described in this proxy statement/prospectus/information statement. If your shares are held in the name of a bank, broker or other nominee, please follow the instructions on the voting instruction form furnished by your bank, broker or other nominee.
If you own shares in street name through an account with a bank, broker or other nominee and you decide to attend the Angion special meeting, you cannot vote at the Angion special meeting unless you present a “legal proxy”, issued in your name from your bank, broker or other nominee. If your shares are held in a brokerage account or by a bank or other nominee, your ability to vote by telephone or the Internet depends on your broker’s voting process. Please follow the directions provided to you by your broker, bank or nominee.
THE ANGION BOARD HAS UNANIMOUSLY DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS ADVISABLE TO, AND IN THE BEST INTERESTS OF, ANGION AND ITS STOCKHOLDERS. THE ANGION BOARD UNANIMOUSLY RECOMMENDS THAT ANGION’S COMMON STOCKHOLDERS VOTE “FOR” THE STOCK ISSUANCE PROPOSAL, THE REVERSE STOCK SPLIT PROPOSAL, THE EXCULPATION PROPOSAL, EACH OF THE NOMINEES NAMED IN THE DIRECTOR ELECTION PROPOSAL, THE ACCOUNTING FIRM PROPOSAL AND THE ADJOURNMENT PROPOSAL.
By Order of the Angion Board of Directors,
Jay R. Venkatesan, M.D.
President and Chief Executive Officer
Newton, Massachusetts
   , 2023

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ABOUT THIS DOCUMENT
This document, which forms part of a registration statement on Form S-4 filed with the SEC by Angion, constitutes a prospectus of Angion under the Securities Act of 1933, as amended (Securities Act), with respect to the shares of Angion common stock to be issued pursuant to the Merger Agreement, between Angion and Elicio, pursuant to the Merger. This document also constitutes a notice of a meeting and a proxy statement of Angion under Section 14(a) of the Securities Exchange Act of 1934, as amended (Exchange Act) with respect to the Angion special meeting at which Angion stockholders will be asked to consider and vote on a proposal to approve the issuance of Angion common stock to the securityholders of Elicio, as well as to consider and vote on certain other proposals.
No one has been authorized to provide you with information that is different from that contained in this proxy statement/prospectus/information statement. This proxy statement/prospectus/information statement is dated as of the date set forth on the cover hereof. You should not assume that the information contained in this proxy statement/prospectus/information statement is accurate as of any date other than that date. Neither the mailing of this proxy statement/prospectus/information statement to Elicio stockholders nor the issuance by Angion of Angion common stock in connection with the proposed Merger will create any implication to the contrary.
This proxy statement/prospectus/information statement does not constitute an offer to sell, or a solicitation of an offer to buy, any securities, or the solicitation of a proxy, in any jurisdiction in which or from any person to whom it is unlawful to make any such offer or solicitation in such jurisdiction.
Information contained in this proxy statement/prospectus/information statement regarding Elicio and its business, operations, management and other matters has been provided by Elicio and information contained in this proxy statement/prospectus/information statement regarding Angion and its business, operations, management and other matters has been provided by Angion.
If you would like additional copies of this proxy statement/prospectus/information statement or if you have questions about the proposed Merger or the proposals to be presented at the Angion special meeting, please contact Elicio’s proxy solicitor listed below. You will not be charged for any of the documents that you request.
You may also request additional copies from Angion’s proxy solicitor using the following contact information:
Mackenzie Partners, Inc.
Stockholders call toll-free: 1-800-322-2885

Call Collect: 212-929-5500
Email: Angion@mackenziepartners.com
To ensure timely delivery of these documents, any request should be made no later than    , 2023 to receive them before the Angion special meeting.
Angion intends to mail this proxy statement/prospectus/information statement on or about    , 2023, to all stockholders of record entitled to vote at the Angion special meeting.
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QUESTIONS AND ANSWERS ABOUT THE MERGER
Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus/information statement does not give effect to the proposed reverse stock split (Reverse Stock Split) of common stock of Angion, as described in Proposal No. 2 beginning on page 167 of this proxy statement/prospectus/information statement.
The following section provides answers to frequently asked questions about the proposed merger transaction and the Angion special meeting. This section, however, provides only summary information. For a more complete response to these questions and for additional information, please refer to the cross-referenced sections.
Q:
What is the Merger?
A:
Angion, Merger Sub, and Elicio entered into the Merger Agreement on January 17, 2023. The Merger Agreement, as it may be further amended from time to time, contains the terms and conditions of the proposed merger transaction among Angion, Merger Sub and Elicio. Under the Merger Agreement, Merger Sub will merge with and into Elicio, with Elicio surviving as a wholly owned subsidiary of Angion. This transaction is referred to as the Merger.
The Merger will become effective at the time the Certificate of Merger has been duly filed with the Secretary of State of the State of Delaware or the Effective Time. At the Effective Time, each share of Elicio preferred stock outstanding immediately prior to the Effective Time and after giving effect to an automatic conversion of each share of preferred stock of Elicio into shares of Elicio common stock (the Preferred Stock Conversion, excluding shares held as treasury stock by Elicio or held or owned by Angion, Merger Sub or any subsidiary of Angion or Elicio and excluding shares held by stockholders who have exercised and perfected appraisal rights as more fully described in the section titled “The Merger Agreement—Appraisal Rights and Dissenters’ Rights” beginning on page 148 of this proxy statement/prospectus/information statement) will be automatically converted solely into the right to receive a number of shares of Angion common stock calculated using an exchange ratio formula described in the Merger Agreement (Exchange Ratio).
Immediately following the Merger, the pre-Merger equity holders of Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. The exchange ratio formula is based upon an Elicio fixed valuation of $95 million and an Angion valuation of $50.1 million, subject to certain adjustments, including based upon Angion Net Cash at Closing, as more fully described in the section titled “The Merger Agreement—Merger Consideration and Exchange Ratio” beginning on page 135 of this proxy statement/prospectus/information statement. A $25 million Angion Net Cash threshold is a condition for Elicio to be required to complete the Merger (Net Cash Condition).
If Angion holds less than $26.5 million of net cash at the closing of the Merger, the equity holders of Angion (pre-Merger) are expected to hold less than 34.5% of the outstanding shares of Angion common stock on a fully diluted basis and if Angion holds more than $31.5 million of net cash at the closing of the Merger, the equity holders of Angion (pre-Merger) are expected to hold more than 34.5% of the outstanding shares of Angion common stock on a fully diluted basis, as more fully described in the section titled “The Merger Agreement—Merger Consideration and Exchange Ratio” beginning on page 135 of this proxy statement/prospectus/information statement.
At the Effective Time, Angion’s stockholders will continue to own and hold their existing shares of Angion common stock, subject to adjustment in connection with the Reverse Stock Split. All outstanding and unexercised options to purchase shares of Angion common stock will remain effective and outstanding. Each option to purchase shares of Elicio common stock that is outstanding and unexercised immediately prior to the Effective Time, whether or not vested, will be converted into an option to purchase shares of Angion common stock, with the number of Angion shares subject to such option and the exercise price being appropriately adjusted to reflect the exchange ratio. Each outstanding and unexercised warrant to purchase Elicio common stock immediately prior to the Effective Time will be converted into and become a warrant to purchase shares of Angion common stock. Substantially concurrently with the completion of the Merger, Angion will change its corporate name to “Elicio Therapeutics, Inc.” as required by the Merger Agreement.
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Q:
When will the Exchange Ratio be final?
A:
Angion and Elicio will agree to an anticipated closing date at least 15 calendar days prior to the Angion special meeting of stockholders (the Anticipated Closing Date). At least ten calendar days prior to the Angion special meeting of stockholders, Angion will deliver to Elicio a schedule (Net Cash Schedule) setting forth the estimated calculation of Angion Net Cash as of the Anticipated Closing Date. For further details, see the section titled “The Merger Agreement—Calculation of Angion Net Cash” beginning on page 142 of this proxy statement/prospectus/information statement.
Q:
What will happen to Angion if, for any reason, the Merger does not close?
A:
If, for any reason, the Merger does not close, the board of directors of Angion (Angion Board) may elect to, among other things, continue the business of Angion, attempt to continue to sell or otherwise dispose of the various assets of Angion, dissolve and liquidate its assets or commence bankruptcy proceedings. Under certain circumstances, Angion may be obligated to pay Elicio a termination fee of either $1 million or $2 million and reimburse certain expenses of Elicio up to $500,000, as more fully described in the section titled “The Merger Agreement—Termination and Termination Fees” beginning on page 151 of this proxy statement/prospectus/information statement. If Angion decides to dissolve and liquidate its assets, Angion would be required to pay all of its debts and contractual obligations, and to set aside certain reserves for potential future claims. There can be no assurances as to the amount or timing of available cash left to distribute to stockholders after paying the debts and other obligations of Angion and setting aside funds for reserves.
Q:
Why are the two companies proposing to merge?
A:
The Merger will result in a clinical-stage biopharmaceutical company advancing Elicio’s proprietary lymph node-targeting Amphiphile (AMP) technology to develop immunotherapies, with a focus on ELI-002, a therapeutic cancer vaccine targeting mKRAS-driven tumors. For a discussion of Angion’s and Elicio’s reasons for the Merger, please see the section titled “The Merger—Angion Reasons for the Merger” beginning on page 108 of this proxy statement/prospectus/information statement and “The Merger—Elicio Reasons for the Merger” beginning on page 111 of this proxy statement/prospectus/information statement.
Q:
Why am I receiving this proxy statement/prospectus/information statement?
A:
You are receiving this proxy statement/prospectus/information statement because you have been identified as a holder of Angion common stock as of the record date, or a stockholder of Elicio eligible to execute the Elicio written consent. If you are a common stockholder of Angion, you are entitled to vote at the Angion special meeting, which has been called for the purpose of approving the following proposals:
1.
Proposal 1 - the issuance of shares of Angion capital stock pursuant to the Merger, which will represent more than 20% of the shares of Angion common stock outstanding immediately prior to the Merger and result in a change of control of Angion, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), referred to as the Stock Issuance Proposal;
2.
Proposal 2 - the amendment to the amended and restated certificate of incorporation of Angion to effect a reverse stock split of Angion common stock at a ratio within the range between 5-for-1 to 30-for-1 (with such ratio to be mutually agreed upon by Angion and Elicio prior to the effectiveness of the Merger or, if the Stock Issuance Proposal is not approved by Angion stockholders, at a ratio as determined solely by the Angion Board), referred to as the Reverse Stock Split Proposal;
3.
Proposal 3 - the amendment to the amended and restated certificate of incorporation of Angion to provide for the exculpation of officers, referred to as the Exculpation Proposal;
4.
Proposal 4 - the election of the Angion Board’s nominees, Itzhak Goldberg, M.D., F.A.C.R. and Allen R. Nissenson, M.D., to the Angion Board in the class of directors to hold office until the 2026 Annual Meeting of Stockholders, referred to as the Director Election Proposal;
5.
Proposal 5 - the ratification of the selection of Moss Adams LLP as Angion’s independent registered public accounting firm for the fiscal year ending December 31, 2023, referred to as the Accounting Firm Proposal; and
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6.
Proposal 6 - the postponement or adjournment of the Angion special meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of the Stock Issuance Proposal and/or the Reverse Stock Split Proposal, referred to as the Adjournment Proposal.
Angion does not expect that any matter other than these six proposals (the Angion Proposals) will be brought before the Angion special meeting.
If you are a stockholder of Elicio, you are requested to sign and return the Elicio written consent to (i) adopt the Merger Agreement and approve the transactions and actions contemplated by the Merger Agreement, including the Merger, (ii) acknowledge that your approval is irrevocable and that you are aware of your rights to demand appraisal for your shares pursuant to Section 262 of the DGCL and that you have received and read a copy of Section 262 of the DGCL, (iii) consent to conversion of Elicio’s preferred stock to Elicio common stock immediately prior to the closing of the Merger, if you are a Elicio preferred stockholder, and (iv) acknowledge that by your approval of the Merger you are not entitled to appraisal rights or dissenters’ rights with respect to your shares in connection with the Merger and thereby waive any rights to receive payment of the fair value of your capital stock under the DGCL (items (i) through (iv), collectively, the Elicio Stockholder Matters).
This document serves as: (x) a proxy statement of Angion used to solicit proxies for the Angion special meeting, (y) a prospectus of Angion used to offer shares of Angion common stock (i) in exchange for shares of Elicio capital stock in the Merger and (ii) upon exercise of the warrants to purchase shares of Elicio common stock assumed in the Merger in exchange for the warrants to purchase shares of Angion common stock and (z) an information statement of Elicio used to solicit the written consent of its stockholders for the adoption of the Merger Agreement and the approval of the Merger and related transactions after the declaration of the effectiveness of this Registration Statement, of which this proxy statement/prospectus/information statement is a part. Information about the Angion special meeting, the Merger, the Merger Agreement and the other business to be considered by Angion stockholders at the Angion special meeting, and by Elicio stockholders to consider in determining whether to sign and return the Elicio written consent, is contained in this proxy statement/prospectus/information statement. Angion stockholders and Elicio stockholders should read this information carefully and in its entirety. The enclosed voting materials allow Angion stockholders to vote their shares by proxy without attending the Angion special meeting.
Q:
What is required to consummate the Merger?
A:
To consummate the Merger, Angion’s common stockholders must approve the Required Angion Closing Stockholder Matters (Proposal Nos. 1 and 2 above) and Elicio’s stockholders must approve the Elicio Stockholder Matters.
Certain of Elicio’s stockholders and certain of Angion’s stockholders are parties to Support Agreements with Angion and Elicio whereby such stockholders have agreed, subject to the terms of the Support Agreements, to vote their shares (or execute a written consent) in favor of the Required Angion Closing Stockholder Matters or the Elicio Stockholder Matters, as applicable.
In addition to the requirement of obtaining stockholder approval of the Required Angion Closing Stockholder Matters and the Elicio Stockholder Matters, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived. For a complete description of the closing conditions under the Merger Agreement, refer to the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 139 of this proxy statement/prospectus/information statement.
In the event of a waiver of a condition, the Angion Board will evaluate the materiality of any such waiver to determine whether amendment of this proxy statement/prospectus/information statement and resolicitation of stockholder approval is necessary. For more information, refer to the section titled “Risk Factors Related to the Merger—Angion or Elicio may waive one or more of the conditions to the Merger without recirculation of this proxy statement/prospectus/information statement or resoliciting stockholder approval” beginning on page 25 of this proxy statement/prospectus/information statement.
Q:
What will Elicio’s stockholders, option holders and warrant holders receive in the Merger?
A:
Each share of Elicio capital stock outstanding will be converted into the right to receive a number of shares of Angion common stock calculated using the Exchange Ratio. Angion will assume outstanding and unexercised options to purchase shares of Elicio capital stock, and in connection with the Merger such options will be converted into options
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to purchase shares of Angion common stock, with the number of Angion shares subject to such option and the exercise price being appropriately adjusted to reflect the Exchange Ratio. Each outstanding and unexercised warrant to purchase Elicio common stock immediately prior to the Effective Time will be converted into and become a warrant to purchase shares of Angion common stock, adjusted to reflect the Exchange Ratio and treated in accordance with the terms thereof. For a more complete description of what Elicio’s stockholders and option holders will receive in the Merger, please see the section titled “The Merger Agreement—Merger Consideration and Exchange Ratio” beginning on page 135 of this proxy statement/prospectus/information statement.
Q:
What will Angion’s stockholders and option holders receive in the Merger?
A:
At the Effective Time, Angion’s stockholders will continue to own and hold their existing shares or options to purchase shares of Angion common stock.
Q:
Who will be the directors of Angion following the Merger?
A:
At the Effective Time, the combined company is expected to initially have a nine-member board of directors, comprising (a) Robert Connelly, Julian Adams, Ph.D., Carol Ashe, Yekaterina (Katie) Chudnovsky, Daphne Karydas, and Assaf Segal, each as an Elicio designee and (b) Jay Venkatesan, M.D., MBA, Karen J. Wilson, and Allen R. Nissenson, M.D., each as an Angion designee, until their respective successors are duly elected or appointed and qualified or their earlier death, resignation or removal. The aforementioned board of directors will have an audit committee, a compensation committee and a nominating and corporate governance committee, in accordance with the rules of Nasdaq. All of Angion’s current directors other than Dr. Venkatesan, Karen J. Wilson, and Allen R. Nissenson, M.D. are expected to resign from their positions as directors of Angion, effective upon the Effective Time.
Q:
Who will be the executive officers of Angion following the Merger?
A:
Immediately following the Merger, the executive management team of the combined company is expected to comprise the following individuals with such additional officers as may be added by Elicio or the combined company:
Name
Position with the Combined Company
Current Position at Elicio
Robert Connelly
Chief Executive Officer, President and Director
Chief Executive Officer
 
 
 
Daniel Geffken
Interim Chief Financial Officer
Interim Chief Financial Officer
 
 
 
Christopher Haqq, M.D., Ph.D.
Executive Vice President, Head of Research and Development and Chief Medical Officer
Executive Vice President, Head of Research and Development and Chief Medical Officer
 
 
 
Annette Matthies, Ph.D.
Chief Business Officer
Chief Business Officer
 
 
 
Peter DeMuth, Ph.D.
Chief Scientific Officer
Chief Scientific Officer
Q:
As a stockholder of Angion, how does the Angion Board recommend that I vote?
A:
After careful consideration, the Angion Board unanimously recommends that the holders of Angion common stock vote:
FOR” Proposal 1 - the Stock Issuance Proposal;
FOR” Proposal 2 - the Reverse Stock Split Proposal;
FOR” Proposal 3 - the Exculpation Proposal.
FOR” Proposal 4 - the election of the Angion Board’s nominees in the Director Election Proposal;
FOR” Proposal 5 - the Accounting Firm Proposal; and
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FOR” Proposal 6 - the Adjournment Proposal.
For more information on each proposal and the Angion Board’s recommendations, please see the section titled “Matters Being Submitted to a Vote of Angion’s Stockholders” beginning on page 166 of this proxy statement/prospectus/information statement.
Q:
How many votes are needed to approve each proposal?
A:
Approval of each of the Stock Issuance Proposal, the Accounting Firm Proposal, and the Adjournment Proposal requires the affirmative vote of the holders of a majority of the voting power of the shares outstanding on the record date for the Angion special meeting present in person, by remote communication, or represented by proxy at the meeting and voting affirmatively or negatively (excluding abstentions and broker non-votes) on this matter.
Approval of each of the Reverse Stock Split Proposal and the Exculpation Proposal requires the affirmative vote of the holders of a majority of the Angion common stock outstanding on the record date for the Angion special meeting. Abstentions and broker non-votes, if any, will have the same effect as “Against” votes.
With respect to the Director Election Proposal, directors are elected by a plurality of the affirmative votes cast in person or by proxy at the Angion special meeting, and the two nominees for director receiving the highest number of affirmative votes will be elected. Only votes “For” will affect the outcome of the vote; “Withhold” votes and broker non-votes will have no effect on the outcome of the vote.
Q:
As a stockholder of Elicio, how does the board of directors of Elicio recommend that I vote?
A:
After careful consideration, the Elicio Board unanimously recommends that the Elicio stockholders execute the written consent indicating their vote in favor of the Elicio Stockholder Matters.
Q:
What risks should I consider in deciding whether to vote in favor of the Angion Proposals or to execute and return the written consent, as applicable?
A:
You should carefully review the section of the proxy statement/prospectus/information statement titled “Risk Factors,” which sets forth certain risks and uncertainties related to the Merger, risks and uncertainties to which the combined company’s business will be subject, and risks and uncertainties to which each of Angion and Elicio, as an independent company, is subject.
Q:
When do you expect the Merger to be consummated?
A:
We anticipate that the Merger will be consummated during the second quarter of 2023, soon after the Angion special meeting to be held on    , 2023 but we cannot predict the exact timing. For more information, please see the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 139 of this proxy statement/prospectus/information statement.
Q:
What are the material U.S. federal income tax consequences of the Merger to U.S. holders of Elicio shares?
A:
Angion and Elicio intend the Merger to qualify as a reorganization within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (Code), as described in the section titled “The Merger—Material U.S. Federal Income Tax Consequences of the Merger” beginning on page 128 of this proxy statement/prospectus/information statement. If the Merger so qualifies, Elicio stockholders who are U.S. holders (as defined in the section titled “The Merger—Material U.S. Federal Income Tax Consequences of the Merger” beginning on page 128 of this proxy statement/prospectus/information statement) generally will not recognize gain or loss for U.S. federal income tax purposes on the receipt of shares of Angion common stock issued in connection with the Merger. Each Elicio stockholder who is a U.S. holder who receives cash in lieu of a fractional share of Angion common stock generally will recognize capital gain or loss in an amount equal to the difference between the amount of cash received in lieu of such fractional share and such Elicio stockholder’s tax basis allocable to such fractional share.
If the Merger does not qualify as a reorganization within the meaning of Section 368(a) of the Code, then each Elicio stockholder who is a U.S. holder will generally recognize capital gain or loss for U.S. federal income tax purposes on the receipt of shares of Angion common stock issued in connection with the Merger, as well as on
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any cash such Elicio stockholder receives in lieu of a fractional share of Angion common stock. The tax consequences to each Elicio stockholder will depend on that stockholder’s particular circumstances. Each Elicio stockholder should consult with his, her or its tax advisor for a full understanding of the tax consequences of the Merger to that Elicio stockholder.
Q:
What are the material U.S. federal income tax consequences of the Reverse Stock Split to U.S. holders of Angion shares?
A:
Angion intends to treat the Reverse Stock Split as a “recapitalization” for U.S. federal income tax purposes. If it so qualifies, an Angion stockholder who is a U.S. holder (as defined in the section titled “Matters Being Submitted to a Vote of Angion’s Stockholders—Proposal No. 2: Approval of an Amendment to the Amended and Restated Certificate of Incorporation of Angion Effecting the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split” beginning on page 167 of this proxy statement/prospectus/information statement) should not recognize gain or loss upon the Reverse Stock Split (other than in respect of cash received in lieu of fractional shares). A U.S. holder’s aggregate tax basis in the shares of Angion common stock received pursuant to the Reverse Stock Split should equal the aggregate tax basis of the shares of Angion common stock surrendered (excluding any portion of such basis that is allocated to any fractional share of Angion common stock), and such U.S. holder’s holding period in the shares of Angion common stock received should include the holding period in the shares of Angion common stock surrendered. Treasury Regulations provide detailed rules for allocating the tax basis and holding period of the shares of Angion common stock surrendered to the shares of Angion common stock received in a “recapitalization”. U.S. holders of shares of Angion common stock acquired on different dates and at different prices should consult their tax advisors regarding the allocation of the tax basis and holding period of such shares.
Please review the information in the section titled “Matters Being Submitted to a Vote of Angion’s Stockholders—Proposal No. 2: Approval of an Amendment to the Amended and Restated Certificate of Incorporation of Angion Effecting the Reverse Stock Split—Material U.S. Federal Income Tax Consequences of the Reverse Stock Split” beginning on page 171 of this proxy statement/prospectus/information statement for a more complete description of the material U.S. federal income tax consequences of the Reverse Stock Split to Angion U.S. holders.
Q:
What do I need to do now?
A:
Angion and Elicio urge you to read this proxy statement/prospectus/information statement carefully, including its annexes and information incorporated herein, and to consider how the Merger affects you.
If you are a common stockholder of Angion, please vote your shares as soon as possible so that your shares will be represented at the Angion special meeting. Please follow the instructions set forth on the enclosed Angion proxy card or on the voting instruction form provided by the record holder of your shares if your shares are held in the name of your bank, broker or other nominee.
If you are a stockholder of Elicio, you may execute and return your written consent to Elicio in accordance with the instructions provided by Elicio once this Registration Statement is declared effective by the SEC.
Q:
When and where is the Angion special meeting? What must I do to attend the Angion special meeting?
A:
The Angion special meeting will be held exclusively online via live audio-only webcast on    , 2023 at 9:00 a.m. Pacific Time. Online check-in will begin at 8:45 a.m. Pacific Time, and Angion encourages you to allow ample time for the online check-in procedures. Please note that you will not be able to attend the Angion special meeting in person.
You or your authorized proxy may attend the Angion special meeting if you were a registered or beneficial stockholder of Angion common stock as of the record date.
You will be able to vote your shares and submit questions during the Angion special meeting webcast by logging in to the website listed above using the 16-digit control number included in your proxy card. If you wish to submit a question during the Angion special meeting, log into the Angion special meeting platform at www.virtualshareholdermeeting.com/ANGN2023SM, type your question into the “Ask a Question” field, and click “Submit.” Angion will respond to as many properly submitted questions during the relevant portion of the Angion special meeting agenda as time allows.
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If Angion experiences technical difficulties during the Angion special meeting (e.g., a temporary or prolonged power outage), Angion will determine whether the Angion special meeting can be promptly reconvened (if the technical difficulty is temporary) or whether the Angion special meeting will need to be reconvened on a later day (if the technical difficulty is more prolonged). In any situation, Angion will promptly notify stockholders of the decision via www.virtualshareholdermeeting.com/ANGN2023SM. Angion will have technicians ready to assist you with any technical difficulties you may have accessing the Angion special meeting website. If you encounter any difficulties accessing the Angion special meeting website during the check-in or meeting time, please call the technical support number that will be posted on the Angion special meeting website log-in page at www.virtualshareholdermeeting.com/ANGN2023SM.
If you own shares in street name through an account with a bank, broker or other nominee, please send proof of your Angion share ownership as of the record date (for example, a brokerage firm account statement or a “legal proxy” from your intermediary) along with your registration request. If you are not sure what proof to send, check with your intermediary.
If your shares are registered in your name with Angion’s stock registrar and transfer agent, Continental Stock Transfer & Trust Company, no proof of ownership is necessary because Angion can verify your ownership.
Q:
How are votes counted?
A:
Votes will be counted by the inspector of elections appointed for the meeting, who will separately count votes “FOR” and “AGAINST,” abstentions and, if applicable, broker non-votes.
Angion does not expect that any matters other than the Angion Proposals will be brought before the Angion special meeting.
Q:
What are “broker non-votes”?
A:
Brokers who hold shares in street name for customers have the authority to vote on “routine” proposals when they have not received instructions from beneficial owners. However, brokers are precluded from exercising their voting discretion with respect to approval of non-routine matters, and, as a result, absent specific instructions from the beneficial owner of such shares, brokers are not empowered to vote those shares, referred to generally as “broker non-votes.” Broker non-votes, if any, will be treated as shares that are present at the Angion special meeting for purposes of determining whether a quorum exists but will not have any effect for the purpose of voting on Proposal No. 1 (Stock Issuance Proposal), Proposal No. 4 (Director Election Proposal), Proposal No. 5 (Accounting Firm Proposal) and Proposal No. 6 (Adjournment Proposal). Broker non-votes, if any, will have the same effect as “AGAINST” votes for Proposal No. 2 (Reverse Stock Split Proposal) and Proposal No. 3 (Exculpation Proposal).
Q:
What will happen if I return my proxy form without indicating how to vote?
A:
If you submit your proxy form without indicating how to vote your shares on any particular proposal, the common stock represented by your proxy will be voted as recommended by the Angion Board with respect to that proposal.
Q:
May I change my vote after I have submitted a proxy or voting instruction form?
A:
Angion’s common stockholders of record, other than those Angion stockholders who are parties to voting agreements, may change their vote at any time before their proxy is voted at the Angion special meeting in one of following ways:
By sending a written notice to the Secretary of Angion stating that it would like to revoke its proxy.
By duly executing a subsequently dated proxy relating to the same shares of common stock and return it in the postage-paid envelope provided or similar means, which subsequent proxy is received before the prior proxy is exercised at the Angion special meeting;
Duly submitting a subsequently dated proxy relating to the same shares of common stock by telephone or via the Internet (i.e., your most recent duly submitted voting instructions will be followed) before 11:59 p.m. Eastern Time on    , 2023; and
By attending the Angion special meeting and voting such shares during the Angion special meeting.
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If a stockholder who owns Angion shares in “street name” has instructed a broker to vote its shares of Angion common stock, the stockholder must follow directions received from its broker to change those instructions.
Q:
Who is paying for this proxy solicitation?
A:
Angion will pay for the cost of printing and filing of this proxy statement/prospectus/information statement and the proxy card. Arrangements will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of Angion common stock for the forwarding of solicitation materials to the beneficial owners of Angion common stock. Angion will reimburse these brokers, custodians, nominees and fiduciaries for the reasonable out-of-pocket expenses they incur in connection with the forwarding of solicitation materials. In addition, Angion has engaged Mackenzie Partners, Inc., a proxy solicitation firm, to solicit proxies from Angion’s stockholders for a fee of up to $9,500 plus certain additional costs associated with solicitation campaigns. Fees paid to the SEC in connection with filing the statement/prospectus/information statement, and any amendments and supplements thereto, with the SEC will be paid by Angion.
Q:
What is the quorum requirement?
A:
A quorum of stockholders is necessary to hold a valid meeting. The presence at the Angion special meeting, virtually or represented by proxy, of the holders of a majority of the voting power of the stock issued, outstanding and entitled to vote thereat, as of the record date, will constitute a quorum for the transaction of business at the Angion special meeting.
Your shares will be counted towards the quorum if you submit a valid proxy (or one is submitted on your behalf by your broker, bank or other nominee) or if you attend the Angion special meeting and vote your shares during the Angion special meeting. Abstentions and broker non-votes, if applicable, will also be counted towards the quorum requirement. If there is no quorum, the person presiding over the Angion special meeting, or the holders of a majority of shares present at the Angion special meeting or represented by proxy, may adjourn the meeting to another date.
Q:
Should Angion’s and Elicio’s stockholders send in their stock certificates now, to the extent they have any?
A:
No. After the Merger is consummated, Elicio’s stockholders will receive written instructions from the exchange agent for exchanging their certificates representing shares of Elicio capital stock for certificates representing shares of Angion common stock. Each Elicio stockholder who otherwise would be entitled to receive a fractional share of Angion common stock will be entitled to receive an amount in cash, without interest, determined by multiplying such fraction by the volume-weighted average closing trading price of a share of Angion common stock on Nasdaq for the five consecutive trading days ending five trading days immediately prior to the date upon which the Merger becomes effective.
In addition, Angion’s stockholders will receive written instructions, as applicable, from Angion’s transfer agent, Continental Stock Transfer & Trust Company, for exchanging their certificates representing shares Angion common stock for new certificates giving effect to the Reverse Stock Split, if effected. Angion’s stockholders will also receive a cash payment in lieu of any fractional shares, determined by multiplying such fraction by the fair market value per share of Angion common stock immediately prior to the effective time of the Reverse Stock Split as determined by the Angion Board.
Q:
Who can help answer my questions?
A:
If you are a stockholder of Angion and would like additional copies, without charge, of this proxy statement/prospectus/information statement or if you have questions about the Merger, including the procedures for voting your shares, you should contact Mackenzie Partners, Inc., Angion’s proxy solicitor, by telephone, toll-free, at 1-800-322-2885 (toll-free), 212-929-5500 (call collect) or by email at Angion@mackenziepartners.com.
If you are a stockholder of Elicio, and would like additional copies, without charge, of this proxy statement/prospectus/information statement or if you have questions about the Merger, including the procedures for voting your shares, you should contact:
451 D Street, 5th Floor, Suite 501
Boston, Massachusetts 02210
(857) 209-0050
Attention: Chief Executive Officer
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PROSPECTUS SUMMARY
This summary highlights selected information from this proxy statement/prospectus/information statement and may not contain all of the information that is important to you. To better understand the Merger, the proposals being considered at the Angion special meeting and Elicio’s stockholder actions that are the subject of the written consent, you should read this entire proxy statement/prospectus/information statement carefully, including the Merger Agreement attached as Annex A and the other annexes to which you are referred herein. For more information, please see the section titled “Where You Can Find More Information” beginning on page 307 of this proxy statement/prospectus/information statement.
The Companies
Angion Biomedica Corp.
7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
Angion is a biopharmaceutical company that has focused on the discovery, development and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases. Angion was incorporated in Delaware in 1998.
Angion’s product candidates and programs include ANG-3070, a highly selective oral tyrosine kinase receptor inhibitor (TKI) in development as a treatment for fibrotic diseases, a Rho Associated Coiled-Coil Containing Protein Kinase 2 (ROCK2) preclinical program targeted towards the treatment of fibrotic diseases, a Cytochrome P450 Family 11 Subfamily B Member 2 (CYP11B2) preclinical program targeted towards diseases related to aldosterone synthase dysregulation, and a CYP26 (retinoic acid metabolism) inhibitor program targeted towards a number of indications, including cancer.
Angion has suspended clinical development activities and does not have any products approved for sale. In July 2022, Angion took steps to conserve cash resources and cut operating expenses, reducing its workforce significantly while evaluating strategic alternatives. Strategic alternatives were evaluated with a goal to enhance stockholder value, including the possibility of a merger or sale of Angion. On January 17, 2023, Angion announced the entry into the Merger Agreement.
Elicio Therapeutics, Inc.
451 D Street, 5th Floor, Suite 501,
Boston, MA 02210
(857) 209-0050
Elicio is a clinical-stage biotechnology company pioneering the development of therapeutic cancer vaccines for patients with limited treatment options and poor outcomes. Through its AMP platform technology, Elicio’s goal is to re-engineer the body’s immune response to defeat diseases using potent lymph node targeted vaccines and immunotherapies.
Elicio’s proprietary AMP technology precisely traffics immuno-modulatory molecules to the lymph nodes, the “schoolhouse” of the immune system, enhancing the magnitude, potency, functionality, and durability of the immune response. The lymph nodes are a primary site in the body where most immune cells are located. The lymph nodes are where the immune system naturally collects information about health and disease in order to orchestrate the mechanisms of immunity which protect us from pathogens and tumors. By efficiently targeting these sites within the body we are taking advantage of the power and the unique biology of the lymph nodes to improve responses across a broad range of diseases. Elicio’s is utilizing its lymph-node targeting technology to build a pipeline of therapeutic cancer vaccines, which will be the focus of Elicio. Other applications of the AMP technology, such as infectious disease (ID) vaccines and immune cell therapies, will be developed through partnerships.
Elicio’s core business is the development of therapeutic cancer vaccines. ELI-002, its lead clinical program, is designed to stimulate an immune response against the Kirsten rat sarcoma virus (KRAS) mutations driving 25% of solid tumors. ELI-002 is currently being studied in AMPLIFY-201 in patients with mutant (m)KRAS-driven Pancreatic ductal adenocarcinoma (PDAC) and Colorectal cancer (CRC).
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Arkham Merger Sub, Inc.
7-57 Wells Avenue
Newton, Massachusetts 02459
(857) 336-4001
Merger Sub is a wholly-owned subsidiary of Angion and was formed solely for the purposes of carrying out the Merger.
The Merger (see page 100)
On January 17, 2023, Angion, Merger Sub, and Elicio entered into the Merger Agreement, pursuant to which Merger Sub will merge with and into Elicio, with Elicio surviving as a wholly owned subsidiary of Angion. Angion common stock will be issued to the stockholders of Elicio at the Effective Time and Angion will assume each Elicio option and warrant which will become options and warrants to purchase Angion common stock at the Effective Time. In connection with the Closing, Angion will change its name to “Elicio Therapeutics, Inc.” References to the combined company in this proxy statement/prospectus/information statement are references to Angion and its consolidated subsidiaries following the Merger and references to the surviving company are to Elicio following the Merger.
Angion and Elicio expect the Merger to be consummated during the second quarter of 2023, subject to satisfaction or waiver of certain conditions to the Closing, including, among other things, approval by Angion’s stockholders of the Stock Issuance Proposal and the Reverse Stock Split Proposal (collectively, the Required Angion Closing Stockholder Matters).
Immediately following the Merger, the pre-Merger equity holders of Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. The Net Cash Condition means that Angion Net Cash must be no less than $25 million in order for Elicio to be required to complete the Merger. For a more complete description of the Merger and the potential adjustments in the Exchange Ratio, please see the section titled “The Merger Agreement—Merger Consideration and Exchange Ratio.”
Reasons for the Merger (see page 108)
The Angion Board considered various reasons for the Merger, as described later in this proxy statement under the section titled “The Merger—Angion Reasons for the Merger.”
Opinion of Angion’s Financial Advisor (see page 112)
Angion engaged Oppenheimer to serve as a financial advisor to Angion in connection with reviewing and considering other potential strategic transaction opportunities, including the proposed Merger. At the January 13, 2023 meeting of the Angion Board, representatives of Oppenheimer rendered Oppenheimer’s oral opinion, which was subsequently confirmed by delivery of a written opinion to the Angion Board dated January 13, 2023, as to the fairness, as of such date, from a financial point of view, to Angion of the Exchange Ratio in the Merger pursuant to the Merger Agreement, based upon and subject to the assumptions made, procedures followed, matters considered and qualifications and limitations on the scope of the review undertaken by Oppenheimer in connection with the preparation of its opinion.
The full text of the written opinion of Oppenheimer, dated January 13, 2023, which sets forth, among other things, the various assumptions made, procedures followed, matters considered and qualifications and limitations on the scope of the review undertaken, is attached as Annex B to this document. Oppenheimer provided its opinion for the information and assistance of the Angion Board (in its capacity as such) in connection with, and for purposes of, its consideration of the Merger, and its opinion only addresses whether the Exchange Ratio in the Merger pursuant to the Merger Agreement was fair, from a financial point of view, to Angion. The opinion of Oppenheimer did not address any other term or aspect of the Merger Agreement or the Merger. The Oppenheimer opinion does not constitute a recommendation to the Angion Board or any holder of Angion’s common stock as to how the Angion Board, such stockholder or any other person should vote or otherwise act with respect to the Merger or any other matter, or whether to enter into a support agreement with either Angion or Elicio.
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Merger Consideration and Exchange Ratio (see page 135)
Pursuant to the Merger Agreement, at the Effective Time, each share of Elicio capital stock outstanding immediately prior to the Effective Time and after giving effect to the Preferred Stock Conversion will be automatically converted solely into the right to receive a number of shares of Angion common stock equal to the Exchange Ratio.
No fractional shares of Angion common stock will be issued in connection with the Merger, and no certificates or scrip for any such fractional shares will be issued. Any holder of Elicio capital stock who would otherwise be entitled to receive a fraction of a share of Angion common stock (after aggregating all fractional shares of Angion common stock issuable to such holder) will, in lieu of such fraction of a share and upon such holder’s surrender of a letter of transmittal in accordance with the Merger Agreement and any accompanying documentation required therein, be paid in cash the dollar amount (rounded up to the nearest whole cent), without interest, determined by multiplying such fraction by the volume weighted average closing trading price of a share of Angion common stock (Angion Closing Price) on Nasdaq for the five consecutive trading days ending three trading days immediately prior to the date of the public announcement of the Merger Agreement, which is equal to $0.9110.
The Exchange Ratio formula is derived based upon an Elicio fixed valuation of $95 million and an Angion valuation of $50.1 million, subject to certain adjustments, including based upon Angion Net Cash at Closing. The calculation of Angion Net Cash at Closing includes, among other things, a credit for cash proceeds Angion receives from the sale, transfer, license, assignment or other divestiture of its intellectual property and other assets and technology in existence on the date of the Merger Agreement prior to or substantially concurrently with the Closing and a reduction for certain liabilities. The Net Cash Condition means that Angion Net Cash must be no less than $25 million in order for Elicio to be required to complete the Merger.
Immediately following the Merger, the pre-Merger equity holders of Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million.
For a more complete description of the Merger, the potential adjustments in the Exchange Ratio and the calculation of Angion Net Cash, please see the section titled “The Merger Agreement —Merger Consideration and Exchange Ratio.
Treatment of Elicio Stock Options (see page 138)
Under the terms of the Merger Agreement, each option to purchase shares of Elicio common stock that is outstanding and unexercised immediately prior to the Effective Time, whether or not vested, will be converted into an option to purchase shares of Angion common stock. Angion will assume the Elicio’s 2022 Equity Incentive Plan and Elicio’s 2012 Equity Incentive Plan (together, the Elicio Plans), and all rights with respect to each outstanding option to purchase Elicio common stock in accordance with its terms and the terms of the stock option agreement by which such option is evidenced.
Accordingly, from and after the Effective Time: (i) each outstanding Elicio stock option assumed by Angion may be exercised solely for shares of Angion common stock; (ii) the number of shares of Angion common stock subject to each outstanding Elicio stock option assumed by Angion will be determined by multiplying (A) the number of shares of Elicio common stock that were subject to such Elicio stock option, as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio, and rounding the resulting number down to the nearest whole number of shares of Angion common stock; (iii) the per share exercise price for the Angion common stock issuable upon exercise of each Elicio stock option assumed by Angion will be determined by dividing (A) the per share exercise price of Angion common stock subject to such Elicio stock option, as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio and rounding the resulting exercise price up to the nearest whole cent; and (iv) any restriction on the exercise of any Elicio stock option assumed by Angion will continue in full force and effect and the term, exercisability, vesting schedule, accelerated vesting provisions, and any other provisions of such Elicio stock option will otherwise remain unchanged; provided, however, that the Angion Board or a committee thereof will succeed to the authority and responsibility of the board of directors of Elicio or any committee thereof with respect to each Elicio stock option assumed by Angion.
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Treatment of Elicio Warrants (see page 138)
Under the terms of the Merger Agreement, each warrant to purchase shares of Elicio common stock that is outstanding and unexercised immediately prior to the Effective Time, will be converted into and become a warrant to purchase shares of Angion common stock and Angion will assume each Elicio warrant in accordance with its terms.
Accordingly, from and after the Effective Time: (i) each outstanding Elicio warrant assumed by Angion may be exercised solely for shares of Angion common stock; (ii) the number of shares of Angion common stock subject to each outstanding Elicio warrant assumed by Angion will be determined by multiplying (A) the number of shares of Elicio common stock, or the number of shares of Elicio preferred stock issuable upon exercise of the Elicio warrant, as applicable, that were subject to such Elicio warrant, as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio, and rounding the resulting number down to the nearest whole number of shares of Angion common stock; (iii) the per share exercise price for the Angion common stock issuable upon exercise of each Elicio warrant assumed by Angion will be determined by dividing (A) the per share exercise price of Angion common stock subject to such Elicio warrant as in effect immediately prior to the Effective Time, by (B) the Exchange Ratio and rounding the resulting exercise price up to the nearest whole cent; and (iv) any restriction on the exercise of any Elicio warrant assumed by Angion will continue in full force and effect and the term and other provisions of such Elicio warrant will otherwise remain unchanged.
Conditions to the Completion of the Merger (see page 139)
The obligations to consummate the Merger and the other transactions and actions contemplated by the Merger Agreement (collectively, the Contemplated Transactions) are subject to the satisfaction or waiver, on or prior to the Effective Time, of the conditions set forth in the section titled “The Merger Agreement—Conditions to the Completion of the Merger” below.
Non-Solicitation (see page 144)
Capitalized terms in this section are as defined in the section titled “Merger Agreement—Non-Solicitation.”.
Angion and Elicio and their respective subsidiaries are prohibited by the terms of the Merger Agreement, other than, in the case of Angion, with respect to any Asset Disposition (as defined below), from, directly or indirectly, (i) soliciting, initiating or knowingly encouraging, inducing or facilitating the communication, making, submission or announcement of any Acquisition Proposal (as defined below) or Acquisition Inquiry (as defined below) or taking any action that could reasonably be expected to lead to an Acquisition Proposal or Acquisition Inquiry; (ii) furnishing any non-public information regarding such party to any person in connection with or in response to an Acquisition Proposal or Acquisition Inquiry; (iii) engaging in discussions or negotiations with any person with respect to any Acquisition Proposal or Acquisition Inquiry; (iv) approving, endorsing or recommending any Acquisition Proposal; (v) executing or entering into any letter of intent or any contract contemplating or otherwise relating to any Acquisition Transaction (as defined below) (other than, in the case of Angion, a confidentiality agreement permitted as described below); or (vi) publicly proposing to do any of the foregoing.
Subject to certain restrictions and prior to obtaining the approval of the Required Angion Closing Stockholder Matters by the Required Angion Stockholder Vote (as defined below), Angion and its subsidiaries may furnish non-public information regarding Angion or any of its subsidiaries to, and enter into discussions or negotiations with, any person in response to a bona fide Acquisition Proposal by such person, which the Angion Board determines in good faith, after consultation with its outside financial advisor and outside legal counsel, constitutes, or is reasonably likely to result in, a Superior Offer (as defined below) (and is not withdrawn) if: (A) none of Angion, any of its subsidiaries or any of their respective representatives have breached the non-solicitation restrictions in the Merger Agreement in any material respect, (B) the Angion Board concludes in good faith, based on the advice of outside legal counsel, that the failure to take such action is reasonably likely to be inconsistent with the fiduciary duties of the Angion Board under applicable law; (C) substantially contemporaneously with furnishing any such nonpublic information to such person, Angion gives Elicio notice of Angion’s intention to furnish nonpublic information to or enter into discussions with, such person and furnishes such nonpublic information to Elicio (to the extent such information has not been previously furnished to Elicio), and (D) Angion receives from such person an executed confidentiality agreement containing provisions (including nondisclosure provisions, use restrictions, non-solicitation provisions, no hire and “standstill” provisions), in the aggregate, at least as favorable to it as those contained in the confidentiality agreement entered into between Angion and Elicio in connection with the Merger.
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For a more complete description of the non-solicitation provisions, please see the section titled “The Merger Agreement—Non-Solicitation.”
Termination and Termination Fees (see page 151)
Capitalized Terms are as defined in the section titled “Merger Agreement—Termination and Termination Fees.
The Merger Agreement contains certain customary termination rights, including the right of Angion to terminate the Merger Agreement if the Elicio Stockholder Written Consent (as defined below) has not been obtained within three business days of the date of the Registration Statement becoming effective, the right of Angion or Elicio to terminate the Merger Agreement if Angion’s stockholders fail to adopt and approve the Required Angion Closing Stockholder Matters, the right of Elicio to terminate the Merger Agreement if the Angion Board changes or withdraws its recommendation in favor of the Required Angion Closing Stockholder Matters or approves or enters into an agreement relating to an Acquisition Proposal and the right of Angion to terminate the Merger Agreement under certain circumstances to enter into an agreement relating to a Superior Offer.
Upon termination of the Merger Agreement by Elicio or Angion in certain circumstances, a termination fee of $1 million may be payable by Elicio to Angion or by Angion to Elicio. Additionally, in the event of a termination under certain circumstances, including a termination of the Merger Agreement by Angion to enter into an agreement relating to a Superior Offer, a termination fee of $2 million or $1 million may be payable by Angion to Elicio. Angion has agreed to reimburse Elicio for up to $500,000 in expenses if the Merger Agreement is terminated due to the failure to obtain the approval of the Required Angion Closing Stockholder Matters from Angion’s stockholders, if the Net Cash Condition (as defined below) is not satisfied as of the End Date (as defined below) or in the event of the failure of Elicio to consummate the Contemplated Transactions (as defined below) solely as a result of an Angion Material Adverse Effect (as defined below). Elicio has agreed to reimburse Angion for up to $500,000 in expenses if the Merger Agreement is terminated due to a breach or inaccuracy of any representation, warranty, covenant or agreement by Elicio or in the event of the failure of Elicio to consummate the Contemplated Transactions solely as a result of an Elicio Material Adverse Effect.
For a more complete description of the termination provisions and termination fees, please see the section titled “The Merger Agreement—Termination and Termination Fees.”
Support Agreements (see page 156)
Concurrently with the execution of the Merger Agreement, executive officers, directors and stockholders of Angion entered into support agreements (Angion Support Agreements) in favor of Elicio relating to the Merger. The Angion Support Agreements provide, among other things, that such officers, directors and stockholders will vote all of their shares of Angion common stock: (i) in favor of adopting the Merger Agreement and approving the Merger, the Required Angion Closing Stockholder Matters, and the other Contemplated Transactions, (ii) against any proposal made in opposition to, or in competition with, the Merger Agreement or the Merger and (iii) against any acquisition proposal involving a third party.
Concurrently with the execution of the Merger Agreement, executive officers, directors and stockholders of Elicio entered into support agreements (Elicio Support Agreements, together with the Angion Support Agreements, the Support Agreements) in favor of Angion relating to the Merger. The Elicio Support Agreements provide, among other things, that such executive officers, directors and stockholders vote all of their shares of Elicio capital stock: (i) in favor of adopting the Merger Agreement and approving the Merger, the Elicio Stockholder Matters, and the other Contemplated Transactions, (ii) against any proposal made in opposition to, or in competition with, the Merger Agreement or the Merger and (iii) against any acquisition proposal involving a third party.
Lock-Up Agreements (see page 156)
Concurrently with the execution of the Merger Agreement, (i) certain executive officers, directors, and stockholders of Elicio and (ii) certain directors of Angion, entered into lock-up agreements (Lock-Up Agreements), pursuant to which such persons accepted certain restrictions on transfers of the shares of Angion common stock held by such persons for the 180-day period following the Effective Time.
Bridge Loan (see page 156)
In connection with execution of the Merger Agreement, Angion made a bridge loan to Elicio pursuant to a note purchase agreement (Note Purchase Agreement) and promissory notes (Notes) up to an aggregate principal amount of $12.5 million, issued with a 20% original issue discount, with an initial closing held substantially concurrently
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with the execution of the Merger Agreement for a principal amount of $6.25 million on account of a $5.0 million loan and an additional closing for a principal amount of $6.25 million on account of a $5.0 million loan upon delivery by Elicio to Angion of Elicio’s audited financial statements for the year ended December 31, 2022.
For a description of the Note Purchase Agreement and the Notes, please see the section titled “Agreements Related to the Merger—Bridge Loan.
Appraisal Rights (see page 148)
Angion stockholders are not entitled to appraisal rights in connection with the Merger. Holders of Elicio common stock are entitled to appraisal rights in connection with the Merger under Section 262 of the DGCL. For more information about such rights, please see the provisions of Section 262 of the DGCL attached as Annex C and the section titled “The Merger Agreement—Appraisal Rights and Dissenters’ Rights” beginning on page 148 of this proxy statement/prospectus/information statement.
Management Following the Merger (see page 263)
Immediately following the Merger, the executive management team of the combined company is expected to comprise the following individuals with such additional officers as may be added by Elicio or the combined company:
Name
Position with the Combined Company
Current Position at Elicio
Robert Connelly
Chief Executive Officer, President and Director
Chief Executive Officer
Daniel Geffken
Interim Chief Financial Officer
Interim Chief Financial Officer
Christopher Haqq, M.D., Ph.D.
Executive Vice President, Head of Research and Development and Chief Medical Officer
Executive Vice President, Head of Research and Development and Chief Medical Officer
Annette Matthies, Ph.D.
Chief Business Officer
Chief Business Officer
Peter DeMuth, Ph.D.
Chief Scientific Officer
Chief Scientific Officer
Directors of the Combined Company Following the Merger
At the Effective Time, the combined company is expected to initially have a nine-member board of directors, comprised of (a) Robert Connelly, Julian Adams, Ph.D., Carol Ashe, Yekaterina (Katie) Chudnovsky, Daphne Karydas, and Assaf Segal each as an Elicio designee and (b) Jay Venkatesan, M.D., MBA, Karen J. Wilson, and Allen R. Nissenson, M.D., each as an Angion designee, until their respective successors are duly elected or appointed and qualified or their earlier death, resignation or removal.
The aforementioned board of directors will have an audit committee, a compensation committee and a nominating and corporate governance committee, in accordance with the Nasdaq rules. All of Angion’s current directors, other than Dr. Venkatesan, Karen J. Wilson and Allen R. Nissenson, M.D., are expected to resign from their positions as directors of Angion, effective as of the Effective Time.
Interests of Certain Directors and Executive Officers of Angion and Elicio in the Merger (see pages 121 and 124)
In considering the recommendation of the Angion Board with respect to the issuance of Angion common stock pursuant to the Merger Agreement and the other matters to be acted upon by Angion’s stockholders at the Angion special meeting, Angion’s stockholders should be aware that certain members of the Angion Board and current and former executive officers of Angion have interests in the Merger that may be different from, or in addition to, interests they have as Angion’s stockholders.
On January 13, 2023, the Angion Board adopted the Angion Biomedica Corp. Retention Bonus Plan (Retention Bonus Plan), providing for the payment of a cash retention bonus equal to 100% of a participant’s base salary, 65% of which becomes earned and payable upon the occurrence of a corporate triggering event (defined to include a change in control (as defined in Angion’s 2021 Incentive Award Plan), a reverse merger or a dissolution) and 35% of which becomes earned and payable three months after the occurrence of such corporate triggering event, subject in each case to earlier payment upon the occurrence of a qualifying termination of the participant’s employment by
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Angion without “cause” or by the participant for “good reason,” each as defined in the Retention Bonus Plan. Participants in the Retention Bonus Plan include Jay Venkatesan, M.D., Angion’s President, Chief Executive Officer and Chairman, and Jennifer Rhodes, Angion’s Executive Vice President, Chief Business Officer, General Counsel, Chief Compliance Officer and Secretary. Upon the earlier of a corporate triggering event or a qualifying termination, time-based equity awards will vest in full, the post-termination exercise period of options held by the participant will be extended by four years (but no later than the original term of the option) and participants will receive an additional lump sum cash payment (approximately $1,464,000 in the case of Dr. Venkatesan and $642,000 in the case of Ms. Rhodes, in each case less applicable withholding). Participants will no longer have the right to receive any payments under Angion’s Executive Separation Benefits Plan. The receipt of payments under the Retention Bonus Plan is subject to the execution of a general release of claims by the participant. Concurrently, the Angion Board approved modifications of the Angion stock options held by Gregory Curhan, Angion’s Chief Financial Officer, such that, upon the earlier of a corporate triggering event or a qualifying termination and subject to Mr. Curhan’s execution of a general release of claims, one option granted in 2022 will vest in full and the post-termination exercise period of all options will be extended by four years (but no later than the original term of the option).
As of December 31, 2022, Angion’s directors and executive officers (including affiliates) beneficially owned, in the aggregate approximately 19.3% of the outstanding shares of Angion common stock. As of December 31, 2022, Angion’s named executive officers and directors collectively owned unvested stock options to purchase 1,058,612 shares of Angion common stock and vested stock options to purchase 2,231,678 shares of Angion common stock. All outstanding and unexercised options to purchase shares of Angion common stock will remain effective and outstanding.
The compensation arrangements with Angion’s officers and directors are discussed in greater detail in the section titled “The Merger—Interests of the Angion Directors and Executive Officers in the Merger” beginning on page 121 of this proxy statement/prospectus/information statement. Additionally, as described elsewhere in this proxy statement/prospectus/information statement, including in the section captioned “Management Following the Merger” beginning on page 263 of this proxy statement/prospectus/information statement, one of Angion’s directors is expected to become the director of the combined company upon the closing of the Merger.
In considering the recommendation of the Elicio Board with respect to adopting the Merger Agreement, Elicio’s stockholders should be aware that members of the Elicio Board and the executive officers of Elicio may have interests in the Merger that may be different from, or in addition to, the interests of Elicio’s stockholders. The Elicio Board was aware of these potential conflicts of interest and considered them, among other matters, in reaching its decision to approve the Merger Agreement, the Merger, and the Contemplated Transactions.
As described elsewhere in this proxy statement/prospectus/information statement, including in the section titled “The Merger—Management Following the Merger,” certain of Elicio’s directors and executive officers are expected to become the directors and executive officers of the combined company upon the closing of the Merger.
Angion’s executive officers and directors, and Elicio’s executive officers, directors and certain affiliated stockholders have entered into the Support Agreements, pursuant to which such directors, officers and certain stockholders, respectively, have agreed, solely in their capacity as stockholders of Angion and Elicio, respectively, to vote all of their shares of Angion common stock or Elicio capital stock in favor of, among other things, the adoption or approval, respectively, of the Merger Agreement and the transactions contemplated therein in connection with the Merger. The Support Agreements are discussed in greater detail in the section titled “Agreements Related to the Merger” beginning on page 156 of this proxy statement/prospectus/information statement.
Risk Factors and Risk Factor Summary (see page 20)
Both Angion and Elicio are subject to various risks associated with their businesses and their industries. In addition, the Merger, including the possibility that the Merger may not be completed, poses a number of risks to each company and its respective stockholders. You should carefully read this proxy statement/prospectus/information statement, including the annexes, and especially consider the material risks discussed below and these and other risks discussed in greater detail under the section titled “Risk Factors” beginning on page 20 of this proxy statement/prospectus/information statement. Angion and Elicio encourage you to read and consider all of these risks carefully.
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Risks Related to the Merger
The Exchange Ratio is not adjustable based on the market price of Angion common stock so the consideration at the closing of the Merger may have a greater or lesser value than at the time the Merger Agreement was signed;
Angion’s net cash may be less than $26.5 million at the Closing, which would result in Angion’s stockholders owning a smaller percentage of the combined organization and, if Angion’s net cash is less than $25.0 million as of the End Date (as defined below), could even result in the termination of the Merger Agreement;
Failure to complete the Merger may result in Angion or Elicio paying a termination fee to the other party and could harm the common stock price of Angion and future business and operations of each company;
If the conditions to the closing of the Merger are not met, the Merger may not occur;
Lawsuits have been filed, and additional lawsuits may be filed, relating to the Merger. An adverse ruling in any such lawsuit may prevent the Merger from being consummated;
The Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide changes and/or other causes;
Some executive officers and directors of Angion and Elicio have interests in the Merger that are different from the respective stockholders of Angion and Elicio and that may influence them to support or approve the Merger without regard to the interests of the respective stockholders of Angion and Elicio;
The market price of Angion common stock following the Merger may decline as a result of the Merger;
Angion and Elicio securityholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company following the closing of the Merger as compared to their current ownership and voting interest in the respective companies;
During the pendency of the Merger, Angion and Elicio may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses;
Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement;
Because the lack of a public market for Elicio capital stock makes it difficult to evaluate the fairness of the Merger, the shareholders of Elicio may receive consideration in the Merger that is less than the fair market value of Elicio capital stock and/or Angion may pay more than the fair market value of Elicio’s capital stock;
The opinion delivered by Oppenheimer to the Angion Board prior to the entry into the Merger Agreement does not reflect changes in circumstances that may have occurred since the date of the opinion;
The Financial Projections included in the section titled “The Merger—Certain Unaudited Financial Projections,” which were considered by the Angion Board in evaluating the Merger and used by Oppenheimer in rendering its opinion and performing its related financial analyses, reflect numerous variables, estimates and assumptions and are inherently uncertain. If any of these variables, estimates and assumptions prove to be wrong, such as the assumptions relating to the approval of Elicio’s product candidates, the actual results for Elicio’s business may be materially different from the results reflected in the Financial Projections;
The Merger may fail to qualify as a reorganization for U.S. federal income tax purposes, resulting in recognition of taxable gain or loss by Elicio stockholders who are U.S. Holders in respect of their Elicio capital stock;
The combined organization may become involved in securities class action litigation that could divert management’s attention and harm the combined organization’s business and insurance coverage may not be sufficient to cover all costs and damages; and
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If any of the events described in under the section titled “Risk Factors—Risks Related to the Merger” occur, those events could cause the potential benefits of the Merger not to be realized.
Risks Related to Angion
Angion’s recent organizational changes and cost cutting measures may not be successful;
Angion may not be able to comply with Nasdaq’s continued listing standards;
Angion has temporarily suspended its clinical programs and has no products approved for sale, which makes it difficult to assess its future viability;
To achieve Angion’s goals it will require substantial additional funding, which capital may not be available to Angion on acceptable terms, or at all, and, if not so available, may require Angion to delay, limit, reduce or cease operations and
Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions could adversely affect Angion’ current financial condition and projected business operations.
Risks Related to Elicio
Elicio has a history of operating losses that are expected to continue for the foreseeable future, and it is unable to predict the extent of future losses, or whether it will generate significant revenues or achieve or sustain profitability;
Elicio will require substantial additional capital to finance its operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force it to delay, limit, reduce or terminate its research and development programs, commercialization efforts or cease operations;
Elicio has never generated revenue from product sales and may never become profitable;
Elicio’s product candidates are at an early stage of development and may not be successfully developed or commercialized;
The FDA regulatory approval process is lengthy, time-consuming, and inherently unpredictable, and Elicio may experience significant delays in the clinical development and regulatory approval, if any, of its product candidates;
If any product candidate that Elicio successfully develops does not achieve broad market acceptance among physicians, patients, health care payors and the medical community, the revenues that it generates from their sales will be limited; and
Elicio’s success will depend upon intellectual property and proprietary technologies, and it may be unable to protect its intellectual property.
Risks Related to the Combined Company
The combined company will need to raise additional financing in the future to fund its operations, which may not be available to it on favorable terms or at all;
The market price of the combined company’s common stock is expected to be volatile, and the market price of the common stock may drop following the Merger;
The combined company will incur costs and demands upon management as a result of complying with the laws, rules and regulations affecting public companies; and
Anti-takeover provisions in the combined company’s charter documents and under Delaware law could make an acquisition of the combined company more difficult and may prevent attempts by the combined company stockholders to replace or remove the combined company management.
Regulatory Approvals (see page 128)
In the United States, Angion must comply with applicable federal and state securities laws and the rules and regulations of Nasdaq in connection with the issuance of shares of Angion common stock to Elicio’s stockholders in
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connection with the transactions contemplated by the Merger Agreement and the filing of this proxy statement/prospectus/information statement with the SEC. Angion does not intend to seek any regulatory approval from antitrust authorities to consummate the Contemplated Transactions.
Nasdaq Stock Market Listing (see page 131)
Shares of Angion common stock are currently listed on The Nasdaq Global Select Market under the symbol “ANGN.” Elicio has filed an initial listing application with Nasdaq pursuant to Nasdaq’s “reverse merger” rules. After completion of the Merger, Angion will be renamed “Elicio Therapeutics, Inc.” and expects to trade on The Nasdaq Global Market under the symbol “ELTX.” Under the Merger Agreement, each of Elicio’s and Angion’s obligation to complete the Merger is subject to the satisfaction or waiver by each of the parties, at or prior to the Merger, of various conditions, including that the shares of Angion common stock to be issued in the Merger have been approved for listing (subject to official notice of issuance) on Nasdaq as of the closing of the Merger. The terms of the Merger Agreement permit that this condition may be waived by agreement among Elicio, Angion and Merger Sub, without recirculation or resolicitation of this proxy statement/prospectus/information statement.
Anticipated Accounting Treatment (see page 131)
The Merger will be treated by Angion as a reverse recapitalization under U.S. generally accepted accounting principles (GAAP). For accounting purposes, Elicio is considered to be the accounting acquirer in this transaction.
Description of Angion and Elicio Capital Stock (see page 294)
Both Angion and Elicio are incorporated under the laws of the State of Delaware and, accordingly, the rights of the stockholders of each are currently, and will continue to be, governed by the DGCL. If the Merger is completed, Elicio stockholders will become Angion stockholders, and their rights will be governed by the DGCL, the amended and restated bylaws of Angion and the amended and restated certificate of incorporation of Angion, as may be amended by the Reverse Stock Split Proposal and the Exculpation Proposal if approved by the Angion stockholders at the Angion special meeting. The rights of Angion stockholders contained in Angion’s amended and restated certificate of incorporation, and amended and restated bylaws differ from the rights of Elicio stockholders under Elicio’s current amended and restated certificate of incorporation and bylaws, as more fully described under the section titled “Comparison of Rights of Holders of Angion Stock and Elicio Stock” beginning on page 294 of this proxy statement/prospectus/information statement.
Angion Stockholder Meeting (see page 93)
The Angion special meeting will be held exclusively online via audio-only webcast on      , 2023 at 9:00 a.m. Pacific Time, unless postponed or adjourned to a later date. The Angion special meeting can be accessed by visiting www.virtualshareholdermeeting.com/ANGN2023SM, where you will be able to vote your shares and submit questions during the Angion special meeting webcast by logging in to the website listed above using the 16-digit control number included in your proxy card. Online check-in will begin at 8:45 a.m. Pacific Time, and Angion encourages you to allow ample time for the online check-in procedures. Please note that you will not be able to attend the Angion special meeting in person. For more information on the Angion special meeting, see the section titled “The Special Meeting of Angion’s Stockholders” beginning on page 93 of this proxy statement/prospectus/ information statement.
Market Price and Dividend Information
Angion common stock is currently listed on The Nasdaq Global Select Market under the symbol “ANGN.” Elicio is a private company and its common stock and preferred stock are not publicly traded.
Angion Common Stock
The closing price of Angion common stock on January 13, 2023, the trading day immediately prior to the public announcement of the Merger on January 17, 2023, as reported on The Nasdaq Global Select Market, was $1.02 per share. The closing price of Angion common stock on March 28, 2023, as reported on The Nasdaq Global Select Market, was $0.48 per share.
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Because the market price of Angion common stock is subject to fluctuation, the market value of the shares of Angion common stock that Elicio stockholders will be entitled to receive in the Merger may increase or decrease.
Assuming successful application for initial listing with Nasdaq, following the consummation of the Merger, Angion anticipates that the Angion common stock will trade under Angion’s new name “Elicio Therapeutics, Inc.” and the new trading symbol “ELTX” on The Nasdaq Global Market.
As of    , 2023, the record date for the Angion special meeting, there were approximately 120 holders of record of the Angion common stock.
Dividends
Angion has never declared or paid any cash dividends on the Angion common stock and does not anticipate paying cash dividends on Angion common stock for the foreseeable future. Notwithstanding the foregoing, any determination to pay cash dividends subsequent to the Merger will be at the discretion of the combined organization’s then-current board of directors and will depend upon a number of factors, including the combined organization’s results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors the then-current board of directors deems relevant.
Elicio has never declared or paid any cash dividends on shares of the Elicio capital stock except for $2,645,438 accrued and unpaid dividends on its Series A Preferred Stock. Elicio anticipates that the combined company will retain all of its future earnings to advance the clinical trials for its product candidates, and does not anticipate paying any cash dividends on shares of its common stock in the foreseeable future. Any future determination to declare cash dividends on shares of the combined company’s common stock will be made at the discretion of its board of directors, subject to applicable law and contractual restrictions and will depend on its financial condition, results of operations, capital requirements, general business conditions and other factors that its board of directors may deem relevant.
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 RISK FACTORS
The combined company will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement/prospectus/ information statement, you should carefully consider the material risks described below before deciding how to vote your shares of Angion common stock. In addition, you should read and consider the risks associated with the business of Angion because these risks may also affect the combined company. These risks can be found in Angion’s Annual Report on Form 10-K, as updated by subsequent Quarterly Reports on Form 10-Q, all of which are filed with the SEC. You should also read and consider the other information in this proxy statement/prospectus/information statement. Realization of any of the risks described below, any of the uncertainties described under “Cautionary Statement Regarding Forward-Looking Statements” could have a material adverse effect on Angion’s, Elicio’s or the combined company’s businesses, financial condition, cash flows and results of operations. Please see the section titled “Where You Can Find More Information” beginning on page 307 of this proxy statement/prospectus/information statement.
Risks Related to the Merger
The Exchange Ratio is not adjustable based on the market price of Angion common stock so the consideration at the closing of the Merger may have a greater or lesser value than at the time the Merger Agreement was signed.
The relative proportion of the combined company that the Angion stockholders will own when the Merger closes will be based on the relative valuations of Angion and Elicio as negotiated by the parties and as specified in the Merger Agreement. Immediately following the Merger, the pre-Merger equity holders of Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected to hold approximately 34.5% of the outstanding shares of Angion common stock, in each case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. The Exchange Ratio formula is derived based upon an Elicio fixed valuation of $95 million and an Angion valuation of $50.1 million, subject to certain adjustments, including based upon Angion Net Cash at Closing. The calculation of Angion Net Cash at Closing includes, among other things, a credit for cash proceeds Angion receives from the sale, transfer, license, assignment or other divestiture of its intellectual property and other assets and technology in existence on the date of the Merger Agreement prior to or substantially concurrently with the Closing and a reduction for certain liabilities. The Net Cash Condition means that Angion Net Cash must be no less than $25 million in order for Elicio to be required to complete the Merger. For a more complete description of the Merger and the potential adjustments in the Exchange Ratio, please see the section titled “The Merger Agreement —Merger Consideration and Exchange Ratio” beginning on page 135 of this proxy statement/prospectus/information statement. In addition, if the Net Cash Condition is not satisfied as of the End Date, Elicio has the right to terminate the Merger Agreement.
Angion’s net cash may be less than $26.5 million at the Closing, which would result in Angion’s stockholders owning a smaller percentage of the combined organization and, if Angion’s net cash is less than $25.0 million as of the End Date, could even result in the termination of the Merger Agreement
For purposes of the Merger Agreement, net cash is subject to certain reductions, including, without limitation, accounts payable, accrued expenses (except those related to the Merger), current liabilities payable in cash, unpaid expenses related to the Merger and certain other unpaid obligations, including outstanding lease obligations. In the event the amount of Angion’s cash is smaller or such reductions are greater than anticipated, Angion stockholders could hold a significantly smaller portion of the combined organization.
Failure to complete the Merger may result in Angion or Elicio paying a termination fee to the other party and could harm the common stock price of Angion and future business and operations of each company.
If the Merger is not completed, each of Angion and Elicio is subject to the following risks:
upon termination of the Merger Agreement, Angion may be required to pay Elicio a termination fee of $2.0 million or $1.0 million, under certain circumstances, and/or up to $500,000 in expense reimbursements; or Elicio may be required to pay Angion a termination fee of $1.0 million, under certain circumstances, and/or up to $500,000 in expense reimbursements;
the parties will have incurred significant expenses related to the Merger, such as legal and accounting fees, which must be paid even if the Merger is not completed;
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the price of Angion’s common stock may decline and remain volatile; and
Angion may be forced to cease its operations, dissolve and liquidate its assets.
In addition, if the Merger Agreement is terminated and the Angion Board or Elicio Board determines to seek another business combination, there can be no assurance that either Angion or Elicio will be able to find a partner willing to provide equivalent or more attractive consideration than the consideration to be provided by each party in the Merger or any partner at all.
If the conditions to the closing of the Merger are not met, the Merger may not occur.
Even if the Stock Issuance Proposal is approved by the stockholders of Angion, specified conditions must be satisfied or waived to complete the Merger. These conditions are set forth in the Merger Agreement and described in the section titled “The Merger Agreement—Conditions to the Completion of the Merger” beginning on page 139 of this proxy statement/prospectus/information statement. Angion and Elicio cannot assure you that all of the conditions will be satisfied or waived. If the conditions are not satisfied or waived, the Merger may not occur or will be delayed, and Angion and Elicio each may lose some or all the intended benefits of the Merger.
Lawsuits have been filed, and additional lawsuits may be filed, relating to the Merger. An adverse ruling in any such lawsuit may prevent the Merger from being consummated.
Following the announcement of Angion’s entry into the Merger Agreement with Elicio on January 17, 2023, and the initial filing of this Registration Statement on February 13, 2023, a lawsuit was filed in the United States District Court for the Eastern District of New York on February 17, 2023 by a purported stockholder of Angion in connection with the Merger. The lawsuit was captioned Klein v. Angion Biomedica Corp., et al., No. 1:23-cv-01313 (E.D.N.Y.). The Klein complaint named as defendants Angion, and the members of the Angion Board. The Klein complaint alleged claims for breaches of fiduciary duty against the members of the Angion Board, aiding and abetting breaches of fiduciary duty against Angion, violations of Section 14(a) of the Exchange Act and Rule 14a-9 promulgated thereunder against all defendants, and violations of Section 20(a) of the Exchange Act against the members of the Angion Board. The plaintiff contended that the registration statement on Form S-4 filed on February 13, 2023 omitted or misrepresented material information regarding the Merger, rendering the Registration Statement false and misleading. The Klein complaint sought injunctive and declaratory relief, as well as damages. On February 21, 2023, the plaintiff filed a notice of voluntary dismissal of the Klein lawsuit. Although the plaintiffs voluntarily dismissed this case, litigation of this type is prevalent in mergers involving public companies, and other potential plaintiffs may file lawsuits challenging the Merger.
The outcome of any additional future litigation is uncertain. Such litigation, if not resolved, could prevent or delay completion of the Merger and result in substantial costs to Angion, including any costs associated with the indemnification of directors and officers. One of the conditions to the completion of the Merger is the absence of any law or order from a governmental entity (whether temporary, preliminary or permanent) that is in effect and restrains, enjoins or otherwise prohibits the consummation of the Merger. Therefore, if a plaintiff were successful in obtaining an injunction prohibiting the consummation of the Merger on the agreed-upon terms, then such injunction may prevent the Merger from being completed, or from being completed within the expected timeframe. The defense or settlement of any lawsuit or claim that remains unresolved at the time the Merger is completed may adversely affect the combined company’s business, financial condition, results of operations and cash flows. In addition, although Angion Net Cash is increased by 50% of the aggregate costs associated with stockholder litigation brought or threatened in writing against Angion or its directors or officers related to the Contemplated Transactions, the other 50% of such costs would reduce Angion Net Cash and may adversely affect Angion’s ability to meet the Net Cash Condition.
The Merger may be completed even though material adverse changes may result from the announcement of the Merger, industry-wide changes and/or other causes.
In general, either Angion or Elicio can refuse to complete the Merger if there is a material adverse change affecting the other party between January 17, 2023, the date of the Merger Agreement, and the closing of the Merger. However, certain types of changes do not permit either party to refuse to complete the Merger, even if such change could be said to have a material adverse effect on Angion or Elicio, including:
general business or economic conditions generally affecting the industry in which Elicio or Angion operate;
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acts of war, the outbreak or escalation of armed hostilities, acts of terrorism, earthquakes, wildfires, hurricanes or other natural disasters, health emergencies, including pandemics (including COVID-19 and any evolutions or mutations thereof) and related or associated epidemics, disease outbreaks or quarantine restrictions;
changes in financial, banking or securities markets;
any change in the stock price or trading volume of Angion common stock;
any failure by Angion to meet internal or analysts’ expectations or projections or the results of operations of Angion;
any change in or affecting clinical trial programs or studies conducted by or on behalf of Angion or its subsidiaries;
any change from continued losses from operations or decreases in cash balances of Elicio or any of its subsidiaries or on a consolidated basis among Elicio and its subsidiaries;
any change in, or any compliance with or action taken for the purpose of complying with, any law or GAAP (or interpretations of any law or GAAP); or
any change resulting from the announcement of the Merger Agreement or the pendency of the Contemplated Transactions;
the taking of any action required to be taken by the Merger Agreement; or
any reduction in the Angion’s cash and cash equivalents as a result of winding down its activities associated with the termination of its research and development activities.
If adverse changes occur and Angion and Elicio still complete the Merger, the stock price of the combined company following the closing of the Merger may suffer. This in turn may reduce the value of the Merger to the stockholders of Angion, Elicio or both.
Some executive officers and directors of Angion and Elicio have interests in the Merger that are different from the respective stockholders of Angion and Elicio and that may influence them to support or approve the Merger without regard to the interests of the respective stockholders of Angion and Elicio.
Some officers and directors of Angion and Elicio are parties to arrangements that provide them with interests in the Merger that are different from the respective stockholders of Angion and Elicio, including, among others, service as an officer or director of the combined company following the closing of the Merger, severance and retention benefits, the acceleration of equity award vesting, and continued indemnification. For more information regarding the interests of the Angion and Elicio executive officers and directors in the Merger, see the sections titled “The Merger—Interests of the Angion Directors and Executive Officers in the Merger” and “The Merger—Interests of the Elicio Directors and Executive Officers in the Merger” of this proxy statement/prospectus/information statement.
The market price of Angion common stock following the Merger may decline as a result of the Merger.
The market price of Angion common stock may decline as a result of the Merger for a number of reasons, including if:
investors react negatively to the prospects of the combined company’s business and prospects following the closing of the Merger;
the effect of the Merger on the combined company’s business and prospects following the closing of the Merger is not consistent with the expectations of financial or industry analysts; or
the combined company does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by stockholders or financial or industry analysts.
Angion and Elicio securityholders will have a reduced ownership and voting interest in, and will exercise less influence over the management of, the combined company following the closing of the Merger as compared to their current ownership and voting interest in the respective companies.
Immediately following the Merger, the pre-Merger equity holders of Elicio are expected to hold approximately 65.5% of the outstanding shares of Angion common stock and the pre-Merger equity holders of Angion are expected
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to hold approximately 34.5% of the outstanding shares of Angion common stock, in each case, on a fully diluted basis, subject to certain assumptions, including Angion Net Cash at Closing being between $26.5 million and $31.5 million. These estimates are based on the anticipated Exchange Ratio and are subject to adjustment as provided in the Merger Agreement. A $25.0 million Angion Net Cash threshold is a condition to the completion of the Merger. For a more complete description of the Merger and the potential adjustments in the Exchange Ratio, please see the section titled “The Merger Agreement—Merger Consideration and Exchange Ratio” beginning on page 135 of this proxy statement/prospectus/information statement.
In addition, the nine-member board of directors of the combined company will initially consist of six individuals with prior affiliations with Elicio and three individuals with prior affiliation with Angion. Consequently, securityholders of Elicio and Angion will be able to exercise less influence over the management and policies of the combined company following the closing of the Merger than they currently exercise over the management and policies of their respective companies.
During the pendency of the Merger Agreement, Angion and Elicio may not be able to enter into a business combination with another party at a favorable price because of restrictions in the Merger Agreement, which could adversely affect their respective businesses.
Covenants in the Merger Agreement impede the ability of Angion and Elicio to make acquisitions, subject to specified exceptions relating to fiduciary duties, or complete other mergers, sales of assets or other business combinations that are not in the ordinary course of business pending completion of the Merger. As a result, if the Merger is not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, initiating, encouraging or entering into specified extraordinary transactions, such as a merger, sale of assets or other business combination, with any third party, subject to specified exceptions, even if any such transaction could be favorable to such party’s stockholders.
Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the arrangements contemplated by the Merger Agreement.
The terms of the Merger Agreement prohibit each of Angion and Elicio from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances when such party’s board of directors determines in good faith, after consultation with its outside financial advisor and outside counsel, that an unsolicited competing proposal constitutes, or is reasonably likely to result in, a superior competing proposal and, after consultation with its outside counsel, that failure to take such action is reasonably likely to be inconsistent with the fiduciary duties of the applicable board of directors. In addition, if Angion or Elicio terminate the Merger Agreement under specified circumstances, including terminating because of a decision of the Angion Board to recommend a superior competing proposal, Angion may be required to pay Elicio a termination fee of $2.0 million or $1.0 million or up to $500,000 in expense reimbursements or Elicio may be required to pay Angion a termination fee of $1.0 million, or up to $500,000 in expense reimbursements, as defined and described under “The Merger Agreement—Termination of the Merger Agreement and Termination Fee.” This termination fee may discourage third parties from submitting competing proposals to Angion or its stockholders and may cause the Angion Board to be less inclined to recommend a competing proposal.
Because the lack of a public market for Elicio’s capital stock makes it difficult to evaluate the fairness of the Merger, the shareholders of Elicio may receive consideration in the Merger that is less than the fair market value of Elicio’s capital stock and/or Angion may pay more than the fair market value of Elicio’s capital stock.
The outstanding capital stock of Elicio is privately held and is not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of Elicio’s capital stock. Because the percentage of Angion equity to be issued to Elicio shareholders was determined based on negotiations between the parties, it is possible that the value of the Angion common stock to be received by Elicio shareholders will be less than the fair market value of Elicio’s capital stock, or Angion may pay more than the aggregate fair market value for Elicio’s capital stock.
The opinion delivered by Oppenheimer to the Angion Board prior to the entry into the Merger Agreement does not reflect changes in circumstances that may have occurred since the date of the opinion.
The Angion Board has not obtained an updated opinion either as of the date of this proxy statement/prospectus/information statement or as of any other date subsequent to the date of the opinion from Oppenheimer, Angion’s financial advisor. Changes in circumstances, including in the operations and prospects of
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Angion or Elicio, stock prices, general market and economic conditions and other factors, some or all of which may be beyond the control of Angion and Elicio, including the recent increases in inflation and lending rates that have caused higher than normal volatility in the financial markets generally, are not reflected in its opinion. The opinion does not speak as of any date other than the date of the opinion.
The Financial Projections for Elicio included in the section titled “The Merger—Certain Unaudited Financial Projections”, which were considered by the Angion Board in evaluating the Merger and used by Oppenheimer in rendering its opinion and performing its related financial analyses, reflect numerous variables, estimates and assumptions and are inherently uncertain. If any of these variables, estimates and assumptions prove to be wrong, such as the assumptions relating to the approval of Elicio’s product candidates, the actual results for Elicio’s business may be materially different from the results reflected in the Financial Projections.
As further described below in the section titled “The Merger—Certain Unaudited Financial Projections”, in connection with the Angion Board’s evaluation of the Merger, preliminary internal financial forecasts for Elicio were prepared by the management of Elicio and provided to the management of Angion, and then adjusted by the management of Angion, solely for use by Angion’s financial advisor, Oppenheimer, in connection with the rendering of its opinion and performing its related financial analyses, as described below under “The Merger—Opinion of Angion’s Financial Advisor”. The Financial Projections reflect numerous variables, estimates, and forecasts made by Angion’s and Elicio’s respective management at the time the initial financial forecasts were prepared by Elicio and adjusted by Angion. If any of these variables, estimates and assumptions prove to be wrong, the actual results for Elicio’s business may differ materially from the results reflected in the Financial Projections.
The estimated probabilities of success included in the Financial Projections take into account a range of potential outcomes, including outcomes in which product candidates fail to achieve commercial launch due to commercial and regulatory uncertainty (including failure to obtain regulatory authorization to market the applicable product candidate) as well as economic and portfolio management decisions and competition, and these assumptions, including those with respect to regulatory approval and probability of success more broadly, are inherently uncertain and could prove inaccurate. If ELI-002 does not receive marketing authorization when anticipated, for the indications anticipated, or at all, the actual results of the combined company’s business will differ materially from the results reflected in the Financial Projections. For example, while the Financial Projections reflect the probability of success assessments described below in the section titled “The Merger—Certain Unaudited Financial Projections” for ELI-002, if ELI-002 is not approved then actual results will differ materially, including the potential for ELI-002 to generate no revenue at all.
In addition, the Financial Projections cover a significant period of time, specifically through 2039. This extended period was used in light of the anticipated timing for regulatory approval and the initiation of commercial sales of ELI-002. However, the risks and uncertainties regarding the Financial Projections, including the potential for adverse developments such as delays in obtaining or failure to obtain regulatory approvals or additional competition or changes in the competitive or regulatory landscape, increase with each successive year and the likelihood that the actual results will differ materially from the projected results increase with each successive year. The Financial Projections also do not reflect general business, economic, market and financial conditions and any changes in any of these conditions over the period of the projections could result in the actual results differing materially from the results reflected in the Financial Projections.
The Merger may fail to qualify as a reorganization for U.S. federal income tax purposes, resulting in recognition of taxable gain or loss by Elicio stockholders who are U.S. holders in respect of their Elicio capital stock.
Angion and Elicio intend for the Merger to qualify as a reorganization within the meaning of Section 368(a) of the Code, as described in the section titled “The Merger—Material U.S. Federal Income Tax Consequences of the Merger” in this proxy statement/prospectus/information statement, and, subject to the limitations and qualifications described therein, in the opinion of Cooley LLP and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. the Merger will qualify as a reorganization within the meaning of Section 368(a) of the Code.
In the event that the Merger does not qualify as a reorganization, the Merger would result in taxable gain or loss for each Elicio stockholder who is a U.S. holder, with the amount of such gain or loss determined by the amount that each such Elicio stockholder's adjusted tax basis in the Elicio capital stock surrendered is less or more than the fair market value of the Angion common stock and any cash in lieu of a fractional share received in exchange therefor. Each holder of Elicio capital stock is urged to consult with his, her or its own tax advisor with respect to the tax consequences of the Merger.
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The combined organization may become involved in securities class action litigation that could divert management's attention and harm the combined organization's business and insurance coverage may not be sufficient to cover all costs and damages.
In the past, securities class action or shareholder derivative litigation often follows certain significant business transactions, such as the sale of a business division or announcement of a Merger. The combined organization may become involved in this type of litigation in the future. Litigation often is expensive and diverts management's attention and resources, which could adversely affect the combined organization's business.
Angion or Elicio may waive one or more of the conditions to the Merger without recirculation of this proxy statement/prospectus/information statement or resoliciting stockholder approval.
Conditions to Angion’s or Elicio’s obligations to complete the Merger may be waived, in whole or in part, to the extent permitted by law, either unilaterally or by agreement of Angion, Elicio and Merger Sub. In the event of a waiver of a condition, the Angion Board will evaluate the materiality of any such waiver to determine whether amendment of this proxy statement/prospectus/information statement and resolicitation of stockholder approval is necessary.
In the event that the Angion Board, in its own reasonable discretion, determines any such waiver is not significant enough to require recirculation of this proxy statement/prospectus/information statement and re-solicitation of its stockholders, it will have the discretion to complete the Merger without seeking further stockholder approval, which decision may have a material adverse effect on the Angion stockholders. For example, if Angion and Elicio agree to waive the requirement that the shares of Angion common stock to be issued in the Merger have been approved for listing (subject to official notice of issuance) on Nasdaq as of the closing of the Merger, and their respective boards of directors elect to proceed with the closing of the Merger, Nasdaq may notify the combined company of its determination to delist the company’s securities based upon the failure to satisfy the initial inclusion criteria in the Nasdaq application. The combined company may appeal the determination to a hearings panel, which will stay the delisting action pending a panel decision. If the combined company does not appeal the determination, its common stock will be delisted.
For more information about the conditions to the completion of the Merger, see the section titled “The Merger Agreement–Conditions to the Completion of the Merger.”
Nasdaq may delist the combined company’s securities from trading on its exchange, which could limit investors’ ability to make transactions in its securities and subject the combined company to additional trading restrictions.
Currently, Angion’s common stock is publicly traded on Nasdaq. In connection with the proposed Merger, Elicio has filed an initial listing application with Nasdaq pursuant to Nasdaq’s “reverse merger” rules. The combined company will be required to meet the initial listing requirements for its securities to be listed on Nasdaq.
If Angion and Elicio fail to meet the Nasdaq listing requirements and their respective boards choose to close the merger without Nasdaq’s approval then Nasdaq may notify the combined company of its determination to delist the company’s securities based upon the failure to satisfy the criteria in the Nasdaq application. For more information, refer to the section titled “Risk Factors Related to the Merger—Angion or Elicio may waive one or more of the conditions to the Merger without recirculation of this proxy statement/prospectus/information statement or resoliciting stockholder approval” beginning on page 25 of this proxy statement/prospectus/information statement.
We cannot assure you that the combined company will be able to meet those initial listing requirements. Even if the combined company’s securities are so listed, the combined company may be unable to maintain the listing of its securities in the future. In order to continue listing its securities on Nasdaq following the proposed Merger, the combined company will be required to maintain certain financial, distribution and stock price levels. If Nasdaq delists the combined company’s securities from trading on its exchange at closing of the Merger (or thereafter) and the combined company is not able to list its securities on another national securities exchange or regain compliance with Nasdaq, the combined company’s securities could be quoted on an over-the-counter market. If this were to occur, the combined company could face significant material adverse consequences, including:
a limited availability of market quotations for its securities;
reduced liquidity for its securities;
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a determination that the combined company’s common stock is a “penny stock” which will require brokers trading in the combined company’s common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;
a limited amount of news and analyst coverage; and
a decreased ability to issue additional securities or obtain additional financing in the future.
The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts states from regulating the sale of certain securities, which are referred to as “covered securities.” Since Angion’s common stock is listed on Nasdaq, they are covered securities. Although states are preempted from regulating the sale of covered securities, the federal statute does allow states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then states can regulate or bar the sale of covered securities in a particular case. If Angion was no longer listed on Nasdaq, its securities would not be covered securities and it would be subject to regulation in each state in which it offers its securities, including in connection with the Merger.
Risks Related to Angion
Risks Relating to Angion’s 2022 Strategic Realignment
Angion’s recent organizational changes and cost cutting measures may not be successful.
In July 2022, Angion implemented a reduction-in-force affecting a majority of its workforce and a process to explore strategic options for enhancing and preserving shareholder value (2022 Strategic Realignment), which resulted in Angion and Elicio entering into the Merger Agreement. As of March 28, 2023, Angion had only three employees. The reductions in workforce and cost cutting measures will make it difficult for it to resume development activities Angion has suspended or pursue new initiatives if it does not successfully complete the Merger, requiring it to hire qualified replacement personnel, which may require it to incur additional and unanticipated costs and expenses. As a result of the loss of services of substantially all of Angion’s personnel, including several of its executive officers, Angion may be unable to continue its operations and meet its ongoing obligations if it does not successfully complete the Merger. Any of these unintended consequences may have a material adverse impact on Angion’s business, financial condition, and results of operations.
Angion may not be able to comply with Nasdaq’s continued listing standards.
Angion common stock trades on The Nasdaq Global Select Market under the symbol “ANGN.” There is also no guarantee Angion will be able to perpetually satisfy Nasdaq’s continued listing requirements to maintain its listing on Nasdaq for any periods of time. Among the conditions required for continued listing on Nasdaq, Angion is required to maintain a stock price over $1.00 per share pursuant to Rule 5550(a)(2) of the Nasdaq Listing Rules. On December 15, 2022, Angion received a letter from Nasdaq notifying it that for the last 30 consecutive business days the bid price of Angion’s common stock had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements of Nasdaq listing rule 5450(a)(1). If Angion’s common stock does not achieve compliance by June 13, 2023, Angion may be eligible for an additional 180-day period to regain compliance if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the bid price requirement, and provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. However, if it appears to the Nasdaq staff that Angion will not be able to cure the deficiency, or if Angion does not meet the other listing standards, Nasdaq could provide notice that Angion’s common stock will become subject to delisting. In the event Angion receives notice that its common stock is being delisted, Nasdaq rules permit Angion to appeal any delisting determination.
In addition, even if Angion demonstrates compliance with the requirement above, Angion will have to continue to meet other objective and subjective listing requirements to continue to be listed on Nasdaq, which it may not be able to continue to meet. Delisting from Nasdaq could make trading Angion common stock more difficult for investors, potentially leading to declines in Angion’s share price and liquidity. Without a Nasdaq listing, stockholders may have a difficult time obtaining a quote for the sale or purchase of Angion common stock, the sale or purchase of Angion common stock would likely be made more difficult, and the trading volume and liquidity of Angion common stock could decline. Delisting from Nasdaq could also result in negative publicity and could also make it more difficult for Angion to raise additional capital.
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Risks Relating to Angion’s Financial Position and Need for Additional Capital
Angion has temporarily suspended its clinical programs and has no products approved for sale, which makes it difficult to assess its future viability.
Angion is a biopharmaceutical company that has suspended its clinical programs, has only a small number of preclinical programs, and has no products approved for sale. Drug development is a highly speculative undertaking and involves a substantial degree of risk. Angion has not yet submitted any product candidates for approval or received approval of any product candidate by regulatory authorities in any jurisdiction, including the FDA. Angion does not expect to generate revenue from product sales unless it, or its collaborators, resume clinical development of Angion’s product candidates and obtain approval and commercialize its product candidates, which Angion does not expect to occur for several years, if ever. Angion expects to continue to incur net losses for the foreseeable future to the extent it advances its product candidates through preclinical and clinical and development, and as it continues to incur expenses to protect its intellectual property, maintain its general and administrative support functions, and incur costs associated with operating as a public company. If Angion is unable to enroll clinical trials for any of its product candidates, or it fails in clinical trials or does not gain regulatory approval, Angion may never generate revenue or become profitable.
To achieve Angion’s goals it will require substantial additional funding, which capital may not be available to Angion on acceptable terms, or at all, and, if not so available, may require Angion to delay, limit, reduce or cease operations.
Angion has invested and, to the extent it resumes clinical development and clinical trials of its product candidates following its 2022 Strategic Realignment process, will continue to invest a significant portion of its efforts and financial resources in research and development activities. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. Angion will require substantial additional future capital to complete clinical development, including additional clinical trials, and seek regulatory approval to bring its product candidates to market. Regulatory authorities in the United States and elsewhere could also require Angion to perform additional preclinical studies or clinical trials to receive or maintain regulatory approval of its product candidates, and its expenses would further increase beyond what Angion currently expects. Because successful development of Angion’s product candidates is uncertain, Angion is unable to estimate the actual funds it will require to complete research and development of its product candidates as well as the costs of commercializing any of its wholly-owned product candidates and those for which Angion retains the right to commercialize.
In addition, whether or not Angion resumes clinical trials of its product candidates, it will continue to incur costs:
to maintain, expand and defend the scope of its intellectual property portfolio, including the amount and timing of any payments Angion may be required to make, or Angion may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights, and
the costs associated with being a public company, including Angion’s need to implement additional internal systems and infrastructure, including financial and reporting systems.
Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions could adversely affect Angion’ current financial condition and projected business operations.
Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems. For example, on March 10, 2023, Silicon Valley Bank (SVB), where Angion held substantially all of its cash and cash equivalents, was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation, (FDIC), as receiver. On March 12, 2023, the Department of the Treasury, the Federal Reserve, and the FDIC jointly released a statement that depositors at SVB would have access to their funds, even those funds in excess of the standard FDIC insurance limits, under a systemic risk exception. As of March 13, 2023, Angion had access to its cash and cash equivalents at SVB, and at the end of March 2023 transferred substantially all of its cash and cash equivalents from SVB to an asset manager and only held a small portion of its cash and cash equivalents in deposit accounts; however, there is uncertainty in the markets regarding the stability of regional banks and the safety of
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deposits in excess of the FDIC insured deposit limits. The ultimate outcome of these events cannot be predicted, but these events could have a material adverse effect on Angion’s business operations as well as its ability to complete the Merger.
Risks Relating to the Development and Regulatory Approval of Angion’s Product Candidates
COVID-19 could adversely impact Angion’s business, including any clinical trials and its financial condition.
Angion has been and continues to be subject to risks related to public health crises such as the global pandemic associated with COVID-19. As COVID-19 continues to persist around the globe, to the extent Angion resumes clinical trials or commences new clinical trials, Angion may experience disruptions that could severely impact its business and clinical trials, including:
delays or difficulties in enrolling patients in clinical trials;
delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as Angion’s clinical trial sites and hospital staff supporting the conduct of its clinical trials;
interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others or interruption of clinical trial subject visits and study procedures, the occurrence of which could affect the integrity of clinical trial data;
the risk that participants enrolled in Angion’s clinical trials will acquire COVID-19 while the clinical trial is ongoing, which could impact the results of the clinical trial, including by increasing the number of observed adverse events;
limitations in employee resources that would otherwise be focused on the conduct of Angion’s clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
delays in receiving authorizations from local regulatory authorities to initiate Angion’s planned clinical trials;
delays in clinical sites receiving the supplies and materials needed to conduct Angion’s clinical trials;
interruption in global shipping that may affect the transport of clinical trial materials, such as investigational drug product used in Angion’s clinical trials;
changes in local regulations as part of a response to the COVID-19 pandemic which may require Angion to change the ways in which Angion’s clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;
interruptions or delays in preclinical studies due to restricted or limited operations at Angion’s research and development laboratory facilities or at its third-party clinical research organizations;
delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees; and
refusal of the FDA to accept data from clinical trials in affected geographies outside the United States.
The global pandemic of COVID-19 continues to evolve. The extent to which COVID-19 may impact Angion’s business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the geographic spread of the disease and its variants, business closures or business disruptions, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.
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Product development and regulatory approval involve a lengthy and expensive process with uncertain outcomes. Angion cannot be certain any of its product candidates will receive or maintain regulatory approval and, without regulatory approval, it and its collaborators will not be able to market its product candidates.
Angion currently has suspended its clinical programs and has no products approved for sale, and even if Angion resumes clinical trials Angion cannot guarantee it will ever have approved products it or its collaborators can market and sell. The development of a product candidate and issues relating to its approval and marketing are subject to extensive regulation by regulatory authorities, including the FDA in the United States and other regulatory authorities in other foreign countries, with regulations differing from country to country. Angion is not permitted to market its product candidates in the United States or elsewhere until it receives regulatory approval and/or marketing authorization, such as approval of a New Drug Application (NDA) from the FDA. Angion has not submitted any marketing applications for any of its product candidates.
New drug marketing applications must include extensive preclinical and clinical data and supporting information to establish the product candidate's safety and effectiveness for each desired indication. Such marketing applications must also include significant information regarding the chemistry, manufacturing, and controls for the product. Even if Angion resumes clinical trials of its product candidates, obtaining approval of its product candidates will be a lengthy, expensive, and uncertain process, and it may not be successful. Specifically, the review processes of the FDA and foreign regulatory authorities can take years to complete, and approval is never guaranteed. Even if a product is approved, the FDA or foreign regulatory authorities may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming additional clinical trials or reporting as conditions of approval. The FDA or foreign regulatory authorities also may not approve Angion’s product candidates with the labeling it believes is necessary or desirable for the successful commercialization of its product candidates. Obtaining regulatory approval for marketing of a product candidate in one country does not ensure Angion will be able to obtain regulatory approval in any other country.
If Angion resumes clinical trials, it cannot predict whether the clinical trials of its product candidates will be successful, or whether regulators will agree with its conclusions regarding the preclinical studies and clinical trials Angion has conducted to date or it conducts in the future. If Angion is unable to obtain approval from regulatory authorities for any of its product candidates, Angion may not be able to generate sufficient revenue to become profitable or to continue its operations.
Delays or difficulties in the commencement, enrollment and completion of clinical trials could result in increased costs to Angion and delay or limit Angion’s ability to obtain regulatory approval its product candidates.
If Angion resumes or commences clinical trials, delays in the commencement, enrollment, and completion of clinical trials would increase its product development costs beyond what it expects or could limit the regulatory approval of its product candidates. Delays in any of Angion’s clinical trials may increase the amount of additional funding Angion will require to complete these trials.
Changes in regulatory requirements and related guidance related to regulatory approval may also occur and Angion may need to amend clinical trial protocols to reflect these changes. Amendments may require Angion to resubmit clinical trial protocols to Institutional Review Boards (IRB) for re-examination, which may impact the costs, timing or successful completion of its clinical trials.
Furthermore, if Angion is required to conduct additional clinical trials or other preclinical studies of Angion’s product candidates beyond those it contemplates, its ability to obtain or maintain regulatory approval of these product candidates and generate revenue from their sales would be similarly harmed.
Clinical failure can occur at any stage of clinical development, and the results of earlier clinical trials are not necessarily predictive of future results.
Clinical failure can occur at any stage of Angion’s clinical development. For example, in the fourth quarter of 2021, Angion disclosed the results of the ANG-3777 Phase 3 clinical trial for delayed graft function (DGF) and AKI associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI), neither of which met their primary endpoints despite the existence of encouraging preclinical and clinical data for ANG-3777 established prior to initiating such studies. Clinical trials may produce negative or inconclusive results, and Angion or its collaborators may decide, or regulators may require Angion, to conduct additional clinical trials or preclinical studies. In addition, data obtained from trials and studies are susceptible to various interpretations, and regulators may not interpret Angion’s data as favorably as Angion does, which may delay, limit or prevent regulatory approval. Success in
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preclinical studies and early clinical trials does not ensure subsequent clinical trials will generate the same or similar results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. A number of companies in the pharmaceutical industry, including those with greater resources and experience than Angion, have suffered significant setbacks in Phase 3 registration trials, even after seeing promising results in earlier clinical trials or preclinical studies.
In addition, the design of a clinical trial can determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinical trial is well advanced. Angion has limited experience in designing clinical trials as it has never previously completed a Phase 3 registration trial with results sufficient to obtain regulatory approval or submitted an NDA to the FDA or a marketing application to any foreign regulatory authority, and it may be unable to design and execute a clinical trial to support regulatory approval. Further, clinical trials of potential products often reveal it is not practical or feasible to continue development efforts, as has occurred with the clinical development of ANG-3070.
If Angion resumes or commence clinical trials, the product candidates in those clinical trials may be the subject of clinical trial failures or found to be unsafe or lack efficacy, and if that were to occur Angion would not be able to obtain regulatory approval for them and its business would be harmed.
Angion’s product candidates may have undesirable side effects which may delay or halt clinical development or prevent marketing approval or, if approval is received, require them to be taken off the market, require them to include safety warnings, or otherwise limit their sales.
The results of any clinical trials of Angion’s product candidates may show such product candidates led to patient safety concerns or undesirable or unacceptable side effects, creating risk to the patient which is deemed to outweigh the potential benefits of treatment to that patient. Unforeseen side effects from any of Angion’s product candidates could arise either during clinical development or, if approved, after the approved product has been marketed. Any such event could interrupt, delay or halt such clinical trials, resulting in the denial of regulatory approval by the FDA and other regulatory authorities or result in restrictive label warnings, if approved. In light of widely publicized events concerning the safety risk of certain drug products, regulatory authorities, members of Congress, the Government Accounting Office, medical professionals and the general public have raised concerns about potential drug safety issues. These events have resulted in the withdrawal of drug products, revisions to drug labeling that further limit use of the drug products and establishment of risk management programs that may, for instance, restrict distribution of drug products. The increased attention to drug safety issues may result in a more cautious approach by the FDA to clinical trials. Data from clinical trials may receive greater scrutiny with respect to safety, which may make the FDA or other regulatory authorities more likely to terminate clinical trials before completion, or require longer or additional clinical trials that may result in substantial additional expense and a delay or failure in obtaining approval or approval for a more limited indication than originally sought.
Angion has relied, and may continue to rely, on single-source third party contract manufacturing organizations to manufacture and supply Angion’s product candidates, and if the FDA or foreign regulatory authorities do not approve these manufacturing facilities or if these organizations fail to perform, Angion’s ability to conduct clinical trials and obtain regulatory approval for its product candidates may be harmed.
Angion does not own facilities for clinical and commercial manufacturing of its product candidates, and to the extent it resumes or commences clinical trials of any of its product candidates, it will rely upon third-party contract manufacturing organizations to manufacture and supply product candidates for its clinical trials and will rely on such manufacturers to meet commercial demand.
Additionally, the facilities at which any of Angion’s product candidates are manufactured must be the subject of a satisfactory inspection before the FDA or the regulators in other jurisdictions approve the product candidate manufactured at that facility. Angion is completely dependent third-party vendors for compliance with the current Good Manufacturing Practice requirements (cGMP), and the requirements of United States and non-United States regulators for the manufacture of Angion’s active ingredients, drug products, and finished products. If Angion’s manufacturers cannot successfully manufacture material conforming to Angion’s specifications and cGMP of any applicable governmental agency, Angion’s product candidates will not be approved or, if already approved, may be subject to recalls or demands by regulatory agencies to stop selling the product until manufacturing issues are resolved.
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If Angion is able to develop and obtain regulatory approval for any of its product candidates, its business will be materially harmed if it is unable to successfully commercialize such approved products.
Even if Angion pursues and receives regulatory approval of any product candidate, it is uncertain whether Angion will be able to successfully commercialize such product. Angion’s marketing of any approved product will be limited to the product’s approved use and potentially subject to other limitations as set forth in its approved prescribing information and package insert. Accordingly, Angion cannot ensure any of its future approved products will be successfully developed, approved or commercialized. If Angion is unable to successfully commercialize any future approved products, Angion may not be able to generate sufficient revenue to operate its business.
Risks Relating to Angion’s Business
Angion faces competition from other biotechnology and pharmaceutical companies and its operating results will suffer if Angion fails to compete effectively.
The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. Angion will have competitors in the United States, Europe, and other jurisdictions, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical and generic drug companies, and universities and other research institutions, for any of Angion’s product candidates it determines to pursue. Many of these competitors have greater financial and other resources, such as larger research and development staff and more experienced marketing and manufacturing organizations. Large pharmaceutical companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients, and manufacturing pharmaceutical products. These companies also have significantly greater research, sales, and marketing capabilities and collaborative arrangements in Angion’s target markets with leading companies and research institutions. Established pharmaceutical companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds potentially making the product candidates Angion develops obsolete. As a result of all of these factors, any of these competitors may succeed in obtaining patent protection and/or FDA approval or discovering, developing, and commercializing drugs for kidney, heart, liver, lung and other diseases Angion is targeting before Angion does. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. In addition, many universities and private and public research institutes may become active in Angion’s target disease areas.
Angion will depend on single third-party suppliers for the manufacture and supply of drug substance and potential future commercial product supplies for its product candidates, and any performance failure on the part of its supplier could delay the development and potential commercialization of its product candidates.
To the extent Angion resumes or commences clinical trials of its product candidates, Angion cannot be certain its drug substance supplier will continue to provide it with sufficient quantities of drug substance, or its manufacturers will be able to produce sufficient quantities of drug product incorporating such drug substance, to satisfy its anticipated specifications and quality requirements, or such quantities can be obtained at pricing necessary to sustain acceptable pharmaceutical margins for any of its product candidates, if approved. Angion’s dependence on a single supplier for its drug substance and the challenges it may face in obtaining adequate supply of drug substance involves several risks, including limited control over pricing, availability, quality and delivery schedules, and such risks may be heightened as a result of the COVID-19 pandemic. Any supply interruption in drug substance or drug product could materially harm Angion’s ability to complete its development program for such indications, until a new source of supply, if any, could be identified and qualified. Angion may be unable to find a sufficient alternative supply channel in a reasonable time or on commercially reasonable terms. Any performance failure on the part of Angion’s suppliers could delay the development and potential commercialization of Angion’s product candidates, including limiting supplies necessary for clinical trials and regulatory approvals, which would have a material adverse effect on Angion’s business.
Angion faces potential product liability exposure, and if successful claims are brought against it, Angion may incur substantial liability for a product candidate and may have to limit its commercialization.
The use of Angion’s product candidates in clinical trials and the sale of any products for which Angion may obtain marketing approval exposes it to the risk of product liability claims. Product liability claims may be brought against Angion or its collaborators by participants enrolled in Angion’s past and any future clinical trials, patients, healthcare providers, or others using, administering, or selling Angion’s products. If Angion cannot successfully defend itself against any such claims, it would incur substantial liabilities.
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Under the terms of the government grant funding Angion has received, the government may compel Angion to license to a third party, or suspend, terminate or withhold grant funding.
A significant amount of Angion’s discovery and initial clinical research it has conducted has been funded principally by United States government grants and contracts. As with all other pharmaceutical research programs supported in part by federal research dollars, conducting research under federal grants required Angion to grant the U.S. government a nonexclusive, nontransferable, irrevocable, paid-up license for the government to practice or have the invention practiced on its behalf throughout the world. Under certain circumstances, the government can require the grantee to license a third party, or the government may take title and grant a license itself, known as march-in rights, which may occur if the invention is not brought to practical use within a reasonable time, if health or safety issues arise, if public use of the invention is in jeopardy, or if other legal requirements are not satisfied. Although, to Angion’s knowledge, the U.S. government has never forced a grantee to license a third party or taken title and granted a license itself, these march-in rights are available to the government, and Angion cannot assure you the government will not exercise such rights in the future.
Under the terms and conditions of the government grant funding, Angion is obligated to comply with various reporting requirements and to take certain administrative actions. Material noncompliance with the terms and conditions of the grant funding may result in one or more enforcement actions by the grant agency. These enforcement actions include denying funds for the cost of funded activities, suspending the grant in whole or in part, pending corrective action, and withholding further grant awards. The grant agency may also terminate the grant for cause, or take other legally available remedies.
Risks Relating to Angion’s Intellectual Property
It is difficult and costly to protect Angion’s proprietary rights, and Angion may not be able to ensure their protection. If Angion’s patent position and potential regulatory exclusivity do not adequately protect Angion’s product candidates, others could compete against Angion more directly, which would harm Angion’s business, possibly materially.
Angion’s success will depend in part on obtaining and maintaining patent protection and trade secret protection of its current and future product candidates, and their methods of manufacture and use. Angion’s ability to stop third parties from making, using, selling, offering to sell or importing its product candidates is dependent upon the extent to which it has rights under valid and enforceable patents and/or trade secrets that cover these activities. The patent positions of biotechnology and pharmaceutical companies can be highly uncertain and involve complex legal and factual questions. No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the United States or in many jurisdictions outside of the United States. Changes in either the patent laws or interpretations of patent laws in the United States and other countries may diminish the value of Angion’s intellectual property. Accordingly, Angion cannot predict the breadth of claims that may be issued in relevant jurisdictions from its present or future patent filings, or those it licenses from third parties, and further cannot predict the extent to which it will be able to enforce such issued claims in jurisdictions important to its business. If any patents Angion obtains or licenses are deemed invalid and unenforceable, Angion’s ability to commercialize or license its technology could be adversely affected.
It is possible others have filed, and in the future may file, patent applications covering products and technologies similar, identical or competitive to ours, or are otherwise important to Angion’s business. Angion cannot be certain any patent filings owned by a third party will not have priority over patent applications filed or in-licensed by it, or it or its licensors will not be involved in interference, opposition or invalidity proceedings before United States or foreign patent offices. The costs of defending Angion’s patents or enforcing Angion’s proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the outcome can be uncertain. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, Angion’s patent rights, and/or could allow third parties to commercialize Angion’s technology or products and compete directly with Angion, without payment to Angion. Furthermore, third-party filings may issue as patents infringed by Angion’s manufacture or commercialization of Angion’s products. Licenses may not be available to such third-party patents, and challenges to their validity or infringement may be expensive and may not succeed. If the breadth or strength of protection provided by Angion’s patents and patent applications is threatened, or if Angion is perceived or found to infringe intellectual property rights of others, it could dissuade companies from collaborating with Angion to license, develop or commercialize current or future product candidates, and could impede or preclude Angion’s ability to commercialize its products.
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The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and Angion’s owned and licensed patents may be challenged in the courts or patent offices in the United States and abroad. Angion may become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging its patent rights or the patent rights of others. Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, any of which could limit Angion’s ability to stop others from using or commercializing similar or identical technology and products, and/or limit the duration of the patent protection of Angion’s technology and products.
Without patent protection for Angion’s compounds, pharmaceutical compositions, or formulations of Angion’s product candidates, Angion’s ability to stop others from using or selling its products, or other competitive products including its compounds, may be limited.
If the patent applications Angion holds or has in-licensed with respect to present or future product candidates fail to issue, if their breadth and/or strength of protection is limited or challenged, or if they fail to provide meaningful exclusivity for present or future product candidates, it could dissuade companies from collaborating with Angion to develop future candidates and threaten Angion’s ability to commercialize future commercial products. Any such outcome could have a materially adverse effect on Angion’s business.
Angion may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.
If Angion chooses to go to court to stop another party from using the inventions claimed in any patents it obtains, that individual or company has the right to ask the court to rule such patents are invalid or should not be enforced against that third party. These lawsuits are expensive, would consume time and resources and would divert the attention of managerial and scientific personnel even if Angion were successful in stopping the infringement of such patents. In addition, there is a risk the court will decide such patents are not valid and Angion does not have the right to stop the other party from using the inventions.
There is also a risk, even if the validity of such patents is upheld, the court will refuse to stop the other party on the grounds such other party's activities do not infringe Angion’s patents. In addition, the United States Supreme Court has recently modified some tests used by the USPTO in granting patents over the past 20 years, which may decrease the likelihood Angion will be able to obtain patents and increase the likelihood of challenge of any patents Angion obtains or licenses.
Angion may infringe the intellectual property rights of others, which may prevent or delay its product development efforts and stop it from commercializing, or increase the costs of commercializing, its product candidates.
Angion’s success will depend in part on Angion’s ability to operate without infringing the proprietary rights of third parties. Angion cannot guarantee its products or product candidates, or their manufacture or use, will not infringe third-party patents. Furthermore, a third party may claim Angion or its manufacturing or commercialization collaborators are using inventions covered by the third party's patent rights. It is also possible a third party might allege Angion’s products or product candidates, or their manufacture or use, incorporate or rely on trade secrets improperly received from the third party. A third-party alleging violations of their intellectual property rights may go to court to stop Angion from engaging in Angion’s normal operations and activities, including making or selling Angion’s candidates. Defense of such claims, regardless of their merit, are costly and could affect Angion’s results of operations and divert the attention of managerial and scientific personnel.
There is a risk a court would decide Angion or its commercialization collaborators are infringing the third party's intellectual property rights and would order Angion or its collaborators to stop relevant activities. In that event, Angion or its commercialization collaborators may not have a viable way to avoid the infringement and may need to halt commercialization of the relevant product. In addition, there is a risk a court will order Angion or its collaborators to pay the other party damages for having infringed the other party's intellectual property rights. In the future, Angion may agree to indemnify its commercial collaborators against certain intellectual property infringement claims brought by third parties. The pharmaceutical and biotechnology industries have produced a proliferation of patents, and it is not always clear to industry participants, including Angion, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by the courts, and the interpretation is not always uniform.
If Angion is sued for patent or other intellectual property (e.g., trade secret, trademark, etc.) infringement, it could incur significant costs, and delays in its product development or commercialization.
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Angion’s competitors may have filed, and may in the future file, patent applications covering technology like ours. Any such patent application may have priority over Angion’s patent applications, which could further require Angion to obtain rights to issued patents covering such technologies. If another party has filed a United States patent application on inventions similar to ours, Angion may have to participate in an interference or derivation proceeding declared by the USPTO to determine priority of invention in the United States. The costs of these proceedings could be substantial, and it is possible such efforts would be unsuccessful if, unbeknownst to Angion, the other party had independently arrived at the same or similar invention prior to Angion’s own invention, resulting in a loss of Angion’s United States patent position with respect to such inventions, and granting such position to the third party, so Angion may need to seek a license from such third party to continue its use of the technologies, which license might not be available, or might impose significant costs.
Other countries have similar laws permitting secrecy of patent applications and may be entitled to priority over Angion’s applications in such jurisdictions.
In addition, Angion may be subject to claims that it is infringing other intellectual property rights, such as trademarks or copyrights, or misappropriating the trade secrets of others, and to the extent its employees, consultants or contractors use intellectual property or proprietary information owned by others in their work for Angion, disputes may arise as to the rights in related or resulting know-how and inventions.
Angion may not have sufficient resources to bring actions alleging intellectual property infringement to a successful conclusion. In addition, if Angion does not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid, it may incur substantial monetary damages, encounter significant delays in bringing its product candidates to market and be precluded from manufacturing or selling its product candidates. Furthermore, even if Angion is successful in proceedings relating to alleged intellectual property infringement or misappropriation, it may incur substantial costs and divert management's time and attention in pursuing these proceedings, which could have a material adverse effect on Angion.
Some of Angion’s competitors may be able to sustain the costs of complex litigation more effectively than Angion can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on Angion’s ability to raise the funds necessary to continue its operations.
Obtaining and maintaining Angion’s patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and Angion’s patent protection could be reduced or eliminated for non-compliance with these requirements.
Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. Angion has systems in place to remind it to pay these fees, and it employs an outside firm and relies on its outside counsel to pay these fees due to the USPTO and non-United States patent agencies. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. Angion employs reputable law firms and other professionals to help it comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, Angion’s competitors might be able to enter the market and this circumstance could have a material adverse effect on Angion’s business.
The laws of some foreign countries do not protect proprietary rights to the same extent as do the laws of the United States, and Angion may encounter significant problems in securing and defending its intellectual property rights outside the United States.
Many companies have encountered significant problems in protecting and defending intellectual property rights in certain countries. The legal systems of certain countries, particularly certain developing countries, do not always favor the enforcement of patents, trade secrets, and other intellectual property rights, particularly those relating to pharmaceutical products, which could make it difficult for Angion to stop infringement of its patents, misappropriation of its trade secrets, or marketing of competing products in violation of its proprietary rights.
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Proceedings to enforce Angion’s intellectual property rights in foreign countries could result in substantial costs, divert Angion’s efforts and attention from other aspects of its business, and put Angion’s patents in these territories at risk of being invalidated or interpreted narrowly, or Angion’s patent applications at risk of not being granted, and could provoke third parties to assert claims against Angion. Angion may not prevail in all legal or other proceedings it may initiate and, if Angion were to prevail, the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, Angion’s efforts to enforce its intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property it develops or licenses.
Risks Relating to Angion Common Stock
Angion’s stock price may be volatile and you may not be able to resell shares of Angion common stock at or above the price you paid.
The trading price of Angion common stock could be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond Angion’s control. These factors include those discussed above.
In addition, the stock markets in general, and the markets for pharmaceutical and biotechnology stocks in particular, have experienced extreme volatility that may have been unrelated to the operating performance of the issuer. These broad market fluctuations may adversely affect the trading price or liquidity of Angion common stock. In the past, when the market price of a stock has been volatile, holders of that stock have sometimes instituted securities class action litigation against the issuer. If Angion were to become involved in securities litigation, it could incur substantial costs and resources and the attention of Angion’s management could be diverted from the operation of Angion’s business.
Angion is an “emerging growth company” and as a result of the reduced disclosure and governance requirements applicable to emerging growth companies, Angion common stock may be less attractive to investors.
Angion is an “emerging growth company,” as defined in Jumpstart Our Business Act of 2012, (JOBS Act), and Angion intends to continue taking advantage of certain exemptions from various reporting requirements applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404, reduced disclosure obligations regarding executive compensation in Angion’s periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and obtaining stockholder approval of any golden parachute payments not previously approved. In addition, as an “emerging growth company,” the JOBS Act allows Angion to delay adoption of new or revised accounting pronouncements applicable to public companies until such pronouncements are made applicable to private companies. Angion has elected to use this extended transition period under the JOBS Act. As a result, Angion’s financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards applicable to public companies, which may make comparison of Angion’s financials to those of other public companies more difficult. Even after Angion no longer qualifies as an emerging growth company, it may still qualify as a “smaller reporting company” which would allow it to take advantage of many of the same exemptions from disclosure requirements including not being required to comply for a period of time with the auditor attestation requirements of Section 404, and reduced disclosure obligations regarding executive compensation in this report and Angion’s periodic reports and proxy statements.
Angion cannot predict if investors will find Angion common stock less attractive because Angion will rely on these exemptions. If some investors find Angion common stock less attractive as a result, there may be a less active trading market for Angion common stock and Angion’s stock price may be more volatile. Angion may take advantage of these reporting exemptions until it is no longer an emerging growth company or smaller reporting company.
Angion has completed and may in the future complete related party transactions that were not and may not be conducted on an arm's length basis.
Angion has in the past and continues to be party to certain transactions with certain entities affiliated with Dr. Goldberg, director and Chairman Emeritus on the Angion Board, as well as certain of his immediate family members. For instance, in November 2013, Angion granted Ohr Cosmetics, LLC (Ohr), an affiliated company, an exclusive worldwide license, with the right to sublicense, under Angion’s patent rights covering Angion’s CYP26 inhibitors, including ANG-3522, for the use in treating conditions of the skin or hair. Angion owns, and the family
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of Dr. Goldberg owns, approximately 2.4% and 78.7%, respectively, of the membership interests in Ohr. Dr. Goldberg's son is the manager of Ohr. In addition, Dr. Venkatesan, Angion's President and Chief Executive Officer and director, and Mr. Ganzi, Angion's lead independent director, each own approximately 1.6% of the membership interests in Ohr.
In addition, prior to March 2023, Angion rented office and laboratory space in Uniondale, New York from NovaPark LLC (NovaPark), an affiliated company, under a lease that was scheduled to expire on June 20, 2026. The space Angion rents is part of an approximately 110,000-square-foot general laboratory and development facility (NovaPark Facility) for biological and chemistry research owned by NovaPark. In March 2023, Angion entered into a Surrender Agreement with NovaPark which terminated the Uniondale, New York lease for a termination fee of $3.03 million and entered into a Membership Interest Redemption Agreement with NovaPark to relinquish its 10% membership interest in NovaPark. Prior to entering into the Membership Interest Redemption Agreement, Angion owned, and Dr. Goldberg and Rina Kurz, Dr. Goldberg's spouse, owned 10%, 45% and 45%, respectively, of the membership interests in NovaPark.
Provisions in Angion’s charter documents and under Delaware law could discourage a takeover stockholders may consider favorable and may lead to entrenchment of management.
Angion’s amended and restated certificate of incorporation and amended and restated bylaws contain provisions that could delay or prevent changes in control or changes in Angion’s management without the consent of the Angion Board. These provisions include the following:
a classified board of directors with three-year staggered terms, which may delay the ability of stockholders to change the membership of a majority of the Angion Board;
no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;
the exclusive right of the Angion Board to elect a director to fill a vacancy created by the expansion of the Angion Board or the resignation, death or removal of a director, which prevents stockholders from being able to fill vacancies on the Angion Board;
the ability of the Angion Board to authorize the issuance of shares of preferred stock and to determine the price and other terms of those shares, including preferences and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquiror;
the ability of the Angion Board to alter Angion’s amended and restated bylaws without obtaining stockholder approval;
the required approval of at least 66 2/3% of the shares entitled to vote at an election of directors to adopt, amend or repeal Angion’s amended and restated bylaws or repeal the provisions of Angion’s amended and restated certificate of incorporation regarding the election and removal of directors;
a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of Angion’s stockholders;
the requirement that a special meeting of stockholders may be called only by Angion’s chief executive officer or president or chairperson of the Angion Board or by the Angion Board directors, which may delay the ability of Angion’s stockholders to force consideration of a proposal or to take action, including the removal of directors; and
advance notice procedures stockholders must comply with in order to nominate candidates to the Angion Board or to propose matters to be acted upon at a stockholders' meeting, which may discourage or deter a potential acquiror from conducting a solicitation of proxies to elect the acquiror's own slate of directors or otherwise attempting to obtain control of Angion.
Angion is also subject to the anti-takeover provisions contained in Section 203 of the DGCL. Under Section 203, a corporation may not, in general, engage in a business combination with any holder of 15% or more of its capital stock unless the holder has held the stock for three years or, among other exceptions, the Angion Board has approved the transaction.
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Angion’s amended and restated certificate of incorporation and amended and restated bylaws provide for an exclusive forum in the Court of Chancery of the State of Delaware for certain disputes between Angion and its stockholders, which could limit Angion’s stockholders’ ability to obtain a favorable judicial forum for disputes with Angion or its directors, officers or employees.
Angion’s amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware (or, in the event that the Court of Chancery does not have jurisdiction, the federal district court for the District of Delaware or other state courts of the State of Delaware) is the exclusive forum for any derivative action or proceeding brought on Angion’s behalf, any action asserting a claim of breach of fiduciary duty, any action asserting a claim against Angion arising pursuant to the DGCL, Angion’s amended and restated certificate of incorporation or Angion’s amended and restated bylaws, or any action asserting a claim against Angion that is governed by the internal affairs doctrine; provided that, the exclusive forum provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction; and provided further that, if and only if the Court of Chancery of the State of Delaware dismisses any such action for lack of subject matter jurisdiction, such action may be brought in another state or federal court sitting in the State of Delaware. Angion’s amended and restated certificate of incorporation and amended and restated bylaws also provide the federal district courts of the United States of America will be the exclusive forum for the resolution of any complaint asserting a cause of action against Angion or any of its directors, officers, employees or agents and arising under the Securities Act. Nothing in Angion’s amended and restated certificate of incorporation or amended and restated bylaws precludes stockholders that assert claims under the Exchange Act from bringing such claims in state or federal court, subject to applicable law.
Angion believe these provisions may benefit it by providing increased consistency in the application of Delaware law and federal securities laws by chancellors and judges, as applicable, particularly experienced in resolving corporate disputes, efficient administration of cases on a more expedited schedule relative to other forums and protection against the burdens of multi-forum litigation. This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with Angion or any of its directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims, although Angion’s stockholders will not be deemed to have waived Angion’s compliance with federal securities laws and the rules and regulations thereunder. Furthermore, the enforceability of similar choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is possible a court could find these types of provisions to be inapplicable or unenforceable. While the Delaware courts have determined such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive-forum provisions, and there can be no assurance such provisions will be enforced by a court in those other jurisdictions. If a court were to find the choice of forum provision contained in Angion’s amended and restated certificate of incorporation and amended and restated bylaws to be inapplicable or unenforceable in an action, Angion may incur additional costs associated with resolving such action in other jurisdictions, which could adversely affect its business and financial condition.
Security breaches, cyber-attacks or other disruptions or incidents could expose Angion to liability and affect its business and reputation.
Angion is increasingly dependent on its information technology systems and infrastructure for its business. Angion, its collaborators and its service providers collect, store, and transmit sensitive information including intellectual property, proprietary business information, clinical trial data and personal information in connection with Angion’s business operations. The secure maintenance of this information is critical to Angion’s operations and business strategy. Some of this information could be an attractive target of criminal attack by third parties with a wide range of motives and expertise, including organized criminal groups, “hacktivists,” patient groups, disgruntled current or former employees, nation-state and nation-state supported actors and others. Cyber-attacks are of ever-increasing levels of sophistication, and despite Angion’s security measures, its information technology and infrastructure may be vulnerable to such attacks or may be breached, including due to employee error or malfeasance. Angion has implemented information security measures to protect its systems, proprietary information and sensitive data, including the personal information of clinical trial participants against the risk of inappropriate and unauthorized external use and disclosure and other types of compromise. However, despite these measures, and due to the ever-changing information cyber-threat landscape, Angion cannot guarantee these measures will be adequate to detect, prevent or mitigate security breaches and other incidents and Angion may be subject to data breaches through cyber-attacks, malicious code (such as viruses and worms), phishing attacks, social engineering schemes, and insider theft or misuse. Any such breach could compromise Angion’s networks and the information stored there could be
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accessed, modified, destroyed, publicly disclosed, lost or stolen. If Angion’s systems become compromised, Angion may not promptly discover the intrusion. Like other companies in Angion’s industry, Angion has experienced attacks to its data and systems, including malware and computer viruses. Any security breach or other incident, whether real or perceived, would cause Angion to lose product sales, if any, and suffer reputational damage and loss of customer confidence. Such incidents could result in costs to respond to, investigate and remedy such incidents, notification obligations to affected individuals, government agencies, credit reporting agencies and other third parties, legal claims or proceedings, and liability under Angion’s contracts with other parties and federal and state laws that protect the privacy and security of personal information. If a security breach, cyber-attack, or other disruption is the result of state-sponsored activities, it may be considered an “act-of-war”, potentially making Angion ineligible for reimbursement under its insurance policies covering such attacks. Any one of these events could cause Angion’s business to be materially harmed and its results of operations would be adversely impacted.
Risks Related to Elicio
Risks Related to Elicio’s Operating History, Financial Position and Capital Requirements
Elicio has a history of operating losses that are expected to continue for the foreseeable future, and it is unable to predict the extent of future losses, or whether it will generate significant revenues or achieve or sustain profitability.
Elicio has focused on product development and has not generated any revenues to date. Additionally, it expects to continue to incur operating losses for the foreseeable future. These operating losses have adversely affected and are likely to continue to adversely affect Elicio’s working capital, total assets and stockholders’ deficit.
Since Elicio is an early-stage company, its prospects must be considered in light of the uncertainties, risks, expenses, and difficulties frequently encountered by companies in their early stages of operations. Specifically, it has generated operating losses each year since its inception, including $28.2 million and $26.4 million for the years ended December 31, 2022 and 2021, respectively. Elicio expects to make substantial expenditures and incur increasing operating costs in the future and its accumulated deficit will increase significantly as it expands development and clinical trial activities for its product candidates. Because of the risks and uncertainties associated with product development, Elicio is unable to predict the extent of any future losses, whether it will ever generate significant revenues or if it will ever achieve or sustain profitability.
Elicio believes that its cash on hand, along with the minimum cash of $25 million required to be delivered by Angion in the Merger, will enable it to fund its operations through calendar year 2023 based on its current plan. Elicio is dependent on obtaining, and is continuing to pursue, necessary funding from outside sources, including obtaining additional funding from the issuance of securities in order to continue its operations. Without adequate funding, it may not be able to meet its financial obligations.
Elicio has not demonstrated an ability to perform the functions necessary for the successful commercialization of any products. The successful commercialization of any of its products will require it to perform a variety of functions, including:
continuing to undertake preclinical and clinical development;
engaging in the development of product candidate formulations and manufacturing processes;
interacting with the applicable regulatory authorities and pursuing other required steps for regulatory approval;
engaging with payors and other pricing and reimbursement authorities;
submitting marketing applications to and receiving approval from the applicable regulatory authorities; and
manufacturing the applicable products and product candidates in accordance with regulatory requirements and, if ultimately approved, conducting sales and marketing activities in accordance with health care, FDA and similar foreign regulatory authority laws and regulations.
Elicio has a limited operating history and it expects a number of factors to cause its operating results to fluctuate on a quarterly and annual basis, which may make it difficult to predict its future performance.
Elicio is a clinical stage biopharmaceutical company with a limited operating history. Its operations to date have been primarily limited to organizing and staffing its company, acquiring, developing and securing its proprietary technology and preclinical and clinical development of its product candidates. It has not yet successfully completed
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any clinical trials for any of its product candidates, manufactured its product candidates at commercial scale or conducted sales and marketing activities that will be necessary to successfully commercialize its product candidates, if approved. Consequently, any predictions made about its future success or viability may not be as accurate as they could be if it had a longer operating history or commercialized products. Elicio’s financial condition has varied significantly in the past and will continue to fluctuate from quarter-to-quarter or year-to-year due to a variety of factors, many of which are beyond its control. Factors relating to its business that may contribute to these fluctuations include other factors described elsewhere in this proxy statement/prospectus/information statement and also include, among other things:
Elicio’s ability to obtain additional funding to develop its product candidates;
Elicio’s ability to conduct and complete nonclinical studies and clinical trials,
delays in the commencement, enrollment and timing of clinical trials;
the success of Elicio’s nonclinical studies and clinical trials through all phases of development;
any delays in regulatory review and approval of product candidates in clinical development;
Elicio’s ability to obtain and maintain regulatory approval for its product candidates in the United States and foreign jurisdictions;
potential toxicity and/or side effects of Elicio’s product candidates that could delay or prevent commercialization, limit the indications for any approved products, require the establishment of risk evaluation and mitigation strategies, or cause an approved drug to be taken off the market;
Elicio’s ability to establish or maintain partnerships, collaborations, licensing or other arrangements;
market acceptance of Elicio’s product candidates, if approved;
competition from existing products, new products or new therapeutic approaches that may emerge;
the ability of patients or health care providers to obtain coverage of or sufficient reimbursement for Elicio’s products;
Elicio’s ability to leverage its proprietary AMP technology platform to discover and develop additional product candidates;
Elicio’s ability and its licensors’ abilities to successfully obtain, maintain, defend and enforce intellectual property rights important to its business; and
potential product liability claims.
Accordingly, the results of any quarterly or annual periods should not be relied upon as indications of future operating performance.
Elicio will require substantial additional capital to finance its operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force it to delay, limit, reduce or terminate its research and development programs, commercialization efforts or cease operations.
Elicio’s operations have consumed substantial amounts of cash. During the years ended December 31, 2022 and 2021, it incurred research and development expenses of $18.1 million and $17.9 million, respectively. Elicio will require substantial additional funds to support its continued research and development activities, including the anticipated costs of nonclinical studies and clinical trials, regulatory approvals and potential commercialization. Additionally, its estimates on future financial needs may be based on assumptions that prove to be wrong, and it may spend its available financial resources much faster than it expects.
Until such time, if ever, that Elicio can generate sufficient product revenue and achieve profitability, it expects to seek to finance future cash needs through equity or debt financings and/or corporate collaboration, licensing arrangements and grants. It currently has no other commitments or agreements relating to any of these types of transactions and cannot be certain that additional funding will be available to it on acceptable terms, or at all. Furthermore, the ongoing impact of COVID-19 and geopolitical instability, including the recent military conflict between Russia and Ukraine, as well as the impact of inflationary pressures and resulting rise in interest rates, on
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global financial markets could make the terms of any available financing less attractive to Elicio and more dilutive to its existing stockholders. If it is unable to raise additional capital, it will have to delay, curtail or eliminate one or more of its research and development programs or cease operations. Additionally, raising additional capital may cause dilution to its stockholders.
Elicio has never generated revenue from product sales and may never become profitable.
Elicio’s ability to generate product sales and achieve profitability depends on its ability, alone or with collaborative partners, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize its current and future product candidates. It does not anticipate generating product sales for the next several years, if ever.
Elicio’s product candidates will require additional clinical, manufacturing, and non-clinical development, regulatory approval, commercial manufacturing arrangements, establishment of a commercial organization, significant marketing efforts, and further investment before it generates any product sales. It cannot guarantee that it will meet its timelines for its development programs, which may be delayed or not completed for a number of reasons. Elicio’s ability to generate future revenues from product sales depends heavily on its, or its collaborators’, ability to successfully:
complete research and obtain favorable results from nonclinical and clinical development of Elicio’s current and future product candidates, including addressing any clinical holds that may be placed on its development activities by regulatory authorities;
seek and obtain regulatory and marketing approvals for any of Elicio’s product candidates for which it completes clinical trials, as well as their manufacturing facilities;
launch and commercialize any of Elicio’s product candidates for which it obtains regulatory and marketing approval by establishing a sales force, marketing, and distribution infrastructure or, alternatively, collaborating with a commercialization partner;
qualify for coverage and establish adequate reimbursement by government and third-party payors for any of Elicio’s product candidates for which it obtains regulatory and marketing approval;
develop, maintain, and enhance a sustainable, scalable, reproducible, and transferable manufacturing process for the product candidates Elicio may develop;
establish and maintain supply and manufacturing capabilities or capacities internally or with third parties that can provide adequate, in both amount and quality, products, and services to support clinical development and the market demand for any of Elicio’s product candidates for which it obtains regulatory and marketing approval;
obtain market acceptance of current or any future product candidates as viable treatment options and effectively compete with other therapies to establish market share;
maintain a continued acceptable safety and efficacy profile of Elicio’s product candidates following launch;
address competing technological and market developments;
implement internal systems and infrastructure, as needed;
negotiate favorable terms in any collaboration, licensing, or other arrangements into which Elicio may enter and perform its obligations in such collaborations;
maintain, protect, enforce, defend, and expand Elicio’s portfolio of intellectual property rights, including patents, trade secrets, and know-how;
avoid and defend against third-party interference, infringement, and other intellectual property claims; and
attract, hire, and retain qualified personnel.
Even if one or more of Elicio’s current and future product candidates are approved for commercial sale, it anticipates incurring significant costs associated with commercializing any approved product candidate. Its expenses could increase beyond its expectations if it is required by the FDA or other regulatory authorities to perform clinical and other studies in addition to those that it currently anticipates. If it is required to conduct additional clinical trials
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or other testing of its product candidates that it develops beyond those that it currently expects, if it is unable to successfully complete clinical trials of its product candidates or other testing, if the results of these trials or tests are not positive or are only modestly positive, or if there are safety concerns, Elicio may be delayed in obtaining marketing approval for its product candidates, not obtain marketing approval at all, or obtain more limited approvals. Even if it is able to generate revenues from the sale of any approved product candidates, it may not become profitable and may need to obtain additional funding to continue operations.
Even if Elicio does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. Its failure to become and remain profitable would decrease the value of Elicio and could impair its ability to raise capital, maintain its research and development efforts, expand its business or continue its operations. A decline in the value of Elicio also could cause its stockholders to lose all or part of their investment.
Elicio’s recurring losses from operations have raised substantial doubt regarding its ability to continue as a going concern.
Elicio’s recurring losses from operations raise substantial doubt about its ability to continue as a going concern, and as a result, its independent registered public accounting firm included an explanatory paragraph in its report on Elicio’s financial statements as of and for the year ended December 31, 2022 included elsewhere herein with respect to this uncertainty. This going concern opinion could materially limit Elicio’s ability to raise additional funds through the issuance of new debt or equity securities or otherwise. Future reports on its financial statements may include an explanatory paragraph with respect to its ability to continue as a going concern. Elicio has incurred significant losses since its inception and has never been profitable, and it is possible it will never achieve profitability. It has devoted a majority of its resources to developing ELI-002 and ELI-004, but these product candidates cannot be marketed until regulatory approvals have been obtained. Meaningful revenues will likely not be available unless ELI-002, ELI-004, or any of its current or future product candidates are approved by the FDA or comparable regulatory agencies in other countries and successfully marketed, either by Elicio or a partner, an outcome which may not occur. Elicio believes that its cash on hand, along with the minimum cash of $25 million required to be delivered by Angion in the Merger, will enable it to fund its operations through calendar year 2023 based on its current plan. This period could be shortened if there are any significant increases in planned or actual spending on development programs or more rapid progress of development programs than anticipated. There is no assurance that financing will be available when needed to allow it to continue as a going concern. The perception that Elicio may not be able to continue as a going concern may cause others to choose not to do business with it due to concerns about its ability to meet its contractual obligations.
Risks Related to the Development of Elicio’s Products
Elicio’s product candidates are at an early stage of development and may not be successfully developed or commercialized.
Elicio initiated the AMPLIFY-201 trial for ELI-002 in 2021, targeting KRAS, which product candidate also includes ELI-004, its universal AMP-modified CpG adjuvant and has not previously conducted clinical trials with its product candidates. All of its other product candidates are in preclinical development and will require substantial further capital expenditures, development, testing, and regulatory approval prior to commercialization. Elicio has limited experience designing clinical trials and has not yet filed or supported a marketing application. It may be unable to design and execute a clinical trial that ultimately supports marketing approval.
The time required to obtain approval from the FDA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of regulatory authorities. The outcome of studies is also inherently uncertain. Of the large number of drugs in development, only a small percentage successfully complete the regulatory approval process and are commercialized. The results of nonclinical studies, interim or top-line study results, and early clinical trials of Elicio’s product candidates may not be predictive of the results of later-stage clinical trials. Failure can occur at any time during the clinical trial process. Product candidates in later stages of clinical trials may fail to show the desired safety, purity, and potency traits despite having progressed through nonclinical studies and initial clinical trials. Nonclinical and early clinical studies may also reveal unfavorable product candidate characteristics, including safety concerns. A number of companies have suffered significant setbacks in advanced clinical trials, notwithstanding promising results in earlier trials. In some instances, there can be significant variability in results between different clinical trials of the same product candidate due to numerous factors, including changes in trial
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procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants.
Accordingly, even if Elicio is able to obtain the requisite financing to fund its development programs, it cannot assure you that its product candidates will be successfully developed or commercialized. Its failure to develop, manufacture or receive regulatory approval for or successfully commercialize any of its product candidates could result in the failure of its business and a loss of all of its stockholders’ investment.
Elicio’s product candidates are in various stages of development and it will not be able to commercialize its product candidates if its nonclinical and clinical studies do not produce successful results and/or its clinical trials do not demonstrate the safety and efficacy of its product candidates; early results and early understanding of product candidate potential may not be predictive of later success. Any product candidates currently in clinical development or that Elicio advances into clinical development are subject to extensive regulation, which can be costly and time-consuming, and it may experience unanticipated delays or be unable to receive the required approvals to commercialize its product candidates.
Product candidates are susceptible to the risks of failure inherent at any stage of product development, including the occurrence of unexpected or unacceptable adverse events or the failure to demonstrate efficacy in clinical trials. Clinical development is expensive and can take many years to complete, and its outcome is inherently uncertain. The results of nonclinical studies, preliminary clinical trial results, and early clinical trials of Elicio’s product candidates may not be predictive of the results of later-stage clinical trials. Its product candidates may not perform as it expects, may ultimately have a different than expected or no impact at all, may have a different mechanism of action than it initially understands or than it expects in humans, and may not ultimately prove to be safe or effective.
The nonclinical and clinical development, manufacturing, packaging, labeling, storage, record-keeping, advertising, promotion, post-approval monitoring and reporting, import, export, marketing and distribution, among other activities, of Elicio’s product candidates are subject to extensive regulation by the FDA and by comparable health authorities in foreign markets. Elicio is not permitted to market or promote its product candidates in the United States until it receives a Biologics License Application (BLA) from the FDA, or in any jurisdictions outside of the United States until it receives similar authorization from analogous foreign authorities, and it may never receive such regulatory approvals for any of its product candidates.
Some of Elicio’s product candidates have only been tested in a nonclinical setting and while those studies have been subject to certain regulatory requirements in order to support product development and regulatory progression, as such product candidates progress they will require clinical trials (which are subject to much more extensive requirements, including good clinical practice standards), as well as additional manufacturing development, before it will be able to submit marketing applications to the applicable regulatory authorities. Even if its product candidates are approved, they may be subject to limitations on the indicated uses and populations for which they may be marketed. They may also be subject to other conditions of approval, may contain significant safety warnings, including boxed warnings, contraindications, and precautions, may not be approved with label statements necessary or desirable for successful commercialization, or may contain requirements for costly post-market testing and surveillance, or other requirements, including the submission of a risk evaluation and mitigation strategy (REMS) to monitor the safety or efficacy of the products. If Elicio does not receive regulatory authority approval for, and successfully commercialize its product candidates, it will not be able to generate revenue from these product candidates in the foreseeable future, or at all. Any significant delays in obtaining approval for and commercializing its product candidates could have a material adverse impact on its business and financial condition.
The process of product candidate development and obtaining marketing approval is expensive, often takes many years and can vary substantially based upon the type, complexity and novelty of the products involved and the conditions that they are intended to treat. The number and nature of nonclinical studies and clinical trials that will be required for regulatory approval also varies depending on the product candidate, the disease or condition that the product candidate is designed to address and the regulations applicable to any particular product candidate. Elicio has not previously submitted a marketing application to the FDA, or a similar marketing application to any comparable foreign authorities, for any product candidate, and it cannot be certain that its product candidates will be successful in clinical trials or receive regulatory approval.
In addition to significant clinical testing requirements, Elicio’s ability to obtain marketing approval for its product candidates depends on obtaining the final results of required nonclinical testing, including characterization of the manufactured components of its product candidates and validation of its manufacturing processes. Regulatory
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authorities may determine that its product manufacturing processes, testing procedures or facilities are insufficient to justify approval. Approval policies or regulations, or the type and amount of data necessary to gain approval, may change and may vary among jurisdictions. Moreover, regulatory authorities have substantial discretion in the biopharmaceutical approval process, including the ability to refuse to accept an application and to delay, limit or deny approval of a product candidate for many reasons, such as a determination that Elicio’s data is insufficient for approval or that additional nonclinical studies, clinical trials or other data or development work is necessary. Despite the time and expense invested in the development of product candidates, regulatory approval is never guaranteed.
Elicio’s product candidates may fail at any stage of preclinical or clinical development, and may also reveal unfavorable product candidate characteristics, including safety concerns or the failure to demonstrate efficacy in initial clinical trials. Further, its product candidates may not receive regulatory approval even if they are successful in clinical trials. Although Elicio has completed preclinical validation, including toxicology testing and clinical supply manufacturing development for ELI-002 and anticipates completing the preclinical development necessary to file additional INDs for other product candidates in the future, it may experience numerous unforeseen events before, during, or as a result of clinical trials that could delay or prevent its ability to commence or complete development, commence or complete clinical trials, receive marketing approval or commercialize its product candidates, including:
Elicio may be unable to generate sufficient nonclinical, toxicology, or other in vivo or in vitro data to support the initiation of clinical trials;
regulators or IRBs or Independent Ethics Committees (IECs) may not authorize Elicio or its investigators to commence or continue a clinical trial, conduct a clinical trial at a prospective trial site, or amend trial protocols, or may require that it modifies or amends its clinical trial protocols;
Elicio, regulators, independent data safety monitoring committees, IRBs or IECs, or its data monitoring committee(s) may recommend or require the suspension or termination of clinical research for various reasons, including non-compliance with regulatory requirements or a finding that participants are being exposed to unacceptable health risks, undesirable side effects, or a failure of the product candidate to demonstrate any benefit to subjects, or other unexpected characteristics (alone or in combination with other products) of the product candidate, or due to findings of undesirable effects caused by a chemically or mechanistically similar therapeutic or therapeutic candidate;
new information may emerge regarding Elicio’s product candidates or technology platform that result in continued development of some or all of its product candidates being deemed undesirable;
Elicio may have delays identifying, recruiting and training suitable clinical investigators or investigators may withdraw from its studies;
Elicio may experience delays in reaching, or failing to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites or contract research organizations (CROs). Contractual terms can be subject to extensive negotiation, may be subject to modification from time to time and may vary significantly among different CROs and trial sites;
Elicio may have delays in adding new investigators or clinical trial sites, or it may experience a withdrawal of clinical trial sites;
the number of patients required for clinical trials of Elicio’s product candidates may be larger than it anticipates, enrollment in these clinical trials may be slower than it anticipates, or participants may drop out of these clinical trials or be lost to follow-up at a higher rate than it anticipates for a number of reasons, such as adverse events, an inadequate treatment response, fatigue with the clinical trial process or personal issues;
patients who enroll in Elicio’s studies may misrepresent their eligibility or may otherwise not comply with clinical trial protocols, resulting in the need to drop those patients from those studies, increase the needed enrollment size for those studies, or extend the duration of those studies;
there may be flaws in Elicio’s study design, which may not become apparent until a study is well advanced;
Elicio’s contractors may fail to comply with regulatory requirements or clinical trial protocols, or meet their contractual obligations to it in a timely manner, or at all, or it may be required to engage in additional clinical trial site monitoring;
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regulatory authorities or IRBs/IECs may disagree with the design, including endpoints, scope, or implementation of Elicio’s clinical trials, or regulatory authorities may disagree with its intended indications;
regulatory authorities may disagree with the formulation for Elicio’s product candidates, or its product candidate dose or dosing schedule;
Elicio may be unable to demonstrate to the satisfaction of regulatory authorities that a product candidate is safe, pure, and potent for any indication;
regulatory authorities may not accept, or Elicio or its clinical trials may not meet the criteria required to submit, clinical data from trials which are conducted outside of their jurisdictions;
the results of clinical trials may be negative or inconclusive, may not meet the level of statistical significance required for, or may not otherwise be sufficient to support marketing approval, and Elicio may decide, or regulatory authorities may require it, to conduct additional clinical trials, analyses, reports, data, or nonclinical studies, or abandon product development programs;
Elicio’s product candidates may have undesirable or unintended side effects, toxicities, or other characteristics that preclude marketing approval or prevent or limit commercial use;
Elicio may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks or otherwise provide an advantage over current standard of care (SOC) or current or future competitive therapies in development;
the standard of care for the indications Elicio is investigating may change, which changes could impact the meaningfulness of its resulting study data or which may necessitate changes to its studies;
regulatory authorities may disagree with Elicio’s scope, design, including endpoints, implementation, or its interpretation of data from nonclinical studies or clinical trials;
regulatory authorities may require Elicio to amend its studies, perform additional or unanticipated clinical trials or nonclinical studies or manufacturing development work to obtain approval or initiate clinical trials, or it may decide to do so or abandon product development programs;
regulatory authorities may find that Elicio or its third-party manufacturers do not satisfy regulatory requirements and standards for the facilities and operations used in the manufacture of its product candidates;
the cost of clinical trials of Elicio’s product candidates may be greater than it anticipates, or it may have insufficient funds for a clinical trial or to pay the substantial user fees required by the FDA or other regulatory authorities upon the filing of a marketing application;
the supply or quality of Elicio’s product candidates or other materials necessary to conduct clinical trials of its product candidates may be insufficient or inadequate;
regulatory authorities may take longer than Elicio anticipates to make a decision on its product candidates; or
changes in or the enactment of the approval policies, statutes, or regulations of the applicable regulatory authorities may significantly change in a manner rendering Elicio’s nonclinical or clinical data insufficient for approval.
Furthermore, Elicio expects to rely on CROs and clinical trial sites to ensure the proper and timely conduct of its clinical trials and, while it expects to enter into agreements governing their committed activities, it has limited influence over their actual performance.
A clinical trial may be suspended or terminated by Elicio, its partners, the IRBs of the institutions in which such trials are being conducted, the DSMB for such trial or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or Elicio’s clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug or therapeutic biologic, changes in governmental regulations or administrative actions or lack of
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adequate funding to continue the clinical trial. If Elicio experiences delays in the completion of, or termination of, any clinical trial of any of its potential future product candidates, the commercial prospects of such product candidate will be harmed, and its ability to generate product revenue from such product candidates will be delayed. In addition, any delays in completing its clinical trials will increase its costs, slow its product development and approval process and jeopardize its ability to commence product sales and generate revenue, and it may not have the financial resources to continue development of the product candidate that is affected or any of its other product candidates. It may also lose, or be unable to enter into, collaborative arrangements for the affected product candidate and for other product candidates that it is developing. Any of these occurrences may materially and adversely affect Elicio’s business, financial condition, results of operations and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of its potential future product candidates.
Preliminary results from Elicio’s nonclinical studies and clinical trials that it announces or publishes from time to time may change as more patient data becomes available and as the data undergoes audit and verification procedures.
From time to time, Elicio may publish interim, topline, or preliminary results from its nonclinical studies and clinical trials. Preliminary and interim results from its clinical trials are not necessarily predictive of final results and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary, interim and topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data it previously published. As a result, preliminary, interim and topline data should be viewed with caution until the final data are available. Material adverse changes in the final data compared to the preliminary, interim or topline data could significantly harm Elicio’s business prospects.
Further, others, including regulatory agencies, may not accept or agree with Elicio’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or therapeutic product, if any, and Elicio in general. In addition, the information it chooses to publicly disclose regarding a particular nonclinical study or clinical trial is based on what is typically extensive information, and you or others may not agree with what it determines is the material or otherwise appropriate information to include in its disclosure, and any information it determines not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular therapeutic product, if any, product candidate or its business. If the preliminary, interim and topline data that it reports differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, its ability to obtain approval for, and commercialize, its product candidates may be harmed, which could harm its business, operating results, prospects or financial condition.
The FDA or comparable foreign regulatory authorities may disagree with Elicio’s regulatory plans and it may fail to obtain regulatory approval of its product candidates.
The FDA standard for approval of a biologic generally requires two adequate, well-controlled clinical trials, each convincingly demonstrating the product candidate’s safety and effectiveness, or one large and robust, well-controlled trial providing substantial evidence that the product candidate is safe and effective for its proposed indication. Phase 3 clinical trials typically involve hundreds of patients, have significant costs and take years to complete. Product candidates studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may be eligible for accelerated approval and may be approved on the basis of adequate and well-controlled clinical trials establishing that the product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA usually requires a sponsor of a drug or biologic receiving accelerated approval to perform post-marketing studies to verify and describe the predicted effect on irreversible morbidity or mortality or other clinical endpoint, and the drug or biologic may be subject to withdrawal procedures by the FDA that are more accelerated than those available for regular approvals.
Elicio’s clinical trial results may not support either accelerated or regular approval. The results of nonclinical studies and clinical trials may not be predictive of the results of later-stage clinical trials, and product candidates in
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later stages of clinical trials may fail to show the desired safety and efficacy despite having progressed through nonclinical studies and initial clinical trials. In addition, Elicio’s product candidates could fail to receive regulatory approval for many reasons, including the following:
the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of Elicio’s clinical trials;
the population studied in the clinical program may not be sufficiently broad or representative to assure safety in the full population for which Elicio seeks approval;
Elicio may be unable to demonstrate that its product candidates’ risk-benefit ratios for their proposed indications are acceptable;
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
Elicio may be unable to demonstrate that the clinical and other benefits of its product candidates outweigh their safety risks;
the FDA or comparable foreign regulatory authorities may disagree with Elicio’s interpretation of data from nonclinical studies or clinical trials;
the data collected from clinical trials of Elicio’s product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes, Elicio’s own manufacturing facilities, or a third-party manufacturer’s facilities with which it contracts for clinical and commercial supplies; and
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering Elicio’s clinical data insufficient for approval.
Failure to obtain regulatory approval to market any of Elicio’s product candidates would significantly harm its business, results of operations, and prospects.
Elicio may not be successful in its efforts to use and expand its discovery engine to build a pipeline of product candidates.
A key element of Elicio’s strategy is to use and expand its discovery engine to build a pipeline of product candidates and progress these product candidates through preclinical and clinical development for the treatment of various diseases. Although its research efforts to date suggest that complex amphiphilic molecules can deliver conventional immunomodulatory payloads including peptides, proteins and nucleic acids directly and preferentially to lymph nodes, this hypothesis may prove incorrect, or Elicio may not be able to identify a product candidate that is safe or effective as a treatment for various cancers or for other diseases. It also may not be able to identify an amphiphile product candidate that it can demonstrate to be safe or effective, and it may not be able to develop any other product candidates. Its scientific research that forms the basis of its efforts to discover product candidates based on its discovery engine is ongoing. Further, the scientific evidence to support the feasibility of developing viable product candidates based on its platform has not been established. Elicio’s discovery engine may not be proven to be superior to competing technologies.
Even if Elicio is successful in building its pipeline of product candidates, the potential product candidates that it identifies may not be suitable for clinical development or generate acceptable clinical data, including as a result of being shown to have unacceptable toxicity or other characteristics that indicate that they are unlikely to be products that will receive marketing approval from the FDA or other regulatory authorities or achieve market acceptance. Investment in biopharmaceutical product development involves significant risk that any potential product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval, and become commercially viable. Elicio cannot provide you any assurance that it will be able to successfully advance any of these additional product candidates through the development process. Its research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development or commercialization for many reasons, including the following:
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Elicio’s platform may not be successful in identifying additional product candidates;
Elicio may not be able or willing to assemble sufficient resources to acquire or discover additional product candidates;
Elicio’s product candidates may not succeed in nonclinical or clinical testing;
a product candidate may upon further study demonstrate harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;
competitors may develop alternatives that render Elicio’s product candidates obsolete or less attractive;
product candidates Elicio develops may nevertheless be covered by third parties’ patents or other exclusive rights;
the market for a product candidate may change during Elicio’s program so that the continued development of that product candidate is no longer reasonable;
a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and
a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if applicable.
If any of these events occur, Elicio may be forced to abandon its development efforts for a program or programs, or it may not be able to identify, discover, develop, or commercialize additional product candidates, which would have a material adverse effect on its business and could potentially cause it to cease operations. Even if it receives FDA approval to market additional product candidates, whether for the treatment of cancers or other diseases, it cannot assure you that any such product candidates will be successfully commercialized, widely accepted in the marketplace or more effective than other commercially available alternatives.
Elicio’s Phase 1 study of ELI-002 is designed to require, as part of screening to determine whether subjects meet inclusion criteria, the use of an investigational in vitro diagnostic device. If Elicio is not able to successfully collaborate or partner with a third-party company for the development and authorization of such a device, Elicio may not be able to receive marketing authorization for ELI-002.
The Phase 1 trial for ELI-002 (AMPLIFY-201) employs an investigational in vitro diagnostic device, or IVD, that identifies gene mutations in KRAS and NRAS and detects circulating tumor DNA, or ctDNA, to identify patients who show signs of minimal residual disease in their blood, but before relapse is detected in traditional radiographic scans. Based on Elicio’s Phase 1 study design, it must account for and address the investigational status of this device from a regulatory perspective through the course of clinical development (for example, through the compliance with any applicable investigational device exemption requirements). Additionally, because this IVD will be used to select patients who may be appropriate to receive Elicio’s product candidate, the test will be considered a companion diagnostic device. Companion diagnostic devices are subject to regulation by the FDA and comparable foreign regulatory authorities as medical devices and Elicio anticipates that separate regulatory marketing authorization will be required for the device prior to commercialization of ELI-002. Elicio plans to collaborate with appropriate companion diagnostic developers to seek marketing authorization from the FDA’s Center for Devices and Radiological Health, or CDRH. If Elicio’s companion diagnostic partner experiences any delays in development or is not able to successfully develop and obtain marketing authorization for its companion diagnostic, or does not comply with the FDA’s medical device regulations:
the development of ELI-002 may be delayed because it may be difficult to identify patients for enrollment in Elicio’s clinical trials in a timely manner;
ELI-002 may not receive marketing approval if its safe and effective use depends on a companion diagnostic and none is commercially available; and
Elicio may not realize the full commercial potential of ELI-002 if it receives marketing approval if, among other reasons, it is unable to appropriately identify patients or types of tumors with the specific genetic alterations targeted by these product candidates.
Even if ELI-002 and any associated companion diagnostics are approved for marketing, the need for companion diagnostics may slow or limit adoption of ELI-002. Although Elicio believes genetic testing is becoming more
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prevalent in the diagnosis and treatment of cancer, ELI-002 may be perceived negatively compared to alternative treatments that do not require the use of companion diagnostics, either due to the additional cost of the companion diagnostic or the need to complete additional procedures to identify biomarkers prior to administering Elicio’s product candidates.
If any of these events were to occur, Elicio’s business and growth prospects would be harmed, possibly materially.
Elicio may seek designations under FDA programs designed to facilitate and potentially expedite product candidate development, such as fast track or breakthrough therapy designation. Its product candidates may not receive any such designations or if they do receive such designations they may not lead to faster development or regulatory review or approval and it does not increase the likelihood that its product candidates will receive marketing approval.
Elicio may seek designations under the FDA’s expedited programs for serious conditions, such as fast track or breakthrough therapy designation, which are intended to facilitate and expedite the development or regulatory review or approval process for product candidates. Descriptions of the fast track and breakthrough therapy designations are included under “Description of Elicio’s Business—Government Regulation and Product Approval—FDA Regulation—Fast Track, Breakthrough Therapy and Priority Review Designations.”
The granting of fast track or breakthrough therapy designation to an investigational product is entirely within the FDA’s discretion. Accordingly, even if Elicio believes one of its product candidates meets the criteria for a designation, the FDA may disagree and instead determine not to grant such designation. In any event, the receipt of a fast track or breakthrough therapy designation for a product candidate may not result in a faster development process, review, or approval compared to product candidates considered for approval under conventional FDA procedures and does not assure ultimate marketing approval by the FDA. In addition, the FDA may later decide that the product candidate no longer meets the designation conditions, in which case any granted designations may be revoked, or the agency may decide that the time period for review or approval of the product candidate will not be shortened.
If Elicio is unable to obtain approval via the accelerated approval pathway, it may be required to conduct additional nonclinical studies or clinical trials. Even if it receives accelerated approval from the FDA, the FDA may seek to withdraw accelerated approval.
Elicio may seek an accelerated approval development pathway for its product candidates. See “Description of Elicio’s Business—Government Regulation and Product Approval—FDA Regulation—Accelerated Approval Pathway” for a description of the accelerated approval pathway.
If Elicio chooses to pursue accelerated approval, it intends to seek feedback from the FDA or will otherwise evaluate its ability to seek and receive such accelerated approval. After Elicio’s evaluation of the feedback from the FDA or other factors, it may decide not to pursue or submit a BLA for accelerated approval or any other form of expedited development, review or approval. Furthermore, if it submits an application for accelerated approval, there can be no assurance that such application will be accepted or that approval will be granted on a timely basis, or at all. The FDA also could require Elicio to conduct further studies or trials prior to considering its application or granting approval of any type, and may require it to have a confirmatory trial to verify the clinical benefit of the product underway and partially or fully enrolled before granting approval. Elicio might not be able to fulfill the FDA’s requirements in a timely manner, which would cause delays, or approval might not be granted because its submission is deemed incomplete by the FDA.
Even if Elicio receives accelerated approval from the FDA, it will be subject to rigorous post-marketing requirements, including the completion of confirmatory post-market clinical trials, submission to the FDA of periodic progress reports on confirmatory trials, and submission to the FDA of all promotional materials prior to their dissemination. The FDA could seek to withdraw accelerated approval for multiple reasons, including if Elicio fails to conduct any required post-market study with due diligence; a post-market study does not confirm the predicted clinical benefit; other evidence shows that the product is not safe or effective under the conditions of use; or Elicio disseminates promotional materials that are found by the FDA to be false and misleading. Under the Consolidated Appropriations Act for 2023, the FDA may use expedited procedures to withdraw any product for which Elicio receives accelerated approval if its confirmatory trials fail to verify the purported clinical benefits.
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A failure to obtain accelerated approval or any other form of expedited development, review or approval for a product candidate that Elicio may choose to develop would delay its commercialization of such product candidate, could increase the cost of development of such product candidate and could harm its competitive position in the marketplace.
If Elicio applies for orphan drug designation from the FDA, there is no guarantee that it will be able to obtain or maintain this designation, receive this designation for any of its other product candidates, or receive or maintain any corresponding benefits, including periods of exclusivity.
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States when there is no reasonable expectation that the cost of developing and making available the drug or biologic in the United States will be recovered from sales in the United States for that drug or biologic. Orphan drug designation must be requested before submitting a BLA. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages, and user-fee waivers. After the FDA grants orphan drug designation, the generic identity of the drug and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
If a product that has orphan drug designation subsequently receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve any other applications, including a BLA, to market the same biologic for the same indication for seven years, except in limited circumstances such as a showing of clinical superiority to the product with orphan drug exclusivity or if FDA finds that the holder of the orphan drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs of patients with the disease or condition for which the drug was designated. As a result, even if one of Elicio’s drug candidates receives orphan exclusivity, the FDA can still approve other drugs that have a different active ingredient for use in treating the same indication or disease. Furthermore, the FDA can waive orphan exclusivity if Elicio is unable to manufacture sufficient supply of its product.
Elicio plans to seek orphan drug designation for some or all of its product candidates in specific orphan indications for which there is a medically plausible basis for their use, but exclusive marketing rights in the United States may be limited if Elicio seeks approval for an indication broader than the orphan designated indication and may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. In addition, although Elicio intends to seek orphan drug designation for other product candidates, it may never receive such designations.
Elicio may expend its limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
Because Elicio has limited financial and managerial resources, it focuses on research programs and product candidates that it identifies for specific indications. As a result, it may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. its resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities. Its spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products. If Elicio does not accurately evaluate the commercial potential or target market for a particular product candidate, it may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for it to retain sole development and commercialization rights to such product candidate.
Any future product candidates for which Elicio intends to seek approval as biologic products may face competition sooner than anticipated.
Even if Elicio is successful in achieving regulatory approval to commercialize a product candidate ahead of its competitors, its product candidates may face competition from biosimilar products. In the United States, Elicio’s amphiphile product candidates are expected to be regulated by the FDA as biological products, and Elicio intends to
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seek approval for these product candidates pursuant to the BLA pathway. The enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar and interchangeable biological products based on a previously licensed reference product. Under the BPCIA, an application for a biosimilar biological product cannot be approved by the FDA until 12 years after the original reference biological product was approved under a BLA. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain when such processes intended to implement BPCIA may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for Elicio’s product candidates.
Elicio believes that any of its product candidates approved as a biological product under a BLA should qualify for the 12-year period of exclusivity available to reference biological products. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider Elicio’s product candidates to be reference biological products pursuant to its interpretation of the exclusivity provisions of the BPCIA for competing products, potentially creating the opportunity for generic follow-on biosimilar competition sooner than anticipated. Moreover, the extent to which a biosimilar product, once approved, will be substituted for any one of Elicio’s reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing including whether a future competitor seeks an interchangeability designation for a biosimilar of one of Elicio’s products. Under the BPCIA as well as state pharmacy laws, only interchangeable biosimilar products are considered substitutable for the reference biological product without the intervention of the health care provider who prescribed the original biological product. However, as with all prescribing decisions made in the context of a patient-provider relationship and a patient’s specific medical needs, health care providers are not restricted from prescribing biosimilar products in an off-label manner. In addition, a competitor could decide to forego the abbreviated approval pathway available for biosimilar products and to submit a full BLA for product licensure after completing its own nonclinical studies and clinical trials. In such a situation, any exclusivity for which Elicio’s products candidates may be eligible under the BPCIA would not prevent the competitor from marketing its biological product as soon as it is approved.
In Europe, the European Commission has granted marketing authorizations for several biosimilar products pursuant to a set of general and product class-specific guidelines for biosimilar approvals issued over the past few years. In addition, companies may be developing biosimilar products in other countries that could compete with Elicio’s products, if approved.
If competitors are able to obtain marketing approval for biosimilars referencing Elicio’s product candidates, if approved, Elicio’s future products may become subject to competition from such biosimilars, whether or not they are designated as interchangeable, with the attendant competitive pressure and potential adverse consequences. Such competitive products may be able to immediately compete with Elicio in each indication for which its product candidates may have received approval.
If Elicio encounters difficulties enrolling patients in its clinical trials, its clinical development activities could be delayed or otherwise adversely affected.
Elicio may experience difficulties in patient enrollment in its clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on Elicio’s ability to enroll a sufficient number of subjects who remain in the trial until its conclusion. Elicio may not be able to initiate or continue conducting clinical trials for its product candidates if it is unable to locate and enroll a sufficient number of eligible subjects to participate in these trials. The enrollment of patients depends on many factors, including:
the number of clinical trials for other product candidates in the same therapeutic area that are currently in clinical development, and Elicio’s ability to compete with such trials for subjects and clinical trial sites;
the severity of the disease under investigation and the existence of current treatments;
the perceived risks and benefits of the product candidate, including the potential advantages or disadvantages of the product candidate being studied in relation to other available therapies;
the subject eligibility criteria defined in the protocol, as well as Elicio’s ability to compensate subjects for their time and effort;
the size and nature of the patient population;
the proximity and availability of clinical trial sites for prospective subjects;
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the design of the trial, including factors such as frequency of required assessments, length of the study and ongoing monitoring requirements;
subjects’ and investigators’ ability to comply with the specific instructions related to the trial protocol, proper documentation, and use of the product candidate;
Elicio’s ability to recruit clinical trial investigators with the appropriate competencies and experience;
patient referral practices of physicians and the effectiveness of publicity created by clinical trials sites regarding the trial;
the ability to adequately monitor subjects during and after treatment and compensate them for their time and effort;
the ability of Elicio’s clinical study sites, CROs, and other applicable third parties to facilitate timely enrollment;
the ability of clinical trial sites to enroll subjects that meet all inclusion criteria and any patient exclusion due to erroneous enrollment;
Elicio’s ability to obtain and maintain subject informed consents; and
the risk that subjects enrolled in clinical trials will drop out of the trials before completion of the study or not return for post-study follow-up, especially subjects in control groups.
In addition, Elicio’s clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as its product candidates, and this competition will reduce the number and types of patients available to it, because some patients who might have opted to enroll in Elicio’s trials may instead opt to enroll in a trial being conducted by one of its competitors. Because the number of qualified clinical investigators is limited, Elicio may conduct some of its clinical trials at the same clinical trial sites that some of its competitors use, which will reduce the number of patients who are available for its clinical trials at such clinical trial sites. Moreover, because its product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use conventional therapies, such as chemotherapy, rather than enroll patients in any future clinical trial.
Elicio’s inability to enroll a sufficient number of subjects for its clinical trials would result in significant delays and could require it to abandon one or more clinical trials altogether. Moreover, a significant number of withdrawn subjects would compromise the quality of its data. Enrollment delays in its clinical trials may result in increased development costs for its product candidates, or the inability to complete development of its product candidates, which could cause the value of its company to decline, limit its ability to obtain additional financing, and materially impair its ability to generate revenues.
Any product candidate Elicio advances into clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent its regulatory approval or commercialization or limit its commercial potential.
As with most biological products, use of Elicio’s product candidates could be associated with side effects or adverse events, which can vary in severity from minor reactions to death and in frequency from infrequent to prevalent. Undesirable side effects caused by any potential future product candidate could cause regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities. While Elicio has only recently initiated the AMPLIFY-201 trial, and it has not yet initiated clinical trials for any potential future product candidates, it is likely that there will be side effects associated with their use. Results of its clinical trials could reveal a high and unacceptable severity and prevalence of these side effects. In such an event, its trials could be suspended or terminated, and the FDA or other regulatory authorities could order it to cease further development of or deny approval of a product candidate for any or all targeted indications. Such side effects could also affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may materially and adversely affect Elicio’s business and financial condition and impair its ability to generate revenues.
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Further, clinical trials by their nature utilize a sample of the potential patient population. With a limited number of patients and limited duration of exposure, rare and severe side effects of a product candidate may only be uncovered when a significantly larger number of patients are exposed to the product candidate or when patients are exposed for a longer period of time.
If one or more of Elicio’s product candidates receives marketing approval, and Elicio or others later identify undesirable side effects caused by such products, including during any long-term follow-up observation period recommended or required for patients who receive treatment using Elicio’s products, a number of potentially significant negative consequences could result, including:
regulatory authorities may withdraw or limit their approvals of such products;
regulatory authorities may require the addition of labeling statements, specific warnings or contraindications;
Elicio may be required to create a REMS plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for health care providers, and/or other elements to assure safe use;
Elicio may be required to change the way such products are distributed or administered, or change the labeling of the products;
the FDA or a comparable foreign regulatory authority may require Elicio to conduct additional clinical trials or costly post-marketing testing and surveillance to monitor the safety and efficacy of the products;
Elicio may decide to recall such products from the marketplace after they are approved;
Elicio could be sued and held liable for harm caused to individuals exposed to or taking its products; and
Elicio’s reputation may suffer.
In addition, adverse side effects caused by any therapeutics that may be similar in nature to Elicio’s product candidates could delay or prevent regulatory approval of its product candidates, limit the commercial profile of an approved label for its product candidates, or result in significant negative consequences for its product candidates following marketing approval.
Any of these events could prevent Elicio from achieving or maintaining market acceptance of the affected product candidates and could substantially increase the costs of commercializing its product candidates, if approved, and significantly impact its ability to successfully commercialize its product candidates and generate revenues.
Elicio may form or seek strategic partnerships or enter into additional licensing arrangements in the future, and it may not realize the benefits of such alliances or licensing arrangements.
From time to time, Elicio may form or seek strategic partnerships or collaborations or enter into additional licensing arrangements with third parties that it believes will complement or augment its development and commercialization efforts with respect to its product candidates and any future product candidates that it may develop. Any such relationships may require it to incur non-recurring and other charges, increase its near and long-term expenditures, issue securities that dilute its existing stockholders or disrupt its management and business. These relationships also may result in a delay in the development of its product candidates if it becomes dependent upon the other party and such other party does not prioritize the development of Elicio’s product candidates relative to its other development activities. Additionally, any collaborations, or licensing arrangements would be subject to the same product candidate development and compliance risks and obligations as Elicio would be if it were to develop the product candidate on its own. Should any third party with which it enters into any of these arrangements not comply with the applicable regulatory requirements, it or they may be subject to regulatory enforcement action and it or they may be delayed or prevented from obtaining marketing approval for the applicable product candidate.
In addition, Elicio faces significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, Elicio may not be successful in its efforts to establish a strategic partnership or other alternative arrangement for its product candidates because they may be deemed to be at too early of a stage of development for collaborative effort, and third parties may not view its product candidates as having the requisite potential to demonstrate safety and efficacy. If Elicio licenses products or acquires businesses, it may not be able to realize the benefit of such transactions if it is unable to successfully integrate them with its existing
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operations and company culture. Any licensed products or acquired businesses may also subject Elicio to the risk of regulatory enforcement should the product or business not be compliant with applicable regulatory requirements. Elicio cannot be certain that, following a strategic transaction or licensing arrangement, it will achieve the revenue or specific net income that justifies such a transaction.
Elicio relies on contract manufacturing organizations to manufacture its nonclinical and clinical pharmaceutical supplies and expects to continue to rely on CMOs to produce commercial supplies of any approved product candidate, and its dependence on CMOs could adversely impact its business.
Elicio relies on contract manufacturing organizations (CMOs) for the manufacture of nonclinical and clinical supplies for its product candidates and plans to continue to do so for commercial supplies should it receive marketing approval for any of its product candidates. This reliance also results in its reduced control over the manufacture of its product candidates and the protection of its trade secrets and know-how from misappropriation or inadvertent disclosure, which may adversely affect its future business prospects. Nevertheless, as the developer of the product candidates and sponsor of clinical trials involving such product candidates, it continues to have regulatory obligations to maintain oversight of the CMOs to ensure compliance with, among other things, contractual obligations, specifications, and cGMP.
In complying with the manufacturing regulations of the FDA and other comparable foreign regulatory authorities, Elicio and its third-party suppliers must spend significant time, money and effort in the areas of design and development, testing, production, record-keeping and quality control to assure that the products meet applicable specifications and other regulatory requirements. Although its agreements with its CMOs require them to perform according to certain cGMP such as those relating to quality control, quality assurance and qualified personnel, Elicio cannot control the conduct of its CMOs to implement and maintain these standards. If its CMOs do not successfully carry out their contractual duties, meet expected deadlines or manufacture its product candidates in accordance with regulatory requirements, if there are disagreements between Elicio and such parties, or if such parties are unable to support the commercialization of any of its product candidates for which it obtains marketing approval, it may not be able to produce, or may be delayed in producing sufficient product to meet its supply requirements. Any delays in obtaining adequate supplies on adequate terms with respect to Elicio’s product candidates and components, due to manufacturing issues, global trade policies, or for other reasons, may delay the development, approval, or commercialization of its product candidates.
Elicio may not succeed in its efforts to establish manufacturing relationships on commercially reasonable terms. Its product candidates may compete with other products and product candidates for access to manufacturing facilities, of which there are a limited number that operate under cGMP conditions and that are both capable of manufacturing its product candidates and willing to do so. Even if it does establish such collaborations or arrangements, its CMOs may breach, terminate, or not renew these agreements. These facilities may also be affected by the ongoing COVID-19 pandemic, natural disasters, such as floods or fires, or such facilities could face manufacturing issues, such as contamination or adverse regulatory findings following a regulatory inspection. Further, Elicio’s CMOs may be temporarily unable to manufacture its product candidates due to government restrictions, requirements, or limitations. If its CMOs cease to manufacture its product candidates for any reason, Elicio would experience delays in obtaining sufficient quantities of its product for it to meet commercial demand if it receives marketing approval or in advancing its development programs while it identifies and qualifies replacement suppliers. Elicio could also incur added costs and delays in identifying and qualifying any such replacements and transferring any necessary technology and processes. The terms of a new arrangement may also be less favorable than any prior arrangements, if it is able to negotiate a new arrangement at all. The addition of a new or alternative CMO may also require FDA approval and may have a material adverse effect on its business.
Elicio or its CMOs may also encounter shortages in the raw materials or substances necessary to produce its product candidates in the quantities and at the quality needed for its nonclinical studies and clinical trials or, if any of its product candidates are approved for commercialization, to produce its products on a commercial scale, meet an increase in demand, or compete effectively. Such shortages may occur for a variety of reasons, including capacity constraints, delays or disruptions in the market, and shortages caused by the purchase of such materials by its competitors or others. Elicio’s or its third-party manufacturers’ failure to obtain the raw materials or substances necessary to manufacture sufficient quantities of its product candidates may have a material adverse effect on its business.
Moreover, any problems or delays Elicio experiences in preparing for commercial-scale manufacturing of a product candidate or component, including manufacturing validation, may result in a delay in a future marketing
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approval, if any, or commercial launch of any of its product candidates, should they receive regulatory approval, or may impair its ability to manufacture commercial quantities or manufacture such quantities at an acceptable cost, which could result in the delay, prevention, or impairment of commercialization of its product candidates, if approved, and could adversely affect its business. Furthermore, if the future manufacturers of the commercial supplies of its products, if approved, fail to deliver the required commercial quantities of its product candidates on a timely basis and at commercially reasonable prices, it would likely be unable to meet demand for its products and it could lose potential revenues. The manufacture of biological products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of biologics often encounter difficulties in production, particularly in scaling up initial production. These problems include difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel, and compliance with strictly enforced federal, state, and foreign regulations. If Elicio’s manufacturers were to encounter any of these difficulties and were unable to perform as agreed, its ability to provide its product candidates for use in nonclinical studies or its current and planned clinical trials, or, if any of its product candidates are approved, its ability to produce its product for commercial use, could be jeopardized.
In addition, all manufacturers of Elicio’s product candidates used in clinical trials and of its products for commercial supply, should any of Elicio’s product candidates receive regulatory approval, must comply with cGMP regulations promulgated by the FDA and equivalent foreign regulatory authorities that are applicable to both finished products and their active components used both for clinical and commercial supply. Regulatory authorities enforce these requirements through facility inspections. CMO facilities must be satisfactory to the FDA and equivalent foreign regulatory authorities as determined by inspections that will be conducted after Elicio submits its marketing applications to the appropriate agencies and prior to product approval and commercialization. Its CMOs will also be subject to continuing, periodic regulatory authority inspections should its product candidates receive marketing approval. Further, Elicio, in cooperation with its CMOs, must supply all necessary chemistry, manufacturing, and control documentation to the FDA and equivalent foreign regulatory authorities in support of a marketing application on a timely basis.
The cGMP include quality control, quality assurance, and the maintenance of records and documentation. Manufacturers of Elicio’s product candidates may be unable to comply with its specifications, cGMP or with other applicable regulatory requirements. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of a product candidate that may not be detectable in final product testing. If its CMOs cannot successfully manufacture material that conforms to its specifications and the applicable regulatory requirements, they may not be able to secure or maintain regulatory acceptance of their manufacturing facilities for the purpose of producing Elicio’s product candidates.
Deviations from manufacturing requirements may also require reporting and remedial measures that may be costly and/or time-consuming for Elicio or a third party to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales, if any of its product candidates receives regulatory approval, or the temporary or permanent closure of a facility. Any such remedial measure could materially harm its business. Any delay in obtaining products or product candidates that comply with the applicable regulatory requirements may result in delays to nonclinical studies and clinical trials, or potential product approvals or commercialization. Any such delay may also require that Elicio conducts additional studies.
While Elicio is ultimately responsible for the manufacture and regulatory compliance of its products and product candidates, it has little control over its manufacturers’ compliance with these regulations and standards other than through its contractual arrangements. If the FDA or a comparable foreign regulatory authority does not find these facilities satisfactory for the manufacture of its products, if approved, or product candidates or if such authorities find such facilities to be noncompliant in the future, Elicio may need to find alternative manufacturing facilities, which would significantly impact its ability to develop, obtain and maintain regulatory approval for or market its product candidates, if approved. Any new manufacturers would need to either obtain or develop the necessary manufacturing know-how, and obtain the necessary equipment and materials, which may take substantial time and investment. Elicio must also receive FDA or other relevant comparable regulatory authority approval for the use of any new manufacturers for commercial supply.
Elicio’s failure, or the failure of its third-party manufacturers, to comply with applicable regulatory requirements may result in regulatory enforcement actions against its manufacturers or itself, including fines and civil and criminal penalties, including suspension of or restrictions on production, injunctions, delay, withdrawal or denial of product
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approval or supplements to approved products, clinical holds or termination of clinical studies, warning or untitled letters, regulatory authority communications warning the public about safety issues with a product, refusal to permit the import or export of a product, product seizure, detention, or recall, operating restrictions, civil penalties, criminal prosecution, corporate integrity agreements, or consent decrees and equivalent foreign sanctions. Depending on the severity of any potential regulatory action, supplies of its product candidates or products, if approved, could be interrupted or limited, which could have a material adverse effect on its business.
Elicio relies on third parties to conduct some of its nonclinical studies and all of its clinical trials. If these third parties do not meet its deadlines or otherwise conduct the trials as required, its development programs could be delayed or unsuccessful and it may not be able to obtain regulatory approval for or commercialize its product candidates when expected or at all.
Elicio does not have the ability to conduct all aspects of its clinical trials itself and does not currently plan to independently conduct clinical trials. It uses third parties, such as CROs, to conduct, supervise, and monitor the AMPLIFY-201 trial and will rely upon such CROs, as well as medical institutions, investigators and consultants, to conduct this trial and any future clinical trials that it may conduct in accordance with its protocols and applicable laws and regulations. In addition, it occasionally uses third parties to conduct its nonclinical studies. Elicio’s CROs, investigators and other service providers play a significant role in the conduct of these trials and the subsequent collection and analysis of data from such trials.
Elicio’s service providers are not its employees and, except for remedies available to it under its agreements with such third parties, as a result it will have less control over the timing, quality and other aspects of such nonclinical studies and clinical trials than it would have if it were to conduct them on its own. If these third parties do not successfully carry out their contractual duties to Elicio, meet Elicio’s expected timelines or conduct its nonclinical studies or clinical trials in accordance with regulatory requirements or its stated protocols, if they need to be replaced or if the quality or accuracy of the data they obtain is compromised due to their failure to adhere to Elicio’s protocols or applicable regulatory requirements or for other reasons, Elicio’s trials may need to be repeated, extended, delayed, or terminated. Further, Elicio may not be able to obtain, or may be delayed in obtaining, marketing approvals for its product candidates, it may fail or be delayed in its efforts to successfully commercialize its product candidates, if approved. Such failures may also subject Elicio or its third-party service providers to regulatory enforcement actions. As a result, Elicio’s results of operations and the commercial prospects for its product candidates could be harmed, its costs could increase and its ability to generate revenues could be delayed. To the extent it is unable to successfully identify and manage the performance of service providers in the future, its business may be materially and adversely affected. Elicio’s third-party service providers may also have relationships with other entities, some of which may be its competitors, for whom they may also be conducting trials or other therapeutic development activities that could harm its competitive position.
Agreements with third parties conducting or otherwise assisting with Elicio’s nonclinical studies or clinical trials might terminate for a variety of reasons, including a failure to perform by such parties. If any of its relationships with these third parties terminate, it may not be able to enter into arrangements with suitable alternative providers or do so on commercially reasonable terms. Switching or adding third parties involves additional cost and requires management time and focus. There is also a natural transition period when a new third party commences work. As a result, if Elicio needs to enter into alternative arrangements, it could delay its product development activities and adversely affect its business. Although it carefully manages its relationships with its third parties, there can be no assurance that it will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on its business, financial condition and prospects, and results of operations.
Elicio’s reliance on third parties for development activities will reduce its control over these activities. Nevertheless, Elicio is responsible for ensuring that each of its studies is conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and its reliance on third parties does not relieve it of its oversight and regulatory responsibilities. For example, it will remain responsible for ensuring that each of its trials is conducted in accordance with the general investigational plan and protocols for that trial. Elicio must also ensure that its nonclinical studies are conducted in accordance with good laboratory practice (GLP) requirements, as appropriate. Moreover, the FDA and comparable foreign regulatory authorities require it to comply with established good clinical practice (GCP) standards for conducting, recording, and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial participants are protected. In addition, Elicio’s clinical trials must be conducted with product candidates that were produced under cGMP conditions. Regulatory authorities enforce these requirements through periodic inspections of trial sponsors,
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clinical and nonclinical investigators, manufacturers, and trial sites. If Elicio or any of its third-party service providers fails to comply with applicable regulatory requirements, it or they may be subject to enforcement or other legal actions, the data generated in its trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require it to perform additional studies, which may significantly delay its clinical development plans and the regulatory approval process. Elicio cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that Elicio, its third-party service providers, or clinical trial sites is in substantial compliance with the applicable regulatory requirements.
In addition, Elicio will be required to report certain financial interests of its third-party investigators if these relationships exceed certain financial thresholds or meet other criteria. The FDA or comparable foreign regulatory authorities may question the integrity of the data from those clinical trials conducted by investigators who may have conflicts of interest. Elicio is also required to register certain clinical trials and post the results of certain completed clinical trials on a government-sponsored database, clinicaltrials.gov, within specified timeframes. Failure to do so can result in enforcement actions and adverse publicity.
Elicio relies on other third parties to store and distribute its product candidates for nonclinical studies and clinical trials that it conducts.
Elicio also relies on other third parties to store and distribute its product candidates for the nonclinical studies and clinical trials that it is conducting or plan to conduct. Any performance failure, or failure to comply with applicable regulations, on the part of its distributors could delay development, the regulatory approval process, or potential commercialization of its product candidates, producing additional losses and depriving it of potential product revenue.
Elicio may incur substantial product liability or indemnification claims relating to the clinical testing of its product candidates.
Elicio faces an inherent risk of product liability exposure related to the testing of its product candidates in human clinical trials, and claims could be brought against it if the use or misuse of one of its product candidates causes, or merely appears to have caused, personal injury or death. Elicio will face an even greater risk of product liability if it receives marketing approval for and commercialize any of its product candidates. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. Product liability claims might be brought against it by consumers, health care providers or others using, administering or selling its products.
Any claims against Elicio, regardless of their merit, could severely harm its financial condition, strain its management and other resources or destroy the prospects for commercialization of the product which is the subject of any such claim. For instance, product liability claims may result in:
loss of revenue from decreased demand for Elicio’s products and/or product candidates;
impairment of Elicio’s business reputation or financial stability;
incurred costs and time of related litigation;
substantial monetary awards to patients or other claimants, and loss of revenue;
diversion of management attention;
withdrawal of clinical trial participants and potential termination of clinical trial sites or entire clinical programs;
the inability to commercialize Elicio’s product candidates;
significant negative media attention;