UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (date of earliest event reported)
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||||||||
(Address of Principal Executive Offices) | (Zip Code) | |||||||||||||
(415 ) 655-4899
Registrant's telephone number, including area code
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition
On August 12, 2021, Angion Biomedica Corp., a Delaware corporation (the “Company”), issued a press release announcing the Company’s financial results for the fiscal quarter ended June 30, 2021. The press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
The information furnished with this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit Number | Exhibit Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ANGION BIOMEDICA CORP. | |||||||||||||||||
| By: | /s/ JAY R. VENKATESAN, M.D. | ||||||||||||||||
Date: August 12, 2021 | Jay R. Venkatesan, M.D. President and Chief Executive Officer and Director | ||||||||||||||||
Angion Provides Corporate Update and Reports Second Quarter 2021 Financial Results
--Topline data in ANG-3777 Phase 3 study now expected to be announced in early Q4 rather than at year end
-- Phase 1 data demonstrated ANG-3070 was well-tolerated across dose cohorts, achieving drug exposures in humans exceeding exposures in which activity was demonstrated in animal models of proteinuric kidney diseases
-- A global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases will begin enrolling patients this year
Uniondale, NY – August 12, 2021 – Angion Biomedica Corp (NASDAQ:ANGN), a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases, today provided a corporate update and reported financial results for the quarter ended June 30, 2021.
“I’m excited to announce we are pulling forward the planned release of topline data from the ANG-3777 Phase 3 trial in transplant-associated acute kidney injury, also known as delayed graft function (DGF), to early in the fourth quarter of 2021 because data cleaning for the clinical trial database is being completed faster than expected. We now expect the Phase 3 DGF trial to be the next data release from the ANG-3777 program,” said Dr. Jay R. Venkatesan, Angion’s President and Chief Executive Officer. “We are also very pleased with the results we announced last week from the Phase 1 ANG-3070 healthy volunteer study. These data, particularly the side effect profile seen in the Phase 1 study and the ability to achieve drug exposure in humans exceeding exposures in which activity was demonstrated in animal models, solidify our belief that ANG-3070 is a potentially best-in-class oral therapy for the treatment of fibrosis.”
Upcoming 2021 Key Milestones
| Programs | Milestones | ||||
| ANG-3777 | • Topline Phase 3 data for ANG-3777 in transplant-associated acute kidney injury, also known as delayed graft function, expected in early Q4 2021 • Topline Phase 2 data for ANG-3777 in acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass, expected in Q4 2021 after the DGF data release • IND filing for ANG-3777 Phase 2 trial in acute CNS injury expected in 2022 | ||||
| ANG-3070 | • Angion Virtual Fibrosis R&D Day scheduled to be held on September 20, 2021 • Enrollment of the first patient in the ANG-3070 Phase 2 trial for primary proteinuric kidney diseases, expected in 2021 | ||||
Recent Corporate Highlights
•Reported positive data from the Phase 1 healthy volunteer study of ANG-3070
•ANG-3070 was well-tolerated across dose cohorts, while achieving drug exposures in humans exceeding exposures in which activity was demonstrated in animal models of proteinuric kidney diseases
•Pharmacokinetic data are supportive of potential once-daily dosing
•The FDA has accepted an IND application supporting the initiation of a randomized, double-blind, and placebo-controlled global Phase 2 study of ANG-3070 in approximately 100 patients with primary proteinuric kidney diseases, including IgA nephropathy and focal segmental glomerulosclerosis (FSGS)
•Ongoing progress on ROCK-2 and CYP11B2 programs
•Angion to hold Virtual Fibrosis R&D Day at 10:00 a.m. US Eastern Daylight Time on September 20, 2021 (additional details on the event to be forthcoming)
Second Quarter 2021 Financial Results
As of June 30, 2021, Angion had cash and cash equivalents totaling $117.3 million. Angion expects current cash resources, combined with the potential milestones payable under its license agreement with Vifor for the development and commercialization of ANG-3777 in renal indications, to be sufficient to fund planned operations into 2022.
Contract revenue for the three months ended June 30, 2021 was $0.5 million compared with zero for the three months ended June 30, 2020.
Grant revenue for the three months ended June 30, 2021 was zero compared with $0.7 million for the three months ended June 30, 2020.
Research and development expenses for the three months ended June 30, 2021 were $14.4 million compared with $12.2 million for the three months ended June 30, 2020.
General and administrative expenses for the three months ended June 30, 2021 were $4.3 million compared with $5.4 million for the three months ended June 30, 2020.
Net loss for the three months ended June 30, 2021 was $17.1 million, or $0.58 per diluted share, compared with $20.3 million, or $1.40 per diluted share, for the three months ended June 30, 2020.
About Angion
Angion is committed to transforming the treatment paradigm for patients suffering from acute organ injuries and fibrotic diseases for which there are no approved medicines or where existing approved medicines have limitations. Angion’s lead product candidate, ANG-3777, is a hepatocyte growth factor (HGF) mimetic currently being evaluated in a Phase 3 registration trial for delayed graft function in patients undergoing deceased donor kidney transplantation and a Phase 2 trial in cardiac-surgery associated acute kidney injury. Angion is scheduled to begin a Phase 2 trial evaluating ANG-3070, an oral tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in patients with primary proteinuric kidney diseases. Additionally, Angion has preclinical programs for a rho kinase 2 (ROCK2) inhibitor and a CYP11B2 (aldosterone synthase) inhibitor. For more information, please visit www.angion.com.
Forward Looking Statements
Statements contained in this press release regarding matters that may occur in the future are “forward looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements in this press release regarding Angion’s expectations that topline data in ANG-3777 Phase 3 study will be announced in early Q4, a global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases will begin enrolling patients this year, release of topline data from the ANG-3777 Phase 3 trial in transplant-associated acute kidney injury will be in the fourth quarter of 2021, the next data release from the ANG-3777 program is the Phase 3 DGF trial, ANG-3070 is a potentially best-in-class oral therapy for the treatment of fibrosis, and Angion’s current cash resources, combined with the potential milestones payable under its license agreement with Vifor for the development and commercialization of ANG-3777 in renal indications will be sufficient to fund planned operations into 2022, as well as the statements under the caption “Upcoming 2021 Key Milestones.” Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: Angion’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of ANG-3777 and its other product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials; the results of preclinical studies may not be predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to raise additional capital; and the effects of COVID-19 on the Company’s clinical programs and business operations. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the Securities and Exchange Commission on August 12, 2021, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange
Commission. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Angion undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
Contact
Daniel Ferry
LifeSci Advisors
617-430-7576
daniel@lifesciadvisors.com
ANGION BIOMEDICA CORP.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
Revenue: | |||||||||||||||||||||||
Contract revenue | $ | 540 | $ | — | $ | 911 | $ | — | |||||||||||||||
Grant revenue | — | 729 | — | 1,594 | |||||||||||||||||||
Total revenue | 540 | 729 | 911 | 1,594 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Cost of grant revenue | — | 333 | — | 716 | |||||||||||||||||||
Research and development | 14,444 | 12,230 | 28,742 | 21,826 | |||||||||||||||||||
General and administrative | 4,340 | 5,435 | 10,352 | 8,890 | |||||||||||||||||||
Total operating expenses | 18,784 | 17,998 | 39,094 | 31,432 | |||||||||||||||||||
Loss from operations | (18,244) | (17,269) | (38,183) | (29,838) | |||||||||||||||||||
Other income (expense), net | 1,172 | (3,072) | (15,576) | (3,725) | |||||||||||||||||||
Net loss | (17,072) | (20,341) | (53,759) | (33,563) | |||||||||||||||||||
Net loss per common share, basic and diluted | $ | (0.58) | $ | (1.40) | $ | (2.02) | $ | (2.32) | |||||||||||||||
Weighted average common shares outstanding, basic and diluted | 29,670,329 | 14,514,670 | 26,574,290 | 14,488,746 | |||||||||||||||||||
ANGION BIOMEDICA CORP.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(unaudited)
| June 30, | December 31, | ||||||||||
| 2021 | 2020 | ||||||||||
| ASSETS | |||||||||||
| Current assets | |||||||||||
| Cash and cash equivalents | $ | 117,313 | $ | 34,607 | |||||||
| Prepaid expenses and other current assets | 2,389 | 7,690 | |||||||||
| Total current assets | 119,702 | 42,297 | |||||||||
| Property and equipment, net | 412 | 156 | |||||||||
| Right of use assets | 4,364 | 4,072 | |||||||||
| Investments in related parties | 843 | 822 | |||||||||
| Other assets | 38 | — | |||||||||
| Total assets | $ | 125,359 | $ | 47,347 | |||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |||||||||||
| Current liabilities | |||||||||||
| Accounts payable | $ | 9,307 | $ | 5,578 | |||||||
| Accrued expenses | 4,675 | 6,665 | |||||||||
| Lease liability—current | 847 | 611 | |||||||||
| Deferred revenue—current | 5,181 | 3,942 | |||||||||
| Warrant liability | 514 | 10,704 | |||||||||
| Convertible promissory notes payable at fair value | — | 51,170 | |||||||||
| Series C convertible preferred stock at amortized cost | — | 26,001 | |||||||||
| Series C convertible preferred stock at fair value | — | 2,518 | |||||||||
| Other short-term debt | — | 260 | |||||||||
| Total current liabilities | 20,524 | 107,449 | |||||||||
| Lease liability—noncurrent | 3,932 | 3,847 | |||||||||
| Deferred revenue—noncurrent | 23,714 | 25,865 | |||||||||
| Other long-term debt | — | 635 | |||||||||
| Total liabilities | 48,170 | 137,796 | |||||||||
| Commitments and contingencies—Note 11 | |||||||||||
| Stockholders' equity (deficit) | |||||||||||
| Common stock | 303 | 156 | |||||||||
| Treasury stock | (4,210) | (1,846) | |||||||||
| Additional paid-in capital | 295,636 | 72,136 | |||||||||
| Accumulated other comprehensive loss | (219) | (333) | |||||||||
| Accumulated deficit | (214,321) | (160,562) | |||||||||
| Total stockholders' equity (deficit) | 77,189 | (90,449) | |||||||||
| Total liabilities and stockholders' equity (deficit) | $ | 125,359 | $ | 47,347 | |||||||