SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
May 17, 2021
Date of Report (date of earliest event reported)
ANGION BIOMEDICA CORP.
(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.)
51 Charles Lindbergh Boulevard
(Address of Principal Executive Offices)
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):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common Stock||ANGN||The Nasdaq Global Select Market|
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 May 17, 2021, Angion Biomedica Corp., a Delaware corporation (the “Company”), issued a press release announcing the Company’s financial results for the fiscal quarter ended March 31, 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
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: May 17, 2021
Jay R. Venkatesan, M.D.
President and Chief Executive Officer and Director
Angion Provides Corporate Update and Reports First Quarter 2021 Financial Results
Uniondale, NY – May 17, 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 March 31, 2021.
“Angion has accomplished a great deal so far in 2021,” said Dr. Jay R. Venkatesan, Angion’s President and Chief Executive Officer. “We have completed enrollment in two ANG-3777 Phase 2 trials and successfully executed an initial public offering and concurrent private placement raising gross proceeds of $117 million to help finance the advancement of our clinical pipeline towards regulatory approvals. We continue to execute our strategies for ANG-3777 and ANG-3070 and look forward to sharing data from both these programs in 2021.”
Upcoming 2021 Key Milestones
• Topline Phase 2 data for ANG-3777 in acute lung injury associated with COVID 19 related pneumonia in H1 2021
• Topline Phase 2 data for ANG-3777 in acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery in H2 2021
• Topline Phase 3 data for ANG-3777 in transplant-associated acute kidney injury, also known as delayed graft function, by the end of 2021
• Phase 1 data from healthy volunteer study in H1 2021
• Initiation of Phase 2 trial of ANG-3070 in patients with proteinuric kidney diseases in 2021
2021 Corporate Highlights
• Completed enrollment of the ANG-3777 Phase 2 trial in cardiac surgery-associated acute kidney injury (CSA-AKI)
• Completed enrollment of the ANG-3777 Phase 2 trial in Brazil in patients with acute lung injury associated with COVID-19 pneumonia who are at high risk of progressing to Acute Respiratory Distress Syndrome (ARDS)
• Closed a successful initial public offering and concurrent private placement with aggregate gross proceeds of $117.0 million
First Quarter 2021 Financial Results
As of March 31, 2021, Angion had cash and cash equivalents totaling $130.5 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 March 31, 2021 was $0.4 million compared with zero for the three months ended March 31, 2020.
Grant revenue for the three months ended March 31, 2021 was zero compared with $0.9 million for the three months ended March 31, 2020.
Research and development expenses for the three months ended March 31, 2021 were $14.3 million compared with $9.6 million for the three months ended March 31, 2020.
General and administrative expenses for the three months ended March 31, 2021 were $6.0 million compared with $3.5 million for the three months ended March 31, 2020.
Net losses for the three months ended March 31, 2021 were $36.7 million compared with $13.2 million for the three months ended March 31, 2020.
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, a Phase 2 trial in cardiac-surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19 related pneumonia at high risk for acute respiratory distress syndrome. Angion is also currently evaluating ANG-3070, a tyrosine kinase receptor inhibitor for the treatment of fibrotic disease, in Phase 1. 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 regarding the potential safety and efficacy of the Company’s product candidates, including ANG-3777 and ANG-3070, the potential results and outcomes of our clinical development programs involving ANG-3777 or other product candidates, the timing of the availability of and Angion’s disclosure of topline data from such programs, and the adequacy of our cash resources over time. 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 to 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; 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 March 31, 2021, filed with the Securities and Exchange Commission on May 17, 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.
ANGION BIOMEDICA CORP.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
|Three Months Ended March 31,|
|$||371 ||$||— |
|— ||865 |
|371 ||865 |
Cost of grant revenue
|— ||383 |
Research and development
|14,298 ||9,596 |
General and administrative
|6,012 ||3,455 |
Total operating expenses
|20,310 ||13,434 |
Loss from operations
Other income (expense), net
Net loss per common share, basic and diluted
Weighted average common shares outstanding, basic and diluted
|23,443,851 ||14,462,823 |
ANGION BIOMEDICA CORP.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
|March 31,||December 31,|
|Cash and cash equivalents||$||130,456 ||$||34,607 |
|Prepaid expenses and other current assets||3,042 ||7,690 |
|Total current assets||133,498 ||42,297 |
|Property and equipment, net||246 ||156 |
|Right of use assets||4,541 ||4,072 |
|Investments in related parties||877 ||822 |
|Other assets||38 ||— |
|Total assets||$||139,200 ||$||47,347 |
|LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)|
|Accounts payable||$||6,690 ||$||5,578 |
|Accrued expenses||4,092 ||6,665 |
|Lease liability—current||780 ||611 |
|Deferred revenue—current||3,792 ||3,942 |
|Warrant liability||714 ||10,704 |
|Convertible promissory notes payable at fair value||— ||51,170 |
|Series C convertible preferred stock at amortized cost||— ||26,001 |
|Series C convertible preferred stock at fair value||— ||2,518 |
|Other short-term debt||895 ||260 |
|Total current liabilities||16,963 ||107,449 |
|Lease liability—noncurrent||4,150 ||3,847 |
|Deferred revenue—noncurrent||25,644 ||25,865 |
|Other long-term debt||— ||635 |
|Total liabilities||46,757 ||137,796 |
|Stockholders' equity (deficit)|
|Common stock||300 ||156 |
|Additional paid-in capital||292,670 ||72,136 |
|Accumulated other comprehensive loss||(287)||(333)|
|Total stockholders' equity (deficit)||92,443 ||(90,449)|
|Total liabilities and stockholders' equity (deficit)||$||139,200 ||$||47,347 |