0001601485-22-000036.txt : 20220516 0001601485-22-000036.hdr.sgml : 20220516 20220516160542 ACCESSION NUMBER: 0001601485-22-000036 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20220516 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220516 DATE AS OF CHANGE: 20220516 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Angion Biomedica Corp. CENTRAL INDEX KEY: 0001601485 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 113430072 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39990 FILM NUMBER: 22928783 BUSINESS ADDRESS: STREET 1: 51 CHARLES LINDBERGH BOULEVARD CITY: UNIONDALE STATE: NY ZIP: 11553 BUSINESS PHONE: (415) 655-4899 MAIL ADDRESS: STREET 1: 51 CHARLES LINDBERGH BOULEVARD CITY: UNIONDALE STATE: NY ZIP: 11553 8-K 1 angn-20220516.htm 8-K angn-20220516
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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): May 16, 2022
ANGION BIOMEDICA CORP.
(Exact name of registrant as specified in its charter)
Delaware
001-39990
11-3430072
(State or other jurisdiction of incorporation or organization)
(Commission File Number)
(IRS Employer Identification No.)
51 Charles Lindbergh Boulevard
Uniondale, New York 11553
(Address of principal executive offices, including 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):

☐ 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)(Name of exchange on which registered)
Common StockANGNThe 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. o


Item 2.02 Results of Operations and Financial Condition

On May 16, 2022, 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, 2022. 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
104Cover 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: May 16, 2022
Jay R. Venkatesan, M.D.
President and Chief Executive Officer and Director

 EX-99.1 2 ex991_03312022-8k.htm EX-99.1 Document

Angion Provides Corporate Update and Reports First Quarter 2022 Financial Results
-- Ended the quarter with $73M in cash and cash equivalents sufficient to fund operations well into 2023
Uniondale, NY – May 16, 2022 – Angion Biomedica Corp (NASDAQ:ANGN), a biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address fibrotic diseases, today provided a corporate update and reported its financial results for the quarter ended March 31, 2022.
“In the first quarter of 2022, we made good progress on our strategic objectives for the year,” said Dr. Jay R. Venkatesan, Angion’s President and Chief Executive Officer. “Enrollment in JUNIPER, the Phase 2 dose-finding trial of our oral tyrosine kinase inhibitor ANG-3070 in primary proteinuric kidney diseases, continues and we are advancing ANG-3070 toward clinical development in idiopathic pulmonary fibrosis, a serious and fatal disease for which new treatment options are needed.”
Angion also announced earlier today the U.S. Food and Drug Administration’s (FDA) acceptance of an Investigational New Drug (IND) application supporting the clinical development of ANG-3070 in idiopathic pulmonary fibrosis (IPF) and clearance to begin a Phase 1b study of ANG-3070 in patients with IPF. Topline data from this Phase 1b study are expected in 2022.
Angion’s Strategic Objectives in 2022
•Develop ANG-3070 for treatment of patients with primary proteinuric kidney diseases (PPKDs) including focal segmental glomerular sclerosis (FSGS) and IgA nephropathy (IgAN), which are the subject of Angion’s JUNIPER Phase 2 trial
•Develop ANG-3070 for treatment of patients with idiopathic pulmonary fibrosis (IPF), with a planned IND filing in IPF by the end of 2022
•Nominate a lead compound and initiate IND-enabling studies for one or more of the preclinical rho kinase 2 (ROCK2) or CYP11B2 (aldosterone synthase) inhibitor programs
First Quarter 2022 Financial Results
As of March 31, 2022, Angion had cash and cash equivalents totaling $73.0 million. Angion expects current cash resources to be sufficient to fund planned operations well into 2023.
Contract revenue for the quarter ended March 31, 2022 was $1.6 million compared with $0.4 million in the same period in 2021. Since Angion does not intend to continue the clinical development plan for ANG-3777 currently set forth in Angion’s license agreement with Vifor International, Ltd, which had included a Phase 3 study in cardiac surgery associated with cardiopulmonary bypass (CSA-AKI) and a Phase 4 confirmatory study in delayed graft function (DGF), Angion performed a reassessment of the performance period and estimated costs for the completion of the performance obligations. This accelerated the revenue recognition related to the upfront payment received by Angion from Vifor Pharma when the license agreement with Vifor Pharma was entered into in 2020.
Research and development expenses for the quarter ended March 31, 2022 were $11.7 million compared with $14.3 million in the same period in 2021. The decrease in research and development expenses was primarily due to a net decrease of $4.4 million in personnel-related expenses as a result of the reduction in force event during the quarter ended March 31, 2022 and a decrease of $2.9 million in CRO expenses from decreased clinical trial activities, primarily related to the completion of ANG-3777 trials, offset by severance-related charges of $2.7 million and an increase of $2.0 million in CRO and CMO expenses from increased clinical and non-clinical trial activities, primarily related to the development of ANG-3070.
General and administrative expenses for the quarter ended March 31, 2022 were $4.5 million compared with $6.0 million in the same period in 2021. The decrease in general and administrative expenses was primarily due to a net decrease of $2.3 million in personnel-related expenses as a result of the reduction in force event during the quarter


ended March 31, 2022, offset by severance-related charges of $0.5 million and an increase of $0.3 million in business insurance expense.
Other income (expense) for the quarter ended March 31, 2022 was $0.2 million compared with ($16.7 million) in the same period in 2021. The increase in other income (expense) was primarily due to a decrease in expense of $14.6 million from the change in fair value related to our warrant liability, convertible notes, and Series C convertible preferred stock for which we elected the fair value option as most of these instruments were no longer outstanding after our IPO. There was also a decrease of $2.2 million in interest expense, primarily related to $2.2 million of amortization of debt issuance costs from the issuance of Series C convertible preferred stock issued during the quarter ended March 31, 2021.
Net loss for the quarter ended March 31, 2022 was $14.2 million, or $0.48 per diluted share, compared with $36.7 million, or $1.56 per diluted share, for the three months ended 2021.
About Angion
Angion is committed to transforming the treatment paradigm for patients suffering from fibrotic diseases for which there are no approved medicines or where existing approved medicines have known limitations. Angion’s lead product candidate is ANG-3070, a highly selective oral tyrosine kinase receptor inhibitor in development for the treatment of fibrotic, kidney and lung diseases. Enrollment is ongoing in JUNIPER, a dose-finding Phase 2 trial of ANG-3070 in primary proteinuric kidney diseases (NCT04939116). Additionally, Angion has preclinical programs focused on 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 the potential of ANG-3070 as a treatment for primary proteinuric kidney diseases, specifically FSGS and IgAN, and as a treatment for IPF, Angion’s plan to initiate a Phase 1b study of ANG-3070 in IPF in 2022 and to report data in 2022, Angion’s intentions to not pursue the clinical development plan currently set forth in the license agreement with Vifor Pharma, and Angion’s expectations that its cash and cash equivalents will be sufficient to fund operations well into 2023, as well as the statements under the caption “Angion’s Strategic Objectives in 2022.” 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-3070 and its other product candidates; the accuracy of Angion’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 costs of clinical trials may exceed expectations; Angion’s ability to raise additional capital; and the effects of COVID-19 on Angion’s clinical programs and business operations. For a fuller description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see Angion’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission on March 30, 2022, Angion’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, to be filed with the Securities and Exchange Commission on May 16, 2022, especially, in each case, under the caption “Risk Factors,” as well as other documents that may be filed by Angion 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
David D. Miller
Sr. Director of Corporate Affairs
investors@angion.com


ANGION BIOMEDICA CORP.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
Three Months Ended March 31,
20222021
Revenue:
Contract revenue
$1,648 $371 
Total revenue
1,648 371 
Operating expenses:
Research and development
11,667 14,298 
General and administrative
4,466 6,012 
Total operating expenses
16,133 20,310 
Loss from operations
(14,485)(19,939)
Other income (expense), net
245 (16,748)
Net loss
(14,240)(36,687)
Net loss per common share, basic and diluted
$(0.48)$(1.56)
Weighted average common shares outstanding, basic and diluted
29,959,251 23,443,851 


ANGION BIOMEDICA CORP.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
March 31,
2022		December 31,
2021
Assets
Current assets
Cash and cash equivalents$73,002 $88,756 
Grants receivable— 806 
Prepaid expenses and other current assets3,237 1,685 
Total current assets76,239 91,247 
Property and equipment, net419 451 
Operating lease right-of-use assets3,790 3,986 
Investments in related parties732 723 
Other assets78 106 
Total assets$81,258 $96,513 
Liabilities and stockholders’ equity
Current liabilities
Accounts payable$3,433 $4,710 
Accrued expenses5,242 3,219 
Operating lease liabilities, current918 894 
Financing obligation, current60 58 
Deferred revenue, current653 2,301 
Warrant liability75 114 
Total current liabilities10,381 11,296 
Operating lease liabilities, noncurrent3,236 3,475 
Financing obligation, noncurrent219 235 
Other liabilities, noncurrent220 — 
Total liabilities14,056 15,006 
Commitments and contingencies
Stockholders' equity
Common stock300 300 
Additional paid-in capital296,476 296,445 
Accumulated other comprehensive loss(199)(103)
 Accumulated deficit(229,375)(215,135)
Total stockholders' equity67,202 81,507 
Total liabilities and stockholders' equity$81,258 $96,513 

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