Angion Provides Corporate Update and Reports Second Quarter 2021 Financial Results

Rhea-AI Summary

Angion Biomedica Corp (NASDAQ:ANGN) has announced a shift in timeline for the ANG-3777 Phase 3 trial data release to early Q4 2021, due to expedited data cleaning. The company is also optimistic about ANG-3070, which demonstrated favorable tolerability in Phase 1 trials and achieved drug exposure exceeding that in preclinical models. They plan to begin a Phase 2 trial for ANG-3070 in primary proteinuric kidney diseases this year. As of June 30, 2021, Angion held $117.3 million in cash, expected to sustain operations through Q4 2022.

Positive

• ANG-3777 Phase 3 topline data release brought forward to early Q4 2021.
• ANG-3070 shows promising Phase 1 results with a favorable side effect profile.
• Cash and equivalents of $117.3 million sufficient to fund operations into Q4 2022.

Negative

• Net loss of $17.1 million for Q2 2021, though an improvement from $20.3 million in Q2 2020.
• Research and development expenses increased to $14.4 million, up from $12.2 million in the previous year.

-- 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, N.Y., Aug. 12, 2021 (GLOBE NEWSWIRE) -- 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 at least into the fourth quarter of 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.

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
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

FAQ

What is the updated timeline for ANG-3777 topline data?

The topline data from the ANG-3777 Phase 3 trial is now expected to be announced in early Q4 2021.

What were the results of the ANG-3070 Phase 1 study?

The Phase 1 study of ANG-3070 demonstrated good tolerability and drug exposure exceeding that shown in animal models.

When will the ANG-3070 Phase 2 trial begin?

Enrollment for the ANG-3070 Phase 2 trial is expected to begin this year.

How much cash does Angion Biomedica have?

As of June 30, 2021, Angion Biomedica had cash and cash equivalents totaling $117.3 million.

What was Angion Biomedica's net loss for Q2 2021?

Angion reported a net loss of $17.1 million, or $0.58 per diluted share, for the three months ended June 30, 2021.