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 |
|
| ANG-3070 |
|
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.
