ANGN Angion Biomedica Corp.

2.19
-0.02  -1%
Previous Close 2.21
Open 2.16
52 Week Low 2.15
52 Week High 26.3
Market Cap $65,604,698
Shares 29,956,483
Float 16,438,873
Enterprise Value $-32,555,303
Volume 125,743
Av. Daily Volume 234,631
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Drug Pipeline

Drug Stage Notes
ANG-3070
Idiopathic Pulmonary Fibrosis
Phase 2
Phase 2
Phase 2 IND to be filed by year-end 2022.
ANG-3070
Primary proteinuric kidney diseases
Phase 2
Phase 2
Phase 2 trial initiated, noted January 4, 2022.
ANG-3777 - GUARD
Acute Kidney Injury associated with cardiac surgery
Phase 2
Phase 2
Phase 2 data demonstrated that trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC), noted December 9, 2021.
ANG-3777
Acute kidney injury (AKI) / Delayed Graft Function
Phase 3
Phase 3
Phase 3 trial did not met the primary endpoint, noted October 26, 2021.
ANG-3777
Acute lung injury in patients with COVID-19
Phase 2
Phase 2
Phase 2 trial did not meet primary or secondary efficacy endpoints - June 29, 2021.

Latest News

  1. -- First patient enrolled in the Phase 2 trial of ANG-3070 in primary proteinuric kidney diseases

    -- Angion will end 2021 with approximately $88.8 million in cash and cash equivalents

    UNIONDALE, N.Y., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Angion Biomedica Corp (NASDAQ:ANGN), a biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address fibrotic diseases and acute organ injuries, today provided a corporate update and announced the first patient has been dosed in its Phase 2 trial of ANG-3070, an oral tyrosine kinase receptor inhibitor, in patients with primary proteinuric kidney diseases.

    ANG-3070 Program Update
    Angion's lead product candidate is ANG-3070, a highly selective…

    -- First patient enrolled in the Phase 2 trial of ANG-3070 in primary proteinuric kidney diseases

    -- Angion will end 2021 with approximately $88.8 million in cash and cash equivalents

    UNIONDALE, N.Y., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Angion Biomedica Corp (NASDAQ:ANGN), a biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address fibrotic diseases and acute organ injuries, today provided a corporate update and announced the first patient has been dosed in its Phase 2 trial of ANG-3070, an oral tyrosine kinase receptor inhibitor, in patients with primary proteinuric kidney diseases.

    ANG-3070 Program Update

    Angion's lead product candidate is ANG-3070, a highly selective oral tyrosine kinase receptor inhibitor in development as a treatment for fibrotic diseases, particularly in the kidney and lung.

    Angion enrolled the first patient in its global dose-finding Phase 2 trial of ANG-3070 prior to the end of 2021. This is a randomized, double-blind, placebo-controlled trial intended to assess the safety and efficacy of ANG-3070 in adult patients with focal segmental glomerulosclerosis (FSGS) or immunoglobulin A nephropathy (IgAN), two types of primary proteinuric kidney diseases. The trial will enroll 100 patients equally among four treatment arms: 200mg ANG-3070 1x/day, 400mg ANG-3070 1x/day, 300mg ANG-3070 2x/day, and placebo with dosing for 12 weeks. The primary endpoint in the study is the percentage change in 24-hour urinary protein excretion at week 12.

    "We are pleased to start dosing the first patients in this trial," said John Neylan, M.D., Chief Medical Officer. "With positive Phase 1 study data reported earlier this year and demonstrated in vivo proof-of-concept for ANG-3070 in several animal models as an anti-fibrotic agent, this Phase 2 trial in patients with primary proteinuric kidney diseases is the next step to bring this potential treatment to patients with a variety of fibrotic diseases proven difficult to treat or for which there are limited treatment options."

    Angion also expects to file an IND at the end of 2022 for a global Phase 2 trial of ANG-3070 in patients with idiopathic pulmonary fibrosis. Additional details as to patient population, trial size, and trial endpoints will be announced later this year.

    ANG-3070 was featured in a recent R&D Day conducted by Angion. A replay of this event is available in the events and presentations of the company's website at www.angion.com.

    Corporate Update

    Angion ended 2021 with approximately $88.8 million in cash and cash equivalents and expects these funds to be sufficient for operations well into 2023. The company will report complete financial results when it files its 10-K with the U.S. Securities and Exchange Commission in March of 2022.

    Angion and its partner Vifor Pharma continue to analyze the full data sets from the ANG-3777 clinical trial readouts reported in the fourth quarter of 2021. Angion expects to communicate its future plans for ANG-3777 in the first quarter of 2022.

    Investor Event

    Angion's management team will participate virtually in the H.C. Wainwright BioConnect Conference.

    Details are as follows:

    Event: H.C. Wainwright BioConnect Conference

    Date: Monday, January 10th

    Time: 7:00am Eastern US Time

    The webcast of the presentation will be accessible online by visiting the events and presentations page under the investors section of Angion's website at https://ir.angion.com/events-presentations. The webcast will remain archived on Angion's website for approximately 30 days.

    About ANG-3070

    ANG-3070 is a highly selective oral tyrosine kinase receptor inhibitor in development as a treatment for fibrotic diseases, particularly in the kidney and lung. ANG-3070 has demonstrated activity as an anti-fibrotic agent in a variety of animal models. A Phase 1 healthy volunteer study demonstrated ANG-3070 to have a favorable safety and PK profile, producing plasma concentrations which exceeded those demonstrating activity in animal models of proteinuric kidney diseases. Enrollment is ongoing in a dose-finding Phase 2 trial of ANG-3070 in primary proteinuric kidney diseases.

    About Angion Biomedica Corp.

    Angion is committed to transforming the treatment paradigm for patients suffering from fibrotic diseases and acute organ injuries for which there are no approved medicines or where existing approved medicines have 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 a dose-finding Phase 2 trial of ANG-3070 in primary proteinuric kidney diseases. Angion's ANG-3777 is a hepatocyte growth factor (HGF) mimetic. Angion and Vifor are evaluating next steps in this program based upon the full data set from the ANG-3777 Phase 2 GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI). 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 Statement

    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 various fibrotic diseases' future enrollment of the global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases; Angion's expectations to file an IND at the end of 2022 and announce additional details on a global Phase 2 trial of ANG-3070 in patients with idiopathic pulmonary fibrosis later in 2022; and Angion's expectations that its cash and cash equivalents to be sufficient for operations well into 2023. 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: analysis of trial results or continuing enrollment in clinical trials could be delayed for reasons outside of Angion's control, including the effects of COVID-19 on Angion's clinical programs and business operations; and unexpected costs may be incurred in connection with the clinical trial or other conduct of Angion's business. For a description of additional risks and uncertainties, see Angion's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission on November 12, 2021, particularly the information 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 Miller

    Director of Communications & Investor Relations



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  2.  

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211209006035/en/

    AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

    Vifor Pharma and Angion Biomedica Corp. (NASDAQ:ANGN) today announced results from the exploratory phase-II GUARD trial of Angion's ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data, based on the signal demonstrated in the clinically-relevant MAKE90 secondary endpoint.

    The GUARD trial…

     

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211209006035/en/

    AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

    Vifor Pharma and Angion Biomedica Corp. (NASDAQ:ANGN) today announced results from the exploratory phase-II GUARD trial of Angion's ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data, based on the signal demonstrated in the clinically-relevant MAKE90 secondary endpoint.

    The GUARD trial was designed as a signal-finding trial with a primary objective determining the feasibility of advancing ANG-3777 into a global phase-III trial based upon activity and safety of ANG-3777 in patients at risk for CSA-AKI, as there are no approved therapies for these patients.

    Topline results appear below. P-values noted were not adjusted for multiple comparisons:

    • The primary endpoint was percentage increase in serum creatinine based upon AUC as measured between 24 hours after the end of surgery through day 6, and indicated there was no significant difference in this short-term endpoint between ANG‑3777 and placebo (8.4% vs. 7.3%, p=0.77).
    • The secondary endpoint of MAKE90, which has historically been acceptable to global regulatory agencies as an approvable endpoint, indicated a potential benefit in patients receiving ANG-3777 with fewer patients in the ANG-3777 arm having a MAKE90 event compared to those in the placebo arm (14.7% vs. 21.5%, adjusted odds ratio of 0.60, p=0.155). MAKE90 is a composite endpoint combining death, initiation of renal replacement therapy, or a greater than 25% decline in Estimated Glomerular Filtration Rate (eGFR) present 90 days after the surgery. The GUARD trial was not powered to demonstrate a statistically significant result on this endpoint.
    • The number of patients who experienced a decline in kidney function as measured by a >25% decrease in eGFR at Day 90 was fewer in the group treated with ANG-3777 (5.6% vs. 16.2%, p=0.012). Other secondary endpoints did not show a clinical benefit, including endpoints on MAKE30, the incidence of AKI through Day 6.

    The overall safety profile of ANG-3777 in this trial was consistent with the overall experience in its clinical development program and comparable to placebo.

    "With the results of this trial, we now have a body of data on the efficacy and safety of ANG-3777 in both transplant and surgery-associated kidney injury," said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. "Together with our partner Angion, we look forward to thoroughly analyze the full data set and to continue exploring the potential of ANG-3777."

    "This is a preliminary data picture from the trial, and we need additional time to analyze the full data set before determining how we might bring ANG-3777 to patients," stated John Neylan, MD, Angion's Chief Medical Officer. "I would like to thank the patients, their families, and the investigators and their staff members who participated and worked diligently to make this trial possible."

    About Vifor Pharma Group

    Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange ((SIX Swiss Exchange, VIFN, OTC:GNHAF).

    For more information, please visit viforpharma.com.

    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 ANG-3777 is a hepatocyte growth factor (HGF) mimetic. Angion and Vifor Pharma are evaluating the full data set from the Phase 2 GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI). Angion is evaluating ANG-3070, a highly-selective, orally-bioavailable tyrosine kinase receptor inhibitor in development for the treatment of fibrotic kidney and lung diseases and currently enrolling an exploratory Phase 2 trial 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.

    About ANG-3777

    ANG-3777 is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue repair and organ repair. ANG-3777 has a substantially longer half-life than HGF. Angion and Vifor Pharma are evaluating the full data set from the phase-II GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI). In November 2020, Vifor Pharma and Angion signed a $1.8 billion total potential value license agreement for global rights outside Greater China to commercialize ANG-3777 in nephrology indications only.

    About the GUARD phase-II study

    In the GUARD (Guard Against Renal Damage) trial, a total of 275 patients were randomized 1:1 to receive four doses of ANG-3777 or placebo < 4 hours after the completion of cardiac surgery. Patients eligible for the GUARD trial were determined to be at risk for acute kidney injury based upon multiple factors, including age, baseline renal function, and complexity of the surgical procedure. Thirty-one centers in the U.S., Canada, Brazil, and Georgia participated in this exploratory phase-II trial. The primary endpoint was mean AUC of the percent increase in serum creatinine above baseline, starting from 24 hours after the end of cardiopulmonary bypass surgery through Day 6. MAKE90 is a composite endpoint combining death, initiation of renal replacement therapy, or a greater than 25% decline in eGFR. eGFR decline by >25% assessed at 90 days was calculated using the CKD-EPI formula.

    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 future analyses of the of topline data from the ANG-3777 Phase 2 exploratory trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery, the potential for a Phase 3 study of ANG-3777 in CSA-AKI, and the the expectation that global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases will begin enrolling patients this year. 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: analysis of trial results or commencing enrollment in clinical trials could be delayed for reasons outside of Angion's control, including the effects of COVID-19 on Angion's clinical programs and business operations. For a description of additional risks and uncertainties, see Angion's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission on November 12, 2021, particularly the information 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.

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  3. -- Angion to host a conference call today at 4:30 p.m. EST

    UNIONDALE, N.Y. and ST. GALLEN, Switzerland, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Angion Biomedica Corp. (NASDAQ:ANGN) and Vifor Pharma today announced results from the exploratory Phase 2 GUARD trial of Angion's ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data based on the signal demonstrated in the clinically relevant MAKE90 secondary endpoint.

    The GUARD (Guard Against Renal Damage) trial was designed…

    -- Angion to host a conference call today at 4:30 p.m. EST

    UNIONDALE, N.Y. and ST. GALLEN, Switzerland, Dec. 09, 2021 (GLOBE NEWSWIRE) -- Angion Biomedica Corp. (NASDAQ:ANGN) and Vifor Pharma today announced results from the exploratory Phase 2 GUARD trial of Angion's ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data based on the signal demonstrated in the clinically relevant MAKE90 secondary endpoint.

    The GUARD (Guard Against Renal Damage) trial was designed as a signal-finding trial with a primary objective of determining the feasibility of advancing ANG-3777 into a global Phase 3 trial based upon activity and safety of ANG-3777 in patients at risk for CSA-AKI, as there are no approved therapies for these patients.

    Topline results from the Phase 2 GUARD trial appear below. P-values noted were not adjusted for multiple comparisons:

    • The primary endpoint was percentage increase in serum creatinine based upon AUC as measured between 24 hours after the end of surgery through day 6, and indicated there was no significant difference in this short-term endpoint between ANG-3777 and placebo (8.4% vs. 7.3%, p=0.77)
    • The secondary endpoint of MAKE90, which has historically been acceptable to global regulatory agencies as an approvable endpoint, indicated a potential benefit in patients receiving ANG-3777, with fewer patients in the ANG-3777 arm having a MAKE90 event compared to those in the placebo arm. (14.7% vs. 21.5%, adjusted odds ratio of 0.60, p=0.155). MAKE90 is a composite endpoint combining death, initiation of renal replacement therapy, or a greater than 25% decline in Estimated Glomerular Filtration Rate (eGFR) present 90 days after the surgery. The GUARD trial was not powered to demonstrate a statistically significant result on this endpoint.
    • The number of patients who experienced a decline in kidney function as measured by a ≥25% decrease in eGFR at Day 90 was fewer in the group treated with ANG-3777 (5.6% vs. 16.2%, p=0.012). Other secondary endpoints did not show a clinical benefit, including endpoints on MAKE30 and the incidence of AKI through Day 6.

    The overall safety profile of ANG-3777 in this trial was consistent with the overall experience in its clinical development program and comparable to placebo.

    "This is a preliminary data picture from the trial, and we need additional time to analyze the full data set before determining how we might bring ANG-3777 to patients," stated John Neylan, MD, Angion's Chief Medical Officer. "I would like to thank the patients, their families, and the investigators and their staff members who participated and worked diligently to make this trial possible."

    "With the results of this trial, we now have a body of data on the efficacy and safety of ANG-3777 in both transplant and surgery-associated kidney injury," said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. "Together with our partner Angion, we look forward to analyzing the full data set and to continue exploring the potential of ANG-3777."

    Patients eligible for the GUARD trial were determined to be at risk for acute kidney injury based upon multiple factors, including age, baseline renal function, and complexity of the surgical procedure. Thirty-one centers in the U.S., Canada, Brazil, and Georgia participated in this exploratory Phase 2 trial. The primary endpoint was mean AUC of the percent increase in serum creatinine above baseline, starting from 24 hours after the end of cardiopulmonary bypass surgery through Day 6. A total of 275 patients were randomized 1:1 to receive four doses of ANG-3777 or placebo ≤ 4 hours after the completion of cardiac surgery. Estimated GFR decline by ≥25% assessed at 90 days was calculated using the CKD-EPI formula.

    Conference Call

    The Angion management team will host a conference call today at 4:30 p.m. EST to discuss the topline data. The dial-in number for the conference call is 1-877-407-0792 for domestic participants and 1-201-689-8263 for international participants, with Conference ID 13725594. A live webcast of the conference call can be accessed at the "Events & Presentations" page on the Angion website at https://ir.angion.com/events-presentations. A replay will be available on this website shortly after conclusion of the event.

    About ANG-3777

    ANG-3777 is a small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue repair and organ repair. ANG-3777 has a substantially longer half-life than HGF. Angion and Vifor are evaluating the full data set from the Phase 2 GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI). In November 2020, Vifor Pharma and Angion signed a $1.8 billion total potential value license agreement for global rights outside Greater China to commercialize ANG-3777 in nephrology indications only.

    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 ANG-3777 is a hepatocyte growth factor (HGF) mimetic. Angion and Vifor are evaluating the full data set from the ANG-3777 Phase 2 GUARD trial in patients at risk for acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI). Angion's ANG-3070 is a highly-selective, orally-bioavailable tyrosine kinase receptor inhibitor in development for the treatment of fibrotic kidney and lung diseases with an exploratory Phase 2 trial in patients with primary proteinuric kidney diseases expected to begin enrolling patients in 2021. 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.

    About Vifor Pharma Group

    Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange ((SIX Swiss Exchange, VIFN, OTC:GNHAF). For more information, please visit viforpharma.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 future analyses of the of topline data from the ANG-3777 Phase 2 exploratory trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery, the potential for a Phase 3 study of ANG-3777 in CSA-AKI, and the expectation that global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases will begin enrolling patients this year. 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: analysis of trial results or commencing enrollment in clinical trials could be delayed for reasons outside of Angion's control, including the effects of COVID-19 on Angion's clinical programs and business operations. For a description of additional risks and uncertainties, see Angion's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission on November 12, 2021, particularly the information 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
    Daniel Ferry
    LifeSci Advisors
    617-430-7576
    

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  4. UNIONDALE, N.Y., Nov. 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 September 30, 2021.

    "We continue to expect enrollment of the first patient in our exploratory global Phase 2 trial of ANG-3070 in primary proteinuric diseases before the end of the year. Based upon the Phase 1 data we reported earlier in the year, we believe ANG-3070, if approved, has the potential to be a best-in-class oral TKI for patients with kidney and lung fibrosis," said…

    UNIONDALE, N.Y., Nov. 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 September 30, 2021.

    "We continue to expect enrollment of the first patient in our exploratory global Phase 2 trial of ANG-3070 in primary proteinuric diseases before the end of the year. Based upon the Phase 1 data we reported earlier in the year, we believe ANG-3070, if approved, has the potential to be a best-in-class oral TKI for patients with kidney and lung fibrosis," said Dr. Jay R. Venkatesan, Angion's President and Chief Executive Officer. "We are also looking forward to reporting data from our exploratory Phase 2 trial of ANG-3777 in CSA-AKI later this quarter."

    Upcoming Key Milestones

    ProgramsMilestones
    ANG-3777
    • Topline Phase 2 data for ANG-3777 in acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass (CSA-AKI), expected in Q4 2021
    ANG-3070
    • Enrollment of first patient in the exploratory global Phase 2 trial in patients with primary proteinuric disease expected in Q4 2021

    Recent Corporate News

    • Reported data from the Phase 3 trial of ANG-3777 in patients with delayed graft function. ANG-3777 did not achieve statistical significance on the primary endpoint and demonstrated an inconsistent benefit on key secondary endpoints in this trial. Based upon these data, it is not expected there is sufficient evidence to support an indication in the studied DGF population.
    • Presented four posters on ANG-3070 at the 2021 Kidney Week conference, including details on the design of the exploratory global Phase 2 trial of ANG-3070 for patients with primary proteinuric kidney diseases
    • Held a well-attended ANG-3070 Virtual R&D Day on September 20th, a recording of which is available in the Events & Presentations page of the company website.
      • Described in greater detail positive data from the Phase 1 healthy volunteer study of ANG-3070
      • Presented preclinical data in several models of kidney and lung fibrosis
      • Heard from experts in kidney fibrosis and lung fibrosis about the unmet medical needs in both indications
    • Ongoing progress on preclinical programs for a rho kinase 2 (ROCK2) inhibitor and a CYP11B2 (aldosterone synthase) inhibitor.

    Third Quarter 2021 Financial Results

    As of September 30, 2021, Angion had cash and cash equivalents totaling $102.7 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 through the end of 2022.

    Contract revenue for the three months ended September 30, 2021 was $1.5 million compared with zero for the three months ended September 30, 2020. The increase was attributable to revenue recognized related to the upfront payment from Vifor Pharma pursuant to the Vifor License Agreement entered into in November 2020.

    Grant revenue for the three months ended September 30, 2021 was zero compared with $0.8 million for the three months ended September 30, 2020. The decrease was attributable to timing of grant cost reimbursement.

    Research and development expenses for the three months ended September 30, 2021 were $13.3 million compared with $6.1 million for the three months ended September 30, 2020. The increase in research and development expenses was primarily due to an increase in clinical and preclinical costs during the quarter attributable to the development of ANG-3777 and ANG-3070 plus increased costs due to higher headcount.

    General and administrative expenses for the three months ended September 30, 2021 were $3.9 million compared with $6.0 million for the three months ended September 30, 2020. The decrease in general and administrative expenses was primarily due to a net decrease in professional fees and services related to completion of Angion's February 2021 IPO.

    Net loss for the three months ended September 30, 2021 was $15.7 million, or $0.53 per diluted share, compared with $17.7 million, or $1.19 per diluted share, for the three months ended September 30, 2020. The decrease in loss per share was primarily due to an increase in the total shares outstanding upon the company's IPO.

    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. An exploratory Phase 2 trial of ANG-3777 for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery is ongoing with data expected in the fourth quarter of 2021. 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 2 study in CSA-AKI will be announced in Q4, a global Phase 2 trial of ANG-3070 in patients with primary proteinuric kidney diseases will begin enrolling patients this year, and the availability of cash resources, as well as the statements under the caption "Upcoming 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, 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 unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; 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 description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, see Angion's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the Securities and Exchange Commission on November 12, 2021, 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

    Daniel Ferry

    LifeSci Advisors

    617-430-7576



    ANGION BIOMEDICA CORP.


    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

    (unaudited)

     Three Months Ended September 30, Nine Months Ended September 30,
     2021 2020 2021 2020
    Revenue:       
    Contract revenue$1,460   $   $2,371   $  
    Grant revenue   827      2,421  
    Total revenue1,460   827   2,371   2,421  
    Operating expenses:       
    Cost of grant revenue   348      1,064  
    Research and development13,288   6,086   42,030   27,912  
    General and administrative3,930   5,978   14,282   14,868  
    Total operating expenses17,218   12,412   56,312   43,844  
    Loss from operations(15,758)  (11,585)  (53,941)  (41,423) 
    Other income (expense), net54   (6,084)  (15,522)  (9,809) 
    Net loss(15,704)  (17,669)  (69,463)  (51,232) 
    Net loss per common share, basic and diluted$(0.53)  $(1.19)  $(2.51)  $(3.51) 
    Weighted average common shares outstanding, basic and diluted 29,829,577    14,847,534    27,671,310    14,609,213  



    ANGION BIOMEDICA CORP.


    Condensed Consolidated Balance Sheets

    (in thousands)

    (unaudited)

     September 30, December 31,
     2021 2020
        
    ASSETS   
    Current assets   
    Cash and cash equivalents$102,736   $34,607  
    Prepaid expenses and other current assets1,657   7,690  
    Total current assets104,393   42,297  
    Property and equipment, net475   156  
    Right of use assets4,177   4,072  
    Investments in related parties862   822  
    Other assets33     
    Total assets$109,940   $47,347  
    LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)   
    Current liabilities   
    Accounts payable$7,679   $5,578  
    Accrued expenses5,349   6,665  
    Lease liability—current870   611  
    Deferred revenue—current3,662   3,942  
    Warrant liability386   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 liabilities17,946   107,449  
    Lease liability—noncurrent3,706   3,847  
    Deferred revenue—noncurrent23,774   25,865  
    Other long-term debt   635  
    Total liabilities45,426   137,796  
    Commitments and contingencies   
    Stockholders' equity (deficit)   
    Common stock304   156  
    Treasury stock(4,210)  (1,846) 
    Additional paid-in capital298,518   72,136  
    Accumulated other comprehensive loss(73)  (333) 
    Accumulated deficit(230,025)  (160,562) 
    Total stockholders' equity (deficit)64,514   (90,449) 
    Total liabilities and stockholders' equity (deficit)$109,940   $47,347  

     



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  5. UNIONDALE, N.Y., Nov. 05, 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 presented four posters at the American Society of Nephrology's Kidney Week 2021 virtual meeting, which is being held from November 4 to 7, 2021.

    "We are excited to present these promising preclinical data for our investigational product candidate ANG-3070 across multiple serious fibrotic kidney diseases at this year's Kidney Week. These data show the broad potential for ANG-3070 across a wide range of renal dysfunction," stated Jay Venkatesan, M.D., Angion's President…

    UNIONDALE, N.Y., Nov. 05, 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 presented four posters at the American Society of Nephrology's Kidney Week 2021 virtual meeting, which is being held from November 4 to 7, 2021.

    "We are excited to present these promising preclinical data for our investigational product candidate ANG-3070 across multiple serious fibrotic kidney diseases at this year's Kidney Week. These data show the broad potential for ANG-3070 across a wide range of renal dysfunction," stated Jay Venkatesan, M.D., Angion's President and CEO. "The presentation on the design of our Phase 2 trial of ANG-3070 in patients with PPKD discusses the disease, high unmet medical need of patients, and rationale of the study design based on the preclinical and Phase 1 study data. We expect to enroll the first patient in the Phase 2 study by the end of 2021."

    All Angion's posters are now available on the Kidney Week 2021 website. All four presentations are also available on the Publications page of the company website (click here).

    Poster Presentation Details:

    Safety and Efficacy of ANG-3070 in Patients with Primary Proteinuric Kidney Disease: A Phase 2 Study Design

    This presentation describes the study design of Angion's Phase 2 study of ANG-3070, an oral tyrosine kinase receptor inhibitor, in patients with primary proteinuric kidney diseases (PPKD).

    Key highlights from the presentation include:

    • There is a significant unmet medical need in patients with PPKDs and persistent proteinuria due to the lack of effective treatments
    • Animal data suggest inhibition of the receptor tyrosine kinases PDGFRα/β and DDR1/2 have the potential to prevent renal function decline and the progression of chronic kidney disease to end-stage kidney disease
    • This Phase 2 exploratory study will evaluate safety and efficacy of ANG-3070 in patients with persistent proteinuria on standard of care and test the hypothesis ANG-3070 can reduce proteinuria, a surrogate marker of disease progression
    • The trial will enroll patients with focal segmental glomerulosclerosis (FSGS) and immunoglobulin A nephropathy (IgAN), two types of primary proteinuric kidney diseases
    • The Phase 2 data will help determine the dose and enrichment strategy for the potential Phase 3 pivotal study design

    Effect of ANG-3070 in the Passive Heymann Nephritis Rat Model of Primary Proteinuric Kidney Disease

    This presentation describes preclinical data from a study of ANG-3070 in a rat model of proteinuric passive heymann nephritis (PHN), which is reminiscent of human membranous nephropathy, a serious primary proteinuric kidney disease (PPKD) for which there are no approved treatments.

    Key highlights from the presentation include:

    • ANG-3070 reduced proteinuria, renal fibrosis, glomerulosclerosis, and PDGFRβ expression levels in a rat model of membranous nephropathy
    • The lowest dose tested (15 mg/kg) had the lowest drug exposure and was sufficient to elicit the beneficial effects of ANG-3070

    Effects of ANG-3070 in a Mouse Model of Alport Syndrome

    This presentation describes preclinical data from a study to evaluate the effect of ANG-3070 in a mouse model of human alport syndrome (AS), a serious PPKD for which there are no approved treatments.

    Key highlights from the presentation include:

    • ANG-3070 increased survival and reduced proteinuria and protein to creatinine ratio in a mouse model of AS
    • Treatment with ANG-3070 reduced renal damage and renal fibrosis in AS mice
    • ANG-3070 may be an effective treatment and novel therapeutic for AS

    Effect of ANG-3070 in the Unilateral Ureteral Obstruction Mouse Model of Renal Fibrosis

    This presentation describes preclinical data from a study of ANG-3070 in a mouse unilateral ureteral obstruction (UUO) model, a well-established model for obstructive renal disease. The study was designed to determine whether ANG-3070 can slow the progression of fibrosis in the UUO mouse model of renal fibrosis.

    Key highlights from the presentation include:

    • ANG-3070 reduced renal fibrosis in UUO mice compared with vehicle, as indicated by:
      • Reduced renal damage, assessed by histological staining
      • Decreased collagen deposition, shown by picrosirius red staining
      • Reduction in myofibroblast formation, demonstrated by smooth muscle alpha-actin staining
    • ANG-3070 treatment showed no obvious effect on body weight or kidney weight

    About ANG-3070

    ANG-3070 is a highly selective, orally-bioavailable small molecule tyrosine kinase receptor inhibitor in development as a treatment for fibrotic diseases, particularly in the lung and kidney. ANG-3070 has demonstrated activity as an anti-fibrotic agent in a variety of animal models in the kidney, lungs, and gastrointestinal system. A Phase 1 healthy volunteer study demonstrated ANG-3070 to have a favorable safety and PK profile, producing drug exposures which exceeded those demonstrating activity in animal models of proteinuric kidney diseases. The first patient in an exploratory Phase 2 trial of ANG-3070 in primary proteinuric kidney diseases is expected to be enrolled by the end of 2021.

    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. An exploratory Phase 2 trial of ANG-3777 for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery is ongoing with data expected in the fourth quarter of 2021. 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.



    Contact
    Daniel Ferry
    LifeSci Advisors
    617-430-7576
    

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