ANGN Angion Biomedica Corp.

9.98
+0.11  (+1%)
Previous Close 9.87
Open 9.95
52 Week Low 9.0301
52 Week High 26.3
Market Cap $297,388,022
Shares 29,798,399
Float 16,280,789
Enterprise Value $200,945,157
Volume 354,200
Av. Daily Volume 149,614
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Upcoming Catalysts

Drug Stage Catalyst Date
ANG-3777
Acute kidney injury (AKI) / Delayed Graft Function
Phase 3
Phase 3
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ANG-3777
Acute Kidney Injury associated with cardiac surgery
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
ANG-3070
Primary proteinuric kidney diseases
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 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. UNIONDALE, N.Y., Sept. 08, 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, announced today it is scheduled to host a virtual research and development day focused on its product candidate ANG-3070, a novel, highly selective, and orally-bioavailable small molecule tyrosine kinase receptor inhibitor in clinical development for the treatment of fibrotic diseases, including those in the kidney and lung, at 10:00am EDT on Monday, September 20th.

    The event will feature presentations by two medical experts, including Joseph V. Bonventre, M.D…

    UNIONDALE, N.Y., Sept. 08, 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, announced today it is scheduled to host a virtual research and development day focused on its product candidate ANG-3070, a novel, highly selective, and orally-bioavailable small molecule tyrosine kinase receptor inhibitor in clinical development for the treatment of fibrotic diseases, including those in the kidney and lung, at 10:00am EDT on Monday, September 20th.

    The event will feature presentations by two medical experts, including Joseph V. Bonventre, M.D., Ph.D., Harvard Medical School, who will discuss the current treatment landscape and unmet medical needs of patients with kidney fibrosis, and Gregory P. Downey, M.D., National Jewish Health, who will discuss the current treatment landscape and unmet medical needs of patients with lung fibrosis.

    With this context, Angion's Chief Medical Officer, Dr. John Neylan, and Dr. Shakil Aslam, its VP of Early Clinical Development and Translational Medicine, will discuss the pre-clinical and clinical rationale for the development of ANG-3070, which is currently being investigated in a Phase 2 study in patients with primary proteinuric kidney disease.

    A live Q&A will follow the presentations.

    To register for the R&D Day, please click here.

    Invited Medical Experts

    Dr. Joseph V. Bonventre is the Samuel A. Levine Professor of Medicine at Harvard Medical School. He is Chief of the Renal Unit and Chief of the Engineering in Medicine Division at Brigham and Women's Hospital, Director of Health Sciences and Technology at Massachusetts General Hospital, and professor at the Harvard-MIT Health Sciences and Technology, Brigham and Women's Hospital. Dr. Bonventre is a member of the Kidney Cancer Program at the Dana-Farber/Harvard Cancer Center.

    Dr. Bonventre has authored more than 360 original publications and 150 invited chapters and reviews, has received two MERIT awards from the National Institutes of Diabetes and Digestive and Kidney Disorders (NIDDK), and his work has been cited more than 52,000 times with an h-index of 117. He has been elected to the American Society of Clinical Investigation, the Association of American Physicians, and the American Institute for Medical and Biological Engineering.

            

    Dr. Gregory P. Downey is a Professor of Medicine, Pediatrics, and Biomedical Research and the Executive Vice President for Academic Affairs at National Jewish Health in Denver, CO. Dr. Downey is also a Professor of Medicine and Immunology and Microbiology and the Associate Dean of the School of Medicine at the University of Colorado, Denver.

    Dr. Downey's primary research is focused on the mechanisms of lung injury, repair, and fibrosis and he is an internationally recognized leader in this field. He has authored over 240 peer-reviewed publications, reviews, and book chapters and his work has been cited more than 17,000 times. He is the President-Elect of the American Thoracic Society.

    Angion Biomedica Corp.

    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.

    Investor Contact:

    Daniel Ferry

    LifeSci Advisors        

    daniel@lifesciadvisors.com

    P: 617-430-7576



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  2. UNIONDALE, N.Y., Sept. 02, 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 announced its management team will present virtually at the H.C. Wainwright 23rd Annual Global Investment Conference and participate in a fireside chat with Oppenheimer Senior Biotech Analyst Justin Kim at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit.

    Details are as follows:

    Event: H.C. Wainwright 23rd Annual Global Investment Conference
    Date: Monday, September 13th
    Time: 7:00am Eastern US Daylight Time

    Event: Oppenheimer Fall Healthcare Life

    UNIONDALE, N.Y., Sept. 02, 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 announced its management team will present virtually at the H.C. Wainwright 23rd Annual Global Investment Conference and participate in a fireside chat with Oppenheimer Senior Biotech Analyst Justin Kim at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit.

    Details are as follows:

    Event: H.C. Wainwright 23rd Annual Global Investment Conference

    Date: Monday, September 13th

    Time: 7:00am Eastern US Daylight Time

    Event: Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date: Wednesday, September 22nd

    Time: 10:45am Eastern US Daylight Time

    Webcasts of the presentation and fireside chat 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 webcasts of both events will remain archived on Angion's website for approximately 30 days.

    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.



    Contact
    Daniel Ferry
    LifeSci Advisors
    617-430-7576
    daniel@lifesciadvisors.com

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  3. -- 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…

    -- 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

    ProgramsMilestones
    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 revenue540  729  911  1,594 
    Operating expenses:       
    Cost of grant revenue  333    716 
    Research and development14,444  12,230  28,742  21,826 
    General and administrative4,340  5,435  10,352  8,890 
    Total operating expenses18,784  17,998  39,094  31,432 
    Loss from operations(18,244) (17,269) (38,183) (29,838)
    Other income (expense), net1,172  (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 diluted29,670,329  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 assets2,389  7,690 
    Total current assets119,702  42,297 
    Property and equipment, net412  156 
    Right of use assets4,364  4,072 
    Investments in related parties843  822 
    Other assets38   
    Total assets$125,359   $47,347  
    LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)   
    Current liabilities   
    Accounts payable$9,307  $5,578 
    Accrued expenses4,675  6,665 
    Lease liability—current847  611 
    Deferred revenue—current5,181  3,942 
    Warrant liability514  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 liabilities20,524  107,449 
    Lease liability—noncurrent3,932  3,847 
    Deferred revenue—noncurrent23,714  25,865 
    Other long-term debt  635 
    Total liabilities48,170  137,796 
    Commitments and contingencies   
    Stockholders' equity (deficit)   
    Common stock303  156 
    Treasury stock(4,210) (1,846)
    Additional paid-in capital295,636  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  
            



    Contact
    Daniel Ferry
    LifeSci Advisors
    617-430-7576
    daniel@lifesciadvisors.com

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    • 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
    • Pharmacokinetic data potentially supportive of once-daily dosing
    • An international Phase 2 trial in patients with primary proteinuric kidney diseases will begin enrolling patients in the second half of this year
    • Company to host a Virtual Fibrosis R&D Day on September 20, 2021

    UNIONDALE, N.Y., Aug. 03, 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 announced…

    • 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
    • Pharmacokinetic data potentially supportive of once-daily dosing
    • An international Phase 2 trial in patients with primary proteinuric kidney diseases will begin enrolling patients in the second half of this year
    • Company to host a Virtual Fibrosis R&D Day on September 20, 2021

    UNIONDALE, N.Y., Aug. 03, 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 announced positive results from its Phase 1 study in healthy volunteers for ANG-3070, a novel oral tyrosine kinase receptor inhibitor (TKI) being developed for the treatment of fibrotic diseases. Angion also announced the FDA's acceptance of an IND application supporting the initiation of a Phase 2 trial in patients with primary proteinuric kidney diseases in 2021. Additionally, the Company announced it will host a Virtual Fibrosis R&D Day on September 20, 2021.

    Key findings from the ANG-3070 Phase 1 healthy volunteer study included:

    • ANG-3070 achieved drug exposures in humans exceeding exposures in which activity was demonstrated in animal models of proteinuric kidney diseases
    • ANG-3070 demonstrated a favorable safety and tolerability profile, including with respect to gastrointestinal side effects, which was encouraging given the well-recognized incidence and severity of these side effects in approved TKIs
    • Pharmacokinetic data supportive of potential once-daily oral dosing for ANG-3070

    The Phase 1 study was a randomized, double-blind, and placebo-controlled study in healthy volunteers conducted in Australia to assess the safety, tolerability, pharmacokinetics, and food effect of ANG-3070 dosed orally. The study consisted of both single-and multiple-ascending dose cohorts and enrolled 97 healthy volunteers, with 72 volunteers receiving ANG-3070 and 25 volunteers receiving placebo. Doses studied in the study ranged from 50mg to 600mg and included both once daily and twice daily regimens.

    "We are very pleased with the results from the Phase 1 healthy volunteer study of ANG-3070," said John F. Neylan, M.D., Angion's Chief Medical Officer. "The data from this study surpassed expectations, where ANG-3070 exposures seen in the study exceeded the levels of drug exposure needed to demonstrate activity in our animal models of kidney disease. The favorable safety and PK profile seen in the study allows us the flexibility to use a range of dose levels as we explore the efficacy of ANG-3070 in a Phase 2 trial in patients with primary proteinuric kidney diseases."

    ANG-3070 demonstrated a favorable safety and tolerability profile in the study. There were no serious adverse events reported at any dose schedule or level. The reported (non-serious) adverse events were seen mostly at higher doses, 600 mg administered once-daily and 500 mg administered twice-daily over two weeks. These adverse events included nausea, abdominal cramps, and diarrhea, and were considered mild to moderate in severity. This was encouraging given the well-recognized incidence and severity of these side effects in approved TKIs.

    The international Phase 2 clinical trial of ANG-3070 will be a randomized, double-blind, and placebo-controlled study of ANG-3070 in approximately 100 patients with primary proteinuric kidney diseases, including IgA nephropathy and focal segmental glomerulosclerosis (FSGS). The study will investigate three dose levels of ANG-3070, 200mg and 400mg once a day and 300mg twice a day, compared to placebo. The primary endpoint of the study is the percentage change in 24-hour urinary protein excretion at the end of 12 weeks of dosing. This exploratory Phase 2 trial is expected to enroll its first patient in the second half of this year.

    Virtual Fibrosis R&D Day

    The Company also announced it will host a Virtual Fibrosis R&D Day on September 20, 2021, at 10am US Eastern Daylight Time via a live online webcast. During the event, the Company will cover the potential of ANG-3070 for the treatment of kidney and lung fibrosis and provide additional data from preclinical studies of ANG-3070.

    About ANG-3070

    ANG-3070 is a highly selective, orally-bioavailable small molecule tyrosine kinase receptor inhibitor developed 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 in the second half of this year.

    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 regarding the potential safety and efficacy of ANG-3070 in fibrotic diseases, such as primary proteinuric kidney diseases, the potential results and outcomes of our clinical development program involving ANG-3070, and the timing of the initiation of the ANG-3070 Phase 2 study. 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 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.



    Contact
    Daniel Ferry
    LifeSci Advisors
    617-430-7576
    daniel@lifesciadvisors.com

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  4. UNIONDALE, N.Y., June 29, 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 announced that its exploratory Phase 2 ALI-201 trial of ANG-3777 in patients with severe COVID-19 related pneumonia at high risk for acute respiratory distress syndrome (ARDS) did not meet the primary or secondary efficacy endpoints. The adverse events and overall safety of the trial were consistent with previously published reports in patients hospitalized with severe COVID-19 pneumonia.

    "The ALI-201 study sought to address a patient population severely ill…

    UNIONDALE, N.Y., June 29, 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 announced that its exploratory Phase 2 ALI-201 trial of ANG-3777 in patients with severe COVID-19 related pneumonia at high risk for acute respiratory distress syndrome (ARDS) did not meet the primary or secondary efficacy endpoints. The adverse events and overall safety of the trial were consistent with previously published reports in patients hospitalized with severe COVID-19 pneumonia.

    "The ALI-201 study sought to address a patient population severely ill with COVID-19, a multi-system inflammatory condition, which differs markedly from our prior and ongoing clinical trials of ANG-3777 related to transplantation and cardiovascular surgery where the acute kidney injury is a discrete event," stated Dr. John F. Neylan, Angion's Chief Medical Officer. "Patients in the ALI-201 trial had ongoing and accumulating injury from symptomatic COVID-19 on average 11 days before receiving drug with organ systems under continued attack from the SARS-CoV-2 virus. In contrast, patients in our ongoing trials receive ANG-3777 within 1-3 days after the targeted organ injury. COVID-19 is a severe systemic disease presenting significant challenges to both new and previously approved therapeutics."

    "We were pleased to be part of the attempt to help patients severely ill with COVID-19 and extend our deepest gratitude to the patients, their families, investigators, and site staff who participated in this study," commented Dr. Jay R. Venkatesan, Angion's President and Chief Executive Officer. "With the increasing availability of approved COVID-19 vaccines and the widespread assumption vaccines will reduce infection rates around the world, we will not continue the development of this COVID-19 program. Based on the promising activity of ANG-3777 in multiple animal models of lung injury, we will continue to evaluate the clinical development of ANG-3777 for acute lung injury populations."

    The ALI-201 study was a small exploratory Phase 2 double-blind, randomized, and placebo-controlled trial conducted in Brazil to evaluate the safety and efficacy of four doses of ANG-3777 in the reduction of severity and progression of acute lung injury in patients with COVID-19 associated pneumonia who are at high risk of progressing to ARDS. The primary endpoint of the trial was survival free from the need for mechanical ventilation or dialysis at 28 days. The active arm of the trial did not show a statistically significant difference over the standard of care arm. A total of 120 patients were randomized 1:1 in the trial, with 59 patients in the active treatment arm and 61 patients in the standard of care arm.

    The number of adverse events, serious adverse events, and fatal events reported in ALI-201 were slightly higher for those subjects in the active treatment arm compared to those in the standard of care control arm, although no new or unexpected safety signals resulted from the trial. None of the fatal events in this trial of advanced COVID-19 patients were attributed by study investigators to either ANG-3777 or standard of care in the control arm.

    The company expects to report data from the ANG-3777 Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, by the end of 2021. The company also expects to report data from the ANG-3777 Phase 2 proof of-concept trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery in the second half of 2021.

    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 and Angion believes ANG-3777 has the potential to be a first-in-class therapeutic addressing acute organ injury. The ongoing clinical trials of ANG-3777 include a placebo-controlled Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function and a Phase 2 proof of-concept trial for the treatment of acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery. In November 2020, Vifor Pharma and Angion signed a license agreement worth up to $1.9 billion in development, commercial, and sales milestones plus royalties on net sales of up to 40% for global rights outside Greater China to commercialize ANG-3777 in nephrology indications. Sinovant Sciences and Angion signed a development and licensing agreement for ANG-3777 in Greater China in 2018.

    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 evaluating 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 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 ANG-3777 and the timing of the availability of and Angion's disclosure of topline data from such studies. 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; and regulatory developments in the United States, and other foreign countries. 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, particularly under the caption "Risk Factors," as well as other documents filed from time to time by the Company 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
    daniel@lifesciadvisors.com

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