ANGN Angion Biomedica Corp.

13.03
+0.01  (+0%)
Previous Close 13.02
Open 13.1
52 Week Low 12.45
52 Week High 26.3
Market Cap $386,511,418
Shares 29,663,194
Float 16,145,584
Enterprise Value $279,974,966
Volume 329,668
Av. Daily Volume 64,936
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Upcoming Catalysts

Drug Stage Catalyst Date
ANG-3070
Healthy volunteers
Phase 1
Phase 1
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ANG-3777
Acute lung injury in patients with COVID-19
Phase 2
Phase 2
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ANG-3777
Acute Kidney Injury associated with cardiac surgery
Phase 2
Phase 2
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ANG-3777
Acute kidney injury (AKI) / Delayed Graft Function
Phase 3
Phase 3
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Latest News

  1. UNIONDALE, N.Y., May 17, 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 March 31, 2021.

    "Angion has accomplished a great deal so far in 2021," said Dr. Jay R. Venkatesan, Angion's President and Chief Executive Officer. "We have completed enrollment in two ANG-3777 Phase 2 trials and successfully executed an initial public offering and concurrent private placement raising gross proceeds of $117 million to help finance the advancement of our clinical…

    UNIONDALE, N.Y., May 17, 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 March 31, 2021.

    "Angion has accomplished a great deal so far in 2021," said Dr. Jay R. Venkatesan, Angion's President and Chief Executive Officer. "We have completed enrollment in two ANG-3777 Phase 2 trials and successfully executed an initial public offering and concurrent private placement raising gross proceeds of $117 million to help finance the advancement of our clinical pipeline towards regulatory approvals. We continue to execute our strategies for ANG-3777 and ANG-3070 and look forward to sharing data from both these programs in 2021."

    Upcoming 2021 Key Milestones

    ProgramsMilestones
    ANG-3777
    • Topline Phase 2 data for ANG-3777 in acute lung injury associated with COVID-19 related pneumonia in H1 2021
    • Topline Phase 2 data for ANG-3777 in acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery in H2 2021
    • Topline Phase 3 data for ANG-3777 in transplant-associated acute kidney injury, also known as delayed graft function, by the end of 2021
    ANG-3070
    • Phase 1 data from healthy volunteer study in H1 2021
    • Initiation of Phase 2 trial of ANG-3070 in patients with proteinuric kidney diseases in 2021

    2021 Corporate Highlights

    • Completed enrollment of the ANG-3777 Phase 2 trial in cardiac surgery-associated acute kidney injury (CSA-AKI)
    • Completed enrollment of the ANG-3777 Phase 2 trial in Brazil in patients with acute lung injury associated with COVID-19 pneumonia who are at high risk of progressing to Acute Respiratory Distress Syndrome (ARDS)
    • Closed a successful initial public offering and concurrent private placement with aggregate gross proceeds of $117.0 million

    First Quarter 2021 Financial Results

    As of March 31, 2021, Angion had cash and cash equivalents totaling $130.5 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 into 2022.

    Contract revenue for the three months ended March 31, 2021 was $0.4 million compared with zero for the three months ended March 31, 2020.

    Grant revenue for the three months ended March 31, 2021 was zero compared with $0.9 million for the three months ended March 31, 2020.

    Research and development expenses for the three months ended March 31, 2021 were $14.3 million compared with $9.6 million for the three months ended March 31, 2020.

    General and administrative expenses for the three months ended March 31, 2021 were $6.0 million compared with $3.5 million for the three months ended March 31, 2020.

    Net losses for the three months ended March 31, 2021 were $36.7 million compared with $13.2 million for the three months ended March 31, 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, a Phase 2 trial in cardiac-surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19 related pneumonia at high risk for acute respiratory distress syndrome. 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 the Company's product candidates, including ANG-3777 and ANG-3070, the potential results and outcomes of our clinical development programs involving ANG-3777 or other product candidates, the timing of the availability of and Angion's disclosure of topline data from such programs, and the adequacy of our cash resources over time. 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 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.



    ANGION BIOMEDICA CORP.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

    (unaudited)

     Three Months Ended March 31,
     2021 2020
    Revenue:   
    Contract revenue$371    $—   
    Grant revenue—    865   
    Total revenue371    865   
    Operating expenses:   
    Cost of grant revenue—    383   
    Research and development14,298    9,596   
    General and administrative6,012    3,455   
    Total operating expenses20,310    13,434   
    Loss from operations(19,939)  (12,569) 
    Other income (expense), net(16,748)  (653) 
    Net loss$(36,687)  $(13,222) 
    Net loss per common share, basic and diluted$(1.56)  $(0.91) 
    Weighted average common shares outstanding, basic and diluted23,443,851    14,462,823   
            





































    ANGION BIOMEDICA CORP.


    Condensed Consolidated Balance Sheets

    (in thousands, except share and per share amounts)

    (unaudited)

     March 31, December 31,
     2021 2020
        
    ASSETS   
    Current assets   
    Cash and cash equivalents$130,456    $34,607   
    Prepaid expenses and other current assets3,042    7,690   
    Total current assets133,498    42,297   
    Property and equipment, net246    156   
    Right of use assets4,541    4,072   
    Investments in related parties877    822   
    Other assets38    —   
    Total assets$139,200    $47,347   
    LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)   
    Current liabilities   
    Accounts payable$6,690    $5,578   
    Accrued expenses4,092    6,665   
    Lease liability—current780    611   
    Deferred revenue—current3,792    3,942   
    Warrant liability714    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 debt895    260   
    Total current liabilities16,963    107,449   
    Lease liability—noncurrent4,150    3,847   
    Deferred revenue—noncurrent25,644    25,865   
    Other long-term debt—    635   
    Total liabilities46,757    137,796   
    Stockholders' equity (deficit)   
    Common stock300    156   
    Treasury stock(2,991)  (1,846) 
    Additional paid-in capital292,670    72,136   
    Accumulated other comprehensive loss(287)  (333) 
    Accumulated deficit(197,249)  (160,562) 
    Total stockholders' equity (deficit)92,443    (90,449) 
    Total liabilities and stockholders' equity (deficit)$139,200    $47,347   
              



    Contact
    Daniel Ferry
    LifeSci Advisors
    617-430-7576
    

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    • Topline data expected in the second half of 2021

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210428005922/en/

    Vifor Pharma and Angion Biomedica Corp. (NASDAQ:ANGN), today announced completion of enrollment for Angion's AKI-002-15 study, a phase-II trial of ANG-3777 in patients at risk of cardiac-surgery associated acute kidney injury (CSA-AKI). This indication is part of the ANG-3777 license agreement both parties signed in November 2020.

    "CSA-AKI is a frequent complication of cardiac bypass surgery seen in about one third of patients and is associated with prolonged hospitalization, progressive kidney failure, and an increased risk of death," commented Dr…

    • Topline data expected in the second half of 2021

    Regulatory News:

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210428005922/en/

    Vifor Pharma and Angion Biomedica Corp. (NASDAQ:ANGN), today announced completion of enrollment for Angion's AKI-002-15 study, a phase-II trial of ANG-3777 in patients at risk of cardiac-surgery associated acute kidney injury (CSA-AKI). This indication is part of the ANG-3777 license agreement both parties signed in November 2020.

    "CSA-AKI is a frequent complication of cardiac bypass surgery seen in about one third of patients and is associated with prolonged hospitalization, progressive kidney failure, and an increased risk of death," commented Dr. John Neylan, Angion's Senior Vice President and Chief Medical Officer. "Currently, there are no approved therapies to prevent this serious condition. This phase-II prevention trial was designed to generate data on ANG-3777 in CSA-AKI patients to help guide future development of ANG-3777 in a phase-III registration trial for CSA-AKI. We are planning to start the confirmatory trial early in 2022, subject to the results of this phase-II trial as well as discussions with the FDA and other relevant health authorities."

    Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group commented: "We are excited that enrollment in the AKI-002-15 phase-II trial has completed. This is an important milestone in a comprehensive clinical program to advance ANG-3777as a potential treatment option to prevent acute kidney injury following cardiac surgery, an indication with a high unmet medical need. Together with our partner Angion, we now look forward to assessing the results from the trial."

    The fully enrolled phase-II trial is a randomized, multi-center, double-blind, placebo-controlled clinical trial with trial sites in the United States, Canada, Brazil, and Georgia. Patients at risk for CSA-AKI were randomized one-to-one to receive four intravenous doses of 2.0 mg/kg of ANG-3777 or placebo over four days. The first dose was given within four hours of the completion of surgery with subsequent doses given at 24-hour intervals. The primary endpoint is mean area under the curve of the percent increase in serum creatinine above baseline, starting from 24 hours after the end of cardiopulmonary bypass surgery through day six. An additional important endpoint is the occurrence of Major Adverse Kidney Events at 90 days (MAKE 90), which has previously been agreed by the FDA as a suitable primary endpoint for a registration trial in this indication. A MAKE 90 "event" is death, initiation of renal replacement therapy or a greater than 25% decline in eGFR present 90 days after the surgery. The AKI-002-15 phase-II trial was designed as a signal-finding trial with the strategic objective to obtain sufficient evidence of efficacy of ANG-3777 to appropriately power and evaluate potential enrichment strategies for a phase-III registration trial.

    About ANG-3777

    ANG-3777 is an investigational small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue and organ repair. ANG-3777 has demonstrated 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. Enrollment is complete in a phase-III registration trial in transplant-associated acute kidney injury, also known as delayed graft function, a phase-II exploratory trial in cardiac-surgery associated acute kidney injury, and a phase-II exploratory trial in patients with acute lung injury associated with COVID-19 pneumonia. In November 2020, Vifor Pharma and Angion signed a license agreement for global rights excluding Greater China to commercialize ANG-3777 in renal indications with up to $1.925 billion in development, commercial, and sales milestones plus royalties on net sales of up to 40%. Sinovant Sciences and Angion signed a development and licensing agreement for ANG-3777 in Greater China in 2018.

    About Vifor Pharma Group

    Vifor Pharma Group is a global pharmaceutical 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 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, a Phase 2 trial in cardiac-surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19 related pneumonia at high risk for acute respiratory distress syndrome. 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.

    Angion 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, the potential results and outcomes of the AKI-002-15 study, and other studies involving ANG-3777 or other product candidates, the timing of the commencement of future clinical trials and the timing of 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 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; 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 Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 30, 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.

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  2. UNIONDALE, N.Y. and ST. GALLEN, Switzerland, April 29, 2021 (GLOBE NEWSWIRE) -- Angion Biomedica Corp (NASDAQ:ANGN) and Vifor Pharma today announced completion of enrollment for Angion's AKI-002-15 study, a Phase 2 trial of ANG-3777 in patients at risk of cardiac-surgery associated acute kidney injury (CSA-AKI). This indication is part of the ANG-3777 license agreement both parties signed in November 2020.

    "CSA-AKI is a frequent complication of cardiac bypass surgery seen in about one third of patients and is associated with prolonged hospitalization, progressive kidney failure, and an increased risk of death," commented Dr. John Neylan, Angion's Senior Vice President and Chief Medical Officer. "Currently, there are no approved therapies…

    UNIONDALE, N.Y. and ST. GALLEN, Switzerland, April 29, 2021 (GLOBE NEWSWIRE) -- Angion Biomedica Corp (NASDAQ:ANGN) and Vifor Pharma today announced completion of enrollment for Angion's AKI-002-15 study, a Phase 2 trial of ANG-3777 in patients at risk of cardiac-surgery associated acute kidney injury (CSA-AKI). This indication is part of the ANG-3777 license agreement both parties signed in November 2020.

    "CSA-AKI is a frequent complication of cardiac bypass surgery seen in about one third of patients and is associated with prolonged hospitalization, progressive kidney failure, and an increased risk of death," commented Dr. John Neylan, Angion's Senior Vice President and Chief Medical Officer. "Currently, there are no approved therapies to prevent this serious condition. This Phase 2 prevention trial was designed to generate data on ANG-3777 in CSA-AKI patients to help guide future development of ANG-3777 in a Phase 3 registration trial for CSA-AKI. We are planning to start the confirmatory trial early in 2022, subject to the results of this Phase 2 trial as well as discussions with the FDA and other relevant health authorities."

    Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group commented: "We are excited that enrollment in the AKI-002-15 Phase 2 trial has completed. This is an important milestone in a comprehensive clinical program to advance ANG-3777 as a potential treatment option to prevent acute kidney injury following cardiac surgery, an indication with a high unmet medical need. Together with our partner Angion, we now look forward to assessing the results from the trial."

    The fully enrolled Phase 2 trial is a randomized, multi-center, double-blind, placebo-controlled clinical trial with trial sites in the United States, Canada, Brazil, and Georgia. Patients at risk for CSA-AKI were randomized one-to-one to receive four intravenous doses of 2.0 mg/kg of ANG-3777 or placebo over four days. The first dose was given within four hours of the completion of surgery with subsequent doses given at 24-hour intervals. The primary endpoint is mean area under the curve of the percent increase in serum creatinine above baseline, starting from 24 hours after the end of cardiopulmonary bypass surgery through day six. An additional important endpoint is the occurrence of Major Adverse Kidney Events at 90 days (MAKE 90), which has previously been agreed by the FDA as a suitable primary endpoint for a registration trial in this indication. A MAKE 90 "event" is death, initiation of renal replacement therapy or a greater than 25% decline in eGFR present 90 days after the surgery. The AKI-002-15 Phase 2 trial was designed as a signal-finding trial with the strategic objective to obtain sufficient evidence of efficacy of ANG-3777 to appropriately power and evaluate potential enrichment strategies for a Phase 3 registration trial.

    About ANG-3777

    ANG-3777 is an investigational small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue and organ repair. ANG-3777 has demonstrated 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. Enrollment is complete in a Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, a Phase 2 exploratory trial in cardiac-surgery associated acute kidney injury, and a Phase 2 exploratory trial in patients with acute lung injury associated with COVID-19 pneumonia. In November 2020, Vifor Pharma and Angion signed a license agreement for global rights excluding Greater China to commercialize ANG-3777 in renal indications with up to $1.925 billion in development, commercial, and sales milestones plus royalties on net sales of up to 40%. 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, a Phase 2 trial in cardiac-surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19 related pneumonia at high risk for acute respiratory distress syndrome. 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.

    About Vifor Pharma Group

    Vifor Pharma Group is a global pharmaceutical 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 expectations regarding the potential safety and efficacy of ANG-3777, the potential results and outcomes of the AKI-002-15 study, and other studies involving ANG-3777 or other product candidates, the timing of the commencement of future clinical trials and the timing of 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; 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 Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 30, 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 and further information:
    
    For Angion:
    Daniel Ferry
    LifeSci Advisors
    617-430-7576
    
    
    Vifor Media Relations
    Nathalie Ponnier
    Global Head Corporate Communications
    +41 79 957 96 73 
    
    
    Vifor Investor Relations
    Julien Vignot
    Head of Investor Relations
    +41 58 851 66 90
    
    
    

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  3. UNIONDALE, N.Y., March 30, 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 fourth quarter and year ended December 31, 2020.

    "This a very exciting time for Angion," said Dr. Jay R. Venkatesan, Angion's President and Chief Executive Officer. "With multiple data readouts across our clinical programs expected over the remainder of 2021, including our lead product candidate ANG-3777, we believe our company is on track to potentially improve outcomes for a number of patient…

    UNIONDALE, N.Y., March 30, 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 fourth quarter and year ended December 31, 2020.

    "This a very exciting time for Angion," said Dr. Jay R. Venkatesan, Angion's President and Chief Executive Officer. "With multiple data readouts across our clinical programs expected over the remainder of 2021, including our lead product candidate ANG-3777, we believe our company is on track to potentially improve outcomes for a number of patient populations. To support these efforts, we recently completed an initial public offering and concurrent private placement raising gross proceeds of $117 million to help finance the advancement of our clinical pipeline towards regulatory approvals."

    "In 2020, we advanced the clinical development of our lead program ANG-3777, a small molecule HGF mimetic, being investigated in acute organ injuries," continued Dr. Venkatesan. "We completed enrollment for our Phase 3 trial in patients with delayed graft function, where we expect to report topline data by the end of 2021. In addition, we signed a transformative licensing agreement with Vifor Pharma for ANG-3777 in renal indications."

    Upcoming 2021 Key Milestones

    ProgramsMilestones
    ANG-3777
    • Topline Phase 2 data for ANG-3777 in acute lung injury associated with COVID-19 related pneumonia in H1 2021
    • Topline Phase 2 data for ANG-3777 in acute kidney injury associated with cardiac surgery involving cardiopulmonary bypass surgery in H1 2021
    • Phase 3 data for ANG-3777 in transplant-associated acute kidney injury, also known as delayed graft function, by the end of 2021
    ANG-3070
    • Phase 1 data from healthy volunteer study in H1 2021
    • Initiation of Phase 2 trial of ANG-3070 in patients with proteinuric kidney diseases in 2021

    Full Year 2020 and Recent Corporate Highlights

    • Closed successful initial public offering and concurrent private placement with aggregate gross proceeds of $117.0 million in February 2021
    • Signed a license agreement with Vifor Pharma for global rights except in Greater China to commercialize ANG-3777 in renal indications, which is valued up to $1.9 billion in development, commercial, and sales milestones plus royalties of up to 40% on net sales
    • Completed enrollment of the Phase 3 trial of ANG-3777 in patients with delayed graft function
    • Completed enrollment of the ANG-3777 Phase 2 trial in Brazil in patients with acute lung injury associated with COVID-19 pneumonia who are at high risk of progressing to ARDS
    • Published results from the Phase 2 trial of ANG-3777 to treat patients with delayed graft function in the scientific journal Transplantation in May 2020
    • Appointed industry leaders Dr. Allen R. Nissenson, Dr. Gilbert S. Omenn, and Karen J. Wilson to the Board of Directors and appointed Victor Ganzi as lead independent director
    • Appointed Jennifer J. Rhodes as Sr. VP, General Counsel, Chief Compliance Officer, and Corporate Secretary

    Fourth Quarter and Full Year 2020 Financial Results

    As of December 31, 2020, Angion had cash and cash equivalents totaling $34.6 million. Subsequent to the end of the year, the Company completed its initial public offering and a concurrent private placement with aggregate gross proceeds of $117.0 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 into 2022.

    Contract revenue for the three and twelve months ended December 31, 2020 was $0.2 million compared with zero in the same periods in 2019.

    Grant revenue for the three months ended December 31, 2020 was $0.3 million compared with $0.7 million for the three months ended December 31, 2019. Grant revenue for the year ended December 31, 2020 was $2.7 million compared with $1.5 million for the year ended December 31, 2019.

    Research and development expenses for the three months ended December 31, 2020 were $11.1 million compared with $10.4 million for the three months ended December 31, 2019. Research and development expenses for the year ended December 31, 2020 were $39.0 million compared with $29.8 million for the year ended December 31, 2019.

    General and administrative expenses for the three months ended December 31, 2020 were $3.1 million compared with $4.1 million for the three months ended December 31, 2019. General and administrative expenses for the year ended December 31, 2020 were $18.0 million compared with $9.6 million for the year ended December 31, 2019.

    Net losses for the three months ended December 31, 2020 were $28.9 million compared with $16.0 million for three months ended December 31, 2019. Net losses for the year ended December 31, 2020 were of $80.1 million compared with $40.7 million for the year ended December 31, 2019.

    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, a Phase 2 trial in cardiac-surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19 related pneumonia at high risk for acute respiratory distress syndrome. 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 the Company's product candidates, including ANG-3777 and ANG-3070, the potential results and outcomes of our clinical development programs involving ANG-3777 or other product candidates, the timing of the availability of and Angion's disclosure of topline data from such programs, and the adequacy of our cash resources over time. 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 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 Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 30, 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

    ANGION BIOMEDICA CORP.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share amounts)

     Three Months Ended December 31, Year Ended December 31,
     2020 2019 2020 2019
            
     (unaudited)    
    Revenue:       
    Contract revenue$193   $   $193   $  
    Grant revenue266   696   2,687   1,487  
    Total revenue459   696   2,880   1,487  
    Operating expenses:       
    Cost of grant revenue126   299   1,190   640  
    Research and development11,065   10,447   38,977   29,837  
    General and administrative3,118   4,143   17,986   9,601  
    Total operating expenses14,309   14,889   58,153   40,078  
    Loss from operations(13,850)  (14,193)  (55,273)  (38,591) 
    Other income (expense), net(15,025)  (1,822)  (24,834)  (2,067) 
    Net loss(28,875)  (16,015)  (80,107)  (40,658) 
    Net loss per common share, basic and diluted$(1.90)  $(1.11)  $(5.43)  $(2.82) 
    Weighted average common shares outstanding, basic and diluted15,206,506   14,435,279   14,762,120   14,435,279  
                    







    ANGION BIOMEDICA CORP.

    Consolidated Balance Sheets

    (in thousands, except share and per share amounts)

     December 31,
     2020 2019
    ASSETS   
    Current assets   
    Cash and cash equivalents$34,607   $5,571  
    Grants receivable   440  
    Prepaid expenses and other current assets7,690   95  
    Total current assets42,297   6,106  
    Property and equipment, net156   209  
    Right of use assets4,072   4,572  
    Investments in related parties822   999  
    Total assets$47,347   $11,886  
    LIABILITIES AND STOCKHOLDERS' DEFICIT   
    Current liabilities   
    Accounts payable$5,578   $11,239  
    Accrued expenses6,665   2,661  
    Lease liability—current611   1,033  
    Deferred revenue—current3,942     
    Warrant liability10,704   5,794  
    Convertible promissory notes payable at fair value51,170   5,848  
    Series C convertible preferred stock at amortized cost26,001     
    Series C convertible preferred stock at fair value2,518     
    Other short-term debt260     
    Total current liabilities107,449   26,575  
    Lease liability—noncurrent3,847   3,897  
    Deferred revenue—noncurrent25,865     
    Other long-term debt635     
    Total liabilities137,796   30,472  
    Stockholders' deficit   
    Series A convertible preferred stock, $0.01 par value per share; 19,448 authorized shares; none issued or outstanding as of December 31, 2020 and 2019, respectively     
    Series B convertible preferred stock, $0.01 par value per share; 73,707 authorized shares; none issued or outstanding as of December 31, 2020 and 2019, respectively     
    Common stock, $0.01 par value per share; 30,000,000 authorized shares; 15,632,809 and 14,758,718 shares issued as of December 31, 2020 and 2019, respectively; 15,316,721 and 14,446,554 shares outstanding as of December 31, 2020 and 2019, respectively156   148  
    Treasury stock, 316,088 and 312,164 and shares outstanding as of December 31, 2020 and 2019, respectively(1,846)  (1,810) 
    Additional paid-in capital72,136   63,531  
    Accumulated other comprehensive loss(333)    
    Accumulated deficit(160,562)  (80,455) 
    Total stockholders' deficit(90,449)  (18,586) 
    Total liabilities and stockholders' deficit$47,347   $11,886  


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  4. UNIONDALE, N.Y., March 25, 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 completion of enrollment for its ALI-201 study, a Phase 2 trial conducted in Brazil of ANG-3777 for 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 acute respiratory distress syndrome, or ARDS.

    To be enrolled in the trial, subjects must have been admitted to the hospital with confirmed COVID-19 disease and either require non-invasive mechanical ventilation…

    UNIONDALE, N.Y., March 25, 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 completion of enrollment for its ALI-201 study, a Phase 2 trial conducted in Brazil of ANG-3777 for 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 acute respiratory distress syndrome, or ARDS.

    To be enrolled in the trial, subjects must have been admitted to the hospital with confirmed COVID-19 disease and either require non-invasive mechanical ventilation or have insufficient blood oxygen saturation while on high flow oxygen administration. The primary endpoint is survival free from the need for mechanical ventilation or dialysis at 28 days. This trial was powered in a manner where only a very substantial improvement in the primary endpoint will result in a statistically significant outcome.

    "We have preclinical data from a number of studies indicating ANG-3777 has activity in models of acute lung injury and ARDS," commented Dr. John Neylan, Angion's Senior Vice President and Chief Medical Officer. "This exploratory Phase 2 trial was designed to detect signals of activity for ANG-3777 in patients at high risk of ARDS in the context of COVID-19 related pneumonia. While powered only to detect a substantial improvement in the primary endpoint, we will evaluate the totality of the data for signals of efficacy and safety to help guide future development of ANG-3777 in conditions related to acute lung injury and ARDS."

    About ANG-3777

    ANG-3777 is an investigational small molecule designed to mimic the biological activity of hepatocyte growth factor (HGF), which activates the c-Met cascade of pathways involved in tissue and organ repair. ANG-3777 has demonstrated 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. Enrollment is complete in a placebo-controlled Phase 3 registration trial in transplant-associated acute kidney injury, also known as delayed graft function, and a Phase 2 exploratory trial in patients with acute lung injury associated with COVID-19 pneumonia. Enrollment is ongoing in a Phase 2 exploratory 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 for global rights outside Greater China to commercialize ANG-3777 in nephrology indications with up to $1.925 billion in development, commercial, and sales milestones plus royalties on net sales of up to 40%. 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, a Phase 2 trial in cardiac-surgery associated acute kidney injury, and a Phase 2 trial in patients with COVID-19 related pneumonia at high risk for acute respiratory distress syndrome. 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, the potential results and outcomes of the ALI-201 study, and other studies involving ANG-3777 or other product candidates, 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; 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 Angion's recently filed full registration statement (including prospectus) filed with the Securities and Exchange Commission on February 4, 2021, particularly under the caption "Risk Factors." 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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