AKRO Akero Therapeutics Inc.

27.33
+0.96  (+4%)
Previous Close 26.37
Open 26.7
52 Week Low 19.58
52 Week High 41.16
Market Cap $951,639,318
Shares 34,820,319
Float 21,982,567
Enterprise Value $670,785,987
Volume 105,330
Av. Daily Volume 272,524
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Efruxifermin (Harmony)
Nonalcoholic Steatohepatitis
Phase 2b
Phase 2b
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
Efruxifermin
Nonalcoholic steatohepatitis (NASH)
Phase 2a
Phase 2a
Phase 2a Cohort C data announced March 22, 2021. 25% of EFX patients (3 of 12) showed NASH resolution. 4 of 12 patients (33%) achieved a one-stage improvement in fibrosis without worsening of NASH.

Latest News

  1. SOUTH SAN FRANCISCO, Calif., April 26, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced the appointment of Yuan Xu, Ph.D., to its board of directors as an independent director.

    "Dr. Xu's extensive experience in establishing and leading biopharmaceutical development and manufacturing capabilities brings a complementary perspective to our Board," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero Therapeutics. "The Akero leadership team looks forward to working with Dr. Xu as we enter late-stage development of our lead NASH candidate efruxifermin."

    Yuan Xu, Ph.D…

    SOUTH SAN FRANCISCO, Calif., April 26, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced the appointment of Yuan Xu, Ph.D., to its board of directors as an independent director.

    "Dr. Xu's extensive experience in establishing and leading biopharmaceutical development and manufacturing capabilities brings a complementary perspective to our Board," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero Therapeutics. "The Akero leadership team looks forward to working with Dr. Xu as we enter late-stage development of our lead NASH candidate efruxifermin."

    Yuan Xu, Ph.D., has a long-standing track record of executive and scientific leadership in biopharmaceutical research, development, manufacturing, commercialization and life-cycle management. Most recently, she served as a board member and chief executive officer for Legend Biotech Co., playing a leading role in its successful IPO. Dr. Xu's prior career as a senior executive includes heading up Merck's Biologics & Vaccines subdivision, as well leading biopharmaceutical development and manufacturing groups for Novartis, Gilead and GlaxoSmithKline. Dr. Xu received a B.S. in biochemistry from Nanjing University and a Ph.D. in biochemistry from the University of Maryland, and she completed her post-doctoral training in virology and gene therapy at the University of California, San Diego.

    "Akero is developing an exciting novel therapy engineered to reproduce the benefits of native FGF21, with encouraging biopsy data indicating potential for rapid reversal of NASH," said Dr. Xu. "I look forward to furthering Akero's efforts to make this highly-differentiated, potentially best-in-class medicine, if approved, available to millions of patients around the world."

    About Akero Therapeutics

    Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead product candidate, efruxifermin (EFX), an engineered Fc-FGF21 fusion protein, is currently being evaluated in a Phase 2b clinical trial (the HARMONY study) as a potential treatment for NASH. Akero is headquartered in South San Francisco. Visit the company at www.akerotx.com for more information.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding the company's business plans and objectives, including future plans or expectations for EFX, upcoming milestones and therapeutic effects of EFX, and our growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress.

    Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the impact of COVID-19 on the company's ongoing and future operations, including potential negative impacts on the company's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of the company's product candidate development activities and planned clinical trials; the company's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; the company's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in the company's most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in the company's other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Christina Tartaglia

    212.362.1200

    Media Contact:

    Jennifer Weismann

    612.716.0556

     



    Primary Logo

    View Full Article Hide Full Article
  2. SOUTH SAN FRANCISCO, Calif., March 23, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced the first patient has been randomized for dosing in its Phase 2b clinical study of Efruxifermin (EFX) in the treatment of patients with F2/F3 NASH (the HARMONY study).

    "Randomization of the first patient in our Phase 2b HARMONY study in F2/F3 patients is yet another key milestone for Akero, which builds on our recent data in cirrhotic patients (F4) and last year's data in patients with F1-F3 fibrosis," said Kitty Yale, chief development officer of Akero. "Screening and enrollment in HARMONY are ahead…

    SOUTH SAN FRANCISCO, Calif., March 23, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced the first patient has been randomized for dosing in its Phase 2b clinical study of Efruxifermin (EFX) in the treatment of patients with F2/F3 NASH (the HARMONY study).

    "Randomization of the first patient in our Phase 2b HARMONY study in F2/F3 patients is yet another key milestone for Akero, which builds on our recent data in cirrhotic patients (F4) and last year's data in patients with F1-F3 fibrosis," said Kitty Yale, chief development officer of Akero. "Screening and enrollment in HARMONY are ahead of schedule and we remain on track to report topline preliminary results in the second half of 2022. We are excited about the potential benefits that EFX may offer to patients with NASH, a serious metabolic disease for which there is no FDA-approved treatment option."

    The Phase 2b HARMONY study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with fibrosis stage 2 or 3. Patients will be randomized to receive once-weekly subcutaneous dosing of 28 or 50mg EFX, or placebo. The primary endpoint for the trial is fibrosis regression at 24 weeks. Patients will continue to receive EFX or placebo after 24 weeks during a long-term follow-up period to provide additional safety data.

    About NASH

    Non-alcoholic steatohepatitis (NASH) is a serious, life-threatening disease that has rapidly emerged as a leading cause of liver failure in the world and is the leading indication for liver transplant among women. An estimated 17.3 million Americans had NASH in 2016, a number that is expected to increase to 27.0 million by 2030. NASH is a severe form of nonalcoholic fatty liver disease (NAFLD) characterized by hepatocyte injury, liver inflammation, and fibrosis that can progress to scarring (cirrhosis), liver failure, cancer and death. There are currently no approved therapies for the disease.

    About Efruxifermin

    Efruxifermin (EFX) is an Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. Previous clinical trials show that EFX has the potential to reverse fibrosis, resolve NASH, reduce liver fat, improve glycemic control and lipoprotein profile, and reduce body weight. EFX is designed to offer convenient once-weekly subcutaneous dosing.

    About Akero Therapeutics

    Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead product candidate, EFX, an engineered Fc-FGF21 fusion protein, is currently being evaluated in a Phase 2b clinical trial as a potential treatment for NASH. Akero is headquartered in South San Francisco. Visit us at www.akerotx.com for more information.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding the Company's business plans and objectives, including future plans or expectations for EFX, upcoming milestones, and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; the Company's Phase 2b HARMONY study including expected timing to complete enrollment and report preliminary results; the Company's Phase 2b SYMMETRY study, including expected timing for initiation and enrollment of the study; the availability of a new drug product presentation to support Phase 3 clinical trials; expectations regarding the Company's use of capital, expenses and other future financial results; statements regarding a potential meeting with the FDA and timing thereof and the potential impact of COVID-19 on strategy, future operations, enrollment and clinical trials. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the impact of COVID-19 on the Company's ongoing and future operations, including potential negative impacts on the Company's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of the Company's product candidate development activities and planned clinical trials; the Company's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; the Company's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in the Company's most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in the Company's other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Christina Tartaglia

    212.362.1200

    Media Contact:

    Jennifer Weismann

    612.716.0556



    Primary Logo

    View Full Article Hide Full Article
  3. -- 33% of patients treated with efruxifermin (EFX) (4 of 12) improved by one fibrosis stage without worsening of NASH --

    -- 25% of EFX patients (3 of 12) showed NASH resolution --

    -- Rapid fibrosis improvement in cirrhotic patients after only 16 weeks of EFX treatment, the highest rate reported publicly to date, suggests direct anti-fibrotic effects --

    SOUTH SAN FRANCISCO, Calif., March 22, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced results of an expansion cohort of a 16-week Phase 2a clinical trial, Cohort C, evaluating efruxifermin (EFX) in the treatment of adult…

    -- 33% of patients treated with efruxifermin (EFX) (4 of 12) improved by one fibrosis stage without worsening of NASH --

    -- 25% of EFX patients (3 of 12) showed NASH resolution --

    -- Rapid fibrosis improvement in cirrhotic patients after only 16 weeks of EFX treatment, the highest rate reported publicly to date, suggests direct anti-fibrotic effects --

    SOUTH SAN FRANCISCO, Calif., March 22, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced results of an expansion cohort of a 16-week Phase 2a clinical trial, Cohort C, evaluating efruxifermin (EFX) in the treatment of adult patients with cirrhotic nonalcoholic steatohepatitis (NASH) (compensated stage 4 fibrosis, Child-Pugh Class A). Of the 17 confirmed compensated cirrhosis (F4) study subjects who volunteered to have end-of-treatment biopsies, 4 of 12 patients (33%) treated with EFX achieved a one-stage improvement in fibrosis without worsening of NASH. Another 3 of 12 EFX patients (25%) achieved NASH resolution. In total, 7 of 12 EFX patients (58%) showed histological improvements. None of the 5 placebo patients (0%) achieved either one-stage improvement in fibrosis without worsening of NASH, or resolution of NASH. In addition, statistically significant improvements in glycemic control and lipoprotein profile, and a trend toward weight loss, were also observed.

    "I believe these data are unprecedented," said Stephen Harrison, M.D., medical director of Pinnacle Clinical Research. "Today's data in cirrhotic patients, who have the highest unmet need, show clear signals of fibrosis improvement without worsening of NASH and NASH resolution, supported by compelling, statistically significant results for non-invasive fibrosis measures. These results set EFX apart."

    Cohort C is an expansion of the Phase 2a BALANCED study evaluating EFX in the treatment of F4 NASH patients, Child-Pugh Class A. Thirty cirrhotic NASH subjects with a historical biopsy-confirmed fibrosis score of F4 were randomized 2:1 to receive either 50mg of EFX or placebo for 16 weeks. A total of 27 subjects were subsequently confirmed by the central reader to have F4 fibrosis at baseline. The primary objective of Cohort C was to assess the safety and tolerability of EFX in NASH patients at greatest risk of progressing to end-stage liver disease, including liver failure and liver cancer. Secondary objectives included assessments of liver stiffness by Fibroscan and serum markers of liver fibrosis, such as the Enhanced Liver Fibrosis (ELF) score and Pro-C3. The trial design was amended to allow voluntary end-of-treatment biopsies.

    Summary of Biopsy Results and Non-Invasive Fibrosis Measurements

    Histology Endpoint (% responders)Placebo

    (n=5)
    50mg

    (n=12)
    Improvement in at least one stage of fibrosis without worsening of NASH,%1,2033
    Resolution of NASH, %1,2025
    Non-invasive measurement (LS Mean)Placebo

    (n=10)
    50mg

    (n=20)
    Liver Stiffness, kPa3-1.9-5.7††
    Pro-C3, μg/L4-3.4-9.0*
    ELF Score4+0.3-0.4*

    1 Study not powered to assess statistical significance of changes in histological endpoints

    2 Liver Biopsy Evaluable Analysis Set (all patients who had baseline and end-of-treatment liver biopsy results)

    3 Liver Stiffness Analysis Set (all subjects with a week 16 FibroScan)

    4 Biomarker Analysis Set (all subjects with a post baseline interpretable measure of ELF or pro-C3, respectively)

    †† p<0.01, versus baseline (ANCOVA)

    * p<0.05, versus placebo (ANCOVA)

    EFX was reported to be generally well-tolerated. The most common adverse event in the EFX group was mild or moderate diarrhea. There were two discontinuations, one in the placebo group and one in the EFX group. There was one serious adverse event in the placebo group and no deaths in either group.

    "The promising results in cirrhotic NASH patients reported today build on the strong results previously reported for patients with F1-F3 fibrosis," said Andrew Cheng, M.D., Ph.D., president and CEO of Akero. "We believe EFX has the potential to be a foundational NASH monotherapy for cirrhotic patients as well as patients with earlier-stages of fibrosis. We look forward to continuing the development of our Phase 2b HARMONY study in patients with F2-F3 fibrosis started in February 2021, and our planned Phase 2b SYMMETRY study in cirrhotic patients (F4 fibrosis), which we plan to initiate in the second half of this year. We remain extremely grateful to all of our study patients and investigators, particularly given that this study cohort was conducted during the COVID-19 pandemic."

    Conference Call / Webcast Details

    The company will host a conference call and webcast with slide presentation at 4:30 p.m. ET (1:30 p.m. PT) today, March 22. The webcast will be made available on Akero's website at www.akerotx.com under the Investors tab in the Events, Presentations & Webcasts section. To access the call, please dial 1-877-282-0556 (U.S. toll free) or 1-270-215-9899 (international) five minutes prior to the start time, and provide Conference ID #1885464. Following the live audio webcast, a replay will be available on the company's website for 90 days.

    About NASH

    Non-alcoholic steatohepatitis (NASH) is a serious, life-threatening disease that has rapidly emerged as a leading cause of liver failure in the world and is the leading indication for liver transplant among women. An estimated 17.3 million Americans had NASH in 2016, a number that is expected to increase to 27.0 million by 2030. NASH is a severe form of nonalcoholic fatty liver disease (NAFLD) characterized by hepatocyte injury, liver inflammation, and fibrosis that can progress to scarring (cirrhosis), liver failure, cancer and death. There are currently no approved therapies for the disease.

    About Efruxifermin

    Efruxifermin (EFX) is an Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. Previous clinical trials show that EFX has the potential to reverse fibrosis, resolve NASH, reduce liver fat, improve glycemic control and lipoprotein profile, and reduce body weight. EFX is designed to offer convenient once-weekly subcutaneous dosing.

    About Akero Therapeutics

    Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead product candidate, EFX, an engineered Fc-FGF21 fusion protein, is currently being evaluated in a Phase 2b clinical trial as a potential treatment for NASH. Akero is headquartered in South San Francisco. Visit www.akerotx.com for more information.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding the Company's business plans and objectives, including future plans or expectations for EFX, upcoming milestones, and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; the Company's Phase 2b HARMONY study including expected timing to complete enrollment and report preliminary results; the Company's Phase 2b SYMMETRY study, including expected timing for initiation and enrollment of the study; the availability of a new drug product formulation to support Phase 3 clinical trials; expectations regarding the Company's use of capital, expenses and other future financial results; statements regarding a potential meeting with the FDA and timing thereof and the potential impact of COVID-19 on strategy, future operations, enrollment and clinical trials. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the impact of COVID-19 on the Company's ongoing and future operations, including potential negative impacts on the Company's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of the Company's product candidate development activities and planned clinical trials; the Company's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; the Company's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in the Company's most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in the Company's other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact:

    Christina Tartaglia

    212.362.1200

    Media Contact:

    Jennifer Weismann

    612.716.0556



    Primary Logo

    View Full Article Hide Full Article
  4. SOUTH SAN FRANCISCO, Calif., March 22, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that the company plans to discuss new efficacy and safety data, including biopsy results, from an expansion cohort of a 16-week Phase 2a clinical trial, Cohort C, evaluating efruxifermin (EFX) in the treatment of adult patients with cirrhotic nonalcoholic steatohepatitis (NASH) in a post-market press release and webcast to be held today, March 22, 2021.

    Conference Call / Webcast Details
    The company will host a conference call and webcast with slide presentation at 4:30 p.m. ET (1:30 p.m. PT) this afternoon…

    SOUTH SAN FRANCISCO, Calif., March 22, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that the company plans to discuss new efficacy and safety data, including biopsy results, from an expansion cohort of a 16-week Phase 2a clinical trial, Cohort C, evaluating efruxifermin (EFX) in the treatment of adult patients with cirrhotic nonalcoholic steatohepatitis (NASH) in a post-market press release and webcast to be held today, March 22, 2021.

    Conference Call / Webcast Details

    The company will host a conference call and webcast with slide presentation at 4:30 p.m. ET (1:30 p.m. PT) this afternoon, March 22, 2021. The webcast of the conference call will be made available on the company's website at www.akerotx.com under the Investors tab in the Events, Presentations & Webcasts section. To access the call via dial-in, please dial 1-877-282-0556 (U.S. toll free) or 1-270-215-9899 (international), Conference ID 1885464, five minutes prior to the start time. Following the live audio webcast, a replay will be available on the company's website for 90 days.

    About Akero Therapeutics

    Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead product candidate, EFX, an engineered Fc-FGF21 fusion protein, is currently being evaluated in Phase 2 clinical trials as a potential treatment for NASH. Akero is headquartered in South San Francisco. Visit us at www.akerotx.com for more information.

    Investor Contact:

    Christina Tartaglia

    212.362.1200

    Media Contact:

    Jennifer Weismann

    612.716.0556

     



    Primary Logo

    View Full Article Hide Full Article
  5. SOUTH SAN FRANCISCO, Calif., March 16, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today reported fourth quarter and full year financial results for the period ending December 31, 2020.

    "In 2020 we reported strong results from our Phase 2a BALANCED study in biopsy-confirmed NASH patients suggesting that our lead asset, efruxifermin (EFX), has the potential to be a foundational monotherapy for treatment of NASH," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "We have been particularly pleased with biopsy data that showed rapid improvements in both fibrosis and NASH…

    SOUTH SAN FRANCISCO, Calif., March 16, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today reported fourth quarter and full year financial results for the period ending December 31, 2020.

    "In 2020 we reported strong results from our Phase 2a BALANCED study in biopsy-confirmed NASH patients suggesting that our lead asset, efruxifermin (EFX), has the potential to be a foundational monotherapy for treatment of NASH," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "We have been particularly pleased with biopsy data that showed rapid improvements in both fibrosis and NASH resolution and look forward to reporting additional biopsy data among cirrhotic patients by April of this year."

    Fourth Quarter Business Highlights

    • During the fourth quarter, the Company reported additional analyses for the main portion of the Phase 2a BALANCED study, including proportion of patients who achieved 50% and 70% relative reductions in liver fat, and extent of improvement in fibrosis among patients with F2 or F3 fibrosis at baseline and of glycemic control among patients with Type 2 diabetes mellitus.
    • Among all EFX-treated patients who were fibrosis stage F2 or F3 at baseline (n=22), 50% experienced a two-stage improvement in fibrosis (n=11), while 68% experienced at least a one-stage improvement in fibrosis (n=15).
    • Based on these rapid improvements in fibrosis observed after only 16 weeks of treatment, the Company believes that EFX has the potential to play an important role in reversing fibrosis for NASH patients.

    Phase 2a BALANCED Study Cohort C Update

    • Data collection for Cohort C of the BALANCED study, including voluntary end-of-treatment biopsies, was completed in February 2021.
    • The Company expects to report preliminary results from Cohort C by April 2021, including safety and tolerability of EFX along with analyses of paired biopsies and non-invasive measures of liver health.

    Phase 2b HARMONY Study Update

    • Screening of subjects for the HARMONY study, a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with fibrosis stage 2 or 3, began in February 2021.
    • The Company expects to complete enrollment in 2021 and report preliminary results in the second half of 2022.

    Regulatory Update

    • An end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) to review HARMONY study results and finalize the proposed Phase 3 protocol, including dose selection and study size, will be requested prior to initiating Phase 3.

    Manufacturing Update

    • Drug substance manufactured by Akero for use in the Phase 2b HARMONY study has been shown to be comparable to that previously manufactured by Amgen.
    • The Company anticipates that a lyophilized formulation of drug product will be available for Phase 3 initiation in the first half of 2023.

    COVID-19 Update

    • The Company's financial results for the year ended December 31, 2020 were not significantly impacted by COVID-19.
    • The COVID-19 pandemic did not materially impact data collection for Cohort C, ongoing enrollment in the Phase 2b HARMONY study or manufacturing of drug substance.

    Full Year and Fourth Quarter 2020 Financial Results

    • Akero's cash, cash equivalents and short-term marketable securities for the year ended December 31, 2020 were $268.4 million.
    • Research and development expenses for the three-month and twelve-month periods ended December 31, 2020 were $25.7 million and $64.9 million, respectively, compared to $13.1 million and $37.0 million for the comparable periods in 2019. These increases are attributable to higher costs related to Akero's EFX program, including third-party contract manufacturing, contract research organization costs associated with the BALANCED and HARMONY studies and internal personnel costs.
    • General and administrative expenses for the three-month and twelve-month periods ended December 31, 2020 were $4.1 million and $15.2 million, respectively, compared to $3.1 million and $8.6 million for the comparable periods in 2019. These increases are attributable to higher expenses for personnel, including non-cash stock-based compensation, and professional services and other costs associated with operating as a public company.
    • Total operating expenses were $29.8 million and $80.2 million for the three-month and twelve-month periods ended December 31, 2020, respectively, compared to $16.2 million and $45.7 million for the comparable periods in 2019.

    About NASH

    Non-alcoholic steatohepatitis (NASH) is a serious, life-threatening disease that has rapidly emerged as a leading cause of liver failure in the world and is the leading indication for liver transplant among women. An estimated 17.3 million Americans had NASH in 2016, a number that is expected to increase to 27.0 million by 2030. NASH is a severe form of nonalcoholic fatty liver disease (NAFLD) characterized by hepatocyte injury, liver inflammation, and fibrosis that can progress to scarring (cirrhosis), liver failure, cancer and death. There are currently no approved therapies for the disease.

    About Cohort C

    Cohort C is an expansion cohort of the Phase 2a BALANCED study evaluating EFX in the treatment of patients with NASH who have compensated cirrhosis (F4), Child-Pugh Class A. Thirty cirrhotic NASH subjects with a biopsy-confirmed fibrosis score of F4 were randomized 2:1 to receive either 50mg of EFX or placebo for 16 weeks. The primary objective of the expansion cohort is to assess safety and tolerability of EFX in NASH patients at the greatest risk of progressing to end-stage liver disease, including liver failure and liver cancer. The trial design includes various non-invasive measures of liver health, including fibrosis markers such as the Enhanced Liver Fibrosis (ELF) score and Pro-C3, as well as liver imaging. The trial design also provided that all patients could volunteer to have end-of-treatment biopsies.

    About the HARMONY Study

    The Phase 2b HARMONY study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with fibrosis stage 2 or 3. Patients will be randomized to receive once-weekly subcutaneous dosing of 28 or 50mg EFX or placebo. The primary endpoint for the trial is fibrosis regression at 24 weeks. Patients will continue to receive EFX or placebo during a long-term follow-up period to provide additional safety data.

    About Efruxifermin

    Efruxifermin (EFX) is an Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. Previous clinical trials show that EFX has the potential to reverse fibrosis, resolve NASH, reduce liver fat, improve glycemic control, improve lipoprotein profile, and reduce body weight. EFX is designed to offer convenient once-weekly subcutaneous dosing.

    About Akero Therapeutics

    Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead product candidate, EFX, an engineered Fc-FGF21 fusion protein, is currently being evaluated in Phase 2 clinical trials as a potential treatment for NASH. Akero is headquartered in South San Francisco. Visit us at www.akerotx.com for more information.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding the Company's business plans and objectives, including future plans or expectations for EFX, upcoming milestones, and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; the Company's plans to report preliminary results for Cohort C of the Phase 2a BALANCED study; the Company's Phase 2b HARMONY study including expected timing to complete enrollment and report preliminary results; the availability of a new drug product formulation to support Phase 3 clinical trials; expectations regarding the Company's use of capital, expenses and other future financial results; statements regarding a potential meeting with the FDA and timing thereof and the potential impact of COVID-19 on strategy, future operations, enrollment and clinical trials. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the impact of COVID-19 on the Company's ongoing and future operations, including potential negative impacts on the Company's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of the Company's product candidate development activities and planned clinical trials; the Company's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; the Company's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in the Company's most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in the Company's other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Akero Therapeutics, Inc.      
    Condensed Consolidated Balance Sheets      
    (Unaudited)      
    (In thousands)      
                 
      December 31, 2020 December 31, 2019      
    Assets            
    Cash, cash equivalents and short-term marketable securities $268,387  $136,400       
    Other current assets  2,958   1,649       
    Non-current assets  1,994   69       
    Total assets $273,339  $138,118       
                 
    Liabilities and Stockholders' Equity            
    Current liabilities $13,111  $9,369       
    Non-current liabilities  1,516   23       
    Stockholders' equity  258,712   128,726       
    Total liabilities and stockholders' equity $273,339  $138,118       
                 
                 
    Akero Therapeutics, Inc.
    Condensed Consolidated Statements of Operations and Comprehensive Loss
    (Unaudited)
    (In thousands, except share and per share amounts)
                 
      Three Months Ended December 31, Twelve Months Ended December 31,
      2020  2019  2020  2019 
    Operating expenses:            
    Research and development $25,709  $13,138  $64,916  $37,046 
    General and administrative  4,074   3,083   15,238   8,605 
    Total operating expenses  29,783   16,221   80,154   45,651 
    Loss from operations  (29,783)  (16,221)  (80,154)  (45,651)
    Other income  72   610   947   1,896 
    Net loss $(29,711) $(15,611) $(79,207) $(43,755)
    Comprehensive loss $(29,730) $(15,617) $(79,204) $(43,761)
    Net loss per common share, basic and diluted $(0.86) $(0.55) $(2.52) $(2.90)
    Weighted-average number of shares used in computing net loss per common share, basic and diluted  34,684,466   28,335,405   31,463,248   15,070,728 
                 

    Investor Contact:

    Christina Tartaglia

    212.362.1200

    Media Contact:

    Jennifer Weismann

    612.716.0556



    Primary Logo

    View Full Article Hide Full Article
View All Akero Therapeutics Inc. News