1. SOUTH SAN FRANCISCO, Calif., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that members of the management team will present at the Morgan Stanley Virtual Global Healthcare Conference on Wednesday, September 15, 2021 at 11:45 a.m. (ET).

    A live webcast of the Company presentation will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcasts, archived replays will be available on the Company's website.

    About Akero Therapeutics
    Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational…

    SOUTH SAN FRANCISCO, Calif., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that members of the management team will present at the Morgan Stanley Virtual Global Healthcare Conference on Wednesday, September 15, 2021 at 11:45 a.m. (ET).

    A live webcast of the Company presentation will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcasts, archived replays will be available on the Company's website.

    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 investigational drug product candidate, efruxifermin (EFX) is a differentiated 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. EFX is designed to offer convenient once-weekly subcutaneous dosing. The consistency and magnitude of effects observed in clinical studies position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in pre-cirrhotic patients with F2/F3 fibrosis and the SYMMETRY study in cirrhotic (F4) patients. Akero is headquartered in South San Francisco. Visit www.akerotx.com for more information.

    Investor Contact:

    Christina Tartaglia

    Stern Investor Relations, Inc.

    212.362.1200

    christina.tartaglia@sternir.com

    Media Contact:

    650.487.6488

    media@akerotx.com



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  2. SOUTH SAN FRANCISCO, Calif., Aug. 13, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today reported second quarter financial results for the period ending June 30, 2021.

    "Our clinical and manufacturing momentum is a testament to our confidence in efruxifermin (EFX), which has the potential to be among the first investigational NASH therapies approved for treatment of both pre-cirrhotic (F2/F3) and cirrhotic (F4) NASH," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "We are excited to initiate our second Phase 2b clinical trial in patients with late-stage cirrhotic NASH…

    SOUTH SAN FRANCISCO, Calif., Aug. 13, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today reported second quarter financial results for the period ending June 30, 2021.

    "Our clinical and manufacturing momentum is a testament to our confidence in efruxifermin (EFX), which has the potential to be among the first investigational NASH therapies approved for treatment of both pre-cirrhotic (F2/F3) and cirrhotic (F4) NASH," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "We are excited to initiate our second Phase 2b clinical trial in patients with late-stage cirrhotic NASH (F4), who are at increased risk of liver failure and thus have the highest unmet medical need."

    Second Quarter Business Highlights & Company Updates

    • During the second quarter, Akero continued to enroll patients in the HARMONY study, a Phase 2b multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed pre-cirrhotic NASH patients (fibrosis stages F2 and F3).
    • During the second quarter, Akero successfully initiated GMP manufacture of drug substance (API) to be used for Phase 3 evaluation of EFX.
    • In July, Nature Medicine published full results of the main portion of Akero's Phase 2a BALANCED trial in biopsy-confirmed NASH patients with F1-F3 fibrosis.
      • Published analysis showed that pre-cirrhotic NASH patients treated for 16 weeks with EFX achieved substantial reductions in liver fat, associated with decreases in markers of liver injury and inflammation, and reversal of fibrosis.
      • The first published clinical evidence of fibrosis regression with an FGF21 analog.
    • In July, Akero initiated its SYMMETRY study, a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with compensated cirrhosis (F4), Child-Pugh class A.
      • Follows Akero's first quarter announcement of topline results from a 30-patient expansion cohort of the Phase 2a BALANCED study of EFX in late-stage (F4) cirrhotic NASH, which showed substantial improvements in fibrosis after 16 weeks of treatment among patients with end-of-treatment biopsies.

    Second Quarter 2021 Financial Results

    • Akero's cash, cash equivalents and short-term marketable securities for the period ended June 30, 2021 were $230.0 million.
    • Akero believes that its cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into the third quarter of 2023.
    • Research and development expenses for the three-month period ended June 30, 2021 were $24.0 million, compared to $13.0 million for the comparable period in 2020. 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 period ended June 30, 2021 were $5.0 million, compared to $3.4 million for the comparable period in 2020. 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 $29.0 million for the three-month period ended June 30, 2021, compared to $16.5 million for the comparable period in 2020.

    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 investigational drug product candidate, efruxifermin (EFX) is a differentiated 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. EFX is designed to offer convenient once-weekly subcutaneous dosing. The consistency and magnitude of effects observed in clinical studies position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in pre-cirrhotic patients with F2/F3 fibrosis and the SYMMETRY study in cirrhotic (F4) patients. 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 Akero'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; Akero's Phase 2a BALANCED clinical trial, including additional analysis of its data and potential therapeutic benefits; Akero's Phase 2b HARMONY and SYMMETRY clinical trials; expectations regarding Akero's use of capital, expenses and other future financial results; 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 Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero'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; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero's most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero 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

    IR@akerotx.com

    Media Contact:

    650.487.6488

    media@akerotx.com





           
    Akero Therapeutics, Inc.      
    Condensed Consolidated Balance Sheets      
    (Unaudited)      
    (In thousands)      
              
     June 30, 2021 December 31, 2020      
    Assets           
    Cash, cash equivalents and short-term marketable securities$230,028  $268,387       
    Other current assets 6,194   2,958       
    Non-current assets 1,787   1,994       
    Total assets$238,009  $273,339       
                
    Liabilities and Stockholders' Equity           
    Current liabilities$16,459  $13,111       
    Non-current liabilities 1,417   1,516       
    Stockholders' equity 220,133   258,712       
    Total liabilities and stockholders' equity$238,009  $273,339       
                
                
    Akero Therapeutics, Inc.
    Condensed Consolidated Statements of Operations and Comprehensive Loss
    (Unaudited)
    (In thousands, except share and per share amounts)
                
     Three Months Ended June 30, Six Months Ended June 30,
     2021 2020 2021 2020
    Operating expenses:           
    Research and development$23,976  $13,037  $34,578  $21,828 
    General and administrative 4,990  $3,417   9,516   7,005 
    Total operating expenses 28,966   16,454   44,094   28,833 
    Loss from operations (28,966)  (16,454)  (44,094)  (28,833)
    Other income,net 33   247   71   740 
    Net loss$(28,933) $(16,207) $(44,023) $(28,093)
    Comprehensive loss$(28,940) $(16,162) $(44,029) $(27,997)
    Net loss per common share, basic and diluted$(0.83) $(0.57) $(1.27) $(0.98)
    Weighted-average number of shares used in computing net loss per common share, basic and diluted 34,814,631   28,602,976   34,779,647   28,551,227 
                

     



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  3. SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today announced the appointment of Yuan Xu, Ph.D., to its Board of Directors as an independent director. Dr. Xu brings to Fate Therapeutics over 25 years of discovery, development, manufacturing, and commercial experience in the global biopharmaceuticals business, most recently serving as the Chief Executive Officer and Board Member of Legend Biotech Corporation where she led the company's efforts in advancing ciltacabtagene autoleucel (cilta-cel) from proof-of-concept in 2018 to BLA preparation in 2020.

    "Yuan is an accomplished leader…

    SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, today announced the appointment of Yuan Xu, Ph.D., to its Board of Directors as an independent director. Dr. Xu brings to Fate Therapeutics over 25 years of discovery, development, manufacturing, and commercial experience in the global biopharmaceuticals business, most recently serving as the Chief Executive Officer and Board Member of Legend Biotech Corporation where she led the company's efforts in advancing ciltacabtagene autoleucel (cilta-cel) from proof-of-concept in 2018 to BLA preparation in 2020.

    "Yuan is an accomplished leader and innovator with extensive experience in guiding development and scaling manufacture of novel therapies, including CAR T-cell therapies such as cilta-cel," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are excited to work with Yuan, and we look forward to benefiting from her deep domain expertise as the Company advances its off-the-shelf, iPSC-derived NK and T-cell product candidates further into clinical development, transitions to large-scale manufacture, and establishes technical operations to support commercial approval."

    Dr. Xu joined Legend Biotech Corporation in March 2018 as chief executive officer and as a director, playing a leading role in the company's IPO, clinical development of the autologous CAR T-cell therapy cilta-cel, and partnership with Janssen until her resignation in August 2020. Prior to Legend, Dr. Xu was Senior Vice President at Merck from August 2015 to August 2017, where she led discovery, preclinical and technical development, and manufacture of the Biologics & Vaccines subdivision. Dr. Xu was Vice President at Gilead from March 2014 to August 2015, where she led biologics and vaccines development and oversaw all operational aspects of the company's Oceanside manufacturing facility as Site Head, and was Vice President at Novartis from 2008 to 2014, where she led several functions in the U.S. and Europe including the biotherapeutics development unit focusing on innovative medicines such as engineered cell therapies, gene therapies, and antibody drug conjugates. Dr. Xu currently serves as an independent director on the board of directors of Akero Therapeutics, Inc. (NASDAQ:AKRO).

    "Fate Therapeutics has pioneered the field of iPSC-derived cell therapy, and has established a clear leadership position in the development of off-the-shelf NK and T-cell cancer immunotherapy with its robust clinical pipeline, novel iPSC product platform, and high-value strategic collaborations," said Dr. Xu. "I look forward to working closely with the Company's board and management team as we move into late-stage clinical development, scale manufacture, and seek to make these innovative cancer medicines more broadly accessible to patients."

    Early in her career, Dr. Xu held positions at Amgen, Chiron, GlaxoSmithKline and Genentech. 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.

    About Fate Therapeutics' iPSC Product Platform

    The Company's proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company's first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company's platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics' iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

    About Fate Therapeutics, Inc.

    Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of, plans related to, and the therapeutic potential of the Company's product candidates, the Company's clinical development and manufacturing strategies, and the Company's plans for the clinical investigation and manufacture of its product candidates. These and any other forward-looking statements in this 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. These risks and uncertainties include, but are not limited to, the risk that results observed in studies of its product candidates, including preclinical studies and clinical trials of any of its product candidates, will not be observed in ongoing or future studies involving these product candidates, the risk that the Company may cease or delay clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, the amount and type of data to be generated, or otherwise to support regulatory approval, difficulties or delays in subject enrollment and continuation in current and planned clinical trials, difficulties in manufacturing or supplying the Company's product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company's periodic filings with the Securities and Exchange Commission, including but not limited to the Company's most recently filed periodic report, and from time to time in the Company's press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

    Contact:

    Christina Tartaglia

    Stern Investor Relations, Inc.

    212.362.1200

    christina@sternir.com



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  4. SOUTH SAN FRANCISCO, Calif., July 14, 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 Judy Chou, Ph.D., to its board of directors as an independent director.

    "Dr. Chou's expertise in biomanufacturing and protein therapeutic development and experience managing regulatory filings and commercial launches make her an asset to our Board," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero Therapeutics. "Akero is fortunate to welcome Dr. Chou and benefit from her strategic insights, particularly as our investigational NASH drug efruxifermin progresses…

    SOUTH SAN FRANCISCO, Calif., July 14, 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 Judy Chou, Ph.D., to its board of directors as an independent director.

    "Dr. Chou's expertise in biomanufacturing and protein therapeutic development and experience managing regulatory filings and commercial launches make her an asset to our Board," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero Therapeutics. "Akero is fortunate to welcome Dr. Chou and benefit from her strategic insights, particularly as our investigational NASH drug efruxifermin progresses in the clinic."

    Judy Chou, Ph.D., is a biotech industry leader with a 25-year track record of driving drug development and biomanufacturing successes in established and emerging growth biopharmaceutical companies. Dr. Chou is currently President & CEO of AltruBio, Inc., a company focused on developing novel therapeutics for immunological diseases. Prior to AltruBio, she was senior vice president and global head of Biotech at Bayer Pharmaceuticals where she oversaw a more than $3 billion biotechnology product portfolio and led drug development and launch activities for the companies' biologics pipeline. Earlier in her career, Dr. Chou held senior pharmaceutical operations and manufacturing roles at Pfizer, Inc., formerly Medivation, and Tanvex Biopharma, Inc. Before joining the industry, Dr. Chou was a research faculty member at Harvard University Medical School, focused on cell biology and neuroscience research. She received her Ph.D. from Yale University and completed her post-doctoral training at Max-Planck Institute in Germany.

    "Akero's rapid progress advancing a differentiated and potentially best-in-class medicine capable of reversing the effects of NASH and restoring liver health is inspiring and compelling," said Dr. Chou. "I look forward to working with Akero's leadership team to guide this novel therapy through the clinic and, if efruxifermin is approved, to introduce it to patients and families."

    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) is a differentiated 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. EFX is designed to offer convenient once-weekly subcutaneous dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in a Phase 2b clinical trial in NASH patients with F2/F3 fibrosis, the HARMONY study. 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 Akero'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; Akero's Phase 2b HARMONY clinical trial; and its 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 Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero'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; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero's most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero 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

    IR@akerotx.com

    Media Contact:

    650.487.6488

    media@akerotx.com



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  5. SOUTH SAN FRANCISCO, Calif., July 08, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that full results of the main portion of its Phase 2a BALANCED trial in biopsy-confirmed NASH patients with F1-F3 fibrosis have been published in Nature Medicine.

    The manuscript, available at this link, provides a comprehensive analysis showing that pre-cirrhotic NASH patients treated for 16 weeks with Akero's investigational drug, efruxifermin (EFX), an FGF21 analog, achieved substantial reductions in liver fat, associated with decreases in markers of liver injury and inflammation, and reversal of fibrosis…

    SOUTH SAN FRANCISCO, Calif., July 08, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that full results of the main portion of its Phase 2a BALANCED trial in biopsy-confirmed NASH patients with F1-F3 fibrosis have been published in Nature Medicine.

    The manuscript, available at this link, provides a comprehensive analysis showing that pre-cirrhotic NASH patients treated for 16 weeks with Akero's investigational drug, efruxifermin (EFX), an FGF21 analog, achieved substantial reductions in liver fat, associated with decreases in markers of liver injury and inflammation, and reversal of fibrosis after only 16 weeks treatment. Numerous endpoints are reported for the first time in Nature Medicine.

    "This disclosure of EFX data in Nature Medicine marks the first published clinical evidence of fibrosis regression with an FGF21 analog and what we believe are the largest reductions in liver fat publicly reported to date across all NASH investigational drug classes," said Kitty Yale, chief development officer of Akero. "We're pleased to contribute to the field of NASH clinical research with publication of these data. We extend gratitude to the trial participants who made this study possible."

    NASH is a serious, potentially life-threatening condition that is a leading cause of liver failure and liver transplantation globally. An estimated 17.3 million Americans had NASH in 2016, a number that is expected to increase to 27.0 million by 2030. There are currently no approved therapies for NASH. Weight loss of 10 percent or more has been shown to reverse NASH by restoring normal levels of liver fat and reducing insulin resistance. Unfortunately, achieving this degree of weight loss through lifestyle change is very challenging.

    "The holy grail for NASH drug development is a therapy that treats the whole person, addressing liver fat accumulation, insulin resistance, and liver cell stress that drive the disease, as well as reducing inflammation, and reversing fibrosis," said Stephen Harrison, MD, medical director of Pinnacle Clinical Research and lead author. "The magnitude and consistency of positive effects in all of these areas demonstrate potential for EFX to be a foundational NASH monotherapy."

    The BALANCED study was a randomized, controlled Phase 2a trial across 27 U.S. sites that enrolled 80 biopsy-confirmed, pre-cirrhotic NASH patients (F1 to F3 fibrosis stage) who received either placebo or EFX for 16 weeks as a weekly subcutaneous injection in one of three doses: 28 mg, 50 mg, or 70 mg. The study met its primary endpoint of absolute change from baseline in hepatic fat fraction measured at week 12, with 48 percent of EFX patients across dose groups achieving normal levels of liver fat (defined as less than 5 percent liver fat), compared with 5 percent of placebo patients. Reductions in liver fat were associated with substantial decreases in markers of liver injury and fibrosis. Consistent with these observations, 50 percent of EFX patients who had F2/F3 fibrosis at baseline and repeat biopsies after 16 weeks of treatment achieved a two-stage regression of fibrosis. Reflecting EFX's potential to have a beneficial impact on whole body metabolism, EFX patients were reported to have significantly improved levels of triglyceride, non HDL-cholesterol and HbA1c, along with a trend toward lower body weight.

    EFX was reported to be generally well tolerated. There were two Serious Adverse Events, one of which occurred prior to dosing, and there were no deaths in the study. Across EFX groups, the most frequent AEs were grade 1 or 2 gastrointestinal events, which were transient in nature.

    The BALANCED study also incorporated a 30-patient expansion cohort in late-stage (F4) cirrhotic NASH. Substantial improvements in fibrosis were evident after 16 weeks of treatment among patients with end-of-treatment biopsies, with 58 percent of EFX patients meeting one of two key biopsy endpoints. Specifically, 4 of 12 patients who received 50mg EFX achieved a one-stage improvement in fibrosis without worsening of NASH1 and 3 of 12 achieved NASH resolution2, in each case compared with 0 of 5 placebo patients. The expansion cohort data are not included in the Nature Medicine publication and will be submitted for potential publication in the future. Topline results are reported here.

    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) is a differentiated 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. EFX is designed to offer convenient once-weekly subcutaneous dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in a Phase 2b clinical trial in NASH patients with F2/F3 fibrosis, the HARMONY study. 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 Akero'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; Akero's Phase 2a BALANCED clinical trial, including additional analysis of its data and potential therapeutic benefits; Akero's Phase 2b HARMONY clinical trial; 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 Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero'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; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero's most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero 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

    IR@akerotx.com

    Media Contact:

    650.487.6488

    media@akerotx.com

    ______________________________

    1 No worsening of NASH mean no increase in NAFLD Activity Score (NAS) for ballooning, inflammation, or steatosis.

    2 NASH resolution is defined as having a NAS of 0 or 1 for lobular inflammation and a score of 0 for ballooning, out of a total possible NAS of 8 (0-3 for steatosis, 0-3 for lobular inflammation, and 0-2 for hepatocyte ballooning).



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  6. SOUTH SAN FRANCISCO, Calif., June 25, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced additional analyses from its Phase 2a BALANCED study of efruxifermin (EFX) in NASH patients with F1-F3 fibrosis, which are being presented by Juan Frias, MD, medical director of the National Cancer Institute, as two posters at the American Diabetes Association's 81st Scientific Sessions (ADA). The posters are available starting at 11:30am ET on June 25, 2021 and will be posted to the company's website. The company's EFX program in NASH is also being featured in a video presentation at the ADA, which can…

    SOUTH SAN FRANCISCO, Calif., June 25, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced additional analyses from its Phase 2a BALANCED study of efruxifermin (EFX) in NASH patients with F1-F3 fibrosis, which are being presented by Juan Frias, MD, medical director of the National Cancer Institute, as two posters at the American Diabetes Association's 81st Scientific Sessions (ADA). The posters are available starting at 11:30am ET on June 25, 2021 and will be posted to the company's website. The company's EFX program in NASH is also being featured in a video presentation at the ADA, which can be accessed from the company's website.

    In a poster presentation titled "Efruxifermin is associated with improved glucose metabolism in patients with NASH and type 2 diabetes" (Abstract 116-LB), Dr. Frias reports improvements in markers of glucose metabolism, insulin sensitivity and lipoprotein profile, with a trend to reduce body weight, in patients with NASH and type 2 diabetes mellitus after 16 weeks of treatment with EFX. These improvements, including a clinically meaningful and statistically significant reduction in HbA1c, were seen on top of concomitant anti-diabetic medications.

    "Improving insulin sensitivity and glucose metabolism is a critical component in the management of NASH because metabolic dysregulation plays a major role in the pathophysiology of this disorder, and because roughly one third of patients with type 2 diabetes also have NASH—often with suboptimal glycemic control," said Dr. Frias. "These preliminary data demonstrating improvements in glucose metabolism with EFX are very encouraging and indicate that EFX may play an important future role in the management of NASH in patients with glucose intolerance."

    In a second poster presentation titled "Increased adiponectin following efruxifermin treatment is associated with improvements in dyslipidemia, glucose metabolism, and liver health in a 16-week, randomized, placebo-controlled NASH trial" (Abstract 119-LB), Dr. Frias reports the contribution of FGFR1c activation by EFX in adipose tissue, as indicated by increased serum adiponectin, to the beneficial effects observed on liver health and glucose metabolism. These secondary analyses highlight the potential of FGFR1c-mediated reprogramming of adipose metabolism in NASH patients to improve liver health. Insulin-sensitizing therapeutics acting predominantly on adipose tissue, such as pioglitazone, have historically been associated with weight gain. A consistent trend toward weight loss in the BALANCED study suggests that EFX may redirect fat away from the liver to adipose tissue in a weight-neutral manner, contributing to the potentially unique therapeutic profile of EFX.   

    "The only way to really treat NASH is to treat the whole body and not just the liver," said Tim Rolph, chief scientific officer of Akero Therapeutics. "The breadth, consistency and magnitude of effects observed following treatment with EFX across clinical trials in patients with metabolic disease appear to derive from EFX's balanced agonism of FGF21's receptors in adipose tissue and liver."

    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) is a differentiated 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. In prior clinical trials, EFX has reversed fibrosis, resolved NASH, reduced liver fat, improved glycemic control, improved lipoprotein profile, and shown a trend to lower body weight. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in a Phase 2b clinical trial in NASH patients with F2/F3 fibrosis, the HARMONY study. 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 Akero'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; Akero's Phase 2a BALANCED clinical trial, including additional analysis of its data and potential therapeutic benefits; Akero's Phase 2b HARMONY clinical trial; 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 Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero'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; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero's most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero 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

    IR@akerotx.com

    Media Contact:

    650.487.6488

    media@akerotx.com

     



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  7. SOUTH SAN FRANCISCO, Calif., June 21, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced additional analyses from its Phase 2a BALANCED study of efruxifermin (EFX) in NASH patients with F1-F3 fibrosis, which were presented in two posters at the 2021 International Liver Congress. These analyses show significant correlations between normalization of liver fat (≤ 5% liver fat content (LFC) by MRI-PDFF) and improvements in markers of liver injury and fibrosis, as well as whole-body metabolism. The new analyses also show that combining ALT response of ≥ 17 U/L with normalization of liver fat increases…

    SOUTH SAN FRANCISCO, Calif., June 21, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced additional analyses from its Phase 2a BALANCED study of efruxifermin (EFX) in NASH patients with F1-F3 fibrosis, which were presented in two posters at the 2021 International Liver Congress. These analyses show significant correlations between normalization of liver fat (≤ 5% liver fat content (LFC) by MRI-PDFF) and improvements in markers of liver injury and fibrosis, as well as whole-body metabolism. The new analyses also show that combining ALT response of ≥ 17 U/L with normalization of liver fat increases the power to predict resolution of NASH (0- or 1-point for lobular inflammation and 0 points for ballooning component of NAFLD Activity Score) and NASH resolution combined with a 1-stage improvement in fibrosis.

    • Abstract No. 1314: "The role of reduction in liver fat content (MRI-PDFF) and ALT in predicting treatment response in NASH: A secondary analysis of the randomized, controlled BALANCED trial," presented by Rohit Loomba, M.D.
    • Abstract No. 1762: "Correlation between changes in liver fat content and improvements in serum markers of liver injury, fibrosis, metabolism, and in histologic parameters following treatment with efruxifermin," presented by Stephen Harrison, M.D.

    "These analyses provide evidence that rapid and substantial liver fat reduction was associated with improvements in markers of liver metabolic health and improvement of NASH histopathology following treatment with efruxifermin," said Kitty Yale, chief development officer of Akero. "These analyses also make an important contribution toward the development of noninvasive markers that can predict histological improvements in NASH. Based on the strength of these correlations, as well as biopsy results from the BALANCED study, we believe treatment with EFX will result in sustained histological improvements in our ongoing and future clinical trials."

    Extent of Reduction of Liver Fat Content (LFC) at Week 12

    EndpointPlaceboa28mg EFX50mg EFX70mg EFX
     Relative Reduction in LFC
     ≥50%5%69%**100%***93%***
     ≥70%5%50%*53%**80%***
     Normalization of LFC
     ≤5% at Week 125%25%*53%**67%***

    *p<0.05, **p<0.01, ***p<0.001

    a A single placebo responder lost 25 pounds over 16 weeks (11% weight reduction)

    Summary of Key Odds Ratios for Liver Fat Normalizationa

    Histologic EndpointOdds Ratio (95% CI)bP valuec
     NASH Resolution14.1 (1.2, 13.2)0.0365
     NAS Reduction by ≥426.4 (1.8, 15.6)0.0068

    a ≤5% Liver Fat Content at Week 12; b Wald 95% Confidence Interval; cFisher's exact test;

    1 0- or 1-point for lobular inflammation and 0 points for ballooning components of NAFLD Activity Score

    2 At least 2 points in lobular inflammation and/or ballooning components of NAFLD Activity Score

    Summary of Key AUROC for Predicting Histological Response Among ALT Respondersa

    Histologic EndpointALT Responders (N=28)ALT Responders with ≤ 5%

    Liver Fat Content (N=16)
     NASH Resolution0.74 (0.56, 0.93)0.83 (0.61, 1)
     NASH Resolution and Fibrosis Improvement of ≥1 Stage0.62 (0.39, 0.86)0.79 (0.90, 70.2)

    a Among Patients with available MRI-PDFF and ALT change at Week 12, and end-of-treatment biopsy (N=54)

    "EFX is the first therapy to have shown at least a 70 percent relative reduction in liver fat in a majority of all patients evaluated, and normalization of liver fat in approximately half of all patients evaluated," said Stephen Harrison, MD, medical director of Pinnacle Clinical Research. "These analyses showing that large reductions or normalization of liver fat correlate with improvements in multiple non-invasive markers and histopathology of NASH suggest the potential of EFX to set a new threshold for magnitude of liver fat reduction and associated removal of the underlying driver of NASH."

    EFX is currently being evaluated in a Phase 2b clinical trial in patients with F2/F3 fibrosis, the HARMONY study. A second Phase 2b clinical trial in patients with Cirrhotic (F4) NASH is planned for the second half of 2021.

    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) is a differentiated 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. In prior clinical trials, EFX has reversed fibrosis, resolved NASH, reduced liver fat, improved glycemic control, improved lipoprotein profile, and reduced body weight. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in a Phase 2b clinical trial in NASH patients with F2/F3 fibrosis, the HARMONY study. 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 Akero'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; Akero's Phase 2a BALANCED clinical trial, including additional analysis of its data and potential therapeutic benefits; Akero's Phase 2b HARMONY clinical trial, including expected timing to complete enrollment and report preliminary results; 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 Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero'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; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero's most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero 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
    IR@akerotx.com
    
    Media Contact:
    650.487.6488
    media@akerotx.com

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  8. - venBio promoted Richard Gaster M.D., Ph.D. to Managing Partner

    venBio today announced the closing of venBio Global Strategic Fund IV, LP ("venBio Fund IV"), its fourth life sciences venture capital fund, exceeding its target and closing on approximately $550 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising corporate pensions, financial institutions, university endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., Aaron Royston, M.D., and Richard Gaster, M.D., Ph.D., venBio Fund IV will continue to invest primarily in therapeutics…

    - venBio promoted Richard Gaster M.D., Ph.D. to Managing Partner

    venBio today announced the closing of venBio Global Strategic Fund IV, LP ("venBio Fund IV"), its fourth life sciences venture capital fund, exceeding its target and closing on approximately $550 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising corporate pensions, financial institutions, university endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., Aaron Royston, M.D., and Richard Gaster, M.D., Ph.D., venBio Fund IV will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs. The venBio team takes an active role with each of their portfolio companies, providing strategic guidance on a range of business activities including intellectual property, chemistry, manufacturing and controls (CMC), as well as assisting with clinical trials: from trial design to endpoints to regulatory deliberations.

    "We remain committed to our unique approach and strategy and hope the results speak for themselves – our portfolio companies have delivered four drugs to market for six clinical indications, and another seven drug candidates are demonstrating promising late-stage efficacy," said Dr. Adelman.

    "Our portfolio is directly impacting patient lives and we could not have accomplished that without the ongoing commitment from our limited partners, and we are grateful for their continued support for Fund IV," said Dr. Goodman. "With Fund IV we intend to continue our proven approach of helping to build 12-15 companies per fund while doubling down on winners by providing stronger support for our portfolio companies in crossover rounds and at IPO."

    "We are delighted to announce with the closing of Fund IV, the promotion of Dr. Rich Gaster to Managing Partner," said Dr. Royston. "Our core investment team and investment strategy remain the same as we launch our new fund."

    "Our strategy at venBio has always been to turn exceptional science into impactful medicine," said Dr. Gaster. "Every member of our team is involved in every investment that we make, and we believe this collaborative approach is what helps drive our success."

    Sidley Austin LLP served as legal adviser to venBio.

    About venBio

    Established in 2011, venBio is a life science venture capital firm that focuses on novel therapeutics for unmet medical needs. Since inception in 2011, venBio has raised nearly $1.5 billion in capital commitments and led investment rounds in 34 companies, including: venBio-founded Labrys Biologics (acquired by Teva) and ALX Oncology (NASDAQ:ALXO); Aragon Pharmaceuticals (acquired by Johnson & Johnson); Seragon Pharmaceuticals (acquired by Roche); Aurinia Pharmaceuticals (NASDAQ:AUPH); Apellis Pharmaceuticals (NASDAQ:APLS); Turning Point Therapeutics (NASDAQ:TPTX); Precision Biosciences (NASDAQ:DTIL); Akero Therapeutics (NASDAQ:AKRO); Harmony Biosciences (NASDAQ:HRMY); and Pharvaris (NASDAQ:PHVS). For more information, please visit www.venbio.com.

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  9. SOUTH SAN FRANCISCO, Calif., June 01, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that it will present results from the Cohort C extension of its Phase 2a BALANCED study, which found positive histological improvements in F4 NASH patients with compensated cirrhosis after 16 weeks of treatment with efruxifermin (EFX), at the 2021 International Liver Congress hosted by the European Association for the Study of the Liver (EASL) on June 26 at 1:00 p.m., Central European Time. Akero will also report data from the BALANCED main study in F2/F3 NASH patients in two other presentations at EASL…

    SOUTH SAN FRANCISCO, Calif., June 01, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that it will present results from the Cohort C extension of its Phase 2a BALANCED study, which found positive histological improvements in F4 NASH patients with compensated cirrhosis after 16 weeks of treatment with efruxifermin (EFX), at the 2021 International Liver Congress hosted by the European Association for the Study of the Liver (EASL) on June 26 at 1:00 p.m., Central European Time. Akero will also report data from the BALANCED main study in F2/F3 NASH patients in two other presentations at EASL and in two presentations at the 81st Meeting of the American Diabetes Association (ADA) taking place June 25-29.

    "We believe the consistency, magnitude and reproducibility of treatment effect sets efruxifermin apart in the NASH arena," said Kitty Yale, chief development officer of Akero. "The data we will present in June at EASL and ADA show consistently strong results for EFX in improving histology, liver health, glycemic control, and lipoprotein profile in patients with F2/F3 NASH, and unprecedented and promising results in patients with F4 compensated cirrhosis. We believe we will continue to see meaningful histologic improvements in our ongoing Phase 2b HARMONY study in NASH patients with F2/F3 fibrosis and the Phase 2b SYMMETRY study in NASH patients with F4 compensated cirrhosis, which we plan to initiate in the second half of this year."

    Presentations at the EASL International Liver Congress, June 23-26:

    • EASL Abstract No. 2800 (Late breaker oral presentation), "Efruxifermin (EFX) improved markers of fibrosis, liver injury and metabolism in F4 NASH patients with compensated cirrhosis," presented by Stephen Harrison, M.D.
    • EASL Abstract No. 1314: "The role of reduction in liver fat content (MRI-PDFF) and ALT in predicting treatment response in NASH: A secondary analysis of the randomized, controlled BALANCED trial," presented by Rohit Loomba, M.D.
    • EASL Abstract No. 1762: "Correlation between changes in liver fat content and improvements in serum markers of liver injury, fibrosis, metabolism, and in histologic parameters following treatment with efruxifermin," presented by Stephen Harrison, M.D.

    Presentations at the 81st ADA Scientific Sessions meeting, June 25-29:

    • ADA Abstract 116-LB: "Efruxifermin is associated with improved glucose metabolism in patients with NASH and type 2 diabetes," presented by Juan P. Frias, M.D.
    • ADA Abstract 119-LB: "Increased adiponectin following efruxifermin treatment is associated with improvements in dyslipidemia, glucose metabolism, and liver health in a 16-week, randomized, placebo-controlled NASH trial," presented by Juan P. Frias, M.D.

    "Patients with type 2 diabetes, many of whom also have NASH with fibrosis, have a significant need for novel therapies that can treat NASH while improving diabetes control and reducing the high risk of cardiovascular disease," said Dr. Juan Frias, Medical Director and Principal Investigator of the National Research Institute. "EFX appears to have the potential to meet this high unmet medical need by reversing liver injury and fibrosis, restoring a healthy lipoprotein profile while enhancing insulin sensitivity, and improving glycemic control even in patients on existing antidiabetic medications."

    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) is a differentiated 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. In prior clinical trials, EFX has reversed fibrosis, resolved NASH, reduced liver fat, improved glycemic control, improved lipoprotein profile, and reduced body weight. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in a Phase 2b clinical trial in NASH patients with F2/F3 fibrosis, the HARMONY study. 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 Akero'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; Akero's Phase 2b HARMONY study and Phase 2b SYMMETRY study including expected timing to complete enrollment and report preliminary results; the availability of a new combination drug product-device to support Phase 3 clinical trials; 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 Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero'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; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero'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 Akero'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. Akero 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

    IR@akerotx.com

    Media Contact:

    650.487.6488

    media@akerotx.com



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  10. SAN FRANCISCO, May 28, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that members of the management team will present at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 2:30 p.m. (ET).

    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 in NASH patients with F2/F3 fibrosis…

    SAN FRANCISCO, May 28, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that members of the management team will present at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 2:30 p.m. (ET).

    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 in NASH patients with F2/F3 fibrosis, the HARMONY study. Akero is headquartered in South San Francisco. Visit www.akerotx.com for more information.

    Investor Contact:

    Christina Tartaglia

    212.362.1200

    IR@akerotx.com

    Media Contact:

    650.487.6488

    media@akerotx.com



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  11. SOUTH SAN FRANCISCO, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today reported first quarter financial results for the period ending March 31, 2021.

    "We continued to build on the strong foundation provided by last year's reports from the Phase 2a BALANCED main study, with new data showing signs of reversing fibrosis in biopsy-confirmed F4 NASH patients with compensated cirrhosis after only 16 weeks of treatment," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "Our histology results, as well as non-invasive markers of fibrosis, indicate that efruxifermin…

    SOUTH SAN FRANCISCO, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today reported first quarter financial results for the period ending March 31, 2021.

    "We continued to build on the strong foundation provided by last year's reports from the Phase 2a BALANCED main study, with new data showing signs of reversing fibrosis in biopsy-confirmed F4 NASH patients with compensated cirrhosis after only 16 weeks of treatment," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "Our histology results, as well as non-invasive markers of fibrosis, indicate that efruxifermin (EFX) acts both directly and indirectly to rapidly reverse fibrosis. Consistent data across three placebo-controlled clinical trials increase our confidence that EFX will be efficacious as a treatment for all stages of NASH. This confidence is reflected in our initiation of two parallel, separate Phase 2b clinical trials in F2-F3 and F4 NASH this year, for which we expect to begin reporting data in the third quarter of 2022."

    First Quarter Business Highlights & Company Updates

    • During the first quarter, Akero reported positive, topline, preliminary results for its 16-week evaluation of EFX in the treatment of adult NASH patients with compensated cirrhosis (F4), Child-Pugh Class A (BALANCED study, Cohort C).
      • Among 12 EFX-treated patients who volunteered to have end-of-treatment biopsies, 7 of 12 (58%) achieved either a one-stage improvement in fibrosis without worsening of NASH or NASH resolution, compared with 0 of 5 (0%) for the placebo group.
      • 4 of 12 (33%) EFX-treated patients achieved a one-stage improvement of fibrosis without worsening of NASH, compared to 0% for placebo, indicating rapid reversal of fibrosis among cirrhotic NASH patients after only 16 weeks of treatment.
      • 3 of 12 (25%) EFX-treated patients achieved NASH resolution compared to 0% for placebo.
      • Improvements in histology were supported by improvements in noninvasive serum-based and imaging markers of fibrosis.
      • EFX-treated patients also experienced improvements in ALT, serum lipids and glycemic control, with a trend toward weight loss, consistent with the results previously observed for patients with F1-F3 fibrosis.
    • During the first quarter, Akero initiated its HARMONY study, a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with fibrosis stage 2 or 3, with the first patient randomized in March.

    Multiple Milestones Anticipated for 2021 and 2022

    • Akero plans to report additional data from the BALANCED main study at the upcoming meeting of the European Association for the Study of the Liver (EASL) on June 23-26, 2021.
      • EASL Abstract No. 1314: "The role of reduction in liver fat content (MRI-PDFF) and ALT in predicting treatment response in NASH: A secondary analysis of the randomized, controlled BALANCED trial," presented by Rohit Loomba, M.D.
      • EASL Abstract No. 1762: "Correlation between changes in liver fat content and improvements in serum markers of liver injury, fibrosis, metabolism, and in histologic parameters following treatment with efruxifermin," presented by Stephen Harrison, M.D.
    • Akero plans to present new data at the upcoming meeting of the American Diabetes Association on June 25-29, 2021, for which two abstracts have been accepted for presentation.
    • Akero expects to initiate its planned SYMMETRY study, a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with compensated cirrhosis (F4), Child-Pugh Class A, in the second half of 2021.
    • Akero expects to report topline, preliminary results for the HARMONY study in the third quarter of 2022, based on the primary histology endpoint after 24 weeks of treatment.
    • Akero expects to complete manufacturing of its planned Phase 3 combination drug/device product in 2022, with release for clinical trials in the first half of 2023.

    First Quarter 2021 Financial Results

    • Akero's cash, cash equivalents and short-term marketable securities for the period ended March 31, 2021 were $250.0 million.
    • Akero believes that its cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into the third quarter of 2023.
    • Research and development expenses for the three-month period ended March 31, 2021 were $10.6 million, compared to $8.8 million for the comparable period in 2020. 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 period ended March 31, 2021 were $4.5 million, compared to $3.6 million for the comparable period in 2020. 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 $15.1 million for the three-month period ended March 31, 2021, compared to $12.4 million for the comparable period in 2020.

    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 was an expansion cohort of the Phase 2a BALANCED study, which evaluated EFX in 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 was 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 included various non-invasive measures of liver health, including markers of liver fibrosis such as Enhanced Liver Fibrosis (ELF) score and Pro-C3, as well as liver ultrasound imaging. The trial design also permitted patients to volunteer for 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 are being randomized to receive once-weekly subcutaneous dosing of 28 or 50mg EFX or placebo. The primary endpoint for the trial is regression of fibrosis at 24 weeks. Patients will continue to receive EFX or placebo during long-term follow-up 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 Akero'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; Akero's Phase 2b HARMONY study and Phase 2b SYMMETRY study including expected timing to complete enrollment and report preliminary results; the availability of a new combination drug product-device to support Phase 3 clinical trials; expectations regarding Akero's use of capital, expenses and other future financial results; 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 Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero'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; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero'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 Akero'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. Akero 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

    IR@akerotx.com

    Media Contact:

    650.487.6488

    media@akerotx.com

    Akero Therapeutics, Inc.
    Condensed Consolidated Balance Sheets
    (Unaudited)
    (In thousands)
           
      March 31, 2021 December 31, 2020
    Assets      
    Cash, cash equivalents and short-term marketable securities $249,984  $268,387 
    Other current assets  5,792   2,958 
    Non-current assets  1,847   1,994 
    Total assets $257,623  $273,339 
           
    Liabilities and Stockholders' Equity      
    Current liabilities $10,136  $13,111 
    Non-current liabilities  1,467   1,516 
    Stockholders' equity  246,020   258,712 
    Total liabilities and stockholders' equity $257,623  $273,339 
           



    Akero Therapeutics, Inc.
    Condensed Consolidated Statements of Operations and Comprehensive Loss
    (Unaudited)
    (In thousands, except share and per share amounts)
           
      Three Months Ended March 31,
      2021  2020 
    Operating expenses:      
    Research and development $10,602  $8,791 
    General and administrative  4,526   3,588 
    Total operating expenses  15,128   12,379 
    Loss from operations  (15,128)  (12,379)
    Other income  38   493 
    Net loss $(15,090) $(11,886)
    Comprehensive loss $(15,089) $(11,835)
    Net loss per common share, basic and diluted $(0.43) $(0.42)
    Weighted-average number of shares used in computing net loss per common share, basic and diluted  34,744,275   28,499,475 
           


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  12. 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

    IR@akerotx.com

    Media Contact:

    Jennifer Weismann

    612.716.0556

    media@akerotx.com 



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  13. 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

    IR@akerotx.com

    Media Contact:

    Jennifer Weismann

    612.716.0556

    media@akerotx.com



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  14. -- 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

    IR@akerotx.com

    Media Contact:

    Jennifer Weismann

    612.716.0556

    media@akerotx.com



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  15. 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

    IR@akerotx.com

    Media Contact:

    Jennifer Weismann

    612.716.0556

    media@akerotx.com

     



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  16. 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

    IR@akerotx.com

    Media Contact:

    Jennifer Weismann

    612.716.0556

    media@akerotx.com



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  17. SAN FRANCISCO, Feb. 23, 2021 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that members of its management team will participate in the following virtual investor conferences in March:

    • Cowen 41st Annual Healthcare Conference on Tuesday, March 2, 2021
    • 2021 H.C. Wainwright Global Life Sciences Conference on Tuesday, March 9, 2021

    A live webcast, if recorded, of Company presentations and Q&A will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcasts, archived replays will be available on the Company's website.

    About Akero Therapeutics

    SAN FRANCISCO, Feb. 23, 2021 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that members of its management team will participate in the following virtual investor conferences in March:

    • Cowen 41st Annual Healthcare Conference on Tuesday, March 2, 2021
    • 2021 H.C. Wainwright Global Life Sciences Conference on Tuesday, March 9, 2021

    A live webcast, if recorded, of Company presentations and Q&A will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcasts, archived replays will be available on the Company's website.

    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 program, 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

    IR@akerotx.com

    Media Contact:

    Jennifer Weismann

    612-716-0556

    media@akerotx.com

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/akero-therapeutics-to-participate-in-upcoming-virtual-healthcare-conferences-in-march-301233943.html

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  18. Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that management will present virtually at the 39th Annual J.P. Morgan Healthcare Conference at 10:50 a.m. EST on Tuesday, January 12, 2021.

    A live webcast of the presentation will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website for 30 days.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering…

    Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that management will present virtually at the 39th Annual J.P. Morgan Healthcare Conference at 10:50 a.m. EST on Tuesday, January 12, 2021.

    A live webcast of the presentation will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website for 30 days.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

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  19. Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that management will participate in a fireside chat at Evercore's 3rd Annual HealthCONx virtual conference at 11:20 a.m. ET on Thursday, December 3, 2020.

    A live webcast of the fireside chat and Q&A will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website for 30 days.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic…

    Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that management will participate in a fireside chat at Evercore's 3rd Annual HealthCONx virtual conference at 11:20 a.m. ET on Thursday, December 3, 2020.

    A live webcast of the fireside chat and Q&A will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website for 30 days.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

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  20. Data to be presented at the Presidential Plenary Talk at The Liver Meeting®

    100% of patients in 50mg group demonstrated more than 50% relative reduction in liver fat

    50% of patients with F2/F3 fibrosis at baseline achieved two stage improvement in fibrosis score

    Type 2 diabetic patients showed improved glycemic control with HbA1c reduced by up to 0.9%

    Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced the presentation of additional data analysis from the Phase 2a BALANCED study at the Presidential Oral Plenary Session at The Liver Meeting®. The data continue to demonstrate the potential of efruxifermin (EFX) as a foundational monotherapy for patients with non-alcoholic steatohepatitis (NASH).

    Overall, the data show large magnitudes…

    Data to be presented at the Presidential Plenary Talk at The Liver Meeting®

    100% of patients in 50mg group demonstrated more than 50% relative reduction in liver fat

    50% of patients with F2/F3 fibrosis at baseline achieved two stage improvement in fibrosis score

    Type 2 diabetic patients showed improved glycemic control with HbA1c reduced by up to 0.9%

    Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced the presentation of additional data analysis from the Phase 2a BALANCED study at the Presidential Oral Plenary Session at The Liver Meeting®. The data continue to demonstrate the potential of efruxifermin (EFX) as a foundational monotherapy for patients with non-alcoholic steatohepatitis (NASH).

    Overall, the data show large magnitudes of reduction in liver fat across all EFX dose groups with 100% of participants in the 50mg EFX dose group achieving more than 50% relative reduction in liver fat and 53% of patients in the same dose group achieving more than 70% relative reduction in liver fat.

    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).

    Additional analysis of the BALANCED data showed substantial improvement in glycemic control for patients with both NASH and Type 2 diabetes, a group that comprises about half of all NASH patients. The company previously reported mean absolute reductions in HbA1c among all study participants of 0.1% for the 28mg dose, 0.4% (p<0.05) for the 50mg dose and 0.5% (p<0.01) for the 70mg dose. In patients with both NASH and Type 2 diabetes, researchers observed decreases of 0.6% in the 50mg dose and 0.9% (p<0.01) in the 70mg dose. Among EFX patients with NASH and Type 2 diabetes, the relative decreases in mean C-peptide levels ranged from 27 to 33% across EFX dose groups, compared to 22 to 29% for all EFX patients.

    "Additional analyses from the BALANCED study, including the proportion of subjects with at least 50 and 70% reductions in liver fat and the high proportion of subjects with F2/F3 fibrosis at baseline with fibrosis improvement, strengthens the potential of EFX to be truly transformative for people living with NASH, with improvements across multiple parameters for NASH and cardio-metabolic conditions," said Andrew Cheng, M.D., Ph.D., president and CEO of Akero. "With some of the strongest results reported to date in NASH, we eagerly anticipate the initiation of our adaptive Phase 2b/3 study of efruxifermin with hopes of improving lives of the more than 17 million Americans who are living with this disease."

    EFX has received European Medicines Agency Priority Medicines (PRIME) designation as a treatment for NASH. Akero plans to begin a Phase 2b/3 adaptive clinical trial in biopsy confirmed NASH patients in the first half of 2021. The company will be using 28mg and 50mg doses for that trial.

    Akero previously reported data from the BALANCED study demonstrating that each of the 28, 50 and 70mg EFX dose groups met the primary endpoint compared to placebo, with absolute reductions of 12%, 13% and 14% of liver fat, respectively, compared with 0.3% for placebo, and relative reductions of 63%, 71% and 72% percent, compared to 0% for placebo. All of these results were highly statistically significant at p<0.001.

    Prior Reporting of secondary and exploratory endpoints revealed that of the 40 EFX treatment responders who had end-of-treatment biopsies, 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis. Additionally, 48% of responders achieved NASH resolution with no worsening of fibrosis. Improvements in glycemic control and dyslipidemia, as well as weight loss, were also observed across all dose groups. Treatment with EFX was generally reported to be well tolerated.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. NASH is a leading cause of liver transplants in the US and Europe.

    About the BALANCED Study

    The Phase 2a BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with NASH. The main study enrolled a total of 80 patients. Participants were randomized to receive weekly subcutaneous doses of efruxifermin (EFX), formerly known as AKR-001, or placebo for up to 16 weeks, with safety and tolerability followed through week 20. The primary efficacy endpoint for the study is absolute change from baseline in hepatic fat fraction measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) at week 12. Secondary measures include change from baseline in ALT at 12 weeks, the number of patients who had a decrease of ≥2 points in the NAFLD activity score (NAS) at 24 weeks and safety and tolerability measures.

    About Efruxifermin

    Efruxifermin (EFX), formerly known as AKR-001, is Akero's lead product candidate for NASH, currently being evaluated in the ongoing Phase 2a BALANCED study. EFX is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX offers convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    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. Such statements include, but are not limited to, statements regarding: Akero's guidance regarding its business plans and objectives for EFX, including the therapeutic potential and clinical benefits thereof, as well as the safety and tolerability of EFX and future clinical development plans; Akero's Phase 2a BALANCED clinical trial, including its results and Akero's analysis of such results; Akero's design, implementation and expected timing of the Phase 2b/3 trial; the potential benefits conferred by the EMA on Akero's PRIME designation; and the potential impact of COVID-19 on patient retention, strategy, future operations and clinical trials.

    Any forward-looking statements in this statement 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 public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, including potential negative impacts on Akero's employees, manufacturers, supply chain and production as well as on global economies and financial markets; 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 risks related to the competitive landscape. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Akero's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the company's 2019 Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Akero's other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  21. SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today reported third quarter financial results for the period ending September 30, 2020.

    "On the heels of reporting strongly positive histological data from our FGF21 analog, efruxifermin (EFX), we executed a number of important objectives in the third quarter that position us for continued success," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "In addition to raising more than $216 million to enable continued development of EFX, we received feedback from the FDA that enables us to continue to pursue EFX development with our proposed adaptive Phase 2b/3 clinical trial design. EFX also received PRIME designation from EMA for development as a NASH therapy. Each of these milestones represents a large step forward in the development of EFX, which we believe has the potential to be a foundational monotherapy for NASH."

    Third Quarter Business Highlights

    • On July 10th, the Company closed an upsized underwritten public offering of 6,012,390 shares of common stock at a price of $36.00 per share. Gross proceeds from the offering, before deducting underwriting discounts, commissions and offering expenses, were approximately $216.4 million.
    • On July 21st, the Company announced publication of data in the journal Cell Reports Medicine from the Phase 1b clinical trial of EFX, which showed its potential to modulate biomarkers associated with metabolic diseases, including NASH.
    • On Sept. 24th, the Company announced that written guidance from the U.S. Food and Drug Administration (FDA) enables implementation of an innovative combined Phase 2b/3 study design for a pivotal EFX clinical trial in NASH patients with F2-F3 fibrosis. Under the planned adaptive trial design, the Company will evaluate the 28 and 50mg EFX doses in a 24-week Phase 2b portion of the trial to inform selection of one of these doses for evaluation in the Phase 3 portion of the study.
    • On Sept. 30th, the Company announced enrollment had been completed for a cohort of the BALANCED study (Cohort C), which is investigating the effects of 16 weeks of EFX treatment on patients with NASH who have compensated cirrhosis (F4), Child-Pugh Class A. The Company expects results from this study cohort to inform long-term development plans for EFX to treat cirrhotic NASH patients, who are at greatest risk of progressing to end-stage liver disease. The Company expects to report the results of the F4 expansion cohort in the first half of 2021.
    • On Oct. 16th, the Company announced that the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation to EFX for treatment of NASH. The designation was based on the positive efficacy data reported from the Company's Phase 2a BALANCED study. The PRIME program is designed to enhance regulatory support in the EU for the development of promising investigational medicines that target unmet medical need.

    Manufacturing Update

    • Manufacture of GMP drug substance (API) at commercial scale was completed in April 2020. GMP drug product for the Company's anticipated Phase 2b clinical trial was manufactured from this API in September 2020.
    • A new lyophilized formulation is being developed for commercial drug product. This formulation will be used for the Phase 3 portion of the adaptive clinical trial design. Scale-up of manufacturing for this new drug product formulation began during the third quarter of 2020 and is expected to be completed in 2022.

    Regulatory Update

    • Submission of multiple Investigational New Drug (IND) amendments are ongoing to support the Phase 2b portion of the adaptive Ph2b/3 study design. The Company remains on track to initiate Phase 2b in the first half of 2021.

    Financial Highlights

    • Akero's cash, cash equivalents and short-term marketable securities at September 30, 2020 were $291.9 million, which includes the net proceeds from the July 10th equity offering.
    • Research and development expenses for the three-month and nine-month periods ended September 30, 2020 were $17.4 million and $39.2 million, respectively, compared to $13.9 million and $23.9 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 and contract research organization costs associated with the BALANCED study and internal personnel costs, including non-cash stock-based compensation.
    • General and administrative expenses for the three-month and nine-month periods ended September 30, 2020 were $4.2 million and $11.2 million, respectively, compared to $2.4 million and $5.5 million for the comparable periods in 2019. These increases are attributable to higher internal personnel costs, including non-cash stock-based compensation and professional services and other costs associated with operating as a public company.
    • Total operating expenses for the three-month and nine-month periods ended September 30, 2020, were $21.5 million and $50.4 million, respectively, compared to $16.3 million and $29.4 million for the comparable periods in 2019.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. As a result, NASH has become a leading cause of liver transplants in the US and Europe.

    About Efruxifermin

    Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. EFX has been shown to increase insulin sensitivity, improve lipoproteins, reduce liver fat and inflammation, and reverse fibrosis. The breadth of desirable metabolic effects offers potential to address the complex, multi-organ/tissue pathogenesis of NASH, including risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native human FGF21, EFX offers convenient once-weekly dosing.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week  Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.  

    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 potential benefits resulting from the PRIME designation of EFX;  Akero's Phase 2a BALANCED study and Phase 2b/3 study including results and expected timing to complete Cohort C; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for EFX; expectations regarding successful scale-up of drug substance manufacturing and release of new drug product for use in clinical trials, including new product formulations; expectations regarding the Company's use of capital, expenses and other future financial results; statements regarding the timing of Company's efforts regarding the IND amendments; the Company's planned efforts to prepare for commercialization of EFX, if approved 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 Akero'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 Akero's Annual Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero 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)







    September 30, 2020



    December 31, 2019

    Assets













    Cash and cash equivalents and short-term marketable securities



    $

    291,870



    $

    136,400

    Other current assets





    6,163





    1,649

    Non-current assets





    2,003





    69

    Total assets



    $

    300,036



    $

    138,118















    Liabilities and Stockholders' Equity













    Current liabilities



    $

    12,014



    $

    9,369

    Non-current liabilities





    1,564





    23

    Stockholders' equity





    286,458





    128,726

    Total liabilities and stockholders' equity



    $

    300,036



    $

    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 September 30, 



    Nine Months Ended September 30, 





    2020



    2019



    2020



    2019

    Operating expenses:

























    Research and development



    $

    17,379



    $

    13,885



    $

    39,207



    $

    23,908

    General and administrative





    4,159





    2,424





    11,164





    5,522

    Total operating expenses





    21,538





    16,309





    50,371





    29,430

    Loss from operations





    (21,538)





    (16,309)





    (50,371)





    (29,430)

    Other income





    135





    755





    875





    1,286

    Net loss



    $

    (21,403)



    $

    (15,554)



    $

    (49,496)



    $

    (28,144)

    Comprehensive loss



    $

    (21,477)



    $

    (15,554)



    $

    (49,474)



    $

    (28,144)

    Net loss per common share, basic and diluted



    $

    (0.63)



    $

    (0.56)



    $

    (1.63)



    $

    (2.66)

    Weighted-average number of shares used in

    computing net loss per common share, basic and

    diluted





    34,002,769





    28,024,779





    30,381,671





    10,589,119

     

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  22. SOUTH SAN FRANCISCO, Calif., Oct. 21, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that management will present at the following investor conferences next month:

    • 29th Annual Credit Suisse Healthcare Conference on Monday, November 9th at 1:15PM EST
    • Jefferies Global Healthcare Conference on Tuesday, November 17th at 1:45PM EST

    A live webcast of each presentation and Q&A will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcasts, archived replays will be available on the Company's website.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

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  23. SOUTH SAN FRANCISCO, Calif., Oct. 16, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to efruxifermin (EFX), an investigational FGF21 analog for the treatment of NASH. The designation was granted based on the positive efficacy data recently reported from the company's Phase 2a BALANCED study. Based on available published data, EFX is believed to be the first drug candidate to receive a PRIME designation for treatment of NASH.

    SOUTH SAN FRANCISCO, Calif., Oct. 16, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to efruxifermin (EFX), an investigational FGF21 analog for the treatment of NASH. The designation was granted based on the positive efficacy data recently reported from the company's Phase 2a BALANCED study. Based on available published data, EFX is believed to be the first drug candidate to receive a PRIME designation for treatment of NASH.

    "We believe the EMA PRIME designation for efruxifermin provides important validation for the potential of EFX to become a foundational NASH monotherapy," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "This designation underscores not only the high level of unmet need for therapeutics to treat this life-threatening disease, but also EFX's potential to address multiple aspects of NASH and its associated comorbidities. We are grateful to the EMA for considering our application and for recognizing the potential benefits EFX could provide to patients, if approved."

    In reaching its decision, the EMA's Committee on Human Medicinal Products (CHMP) indicated preliminary 16-week data from Akero's Phase 2a clinical trial, the BALANCED study of EFX in biopsy-confirmed NASH patients, show EFX's potential to meet unmet medical need for NASH therapies by addressing multiple aspects of NASH-related morbidity and mortality. The CHMP also expressed that the totality of data, including histology data as well as biomarker data, together with better glycemic control and amelioration of dyslipidemia, suggest potential benefit not only for treatment of NASH but also the broader context of metabolic syndrome common in NASH patients.

    The BALANCED study, which evaluated EFX in treatment of biopsy-confirmed NASH patients for just 16 weeks, showed that 48% of all EFX-treated patients achieved at least a one-stage improvement in fibrosis without worsening of NASH, and 48% of all EFX patients achieved resolution of NASH without worsening of fibrosis. Patients treated with EFX also achieved relative reductions of liver fat ranging from 63-72% across three dose groups, compared to 0% for placebo. The study also showed that EFX improved multiple NASH comorbidities, including better glycemic control and improved lipoprotein profile as well as weight loss.

    The PRIME program is designed to enhance regulatory support in the EU for the development of promising investigational medicines that, based on early clinical data, may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. PRIME aims to provide multiple benefits so that these medicines can reach patients earlier: enhanced interaction and early dialogue with EMA, guidance on the overall development plan and regulatory strategy, and the potential for accelerated assessment of the marketing authorization application. For more information please visit the EMA website at www.ema.europa.eu.

    The company plans to initiate a Phase 2b/3 adaptive trial of EFX in biopsy-confirmed NASH patients in the first half of 2021 based on guidance received from the U.S. Food and Drug Administration.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans and impacts more than a third of people with type 2 diabetes worldwide. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. As a result, NASH has become a leading cause of liver transplants in the US and Europe.

    About Efruxifermin

    Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. EFX has been shown to increase insulin sensitivity, improve lipoproteins, reduce liver fat and inflammation, and reverses fibrosis. The breadth of desirable metabolic effects offers potential to address the complex, multi-organ/tissue pathogenesis of NASH, including risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native human FGF21, EFX offers convenient once-weekly dosing.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    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; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for EFX; the PRIME designation of EFX, potential benefits resulting from such designation and related implications; and the potential impact of COVID-19 on strategy, future operations, 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 Akero'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 Akero's Annual Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  24. SOUTH SAN FRANCISCO, Calif., Oct. 2, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that an abstract detailing additional analyses of the data from its Phase 2a BALANCED study of efruxifermin (EFX) has been accepted for presentation at The Liver Meeting Digital Experience™ 2020 of the American Association for the Study of Liver Diseases (AASLD) to be held November 13 - 16.

    The new analyses will be presented in the presidential plenary oral session by Stephen Harrison, M.D., medical director of Pinnacle Clinical Research, in a presentation titled "Efruxifermin (EFX), a long-acting Fc-FGF21 fusion protein, administered for 16 weeks to patients with NASH substantially reduces liver fat and ALT, and improves liver histology: analysis of a randomized, placebo-controlled, Phase 2a study (BALANCED)." The abstract was published in the October supplement of Hepatology, the peer-reviewed journal of AASLD.

    Abstract Title: Efruxifermin (EFX), a long-acting Fc-FGF21 fusion protein, administered for 16 weeks to patients with NASH substantially reduces liver fat and ALT, and improves liver histology: analysis of a randomized, placebo-controlled, Phase 2a study (BALANCED).

    Abstract Number: 8

    Presenting Author: Stephen Harrison, M.D.

    Session Date: November 15, 2020

    Session Time: 9-10:30 a.m. ET

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. As a result, NASH has become a leading cause of liver transplants in the US and Europe.

    About Efruxifermin

    Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. EFX increases insulin sensitivity, improves lipoproteins, reduces liver fat and inflammation, and reverses fibrosis. The breadth of desirable metabolic effects offers potential to address the complex, multi-organ/tissue pathogenesis of NASH, including risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native human FGF21, EFX offers convenient once-weekly dosing. Based on guidance from the U.S. Food and Drug Administration (FDA), EFX will be evaluated in an innovative adaptive Phase 2b/3 pivotal study in biopsy confirmed NASH patients to be initiated in the first half of 2021.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    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; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for EFX; and the potential impact of COVID-19 on strategy, future operations, 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 Akero'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 Akero's Annual Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  25. SAN FRANCISCO, Sept. 30, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that the company has completed enrollment of a cohort of patients with NASH who have compensated cirrhosis (F4), Child-Pugh Class A.

    A total of 30 cirrhotic NASH subjects with a biopsy-confirmed fibrosis score of F4 have been randomized 2:1 to receive either 50mg of efruxifermin (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.

    "We are pleased to have had an opportunity early in our NASH development program to assess whether EFX has the potential to improve clinical outcomes for NASH patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A. These patients could benefit from therapeutic treatment options because they are at the highest risk of progressing to liver failure or liver cancer from NASH," said Kitty Yale, chief development officer of Akero. "Successful enrollment of this expansion cohort amidst the ongoing COVID-19 pandemic is a testimony to the attractiveness of EFX's emerging profile as a potential treatment for NASH."

    The company expects to report the results of the F4 expansion cohort in the first half of 2021.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. As a result, NASH has become a leading cause of liver transplants in the US and Europe.

    About Efruxifermin

    Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. EFX increases insulin sensitivity, improves lipoproteins, reduces liver fat and inflammation, and reverses fibrosis. The breadth of desirable metabolic effects offers potential to address the complex, multi-organ/tissue pathogenesis of NASH, including risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native human FGF21, EFX offers convenient once-weekly dosing.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.  

    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; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for EFX; and the potential impact of COVID-19 on strategy, future operations, 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 Akero'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 Akero's Annual Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  26. SOUTH SAN FRANCISCO, Calif., Sept. 28, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that Andrew Cheng, chief executive officer of Akero, will present virtually at the H.C. Wainwright 4th Annual NASH Conference on Monday, October 5, 2020 at 12:00 p.m. E.T.

    A live webcast of the presentation and Q&A will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA.  For more information, please visit www.akerotx.com.

     

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  27. SOUTH SAN FRANCISCO, Calif., Sept. 24, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that written guidance from the U.S. Food and Drug Administration (FDA) enables the company to implement an innovative combined Phase 2b/3 study design for pivotal efruxifermin (EFX) trials in NASH patients.

    Under the planned adaptive trial design, Akero will evaluate two EFX doses in a 24-week Phase 2b portion of the trial to inform selection of a single dose for evaluation in the Phase 3 portion of the study. The company remains on track to initiate a Phase 2b/3 trial of EFX in biopsy-confirmed NASH patients in the first half of 2021.

    "We are pleased that the FDA found our overall proposed adaptive Phase 2b/3 development program to be acceptable, and we are grateful for the additional clarity the agency provided as we finalize our study protocol," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "We believe that the positive histological data in biopsy-confirmed NASH patients obtained from the BALANCED study provided the foundation necessary to align on an adaptive Phase 2b/3 trial design. Further analysis of data from the BALANCED study has strengthened our confidence in EFX's potential to be a foundational monotherapy in NASH."

    The company will present the results of additional analyses from the BALANCED study at an upcoming scientific meeting.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. As a result, NASH has become a leading cause of liver transplants in the US and Europe.

    About Efruxifermin

    Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. EFX is designed to increase insulin sensitivity, improve lipoproteins, reduce liver fat and inflammation, and reverse fibrosis. This holistic approach offers the potential to address the complex, multi-organ/tissue pathogenesis of NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native human FGF21, EFX offers convenient once-weekly dosing.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week  Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    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; Akero's Phase 2a BALANCED study, including its results and expected timing to report the analysis of additional data; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for EFX; expectations regarding successful scale-up of drug substance manufacturing and release of new drug product for use in clinical trials; 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 Akero'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 Akero's Annual Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  28. SOUTH SAN FRANCISCO, Calif., Sept. 9, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that management will participate in a fireside chat at Morgan Stanley's 18th Annual Global Healthcare Conference at 3:45 p.m. ET on Monday, September 14, 2020.

    A live webcast of the presentation and Q&A will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA.  For more information, please visit www.akerotx.com.

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  29. SAN FRANCISCO, Aug. 12, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today reported second quarter financial results for the period ending June 30, 2020.

    "During the second quarter of 2020, we reported the first histological results for our FGF21 analog, efruxifermin (EFX), formerly AKR-001. We observed improvements in histological parameters of NASH after only 16 weeks of treatment, the magnitude of which is among the highest observed to date across the NASH field, despite other compounds having been evaluated for 24 to 78 weeks. These results have increased our confidence in EFX's potential to become a foundational NASH monotherapy," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "We believe positive histological data in biopsy-confirmed NASH patients could be a prerequisite for the FDA to define a registrational development path for any investigational NASH compound. We look forward to discussing our development path with the FDA and advancing a potentially promising therapy for patients, if our development plan is approved."

    Clinically meaningful improvements in glycemic control, weight loss and lipoproteins were also observed in the main BALANCED study. "The significant reductions in HbA1c and body weight we observed in biopsy-confirmed NASH patients following EFX treatment were firsts for an FGF21 analogue," said Tim Rolph, D.Phil., chief scientific officer of Akero. "Although various preclinical models have shown FGF21 improves glycemic control and weight loss, these improvements have not translated to humans with prior FGF21 analogs. We believe the clinical results observed for EFX can be attributed to EFX's unique engineering, based on pioneering discoveries that enabled the pharmacology of human FGF21 to be reproduced in a long acting FGF21 analog."

    Second Quarter Business Highlights

    • The Company reported secondary and exploratory histology results following 16 weeks of treatment with EFX. Of the 40 biopsy-confirmed NASH patients treated with EFX who had end-of-treatment biopsies:
      • 48% achieved at least a one-stage improvement in fibrosis with no worsening of NASH;
      • 28% achieved at least a two-stage improvement in fibrosis;
      • 48% achieved NASH resolution with no worsening of fibrosis; and
      • 28% achieved both NASH resolution and at least a one-stage improvement in fibrosis.

    These results build on the significant 12-14% absolute reductions (corresponding to 63-72% relative reductions) in liver fat, in each case compared with 0% for placebo. Reductions of 24-32 U/L were observed for ALT, a validated marker of liver damage, compared with 6 U/L for placebo.

    • The Company also reported multiple exploratory endpoints for various biomarkers. Results for patients treated with EFX for 16 weeks include:
      • Significant absolute reductions of 0.4% and 0.5% in HbA1c for the 50 and 70mg dose groups, respectively, compared to a 0.1% increase for placebo;
      • Absolute reductions of 2.3kg and 3.7kg in body weight for the 50 and 70mg dose groups, with the latter attaining significance, compared with an increase of 0.1kg for placebo;
      • Significant 37-45% relative reductions in plasma triglycerides, compared with an 8% increase for placebo;
      • Significant 32-40% relative increases in HDL cholesterol, compared with no change for placebo;
      • Significant 13-20% relative reductions in non-HDL cholesterol, compared with no change for placebo; and
      • No increase in LDL cholesterol.
    • On June 16th, the Company dosed its first patient in an expansion cohort of the BALANCED study, Cohort C, which is designed to assess safety and tolerability of treatment with EFX in NASH patients who have compensated cirrhosis (F4), Child-Pugh Class A. The Company expects the results of Cohort C to inform the long-term development plan for this patient population, which is at greatest risk of progressing to end-stage liver disease.
    • On July 10th, the Company closed an upsized underwritten public offering of 6,012,390 shares of common stock at a price of $36.00 per share, which included the exercise in full by the underwriters of their option to purchase an additional 784,224 shares. The gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $216.4 million. J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C. acted as joint book-running managers for the offering.

    Manufacturing Update

    • Manufacture of GMP drug substance (API) at commercial scale was completed in April 2020. This API has been used to manufacture drug product for our anticipated Phase 2b clinical trial. Release of this drug product is expected during the fourth quarter of this year. 
    • A new formulation of drug product has been developed for use in Phase 3 and commercial launch. Scale up of manufacture for this new drug product will commence during the third quarter of 2020. 

    Regulatory Update

    • FDA's responses to the Company's proposed registrational development plan are expected later this year. The Company has proposed that the 28mg and 50mg doses be evaluated in a Phase 2b clinical trial as part of an adaptive Phase 2b/3 trial design. Submission of Investigational New Drug (IND) amendments to support the Phase 2b clinical trial are expected later this year.

    COVID-19 Update

    • The COVID-19 pandemic has not materially impacted enrollment or data collection for the BALANCED study or preparations for the Company's upcoming clinical trials.

    Financial Highlights

    • Akero's cash, cash equivalents and short-term marketable securities at June 30, 2020 were $102.8 million. Following the July 10th equity offering, the Company's cash, cash equivalents and marketable securities were $305.6 million.
    • Research and development expenses for the three-month and six-month periods ended June 30, 2020 were $13.0 million and $21.8 million, respectively, compared to $6.0 million and $10.0 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 and contract research organization costs associated with the BALANCED study, and internal personnel costs, including non-cash stock-based compensation.
    • General and administrative expenses for the three-month and six-month periods ended June 30, 2020 were $3.4 million and $7.0 million, respectively, compared to $1.6 million and $3.1 million for the comparable periods in 2019. These increases are attributable to higher internal personnel costs, including non-cash stock-based compensation, and professional services and other costs associated with operating as a public company.
    • Total operating expenses for the three-month and six-month periods ended June 30, 2020, were $16.5 million and $28.8 million, respectively, compared to $7.6 million and $13.1 million for the comparable periods in 2019.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. The progressive damage to the liver associated with NASH resembles the pathology associated with excessive alcohol consumption or viral infections. As a result, NASH has become a leading cause of liver transplants in the US and Europe.

    About efruxifermin

    Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. Efruxifermin was designed to increase insulin sensitivity, improve lipoproteins, reduce liver fat and inflammation, and reverse fibrosis. This holistic approach offers the potential to address the complex, multi-organ/tissue pathogenesis of NASH, including improvements in risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native human FGF21, efruxifermin offers convenient once-weekly dosing.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week  Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.  

    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; Akero's Phase 2a BALANCED study, including its results and expected timing to report the analysis of efficacy and safety data; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for EFX; expectations regarding successful scale-up of drug substance manufacturing and release of new drug product for use in clinical trials; expectations regarding the Company's use of capital, expenses and other future financial results; statements regarding the timing of the FDA's review of the registrational development plan; the Company's planned efforts to prepare for commercialization of EFX, if approved 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 Akero'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 Akero's Annual Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero 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)



















    June 30, 2020



    December 31, 2019

    Assets













    Cash and cash equivalents and short-term marketable securities



    $

    102,833



    $

    136,400

    Other current assets





    10,360





    1,649

    Non-current assets





    865





    69

    Total assets



    $

    114,058



    $

    138,118















    Liabilities and Stockholders' Equity













    Current liabilities



    $

    10,393



    $

    9,369

    Non-current liabilities





    2





    23

    Stockholders' equity





    103,663





    128,726

    Total liabilities and stockholders' equity



    $

    114,058



    $

    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 June 30, 



    Six Months Ended June 30, 





    2020



    2019



    2020



    2019

    Operating expenses:

























    Research and development



    $

    13,037



    $

    5,960



    $

    21,828



    $

    10,023

    General and administrative





    3,417





    1,649





    7,005





    3,098

    Total operating expenses





    16,454





    7,609





    28,833





    13,121

    Loss from operations





    (16,454)





    (7,609)





    (28,833)





    (13,121)

    Other income, net





    247





    381





    740





    531

    Net loss



    $

    (16,207)



    $

    (7,228)



    $

    (28,093)



    $

    (12,590)

    Comprehensive loss



    $

    (16,162)



    $

    (7,228)



    $

    (27,997)



    $

    (12,590)

    Net loss per common share, basic and diluted



    $

    (0.57)



    $

    (2.21)



    $

    (0.98)



    $

    (7.29)

    Weighted-average number of shares used in

    computing net loss per common share, basic and

    diluted





    28,602,976





    3,268,390





    28,551,227





    1,726,795

     

     

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  30. SOUTH SAN FRANCISCO, Calif., July 21, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic, non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance, today announced the publication of data in the journal Cell Reports Medicine from the Phase 1 clinical trial of efruxifermin (EFX, formerly AKR-001), a fibroblast growth factor 21 (FGF21) analog, demonstrating its potential to modulate biomarkers associated with metabolic diseases, including NASH.

    In the article entitled, "AKR-001, an Fc-FGF21 analog, showed sustained pharmacodynamic effects on insulin sensitivity and lipid metabolism in type 2 diabetes patients," researchers found that EFX demonstrated a sufficiently prolonged half-life of 3-3.5 days to support weekly dosing. In addition, with a variation in systemic concentration of only 2-fold when dosed weekly, treatment with EFX delivered larger and more consistent improvements in markers of insulin sensitivity and lipid metabolism than previously reported for FGF21 analogs, and it was reported to be generally well tolerated. Weekly administration of 70mg demonstrated larger metabolic effects than dosing every other week with 140mg, even though exposure to EFX was comparable.

    "Efruxifermin is the first FGF21 analog to demonstrate a pharmacokinetic profile that would enable sustained, balanced agonism across all of FGF21's receptors with once weekly dosing," said Tim Rolph, D.Phil., chief scientific officer and co-founder of Akero, and senior author of the manuscript.

    Andrew Cheng, M.D., Ph.D., president and CEO of Akero, added, "The data reported in this study provided the rationale for evaluating the efficacy and safety of EFX in NASH patients in our Phase 2a BALANCED study, which met all endpoints. Our recent readouts of liver fat reductions and improvements in histological measures showed the largest reductions in liver fat and improvements in liver histology reported to date and confirm the promising clinical profile of EFX."

    In patients dosed weekly with 70mg EFX in the Phase 1 study, treatment was associated with an increase in insulin sensitivity as demonstrated by reductions in HOMA-IR. This enhancement of insulin sensivity by EFX was replicated in NASH subjects and associated with better glycemic control, as recently disclosed for the BALANCED study. Treatment with EFX in the Phase 1 study was associated with amelioration of dyslipidemia, prevalent among type 2 diabetes and NASH patients, who are susceptible to cardiovascular disease. An improved lipoprotein profile was also evident with EFX treatment in the BALANCED study. 

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. NASH is a leading cause of liver transplants in the US and Europe.

    About Efruxifermin

    Efruxifermin (EFX), formerly known as AKR-001, is Akero's lead product candidate for NASH, engineered to mimic the biological activity of native FGF21. EFX is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. EFX offers convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, efruxifermin (formerly AKR-001), has been evaluated in 80 patients with F1-F3 fibrosis in the main portion of the BALANCED study, and Akero is currently conducting cohort C of the study in non-decompensated F4 NASH patients.  Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    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. Such statements include, but are not limited to, statements regarding: Akero's guidance regarding its business plans and objectives for EFX, including the therapeutic potential and clinical benefits thereof, as well as the dosing, safety and tolerability of EFX; Akero's Phase 2a BALANCED clinical trial, including its initial primary efficacy results and the top-line safety/tolerability, laboratory measures and paired biopsy results; and the potential impact of COVID-19 on strategy, future operations and clinical trials.

    Any forward-looking statements in this statement 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 public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, including potential negative impacts on Akero's employees, manufacturers, supply chain and production as well as on global economies and financial markets; 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 risks related to the competitive landscape. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Akero's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the company's 2019 Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Akero's other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

     

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  31. SOUTH SAN FRANCISCO, Calif., July 10, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today the closing of its upsized underwritten public offering of 6,012,390 shares of its common stock at a public offering price of $36.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to an additional 784,224 shares of common stock in this offering. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $216.4 million

    SOUTH SAN FRANCISCO, Calif., July 10, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today the closing of its upsized underwritten public offering of 6,012,390 shares of its common stock at a public offering price of $36.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to an additional 784,224 shares of common stock in this offering. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $216.4 million.

    J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C. acted as joint book-running managers for the offering.

    Registration statements relating to these securities became effective on July 7, 2020.  The offering was made only by means of a prospectus, copies of which may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions 1115 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at Prospectus_Department@Jefferies.com; or Evercore Group L.L.C., c/o Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial.

     

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  32. SOUTH SAN FRANCISCO, Calif., July 7, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today the pricing of an underwritten public offering of 5,228,166 shares of its common stock at a public offering price of $36.00 per share, before underwriting discounts and commissions. All of the shares in the offering are to be sold by Akero. In addition, Akero has granted the underwriters a 30-day option to purchase up to an additional 784,224 shares of its common stock. The gross proceeds from the offering, before deducting underwriting discounts and…

    SOUTH SAN FRANCISCO, Calif., July 7, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today the pricing of an underwritten public offering of 5,228,166 shares of its common stock at a public offering price of $36.00 per share, before underwriting discounts and commissions. All of the shares in the offering are to be sold by Akero. In addition, Akero has granted the underwriters a 30-day option to purchase up to an additional 784,224 shares of its common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $188.2 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on or about July 10, 2020, subject to customary closing conditions.

    J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C. are acting as joint book-running managers for the offering.

    Registration statements relating to these securities became effective on July 7, 2020.  The offering is being made only by means of a prospectus, copies of which may be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions 1115 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at Prospectus_Department@Jefferies.com; or Evercore Group L.L.C., c/o Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com.  

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of federal securities laws, which are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. Such forward-looking statements include statements regarding Akero's expectations with respect to the completion and timing of the proposed public offering. Risks and uncertainties that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering.  Additional risks and uncertainties that could affect Akero's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as in its other reports filed with the U.S. Securities and Exchange Commission, including the registration statement relating to the proposed offering. The forward-looking statements in this press release are based on information available to Akero as of the date hereof, and Akero disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Akero's views as of any date subsequent to the date of this press release.

     

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  33. SOUTH SAN FRANCISCO, Calif., July 6, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today that it has commenced an underwritten public offering of 4,750,000 shares of its common stock. All of the shares in the offering will be sold by Akero. In addition, Akero expects to grant the underwriters a 30-day option to purchase an additional 712,500 shares of its common stock in the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to…

    SOUTH SAN FRANCISCO, Calif., July 6, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, announced today that it has commenced an underwritten public offering of 4,750,000 shares of its common stock. All of the shares in the offering will be sold by Akero. In addition, Akero expects to grant the underwriters a 30-day option to purchase an additional 712,500 shares of its common stock in the offering. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Jefferies LLC and Evercore Group L.L.C. are acting as joint book-running managers for the proposed offering.

    A registration statement on Form S-1 relating to these securities has been filed with the U.S. Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy these securities be accepted prior to the time the registration statement becomes effective.

    The offering will be made only by means of a prospectus. A copy of the preliminary prospectus relating to this offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions 1115 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204, or by email at prospectus-eq_fi@jpmchase.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at Prospectus_Department@Jefferies.com; or Evercore Group L.L.C., c/o Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of federal securities laws, which are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. Such forward-looking statements include statements regarding Akero's expectations with respect to the completion, timing and size of the proposed public offering and granting the underwriters a 30-day option to purchase additional shares. Risks and uncertainties that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering.  Additional risks and uncertainties that could affect Akero's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as in its other reports filed with the U.S. Securities and Exchange Commission, including the registration statement relating to the proposed offering. The forward-looking statements in this press release are based on information available to Akero as of the date hereof, and Akero disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Akero's views as of any date subsequent to the date of this press release.

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  34. SOUTH SAN FRANCISCO, Calif., June 30, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced results of a 16-week analysis of secondary and exploratory endpoints in its Phase 2a BALANCED study of efruxifermin (EFX), formerly known as AKR-001, in patients with nonalcoholic steatohepatitis (NASH). Notably, of the 40 treatment responders who had end-of-treatment biopsies, we observed that 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis. In addition, 48% of responders achieved NASH resolution with no worsening of fibrosis. Improvements in glycemic control and dyslipidemia, as well as weight loss, were also…

    SOUTH SAN FRANCISCO, Calif., June 30, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced results of a 16-week analysis of secondary and exploratory endpoints in its Phase 2a BALANCED study of efruxifermin (EFX), formerly known as AKR-001, in patients with nonalcoholic steatohepatitis (NASH). Notably, of the 40 treatment responders who had end-of-treatment biopsies, we observed that 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis. In addition, 48% of responders achieved NASH resolution with no worsening of fibrosis. Improvements in glycemic control and dyslipidemia, as well as weight loss, were also observed across all dose groups. Treatment with EFX was generally reported to be well tolerated.

    "These substantial improvements observed in multiple measures of liver health, particularly the one- and two-stage improvements in fibrosis, are extremely encouraging and among the strongest biopsy results reported in NASH to date," said Stephen Harrison, M.D., medical director of Pinnacle Clinical Research. "I believe Efruxifermin continues to set itself apart as one of the most promising drug candidates in NASH, with impressive histology results after just 16 weeks of treatment."

    Summary of Week 16 Biopsy Endpoints1

    Measure (Mean)

    Placebo

    (N=2)

    All EFX

    (N=40)

    28mg

    (N=13)

    50mg

    (N=13)

    70mg

    (N=14)

    Improvement in at least one stage of fibrosis

    without worsening NAS (%)2

    0

    48

    46

    62

    36

    Improvement in at least two stages of

    fibrosis (%)2

    0

    28

    31

    38

    14

    Resolution of NASH without worsening of

    fibrosis (%)2

    50*

    48

    46

    54

    43

    Combination of improvement in at least one

    stage of fibrosis and NASH resolution (%)2

    0

    28

    31

    39

    14

    NAS Reduction ≥2 points without worsening

    of fibrosis (%)2

    50*

    78

    77

    77

    79

    1 Secondary and exploratory histological endpoints were not powered for statistical significance

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

    * A single placebo responder lost 25 pounds over 16 weeks (11% weight reduction)

    The BALANCED study underscored EFX's potential to address multiple important NASH comorbidities. We observed that all dose groups had mean weight loss over the 16-week study, with the 70 mg dose group achieving a statistically significant 3.7kg (about 8 pounds) reduction in body weight at Week 16. Clinically meaningful improvements in glycemic control were observed, including significant reductions in HbA1c in the 50 and 70 mg dose groups of 0.4 and 0.5, respectively. EFX also improved dyslipidemia, including significant increases in HDL cholesterol and significant decreases in triglycerides observed across all EFX dose groups.

    Summary of Cardio-Metabolic Biomarkers

    Measure (Mean Change From Baseline)

    Placebo

    (N=21)

    28 mg

    (N=19)

    50 mg

    (N=20)

    70 mg

    (N=20)

    Body Weight (kg)1

    +0.1

    -0.3

    -2.3

    -3.7*

    HbA1C (%, absolute)1

    +0.1

    -0.1

    -0.4*

    -0.5**

    Triglycerides (%)1

    +8

    -37***

    -45***

    -43***

    HDL Cholesterol (%)1

    0

    +32***

    +40***

    +40***

    Non-HDL Cholesterol (%)1

    0

    -20***

    -13*

    -15**

    LDL Cholesterol (%)1

    +1

    -14*

    0

    -3

    1 Full Analyses Set (all patients randomized into the study)

    *p<0.05, **p<0.01, ***p<0.001, versus placebo

    EFX was reported to be generally well tolerated. There were no deaths in the study, and there were two Serious Adverse Events, one of which occurred prior to dosing. Across EFX groups, the most frequent AEs were grade 1 or 2 gastrointestinal events, which were transient in nature. There were no discontinuations due to treatment-emergent adverse events in the 50 mg dose group and no discontinuations due to the most common adverse event, diarrhea. There were no treatment-related effects on blood pressure, heart rate or bone mineral density.

    "We believe the BALANCED study data, which exceeded our expectations, demonstrate the strong potential of efruxifermin to be a foundational monotherapy for the treatment of NASH," said Andrew Cheng, M.D., Ph.D., president and CEO of Akero. "We look forward to the continued development of efruxifermin and are working diligently to deliver this potentially leading treatment to patients. We are extremely grateful to all of our investigators and study patients, particularly given that this study cohort was completed amidst the COVID-19 pandemic."

    The BALANCED study is an ongoing randomized, double-blind, placebo-controlled study in NASH patients. The company previously reported that each of the 28, 50 and 70 mg EFX dose groups met the primary endpoint compared to placebo, with absolute reductions of 12, 13 and 14 percent of liver fat, respectively, compared with 0.3 percent for placebo, and relative reductions of 63, 71 and 72 percent, compared to 0 percent for placebo. All of these results were highly statistically significant at p<0.001.

    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, June 30. 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 1-866-652-5200 (U.S. toll free) or 1-412-317-6060 (international) 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 NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. NASH is a leading cause of liver transplants in the US and Europe.

    About the BALANCED Study

    The Phase 2a BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with NASH. The main study enrolled a total of 80 patients. Participants were randomized to receive weekly subcutaneous doses of efruxifermin (EFX), formerly known as AKR-001, or placebo for up to 16 weeks, with safety and tolerability followed through week 20. The primary efficacy endpoint for the study is absolute change from baseline in hepatic fat fraction measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) at week 12. Secondary measures include change from baseline in ALT at 12 weeks, the number of patients who had a decrease of ≥2 points in the NAFLD activity score (NAS) at 24 weeks and safety and tolerability measures.

    About Efruxifermin

    Efruxifermin (EFX), formerly known as AKR-001, is Akero's lead product candidate for NASH, currently being evaluated in the ongoing Phase 2a BALANCED study. EFX is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX offers convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    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. Such statements include, but are not limited to, statements regarding: Akero's guidance regarding its business plans and objectives for EFX, including the therapeutic potential and clinical benefits thereof, as well as the safety and tolerability of EFX and future clinical development plans; Akero's Phase 2a BALANCED clinical trial, including its initial primary efficacy results; and the potential impact of COVID-19 on patient retention, strategy, future operations and clinical trials.

    Any forward-looking statements in this statement 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 public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, including potential negative impacts on Akero's employees, manufacturers, supply chain and production as well as on global economies and financial markets; 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 risks related to the competitive landscape. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Akero's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the company's 2019 Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Akero's other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  35. SOUTH SAN FRANCISCO, Calif., June 29, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced that the company plans to discuss new efficacy and safety data, including biopsy results, from its Phase 2a BALANCED study of AKR-001 in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) in a post-market press release and webcast to be held on Tuesday, June 30, 2020.

    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) tomorrow afternoon, June 30. 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 1-866-652-5200 (U.S. toll free) or 1-412-317-6060 (international) 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 is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health of NASH patients. The company's lead product candidate, AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

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  36. SOUTH SAN FRANCISCO, Calif., June 17, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that the first subject has been dosed in Cohort C, the previously-announced expansion of its Phase 2a BALANCED trial, which will enroll 30 subjects who have NASH with compensated cirrhosis (F4), Child-Pugh Class A.

    "People who have compensated cirrhosis as a result of NASH are in acute need of therapeutics that may be able to delay or to help prevent liver failure," said Kitty Yale, chief development officer of Akero. "Dosing this patient demonstrates the focus of our clinical development team and partners to continue advancing this candidate during the current pandemic. Given the strong results in terms of reduction in liver fat in the topline readout of the Phase 2a BALANCED trial prior to expansion, we believe in the potential for AKR-001 to help reverse the course of this serious disease."

    Thirty adult NASH subjects, demonstrated at baseline by liver biopsy to have cirrhosis with a fibrosis score of 4, will be randomized 2:1 to receive either 50 mg of AKR-001 or placebo for 16 weeks. The primary objective of Cohort C is to assess safety and tolerability of treatment with AKR-001 in NASH patients at greatest risk of progressing to end-stage liver disease.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. NASH is a leading cause of liver transplants in the US and Europe.

    About the BALANCED Study

    The Phase 2a BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with NASH. The main study enrolled a total of 80 patients. Participants were randomized to receive weekly subcutaneous doses of AKR-001 or placebo for up to 16 weeks, with safety and tolerability followed through week 20. The primary efficacy endpoint for the study is absolute change from baseline in hepatic fat fraction measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) at week 12. Secondary measures include change from baseline in ALT at 12 weeks, the number of patients who had a decrease of ≥2 points in the NAFLD activity score (NAS) at 24 weeks and safety and tolerability measures, which remain on track to be reported by the end of the second quarter of 2020 together with safety and tolerability.

    About AKR-001

    AKR-001 is Akero's lead product candidate for NASH, currently being evaluated in the ongoing Phase 2a BALANCED study. AKR-001 is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native FGF21, AKR-001 offers convenient once-weekly dosing and has been well-tolerated in clinical trials to date.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health of NASH patients. The company's lead product candidate, AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in San Francisco, CA. For more information, please visit www.akerotx.com.

    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. Such statements include, but are not limited to, statements regarding: Akero's guidance regarding its business plans and objectives for AKR-001, including the therapeutic potential and clinical benefits thereof, as well as the safety and tolerability of AKR-001; Akero's Phase 2a BALANCED clinical trial, including its initial primary efficacy results and expected timing to report the top-line safety/tolerability, laboratory measures and paired biopsy data from the BALANCED study in the second quarter of 2020; the dosing of its first subject in Cohort C; and the potential impact of COVID-19 on strategy, future operations and clinical trials.

    Any forward-looking statements in this statement 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 public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, including potential negative impacts on Akero's employees, manufacturers, supply chain and production as well as on global economies and financial markets; 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 risks related to the competitive landscape. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Akero's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the company's 2019 Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Akero's other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

     

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  37. SOUTH SAN FRANCISCO, Calif., June 10, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced the appointment of Tom Heyman to its board of directors as an independent director.

    "Mr. Heyman's hands-on knowledge in operational management, coupled with a keen perspective into the business development landscape, brings a unique and valued viewpoint to our company," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero Therapeutics. "The Akero leadership team very much looks forward to working with Mr. Heyman as we advance AKR-001 for the potential treatment for NASH."

    Mr. Heyman has a long-standing track record of leadership and management in the biopharmaceutical industry, with particular experience in business development and venture capital. Spanning his 37-year career with Johnson & Johnson, Mr. Heyman held a diverse range of leadership roles across legal, R&D, business development, general corporate management and equity investments. Previously, Mr. Heyman served as president of JJDC, the venture capital group within Johnson & Johnson, where he managed approximately $1.5 billion of capital and oversaw investments in over 120 companies. Prior to his time at JJDC, Mr. Heyman spent 23 years leading business development for Johnson & Johnson's pharmaceutical group, Janssen.

    "Akero is developing one of the most exciting potential therapeutics for NASH currently in development and has thus far shown phenomenal Phase 2a data," said Mr. Heyman. "I am eager to collaborate with the board and leadership teams as we look to capitalize on this promising data and position the company for long-term success in the NASH space."

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA.  For more information, please visit www.akerotx.com.

    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 AKR-001; Akero's Phase 2a BALANCED study, including its results; the potential impact of COVID-19 on strategy, future operations, enrollment and clinical trials; 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;  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 Akero's Annual Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  38. SOUTH SAN FRANCISCO, Calif., May 26, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that members of the management team will participate in a fireside chat at the Jefferies Virtual Healthcare Conference at 10:30 a.m. ET on Tuesday, June 2, 2020.

    A live webcast will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website.

    About Akero Therapeutics
    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA.  For more information, please visit www.akerotx.com.

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  39. SOUTH SAN FRANCISCO, Calif., May 13, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today reported first quarter financial results for the period ending March 31, 2020.

    "During the first quarter of 2020 we reported results for the primary endpoint and several secondary efficacy endpoints in our ongoing Phase 2a clinical trial, the BALANCED study, and continued to make important progress toward advancing AKR-001 as a potential cornerstone treatment for NASH," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "The reductions in liver fat and ALT observed with AKR-001 are among the largest reductions reported for NASH clinical studies to date – not only in the FGF21 class, but across all mechanisms in development. We are pleased with our progress and look forward to reporting efficacy and safety data, including biopsy results, toward the end of this quarter when we expect the BALANCED study analysis to be completed. We remain on schedule to initiate our Phase 2b clinical trial in NASH patients in the first half of 2021."

    First Quarter Business Highlights

    • Akero reported results for the primary and several secondary efficacy endpoints for the BALANCED study at week 12 of the 16-week dosing period. Each of the three AKR-001 dose groups met the primary endpoint as well as all reported secondary endpoints. These results included highly significant 12-14% absolute reductions in liver fat and 63-72% relative reductions in liver fat (in each case compared with 0% for placebo). Reductions in ALT of 24-32 U/L were observed, compared with 6 U/L for placebo.
    • While the study remains blinded, the tolerability profile of the entire study cohort appeared consistent with results from previous clinical trials evaluating AKR-001 in patients with Type 2 diabetes. The adverse events observed most frequently in prior trials were mild/moderate gastrointestinal events and injection site reactions.
    • These robust efficacy results are expected to provide flexibility in dose selection for the next study. The Company proposes, pending consultation with FDA, to progress two doses for further evaluation.

    COVID-19 and BALANCED Study Update

    • The COVID-19 pandemic has not materially impacted data collection for the BALANCED study or preparations for the Company's upcoming Phase 2b/3 trial.
    • The Company has completed all data collection for the BALANCED study. A total of 50 subjects achieved at least a 30% relative reduction of liver fat at week 12 as measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) and therefore were eligible for end-of-study biopsies. Forty-eight of the biopsy-eligible subjects were treated with AKR-001 compared with two subjects on placebo. End-of-study biopsies have been successfully collected for 42 (84%) of the 50 biopsy-eligible subjects.
    • Toward the end of this quarter, the Company expects to unblind the BALANCED study data and to report efficacy and safety data, including paired biopsy results. We expect to include results for the proportions of subjects who achieved at least a 2-point reduction in NAFLD activity score (NAS), a 1-point reversal in fibrosis score with no worsening of NASH, and NASH resolution with no worsening of fibrosis. Additional expected analyses include biomarkers of liver injury and fibrosis and other relevant measures for NASH studies, together with safety and tolerability.
    • The BALANCED study's Data Monitoring Committee was convened for a review of unblinded safety data following completion of treatment and recommended that a planned expansion cohort (Cohort C) in NASH patients who have compensated cirrhosis (F4), Child-Pugh Class A, proceed without any amendments to the protocol.
    • After a temporary suspension of enrollment plans, the Company began screening for Cohort C on May 7, 2020 and expects to begin enrollment in the second quarter of this year. Cohort C is designed to inform the long-term development plan in patients with NASH who have compensated cirrhosis (F4), Child-Pugh Class A.
    • The Company expects to update the AKR-001 IND after completion of the recommended toxicology package for a biopharmaceutical, enabling a longer-term Phase 2b/3 clinical trial to commence during the first half of 2021. These chronic toxicology studies include 26-week dosing followed by a 13-week recovery period off drug in rats and non-human primates. In addition, a standard package of reproductive and developmental toxicology studies has been completed.
    • The Company also expects to have drug product available in the fourth quarter of 2020 to supply the Phase 2b portion of an anticipated Phase 2b/3 clinical trial beginning in the first half of 2021. Commercial-scale manufacturing of GMP drug substance (API) was completed in April 2020, without any impact from COVID-19. Manufacture of GMP drug product lots is scheduled for the third quarter of 2020.

    Financial Highlights

    • Akero's cash, cash equivalents and short-term marketable securities at March 31, 2020 were $125.3 million.
    • Research and development expenses for the three-month period ended March 31, 2020 were $8.8 million compared to $4.1 million for the comparable period in 2019. These increases are attributable to higher costs related to Akero's AKR-001 program, including third-party contract manufacturing and contract research organization costs associated with the BALANCED study, and internal personnel costs, including non-cash stock-based compensation.
    • General and administrative expenses for the three-month period ended March 31, 2020 were $3.6 million compared to $1.4 million for the comparable period in 2019. These increases are attributable to higher internal personnel costs, including non-cash stock-based compensation, and professional services and other costs associated with operating as a public company.
    • Total operating expenses were $12.4 million for the three-month period ended March 31, 2020, compared to $5.5 million for the comparable period in 2019.

    About NASH
    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. The progressive damage to the liver associated with NASH closely resembles damage caused by excessive alcohol consumption or viral infections, and the disorder is a leading cause of liver transplants in the US and Europe.

    About AKR-001
    AKR-001 is Akero's lead product candidate for NASH. AKR-001 was designed to increase insulin sensitivity, improve lipoproteins, reduce liver fat and inflammation, and reverse fibrosis. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in physiological parameters linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native FGF21, AKR-001 offers convenient once-weekly dosing.

    About Akero Therapeutics
    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    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 AKR-001, upcoming milestones, and therapeutic effects of AKR-001; Akero's Phase 2a BALANCED study, including its results and expected timing to report the analysis of efficacy and safety data; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for AKR-001; expectations for successful completion of nonclinical studies; expectations regarding successful scale-up of drug substance manufacturing and release of new drug product for use in clinical trials; expectations regarding the Company's use of capital, expenses and other future financial results; 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 Akero'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 Akero's Annual Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero 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)



    March 31, 2020


    December 31, 2019

    Assets




    Cash, cash equivalents and short-term marketable securities

    $

    125,285


    $

    136,400

    Other current assets

    933



    1,649

      Non-current assets

    403



    69

            Total assets

    $

    126,621


    $

    138,118

    Liabilities and Stockholders' Equity




    Current liabilities

    $

    8,286


    $

    9,369

    Non-current liabilities


    12



    23

    Stockholders' equity


    118,323



    128,726

    Total liabilities and stockholders' equity

    $

    126,621


    $

    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

    March 31,


    2020


    2019

    Operating expenses:




    Research and development

    $

    8,791


    $

    4,063

    General and administrative

    3,588


    1,449

    Total operating expenses

    12,379


    5,512

    Loss from operations

    (12,379)


    (5,512)

    Other income, net

    493


    150

    Net loss

    $

    (11,886)


    $

    (5,362)

    Comprehensive loss

    $

    (11,835)


    $

    (5,362)

    Net loss per common share - basic and diluted

    $

    (0.42)


    $

    (31.90)

    Weighted-average number of shares used in computing net loss per common share, basic and diluted

    28,499,475


    168,071


     

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  40. venBio Partners LLC today announced the closing of venBio Global Strategic Fund III ("venBio Fund III"), its third life sciences venture capital fund, exceeding its target and closing on approximately $394 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising pharmaceutical companies, corporate pensions, financial institutions, endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., and Aaron Royston, M.D., venBio Fund III will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs…

    venBio Partners LLC today announced the closing of venBio Global Strategic Fund III ("venBio Fund III"), its third life sciences venture capital fund, exceeding its target and closing on approximately $394 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising pharmaceutical companies, corporate pensions, financial institutions, endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., and Aaron Royston, M.D., venBio Fund III will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs. The venBio team typically leads or co-leads investments and takes an active role with each of their portfolio companies.

    "We are grateful for the tremendous support we have received from our current investors during this fundraise," said Dr. Adelman. "We appreciate their ongoing commitment and welcome the broad range of new top-tier investors who have joined them."

    "We remain committed to our founding strategy at venBio, namely to turn great science into impactful medicine," said Dr. Goodman. "Our investment thesis, regardless of stage of company, remains to look for investment opportunities with a 3- to 5-year time horizon."

    "In addition to generating strong financial returns, we're proud of the impact our portfolio companies have made on patients," said Dr. Royston. "We've actively helped build three companies that have developed approved drugs that are on the market today."

    In conjunction with the new fund, venBio has promoted Richard Gaster M.D., Ph.D., to Partner. Dr. Gaster was previously head of translational medicine at Pliant Therapeutics and a Senior Associate at Third Rock Ventures. Prior to Third Rock, he was a resident physician in Harvard's Plastic and Reconstructive Surgery Program and received his M.D. and Ph.D. degrees from Stanford University in the Medical Scientist Training Program.

    About venBio Partners

    Established in 2011, venBio Partners is a life science venture capital firm that focuses on novel therapeutics for unmet medical needs. Since inception, venBio has raised nearly $1 billion in capital commitments and has invested in 29 companies including venBio-founded Labrys Biologics (acquired by Teva), Aragon Pharmaceuticals (acquired by Johnson & Johnson), Seragon Pharmaceuticals (acquired by Roche), Aurinia Pharmaceuticals (NASDAQ:AUPH), Apellis Pharmaceuticals (NASDAQ:APLS), Turning Point Therapeutics (NASDAQ:TPTX), Precision Biosciences (NASDAQ:DTIL) and Akero Therapeutics (NASDAQ:AKRO). For more information, please visit www.venbio.com.

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  41. SAN FRANCISCO, March 31, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced that all three AKR-001 dose groups in the BALANCED study met the primary endpoint of absolute change from baseline in liver fat as measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) – at week 12. Results for the primary endpoint as well as other week 12 efficacy endpoints are summarized in the table below.

    Summary of Week 12 Efficacy Endpoints




    AKR-001 (once weekly dose)

    Measure (Mean)

    Placebo

    (N=21)

    28 mg

    (N=19)

    50 mg

    (N=20)

    70 mg

    (N=20)

    Absolute reduction in liver fat (%)

    -0.3

    -12.3***

    -13.4***

    -14.1***

    Relative reduction in liver fat (%)

    0%

    -63***

    -71***

    -72***

    ≥30% relative reduction in fat (%)

    10

    84***

    85***

    75***

    Reduction in ALT (U/L)

    -6

    -24***

    -30***

    -32***

    ***p<0.001, versus placebo

    "The magnitude and rate of improvements in liver fat content and ALT observed over 12 weeks in the BALANCED study are among the most robust NASH clinical trial results reported to date," said Stephen Harrison, M.D., medical director of Pinnacle Clinical Research. "AKR-001 is emerging as one of the most promising drug candidates in development for this serious disease."

    The BALANCED study is an ongoing randomized, double-blind, placebo-controlled study in NASH patients. While the study remains blinded, the tolerability profile appears consistent with results from previous clinical trials evaluating AKR-001 in patients with Type 2 diabetes. The adverse events observed most frequently in prior trials were mild/moderate gastrointestinal events and injection site reactions.

    After 12 weeks of treatment, patients who have achieved at least a 30% relative reduction in liver fat are eligible for an end-of-study biopsy. Across the AKR-001 dose groups, 75-85% of patients are eligible for biopsies. As of March 30, 2020, 25 end-of-study biopsies have been collected from a total of 50 eligible patients.

    We expect to report the top-line safety/tolerability, laboratory measures and paired biopsy data from the BALANCED study in the second quarter of this year. The extent to which the COVID-19 pandemic will interfere with collection of the remaining biopsies and data from other scheduled clinical visits, including the safety follow-up visit at week 20, is unclear. We are delaying the planned initiation of the BALANCED study cohort C in NASH patients who have compensated cirrhosis (F4), Child-Pugh Class A.

    "We are encouraged by these results, which support continued development of AKR-001 for treatment of NASH," said Andrew Cheng, M.D., Ph.D., president and CEO of Akero. "AKR-001 has the potential to provide NASH patients with an important treatment option when there are still no approved therapies. We look forward to the full data set with anticipation and are preparing for the next steps in AKR-001's development."

    Conference Call / Webcast Details
    The company will host a conference call and webcast with slide presentation today at 8:30 a.m. ET (5:30 a.m. PT). 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 1-866-652-5200 (U.S. toll free) or 1-412-317-6060 (international) 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 NASH
    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. NASH is a leading cause of liver transplants in the US and Europe.

    About the BALANCED Study
    The Phase 2a BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with NASH. The main study enrolled a total of 80 patients. Participants were randomized to receive weekly subcutaneous doses of AKR-001 or placebo for up to 16 weeks, with safety and tolerability followed through week 20. The primary efficacy endpoint for the study is absolute change from baseline in hepatic fat fraction measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) at week 12. Secondary measures include change from baseline in ALT at 12 weeks, the number of patients who had a decrease of ≥2 points in the NAFLD activity score (NAS) at 24 weeks and safety and tolerability measures.

    About AKR-001
    AKR-001 is Akero's lead product candidate for NASH, currently being evaluated in the ongoing Phase 2a BALANCED study. AKR-001 is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native FGF21, AKR-001 offers convenient once-weekly dosing and has been well-tolerated in clinical trials to date.

    About Akero Therapeutics
    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in San Francisco, CA. For more information, please visit www.akerotx.com.

    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. Such statements include, but are not limited to, statements regarding: Akero's guidance regarding its business plans and objectives for AKR-001, including the therapeutic potential and clinical benefits thereof, as well as the safety and tolerability of AKR-001; Akero's Phase 2a BALANCED clinical trial, including its initial primary efficacy results and expected timing to report the top-line safety/tolerability, laboratory measures and paired biopsy data from the BALANCED study in the second quarter of 2020; and the potential impact of COVID-19 on strategy, future operations and clinical trials.

    Any forward-looking statements in this statement 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 public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, which has been labelled a pandemic by the World Health Organization, including potential negative impacts on Akero's employees, manufacturers, supply chain and production as well as on global economies and financial markets; 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 risks related to the competitive landscape. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Akero's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the company's 2019 Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Akero's other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  42. SAN FRANCISCO, March 30, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced that the company plans to discuss the primary endpoint and other Week 12 efficacy endpoint results from the ongoing Phase 2a BALANCED study of AKR-001 in patients with biopsy-confirmed nonalcoholic steatohepatitis, or NASH, in a pre-market press release and webcast to be held on Tuesday, March 31, 2020.

    Conference Call / Webcast Details
    The company will host a conference call and webcast with slide presentation at 8:30 a.m. ET (5:30 a.m. PT) tomorrow morning, March 31. 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 1-866-652-5200 (U.S. toll free) or 1-412-317-6060 (international) 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 is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in San Francisco, CA. For more information, please visit www.akerotx.com.

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  43. SAN FRANCISCO, March 16, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) Company developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients, today reported fourth quarter and full year financial results for the period ending December 31, 2019.

    "We saw in 2019 a period of continued clinical and manufacturing progress for Akero, driven by precision execution by our team," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "Our rapid progress combined with a strong cash position provide the foundation for the continued development of AKR-001, which we believe has the potential to become a cornerstone of NASH treatment."

    Fourth Quarter Business Highlights

    • Enrollment was completed in the Phase 2a BALANCED study in NASH patients. The Company remains on track to report results of the BALANCED study's primary endpoint in the first quarter of 2020. Top-line results related to secondary endpoints, including safety and tolerability as well as paired biopsies for patients who achieve at least 30% relative reduction in liver fat at week 12, will be reported in the second quarter of 2020.
    • The Company has successfully manufactured AKR-001 drug substance at commercial scale as an engineering run at Boehringer Ingelheim. Yield was comparable to the Good Manufacturing Practice (GMP) drug substance originally manufactured by Amgen. Analysis of the drug substance produced by Boehringer Ingelheim confirmed it met the same release specification as previously used for Amgen GMP drug substance. The Company expects to release drug product produced in compliance with current GMP requirements by the fourth quarter of 2020.

    Full Year and Fourth Quarter 2019 Financial Results

    • Akero's cash, cash equivalents and short-term marketable securities at December 31, 2019 were $136.4 million.
    • Research and development expenses for the three-month and twelve-month periods ended December 31, 2019 were $13.1 million and $37.0 million, respectively, compared to $2.0 million and $11.9 million for the comparable periods in 2018. These increases are attributable to higher costs related to Akero's AKR-001 program, including third-party contract manufacturing, contract research organization costs associated with the BALANCED study and internal personnel costs.
    • General and administrative expenses for the three-month and twelve-month periods ended December 31, 2019 were $3.1 million and $8.6 million, respectively, compared to $1.0 million and $1.9 million for the comparable periods in 2018. These increases are attributable to higher expenses for personnel, including non-cash stock-based compensation, and professional services and other costs associated with becoming a public company.
    • Total operating expenses were $16.2 million and $45.7 million for the three-month and twelve-month periods ended December 31, 2019, respectively, compared to $3.0 million and $13.8 million for the comparable periods in 2018.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. The progressive damage to the liver associated with NASH closely resembles damage caused by excessive alcohol consumption or viral infections, and the disorder is a leading cause of liver transplants in the US and Europe.

    About AKR-001

    AKR-001 is Akero's lead product candidate for NASH, currently being evaluated in the ongoing Phase 2a BALANCED study. AKR-001 is designed to increase insulin sensitivity, improve lipoproteins, reduce liver fat and inflammation, and reverse fibrosis. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in physiological parameters linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native FGF21, AKR-001 offers convenient once-weekly dosing and has been well-tolerated in clinical studies to date.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH Company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, AKR-001 is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in San Francisco, CA. For more information, please visit www.akerotx.com.

    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 AKR-001 and the BALANCED study, upcoming milestones, and therapeutic effects of AKR-001; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for AKR-001; expectations for successful completion of nonclinical studies; expectations regarding successful scale-up of drug substance manufacturing and release of new drug product for use in clinical trials; expectations regarding the Company's use of capital, expenses and other future financial results and plans related to development of the Company's current and future product candidates. 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: 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 Akero's most recently-filed Quarterly Report on 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero'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. Akero 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,


    Assets


    2019




    2018



    Cash, cash equivalents and short-term marketable securities


    $

    136,400



    $

    75,975




    Other current assets


    1,649



    1,156




    Non-current assets


    69



    20




            Total assets


    $

    138,118



    $

    77,151




    Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)







    Current liabilities


    $

    9,369



    $

    2,342




    Non-current liabilities


    23






    Redeemable convertible preferred stock




    124,728




    Stockholders' equity (deficit)


    128,726



    (49,919)




    Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)


    $

    138,118



    $

    77,151





















     

    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,



    2019


    2018


    2019


    2018


    Operating expenses:









    Research and development

    $

    13,138



    $

    1,983



    $

    37,046



    $

    11,882



    General and administrative

    3,083



    985



    8,605



    1,896



    Total operating expenses

    16,221



    2,968



    45,651



    13,778



    Loss from operations

    (16,221)



    (2,968)



    (45,651)



    (13,778)



    Other income (expense), net

    610



    (58,504)



    1,896



    (67,936)



    Net loss

    $

    (15,611)



    $

    (61,472)



    $

    (43,755)



    $

    (81,714)



    Comprehensive loss

    $

    (15,617)



    $

    (61,472)



    $

    (43,761)



    $

    (81,714)



    Net loss attributable to common stockholders

    $

    (15,611)



    $

    (61,671)



    $

    (43,755)



    $

    (82,234)



    Net loss per share attributable to common stockholders - basic and diluted

    $

    (0.55)



    $

    (449.52)



    $

    (2.90)



    $

    (795.28)



    Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted

    28,335,405



    137,194



    15,070,728



    103,403



     

     

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  44. SAN FRANCISCO, Jan. 13, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that the ongoing Phase 2a BALANCED study of AKR-001 is being expanded to include an additional cohort of subjects with NASH who have compensated cirrhosis (F4), Child-Pugh Class A.

    Akero Therapeutics, Inc. Logo (PRNewsfoto/Akero Therapeutics, Inc.)

    Thirty NASH subjects, demonstrated at baseline by liver biopsy to have cirrhosis with a fibrosis score of 4, will be randomized 2:1 to receive either 50 mg of AKR-001 or placebo for 16 weeks. The primary objective of the expansion cohort is to assess safety and tolerability of treatment with…

    SAN FRANCISCO, Jan. 13, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that the ongoing Phase 2a BALANCED study of AKR-001 is being expanded to include an additional cohort of subjects with NASH who have compensated cirrhosis (F4), Child-Pugh Class A.

    Akero Therapeutics, Inc. Logo (PRNewsfoto/Akero Therapeutics, Inc.)

    Thirty NASH subjects, demonstrated at baseline by liver biopsy to have cirrhosis with a fibrosis score of 4, will be randomized 2:1 to receive either 50 mg of AKR-001 or placebo for 16 weeks. The primary objective of the expansion cohort is to assess safety and tolerability of treatment with AKR-001 in NASH patients at greatest risk of progressing to end-stage liver disease. The selection of the 50 mg dose for this cohort is based on modeling of data from the Phase 1b trial in Type 2 diabetes as well as availability of drug product.

    "Cirrhotic patients with stage 4 fibrosis present a significant unmet medical need in NASH because of the risk of decompensation and liver failure, where liver transplant becomes the only treatment option," said Kitty Yale, chief development officer of Akero. "AKR-001 may be able to help this vulnerable population."

    About NASH
    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. The progressive damage to the liver associated with NASH closely resembles damage caused by excessive alcohol consumption or viral infections, and the disorder is a leading cause of liver transplants in the US and Europe.

    About AKR-001
    AKR-001 is an Fc-FGF21 fusion protein that has been engineered to mimic the biological activity profile of native FGF21, an endogenous hormone that regulates lipid and energy metabolism, and is secreted throughout the body to alleviate cellular stress. Observations from clinical trials of AKR-001 and other FGF analogs point to AKR-001's potential to reduce liver fat, cellular stress, inflammation and fibrosis in people with non-alcoholic steatohepatitis (NASH), as well as to improve risk factors of cardiovascular disease, the principal cause of death among NASH patients.

    About Akero Therapeutics
    Akero Therapeutics is a clinical-stage biotechnology company focused on the development and commercialization of transformative treatments for patients with NASH and other serious metabolic diseases with high unmet medical need. The Company's lead program AKR-001 is being evaluated in a Phase 2a clinical trial for the treatment of NASH. Akero Therapeutics is headquartered in San Francisco, CA. For more information, please visit www.akerotx.com.

    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. Such statements include, but are not limited to, statements regarding: Akero's guidance regarding its business plans and objectives for AKR-001, including the therapeutic potential and clinical benefits thereof, as well as the potential patient population that may be addressed by AKR-001; and Akero's Phase 2a BALANCED clinical trial, including its expansion to include an additional cohort of subjects with NASH who have compensated cirrhosis, as well as its design, implementation, and timing of the anticipated results.

    Any forward-looking statements in this statement 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: 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 risks related to the competitive landscape. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Akero's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the final prospectus dated June 19, 2019 and filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the United States Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Akero's other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  45. SAN FRANCISCO, Jan. 8, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that CEO Andrew Cheng, M.D., Ph.D., will provide a business overview and update at the J.P. Morgan Healthcare Conference at 7:30 AM Pacific time on Wednesday, January 15, 2020.

    Akero Therapeutics, Inc. Logo (PRNewsfoto/Akero Therapeutics, Inc.)

    A live webcast of the presentation and Q&A will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website.

    About Akero Therapeutics
    Akero Therapeutics is a clinical-stage…

    SAN FRANCISCO, Jan. 8, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that CEO Andrew Cheng, M.D., Ph.D., will provide a business overview and update at the J.P. Morgan Healthcare Conference at 7:30 AM Pacific time on Wednesday, January 15, 2020.

    Akero Therapeutics, Inc. Logo (PRNewsfoto/Akero Therapeutics, Inc.)

    A live webcast of the presentation and Q&A will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website.

    About Akero Therapeutics
    Akero Therapeutics is a clinical-stage biotechnology company focused on the development and commercialization of transformative treatments for patients with NASH and other serious metabolic diseases with high unmet medical need. The Company's lead program AKR-001 is being evaluated in a Phase 2a clinical trial for the treatment of NASH. Akero Therapeutics is headquartered in San Francisco, CA. For more information, please visit www.akerotx.com.

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  46. SAN FRANCISCO, Dec. 16, 2019 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that it has completed enrollment in the Phase 2a BALANCED study of AKR-001, a novel FGF21 analog, for the treatment of NASH.

    Akero Therapeutics, Inc. Logo

    "We believe NASH represents one of the single largest indications that has no approved therapy in the United States and that AKR-001 has the potential to fundamentally change important parameters of disease for people with NASH, including improved lipid profiles, improved glycemic control and reduction of liver fat," said Kitty Yale, chief development…

    SAN FRANCISCO, Dec. 16, 2019 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that it has completed enrollment in the Phase 2a BALANCED study of AKR-001, a novel FGF21 analog, for the treatment of NASH.

    Akero Therapeutics, Inc. Logo

    "We believe NASH represents one of the single largest indications that has no approved therapy in the United States and that AKR-001 has the potential to fundamentally change important parameters of disease for people with NASH, including improved lipid profiles, improved glycemic control and reduction of liver fat," said Kitty Yale, chief development officer for Akero. "We will have two data readouts for this trial next year and are hopeful that our approach of targeting FGF21 will provide a disease-modifying treatment for people affected with NASH."

    The Phase 2a BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed patients with NASH. The study randomized 80 participants to receive weekly subcutaneous doses of AKR-001 or placebo for up to 16 weeks, with safety and tolerability followed through week 20. The primary efficacy endpoint for the study is absolute change from baseline in hepatic fat fraction measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) at week 12. Secondary measures include change from baseline in ALT at 12 weeks, the number of patients who had a decrease of >2 points in the NAFLD activity score (NAS) at 24 weeks and safety and tolerability measures.

    Topline results from the BALANCED study are expected in the first quarter of 2020, with full data readout anticipated in the second quarter of 2020.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. The progressive damage to the liver associated with NASH closely resembles damage caused by excessive alcohol consumption or viral infections, and the disorder is a leading cause of liver transplants in the US and Europe.

    About AKR-001

    AKR-001 is an Fc-FGF21 fusion protein that has been engineered to mimic the biological activity profile of native FGF21, an endogenous hormone that regulates lipid and energy metabolism, and is secreted throughout the body to alleviate cellular stress. Observations from clinical trials of AKR-001 and other FGF analogs point to AKR-001's potential to reduce liver fat, cellular stress, inflammation and fibrosis in people with non-alcoholic steatohepatitis (NASH), as well as to improve risk factors of cardiovascular disease, the principal cause of death among NASH patients.

    About Akero Therapeutics
    Akero Therapeutics is a clinical-stage biotechnology company focused on the development and commercialization of transformative treatments for patients with NASH and other serious metabolic diseases with high unmet medical need. The Company's lead program AKR-001 is being evaluated in a Phase 2a clinical trial for the treatment of NASH. Akero Therapeutics is headquartered in San Francisco, CA. For more information, please visit www.akerotx.com.

    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. Such statements include, but are not limited to, statements regarding: Akero's guidance regarding its business plans and objectives for AKR-001, including the therapeutic potential and clinical benefits thereof, as well as the potential patient population that may be addressed by AKR-001; and Akero's Phase 2a BALANCED clinical trial, including the design, implementation, and timing of the anticipated results.

    Any forward-looking statements in this statement 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: 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 risks related to the competitive landscape. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Akero's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the final prospectus dated June 19, 2019 and filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the United States Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Akero's other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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  47. SAN FRANCISCO, Nov. 13, 2019 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that members of the management team will provide a business overview and update at the Jefferies 2019 London Healthcare Conference at 8:00 a.m. GMT on Wednesday, November 20, 2019.

    A live webcast of the presentation will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website.

    About Akero Therapeutics
    Akero Therapeutics is a clinical-stage biotechnology…

    SAN FRANCISCO, Nov. 13, 2019 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that members of the management team will provide a business overview and update at the Jefferies 2019 London Healthcare Conference at 8:00 a.m. GMT on Wednesday, November 20, 2019.

    A live webcast of the presentation will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website.

    About Akero Therapeutics
    Akero Therapeutics is a clinical-stage biotechnology company focused on the development and commercialization of transformative treatments for patients with NASH and other serious metabolic diseases with high unmet medical need. The Company's lead program AKR-001 is being evaluated in a Phase 2a clinical trial for the treatment of NASH. AKR-001 is an engineered human Fc-FGF21 fusion protein designed to harness the inherent benefits of an endogenous hormone called FGF21, with the potential to reduce liver fat, mitigate inflammation, and reverse fibrosis in NASH patients. Akero Therapeutics is headquartered in San Francisco, CA. For more information, please visit www.akerotx.com.

     

    (PRNewsfoto/Akero Therapeutics, Inc.)

     

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  48. SAN FRANCISCO, Nov. 12, 2019 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today reported third quarter 2019 financial results for the period ending September 30, 2019.

    "The third quarter of 2019 was a period of continued clinical and manufacturing progress for Akero," said Andrew Cheng, M.D., Ph.D., President and Chief Executive Officer. "We remain on track to report results of the BALANCED study's primary endpoint in the first quarter of 2020 and full study results in the second quarter of 2020. We have successfully completed laboratory-scale transfer of AKR-001…

    SAN FRANCISCO, Nov. 12, 2019 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today reported third quarter 2019 financial results for the period ending September 30, 2019.

    "The third quarter of 2019 was a period of continued clinical and manufacturing progress for Akero," said Andrew Cheng, M.D., Ph.D., President and Chief Executive Officer. "We remain on track to report results of the BALANCED study's primary endpoint in the first quarter of 2020 and full study results in the second quarter of 2020. We have successfully completed laboratory-scale transfer of AKR-001 drug substance manufacturing to Boehringer Ingelheim with yield and biological activity comparable to the drug substance originally manufactured by Amgen. We expect to release drug product produced in compliance with current good manufacturing practice requirements and to complete all nonclinical toxicology studies required to support a Phase 2b trial by the fourth quarter of 2020. These actions – and our $147.8 million cash position – provide a strong foundation for the continued development of AKR-001, which we believe has the potential to become a cornerstone of NASH treatment."

    Third Quarter 2019 Financial Results

    • Akero's cash and cash equivalents at September 30, 2019 were $147.8 million.
    • Research and development expenses for the three-month and nine-month periods ended September 30, 2019 were $13.9 million and $23.9 million, respectively, compared to $1.2 million and $9.9 million for the comparable periods in 2018. These increases are attributable to higher costs related to Akero's AKR-001 program, including third-party contract manufacturing, contract research organization costs associated with the BALANCED study and internal personnel costs. 
    • General and administrative expenses for the three-month and nine-month periods ended September 30, 2019 were $2.4 million and $5.5 million, respectively, compared to $0.5 million and $0.9 million for the comparable periods in 2018. These increases are attributable to higher expenses for personnel, including non-cash stock-based compensation, and professional services and other costs associated with becoming a public company.
    • Total operating expenses were $16.3 million and $29.4 million for the three-month and nine-month periods ended September 30, 2019, respectively, compared to $1.7 million and $10.8 million for the comparable periods in 2018.

    About NASH

    NASH is a leading cause of liver failure around the world, driven by the growing global epidemic of obesity. NASH is a severe form of non-alcoholic fatty liver disease (NAFLD) characterized by liver cell (hepatocyte) damage, liver inflammation, and fibrosis that can progress to cirrhosis, liver failure, cancer and death.

    About AKR-001

    AKR-001 is an engineered human Fc-FGF21 fusion protein designed to harness the inherent benefits of an endogenous hormone called FGF21, with the potential to reduce liver fat, mitigate inflammation, and reverse fibrosis in NASH patients. AKR-001 is uniquely designed to deliver sustained signaling through FGF21's receptors with once-weekly subcutaneous dosing.

    About Akero Therapeutics

    Akero Therapeutics is a clinical-stage biotechnology company focused on the development and commercialization of transformative treatments for patients with NASH and other serious metabolic diseases with high unmet medical need. The Company's lead program AKR-001 is being evaluated in a Phase 2a clinical trial for the treatment of NASH. For more information, please visit www.akerotx.com.

    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 AKR-001 and the BALANCED study, upcoming milestones, and therapeutic effects of AKR-001; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for AKR-001; expectations for successful completion of nonclinical studies; expectations regarding successful scale-up of drug substance manufacturing and release of new drug product for use in clinical trials; expectations regarding the company's use of capital, expenses and other future financial results and plans related to development of the company's current and future product candidates. 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: 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 final prospectus dated June 19, 2019 and filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the United States Securities and Exchange Commission (SEC) and elsewhere in Akero's 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. Akero 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)




    September 30,
    2019


    December 31,
    2018

    Assets





    Cash and cash equivalents


    $

    147,835



    $

    75,975

    Other current assets


    2,238



    1,156

    Non-current assets


    70



    20

            Total assets


    $

    150,143



    $

    77,151

    Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit)





    Current liabilities


    $

    6,725



    $

    2,342

    Non-current liabilities


    34



    Redeemable convertible preferred stock




    124,728

    Stockholders' equity (deficit)


    143,384



    (49,919)

    Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)


    $

    150,143



    $

    77,151

     

     

    Akero Therapeutics, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

    (In thousands, except share and per share amounts)



    Three Months Ended
    September 30,


    Nine Months
    Ended
    September 30,


    2019


    2018


    2019


    2018

    Operating expenses:








    Research and development

    $

    13,885



    $

    1,253



    $

    23,908



    $

    9,899


    General and administrative

    2,424



    474



    5,522



    911


    Total operating expenses

    16,309



    1,727



    29,430



    10,810


    Loss from operations

    (16,309)



    (1,727)



    (29,430)



    (10,810)


    Other income (expense), net

    755



    (9,421)



    1,286



    (9,432)


    Net loss and comprehensive loss

    $

    (15,554)



    $

    (11,148)



    $

    (28,144)



    $

    (20,242)


    Net loss attributable to common stockholders

    $

    (15,554)



    $

    (11,399)



    $

    (28,144)



    $

    (20,563)


    Net loss per share attributable to common stockholders - basic and diluted

    $

    (0.56)



    $

    (89.66)



    $

    (2.66)



    $

    (236.67)


    Weighted-average number of shares used in computing net loss per
    share attributable to common stockholders, basic and diluted

    28,024,779



    127,141



    10,589,119



    86,884


     

    (PRNewsfoto/Akero Therapeutics, Inc.)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/akero-therapeutics-reports-recent-highlights-and-third-quarter-2019-financial-results-300955617.html

    SOURCE Akero Therapeutics, Inc.

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  49. WARMINSTER, Pa., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today reports its third quarter 2019 financial results and provides a corporate update.

    "We remain committed to our mission of developing a portfolio of assets with differing mechanisms of action that we believe will form the basis for a functional cure of chronic Hepatitis B", said William Collier, Arbutus' President and Chief Executive Officer. "Our current efforts are focused on completing the Phase 1a/b clinical trial of AB-729, rapidly selecting a next-generation capsid inhibitor for IND-enabling studies to replace our recently discontinued AB-506, evaluating our oral RNA destabilizer…

    WARMINSTER, Pa., Nov. 06, 2019 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (NASDAQ:ABUS), a Hepatitis B Virus (HBV) therapeutic solutions company, today reports its third quarter 2019 financial results and provides a corporate update.

    "We remain committed to our mission of developing a portfolio of assets with differing mechanisms of action that we believe will form the basis for a functional cure of chronic Hepatitis B", said William Collier, Arbutus' President and Chief Executive Officer. "Our current efforts are focused on completing the Phase 1a/b clinical trial of AB-729, rapidly selecting a next-generation capsid inhibitor for IND-enabling studies to replace our recently discontinued AB-506, evaluating our oral RNA destabilizer, AB-452, as well as next-generation compounds in this class, and research on compounds that inhibit PD-L1."

    Recent Corporate Updates

    AB-729

    • In July 2019, the Company initiated a single and multiple dose Phase 1a/1b clinical trial for AB-729, a subcutaneously delivered RNAi agent which has been shown in preclinical models to span all HBV transcripts, reduce all viral antigens, including hepatitis B surface antigen (HBsAg) expression, and inhibit HBV replication.  In this trial, which is designed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-729 in healthy volunteers and in subjects with chronic hepatitis B (CHB) infection, AB-729 will be dosed monthly. 
       
    • Preliminary safety data in single-dose cohorts of healthy subjects and safety and efficacy data in single-dose cohorts of subjects with CHB infection are expected in the first quarter of 2020.

    Capsid Inhibitors

    • In October 2019, Arbutus announced its decision to discontinue the clinical development of AB-506, an oral capsid inhibitor, in Phase 1a/1b clinical development for the treatment of CHB due to safety observations in a Phase 1a 28-day clinical trial in healthy volunteers.  Arbutus intends to present results from the AB-506 Phase 1a/1b clinical trial program at the American Association for the Study of Liver Diseases meeting later this month.
       
    • Arbutus is evaluating a number of oral next-generation capsid inhibitor compounds with chemical scaffolding different from AB-506 that the Company believes have the potential to contribute to the inhibition of HBV replication as part of a combination regimen. The Company's objective is to select one of several lead compounds for IND-enabling studies in December of this year. 

    AB 452

    • Arbutus remains committed to the development of oral RNA-destabilizers that have shown compelling anti-viral effects in multiple HBV preclinical models. AB-452, Arbutus' lead oral RNA-destabilizer is being evaluated in a repeat 90-day preclinical safety study in two species before making a go/no-go decision. We expect that the results of this study will allow us to make that decision early in 2020.  The Company is also continuing to advance back-up compounds with chemical scaffolding different from that of AB-452.

    Early R&D Programs

    • Arbutus continues a focused discovery effort on follow-on compounds for its current HBV pipeline, including efforts to identify compounds potentially capable of reawakening patients' HBV-specific immune response by inhibiting PD-L1.

    New Appointment to Arbutus' Board of Directors

    • Andrew Cheng, M.D., Ph.D., was appointed to the Arbutus Board of Directors.  Previously, Dr. Cheng spent nearly two decades at Gilead Sciences, Inc., where he most recently served as Chief Medical Officer and Executive Vice President.  Dr. Cheng is currently President and Chief Executive Officer of Akero Therapeutics (NASDAQ:AKRO).

    Cash Position and Cash Guidance

    • The Company had approximately $90.1 million in cash and cash equivalents as of September 30, 2019.  The discontinuation of the AB-506 development program is anticipated to reduce cash burn in the short term and the Company believes its existing cash and cash equivalents balance is sufficient to fund operations into early 2021.

    Financial Results

    Cash, Cash Equivalents and Investments

    Arbutus had cash, cash equivalents and short-term investments totaling $90.1 million as of September 30, 2019, as compared to $124.6 million as of December 31, 2018.  The decreased cash balance was due primarily to the $57.7 million used in operating activities during the first nine months of 2019, partially offset by $18.5 million in net proceeds from the sale of a portion of its royalty entitlement on net sales of ONPATTRO in the third quarter of 2019 and $4.7 million of net proceeds from the issuance of shares under its ATM program.  Included in the $57.7 million used in operating activities is a $5.9 million payment for the award rendered in the arbitration proceeding with the University of British Columbia in the third quarter of 2019.

    Net Loss

    Net loss attributable to common shares for the third quarter of 2019, including non-cash charges of $43.8 million related to the impairment of an in-process research and development ("IPR&D") intangible asset and $22.5 million for the impairment of goodwill described further below, was $85.3 million ($1.50 basic and diluted loss per common share) as compared to $27.1 million ($0.49 basic and diluted loss per common share) for the third quarter of 2018.  Net loss attributable to common shares also included non-cash expense for the accrual of coupon on the Company's convertible preferred shares of $2.8 million in the third quarter of 2019 and $2.6 million in the third quarter of 2018, as well as non-cash expense for a proportionate share of Genevant's net losses of $3.5 million in the third quarter of 2019 and $2.8 million in the third quarter of 2018.

    ONPATTRO Royalty Entitlement

    Arbutus has a royalty entitlement on global net sales of ONPATTRO™ (Patisiran) for the lipid nanoparticle delivery (LNP) technology licensed by Arbutus to Alnylam Pharmaceuticals, Inc. (Alnylam) for this product. ONPATTRO is an RNAi therapeutic for the treatment of hereditary ATTR (hATTR) amyloidosis that has been approved by the U.S. Food and Drug Administration and the European Medical Agency. In July 2019, Arbutus sold this royalty entitlement to OCM IP Healthcare Portfolio LP, an affiliate of the Ontario Municipal Employees Retirement System (collectively, OMERS), effective as of January 1, 2019, for $20 million in gross proceeds before advisory fees. OMERS will retain this royalty entitlement until it has received $30 million in royalties, at which point 100% of this royalty entitlement will revert to Arbutus.  OMERS has assumed the risk of collecting up to $30 million of future royalty payments from Alnylam and Arbutus is not obligated to reimburse OMERS if they fail to collect any such future royalties.  Arbutus recognized the $20 million of gross proceeds from this transaction as a liability, net of transaction costs. The Company is amortizing the liability to non-cash interest expense and will continue to recognize the royalty revenue that Alnylam pays to OMERS as non-cash royalty revenue.

    In addition to the royalty entitlement from the Alnylam LNP license agreement, Arbutus is also receiving a second, lower royalty entitlement on global net sales of ONPATTRO originating from a settlement agreement and subsequent license agreement with Acuitas Therapeutics. The royalty entitlement from Acuitas has been retained by Arbutus and is not part of the royalty entitlement sale to OMERS.

    Operating Expenses

    Research and development expenses were $17.7 million in the third quarter of 2019 compared to $16.6 million in the third quarter of 2018.  Research and development expenses in the third quarter of 2019 included costs associated with the Company's Phase 1a/1b clinical trial for its RNAi agent (AB-729), costs associated with the Company's Phase 1a/1b clinical trial for its oral capsid inhibitor (AB-506) that was discontinued in October 2019, and toxicology studies for its HBV RNA Destabilizer (AB-452).  The increase in research and development expenses was due primarily to increased spending in 2019 for the two Phase 1a/1b clinical trials for AB-729 and AB-506.  General and administrative expenses were $3.3 million in the third quarter of 2019 compared to $2.6 million in the third quarter of 2018.  The increase in general and administrative expenses was due primarily to increased stock compensation expense and an increase in insurance premiums.

    In the third quarter of 2019, the Company also recorded a charge of $6.5 million related to an arbitration award from the Company's arbitration with the University of British Columbia.

    Impairment of IPR&D Intangible Assets and Goodwill

    The Company has historically carried IPR&D and goodwill from its acquisition of technologies and business combination as assets.  All acquired IPR&D intangible assets relate to the Company's covalently closed circular DNA ("cccDNA") program.  During the three months ended September 30, 2019, the Company recorded a $43.8 million non-cash impairment expense to reduce the carrying value of its IPR&D intangible assets to zero as of September 30, 2019.  The Company also recognized a corresponding income tax benefit of $12.7 million related to the decrease in its deferred tax liability associated with the IPR&D intangible assets.  The impairment was due to an indefinite delay in further development of the Company's cccDNA program while the Company focuses on its other development programs.

    Goodwill represents the excess of purchase price over the value assigned to the net tangible and identifiable intangible assets in connection with the business combination that formed Arbutus.  For the third quarter of 2019, the Company assessed the changes in circumstances that occurred during the quarter to determine if it was more likely than not that the fair value of the Company was below its carrying amount.  Due to a sustained decrease in the Company's share price in recent months, the Company's market capitalization was reduced below the book value of its net assets and the Company concluded that its fair value was below its carrying amount by an amount in excess of the carrying value of the goodwill.  As a result, the Company recorded a $22.5 million non-cash impairment expense to reduce the carrying value of its goodwill asset to zero as of September 30, 2019.

    Equity Investment Loss in Genevant

    As of September 30, 2019, the Company owned approximately 40% of the common equity of Genevant Sciences Ltd. (Genevant), a company launched with Roivant Sciences Ltd. in April 2018.  Arbutus recorded a loss of $3.5 million in the third quarter of 2019 for its proportionate share of Genevant's net loss.  Financial results of Genevant are recorded on a one-quarter lag basis.

    Outstanding Shares

    The Company had 56,850,172 common shares issued and outstanding as of September 30, 2019. In addition, the Company had approximately 9.1 million stock options outstanding and 1.164 million convertible preferred shares outstanding, which (including the annual 8.75% coupon) will be mandatorily convertible into approximately 23 million common shares on October 18, 2021.



    UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
    (in millions, except share and per share data)

      Three Months Ended
     September 30,
      Nine Months Ended
     September 30,
      2019   2018   2019   2018
    Total revenue $ 3.1     $ 1.6     $ 4.4     $ 4.3  
    Operating expenses              
    Research and development 17.7     16.6     45.2     46.9  
    General and administrative 3.3     2.6     15.9     10.1  
    Depreciation 0.5     0.5     1.5     1.7  
    Site consolidation 0.2     (0.5 )       3.7  
    Impairment of intangible assets 43.8     14.8     43.8     14.8  
    Impairment of goodwill 22.5         22.5      
    Arbitration settlement 6.5         6.5      
    Loss from operations $ (91.4 )   $ (32.4 )   $ (131.0 )   $ (72.9 )
    Other income (loss)              
    Interest income (expense), net (0.6 )   0.7     0.6     2.2  
    Foreign exchange gain (loss)     0.1     0.1     (0.8 )
    Gain on investment             24.9  
    Equity investment loss (3.5 )   (2.8 )   (11.5 )   (2.8 )
    Change in fair value of contingent consideration 0.3     5.6     0.1     6.3  
    Total other income (loss) $ (3.8 )   $ 3.6     $ (10.7 )   $ 29.8  
    Income tax benefit 12.7     4.3     12.7     4.3  
    Net loss (1) $