alfexe/iStock via Getty Images Akero Therapeutics, Inc. (NASDAQ:AKRO) has been able to report positive results from its phase 2b HARMONY study, which used its drug efruxifermin [EFX] for the treatment of patients with pre-cirrhotic MASH or Metabolic dysfunction-associated steatohepatitis with stage 2 or 3 fibrosis. The significance of this is that it is already in the process of testing out this drug in a phase 3 program known as SYNCHRONY. Patients have already been dosed in the first two phase 3 studi ...

Core Insights - Akero Therapeutics released preliminary topline week 96 results from the Phase 2b HARMONY study, demonstrating significant efficacy of efruxifermin (EFX) in improving fibrosis in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1][2][16] - The study showed that 75% of patients in the 50mg EFX group and 46% in the 28mg EFX group achieved at least a one-stage improvement in fibrosis without worsening of MASH, compared to 24% in the placebo group [1][3] - EFX also demonstrated a 2-stage improvement in fibrosis for 36% of the 50mg group and 31% of the 28mg group, significantly higher than the placebo rate of 3% [2][3] Efficacy Results - The primary endpoint of the study was met, with the 50mg EFX group showing a 41% improvement at week 24, which increased to 75% at week 96 [1][3] - The placebo-adjusted effect size for fibrosis improvement without worsening of MASH increased from 21% to 52% for the 50mg EFX group between week 24 and week 96 [4][5] - Among patients with advanced F3 fibrosis, 68% of the 50mg EFX group experienced at least a one-stage improvement in fibrosis without worsening of MASH, compared to 14% for placebo [5][9] Safety and Tolerability - EFX was generally well-tolerated, with no deaths reported and serious adverse events balanced across dose groups [11][12] - The most common adverse events were mild gastrointestinal issues, which were transient [11][12] Future Outlook - Akero is optimistic about the ongoing Phase 3 SYNCHRONY studies, which will further evaluate EFX's efficacy in broader patient populations [6][18] - The company plans to report results from the SYMMETRY study, which focuses on patients with compensated cirrhosis, in the first quarter of 2025 [12][18]

Core Viewpoint - Akero Therapeutics, Inc. (AKRO) has shown a significant price increase of 28.7% over the past four weeks, with a mean price target of $42.88 indicating a potential upside of 58.9% from the current price of $26.99 [1] Price Target Analysis - The average price target consists of eight estimates ranging from a low of $33 to a high of $60, with a standard deviation of $10.60, suggesting variability in analyst opinions [1] - The lowest estimate indicates a potential increase of 22.3%, while the most optimistic estimate suggests a 122.3% upside [1] - A low standard deviation indicates a high degree of agreement among analysts regarding the stock's price movement direction [4] Earnings Estimates and Analyst Sentiment - Analysts are optimistic about AKRO's earnings prospects, as indicated by a trend of upward revisions in earnings estimates, which correlates with potential stock price increases [5] - Over the last 30 days, one estimate has increased, leading to a 0.2% rise in the Zacks Consensus Estimate [5] - AKRO holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors [5] Caution on Price Targets - While price targets are often sought after, their reliability is questioned, as they can mislead investors [2][3] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [3] - Investors should treat price targets with skepticism and not rely solely on them for investment decisions [4]

SOUTH SAN FRANCISCO, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease, will hold an investor conference on Monday, March 4 at 8:00 a.m. ET to share results after 96 weeks of treatment for its HARMONY study, a double-blind, placebo-controlled Phase 2b study evaluating the efficacy of efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated stea ...

Core Insights - Akero Therapeutics reported its fourth quarter and full year financial results for 2023, highlighting advancements in its clinical programs for metabolic diseases, particularly MASH [1][4]. Clinical Development - The company initiated dosing for the first patients in two Phase 3 SYNCHRONY studies targeting pre-cirrhotic MASH, with results from a Phase 2b study expected in the first half of 2024 [1][2]. - The SYNCHRONY Histology study aims to evaluate the safety and efficacy of EFX in improving liver fibrosis after 52 weeks, supporting an application for accelerated approval [2]. - The SYNCHRONY Real-World study will assess EFX's safety in patients with non-invasively diagnosed MASH, while the SYNCHRONY Outcomes study will focus on patients with compensated cirrhosis, expected to start in early 2024 [2]. Financial Performance - Akero's cash and marketable securities totaled $569.3 million as of December 31, 2023, sufficient to fund operations into 2026 [4]. - Research and development expenses increased significantly to $141.8 million for the year, up from $85.3 million in 2022, driven by ongoing clinical trials and related activities [5]. - General and administrative expenses also rose to $31.1 million for the year, compared to $29.9 million in 2022, reflecting higher personnel and operational costs [5]. Product Candidate Overview - Efruxifermin (EFX) is Akero's lead candidate, designed to address MASH by reducing liver fat, inflammation, and fibrosis while improving insulin sensitivity [6]. - EFX is engineered to provide a balanced biological activity profile similar to native FGF21, with a convenient once-weekly dosing regimen [6]. Disease Context - MASH is projected to affect over 25 million Americans by 2030, with no approved treatments currently available, making it a significant area of unmet medical need [7]. - The condition can lead to severe complications, including cirrhosis and liver cancer, highlighting the urgency for effective therapies [7]. Company Overview - Akero Therapeutics is focused on developing treatments for serious metabolic diseases, with a particular emphasis on MASH, which lacks approved therapies [8]. - The company is headquartered in South San Francisco and is advancing multiple clinical trials to address this critical health issue [8].

Company Overview & Business Update Akero Therapeutics provides Q4 and full-year 2023 financial results and business updates, highlighting EFX's progress in MASH treatment [Introduction and CEO Commentary](index=1&type=section&id=Introduction%20and%20CEO%20Commentary) Akero Therapeutics announced Q4 and full-year 2023 financial results and business updates, with the CEO emphasizing EFX's MASH treatment progress, including two Phase 3 SYNCHRONY studies initiated and a third planned for H1 2024, alongside IIb HARMONY results - Akero Therapeutics initiated two Phase 3 SYNCHRONY studies in December 2023 to evaluate EFX for MASH patients[2](index=2&type=chunk) - The company expects to report second on-treatment biopsy results from the Phase 2b HARMONY study in H1 2024 and launch a third Phase 3 SYNCHRONY study for MASH-related cirrhosis patients[2](index=2&type=chunk) [About Akero Therapeutics](index=2&type=section&id=About%20Akero%20Therapeutics) Akero Therapeutics is a clinical-stage company focused on developing innovative therapies for severe metabolic diseases like MASH, with its lead candidate EFX in two Phase 3 trials and a third planned for H1 2024 - Akero Therapeutics is a clinical-stage company dedicated to developing transformative therapies for severe metabolic diseases such as MASH[9](index=9&type=chunk) - The company's lead candidate, EFX, is currently in two Phase 3 clinical trials (SYNCHRONY Histology and SYNCHRONY Real-World), with a third Phase 3 trial (SYNCHRONY Outcomes) planned for H1 2024[9](index=9&type=chunk)[10](index=10&type=chunk) [About Efruxifermin (EFX)](index=2&type=section&id=About%20Efruxifermin%20%28EFX%29) Efruxifermin (EFX) is Akero Therapeutics' lead candidate for MASH, an Fc-FGF21 fusion protein designed to comprehensively address MASH pathology by reducing liver fat and inflammation, reversing fibrosis, and improving insulin sensitivity and lipids, showing good tolerability in trials - EFX is Akero's lead candidate for MASH, an Fc-FGF21 fusion protein designed to mimic the balanced biological activity of natural FGF21[7](index=7&type=chunk) - EFX aims to reduce liver fat and inflammation, reverse fibrosis, improve insulin sensitivity, and enhance lipid profiles to comprehensively address the complex pathology of MASH[7](index=7&type=chunk) - EFX is designed for once-weekly administration and has been generally well-tolerated in clinical trials to date[7](index=7&type=chunk) [About MASH](index=2&type=section&id=About%20MASH) MASH, a severe form of MASLD, is projected to affect over 25 million Americans by 2030, characterized by excessive liver fat, inflammation, and fibrosis, with no approved treatments and being a leading cause of liver transplants and cancer - MASH is a severe form of MASLD, projected to affect over **25 million Americans by 2030**[8](index=8&type=chunk) - MASH is characterized by excessive liver fat accumulation, leading to hepatocyte damage, inflammation, and fibrosis, potentially progressing to cirrhosis, liver failure, cancer, and death[8](index=8&type=chunk) - There are currently no approved treatments for MASH, and it is the fastest-growing cause of liver transplants and liver cancer in the U.S. and Europe[8](index=8&type=chunk) Clinical Program Updates Akero Therapeutics provides updates on its clinical programs, including the ongoing Phase 3 SYNCHRONY trials for EFX in MASH and anticipated results from Phase 2b studies [Phase 3 SYNCHRONY Program Update](index=1&type=section&id=Phase%203%20SYNCHRONY%20Program%20Update) Akero Therapeutics has initiated two of three Phase 3 SYNCHRONY clinical trials to evaluate EFX's safety and efficacy in various MASH patient populations, with the third trial planned for H1 2024, designed to support accelerated and full market approval using a pre-filled syringe - In December 2023, two of the three planned Phase 3 SYNCHRONY clinical trials enrolled their first patients[5](index=5&type=chunk) - The SYNCHRONY Histology study aims to evaluate the safety and efficacy of EFX in biopsy-confirmed pre-cirrhotic MASH (F2-F3) patients, with a primary endpoint supporting accelerated approval[5](index=5&type=chunk) - The SYNCHRONY Outcomes study, expected to launch in H1 2024, will assess the safety and efficacy of EFX in MASH-related compensated cirrhosis (F4) patients, potentially including dual primary endpoints for histological and clinical outcomes[5](index=5&type=chunk) [SYNCHRONY Histology](index=1&type=section&id=SYNCHRONY%20Histology) SYNCHRONY Histology evaluates EFX in pre-cirrhotic MASH (F2-F3) patients, with a primary endpoint of fibrosis improvement and MASH resolution to support accelerated approval - The SYNCHRONY Histology study evaluates 28mg and 50mg doses of EFX for safety and efficacy in biopsy-confirmed pre-cirrhotic MASH (F2-F3) patients[5](index=5&type=chunk) - The primary endpoint is a ≥1-stage improvement in fibrosis and MASH resolution after 52 weeks, designed to support an accelerated approval application for pre-cirrhotic MASH[5](index=5&type=chunk) [SYNCHRONY Real-World](index=1&type=section&id=SYNCHRONY%20Real-World) SYNCHRONY Real-World assesses EFX's safety and tolerability in non-invasively diagnosed MASH or MASLD patients, with results supporting safety evaluation for accelerated approval - The SYNCHRONY Real-World study evaluates the safety and tolerability of EFX in patients with non-invasively diagnosed MASH or MASLD[5](index=5&type=chunk) - Study results will support safety evaluations for inclusion in accelerated approval applications[5](index=5&type=chunk) [SYNCHRONY Outcomes](index=1&type=section&id=SYNCHRONY%20Outcomes) SYNCHRONY Outcomes, expected to start in H1 2024, will evaluate EFX in MASH-related compensated cirrhosis (F4) patients, potentially with dual primary endpoints for histological and clinical outcomes to support full market approval - The SYNCHRONY Outcomes study, anticipated to launch in H1 2024, will evaluate the safety and efficacy of EFX in patients with MASH-related compensated cirrhosis (F4)[5](index=5&type=chunk) - This trial may include two primary endpoints: histological assessment of liver fibrosis regression in a patient cohort after 96 weeks of treatment, and clinical outcome assessments to support full market approval[5](index=5&type=chunk) [EFX Administration Device](index=1&type=section&id=EFX%20Administration%20Device) All EFX Phase 3 studies will use a LyoJect 3S dual-chamber pre-filled syringe for self-administration, designed for commercial use post-approval, with an optimized formulation providing comparable EFX exposure - In all EFX Phase 3 studies, patients will self-administer using a LyoJect 3S dual-chamber pre-filled syringe, a device intended for commercial use upon EFX approval[5](index=5&type=chunk) - The optimized formulation provides EFX blood concentrations comparable to the liquid formulation used in previous clinical studies[5](index=5&type=chunk) [Phase 2b SYMMETRY Study Update](index=1&type=section&id=Phase%202b%20SYMMETRY%20Study%20Update) In the Phase 2b SYMMETRY study for MASH-related cirrhosis, EFX showed statistically significant improvements in MASH resolution and non-invasive markers of liver injury and fibrosis at week 36, despite not reaching statistical significance for fibrosis improvement, with overall good tolerability and 96-week results expected in Q1 2025 - In the 36-week analysis of the Phase 2b SYMMETRY study, EFX treatment groups (28mg and 50mg) showed a trend in liver fibrosis improvement without MASH worsening, but did not reach statistical significance (22% and 24% vs. 14% for placebo, respectively)[5](index=5&type=chunk) - Statistically significant MASH resolution rates were observed in the EFX treatment groups at week 36 (67% for 28mg, 60% for 50mg, vs. 26% for placebo)[9](index=9&type=chunk) - Statistically significant improvements were also observed in non-invasive markers of liver injury and fibrosis, insulin sensitivity, and lipoproteins in the EFX treatment groups[9](index=9&type=chunk) - EFX was generally well-tolerated, with the most common adverse events being transient Grade 1 or 2 gastrointestinal events[9](index=9&type=chunk) - Preliminary top-line results for histopathological and non-invasive measurements after 96 weeks of treatment in the SYMMETRY study are expected in Q1 2025[9](index=9&type=chunk) [Phase 2b HARMONY Study](index=1&type=section&id=Phase%202b%20HARMONY%20Study) The Phase 2b HARMONY study is evaluating EFX's efficacy in pre-cirrhotic MASH patients, with the company expecting to report second on-treatment biopsy results in H1 2024 - The company expects to report second on-treatment biopsy results from the Phase 2b HARMONY study, which targets pre-cirrhotic MASH patients, in H1 2024[2](index=2&type=chunk) Financial Results Akero Therapeutics reports its financial performance, highlighting cash position, increased R&D and G&A expenses, and overall net loss for Q4 and full-year 2023 [Full Year and Fourth Quarter 2023 Financial Highlights](index=2&type=section&id=Full%20Year%20and%20Fourth%20Quarter%202023%20Financial%20Highlights) As of December 31, 2023, Akero Therapeutics held $569.3 million in cash, cash equivalents, and marketable securities, projected to fund operations until 2026, with significant increases in R&D and G&A expenses in Q4 and full-year 2023 due to clinical trial advancements, manufacturing, personnel, and professional service costs Cash, Cash Equivalents, Short-Term and Long-Term Marketable Securities | Metric | December 31, 2023 (Millions USD) | December 31, 2022 (Millions USD) | | :--------------------------------- | :------------------------------- | :------------------------------- | | Cash, cash equivalents, short-term and long-term marketable securities | 569.3 | - | - Akero anticipates its cash, cash equivalents, short-term and long-term marketable securities will be sufficient to support its current operating plan through 2026[9](index=9&type=chunk) Operating Expenses | Expense Category | Q4 2023 (Millions USD) | Q4 2022 (Millions USD) | Full Year 2023 (Millions USD) | Full Year 2022 (Millions USD) | | :----------------- | :--------------------- | :--------------------- | :---------------------------- | :---------------------------- | | Research and development expenses | 53.4 | 18.3 | 141.8 | 85.3 | | General and administrative expenses | 8.5 | 7.1 | 31.1 | 29.9 | | **Total operating expenses** | **61.9** | **25.4** | **172.9** | **115.2** | - The increase in research and development expenses is primarily attributed to the ongoing Phase 2b HARMONY and SYMMETRY studies, the initiation of Phase 3 SYNCHRONY Histology and SYNCHRONY Real-World studies, manufacturing support for Phase 3 and potential market applications, and increased personnel costs[9](index=9&type=chunk) - The increase in general and administrative expenses is mainly due to higher personnel costs, professional services, and other expenses associated with operating as a public company[9](index=9&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Akero Therapeutics' total assets significantly increased to $580,271 thousand as of December 31, 2023, from $356,570 thousand at year-end 2022, primarily driven by higher cash, cash equivalents, and short-term marketable securities, with a corresponding rise in stockholders' equity to $535,306 thousand Condensed Consolidated Balance Sheets | Metric | December 31, 2023 (Thousands USD) | December 31, 2022 (Thousands USD) | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Cash, cash equivalents and short-term marketable securities | 550,010 | 351,449 | | Other current assets | 9,952 | 3,724 | | Non-current assets | 20,309 | 1,397 | | **Total assets** | **580,271** | **356,570** | | Current liabilities | 19,128 | 19,083 | | Non-current liabilities | 25,837 | 10,925 | | Stockholders' equity | 535,306 | 326,562 | | **Total liabilities and stockholders' equity** | **580,271** | **356,570** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Akero Therapeutics reported operating and net losses for both Q4 and full-year 2023, with the full-year net loss expanding to $151,759 thousand from $112,033 thousand in 2022, mainly due to substantial increases in R&D and G&A expenses, resulting in a basic and diluted net loss per share of $2.89 for the full year Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric | Q4 2023 (Thousands USD) | Q4 2022 (Thousands USD) | Full Year 2023 (Thousands USD) | Full Year 2022 (Thousands USD) | | :--------------------------------- | :---------------------- | :---------------------- | :----------------------------- | :----------------------------- | | Research and development expenses | 53,392 | 18,320 | 141,798 | 85,284 | | General and administrative expenses | 8,481 | 7,100 | 31,072 | 29,872 | | **Total operating expenses** | **61,873** | **25,420** | **172,870** | **115,156** | | Operating loss | (61,873) | (25,420) | (172,870) | (115,156) | | Interest expense | (897) | (362) | (3,099) | (739) | | Interest and other income, net | 7,584 | 2,723 | 24,210 | 3,862 | | **Net loss** | **(55,186)** | **(23,059)** | **(151,759)** | **(112,033)** | | Comprehensive loss | (54,410) | (23,022) | (151,526) | (111,969) | | Basic and diluted net loss per share | (0.99) | (0.49) | (2.89) | (2.87) | | Weighted-average shares used to compute net loss per share | 55,717,726 | 46,760,783 | 52,568,159 | 38,984,772 | Forward-Looking Statements This press release contains forward-looking statements under the Private Securities Litigation Reform Act of 1995, concerning Akero Therapeutics' future milestones, business plans, EFX's potential therapeutic effects, Phase 3 SYNCHRONY program design, and new formulation use plans [Forward Looking Statements](index=3&type=section&id=Forward%20Looking%20Statements) This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, regarding Akero Therapeutics' future milestones, business plans, EFX's potential therapeutic effects, Phase 3 SYNCHRONY program design, and new formulation use plans, which are subject to risks and uncertainties that could cause actual results to differ materially - Statements in this press release constitute forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, concerning Akero's future milestones, business plans, and the potential therapeutic effects of EFX[11](index=11&type=chunk) - Forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from expectations, including risks related to the success of product candidate development activities and clinical trials, regulatory developments, funding capabilities, and the ability to enroll patients in the Phase 3 SYNCHRONY studies[11](index=11&type=chunk) Investor & Media Contacts Contact information for investor and media inquiries regarding Akero Therapeutics [Investor Contact](index=3&type=section&id=Investor%20Contact) Investors can contact Christina Tartaglia for further information - Investor Contact: Christina Tartaglia, Phone: 212.362.1200, Email: IR@akerotx.com[12](index=12&type=chunk) [Media Contact](index=3&type=section&id=Media%20Contact) Media can contact Sarah O'Connell for further information - Media Contact: Sarah O'Connell, Phone: 732.456.0092, Email: sarah.oconnell@vergescientific.com[12](index=12&type=chunk)

PART I [Business](index=9&type=section&id=Item%201.%20Business) Akero Therapeutics is a clinical-stage company developing efruxifermin (EFX) for MASH, with a global Phase 3 program initiated after positive Phase 2b results - Akero is a clinical-stage company focused on developing treatments for MASH, with its lead product candidate being **efruxifermin (EFX)**, an analog of fibroblast growth factor 21 (FGF21)[27](index=27&type=chunk) - The company's Phase 3 program, SYNCHRONY, began enrollment in December 2023 and consists of three trials: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes, targeting both pre-cirrhotic and cirrhotic MASH[33](index=33&type=chunk) - EFX has received **Fast Track** and **Breakthrough Therapy** designations from the FDA, and a **PRIME designation** from the EMA, highlighting its potential to address a high unmet medical need in MASH treatment[34](index=34&type=chunk) - Akero acquired exclusive global development and commercialization rights to EFX from Amgen Inc. in June 2018, with patent protection potentially extending up to **2034** in the U.S., and potential extensions to **2045**[36](index=36&type=chunk) [Overview](index=9&type=section&id=Overview) Akero Therapeutics is developing EFX for MASH, with Phase 2b trials showing significant fibrosis regression and MASH resolution, leading to a global Phase 3 program Phase 2b HARMONY Study (Pre-Cirrhotic MASH, F2-F3) Week 24 Results | Endpoint | Placebo (%) | EFX 28mg (%) | EFX 50mg (%) | | :--- | :--- | :--- | :--- | | **≥1-Stage Fibrosis Improvement w/o Worsening MASH** | 20 | 39 | 41 | | **MASH Resolution w/o Worsening Fibrosis** | 15 | 47 | 76 | | **Combined Fibrosis Improvement & MASH Resolution** | 5 | 29 | 41 | Phase 2b SYMMETRY Study (Cirrhosis, F4) Week 36 Results | Endpoint | Placebo (%) | EFX 28mg (%) | EFX 50mg (%) | | :--- | :--- | :--- | :--- | | **≥1-Stage Fibrosis Improvement w/o Worsening MASH** | 14 | 22 | 24 | | **MASH Resolution w/o Worsening Fibrosis** | 26 | 67 (Statistically Significant) | 60 (Statistically Significant) | - EFX has been generally well-tolerated in clinical trials, with most adverse events being mild or moderate, primarily gastrointestinal issues and injection site reactions, and low discontinuation rates due to treatment-emergent adverse events[32](index=32&type=chunk) [Our Strategy](index=12&type=section&id=Our%20Strategy) Akero's strategy focuses on advancing EFX for MASH through clinical development, scaling manufacturing, preparing for U.S. commercialization, and expanding its pipeline - Advance EFX through clinical development for both pre-cirrhotic (F2-F3) and cirrhotic (F4, compensated) MASH, leveraging promising Phase 2b data[39](index=39&type=chunk) - Scale manufacturing with partners Boehringer Ingelheim and Vetter Pharma, and prepare for commercialization in the U.S. while exploring strategic collaborations for other key markets[40](index=40&type=chunk) - Explore EFX for additional metabolic disease indications and build a broader pipeline through development, acquisition, or in-licensing of new product candidates[41](index=41&type=chunk)[42](index=42&type=chunk) [MASH Overview](index=13&type=section&id=MASH%20Overview) MASH is a severe, progressive liver disease with no approved therapies, driven by obesity, and EFX aims to address its metabolic drivers and fibrosis - MASH is a severe form of MASLD, leading to liver inflammation and fibrosis that can progress to cirrhosis and liver failure, closely linked to the global obesity epidemic[45](index=45&type=chunk) - The prevalence of MASH with advanced fibrosis (F2-F4) in the U.S. is projected to grow from **6.7 million** in 2016 to **14.1 million** by 2030[46](index=46&type=chunk) - Currently, there are no approved therapies for MASH, with the standard of care being diet and exercise, but adherence is low; one investigational drug, resmetirom, has completed Phase 3 trials and could be approved in March 2024[53](index=53&type=chunk)[56](index=56&type=chunk) [Clinical Evaluation of EFX](index=18&type=section&id=Clinical%20Evaluation%20of%20EFX) EFX is in a comprehensive Phase 3 SYNCHRONY program for MASH, building on positive Phase 2b results showing significant fibrosis improvement and MASH resolution - The Phase 3 SYNCHRONY program consists of three trials: SYNCHRONY Histology for pre-cirrhotic MASH (F2-F3), SYNCHRONY Real-World for non-invasively diagnosed MASH, and SYNCHRONY Outcomes for cirrhosis due to MASH[69](index=69&type=chunk)[71](index=71&type=chunk) HARMONY Study (F2-F3 MASH) Week 24 Histology Results | Endpoint | Placebo (%) | EFX 28mg (%) | EFX 50mg (%) | | :--- | :--- | :--- | :--- | | **≥1-Stage Fibrosis Improvement w/o Worsening MASH** | 20 | 39 | 41 | | **MASH Resolution w/o Worsening Fibrosis** | 15 | 47 | 76 | SYMMETRY Study (F4 MASH) Week 36 Histology Results | Endpoint | Placebo (%) | EFX 28mg (%) | EFX 50mg (%) | | :--- | :--- | :--- | :--- | | **≥1-Stage Fibrosis Improvement w/o Worsening MASH** | 14 | 22 | 24 | | **MASH Resolution w/o Worsening Fibrosis** | 26 | 67 (p<0.001) | 60 (p<0.001) | - In a study combining EFX with GLP-1 therapy (Cohort D), patients achieved a statistically significant **65% relative reduction in liver fat** compared to a **10% reduction** for GLP-1 alone after 12 weeks[31](index=31&type=chunk)[137](index=137&type=chunk) [Intellectual Property and Commercialization](index=35&type=section&id=Intellectual%20Property%20and%20Commercialization) Akero's commercial success depends on its exclusive EFX license, patent protection, third-party manufacturing, and U.S. commercialization strategy in a competitive MASH market - Akero has an exclusive global license agreement with Amgen for EFX, which includes milestone payments up to **$105 million** and tiered royalties on net sales[141](index=141&type=chunk)[143](index=143&type=chunk) - As of February 14, 2024, the EFX patent portfolio includes **209 issued patents** and **17 pending applications** worldwide, with U.S. patents expected to expire in **2029** but potentially extendable to **2034**[147](index=147&type=chunk)[148](index=148&type=chunk) - The company relies on external CMOs for manufacturing: Boehringer Ingelheim for drug substance and Vetter Pharma for the drug product, including a new lyophilized drug-device combination for Phase 3 trials[151](index=151&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk) - The company faces intense competition from numerous multinational pharmaceutical and biotechnology companies developing therapies for MASH[155](index=155&type=chunk)[156](index=156&type=chunk) [Government Regulation](index=41&type=section&id=Government%20Regulation) Akero's operations are subject to extensive FDA and international regulations, covering EFX development, expedited approval, manufacturing, and post-market compliance, including data privacy - Biological products in the U.S. are regulated by the FDA under the FD&C Act and PHS Act, requiring a multi-step process including nonclinical studies, an effective IND, three phases of clinical trials, and an approved BLA before marketing[161](index=161&type=chunk) - The FDA has various expedited programs to facilitate development of drugs for serious conditions, including **Fast Track**, **Breakthrough Therapy**, accelerated approval, and priority review, which can offer benefits like more frequent FDA interaction and faster review times[180](index=180&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk)[183](index=183&type=chunk) - EFX is considered a combination product (biologic and device), which requires coordinated review by different FDA centers and compliance with both cGMP for biologics and Quality System Regulation (QSR) for devices[197](index=197&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk) - Operations are also subject to healthcare laws like the Anti-Kickback Statute and False Claims Act, as well as data privacy regulations such as HIPAA in the U.S. and GDPR in Europe, which impose stringent requirements and penalties for non-compliance[200](index=200&type=chunk)[201](index=201&type=chunk)[249](index=249&type=chunk) [Risk Factors](index=73&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from EFX's sole product dependence, clinical development uncertainties, third-party manufacturing, intense competition, regulatory hurdles, and substantial capital needs - The company is heavily dependent on the success of EFX, its only product candidate; any failure in its development, approval, or commercialization would significantly harm the business[299](index=299&type=chunk) - Clinical development is fraught with risks, including difficulties in patient enrollment for MASH trials, potential for trial delays or failures, and substantial competition for recruiting patients[265](index=265&type=chunk)[266](index=266&type=chunk)[273](index=273&type=chunk) - Manufacturing of EFX is complex and relies on third-party contractors, creating risks related to production difficulties, supply chain disruptions, and compliance with cGMP standards[285](index=285&type=chunk)[293](index=293&type=chunk) - The company has a history of significant financial losses (**$151.8 million** in 2023) and expects to incur losses for the foreseeable future, requiring substantial additional capital that may not be available on acceptable terms[436](index=436&type=chunk)[442](index=442&type=chunk) - The regulatory approval process is lengthy, costly, and unpredictable, with no guarantee of obtaining approval for EFX, and even if approved, it will be subject to extensive ongoing regulatory scrutiny[372](index=372&type=chunk)[386](index=386&type=chunk) [Unresolved Staff Comments](index=126&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[502](index=502&type=chunk) [Cybersecurity](index=126&type=section&id=Item%201C.%20Cybersecurity) The company's cybersecurity risk management, supported by third parties and overseen by the Audit Committee, has identified no material incidents to date - The company's cybersecurity risk management program is supported by third parties and overseen by the Audit Committee of the Board of Directors[503](index=503&type=chunk)[505](index=505&type=chunk) - The Chief Operating Officer, supported by the Senior Director of IT, is responsible for assessing and managing cybersecurity risk[505](index=505&type=chunk) - The company has not identified any cybersecurity incidents or threats that have had or are reasonably likely to have a material effect on the business[506](index=506&type=chunk) [Properties](index=126&type=section&id=Item%202.%20Properties) The company leases 6,647 square feet of office space in South San Francisco for its headquarters, sufficient until July 2027 - The company leases **6,647 square feet** of office space in South San Francisco, California, which serves as its corporate headquarters[507](index=507&type=chunk) [Legal Proceedings](index=126&type=section&id=Item%203.%20Legal%20Proceedings) As of December 31, 2023, Akero Therapeutics was not a party to any legal proceedings expected to have a material adverse impact - As of December 31, 2023, the company was not party to any legal proceedings expected to have a material adverse impact[508](index=508&type=chunk) [Mine Safety Disclosures](index=127&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[509](index=509&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=127&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Akero's common stock trades on Nasdaq under "AKRO" since June 2019, with no cash dividends paid, and a performance graph is included - The company's common stock began trading on the Nasdaq Global Select Market under the symbol "**AKRO**" on June 20, 2019[510](index=510&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future, retaining all funds for business development[513](index=513&type=chunk) Cumulative Total Shareholder Return Comparison | Company/Index | 6/20/2019 | 12/31/2019 | 12/31/2020 | 12/31/2021 | 12/31/2022 | 12/31/2023 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Akero Therapeutics, Inc.** | $100.00 | $138.72 | $161.25 | $132.19 | $342.50 | $145.94 | | **Nasdaq Composite Index** | $100.00 | $111.44 | $160.08 | $194.32 | $130.00 | $186.45 | | **Nasdaq Biotechnology Index** | $100.00 | $110.89 | $139.37 | $138.49 | $123.38 | $127.99 | [Reserved](index=129&type=section&id=Item%206.%20Reserved) This item is not applicable - Not applicable[522](index=522&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=130&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Akero reported a **$151.8 million net loss** in 2023, driven by increased R&D for EFX Phase 3, with **$569.3 million cash** expected to fund operations into 2026 Results of Operations (Years ended Dec 31, in thousands) | (in thousands) | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | **Research and development** | $141,798 | $85,284 | $81,759 | | **General and administrative** | $31,072 | $29,872 | $19,127 | | **Total operating expenses** | $172,870 | $115,156 | $100,886 | | **Loss from operations** | ($172,870) | ($115,156) | ($100,886) | | **Net loss** | ($151,759) | ($112,033) | ($100,777) | - The **$56.5 million increase** in R&D expenses in 2023 was primarily due to a **$27.9 million increase** in CRO expenses for clinical trials, an **$18.3 million increase** in manufacturing expenses for EFX, and a **$7.5 million milestone payment** to Amgen[542](index=542&type=chunk) - As of December 31, 2023, the company had **$569.3 million** in cash, cash equivalents, and marketable securities, which is expected to fund operations into **2026**[531](index=531&type=chunk) Cash Flow Summary (Years ended Dec 31, in thousands) | (in thousands) | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | **Net cash used in operating activities** | ($145,367) | ($92,517) | ($79,681) | | **Net cash (used in) provided by investing activities** | ($223,623) | ($63,825) | $42,280 | | **Net cash provided by financing activities** | $353,316 | $255,632 | $602 | [Quantitative and Qualitative Disclosures About Market Risk](index=143&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exposed to interest rate risk on its **$569.3 million investment portfolio** and term loan, with foreign currency and inflation risks currently not material - The company is exposed to interest rate risk on its **$569.3 million** portfolio of cash, cash equivalents, and marketable securities, as well as its variable interest rate term loan[582](index=582&type=chunk)[584](index=584&type=chunk) - Foreign currency risk exists due to some transactions in Euros and British Pounds, but a hypothetical **10% change** in exchange rates is not expected to have a material impact[585](index=585&type=chunk) - Inflation has not had a material effect to date, but rising rates could negatively impact future costs for clinical trials, manufacturing, and labor[586](index=586&type=chunk) [Financial Statements and Supplementary Data](index=145&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the company's audited consolidated financial statements for 2021-2023, including an unqualified opinion from Deloitte & Touche LLP - The independent auditor, Deloitte & Touche LLP, issued an **unqualified opinion** on the financial statements and the company's internal control over financial reporting[592](index=592&type=chunk)[593](index=593&type=chunk) Consolidated Balance Sheet Highlights (as of Dec 31, 2023, in thousands) | Account | Amount (in thousands) | | :--- | :--- | | **Total Assets** | **$580,271** | | Cash, cash equivalents, & marketable securities | $569,373 | | **Total Liabilities** | **$44,965** | | Loan payable, noncurrent | $24,964 | | **Total Stockholders' Equity** | **$535,306** | Consolidated Statement of Operations Highlights (Year ended Dec 31, 2023, in thousands) | Account | Amount (in thousands) | | :--- | :--- | | **Total operating expenses** | $172,870 | | **Loss from operations** | ($172,870) | | **Net loss** | ($151,759) | | **Net loss per share** | ($2.89) | - The critical audit matter identified by the auditor relates to the estimation of accrued and prepaid research and development expenses for services performed by CROs and CMOs[597](index=597&type=chunk)[599](index=599&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=182&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[752](index=752&type=chunk) [Controls and Procedures](index=182&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with an unqualified opinion from Deloitte & Touche LLP - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2023[753](index=753&type=chunk) - Based on the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[756](index=756&type=chunk) - The independent registered public accounting firm, Deloitte & Touche LLP, issued an **unqualified opinion** on the effectiveness of the company's internal control over financial reporting as of December 31, 2023[761](index=761&type=chunk) - There were no changes in internal control over financial reporting during the fourth quarter of 2023 that materially affected, or are reasonably likely to materially affect, internal controls[758](index=758&type=chunk) [Other Information](index=185&type=section&id=Item%209B.%20Other%20Information) The company amended its loan agreement to **$150.0 million** on February 28, 2024, and the COO adopted a Rule 10b5-1 trading plan in Q4 2023 - On February 28, 2024, the company amended its loan agreement with Hercules Capital, Inc. to increase total available borrowings to **$150.0 million**[768](index=768&type=chunk) - On December 27, 2023, Jonathan Young, Chief Operating Officer, adopted a Rule 10b5-1 trading plan for the sale of up to **30,000 securities**[771](index=771&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=185&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[772](index=772&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=185&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2024 Proxy Statement, and a Code of Business Conduct is available - The information required for this item is incorporated by reference from the company's definitive Proxy Statement for its 2024 annual meeting of shareholders[773](index=773&type=chunk) - The company has adopted a Code of Business Conduct and Ethics, which is available on its website[774](index=774&type=chunk) [Executive Compensation](index=186&type=section&id=Item%2011.%20Executive%20Compensation) The information required for this item concerning executive compensation is incorporated by reference from the company's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders - The information required for this item is incorporated by reference from the company's definitive Proxy Statement for its 2024 annual meeting of shareholders[776](index=776&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=186&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) The information required for this item concerning security ownership is incorporated by reference from the company's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders - The information required for this item is incorporated by reference from the company's definitive Proxy Statement for its 2024 annual meeting of shareholders[777](index=777&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=186&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The information required for this item concerning certain relationships, related transactions, and director independence is incorporated by reference from the company's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders - The information required for this item is incorporated by reference from the company's definitive Proxy Statement for its 2024 annual meeting of shareholders[778](index=778&type=chunk) [Principal Accounting Fees and Services](index=186&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) The information required for this item concerning principal accounting fees and services is incorporated by reference from the company's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders - The information required for this item is incorporated by reference from the company's definitive Proxy Statement for its 2024 annual meeting of shareholders[779](index=779&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=186&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists consolidated financial statements, confirms no schedules, and provides an index of all required exhibits filed with the Form 10-K - This section lists the consolidated financial statements, confirms no schedules are submitted, and provides an index of all required exhibits filed with the report[780](index=780&type=chunk) [Form 10-K Summary](index=186&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company has elected not to include a summary of the Form 10-K - The Company has elected not to include summary information[780](index=780&type=chunk)

Shares of Akero Therapeutics, Inc. (AKRO) have been struggling lately and have lost 5.9% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullish ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Akero Therapeutics, Inc. (AKRO) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out.Akero Therapeutics, Inc. is one of 1074 individual stocks in the Medical sector. Collectively, these companies sit at #10 in the Z ...

The shares of Akero Therapeutics Inc (NASDAQ:AKRO) have been steadily climbing from their November lows following a steep early October bear gap, though pressure seems to have appeared at the $25 level. Plus, if past is precedent, the biotech name could be headed for a short-term dip. AKRO's recent rally took it within one standard deviation of its 80-day moving average, a trendline with historically bearish implications. According to Schaeffer's Senior Quantitative Analyst Rocky White, the equity stock has ...