SOUTH SAN FRANCISCO, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will present at the BofA Securities 2025 Health Care Conference on Tuesday, May 13, 2025, at 1:40 p.m. P.T. A live webcast of the Company presentation will be available through the investor relations section of the Company's website ...

SOUTH SAN FRANCISCO, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced two oral presentations and an upcoming poster presentation at the European Association for the Study of the Liver (EASL) Congress 2025 taking place May 7-10, 2025, in Amsterdam, the Netherlands. Details for the presentations are as follows: Oral p ...

Efruxifermin (EFX) Efficacy and Safety - Efruxifermin (EFX) demonstrated unprecedented fibrosis improvement after 96 weeks of treatment, with a 39% improvement in completer analysis versus 15% for placebo[10]. - The Phase 2b SYMMETRY study reported the first-ever statistically significant reversal of cirrhosis, with 29% of patients showing improvement compared to 12% for placebo[10]. - 50mg EFX treatment resulted in a 50% improvement in fibrosis with no worsening of MASH at Week 96, compared to 12% in the placebo group[57]. - 70% of patients receiving EFX 28mg and 50mg achieved MASH resolution at Week 96, significantly higher than the 13% in the placebo group[68]. - EFX 50mg achieved a 75% response rate for ≥1 stage fibrosis improvement at Week 96, significantly higher than the placebo[121]. - EFX 50mg demonstrated a 23% improvement in fibrosis at Week 96 compared to 2% in the placebo group, with statistical significance (p<0.01)[130]. - 68% of patients with F3 fibrosis at baseline showed ≥2 stage improvement in fibrosis with EFX 50mg, while only 14% in the placebo group achieved this[137]. - EFX 50mg resulted in a 60% rate of ≥1 stage fibrosis improvement and MASH resolution at Week 96, significantly higher than the 9% in the placebo group (p<0.01)[152]. - EFX 50mg treatment group achieved a significant liver fat reduction of 65% compared to a 9% reduction in the placebo group at Week 12, p<0.001[186]. - 90% of patients in the EFX 50mg group achieved a ≥50% relative reduction in liver fat, compared to 10% in the placebo group, p<0.001[192]. - The EFX 50mg group showed a reduction in liver stiffness by 2.7 kPa, while the placebo group showed no significant change[196]. - EFX 50mg treatment resulted in a decrease in ALT levels from a baseline of 35 U/L to a reduction of 5.3 U/L, while the placebo group showed an increase[200]. Clinical Trials and Study Design - The Phase 3 SYNCHRONY program is actively enrolling patients, with a total of approximately 3,500 participants across three studies focusing on different fibrosis stages[24]. - The SYNCHRONY program includes a comprehensive evaluation of safety, tolerability, and efficacy, with primary endpoints focused on fibrosis improvement and MASH resolution[24]. - The company plans to report results for the primary endpoints of the SYNCHRONY studies in the first half of 2026 and 2027[25]. - The Phase 3 studies are expected to provide critical data on the long-term clinical outcomes and safety of EFX in a broad patient population[24]. - The total treatment duration for the Phase 3 SYNCHRONY trial is approximately 260 weeks, with a randomization of 1:1 for EFX 50mg and placebo[96]. - The study included a total of 1150 patients, with a focus on compensated cirrhosis due to MASH[96]. Safety and Adverse Events - Treatment-emergent adverse events (TEAEs) leading to discontinuation were 3% in placebo, 11% in EFX 28mg, and 18% in EFX 50mg[71]. - The most frequent drug-related treatment-emergent adverse events (TEAEs) included diarrhea (40% for EFX 28mg and 37% for EFX 50mg)[158]. - No deaths were reported in any treatment group, with serious adverse events occurring in 9% of placebo, 10% of EFX 28mg, and 16% of EFX 50mg groups[158]. - 33% of patients in the EFX 50mg group experienced nausea as a treatment-emergent adverse event, compared to 10% in the placebo group[183]. - 5% of patients in the EFX 50mg group discontinued treatment due to drug-related adverse events[183]. Demographics and Baseline Characteristics - As of December 31, 2024, the company has approximately $800 million in cash, sufficient to fund the Phase 3 SYNCHRONY studies through their primary endpoints into the second half of 2027[36]. - The baseline demographics showed that 82% of patients had type 2 diabetes, with an average age of 61 years across the study population[49]. - The baseline demographics indicated that 70% of the placebo group had fibrosis stage F3, while the EFX 50mg group had 63%[110]. - The baseline hepatic fat fraction was 11% in the EFX 50mg group compared to 15% in the placebo group[179]. - 76% of patients in the EFX 50mg group were on Metformin, compared to 70% in the placebo group[181].

Core Viewpoint - Mid-cap stocks, while less prominent than large caps, exhibit significant volatility that can create substantial investment opportunities for those willing to take on risk [1][10]. Group 1: H&E Equipment Services - H&E Equipment Services Inc. (NASDAQ: HEES) has experienced a remarkable 120% increase since mid-January, largely due to acquisition rumors from Herc Holdings Inc. (NYSE: HRI) at a price of $104.89 per share [2][3]. - The stock closed at $98, approximately 7% below the rumored buyout price, presenting a potential low-risk arbitrage opportunity for traders [3]. - Analysts forecast a 12-month price target of $71.33, indicating a downside of 25.69%, with a high forecast of $92.00 and a low of $60.00 [2]. Group 2: Oklo - Oklo Inc. (NYSE: OKLO) has seen a pullback of over 30% after a significant rally, driven by initial optimism regarding its potential for cheap and clean nuclear power [4][5]. - The stock's forecast indicates a 12-month price target of $44.50, representing a 37.66% upside, with a high of $58.00 and a low of $31.00 [4]. - The recent decline may serve as a necessary reset, with expectations for a more measured recovery rather than the previous extreme volatility [6]. Group 3: Akero Therapeutics - Akero Therapeutics Inc. (NASDAQ: AKRO) has maintained a 140% gain since mid-January, supported by strong Phase 2b trial results for its MASH drug, targeting a lucrative market [7][8]. - The stock has a 12-month price forecast of $75.86, suggesting a 58.86% upside, with a high forecast of $109.00 and a low of $38.00 [7]. - Institutional support is evident, with Bank of America upgrading the stock to a Buy and setting a new price target of $63, indicating over 20% upside from its recent closing price of $52 [9].

Financial Performance - The company reported net losses of $252.1 million, $151.8 million, and $112.0 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $826.2 million as of December 31, 2024[528]. - The net loss for the year ended December 31, 2024, was $252.1 million, compared to a net loss of $151.8 million in 2023, reflecting a 66% increase in losses[545]. - The comprehensive loss for 2024 was $251,382,000, compared to $151,526,000 in 2023, representing a 65.9% increase[610]. - The company's accumulated deficit grew to $826,156,000 in 2024, compared to $574,096,000 in 2023, an increase of 44.0%[608]. - The company has not generated any revenue since inception and does not expect to do so in the near future[533]. Capital and Funding - The company has raised capital through various means, including a $25.0 million equity investment from Pfizer, Inc. in 2022 and a $35.0 million term loan from Hercules Capital, Inc.[528]. - The company raised gross proceeds of $127.4 million in 2023 and $80.3 million in 2024 through common stock offerings, with an additional $402.5 million raised in January 2025[557]. - The company raised $344.84 million from a follow-on public offering in 2024, compared to $216.20 million in 2023[617]. - The company anticipates requiring additional funding to complete the clinical development and commercialization of EFX, pending regulatory approval[625]. - The company has outstanding borrowings of $35.0 million under a loan agreement with Hercules, with the potential to borrow an additional $30.0 million until June 15, 2025[569]. Research and Development - The Phase 3 SYNCHRONY program consists of three trials evaluating EFX for patients with compensated cirrhosis (F4) and pre-cirrhotic MASH (F2-F3), with enrollment for the trials beginning in Q4 2023[525][526]. - The company anticipates significant increases in research and development expenses as it advances EFX through later-stage clinical development[535]. - Research and development expenses rose to $247.5 million in 2024, up from $141.8 million in 2023, marking a 75% increase, primarily due to increased costs associated with the EFX program[546]. - The company expects substantial increases in research and development expenses to support ongoing clinical development activities for the EFX program[547]. - The company has entered into various agreements for research and development, with costs recorded as expenses as incurred[641]. Clinical Trials and Product Development - In the SYMMETRY Phase 2b trial, 39% of patients treated with 50mg EFX experienced reversal of cirrhosis at week 96, compared to 15% for the placebo group[522]. - In the HARMONY Phase 2b trial, response rates for ≥1 stage improvement in fibrosis at week 96 were 75% for the 50mg EFX group and 46% for the 28mg EFX group, compared to 24% for placebo[523]. - EFX has shown statistically significant fibrosis regression and MASH resolution in previous Phase 2b trials with over 300 patients treated for up to 96 weeks[619]. - The first clinical milestone payment of $7.5 million was made to Amgen in December 2023, related to the Phase 3 SYNCHRONY program[576]. - The company is focused on developing treatments for metabolic diseases, particularly metabolic dysfunction-associated steatohepatitis (MASH)[619]. Operating Expenses - For the year ended December 31, 2024, total operating expenses increased to $285.4 million from $172.9 million in 2023, representing a 65% increase[545]. - Cash used in operating activities for 2024 was $230.1 million, significantly higher than $145.4 million in 2023, indicating increased operational expenditures[560]. - General and administrative expenses increased to $37.9 million in 2024 from $31.1 million in 2023, a rise of 22% due to higher stock-based compensation and staffing costs[548]. - Stock-based compensation expense was $29.7 million for the year ended December 31, 2024, compared to $21.5 million in 2023, showing an increase in compensation costs[583]. Liquidity and Assets - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $797.8 million, with an additional $402.5 million raised from a public offering in January 2025[532]. - Cash, cash equivalents, and marketable securities totaled $797.8 million as of December 31, 2024, providing a strong liquidity position for future operations[558]. - Total current assets increased to $770,380,000 as of December 31, 2024, up from $559,962,000 in 2023, representing a 37.5% increase[608]. - Cash and cash equivalents increased to $340,238,000 in 2024 from $234,207,000 in 2023, reflecting a 45.2% growth[608]. - The total fair value of short-term and long-term marketable securities was $771,683 as of December 31, 2024, up from $541,965 in 2023[667]. Stock and Equity - The weighted-average number of shares used in computing net loss per common share increased to 67,136,772 in 2024 from 52,568,159 in 2023, a rise of 27.7%[610]. - The company issued 12.65 million shares in a follow-on offering in 2024, contributing to an increase in total shares outstanding to 72.38 million[617]. - The company has reserved 577,089 options under the 2018 Stock Option and Grant Plan and 6,983,360 options under the 2019 Stock Option and Incentive Plan as of December 31, 2024[697]. - The total intrinsic value of stock options outstanding as of December 31, 2024, was $46,487,000, up from $35,133,000 at the end of 2023[710]. - Stock-based compensation classified within research and development expense for 2024 was $11,294,000, compared to $7,579,000 in 2023[717]. Debt and Liabilities - The Company has a Loan Payable under a Loan Agreement with Hercules Capital, with amendments made on June 7, 2023, and February 28, 2024[648]. - The total principal outstanding loan payable is $35,000,000, with an end of term charge of $2,048,000, leading to a total of $37,048,000 including the end of term charge[681]. - The Company reported accrued external research and development expenses of $28,925 as of December 31, 2024, compared to $10,041 in 2023[670]. - The Term Loan bears interest at a variable rate of at least 7.65% and matures on March 1, 2027[673]. - The company has a contingent liability to issue warrants for up to an additional 211,137 shares of common stock under the Loan Agreement as of December 31, 2024[681].

Core Insights - Akero Therapeutics reported significant advancements in its clinical programs for Efruxifermin (EFX), particularly in the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and compensated cirrhosis [2][5][13] Clinical Development - The Phase 2b SYMMETRY study demonstrated a statistically significant reversal of compensated cirrhosis (F4) in patients treated with 50mg EFX for 96 weeks, with 39% of patients showing ≥1 stage improvement in fibrosis [6][11] - The Phase 3 SYNCHRONY program is ongoing, consisting of three randomized, placebo-controlled trials aimed at evaluating the safety and efficacy of EFX in patients with MASH and compensated cirrhosis [10][13] - Preliminary results from the SYNCHRONY Real-World study, which enrolled 601 patients, are expected in the first half of 2026 [10] Financial Performance - For the year ended December 31, 2024, Akero reported cash, cash equivalents, and short- and long-term marketable securities totaling $797.8 million, with a follow-on offering raising $402.5 million in January 2025 [9][10] - Research and development expenses increased to $247.5 million for the year, up from $141.8 million in 2023, primarily due to costs associated with clinical trials [9][17] - The net loss for the year was $252.1 million, compared to a net loss of $151.8 million in 2023, reflecting increased operational expenses [17] Market Context - MASH is a serious condition affecting approximately 17 million Americans, with no approved treatments currently available, highlighting a significant unmet medical need [12][13] - The condition is the fastest-growing cause of liver transplants and liver cancer in the US and Europe, emphasizing the urgency for effective therapeutic options [12]

Akero Therapeutics, Inc. (NASDAQ:AKRO) - Grabar Law Office is investigating whether certain officers and directors of Akero breached their fiduciary duties owed to the company [1] - A securities fraud class action complaint alleges that Akero made false and misleading statements regarding the SYMMETRY study, including that approximately 20% of enrolled patients had cryptogenic cirrhosis and did not have definitive NASH at baseline [3] - The complaint also claims that the results from cryptogenic cirrhosis patients were to be excluded from the calculation of NASH resolution secondary endpoints, and that Akero introduced a confounding factor into the study's design [3] - Akero allegedly misrepresented the nature of the SYMMETRY trial and its usefulness in supporting any new drug application, impacting the likelihood of EFX becoming a commercial treatment for NASH cirrhotics [3] Crocs, Inc. (NASDAQ:CROX) - Grabar Law Office is investigating claims on behalf of shareholders of Crocs, Inc. regarding potential breaches of fiduciary duties by certain officers and directors [5] - A securities fraud class action complaint alleges that Crocs made materially false and misleading statements about the nature and sustainability of HEYDUDE's revenue growth following its acquisition [7] - The complaint indicates that the revenue growth was driven by stocking third-party wholesalers and retailers, and that destocking of excess inventory negatively impacted financial results [8] Extreme Networks, Inc. (NASDAQ:EXTR) - Grabar Law Office is investigating claims on behalf of Extreme Networks shareholders concerning potential breaches of fiduciary duties by certain officers [10] - A securities fraud class action complaint alleges that Extreme Networks made false and misleading statements regarding adverse client demand trends and the fulfillment of backlog orders [12] - The complaint states that Extreme Networks was drawing down its backlog at a faster rate than represented, leading to a misrepresentation of organic demand, revenue growth, and market share gains [12] Domino's Pizza, Inc. (NASDAQ:DPZ) - Grabar Law Office is investigating claims on behalf of Domino's shareholders regarding potential breaches of fiduciary duties by certain officers [14] - A securities fraud class action complaint alleges that Domino's made materially false and misleading statements about its business and financial prospects, particularly concerning challenges faced by its largest master franchisee [16] - The complaint suggests that Domino's was unlikely to meet its previously issued long-term guidance for annual global net store growth, leading to overstated business prospects [16]

Company Overview - Akero Therapeutics is focused on developing efruxifermin as a treatment for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [2][4] - Approximately 22 million patients in the U.S. are estimated to have MASH, with 9 million suffering from clinically significant liver disease [2] Clinical Trial Results - In a phase 2 study, efruxifermin demonstrated a statistically significant reversal of cirrhosis in patients with compensated cirrhosis, with 45% of participants not on GLP-1 drugs experiencing reversal compared to 17% in the placebo group [5][6] - Previous phase 2 studies had failed, but management believed longer treatment durations could yield better outcomes, which was validated by the recent results [5] Market Potential - With only one treatment (Rezdiffra) currently approved for MASH, there is substantial market opportunity for efruxifermin [4][6] - Rezdiffra is not indicated for cirrhosis patients, which positions efruxifermin favorably for potential accelerated approval due to the high unmet need [6][7] Regulatory Considerations - The FDA can grant accelerated approval based on phase 2 results, but post-marketing studies are required to confirm efficacy [7] - There is uncertainty regarding whether efruxifermin will receive accelerated approval, as past midstage successes do not guarantee late-stage success [7] Financial Implications - Following a significant share price increase of 97% on January 27, Akero announced a proposed public offering of stock to fund future clinical trials, which may dilute existing shareholders [8] - The reliance on efruxifermin as the sole pipeline candidate presents a risk; any clinical or regulatory setbacks could lead to a sharp decline in share value [9] Investment Outlook - The recent clinical results provide a strong basis for cautious optimism regarding Akero's prospects, particularly for investors willing to accept higher risk [10]

Core Insights - Akero Therapeutics, Inc. has successfully closed an underwritten public offering, raising approximately $402.5 million through the sale of 6,427,170 shares of common stock at a price of $48.00 per share, along with pre-funded warrants for 1,958,247 shares at a price of $47.9999 each [1] Company Overview - Akero Therapeutics is a clinical-stage company focused on developing transformative treatments for serious metabolic diseases, particularly metabolic dysfunction-associated steatohepatitis (MASH) [5] - The company's lead product candidate, efruxifermin (EFX), is currently undergoing evaluation in three Phase 3 clinical studies targeting different patient populations affected by MASH [5] - The ongoing SYNCHRONY program builds on previous Phase 2b clinical trials, indicating a robust pipeline and commitment to addressing high unmet medical needs in this therapeutic area [5] Offering Details - The offering included the full exercise of the underwriters' option to purchase an additional 1,093,750 shares, demonstrating strong demand for the company's stock [1] - J.P. Morgan, Morgan Stanley, and Jefferies served as joint book-running managers for the offering, with UBS Investment Bank acting as co-manager [2] - The securities were offered under an automatically effective shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) [3]

Core Viewpoint - Akero Therapeutics' shares surged 105.7% following the announcement of positive 96-week data from a mid-stage study of efruxifermin (EFX) for liver disease, indicating significant potential for the treatment of compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) [1][3]. Group 1: Study Results - In the SYMMETRY study, 39% of patients receiving 50mg EFX experienced cirrhosis reversal without worsening of MASH, compared to 15% in the placebo group [2]. - The Intent-to-Treat analysis showed that 29% of the 50mg EFX group achieved cirrhosis reversal without MASH worsening, versus approximately 12% in the placebo group [2]. - The effect size in the 50mg group increased from 10% at week 36 to 24% at week 96, demonstrating the advantages of extended EFX treatment [3]. Group 2: Safety and Tolerability - EFX was generally well tolerated in the study, with no deaths in the EFX group and only one in the placebo group due to pneumonia [6]. - No serious adverse events were linked to EFX, with the most common side effects being mild to moderate gastrointestinal issues that were temporary [6]. Group 3: Competitive Landscape - The positive results from Akero's study also positively impacted shares of rival company 89bio (ETNB), which saw a 33.5% increase in stock price [8]. - 89bio is developing pegozafermin for MASH and has initiated phase III studies for F2-F3 and F4 MASH patients [9]. - Madrigal Pharmaceuticals markets Rezdiffra as the first FDA-approved therapy for noncirrhotic MASH, with a regulatory application under review in the EU [11][12]. Group 4: Market Opportunity - Cirrhosis caused by MASH is a severe condition, with approximately 3 million Americans expected to have MASH-related cirrhosis by 2030, representing a significant market opportunity [13]. - Novo Nordisk is also evaluating semaglutide for MASH, with positive results from a pivotal phase III study and plans for regulatory filings in 2025 [14][15].