Akero(AKRO) - 2025 Q1 - Quarterly Results

Report Overview and Business Updates First Quarter 2025 Highlights Akero Therapeutics reported significant progress in Q1 2025, highlighted by statistically significant reversal of cirrhosis in its Phase 2b SYMMETRY study for its lead candidate, efruxifermin (EFX), accompanied by publication in the New England Journal of Medicine and a successful $402.5 million public offering boosting cash reserves to over $1.1 billion - The Phase 2b SYMMETRY study demonstrated a statistically significant reversal of compensated cirrhosis (F4) due to MASH after 96 weeks of treatment with efruxifermin (EFX)[2] - The SYMMETRY study results were published in the prestigious New England Journal of Medicine, underscoring the importance of the findings[2][3] - Successfully raised $402.5 million in gross proceeds from a follow-on public offering in January 2025[2] - As of March 31, 2025, the company held $1.128 billion in cash, cash equivalents, and marketable securities[2][3] Clinical Trial Updates The company presented positive 96-week data from its Phase 2b SYMMETRY and HARMONY studies at the EASL Congress 2025, demonstrating EFX's potential to reverse both cirrhosis (F4) and pre-cirrhotic fibrosis (F2-F3), with the global Phase 3 SYNCHRONY program actively enrolling across three trials to further evaluate EFX's safety and efficacy Phase 2b SYMMETRY Study (Cirrhosis - F4) The Phase 2b SYMMETRY study showed that EFX is the only known investigational MASH drug to demonstrate a statistically significant reversal of compensated cirrhosis (F4) in a placebo-controlled trial, with 39% of patients on 50mg EFX achieving at least a one-stage improvement in fibrosis without worsening MASH at 96 weeks, a significant 24% effect size over placebo, and non-invasive measures also showing significant improvements SYMMETRY Study: Week 96 Key Biopsy Results | Metric | 50mg EFX Group | Placebo Group | p-value | | :--- | :--- | :--- | :--- | | ≥1-stage fibrosis improvement (no worsening of MASH) | 39% | 15% | 0.009 | | ≥1-stage fibrosis improvement (ITT analysis) | 29% | 12% | 0.031 | SYMMETRY Study: Week 96 Non-Invasive Measures vs. Placebo | Metric | 50mg EFX Group | Placebo Group | p-value | | :--- | :--- | :--- | :--- | | Mean reduction in ELF score | -0.53 | +0.22 | <0.001 | | Mean relative reduction in liver stiffness | -24% | -8% | <0.05 | - Newly presented analyses showed EFX's potential to reverse cirrhosis across key subgroups, including patients with cryptogenic cirrhosis and type 2 diabetes[10] Phase 2b HARMONY Study (Pre-Cirrhotic - F2-F3) Data from the HARMONY study, presented at EASL 2025, demonstrated EFX's potential to reverse fibrosis in pre-cirrhotic MASH patients (F2-F3), with an AI-based qFibrosis® analysis showing a strong response rate in the EFX group across multiple fibrosis endpoints compared to placebo, increasing confidence in the treatment effect - An AI-based qFibrosis® analysis showed 57% of patients on 50mg EFX were responders across three key fibrosis endpoints (qFibrosis®, FibroScan®, ELF Score), compared to only 3% in the placebo group[10] - A post-hoc analysis suggested that the AI tool qFibrosis® may detect fibrosis improvement earlier than conventional histopathology[11] Phase 3 SYNCHRONY Program Update The ongoing global Phase 3 SYNCHRONY program consists of three trials (Real-World, Histology, Outcomes) evaluating EFX for both pre-cirrhotic and cirrhotic MASH, with enrollment for the Real-World study's double-blind portion complete and topline results expected in H1 2026, while the Histology study's 52-week results are anticipated in H1 2027 - The program comprises three trials: SYNCHRONY Real-World (F1-F4), SYNCHRONY Histology (F2-F3), and SYNCHRONY Outcomes (F4)[14] - The SYNCHRONY Real-World study completed enrollment of its 601-patient double-blind cohort, with preliminary topline results expected in the first half of 2026[14] - The SYNCHRONY Histology study (~1,650 patients) remains on track to report 52-week results for primary histology endpoints during the first half of 2027[14] Corporate and Financial Updates Akero significantly strengthened its financial position by raising approximately $402.5 million through a public offering in January 2025, reporting a net loss of $70.7 million for Q1 2025, with increased R&D and G&A expenses driven by the advancement of its Phase 3 program, and the current cash position expected to fund operations into 2028 Follow-On Public Offering On January 30, 2025, Akero closed an underwritten public offering, raising gross proceeds of approximately $402.5 million by issuing 6.427 million common shares at $48.00 per share and 1.958 million pre-funded warrants - Closed an underwritten public offering on January 30, 2025, raising approximately $402.5 million in gross proceeds[5] First Quarter 2025 Financial Results Akero ended Q1 2025 with $1.128 billion in cash and marketable securities, believed to be sufficient to fund operations into 2028, while total operating expenses rose to $80.9 million from $60.0 million year-over-year, primarily due to increased R&D costs for the Phase 3 SYNCHRONY program - Cash, cash equivalents, and marketable securities totaled $1,128.3 million as of March 31, 2025, providing a cash runway into 2028[14] Q1 2025 vs Q1 2024 Operating Expenses (in millions) | Expense Category | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and development | $69.6 | $50.7 | | General and administrative | $11.3 | $9.3 | | Total operating expenses | $80.9 | $60.0 | Financial Statements Condensed Consolidated Balance Sheets As of March 31, 2025, Akero reported total assets of $1.156 billion, a significant increase from $825.9 million at year-end 2024, primarily driven by the proceeds from the public offering, with total stockholders' equity growing to $1.084 billion from $750.1 million over the same period Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total assets | $1,155,843 | $825,886 | | Total liabilities | $71,997 | $75,774 | | Total stockholders' equity | $1,083,846 | $750,112 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended March 31, 2025, Akero reported a net loss of $70.7 million, or ($0.90) per share, compared to a net loss of $53.3 million, or ($0.90) per share, for the same period in 2024, with the increased loss driven by higher R&D expenses for the Phase 3 program, which rose to $69.6 million Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Total operating expenses | $80,882 | $59,954 | | Loss from operations | $(80,882) | $(59,954) | | Net loss | $(70,725) | $(53,344) | | Net loss per common share | $(0.90) | $(0.90) | Company and Product Information About MASH and Cirrhosis MASH (metabolic dysfunction-associated steatohepatitis) is a severe form of liver disease affecting an estimated 17 million Americans, characterized by liver fat accumulation, inflammation, and fibrosis, which can progress to cirrhosis, liver failure, and cancer, and is the fastest-growing reason for liver transplants in the US and Europe, with no currently approved treatments - MASH is a serious form of MASLD estimated to affect 17 million Americans[15] - It is the fastest-growing cause of liver transplants and liver cancer in the US and Europe, and there are no approved treatments[15] - An estimated 3 million Americans are projected to have MASH cirrhosis by 2030[16] About Efruxifermin (EFX) Efruxifermin (EFX) is Akero's lead product candidate, an engineered FGF21 analog being evaluated in three Phase 3 studies for MASH, which has shown potential in Phase 2 trials to reverse fibrosis (including compensated cirrhosis), resolve MASH, and improve cardiovascular risk factors, offering a holistic treatment approach with a convenient once-weekly dosing schedule - EFX is engineered to mimic the biological activity of native FGF21 and is designed for convenient once-weekly dosing[17] - In multiple Phase 2 studies, EFX has been observed to reverse fibrosis, resolve MASH, reduce non-invasive markers of fibrosis, and improve insulin sensitivity and lipoprotein profile[17] About Akero Therapeutics Akero Therapeutics is a clinical-stage company focused on developing transformational treatments for serious metabolic diseases with high unmet medical need, with its lead product candidate, efruxifermin (EFX), currently being evaluated in a comprehensive Phase 3 program (SYNCHRONY) for the treatment of MASH - Akero is a clinical-stage company developing treatments for serious metabolic diseases, including MASH[18] - The lead product candidate, EFX, is being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World[18]