Akero(AKRO) - 2025 Q2 - Quarterly Results

Q2 2025 Earnings Overview Akero Therapeutics reported Q2 2025 financial results and business updates, highlighting significant progress in the EFX clinical program and upcoming Phase 3 readouts Key Highlights & CEO Commentary Akero Therapeutics reported second quarter 2025 financial results and provided business updates, emphasizing significant progress in the EFX clinical program, including the publication of SYMMETRY trial results in the New England Journal of Medicine and upcoming Phase 3 readouts - Published 96-Week Phase 2b SYMMETRY trial results in the New England Journal of Medicine[1] - Three presentations at EASL Congress 2025 highlighted data demonstrating statistically significant reversal of compensated cirrhosis (F4) due to MASH and corroborating EFX's anti-fibrotic activity[1] - CEO Andrew Cheng highlighted continued momentum from SYMMETRY study results and reinforced EFX's anti-fibrotic activity across MASH stages[2] - Preliminary results for Phase 3 SYNCHRONY Real-World expected in H1 2026, and SYNCHRONY Histology readout in H1 2027[2] Cash, Cash Equivalents and Marketable Securities | Date | Amount (Millions) | | :--- | :--- | | June 30, 2025 | $1,086.2 | Clinical Development Updates This section provides updates on the Phase 2b SYMMETRY trial data publication and new insights from the HARMONY study regarding EFX's anti-fibrotic activity Phase 2b SYMMETRY Trial Data Data from the Phase 2b SYMMETRY study, evaluating EFX in patients with compensated cirrhosis (F4) due to MASH, was published in the New England Journal of Medicine, reinforcing EFX's potential as a first-in-class therapy with disease-modifying activity - Data from Phase 2b SYMMETRY study evaluating EFX in patients with compensated cirrhosis (F4) due to MASH was published in the New England Journal of Medicine on May 9, 2025[4] - This peer-reviewed publication reinforces EFX as a potential first- and best-in-class therapy with disease-modifying activity in advanced-stage MASH[4] - Week 96 data demonstrated the potential of EFX 50mg to reverse cirrhosis in high-need MASH subgroups, including patients with cryptogenic cirrhosis and type 2 diabetes[4] Phase 2b HARMONY Study Insights New insights from the Phase 2b HARMONY study demonstrated EFX's ability to improve fibrosis in pre-cirrhotic MASH (F2-F3) using both conventional pathologist scoring and advanced AI-based analysis, with a majority of patients achieving improvements across multiple antifibrotic response measures - New insights from the Phase 2b HARMONY study demonstrated EFX's ability to improve fibrosis in pre-cirrhotic MASH (F2-F3) using both conventional pathologist scoring and advanced AI-based analysis of biopsy images[8] - A majority of individuals treated with 50mg EFX for 96 weeks achieved improvements across qFibrosis® staging, ELF score, and liver stiffness by FibroScan®, in contrast to placebo patients[8] - A supporting poster provided evidence that qFibrosis® may detect fibrosis improvement earlier than conventional pathology scoring[8] Product Candidate and Disease Background This section describes Efruxifermin (EFX) as Akero's lead MASH product candidate and provides background on MASH and cirrhosis as serious, life-threatening diseases About EFX (Efruxifermin) Efruxifermin (EFX), Akero's lead product candidate for MASH, is an FGF21 mimetic currently in three Phase 3 studies. It has shown potential to reverse fibrosis, resolve MASH, reduce non-invasive markers of liver injury, and improve insulin sensitivity and lipoprotein profile, offering a holistic approach to MASH treatment - Efruxifermin (EFX) is Akero's lead product candidate for MASH, currently being evaluated in three ongoing Phase 3 studies[9][10] - In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis due to MASH), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile[9] - EFX is engineered to mimic the biological activity profile of native FGF21, designed for convenient once-weekly dosing, and has been generally well-tolerated in clinical trials[9] Understanding MASH and Cirrhosis MASH is a serious form of MASLD affecting an estimated 17 million Americans, characterized by liver fat accumulation leading to inflammation, fibrosis, and potential progression to cirrhosis, liver failure, and cancer. Cirrhosis due to MASH is a life-threatening disease with no approved treatments, projected to affect 3 million Americans by 2030 - MASH is a serious form of MASLD estimated to affect 17 million Americans, characterized by excessive accumulation of fat in the liver causing stress, injury, inflammation, and fibrosis[6] - Approximately 20% of patients with MASH are expected to progress to cirrhosis, which has a higher risk of mortality[6] - Cirrhosis due to MASH is a life-threatening disease with high risk of liver failure, cancer, and death, with no approved treatments[7] Second Quarter 2025 Financial Performance This section details Akero's Q2 2025 financial results, including increased operating expenses, a strong cash position, and key figures from the condensed consolidated balance sheets and statements of operations Financial Summary Akero reported increased operating expenses in Q2 2025 compared to Q2 2024, primarily due to higher R&D costs for ongoing Phase 3 studies and clinical supply manufacturing, as well as increased personnel and professional services expenses. The company maintains a strong cash position, expected to fund operations into 2028 Cash, Cash Equivalents and Marketable Securities | Date | Amount (Millions) | | :--- | :--- | | June 30, 2025 | $1,086.2 | - Akero believes its cash, cash equivalents and short and long-term marketable securities will be sufficient to fund its current operating plan into 2028[8] Operating Expenses (Three Months Ended June 30) | Expense Category | 2025 (Millions) | 2024 (Millions) | Change (YoY, Millions) | | :--------------- | :--- | :--- | :----------- | | Research and development | $69.3 | $55.3 | +$14.0 | | General and administrative | $11.6 | $10.4 | +$1.2 | | Total operating expenses | $80.9 | $65.7 | +$15.2 | - Increases in R&D expenses were attributable to higher expenses associated with ongoing Phase 3 SYNCHRONY studies, manufacture of clinical supplies, and higher personnel costs[8] - Increases in G&A expenses were attributable to higher expenses for personnel, professional services, and other costs associated with operating as a public company[8] Condensed Consolidated Balance Sheets As of June 30, 2025, Akero Therapeutics reported total assets of $1,109.152 million, an increase from $825.886 million at December 31, 2024, primarily driven by an increase in non-current assets and stockholders' equity Condensed Consolidated Balance Sheets | Item | June 30, 2025 (Thousands) | December 31, 2024 (Thousands) | | :-------------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and short-term marketable securities | $742,315 | $743,078 | | Other current assets | $22,285 | $27,302 | | Non-current assets | $344,552 | $55,506 | | Total assets | $1,109,152 | $825,886 | | Current liabilities | $60,401 | $39,754 | | Non-current liabilities | $22,932 | $36,020 | | Stockholders' equity | $1,025,819 | $750,112 | | Total liabilities and stockholders' equity | $1,109,152 | $825,886 | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended June 30, 2025, Akero reported a net loss of $70.505 million, an increase from $55.987 million in the comparable period of 2024, primarily due to higher research and development and general and administrative expenses. The net loss per common share was $(0.86) for Q2 2025 Condensed Consolidated Statements of Operations and Comprehensive Loss (Three Months Ended June 30) | Item | 2025 (Thousands) | 2024 (Thousands) | | :-------------------------------------------------- | :------- | :------- | | Research and development | $69,254 | $55,322 | | General and administrative | $11,619 | $10,419 | | Total operating expenses | $80,873 | $65,741 | | Loss from operations | $(80,873) | $(65,741) | | Interest expense | $(1,172) | $(1,231) | | Interest and other income, net | $11,540 | $10,985 | | Net loss | $(70,505) | $(55,987) | | Comprehensive loss | $(70,602) | $(56,169) | | Net loss per common share, basic and diluted | $(0.86) | $(0.81) | | Weighted-average number of shares used in computing net loss per common share, basic and diluted | 81,721,387 | 69,160,484 | Condensed Consolidated Statements of Operations and Comprehensive Loss (Six Months Ended June 30) | Item | 2025 (Thousands) | 2024 (Thousands) | | :-------------------------------------------------- | :------- | :------- | | Research and development | $138,821 | $105,972 | | General and administrative | $22,934 | $19,723 | | Total operating expenses | $161,755 | $125,695 | | Loss from operations | $(161,755) | $(125,695) | | Interest expense | $(2,326) | $(2,222) | | Interest and other income, net | $22,851 | $18,586 | | Net loss | $(141,230) | $(109,331) | | Comprehensive loss | $(141,190) | $(109,862) | | Net loss per common share, basic and diluted | $(1.76) | $(1.70) | | Weighted-average number of shares used in computing net loss per common share, basic and diluted | 80,197,494 | 64,234,122 | Corporate Information This section provides an overview of Akero Therapeutics, outlines standard forward-looking statements and associated risks, and lists investor and media contact information About Akero Therapeutics Akero Therapeutics is a clinical-stage company focused on developing treatments for serious metabolic diseases with high unmet medical needs, particularly MASH. Its lead product candidate, EFX, is currently in three Phase 3 clinical studies - Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including MASH[10] - Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three Phase 3 clinical studies: SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World[10] - The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study and the SYMMETRY study[10] Forward-Looking Statements This section contains standard forward-looking statements regarding Akero's business plans, therapeutic potential of EFX, upcoming milestones, and financial expectations. It highlights that actual results may differ materially due to various risks and uncertainties, and the company undertakes no obligation to update these 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[11] - Such statements are subject to risks and uncertainties, including the success, cost, and timing of product candidate development activities and clinical trials, regulatory developments, and Akero's ability to fund operations[11] - 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[11] Investor and Media Contacts This section provides contact information for investor relations and media inquiries - Investor Contact: Christina Tartaglia, 332.322.7430, christina.tartaglia@precisonaq.com[12] - Media Contact: Peg Rusconi, 617.910.6217, peg.rusconi@deerfieldgroup.com[13]