Core Insights - The publication of the 96-week results from the Phase 2b HARMONY trial indicates the potential of efruxifermin (EFX) to significantly reduce the risk of fibrosis progression in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) [1][2][3] Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing treatments for serious metabolic diseases, particularly MASH, which has a high unmet medical need [1][12] - Efruxifermin (EFX) is Akero's lead product candidate, currently being evaluated in three ongoing Phase 3 studies targeting different stages of MASH [9][12] Trial Results - The HARMONY trial was a 96-week multicenter, randomized, double-blind, placebo-controlled study involving 128 adult participants with biopsy-confirmed MASH and moderate to advanced fibrosis [2][11] - In the mITT population at week 96, 49% of participants receiving 50mg EFX achieved at least one stage of fibrosis improvement without worsening of MASH, compared to 19% for placebo (p=0.0030) [3][4] - Improvements in fibrosis were also noted in patients with more advanced disease, indicating EFX's potential effectiveness across different stages of MASH [3][4] Secondary Endpoints - The secondary endpoint of MASH resolution without fibrosis worsening was achieved by 40% of participants receiving 28mg EFX and 37% receiving 50mg EFX, compared to 19% for placebo [4] - A composite endpoint of both MASH resolution and at least one stage of fibrosis improvement was met by 35% and 28% of participants in the 50mg and 28mg EFX groups, respectively, versus 7% for placebo [4] Safety and Tolerability - EFX was generally well tolerated, with a safety profile consistent with previous trials; the most common adverse events were mild to moderate gastrointestinal issues [6] - A small reduction in bone mineral density was observed after 96 weeks of EFX treatment, although the clinical significance of this finding remains to be determined [6] Overall Impact - The sustained reductions in fibrosis and MASH observed in the trial reflect an overall improvement in whole-body metabolic health, including reduced dyslipidemia and increased insulin sensitivity [7] - The results from the HARMONY trial, along with data from the SYMMETRY trial, suggest that EFX has the potential to transform patient outcomes, particularly for those with a high fibrosis burden [3][7]

Company Performance - Akero Therapeutics, Inc. (AKRO) has shown a year-to-date performance increase of approximately 73.5%, significantly outperforming the average loss of 7.5% in the Medical sector [4] - The Zacks Consensus Estimate for AKRO's full-year earnings has increased by 1.4% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [3] Industry Comparison - Akero Therapeutics, Inc. is part of the Medical - Biomedical and Genetics industry, which consists of 489 companies and currently ranks 141 in the Zacks Industry Rank. This industry has experienced a slight decline of about 0.9% year-to-date, further highlighting AKRO's superior performance [6] - In contrast, Aveanna Healthcare (AVAH), another outperforming stock in the Medical sector, belongs to the Medical - Outpatient and Home Healthcare industry, which has seen a year-to-date increase of 3.8% and ranks 40 [7]

[Q2 2025 Earnings Overview](index=1&type=section&id=Q2%202025%20Earnings%20Overview) 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](index=1&type=section&id=Key%20Highlights%20%26%20CEO%20Commentary) 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](index=1&type=chunk) - 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](index=1&type=chunk) - CEO Andrew Cheng highlighted continued momentum from SYMMETRY study results and reinforced EFX's anti-fibrotic activity across MASH stages[2](index=2&type=chunk) - Preliminary results for Phase 3 SYNCHRONY Real-World expected in H1 2026, and SYNCHRONY Histology readout in H1 2027[2](index=2&type=chunk) Cash, Cash Equivalents and Marketable Securities | Date | Amount (Millions) | | :--- | :--- | | June 30, 2025 | $1,086.2 | [Clinical Development Updates](index=1&type=section&id=Clinical%20Development%20Updates) 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](index=1&type=section&id=Phase%202b%20SYMMETRY%20Trial%20Data) 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](index=4&type=chunk) - This peer-reviewed publication reinforces EFX as a potential **first- and best-in-class therapy** with disease-modifying activity in advanced-stage MASH[4](index=4&type=chunk) - 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](index=4&type=chunk) [Phase 2b HARMONY Study Insights](index=2&type=section&id=Phase%202b%20HARMONY%20Study%20Insights) 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](index=8&type=chunk) - 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](index=8&type=chunk) - A supporting poster provided evidence that qFibrosis® may detect fibrosis improvement earlier than conventional pathology scoring[8](index=8&type=chunk) [Product Candidate and Disease Background](index=2&type=section&id=Product%20Candidate%20and%20Disease%20Background) 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)](index=3&type=section&id=About%20EFX%20(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](index=9&type=chunk)[10](index=10&type=chunk) - 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](index=9&type=chunk) - 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](index=9&type=chunk) [Understanding MASH and Cirrhosis](index=2&type=section&id=Understanding%20MASH%20and%20Cirrhosis) 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](index=6&type=chunk) - Approximately **20% of patients with MASH** are expected to progress to cirrhosis, which has a higher risk of mortality[6](index=6&type=chunk) - Cirrhosis due to MASH is a life-threatening disease with high risk of liver failure, cancer, and death, with **no approved treatments**[7](index=7&type=chunk) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Performance) 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](index=2&type=section&id=Financial%20Summary) 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](index=8&type=chunk) 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](index=8&type=chunk) - 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](index=8&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=3&type=section&id=Corporate%20Information) 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](index=3&type=section&id=About%20Akero%20Therapeutics) 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](index=10&type=chunk) - 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](index=10&type=chunk) - The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study and the SYMMETRY study[10](index=10&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) 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](index=11&type=chunk) - 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](index=11&type=chunk) - 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](index=11&type=chunk) [Investor and Media Contacts](index=3&type=section&id=Investor%20and%20Media%20Contacts) This section provides contact information for investor relations and media inquiries - Investor Contact: Christina Tartaglia, 332.322.7430, christina.tartaglia@precisonaq.com[12](index=12&type=chunk) - Media Contact: Peg Rusconi, 617.910.6217, peg.rusconi@deerfieldgroup.com[13](index=13&type=chunk)

PART I. FINANCIAL INFORMATION [Item 1. Condensed Consolidated Financial Statements](index=7&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Presents Akero Therapeutics' unaudited condensed consolidated financial statements, covering balance sheets, operations, equity, cash flows, and detailed notes [Condensed Consolidated Balance Sheets (Unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(Unaudited)) | ASSETS (in thousands) | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :---------------- | | Cash and cash equivalents | $220,449 | $340,238 | | Short-term marketable securities | $521,866 | $402,840 | | Long-term marketable securities | $343,931 | $54,751 | | Total assets | $1,109,152 | $825,886 | | LIABILITIES (in thousands) | | | | Total current liabilities | $60,401 | $39,754 | | Total liabilities | $83,333 | $75,774 | | Total stockholders' equity | $1,025,819 | $750,112 | - Total assets increased by **$283.266 million** from December 31, 2024, to June 30, 2025, primarily driven by a significant increase in long-term marketable securities[21](index=21&type=chunk) - Cash and cash equivalents decreased by **$119.789 million**, while short-term marketable securities increased by **$119.026 million** and long-term marketable securities increased by **$289.180 million**[21](index=21&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20(Unaudited)) | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $69,254 | $55,322 | $138,821 | $105,972 | | General and administrative | $11,619 | $10,419 | $22,934 | $19,723 | | Total operating expenses | $80,873 | $65,741 | $161,755 | $125,695 | | Loss from operations | $(80,873) | $(65,741) | $(161,755) | $(125,695) | | Interest and other income, net | $11,540 | $10,985 | $22,851 | $18,586 | | Net loss | $(70,505) | $(55,987) | $(141,230) | $(109,331) | | Net loss per common share, basic and diluted | $(0.86) | $(0.81) | $(1.76) | $(1.70) | - Net loss increased by **26%** for the three months ended June 30, 2025, to **$70.505 million** from **$55.987 million** in the prior year, and by **29%** for the six months ended June 30, 2025, to **$141.230 million** from **$109.331 million**[25](index=25&type=chunk) - Research and development expenses rose by **25% (QoQ)** and **31% (YoY)** due to increased EFX program costs, particularly CMO and CRO expenses for the Phase 3 SYNCHRONY program[25](index=25&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited)](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)%20(Unaudited)) | (in thousands, except share amounts) | December 31, 2024 | June 30, 2025 | | :----------------------------------- | :---------------- | :------------ | | Common Stock (shares) | 72,383,013 | 79,919,203 | | Additional Paid-In Capital | $1,575,313 | $1,992,209 | | Accumulated Deficit | $(826,156) | $(967,386) | | Total Stockholders' Equity | $750,112 | $1,025,819 | - Total stockholders' equity increased by **$275.707 million** from December 31, 2024, to June 30, 2025, primarily due to additional paid-in capital from stock offerings, partially offset by accumulated deficit[29](index=29&type=chunk) - Additional paid-in capital increased by **$416.896 million**, reflecting proceeds from follow-on public offerings and ATM offerings, as well as stock-based compensation expense[29](index=29&type=chunk) [Condensed Consolidated Statements of Cash Flows (Unaudited)](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(Unaudited)) | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Net cash (used in) operating activities | $(115,910) | $(92,593) | | Net cash (used in) investing activities | $(402,843) | $(198,047) | | Net cash provided by financing activities | $398,964 | $366,788 | | Net (decrease) increase in cash and cash equivalents | $(119,789) | $76,148 | | Cash and cash equivalents at the end of the period | $220,449 | $310,355 | - Net cash used in operating activities increased by **$23.317 million**, reflecting higher net losses and changes in operating assets and liabilities[32](index=32&type=chunk) - Net cash used in investing activities more than doubled, primarily due to increased purchases of marketable securities[32](index=32&type=chunk) - Net cash provided by financing activities increased by **$32.176 million**, driven by proceeds from follow-on public offerings and ATM offerings[32](index=32&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [1. Nature of the business and basis of presentation](index=11&type=section&id=1.%20Nature%20of%20the%20business%20and%20basis%20of%20presentation) Akero Therapeutics is a clinical-stage biotech developing EFX for MASH, in Phase 3, with recurring losses and future capital requirements - Akero Therapeutics is a clinical-stage company developing efruxifermin (EFX) for metabolic dysfunction-associated steatohepatitis (MASH), with an ongoing global Phase 3 SYNCHRONY program targeting approximately **3,500 patients**[34](index=34&type=chunk) - The company has incurred net losses of **$141.230 million** for the six months ended June 30, 2025, and an accumulated deficit of **$967.386 million** as of June 30, 2025[38](index=38&type=chunk) - Existing cash, cash equivalents, and marketable securities of **$1,086.246 million** as of June 30, 2025, are expected to fund operations for at least 12 months from the issuance date, but additional funding will be required for full clinical development and potential commercialization of EFX[40](index=40&type=chunk) [2. Summary of significant accounting policies](index=12&type=section&id=2.%20Summary%20of%20significant%20accounting%20policies) Outlines the company's significant accounting policies, including interim financial statements, use of estimates, credit risk, and adoption/evaluation of new ASUs - The company adopted ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, effective January 1, 2025, which did not materially impact financial statements[46](index=46&type=chunk) - The company is evaluating ASU No. 2024-03 and ASU No. 2025-01, Comprehensive Income - Expense Disaggregation Disclosures, effective for fiscal years beginning after December 15, 2026, and interim periods after December 15, 2027, with no material impact anticipated yet[47](index=47&type=chunk) [3. Fair value measurements](index=13&type=section&id=3.%20Fair%20value%20measurements) Classifies financial assets and liabilities at fair value into a three-level hierarchy, with most assets in Level 1 and 2, and warrant liabilities in Level 3 | Financial Assets (in thousands) | June 30, 2025 Total | Level 1 | Level 2 | Level 3 | | :----------------

Core Insights - Akero Therapeutics reported significant advancements in its clinical program for Efruxifermin (EFX), particularly in reversing compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) as demonstrated in the Phase 2b SYMMETRY trial [1][2][7] Financial Performance - As of June 30, 2025, Akero had cash, cash equivalents, and short-term marketable securities totaling $1,086.2 million, which is expected to fund operations into 2028 [1][13] - Research and development expenses for Q2 2025 were $69.3 million, up from $55.3 million in Q2 2024, attributed to ongoing Phase 3 studies and increased personnel costs [13] - General and administrative expenses rose to $11.6 million in Q2 2025 from $10.4 million in Q2 2024, reflecting higher personnel and professional service costs [13] - Total operating expenses for Q2 2025 were $80.9 million, compared to $65.7 million in the same period of 2024 [13] Clinical Developments - The Phase 2b SYMMETRY trial results were published in the New England Journal of Medicine, reinforcing EFX's potential as a first- and best-in-class therapy for advanced-stage MASH [7] - EFX demonstrated the ability to reverse cirrhosis in high-need subgroups, including patients with cryptogenic cirrhosis and type 2 diabetes, marking a significant milestone in treatment options [7] - The Phase 2b HARMONY study also showed consistent improvements in fibrosis for patients with pre-cirrhotic MASH, utilizing both conventional and AI-based analysis methods [7] Market Context - MASH affects an estimated 17 million Americans, with approximately 20% of patients expected to progress to cirrhosis, highlighting the urgent need for effective treatments [8] - By 2030, it is projected that 3 million Americans will have cirrhosis due to MASH, emphasizing the growing public health challenge [9]

Financial Data and Key Metrics Changes - The company reported a significant improvement in clinical results, particularly in the cirrhotic population, demonstrating a one-stage improvement in fibrosis, which is a first in the field [10][11] - The effect size in the pre-cirrhotic population showed a 75% one-stage improvement of fibrosis with a 50% effect size over placebo, indicating strong performance compared to competitors [11] Business Line Data and Key Metrics Changes - The company highlighted the differentiation of its drug affruxifirmin from competitors, emphasizing its unique modifications that enhance binding and efficacy [6][7] - Clinical data showed a 25% difference in fibrosis improvement between active and placebo groups at week 96, indicating the importance of longer dosing [12][13] Market Data and Key Metrics Changes - The company is positioned to address a large market for NASH treatments, particularly in the F2, F3, and F4 patient populations, with a focus on reversing fibrosis [52] - The competitive landscape includes other FGF21 agents, but the company believes its unique data and efficacy will differentiate it in the market [56][58] Company Strategy and Development Direction - The company is actively preparing for Phase 3 trials, leveraging learnings from Phase 2b studies to refine patient inclusion criteria [19][40] - There is a strategic focus on cirrhosis treatment, with plans to explore other causes of cirrhosis beyond NASH, indicating a broader therapeutic approach [68] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the long-term potential of their drug, particularly in the cirrhotic population, despite acknowledging that not all patients may respond immediately [15][16] - The company is aware of the competitive landscape and is preparing to demonstrate the value of its drug to payers, emphasizing the need for differentiation in a crowded market [60][62] Other Important Information - The company has a strong cash position with $1.128 billion, which is expected to support operations into 2028 [72] - Management noted the importance of combination therapies and the potential for their drug to be used alongside other treatments for NASH [64] Q&A Session Summary Question: How does affruxifirmin differentiate from other agents? - The CEO explained that affruxifirmin has unique modifications that enhance its binding and efficacy compared to other FGF21 agents [6][7] Question: What are the implications of the clinical data presented? - Management highlighted the significance of the one-stage improvement in fibrosis and the importance of longer dosing for better outcomes [10][12] Question: How does the company view the competitive landscape? - The company believes that while there are multiple agents entering the market, its unique data and efficacy will provide a competitive edge [56][58] Question: What is the company's strategy for Phase 3 trials? - The company is refining inclusion criteria based on Phase 2b learnings and is focused on enrolling the right patient populations for success [19][40] Question: How does the company plan to address payer concerns? - Management emphasized the need to demonstrate the drug's value and differentiate it from existing treatments to gain favorable payer access [60][62]

Summary of Akero Therapeutics (AKRO) 2025 Conference Call Company Overview - **Company**: Akero Therapeutics (AKRO) - **Industry**: Biotechnology, specifically focused on liver diseases such as NASH (Non-Alcoholic Steatohepatitis) and cirrhosis Key Points and Arguments Phase III Program Updates - Akero is currently executing multiple Phase III programs, including: - **Synchrony Real World Study**: Non-invasive study completed enrollment, results expected in the first half of 2026 [4] - **Synchrony Histology Study**: F2F3 study, results expected in the first half of 2027 [4] - **Synchrony Outcomes Study**: F4 study, first patient enrolled in September 2024, no guidance on results yet [5] Positive Phase II F4 Cirrhosis Data - Akero reported statistically significant improvement in fibrosis for cirrhotic patients, a first in the industry [7] - The effect size increased from 20% to 52% in pre-cirrhotic patients, indicating strong efficacy [8] - The company has not yet received FDA feedback on the Phase II data [10] FDA Interactions and Breakthrough Designation - Akero has breakthrough therapy designation for both pre-cirrhotic and cirrhotic patients [16] - The likelihood of filing for accelerated approval based on the recent data is considered low, but the company intends to share the data with the FDA [18] Competitive Landscape - Akero faces competition from Madrigal Pharmaceuticals, which has already received approval for its drug in the F2F3 space [57] - Other companies, including those developing FGF21 compounds, are also in the pipeline, indicating a competitive market [76] Study Design and Endpoints - The primary endpoint for the F2F3 study is a combination of fibrosis improvement and NASH resolution, which is different from other companies that may only focus on one [70] - The company is considering interim analyses based on strong data from the ongoing studies [25] Enrollment and Market Position - Enrollment for the F2F3 studies is tracking well, with expectations to complete enrollment by the first half of 2026 for a readout in the first half of 2027 [59][60] - Akero's strong F4 data has helped distinguish it from competitors, making enrollment easier [58] Pharma Interest in NASH - Recent acquisitions, such as GSK's purchase of Boston Therapeutics, indicate growing interest from large pharmaceutical companies in the NASH space [80] - Novo Nordisk is also entering the market, which could increase disease awareness and excitement in the field [82] Other Important Insights - Akero is actively engaging with large pharma companies for potential collaborations and investments [85] - The company is focused on ensuring patient safety and monitoring bone mineral density in ongoing studies [51][46] This summary encapsulates the key discussions and insights from the Akero Therapeutics conference call, highlighting the company's progress, competitive landscape, and future outlook in the biotechnology sector focused on liver diseases.

Company Overview - Akero Therapeutics is a clinical-stage company focused on developing transformational treatments for serious metabolic diseases with high unmet medical needs, including metabolic dysfunction-associated steatohepatitis (MASH) [3] Upcoming Events - Management will present at the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, at 2:40 p.m. E.T. [1] - A live webcast of the presentation will be available on the company's investor relations website, with an archived replay to follow [2] Clinical Development - Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World, targeting different patient populations with MASH [3] - The Phase 3 SYNCHRONY program builds on results from two Phase 2b clinical trials: the HARMONY study and the SYMMETRY study [3]

Company Overview - Akero Therapeutics, Inc. is a clinical-stage company focused on developing transformational treatments for serious metabolic diseases with high unmet medical needs, including metabolic dysfunction-associated steatohepatitis (MASH) [3] Clinical Development - The lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology, SYNCHRONY Outcomes, and SYNCHRONY Real-World, targeting different patient populations affected by MASH [3] - The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials: the HARMONY study for pre-cirrhotic MASH and the SYMMETRY study for compensated cirrhosis due to MASH [3] Upcoming Events - Management will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 8:45 a.m. P.T. [1] - A live webcast of the presentation will be available on the company's investor relations website, with an archived replay to follow [2]

Company Overview - Akero Therapeutics (NASDAQ: AKRO) is actively developing its FGF21 drug efruxifermin, aimed at treating patients with compensated cirrhosis due to MASH and pre-cirrhotic MASH patients [2]. Product Development - The development of efruxifermin is a key focus for Akero Therapeutics, indicating strong progress in addressing significant medical needs within the liver disease space [2].