Akero(US:AKRO)2025-11-07 22:10Financial Performance - The company reported net losses of $81.6 million and $72.7 million for the three months ended September 30, 2025 and 2024, respectively, and net losses of $252.1 million and $151.8 million for the years ended December 31, 2024 and 2023, respectively[142]. - As of September 30, 2025, the company had an accumulated deficit of $1,049.0 million[142]. - The company has not generated any revenue since inception and does not expect to do so in the near future[153]. - Net loss for the three months ended September 30, 2025, was $81.6 million, a 12% increase from a net loss of $72.7 million in 2024[163]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $183.1 million, compared to $163.0 million for the same period in 2024, reflecting a 12.9% increase in cash outflow[180][181]. - Cash provided by financing activities was $364.9 million for the nine months ended September 30, 2025, slightly down from $369.9 million in 2024, indicating a 1.4% decrease[184][185]. Research and Development - The ongoing Phase 3 SYNCHRONY program includes three trials with an expected total enrollment of about 3,500 patients, aimed at supporting marketing approval for patients with pre-cirrhotic MASH and compensated cirrhosis[135]. - In the SYMMETRY Phase 2b trial, 39% of patients treated with 50mg EFX experienced reversal of cirrhosis at week 96, compared to 15% for placebo[137]. - The HARMONY Phase 2b trial showed that at week 96, 75% of patients treated with 50mg EFX achieved ≥1 stage improvement in fibrosis, compared to 24% for placebo[138]. - Research and development expenses are expected to increase substantially due to planned clinical development activities for EFX[156]. - Research and development expenses increased to $78.9 million for the three months ended September 30, 2025, up from $72.2 million in 2024, representing a 9% increase[164]. - Research and development expenses for the nine months ended September 30, 2025, totaled $217.7 million, up from $178.2 million in 2024, reflecting a 22% increase[171]. Expenses and Cash Flow - General and administrative expenses rose to $11.4 million for the three months ended September 30, 2025, compared to $9.5 million in 2024, marking a 20% increase[165]. - General and administrative expenses for the nine months ended September 30, 2025, were $34.3 million, compared to $29.2 million in 2024, an increase of 17%[172]. - Total operating expenses for the three months ended September 30, 2025, were $90.2 million, an increase of 10% from $81.7 million in 2024[163]. - Cash used in investing activities increased significantly to $346.1 million for the nine months ended September 30, 2025, from $125.0 million in 2024, representing a 176.8% increase[182][183]. - The company incurred a loss on extinguishment of loan payable of $1.6 million related to the repayment of the Hercules term loan on September 23, 2025[167][174]. Merger and Funding - The merger with Novo is expected to close around year-end 2025, with each share of common stock converting to $54.00 in cash and a contingent value right[149][151]. - If the proposed merger with Novo is not consummated, the company expects to require additional funding to complete clinical development and commercialization of EFX[188][189]. - A termination fee of $165.0 million may be required if certain closing conditions under the Merger Agreement with Novo are not satisfied[190]. - The company raised $402.5 million from a follow-on public offering in January 2025, contributing to a total of $1,910.4 million in gross proceeds since inception[177][178]. Risks and Future Outlook - The company anticipates significant expenses and operating losses for the foreseeable future, primarily due to ongoing research and development activities[187]. - The company is exposed to interest rate risk, with a portfolio primarily consisting of U.S. Treasury-backed securities and corporate debt securities[196][197]. - Inflation may impact operational costs, including clinical trials and labor costs, although it has not materially affected the company to date[200]. - Non-cancelable purchase and other arrangements increased to $90.7 million as of September 30, 2025, compared to $25.6 million as of December 31, 2024, marking a 254.7% increase[192].