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10-Q - Akero Therapeutics, Inc. (0001744659) (Filer)

Mon, May 12, 11:32 AM (35 days ago)

### Summary of Akero Therapeutics, Inc. (AKRO) Q1 2025 Financial Health and Performance **Quarterly Financial Health:** - **Revenue:** No revenue generated, as expected. - **Profit Margins:** Negative, with a net loss of $70.7 million. - **Cash Flow:** Negative cash flow from operations at $67.7 million, offset by positive cash flow from financing activities at $395.5 million. - **Earnings Changes:** Increased net loss from $53.3 million in Q1 2024 to $70.7 million in Q1 2025. - **Quarterly Performance Discussion:** Increased research and development expenses by $18.9 million, primarily due to clinical trial and manufacturing costs. General and administrative expenses increased by $2.0 million. Interest income increased by $3.7 million. **Trends and Uncertainties:** - **Clinical Development:** Ongoing Phase 3 SYNCHRONY program with expected total enrollment of about 3,500 patients. - **Manufacturing:** Complex and highly regulated, with potential supply disruptions. - **Regulatory Approval:** Uncertainty in obtaining regulatory approvals, with potential delays or rejections. - **Market Acceptance:** Uncertainty in market acceptance and third-party reimbursement. - **Financial Condition:** Significant losses and need for additional capital to support operations. **Future Operations Impact:** - **Research and Development:** Continued investment in clinical trials and manufacturing. - **Commercialization:** Potential challenges in establishing sales, marketing, and distribution capabilities. - **Regulatory Compliance:** Ongoing compliance with regulatory requirements and potential post-approval studies. - **Financial Strategy:** Need for additional funding through equity offerings, debt financings, or strategic alliances.