Summary by Moomoo AI
Clene Inc. reported a Q2 2024 net loss of $6.8 million, compared to a $25.1 million loss in Q2 2023. Total revenue declined 66% to $91,000, while operating expenses decreased 29% to $7.5 million. Research and development expenses fell 37% to $4.2 million, primarily due to reimbursements from the ALS expanded access program and completion of several clinical trials.The company ended Q2 with cash and equivalents of $21.7 million, down from $35.0 million at 2023 year-end. Management indicated substantial doubt about the company's ability to continue as a going concern, noting current cash resources are insufficient to fund operations for the next 12 months without additional financing. The company must maintain at least $5 million in unrestricted cash under its Avenue loan agreement.Clene announced promising long-term CNM-Au8 treatment results for ALS patients, showing approximately 60% decreased risk of death compared to matched controls. The company submitted a briefing book to the FDA in July 2024 ahead of a Type C interaction expected in Q3 2024 to discuss an accelerated approval pathway. Management is planning an international Phase 3 RESTORE-ALS trial targeted to begin in Q2 2025, contingent upon funding.
