Merger and Corporate Structure - On August 16, 2023, the merger between Diffusion Pharmaceuticals Inc. and EIP Pharma, Inc. was completed, resulting in the formation of CervoMed Inc.[16] - The merger between Diffusion Pharmaceuticals Inc. and EIP Pharma, Inc. was completed on August 16, 2023, with EIP becoming a wholly-owned subsidiary of the newly named CervoMed Inc.[16] - Following the merger, a reverse stock split was executed at a ratio of 1-for-1.5, affecting the common stock of the company[16] - A reverse stock split was executed at a ratio of 1-for-1.5, retroactively affecting share and per share figures based on the exchange ratio of 0.1151[16][18]. Clinical Trials and Research - The ongoing RewinD-LB Trial, evaluating neflamapimod for treating dementia with Lewy bodies, was initiated in the second quarter of 2023[21]. - The RewinD-LB Trial, an ongoing Phase 2b clinical trial evaluating neflamapimod for dementia with Lewy bodies, was initiated in the second quarter of 2023[21]. - The company plans to initiate the Restore Trial, a Phase 2 clinical trial for patients recovering from ischemic stroke, in the second quarter of 2025[21]. - The Restore Trial, a Phase 2 clinical trial for patients recovering from ischemic stroke, is expected to begin in the second quarter of 2025[21]. - The company anticipates that the results of the RewinD-LB Trial will be reported in December 2024[21]. Financial Support and Planning - The company received a 21.0 million awarded in January 2023 and an additional $0.3 million in August 2024[21]. - Future obligations under the Vertex Agreement are a consideration for the company's financial planning[25]. - The company is actively managing its cash balances and exploring additional financing options to support its operations and growth[25]. Regulatory and Operational Considerations - The company is focused on obtaining and maintaining regulatory approval for its product candidates, which is critical for future commercialization[25]. - The company emphasizes the importance of obtaining and maintaining regulatory approval for its product candidates[25]. - The performance of third parties, including contract research organizations and manufacturers, is critical to the company's operational success[25]. - The company acknowledges the risks associated with forward-looking statements, including uncertainties in clinical trial outcomes and regulatory approvals[23]. - The company acknowledges that actual results may differ materially from forward-looking statements due to known and unknown factors[26]. - The company has no obligation to update forward-looking statements unless required by law, highlighting the inherent risks and uncertainties in its projections[23]. - There is no obligation to update forward-looking statements after the date of the Annual Report, except as required by law[27]. - Historical data comparisons are not intended to indicate future performance trends unless explicitly stated[27]. - The company anticipates challenges in recruiting participants for clinical trials and maintaining adequate drug supply[25].
CervoMed (CRVO) - 2024 Q4 - Annual Report