CervoMed (US:CRVO)2023-11-12 16:00Financial Performance - Grant revenue for the three months ended September 30, 2023, was $1,526,482, compared to $0 for the same period in 2022[318]. - The net income for the three months ended September 30, 2023, was $2,150,362, compared to a net loss of $882,623 for the same period in 2022[318]. - The company reported a net income of $190,525 for the nine months ended September 30, 2023, compared to a net loss of $4,275,647 for the same period in 2022[364]. - The adjusted net income (loss) for the nine months ended September 30, 2023, was $(5,233,726), compared to $(4,275,647) for the same period in 2022[393]. - Net income per share of common stock (basic) for the three months ended September 30, 2023, was $0.65, compared to a loss of $1.70 for the same period in 2022[318]. Operating Expenses - Total operating expenses for the nine months ended September 30, 2023, were $9,986,739, a significant increase from $2,536,711 in the same period of 2022[318]. - Research and development expenses for the nine months ended September 30, 2023, totaled $5,583,149, up from $955,784 in the same period of 2022[318]. - General and administrative expenses for the three months ended September 30, 2023, were $2,410,124, compared to $573,511 for the same period in 2022[318]. - The loss from operations for the nine months ended September 30, 2023, was $(5,332,445), compared to a loss of $(2,536,711) in the same period of 2022[318]. Stock and Equity - The weighted average shares outstanding for basic net income per share was 3,308,302 for the three months ended September 30, 2023, compared to 518,140 for the same period in 2022[318]. - The company underwent a reverse stock split at a ratio of 1-for-1.5 on August 16, 2023, affecting the common stock structure[306]. - The total number of shares of the Company's common stock outstanding immediately after the Merger was approximately 5,674,277[444]. - The company issued 795,905 shares of common stock and 101,367 pre-funded warrants upon the settlement of Convertible Notes as part of the merger[458]. Grants and Funding - The company was awarded a $21.0 million grant from the NIA in January 2023 to support its ongoing Phase 2b study of neflamapimod, expected to be received over three years[366]. - Total revenue recognized from the National Institute of Aging (NIA) grant was $1.6 million and $4.7 million for the three and nine months ended September 30, 2023, respectively[425]. - As of September 30, 2023, total cash funding of $5.2 million has been received from the NIA grant, with approximately $15.8 million in funding remaining[425]. Clinical Development - The company is currently developing neflamapimod, an investigational drug for treating degenerative brain diseases, and is in a Phase 2b clinical trial for patients with DLB[341]. - The ongoing Phase 2b clinical trial for neflamapimod is expected to complete enrollment in the first half of 2024, with initial results anticipated in the second half of 2024[1]. - Neflamapimod has shown statistically significant improvement in dementia severity (p=0.023) and motor function (p=0.044) in a Phase 2a clinical trial[1]. - The success of the ongoing Phase 2b clinical trial is essential for the company's future revenue projections and market acceptance of its product candidates[328]. Financial Position - As of September 30, 2023, total stockholders' equity was reported at $9,574,200, a significant increase from a deficit of $33,285,059 at the end of 2022[333]. - The company reported an accumulated deficit of $52,078,391 as of September 30, 2023, a slight improvement from $52,268,916 at the end of 2022[333]. - The company has a total liability of $12,414,000 in convertible notes as of September 30, 2023, unchanged from the previous year[352]. - The company anticipates requiring additional financing to support clinical development and operations in the foreseeable future[343]. Cash Flow and Financing - As of September 30, 2023, the company has cash and cash equivalents totaling $10,424,675, an increase from $4,093,579 at the end of 2022[350][364]. - The company raised $810,000 from the sale of common stock during the nine months ended September 30, 2023[364]. - The company reported a significant increase in cash flow from financing activities, totaling $11,242,489 for the nine months ended September 30, 2023[364]. - The company plans to seek funds through equity offerings, debt financings, or other capital sources to support its business strategies[343]. Corporate Changes - On August 16, 2023, the merger between Diffusion Pharmaceuticals Inc. and EIP Pharmaceuticals, Inc. was completed, resulting in EIP becoming a wholly-owned subsidiary of the newly named CervoMed Inc.[324]. - The merger is treated as a reverse recapitalization under US GAAP, with EIP's historical results considered the Company's historical results prior to the merger[324]. - The company changed its corporate name from "Diffusion Pharmaceuticals Inc." to "CervoMed Inc." following the merger with EIP on August 16, 2023[365].