Mergers and Acquisitions - The company closed a merger with ImmunogenX, Inc. on March 13, 2024, acquiring 36,830 shares of Common Stock and 11,777.418 shares of Series G Preferred Stock [429][436][437]. - The company entered into a non-binding term sheet to sell its Niclosamide program, which includes a low seven-figure upfront payment and future milestone and royalty economics, expected to close in the first half of 2024 [430]. Clinical Development - The Latiglutenase program is expected to enter Phase 3 clinical trials in the first half of 2025 after a successful End-of-Phase 2 meeting with the FDA [431]. - The Adrulipase program's Phase 2b study indicated that the primary efficacy endpoint was likely not achieved, and a Type C meeting with the FDA is planned for 2024 to discuss next steps [432]. - The Capeserod program, in-licensed from Sanofi, is expected to initiate a Phase 2 clinical development program for either pediatric ulcerative colitis or gastroparesis [433]. Financial Performance - As of September 30, 2023, IMGX reported total stockholders' equity of $3,278,805, having previously reported $881,960 as of June 30, 2023 [460]. - The company reported a net loss of approximately $15.8 million for the year ended December 31, 2023, an increase of approximately $1.2 million, or 8%, compared to the net loss of approximately $14.6 million for 2022 [500]. - Research and development expenses for the year ended December 31, 2023 totaled approximately $5.0 million, a decrease of approximately $3.8 million, or 43%, from approximately $8.8 million in 2022 [493]. - General and administrative expenses for the year ended December 31, 2023 were approximately $10.7 million, a decrease of approximately $1.3 million, or 10%, from approximately $12.0 million in 2022 [497]. - The company has not generated any revenues from its product candidates since inception [492]. Funding and Capital Structure - The Amended Credit Agreement with a total commitment of $8,212,345.17 includes an interest rate of prime plus 6.00% and a maturity date extended to September 13, 2025 [452]. - On March 6, 2024, IMGX closed a Registered Direct Offering for 525,625 shares at a price of $7.61 per share, generating approximately $4.0 million in gross proceeds [463]. - The company received aggregate gross proceeds of approximately $4.8 million from a warrant exercise inducement offer, involving the exercise of existing warrants for 881,337 shares at a reduced price of $5.50 per share [466]. - The company raised approximately $4.0 million from a Registered Direct Offering in March 2024 [490]. - The company is dependent on obtaining additional funding to continue operations and may never achieve profitability [483]. Regulatory Compliance - On January 4, 2024, IMGX received notice of compliance with Nasdaq's Bid Price Rule after previously being notified of non-compliance on August 24, 2023 [461]. - The company is awaiting a determination from Nasdaq regarding compliance with the Minimum Stockholders' Equity Rule after submitting a plan on October 2, 2023 [460]. - IMGX's Amended Credit Agreement includes covenants that restrict its ability to incur additional indebtedness and engage in certain transactions, with payments personally guaranteed by Jack Syage [455]. Research and Development Costs - IMGX's research and development costs include personnel-related costs, fees to third parties, and expenses for clinical trials, with costs expensed as incurred [477]. - Research and development expenses are expected to increase as IMGX focuses on the clinical development of product candidates, including Latiglutenase, Adrulipase, Capeserod, and Niclosamide [475]. - The company expects to incur substantial expenditures for the development of its product candidates, including Latiglutenase, Adrulipase, Capeserod, and Niclosamide [485]. Strategic Plans - The company plans to opportunistically expand its product pipeline through collaborations and acquisitions [486]. - The company’s ability to issue securities is subject to market conditions and regulatory limitations due to its public float being below $75.0 million [488]. - Smaller reporting companies are not required to provide the information required by this item [515].
First Wave BioPharma(FWBI) - 2023 Q4 - Annual Report