Company Focus and Development - The company is focused on developing Adrulipase, a biologic for treating exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients [173]. - The Phase 2b study of Adrulipase showed safety and tolerability, although the primary efficacy endpoint was not achieved, and the company plans to advance this program in 2025 [180]. - The company is no longer pursuing the Latiglutenase, Capeserod, and Niclosamide programs, indicating a strategic shift in its development focus [173][181][183]. - The company expects to incur substantial expenditures for the development of Adrulipase and will require additional financing to support clinical trials and regulatory approvals [203]. - The company is focused on expanding its product pipeline through collaborations and acquisitions, evaluating potential asset acquisitions and business combinations [204]. Financial Performance - As of March 31, 2025, the company had cash and cash equivalents of approximately $66,000 and cumulative losses attributable to common stockholders of approximately $1.2 million [201]. - The company has not generated any revenues to date and anticipates continuing to incur net losses for the foreseeable future [200][210]. - The net loss for the three months ended March 31, 2025 totaled approximately $1 million, a decrease of approximately $6.8 million, or 122%, compared to the income of approximately $5.6 million recorded for the same period in 2024 [228]. - Research and development expenses for the three months ended March 31, 2025 totaled approximately $16,000, a decrease of approximately $0.6 million, or 97%, compared to the same period in 2024 [221]. - General and administrative expenses for the three months ended March 31, 2025 totaled approximately $0.8 million, a decrease of approximately $7.7 million, or 91%, compared to the same period in 2024 [222]. Cash Flow and Financing - Net cash used in operating activities for Q1 2025 was approximately $0.8 million, primarily due to a net loss of approximately $1.3 million [230]. - Net cash used in operating activities for Q1 2024 was approximately $3.7 million, primarily due to a non-cash change in deferred tax valuation allowance of $14.9 million, partially offset by net income of $5.6 million [231]. - Net cash provided by financing activities for Q1 2025 was approximately $0.7 million, resulting from net proceeds from the draw on the revolver loan [233]. - Net cash provided by financing activities for Q1 2024 was approximately $3.4 million, primarily due to net proceeds from a registered direct offering [234]. - The company has closed on a revolving loan agreement in the principal amount of $2.0 million, with an initial loan amount of $700,000 disbursed [206]. Compliance and Regulatory Matters - Nasdaq granted the company a 180-day extension until September 1, 2025, to regain compliance with the minimum bid price requirement of $1.00 per share [185]. - The company has received a letter from Nasdaq regarding non-compliance with the annual meeting requirement, with an extension granted until June 30, 2025, to regain compliance [189]. - A rescission agreement was announced in March 2025, which will result in the cancellation of shares issued during the merger and the company retaining approximately $695,000 of IMGX's accounts payable [175][193]. - The company terminated its license agreement with Sanofi for Capeserod, effective April 2025, with no payments due to Sanofi [176]. Asset Management - The company plans to dispose of certain assets and liabilities of IMGX, including Latiglutenase and CypCel, within 12 months of the merger [174]. - There were no cash flows from investing activities in Q1 2025, with approximately $0.1 million attributed to net cash acquired in the acquisition of IMGX [232]. - The company reported a net increase in other assets and liabilities of approximately $0.4 million in Q1 2025 [230]. - The impairment of right-of-use assets in Q1 2025 was approximately $0.1 million [230]. - The company experienced a decrease in accounts payable of approximately $0.1 million in Q1 2025 [230]. Accounting Policies - There were no material changes to critical accounting policies during the three months ended March 31, 2025 [236]. - The significant accounting policies are detailed in the Annual Report on Form 10-K/A for the year ended December 31, 2024 [235].
First Wave BioPharma(FWBI) - 2025 Q1 - Quarterly Report