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First Wave BioPharma(FWBI) - 2024 Q4 - Annual Report
FWBIFirst Wave BioPharma(FWBI)2025-04-01 21:12

Development Focus - The company is focused on developing Adrulipase, a biologic for treating exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis patients[367]. - The company has discontinued the Latiglutenase, Capeserod, and Niclosamide programs, indicating a strategic shift in its development focus[367]. - A merger with ImmunogenX was announced in March 2024, but the company plans to dispose of certain assets, including Latiglutenase and CypCel, within 12 months[368]. - The company has terminated its license agreement with Sanofi for Capeserod, effective April 2025[370]. - The company is not pursuing the sale of its Niclosamide program, which was announced in December 2023[373]. - The company is focused on expanding its product pipeline through collaborations and acquisitions, evaluating potential asset acquisitions and business combinations[406]. Financial Performance - The net loss for the year ended December 31, 2024 was approximately 18million,anincreaseofapproximately18 million, an increase of approximately 2.2 million, or 15%, from the net loss of approximately 15.8millionin2023[415].−AsofDecember31,2024,thecompanyhadcashandcashequivalentsofapproximately15.8 million in 2023[415]. - As of December 31, 2024, the company had cash and cash equivalents of approximately 185,000 and negative working capital of approximately 4.3million[403].−Thecompanyanticipatescontinuednetlossesfortheforeseeablefutureandisdependentonobtainingadditionalfundingtocontinueoperations[403].−NetcashusedinoperatingactivitiesfortheyearendedDecember31,2024wasapproximately4.3 million[403]. - The company anticipates continued net losses for the foreseeable future and is dependent on obtaining additional funding to continue operations[403]. - Net cash used in operating activities for the year ended December 31, 2024 was approximately 9.2 million, primarily due to the net loss of approximately 18million[417].−NetcashprovidedbyfinancingactivitiesfortheyearendedDecember31,2024wasapproximately18 million[417]. - Net cash provided by financing activities for the year ended December 31, 2024 was approximately 5.6 million, primarily from the exercise of warrants and issuance of Common Stock[420]. - The company has sustained cumulative losses attributable to common stockholders of approximately 202.4millionasofDecember31,2024[403].ComplianceandRegulatoryMatters−ThecompanyreceivedaletterfromNasdaqonSeptember6,2024,indicatingnon−compliancewiththeminimumbidpricerequirementof202.4 million as of December 31, 2024[403]. Compliance and Regulatory Matters - The company received a letter from Nasdaq on September 6, 2024, indicating non-compliance with the minimum bid price requirement of 1.00 per share, with a compliance deadline extended to September 1, 2025[378][379]. - The company has initiated plans to regain compliance with Nasdaq listing requirements, including holding an annual meeting of stockholders by June 30, 2025[382]. Goodwill and Stock-Based Compensation - Goodwill related to the acquisition of ProteaBio Europe SAS is approximately 1.7millionasofDecember31,2024and2023[427].−Goodwillissubjecttoannualreviewforimpairmentandisnotamortized[426].−ThecarryingvalueofgoodwillisnowdenominatedinU.S.dollarsfollowingthedissolutionofAzurRxSASinOctober2022[427].−Ifactualresultsdifferfromestimates,thecompanymayfaceamaterialimpairmentcharge[427].−Goodwillisimpactedbyestimatesofthefairvaluesofacquiredassetsandassumedliabilities[425].−Thefairvalueofstock−basedcompensationisrecognizedovertherequisiteserviceperiod,generallythevestingperiod[424].−Non−employeeawardsforstock−basedcompensationareremeasuredateachreportingperioduntilthefinalmeasurementdate[424].−Judgmentisusedtodeterminewheneventsindicatingpotentialimpairmentofgoodwillarise[426].Expenses−ResearchanddevelopmentexpensesfortheyearendedDecember31,2024totaledapproximately1.7 million as of December 31, 2024 and 2023[427]. - Goodwill is subject to annual review for impairment and is not amortized[426]. - The carrying value of goodwill is now denominated in U.S. dollars following the dissolution of AzurRx SAS in October 2022[427]. - If actual results differ from estimates, the company may face a material impairment charge[427]. - Goodwill is impacted by estimates of the fair values of acquired assets and assumed liabilities[425]. - The fair value of stock-based compensation is recognized over the requisite service period, generally the vesting period[424]. - Non-employee awards for stock-based compensation are remeasured at each reporting period until the final measurement date[424]. - Judgment is used to determine when events indicating potential impairment of goodwill arise[426]. Expenses - Research and development expenses for the year ended December 31, 2024 totaled approximately 0.9 million, a decrease of approximately 4.1million,or824.1 million, or 82%, from approximately 5.0 million in 2023[409]. - General and administrative expenses for the year ended December 31, 2024 totaled approximately 14.7million,anincreaseofapproximately14.7 million, an increase of approximately 3.9 million, or 36%, from approximately $10.7 million in 2023[411].