Company Focus and Strategy - The company is focused on developing Adrulipase, a recombinant lipase enzyme for patients with cystic fibrosis and chronic pancreatitis, while discontinuing programs for Latiglutenase, Capeserod, and Niclosamide [367]. - In March 2024, the company completed a merger with ImmunogenX, acquiring assets including Latiglutenase and CypCel, but plans to dispose of these assets within 12 months [368]. - The company has initiated a plan to dispose of the Latiglutenase program, which was aimed at treating celiac disease [375]. - The company is no longer pursuing the Niclosamide program, which included multiple Phase 2 clinical trials for various GI conditions [377]. - 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,anincreaseofapproximately2.2 million, or 15%, over the net loss of approximately 15.8millionrecordedfortheyearendedDecember31,2023[415].−ResearchanddevelopmentexpensesfortheyearendedDecember31,2024totaledapproximately0.9 million, a decrease of approximately 4.1million,or825.0 million in 2023 [409]. - General and administrative expenses for the year ended December 31, 2024 totaled approximately 14.7million,anincreaseofapproximately3.9 million, or 36%, compared to 10.7millionin2023[411].−NetcashusedinoperatingactivitiesduringtheyearendedDecember31,2024wasapproximately9.2 million, primarily attributable to the net loss of approximately 18million[417].−NetcashprovidedbyfinancingactivitiesfortheyearendedDecember31,2024wasapproximately5.6 million, primarily due to net proceeds from the exercise of warrants and issuance of Common Stock [420]. - As of December 31, 2024, the company had cash and cash equivalents of approximately 185,000andnegativeworkingcapitalofapproximately4.3 million [403]. Compliance and Agreements - The company received a letter from Nasdaq on September 6, 2024, indicating non-compliance with the minimum bid price requirement of 1.00pershare,withacompliancedeadlineextendedtoSeptember1,2025[378][379].−ArescissionagreementwasannouncedinMarch2025,whichwillresultinthecancellationofsharesandoptionsissuedduringthemerger,withthecompanyretainingapproximately695,000 of IMGX's accounts payable and IMGX responsible for about 9,278,400ofsecureddebt[369][390].−ThecompanyterminateditslicenseagreementwithSanofiforCapeserod,effectiveApril2025,withnopaymentsduetoSanofi[370].−ARevolvingLoanAgreementwasenteredintoonJanuary31,2025,providing2,000,000 in loans, with an initial disbursement of 550,000andaninterestrateof185,000,000 as part of the Revolving Loan Agreement [384]. Goodwill and Stock-Based Compensation - Goodwill related to the acquisition of ProteaBio Europe SAS is approximately $1.7 million as of December 31, 2024 and 2023 [427]. - Goodwill is subject to periodic review for impairment, with judgment used to determine when events indicate potential recoverability issues [426]. - The fair value of stock-based compensation is recognized over the requisite service period, generally the vesting period [424]. Clinical Trials and Research - The company announced topline results from a Phase 2b study of Adrulipase, indicating safety and tolerability, although the primary efficacy endpoint was not achieved [374]. - The company anticipates continued increases in general and administrative expenses to support expanded research and development activities and business development efforts [401].
