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Entero Therapeutics, Inc.(ENTO) - 2024 Q3 - Quarterly Report

Financial Position - Entero Therapeutics reported stockholders' equity of 881,960asofJune30,2023,whichwasbelowthe881,960 as of June 30, 2023, which was below the 2.5 million minimum requirement for Nasdaq listing compliance [176]. - Nasdaq provided Entero a compliance period until March 5, 2025, to regain compliance with the minimum bid price requirement of 1.00pershare[179].Thecompanyhadcashandcashequivalentsofapproximately1.00 per share [179]. - The company had cash and cash equivalents of approximately 0.4 million as of September 30, 2024, and cumulative losses attributable to common stockholders of approximately 190.1million[196].ThecompanyissubjecttoaNoticeofDefaultandAccelerationregardingitsCreditAgreement,witha30dayCurePeriodtoaddresstheEventsofDefault[186].MergersandAcquisitionsThecompanycompletedamergerwithImmunogenX,Inc.inMarch2024,focusingonthebiologicLatiglutenaseforceliacdiseasetreatment[169].EnteroinitiatedaplantodisposeofcertainassetsandliabilitiesofImmunogenX,includingLatiglutenaseandCypCel,within12monthsofthemerger[170].AbindingtermsheetwasenteredintowithJourneyTherapeutics,Inc.fortheacquisitionof100190.1 million [196]. - The company is subject to a Notice of Default and Acceleration regarding its Credit Agreement, with a 30-day Cure Period to address the Events of Default [186]. Mergers and Acquisitions - The company completed a merger with ImmunogenX, Inc. in March 2024, focusing on the biologic Latiglutenase for celiac disease treatment [169]. - Entero initiated a plan to dispose of certain assets and liabilities of ImmunogenX, including Latiglutenase and CypCel, within 12 months of the merger [170]. - A binding term sheet was entered into with Journey Therapeutics, Inc. for the acquisition of 100% of its outstanding equity interests in exchange for 99% of the company's fully-diluted equity [190]. Capital Raising and Financing - In May 2024, Entero announced a Registered Direct Offering, raising approximately 1.1 million from the sale of 275,000 shares of Common Stock at 2.95pershare[173].Thecompanyreceivedgrossproceedsofapproximately2.95 per share [173]. - The company received gross proceeds of approximately 4.0 million from a March 2024 Offering, which included 173,100 shares of Common Stock priced at 7.61each[172].Thecompanyanticipatesneedingtoraisesubstantialadditionalcapitalintheneartermtofundcontinuingoperationsandsatisfyexistingobligations[196].NetcashprovidedbyfinancingactivitiesfortheninemonthsendedSeptember30,2024,wasapproximately7.61 each [172]. - The company anticipates needing to raise substantial additional capital in the near term to fund continuing operations and satisfy existing obligations [196]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was approximately 5.61 million, primarily from registered direct offerings [223]. Operational Performance - Research and development expenses for Q3 2024 totaled approximately 0.2million,adecreaseofapproximately0.2 million, a decrease of approximately 0.8 million, or 80%, compared to 1.0millioninQ32023[204].GeneralandadministrativeexpensesforQ32024totaledapproximately1.0 million in Q3 2023 [204]. - General and administrative expenses for Q3 2024 totaled approximately 1.7 million, a decrease of approximately 0.7million,or300.7 million, or 30%, compared to 2.4 million in Q3 2023 [207]. - Total operating expenses for the three months ended September 30, 2024, decreased to 1.89million,down451.89 million, down 45% from 3.43 million for the same period in 2023 [208]. - Net loss for the three months ended September 30, 2024, was approximately 2.58million,adecreaseof2.58 million, a decrease of 0.85 million or 25% compared to a net loss of approximately 3.43millionforthesameperiodin2023[210].ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2024,totaledapproximately3.43 million for the same period in 2023 [210]. - Research and development expenses for the nine months ended September 30, 2024, totaled approximately 0.88 million, a decrease of 2.84millionor762.84 million or 76% from 3.73 million for the same period in 2023 [212]. - General and administrative expenses for the nine months ended September 30, 2024, increased to approximately 13.54million,anincreaseof13.54 million, an increase of 5.58 million or 70% compared to 7.95millionforthesameperiodin2023[215].Theincreaseingeneralandadministrativeexpenseswasprimarilydueto7.95 million for the same period in 2023 [215]. - The increase in general and administrative expenses was primarily due to 4.0 million in non-cash financial advisor fees related to the IMGX acquisition [216]. - Net cash used in operating activities for the nine months ended September 30, 2024, was approximately 9.05million,comparedto9.05 million, compared to 8.94 million for the same period in 2023 [221]. - Loss from discontinued operations for the nine months ended September 30, 2024, was 2.0million,representingexpensesrelatedtoadisposalgroupclassifiedasheldforsale[218].Incometaxbenefitofapproximately2.0 million, representing expenses related to a disposal group classified as held for sale [218]. - Income tax benefit of approximately 10.6 million was recorded in the nine months ended September 30, 2024, due to the release of a portion of the valuation allowance in connection with the IMGX Merger [217]. - Total cash decrease for the nine months ended September 30, 2024, was approximately 3.34million,comparedtoanincreaseof3.34 million, compared to an increase of 1.93 million for the same period in 2023 [221]. Strategic Initiatives - Entero is exploring strategic alternatives for its Niclosamide program, which is currently under a non-binding term sheet for potential sale [171]. - The company has paused development of non-essential research and development activities and is exploring strategic alternatives, including a potential sale or merger [183]. - The company is exploring various potential strategies, including raising capital and restructuring indebtedness, but there is no assurance these efforts will be successful [196]. Employment and Consulting - As of December 31, 2023, Entero had 9 employees, which increased to 15 after the merger, but was later reduced to 11 employees in July 2024 [180]. - The company entered into a consulting agreement with former CEO James Sapirstein, paying $400 per hour for services rendered [181].