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Iterum Therapeutics(ITRM) - 2024 Q2 - Earnings Call Transcript
ITRMIterum Therapeutics(ITRM)2024-08-16 15:27
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Financial Data and Key Metrics Changes - Total operating expenses decreased to 4millioninQ22024from4 million in Q2 2024 from 10.8 million in Q2 2023, primarily due to reduced R&D costs [10][11] - R&D expenses were 2.1millioninQ22024comparedto2.1 million in Q2 2024 compared to 9 million in the same period of 2023, reflecting a 6.9milliondecrease[11]−NetlossonaGAAPbasiswas6.9 million decrease [11] - Net loss on a GAAP basis was 5 million for Q2 2024, down from 12.2millioninQ22023;onanon−GAAPbasis,thenetlosswas12.2 million in Q2 2023; on a non-GAAP basis, the net loss was 3.8 million compared to 10 million in Q2 2023 [11][12] Business Line Data and Key Metrics Changes - The primary driver for the decrease in R&D expenses was the completion of enrollment in the REASSURE trial, which began in October 2022 and completed in October 2023 [11] Market Data and Key Metrics Changes - As of June 30, the company had 11.7 million in cash and cash equivalents, which, along with proceeds from a recent rights offering of 5.8million,providesarunwayinto2025[8][12]CompanyStrategyandDevelopmentDirection−ThecompanyisfocusedonmaximizingthevalueofsulopenemandpreparingforanupcomingmeetingwiththeFDA′sAntimicrobialDrugsAdvisoryCommitteeregardingitsresubmittedNDAfororalsulopenem[6][7]−Thecompanyisseekingshareholderapprovaltodisapplystatutorypreemptionrightstofacilitatequickercapitalraisingopportunities[9]Management′sCommentsonOperatingEnvironmentandFutureOutlook−ManagementexpressedoptimismabouttheupcomingFDAmeetingandthepotentialapprovaloforalsulopenem,whichwouldbethefirstoralpenemapprovedintheU.S.[6][29]−Thecompanyispreparingfordiscussionsonappropriatepatientpopulationsandstewardshiprelatedtotheuseofsulopenem[17][18]OtherImportantInformation−ThecompanyhasexpandeditsintellectualpropertyestatewithallowedpatentapplicationsintheU.S.andCanadarelatedtosulopenem[7][8]−Thecompanyhasapproximately22.7millionordinarysharesoutstandingand5.8 million, provides a runway into 2025 [8][12] Company Strategy and Development Direction - The company is focused on maximizing the value of sulopenem and preparing for an upcoming meeting with the FDA's Antimicrobial Drugs Advisory Committee regarding its resubmitted NDA for oral sulopenem [6][7] - The company is seeking shareholder approval to disapply statutory preemption rights to facilitate quicker capital raising opportunities [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming FDA meeting and the potential approval of oral sulopenem, which would be the first oral penem approved in the U.S. [6][29] - The company is preparing for discussions on appropriate patient populations and stewardship related to the use of sulopenem [17][18] Other Important Information - The company has expanded its intellectual property estate with allowed patent applications in the U.S. and Canada related to sulopenem [7][8] - The company has approximately 22.7 million ordinary shares outstanding and 11.1 million of exchangeable notes, which could lead to a $14.7 million obligation in January 2025 if not exchanged [12] Q&A Session Summary Question: Can you discuss your perspective on the FDA's concerns regarding antibiotic resistance and the approval of sulopenem? - Management believes the FDA is not reluctant to approve sulopenem but is focused on ensuring it is used appropriately for the right patients [14] Question: What topics do you anticipate will be raised at the Advisory Committee meeting? - Key topics include stewardship and the appropriate patient population for sulopenem [17][18] Question: Are you allowed to include safety data from studies outside of U.K. patients? - Yes, the company will include comprehensive safety data from multiple Phase III studies, which show a clean safety profile for sulopenem [19] Question: Do you think the FDA might narrow the label and indication for sulopenem? - Management indicated that narrowing the label could be challenging without evidence from studied populations [24][25] Question: Will the REASSURE data be discussed, and could superiority aspects be included in the label? - While it is uncertain if superiority will be included in the label, management feels confident about the strength of the data from the REASSURE study [26][27]