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Tourmaline Bio(TRML) - 2024 Q3 - Quarterly Report
TRMLTourmaline Bio(TRML)2024-11-07 13:22

Financial Performance - The company reported net losses of 51.0millionand51.0 million and 29.2 million for the nine months ended September 30, 2024 and 2023, respectively, with an accumulated deficit of 113.0millionasofSeptember30,2024[97].−ThenetlossforthethreemonthsendedSeptember30,2024,was113.0 million as of September 30, 2024[97]. - The net loss for the three months ended September 30, 2024, was 20.2 million, an increase of 14.6millionfromanetlossof14.6 million from a net loss of 5.6 million in the same period of 2023[128]. - As of September 30, 2024, the company has not generated any revenue since inception and does not expect to do so in the near future[116]. - The company expects to incur significant expenses and operating losses for the foreseeable future as it advances clinical development[136]. - The company has raised approximately 359.7millioninaggregategrossproceedssinceinception[137].CashandInvestments−Thecompanyhastotalcash,cashequivalents,andinvestmentsof359.7 million in aggregate gross proceeds since inception[137]. Cash and Investments - The company has total cash, cash equivalents, and investments of 314.4 million as of September 30, 2024[96]. - As of September 30, 2024, the company had 314.4millionincash,cashequivalents,andinvestments,withsufficientworkingcapitalexpectedtofundoperationsinto2027[138].−NetcashusedinoperatingactivitiesfortheninemonthsendedSeptember30,2024,was314.4 million in cash, cash equivalents, and investments, with sufficient working capital expected to fund operations into 2027[138]. - Net cash used in operating activities for the nine months ended September 30, 2024, was 56.4 million, an increase of 37.6millioncomparedto37.6 million compared to 18.7 million for the same period in 2023[148]. - Net cash used in investing activities for the nine months ended September 30, 2024, was 210.7million,asignificantincreasefromlessthan210.7 million, a significant increase from less than 0.1 million in the same period in 2023[149]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was 161.4million,comparedto161.4 million, compared to 88.6 million for the same period in 2023[150]. Research and Development - Research and development expenses for the three months ended September 30, 2024, increased by 15.6millionto15.6 million to 19.3 million compared to 3.8millioninthesameperiodof2023[129].−FortheninemonthsendedSeptember30,2024,researchanddevelopmentexpensesincreasedby3.8 million in the same period of 2023[129]. - For the nine months ended September 30, 2024, research and development expenses increased by 22.1 million to 46.4millioncomparedto46.4 million compared to 24.4 million in the same period of 2023[133]. - The company has reached alignment with the FDA on the ASCVD clinical development program, including a Phase 2 trial evaluating hs-CRP reduction[93]. - Pacibekitug, the company's lead product candidate, is currently being evaluated in a pivotal Phase 2b trial for thyroid eye disease (TED), with topline data expected in the second half of 2025[92]. - The company initiated a Phase 2 trial of pacibekitug in patients with chronic kidney disease and elevated hs-CRP in April 2024, with topline data expected in the first half of 2025[94]. Obligations and Future Funding - The company has an obligation to pay Pfizer up to 128.0millionuponachievingspecificdevelopmentandregulatorymilestonesrelatedtopacibekitug[105].−ThecompanymayneedtopayPfizerupto128.0 million upon achieving specific development and regulatory milestones related to pacibekitug[105]. - The company may need to pay Pfizer up to 128.0 million upon achieving specific development and regulatory milestones and up to 525.0millionuponachievingspecificsalesmilestones[146].−Futurefundingrequirementswilldependonvariousfactors,includingthecostsofclinicaltrialsandregulatoryreviewsforproductcandidates[142].−Thecompanyexpectstoseekadditionalcapitalthroughprivateorpublicequityordebtfinancings,whichmaydiluteexistingstockholders′ownership[141].GeneralandAdministrativeExpenses−GeneralandadministrativeexpensesforthethreemonthsendedSeptember30,2024,increasedby525.0 million upon achieving specific sales milestones[146]. - Future funding requirements will depend on various factors, including the costs of clinical trials and regulatory reviews for product candidates[142]. - The company expects to seek additional capital through private or public equity or debt financings, which may dilute existing stockholders' ownership[141]. General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2024, increased by 2.2 million to 5.1millioncomparedto5.1 million compared to 2.9 million in the same period of 2023[130]. - General and administrative expenses for the nine months ended September 30, 2024, increased by 11.3millionto11.3 million to 17.5 million compared to 6.2millioninthesameperiodof2023[134].BusinessStrategyandOpportunities−Thecompanyisexploringadditionalindicationopportunitiesforpacibekitugandevaluatingnewin−licensingandacquisitionopportunities[95].−Thecompanyremainsanemerginggrowthcompanyandasmallerreportingcompany,allowingittotakeadvantageofcertainregulatoryexemptions[156][158].−Thecompanyissubjecttorisksassociatedwiththedevelopmentofnewbiopharmaceuticalproducts,whichmayleadtounforeseenexpensesanddelays[140].−Otherincome,netforthethreemonthsendedSeptember30,2024,increasedby6.2 million in the same period of 2023[134]. Business Strategy and Opportunities - The company is exploring additional indication opportunities for pacibekitug and evaluating new in-licensing and acquisition opportunities[95]. - The company remains an emerging growth company and a smaller reporting company, allowing it to take advantage of certain regulatory exemptions[156][158]. - The company is subject to risks associated with the development of new biopharmaceutical products, which may lead to unforeseen expenses and delays[140]. - Other income, net for the three months ended September 30, 2024, increased by 3.2 million to 4.3millioncomparedto4.3 million compared to 1.1 million in the same period of 2023[131].