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aTyr Pharma(LIFE) - 2023 Q3 - Quarterly Report
LIFEaTyr Pharma(LIFE)2023-11-09 21:11

Financial Position - As of September 30, 2023, the company reported an accumulated deficit of 453.3millionandexpectstocontinueincurringnetlossesfortheforeseeablefuture[78].Thecompanyhadcash,cashequivalents,restrictedcash,andavailableforsaleinvestmentstotaling453.3 million and expects to continue incurring net losses for the foreseeable future[78]. - The company had cash, cash equivalents, restricted cash, and available-for-sale investments totaling 105.6 million as of September 30, 2023[78]. - As of September 30, 2023, financing lease liabilities totaled 1.9million,with1.9 million, with 2.7 million in cash collateral included in restricted cash[92]. Revenue and Income - The company has not generated any revenues from product sales to date and anticipates increased expenses related to ongoing clinical development and commercialization efforts[87]. - License and collaboration agreement revenues for Q3 2023 were 0.4million,unchangedfromQ32022,consistingofdrugproductmaterialsoldtoKyorinfortheJapanportionoftheEFZOFITstudy[102].FortheninemonthsendedSeptember30,2023,licenseandcollaborationagreementrevenuesremainedat0.4 million, unchanged from Q3 2022, consisting of drug product material sold to Kyorin for the Japan portion of the EFZO-FIT study[102]. - For the nine months ended September 30, 2023, license and collaboration agreement revenues remained at 0.4 million, consistent with the same period in 2022[105]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2023, was 22.2million,adecreasefrom22.2 million, a decrease from 31.5 million in 2022, primarily due to a 10.0millionmilestonepaymentreceivedfromKyorin[84].NetcashusedininvestingactivitiesfortheninemonthsendedSeptember30,2023,was10.0 million milestone payment received from Kyorin[84]. - Net cash used in investing activities for the nine months ended September 30, 2023, was (37.9) million, compared to 45.2millionin2022,influencedbytimingdifferencesininvestmenttransactions[85].NetcashprovidedbyfinancingactivitiesfortheninemonthsendedSeptember30,2023,was45.2 million in 2022, influenced by timing differences in investment transactions[85]. - Net cash provided by financing activities for the nine months ended September 30, 2023, was 60.2 million, significantly higher than 4.5millionin2022,mainlyfroma4.5 million in 2022, mainly from a 48.1 million follow-on public offering[86]. - Total cash and cash equivalents increased by 92,000asofSeptember30,2023,comparedtoa92,000 as of September 30, 2023, compared to a 18.3 million increase in 2022[84]. - Other income (expense), net rose to 1.2millioninQ32023from1.2 million in Q3 2023 from 0.2 million in Q3 2022, attributed to higher cash balances and increased interest rates[104]. - Other income (expense), net for the nine months ended September 30, 2023, increased to 3.3millionfrom3.3 million from 0.6 million in 2022, reflecting higher cash balances and interest rates[106]. Clinical Development - The company received a 10.0millionmilestonepaymentfromKyorinPharmaceuticalinFebruary2023,followingthedosingofthefirstpatientinJapanfortheEFZOFITstudy[83].TheEFZOFITstudyisa52weekclinicaltrialenrolling264subjectswithpulmonarysarcoidosis,withtheprimaryendpointbeingsteroidreduction[70].ThecompanyinitiatedtheEFZOCONNECTstudyinOctober2023,targetingpatientswithsystemicsclerosisassociatedinterstitiallungdisease,withatotalof25patientstobeenrolled[71].Researchanddevelopmentexpensesareexpectedtoincreaseasthecompanyadvancesclinicaltrialsforefzofitimodandotherpotentialtherapies[96].Researchanddevelopmentexpensesincreasedto10.0 million milestone payment from Kyorin Pharmaceutical in February 2023, following the dosing of the first patient in Japan for the EFZO-FIT study[83]. - The EFZO-FIT study is a 52-week clinical trial enrolling 264 subjects with pulmonary sarcoidosis, with the primary endpoint being steroid reduction[70]. - The company initiated the EFZO-CONNECT study in October 2023, targeting patients with systemic sclerosis-associated interstitial lung disease, with a total of 25 patients to be enrolled[71]. - Research and development expenses are expected to increase as the company advances clinical trials for efzofitimod and other potential therapies[96]. - Research and development expenses increased to 10.3 million in Q3 2023 from 9.9millioninQ32022,primarilyduetoa9.9 million in Q3 2022, primarily due to a 1.1 million rise in manufacturing costs and a 0.6millionincreaseinclinicaltrialcosts[103].ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2023,were0.6 million increase in clinical trial costs[103]. - Research and development expenses for the nine months ended September 30, 2023, were 29.5 million, up from 27.9millionin2022,drivenbya27.9 million in 2022, driven by a 5.0 million increase in clinical trial costs[106]. General and Administrative Expenses - General and administrative expenses decreased to 2.6millioninQ32023from2.6 million in Q3 2023 from 3.6 million in Q3 2022, mainly due to a 0.7millionreductioninpersonnelrelatedexpenses[103].GeneralandadministrativeexpensesfortheninemonthsendedSeptember30,2023,decreasedto0.7 million reduction in personnel-related expenses[103]. - General and administrative expenses for the nine months ended September 30, 2023, decreased to 9.8 million from 10.6millionin2022,primarilyduetoa10.6 million in 2022, primarily due to a 0.8 million reduction in personnel-related expenses[106]. Strategic Focus - The company is actively monitoring the impact of geopolitical and macroeconomic conditions on its operations, including inflation and rising interest rates[74]. - The company is focused on advancing its discovery pipeline for tRNA synthetase-derived therapies, leveraging collaborations and internal research efforts[73]. - The company expects to incur significant commercialization expenses if marketing approval is obtained for any product candidates, necessitating substantial additional funding[89]. Capital Expenditures - The company has incurred 5.6millionintenantimprovementcostsforitsnewcorporateheadquarters,withanallowanceofupto5.6 million in tenant improvement costs for its new corporate headquarters, with an allowance of up to 5.5 million for such improvements[91].