Financial Position - As of September 30, 2023, the company reported an accumulated deficit of 453.3millionandexpectstocontinueincurringnetlossesfortheforeseeablefuture[78].−Thecompanyhadcash,cashequivalents,restrictedcash,andavailable−for−saleinvestmentstotaling105.6 million as of September 30, 2023[78]. - As of September 30, 2023, financing lease liabilities totaled 1.9million,with2.7 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,consistingofdrugproductmaterialsoldtoKyorinfortheJapanportionoftheEFZO−FITstudy[102].−FortheninemonthsendedSeptember30,2023,licenseandcollaborationagreementrevenuesremainedat0.4 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,adecreasefrom31.5 million in 2022, primarily due to a 10.0millionmilestonepaymentreceivedfromKyorin[84].−NetcashusedininvestingactivitiesfortheninemonthsendedSeptember30,2023,was(37.9) million, compared to 45.2millionin2022,influencedbytimingdifferencesininvestmenttransactions[85].−NetcashprovidedbyfinancingactivitiesfortheninemonthsendedSeptember30,2023,was60.2 million, significantly higher than 4.5millionin2022,mainlyfroma48.1 million follow-on public offering[86]. - Total cash and cash equivalents increased by 92,000asofSeptember30,2023,comparedtoa18.3 million increase in 2022[84]. - Other income (expense), net rose to 1.2millioninQ32023from0.2 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 3.3millionfrom0.6 million in 2022, reflecting higher cash balances and interest rates[106]. Clinical Development - The company received a 10.0millionmilestonepaymentfromKyorinPharmaceuticalinFebruary2023,followingthedosingofthefirstpatientinJapanfortheEFZO−FITstudy[83].−TheEFZO−FITstudyisa52−weekclinicaltrialenrolling264subjectswithpulmonarysarcoidosis,withtheprimaryendpointbeingsteroidreduction[70].−ThecompanyinitiatedtheEFZO−CONNECTstudyinOctober2023,targetingpatientswithsystemicsclerosis−associatedinterstitiallungdisease,withatotalof25patientstobeenrolled[71].−Researchanddevelopmentexpensesareexpectedtoincreaseasthecompanyadvancesclinicaltrialsforefzofitimodandotherpotentialtherapies[96].−Researchanddevelopmentexpensesincreasedto10.3 million in Q3 2023 from 9.9millioninQ32022,primarilyduetoa1.1 million rise in manufacturing costs and a 0.6millionincreaseinclinicaltrialcosts[103].−ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2023,were29.5 million, up from 27.9millionin2022,drivenbya5.0 million increase in clinical trial costs[106]. General and Administrative Expenses - General and administrative expenses decreased to 2.6millioninQ32023from3.6 million in Q3 2022, mainly due to a 0.7millionreductioninpersonnel−relatedexpenses[103].−GeneralandadministrativeexpensesfortheninemonthsendedSeptember30,2023,decreasedto9.8 million from 10.6millionin2022,primarilyduetoa0.8 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,withanallowanceofupto5.5 million for such improvements[91].