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Atea Pharmaceuticals(AVIR) - 2024 Q2 - Quarterly Report
AVIRAtea Pharmaceuticals(AVIR)2024-08-07 20:45
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Financial Position - The company has 502.2millionincash,cashequivalents,andmarketablesecuritiesasofJune30,2024,whichisexpectedtofundoperationsinto2027[76].−Thecompanyrecordedanetlossof502.2 million in cash, cash equivalents, and marketable securities as of June 30, 2024, which is expected to fund operations into 2027[76]. - The company recorded a net loss of 40.5 million for the three months ended June 30, 2024, compared to a net loss of 28.2millionforthesameperiodin2023,indicatingaworseningfinancialposition[88].−ThenetlossforthesixmonthsendedJune30,2024was28.2 million for the same period in 2023, indicating a worsening financial position[88]. - The net loss for the six months ended June 30, 2024 was 103.7 million, while the net loss for the same period in 2023 was 63.7million[99].−NetcashusedinoperatingactivitiesforthesixmonthsendedJune30,2024was63.7 million[99]. - Net cash used in operating activities for the six months ended June 30, 2024 was 82.1 million, compared to 46.0millionforthesameperiodin2023[98].−Thecompanyexperiencedanetincreaseincash,cashequivalents,andrestrictedcashof46.0 million for the same period in 2023[98]. - The company experienced a net increase in cash, cash equivalents, and restricted cash of 99.6 million for the six months ended June 30, 2024[98]. - Cash, cash equivalents, and marketable securities totaled 502.2millionasofJune30,2024[105].−Thecompanymayrequireadditionalcapitaltomeetoperationalneedsandcapitalrequirementsassociatedwithfutureoperatingplans[96].−Marketvolatility,inflation,andinterestratefluctuationsmaysignificantlyimpacttheavailabilityoffundingsources[96].−Futuredebtfinancingmayimposeadditionalcovenantsthatrestrictoperations,includinglimitationsonincurringadditionaldebt[96].ClinicalTrials−TheSUNRISE−3clinicaltrialforbemnifosbuvirhasfullyenrolled2,295patients,withresultsanticipatedinthesecondhalfof2024[73][74].−TheongoingPhase2clinicaltrialforbemnifosbuvirincombinationwithruzasvirhasenrolled275treatment−naı¨veHCV−infectedpatients,withfinalSVR12resultsexpectedinQ42024[75].−Thelead−incohortoftheHCVtrialshoweda97502.2 million as of June 30, 2024[105]. - The company may require additional capital to meet operational needs and capital requirements associated with future operating plans[96]. - Market volatility, inflation, and interest rate fluctuations may significantly impact the availability of funding sources[96]. - Future debt financing may impose additional covenants that restrict operations, including limitations on incurring additional debt[96]. Clinical Trials - The SUNRISE-3 clinical trial for bemnifosbuvir has fully enrolled 2,295 patients, with results anticipated in the second half of 2024[73][74]. - The ongoing Phase 2 clinical trial for bemnifosbuvir in combination with ruzasvir has enrolled 275 treatment-naïve HCV-infected patients, with final SVR12 results expected in Q4 2024[75]. - The lead-in cohort of the HCV trial showed a 97% SVR12 rate after eight weeks of treatment[75]. - The primary endpoint of the SUNRISE-3 study is all-cause hospitalization or death through Day 29 in the supportive care monotherapy cohort[73]. Revenue and Expenses - The company has not generated any product revenue since inception and does not anticipate revenue from product sales in the foreseeable future[76][80]. - The company does not expect to generate any product revenue until regulatory approval and commercialization of its product candidates are achieved[95]. - Research and development expenses increased by 12.6 million from 22.1millionforthethreemonthsendedJune30,2023,to22.1 million for the three months ended June 30, 2023, to 34.7 million for the three months ended June 30, 2024, primarily due to higher external spend related to clinical trials[89]. - Total research and development costs for the three months ended June 30, 2024, were 34.7million,comparedto34.7 million, compared to 22.1 million for the same period in 2023, reflecting a significant increase in external costs[85]. - Research and development expenses for the six months ended June 30, 2024, were 92.3million,upfrom92.3 million, up from 51.0 million for the same period in 2023, driven by increased external spending on clinical trials[93]. - The company recorded a net reduction in research and development expenses of 1.3millionforthesixmonthsendedJune30,2024,relatedtocreditsreceivedfromRoche,downfrom1.3 million for the six months ended June 30, 2024, related to credits received from Roche, down from 8.9 million for the same period in 2023[84]. - General and administrative expenses decreased by 1.0millionfrom1.0 million from 13.2 million for the three months ended June 30, 2023, to 12.2millionforthethreemonthsendedJune30,2024,mainlyduetolowerprofessionalfees[90].−Stock−basedcompensationexpenseforthesixmonthsendedJune30,2024was12.2 million for the three months ended June 30, 2024, mainly due to lower professional fees[90]. - Stock-based compensation expense for the six months ended June 30, 2024 was 25.3 million, compared to 24.9millionforthesameperiodin2023[99].LicensingAgreements−TheRocheLicenseAgreementforbemnifosbuvirwasterminatedinFebruary2022,grantingthecompanyexclusiverightstodevelopandcommercializetheproduct[78].−TheMerckLicenseAgreementforruzasvirincludesmilestonepaymentsandtieredroyaltiesbasedonnetsales,withthefirstmilestoneof24.9 million for the same period in 2023[99]. Licensing Agreements - The Roche License Agreement for bemnifosbuvir was terminated in February 2022, granting the company exclusive rights to develop and commercialize the product[78]. - The Merck License Agreement for ruzasvir includes milestone payments and tiered royalties based on net sales, with the first milestone of 5 million due upon starting a Phase 3 trial[79]. Operational Plans - The company plans to continue using third-party service providers for clinical development and manufacturing[81]. - The company expects to incur significant expenses as it advances clinical development and prepares for potential commercialization of its product candidates[81]. - The company anticipates continued significant operating expenditures as it seeks regulatory approvals and prepares for potential commercialization of its product candidates[95]. - Interest income and other, net, decreased by $0.7 million for the three months ended June 30, 2024, compared to the same period in 2023, primarily due to lower investment balances[90].