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a Therapeutics(COYA) - 2024 Q3 - Quarterly Report
COYAa Therapeutics(COYA)2024-11-06 13:06

Financial Performance - The company reported net losses of 4.0millionforQ32024,comparedto4.0 million for Q3 2024, compared to 3.4 million for Q3 2023, and 12.0millionfortheninemonthsendedSeptember30,2024,comparedto12.0 million for the nine months ended September 30, 2024, compared to 9.3 million for the same period in 2023[85]. - As of September 30, 2024, the company had an accumulated deficit of 37.8million[85].−Thecompanyhasnotrecognizedanyrevenuefromproductsalesanddoesnotexpecttogeneraterevenueintheforeseeablefuture[117].−Otherincome,netincreasedby37.8 million[85]. - The company has not recognized any revenue from product sales and does not expect to generate revenue in the foreseeable future[117]. - Other income, net increased by 739,712 from 464,693intheninemonthsendedSeptember30,2023,to464,693 in the nine months ended September 30, 2023, to 1,204,405 in the same period of 2024[138]. - Collaboration revenue was 3,552,109fortheninemonthsendedSeptember30,2024,withnocollaborationrevenuesearnedinQ32024duetoincreasedspendingonCOYA302[129].−CashprovidedbyfinancingactivitiesduringtheninemonthsendedSeptember30,2024,was3,552,109 for the nine months ended September 30, 2024, with no collaboration revenues earned in Q3 2024 due to increased spending on COYA 302[129]. - Cash provided by financing activities during the nine months ended September 30, 2024, was 6.3 million, down from 14.3millioninthesameperiodof2023[145][150].ResearchandDevelopment−Theleadasset,COYA302,isacombinationoflowdoseinterleukin−2andCTLA4−Ig,targetingneurodegenerativedisorders[85].−TheproductcandidatepipelineincludesTreg−enhancingbiologics,Treg−derivedexosomes,andautologousTregcelltherapy,focusingonneurodegenerative,autoimmune,andmetabolicdiseases[83].−ThePhase2POCstudyofLDIL−2inALSpatientsshowednodeclineorminimaldeclineinALSFRS−Rscoresat24and48weeks,indicatingsafetyandtolerability[92].−ThePhase2trialofLDIL−2inAlzheimer′sdiseasedemonstratedaclinicallymeaningful4.93−pointimprovementinADAS−Cog14scorescomparedtoplacebo[98].−TheLDIL−2q4wksregimensignificantlyimprovedCSFAβ42levels(p=0.045)comparedtoplacebo,indicatingpotentialbenefitsinADpathology[106].−ThePhase2trialforFTDisanticipatedtoreportclinicaldatainthesecondhalfof2025,assessingsafetyandtolerabilityofLDIL−2[114].−Researchanddevelopmentexpensesprimarilyconsistofcostsrelatedtodiscoveryanddevelopment,includingclinicaltrialexpensesandregulatoryactivities[118].−Researchanddevelopmentexpensesincreasedby14.3 million in the same period of 2023[145][150]. Research and Development - The lead asset, COYA 302, is a combination of low dose interleukin-2 and CTLA4-Ig, targeting neurodegenerative disorders[85]. - The product candidate pipeline includes Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy, focusing on neurodegenerative, autoimmune, and metabolic diseases[83]. - The Phase 2 POC study of LD IL-2 in ALS patients showed no decline or minimal decline in ALSFRS-R scores at 24 and 48 weeks, indicating safety and tolerability[92]. - The Phase 2 trial of LD IL-2 in Alzheimer's disease demonstrated a clinically meaningful 4.93-point improvement in ADAS-Cog14 scores compared to placebo[98]. - The LD IL-2 q4wks regimen significantly improved CSF Aβ42 levels (p = 0.045) compared to placebo, indicating potential benefits in AD pathology[106]. - The Phase 2 trial for FTD is anticipated to report clinical data in the second half of 2025, assessing safety and tolerability of LD IL-2[114]. - Research and development expenses primarily consist of costs related to discovery and development, including clinical trial expenses and regulatory activities[118]. - Research and development expenses increased by 0.6 million from 1.6millioninQ32023to1.6 million in Q3 2023 to 2.2 million in Q3 2024, driven by preclinical advancement of COYA 302[130]. - Research and development expenses for the nine months ended September 30, 2024, reached 9.9million,up9.9 million, up 6.0 million from 3.9millioninthesameperiodof2023[135].−ThecompanyexpectsresearchanddevelopmentexpensestocontinuetogrowinQ42024asitadvancesCOYA301andCOYA302[122].FundingandCapitalRequirements−Thecompanyplanstofinanceoperationsthroughequitysales,debtfinancings,orcollaborations,highlightingtheneedforsubstantialadditionalcapital[89].−Thecompanyhasfundedoperationsprimarilythroughprivateconvertiblepreferredstockofferingsandpublic/privatesecuritiesofferings[85].−Thecompanyexpectsexistingcashandthe3.9 million in the same period of 2023[135]. - The company expects research and development expenses to continue to grow in Q4 2024 as it advances COYA 301 and COYA 302[122]. Funding and Capital Requirements - The company plans to finance operations through equity sales, debt financings, or collaborations, highlighting the need for substantial additional capital[89]. - The company has funded operations primarily through private convertible preferred stock offerings and public/private securities offerings[85]. - The company expects existing cash and the 10.0 million from the October 2024 Private Placement to fund operations into 2026[139]. - The company has no credit facility or committed sources of capital and will need significant additional funds for operational needs and clinical trials[143]. - The company anticipates financing operations through equity offerings, debt financings, and collaborations, but may face challenges due to global economic conditions[144]. Clinical Trials and Studies - Two proof of concept studies reported positive results for LD IL-2 in amyotrophic lateral sclerosis and Alzheimer's Disease[90]. - The Alzheimer's Disease study involved 8 patients and showed enhanced Treg function and reduced neuroinflammation, with no serious adverse events reported[91]. - The company submitted an IND for a Phase 2 study of COYA 302 in ALS patients, with the FDA requiring additional nonclinical data before initiation[93]. - The LD IL-2 q2wks group did not show benefits in exploratory endpoints, highlighting the importance of appropriate dosing for Treg functionality[99]. - The company plans to expand the COYA 302 pipeline to include FTD and PD, targeting complex immune pathways in neurodegenerative diseases[111]. Expenses and Operational Costs - Total operating expenses rose by 886,226from886,226 from 3,564,063 in Q3 2023 to 4,450,289inQ32024[128].−Netlossincreasedby4,450,289 in Q3 2024[128]. - Net loss increased by 599,444 from 3,421,974inQ32023to3,421,974 in Q3 2023 to 4,021,418 in Q3 2024[128]. - General and administrative expenses increased by 1.3millionfrom1.3 million from 5.5 million for the nine months ended September 30, 2023, to 6.7millionforthesameperiodin2024[138].−Generalandadministrativeexpensesareanticipatedtorisetosupportongoingresearchanddevelopmentandpotentialcommercializationefforts[125].AgreementsandCollaborations−ThecompanyenteredintotheDRLDevelopmentAgreement,receivinga6.7 million for the same period in 2024[138]. - General and administrative expenses are anticipated to rise to support ongoing research and development and potential commercialization efforts[125]. Agreements and Collaborations - The company entered into the DRL Development Agreement, receiving a 7.5 million upfront payment and potential additional payments totaling 44.2millionuponachievingcertainmilestones[151].−Thecompanyisentitledtoupto44.2 million upon achieving certain milestones[151]. - The company is entitled to up to 40.0 million in development milestones and up to 677.3millioninsalesmilestonesundertheDRLDevelopmentAgreement[151].−ThecompanyhasalicenseagreementwithMethodistHospital,whichincludesmilestonepaymentstotalingupto677.3 million in sales milestones under the DRL Development Agreement[151]. - The company has a license agreement with Methodist Hospital, which includes milestone payments totaling up to 0.3 million for ALS treatment and royalties of 1% to 10% on annual worldwide net sales[154]. - The company executed a Sponsored Research Agreement with Houston Methodist Research Institute, funding approximately 0.5millionthroughMay2024,lateramendedto0.5 million through May 2024, later amended to 1.0 million through September 2025[156]. - The company entered into an ARScience License Agreement, paying a one-time option fee of 0.1millionforexclusiverightstotwopatentsrelatedtoIL−2formulations[157].−ThecompanyexercisedtheARSOption,resultinginamid−six−figureup−frontfeeandtheactivationoftheARSLicenseAgreement[158].−UndertheARSLicenseAgreement,thecompanywillpay0.1 million for exclusive rights to two patents related to IL-2 formulations[157]. - The company exercised the ARS Option, resulting in a mid-six-figure up-front fee and the activation of the ARS License Agreement[158]. - Under the ARS License Agreement, the company will pay 13.3 million in milestone payments for the first Combination Product and 11.6millionforeachsubsequentnewindication[159].−Thecompanywillalsopay11.6 million for each subsequent new indication[159]. - The company will also pay 11.8 million in milestone payments for the first Mono Product and 5.9millionforeachsubsequentnewindication[159].−ThecompanyenteredintoaLicenseandSupplyAgreementwithDr.Reddy′sLaboratories,payingaone−timeupfrontfeeof5.9 million for each subsequent new indication[159]. - The company entered into a License and Supply Agreement with Dr. Reddy's Laboratories, paying a one-time upfront fee of 0.4 million[161]. - The company will pay up to approximately 2.9millioninpre−approvalregulatorymilestonepaymentsandanadditional2.9 million in pre-approval regulatory milestone payments and an additional 20.0 million for other milestones under the DRL Agreement[161]. - The company will pay single-digit royalties on net sales to Dr. Reddy's Laboratories as part of the DRL Agreement[161].