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a Therapeutics(COYA) - 2024 Q2 - Quarterly Report
COYAa Therapeutics(COYA)2024-08-12 12:13

Financial Performance - The company reported net losses of 2.9millionand2.9 million and 3.1 million for the three months ended June 30, 2024 and 2023, respectively, and 7.9millionand7.9 million and 5.8 million for the six months ended June 30, 2024 and 2023, respectively, with an accumulated deficit of 33.8millionasofJune30,2024[73].−ThenetlossforQ22024was33.8 million as of June 30, 2024[73]. - The net loss for Q2 2024 was 2,891,680, a decrease of 203,695fromanetlossof203,695 from a net loss of 3,095,375 in Q2 2023[96]. - Net loss for the six months ended June 30, 2024, was 7.9millioncomparedtoanetlossof7.9 million compared to a net loss of 5.8 million for the same period in 2023, representing an increase of 2.1million[100].−Cashusedinoperatingactivitieswas2.1 million[100]. - Cash used in operating activities was 2.4 million for the six months ended June 30, 2024, compared to 6.7millionforthesameperiodin2023[110].−AsofJune30,2024,thecompanyhad6.7 million for the same period in 2023[110]. - As of June 30, 2024, the company had 36.6 million in cash and cash equivalents and an accumulated deficit of 33.8million[104].−Thecompanyexpectsexistingcashandcashequivalentstofundoperatingexpensesandcapitalexpendituresinto2026[104].ResearchandDevelopment−COYA302,thecompany′sleadasset,isacombinationofproprietarylowdoseinterleukin−2(COYA301)andtheimmunomodulatorydrugCTLA4−Ig,targetingneurodegenerativedisorders[73].−AproofofconceptstudyforCOYA302in4ALSpatientsshowednodeclineorminimaldeclineintheALSFRS−Rscaleat24and48weeks,indicatingsafetyandtolerability[78].−Thecompanyplanstoconductawell−poweredPhase2studyforCOYA302basedonpositiveproofofconceptdata[78].−ThecompanyisfocusedondevelopingtherapiestotargetTregdysfunction,whichislinkedtoneurodegenerative,autoimmune,andmetabolicdiseases[71].−ThePOCstudyforCOYA301in8ADpatientsshowedimprovedorstablecognitivefunction,enhancedTregfunction,andreducedpro−inflammatorycytokines[80].−APhaseIIclinicaltrialforLDIL−2inAlzheimer′sDiseasehasfullyenrolled38patients,withdatapresentationscheduledforCTAD24inMadridfromOctober29toNovember1,2024[81].−ThecompanyexpandeditspipelinetoincludeFTDandPDforCOYA302,inadditiontoALSandAD,targetingcompleximmunepathwaysinneurodegenerativediseases[82].−Thecompanyexpectsresearchanddevelopmentexpensestocontinuetogrowsignificantlyasitadvancesclinicaltrialsandpreparesregulatoryfilings[90].−Researchanddevelopmentexpensesroseby33.8 million[104]. - The company expects existing cash and cash equivalents to fund operating expenses and capital expenditures into 2026[104]. Research and Development - COYA 302, the company's lead asset, is a combination of proprietary low dose interleukin-2 (COYA 301) and the immunomodulatory drug CTLA4-Ig, targeting neurodegenerative disorders[73]. - A proof of concept study for COYA 302 in 4 ALS patients showed no decline or minimal decline in the ALSFRS-R scale at 24 and 48 weeks, indicating safety and tolerability[78]. - The company plans to conduct a well-powered Phase 2 study for COYA 302 based on positive proof of concept data[78]. - The company is focused on developing therapies to target Treg dysfunction, which is linked to neurodegenerative, autoimmune, and metabolic diseases[71]. - The POC study for COYA 301 in 8 AD patients showed improved or stable cognitive function, enhanced Treg function, and reduced pro-inflammatory cytokines[80]. - A Phase II clinical trial for LD IL-2 in Alzheimer's Disease has fully enrolled 38 patients, with data presentation scheduled for CTAD24 in Madrid from October 29 to November 1, 2024[81]. - The company expanded its pipeline to include FTD and PD for COYA 302, in addition to ALS and AD, targeting complex immune pathways in neurodegenerative diseases[82]. - The company expects research and development expenses to continue to grow significantly as it advances clinical trials and prepares regulatory filings[90]. - Research and development expenses rose by 3.5 million from 1.1millioninQ22023to1.1 million in Q2 2023 to 4.6 million in Q2 2024, primarily due to preclinical advancements for COYA 302[97]. - Research and development expenses rose by 5.4millionfrom5.4 million from 2.3 million for the six months ended June 30, 2023, to 7.7millionforthesixmonthsendedJune30,2024[101].FundingandCapital−Thecompanyhasfundedoperationsprimarilythroughprivateconvertiblepreferredstockofferings,convertibledebtfinancing,andapublicofferingthatclosedinJanuary2023[73].−Thecompanywillneedtoraisesubstantialadditionalcapitaltosupportongoingoperationsandgrowthstrategy[76].−ThecompanyenteredintoaSecuritiesPurchaseAgreementforaprivateplacementof603,136sharesat7.7 million for the six months ended June 30, 2024[101]. Funding and Capital - The company has funded operations primarily through private convertible preferred stock offerings, convertible debt financing, and a public offering that closed in January 2023[73]. - The company will need to raise substantial additional capital to support ongoing operations and growth strategy[76]. - The company entered into a Securities Purchase Agreement for a private placement of 603,136 shares at 8.29 per share, resulting in net proceeds of 4.9millionforaPhase2studyofCOYA302inFTD[84].CollaborationandRevenue−CollaborationrevenueforQ22024was4.9 million for a Phase 2 study of COYA 302 in FTD[84]. Collaboration and Revenue - Collaboration revenue for Q2 2024 was 3,425,271, compared to 0inQ22023,markingasignificantincrease[96].−Otherincome,netincreasedby0 in Q2 2023, marking a significant increase[96]. - Other income, net increased by 0.5 million from the six months ended June 30, 2023, to the same period in 2024, primarily due to interest and dividend income[103]. Agreements and Milestones - The DRL Development Agreement includes potential milestone payments of up to 40.0millionandsalesmilestonesofupto40.0 million and sales milestones of up to 677.3 million related to COYA 302[116]. - The company received a one-time payment of 3.9millionfromDr.Reddy′sundertheFirstAmendmenttotheDRLDevelopmentAgreement[115].−CompanyagreedtomakecontingentmilestonepaymentstoMethodisttotalingupto3.9 million from Dr. Reddy's under the First Amendment to the DRL Development Agreement[115]. - Company agreed to make contingent milestone payments to Methodist totaling up to 0.3 million for ALS treatment and between 0.2millionand0.2 million and 0.4 million for other indications[119]. - Royalty payments to Methodist range from 1% to 10% of annual worldwide net sales of licensed products, with a minimum of 0.1millionannuallystartingJanuary1,2025[119].−SponsoredResearchAgreementwithHoustonMethodistResearchInstituteincreasedfundingfrom0.1 million annually starting January 1, 2025[119]. - Sponsored Research Agreement with Houston Methodist Research Institute increased funding from 0.5 million to 1.0million,extendingthetermthroughSeptember2025[121].−Companywillpayanaggregateof1.0 million, extending the term through September 2025[121]. - Company will pay an aggregate of 13.3 million in developmental milestone payments for the first Combination Product in a new indication under the ARS License Agreement[124]. - Under the DRL Agreement, 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[125]. - Company paid a one-time, non-refundable upfront fee of 0.4millionfortheDRLAgreement[125].−TheARSLicenseAgreementincludestieredpaymentsbasedondevelopmentalmilestones,totaling0.4 million for the DRL Agreement[125]. - The ARS License Agreement includes tiered payments based on developmental milestones, totaling 11.8 million for the first Mono Product in a new indication[124]. - Company is required to pay royalties on sublicense income ranging from 10% to 20% under the ARS License Agreement[124]. - The Methodist License Agreement allows termination if the company is not "Actively Attempting to Develop or Commercialize" after five years[120].