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Annexon(ANNX) - 2024 Q3 - Quarterly Report
ANNXAnnexon(ANNX)2024-11-14 21:10

Financial Performance - The company reported a net loss of 34.8millionforthethreemonthsendedSeptember30,2024,comparedtoanetlossof34.8 million for the three months ended September 30, 2024, compared to a net loss of 32.5 million for the same period in 2023, representing a 7% increase in losses [76]. - Net loss for the nine months ended September 30, 2024, was 89.6million,adecreaseof89.6 million, a decrease of 16.7 million, or 16%, compared to a net loss of 106.3millionin2023[89].−Cashusedinoperatingactivitieswas106.3 million in 2023 [89]. - Cash used in operating activities was 82.0 million for the nine months ended September 30, 2024, compared to 97.7millioninthesameperiodin2023[93].−Interestandotherincome,net,increasedby10197.7 million in the same period in 2023 [93]. - Interest and other income, net, increased by 101% to 4.6 million for the three months ended September 30, 2024, compared to 2.3millionin2023[84].−Interestandotherincomeincreasedby2.3 million in 2023 [84]. - Interest and other income increased by 4.6 million, or 63%, for the nine months ended September 30, 2024, compared to the same period in 2023, primarily due to higher average cash balances and favorable interest rates [91]. - Total operating expenses decreased by 12.1million,or1112.1 million, or 11%, to 101.6 million for the nine months ended September 30, 2024, compared to 113.7millionin2023[89].ResearchandDevelopment−Researchanddevelopmentexpensesincreasedby113.7 million in 2023 [89]. Research and Development - Research and development expenses increased by 2.2 million, or 8%, to 30.1millionforthethreemonthsendedSeptember30,2024,primarilyduetoincreasedconsultingandprofessionalservicescosts[86].−Researchanddevelopmentexpensesdecreasedby30.1 million for the three months ended September 30, 2024, primarily due to increased consulting and professional services costs [86]. - Research and development expenses decreased by 14.4 million, or 16%, to 76.1millionfortheninemonthsendedSeptember30,2024,primarilyduetoreducedcostsinclinicalservicesandcontractmanufacturing[89].−ANX005,theleadcandidateforGuillain−BarreˊSyndrome,showedpositiveresultsinapivotalPhase3trial,withpatientsrecoveringfasterandmorecompletely[74].−ANX007forGeographicAtrophyhasinitiatedpatientdosinginaglobalpivotalPhase3trial,withtoplinedataexpectedinthesecondhalfof2026[75].−ANX1502,anoveloralsmallmoleculeinhibitor,isinaproof−of−conceptstudyforcoldagglutinindisease,withinitialdataexpectedinthefirstquarterof2025[75].−Thecompanyexpectsfutureresearchanddevelopmentexpensestoincreaseasitadvancesproductcandidatesthroughlate−stageclinicaltrialsandpreparesforcommercialization[100].CashandFinancingActivities−Cashandcashequivalentsandshort−terminvestmentstotaled76.1 million for the nine months ended September 30, 2024, primarily due to reduced costs in clinical services and contract manufacturing [89]. - ANX005, the lead candidate for Guillain-Barré Syndrome, showed positive results in a pivotal Phase 3 trial, with patients recovering faster and more completely [74]. - ANX007 for Geographic Atrophy has initiated patient dosing in a global pivotal Phase 3 trial, with topline data expected in the second half of 2026 [75]. - ANX1502, a novel oral small molecule inhibitor, is in a proof-of-concept study for cold agglutinin disease, with initial data expected in the first quarter of 2025 [75]. - The company expects future research and development expenses to increase as it advances product candidates through late-stage clinical trials and prepares for commercialization [100]. Cash and Financing Activities - Cash and cash equivalents and short-term investments totaled 340.1 million as of September 30, 2024 [76]. - The company raised net proceeds of approximately 116.8millioninJune2024throughthesaleofcommonstockandpre−fundedwarrants[102].−InJuly2022,thecompanyraisedapproximately116.8 million in June 2024 through the sale of common stock and pre-funded warrants [102]. - In July 2022, the company raised approximately 122.5 million through the sale of 9,013,834 shares of common stock and warrants [104]. - Cash provided by financing activities was 156.2millionfortheninemonthsendedSeptember30,2024,significantlyupfrom156.2 million for the nine months ended September 30, 2024, significantly up from 17.9 million in 2023 [98]. - The company sold 7,576,067 shares under the 2021 ATM program for net proceeds of approximately 38.4millionduringtheninemonthsendedSeptember30,2024[108].−The2024ATMprogramhasamaximumofferingof38.4 million during the nine months ended September 30, 2024 [108]. - The 2024 ATM program has a maximum offering of 100.0 million, with no sales made as of September 30, 2024, but 750,000 shares were sold post this date for net proceeds of approximately 4.5million[107].−Theweighted−averageexercisepriceforpre−fundedwarrantsexercisedduringtheninemonthsendedSeptember30,2024was4.5 million [107]. - The weighted-average exercise price for pre-funded warrants exercised during the nine months ended September 30, 2024 was 0.307 [105]. - The company issued 2,582,557 shares upon the cashless exercise of pre-funded warrants in March 2023 [104]. - The company had 22,113,062 pre-funded warrants outstanding as of September 30, 2023 [106]. - The 2021 ATM program registration expired on August 15, 2024, prohibiting further sales under this program [108]. Accumulated Deficit and Financial Position - The company has an accumulated deficit of 662.1millionasofSeptember30,2024[76].−AsofSeptember30,2024,thecompanyhadavailablecashandcashequivalentsof662.1 million as of September 30, 2024 [76]. - As of September 30, 2024, the company had available cash and cash equivalents of 340.1 million and an accumulated deficit of $662.1 million [92]. Accounting and Market Risk - The company has not made any material changes to its critical accounting policies as of September 30, 2024 [110]. - There were no quantitative and qualitative disclosures about market risk applicable for the company [112].