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Viridian Therapeutics(VRDN) - 2024 Q4 - Annual Results

Financial Performance - The net loss for the year ended December 31, 2024, was 269.9million,comparedtoanetlossof269.9 million, compared to a net loss of 237.7 million for the same period in 2023[16]. - The net loss for Q4 2024 was 79,725,representinga19.279,725, representing a 19.2% increase from the net loss of 66,860 in Q4 2023, while the full year net loss increased by 13.5% to 269,949from269,949 from 237,734[19]. - The comprehensive loss for Q4 2024 was 80,667,comparedto80,667, compared to 66,457 in Q4 2023, and for the full year, it was 270,297versus270,297 versus 237,006 in 2023[19]. - Total revenue for Q4 2024 remained flat at 72,000comparedtoQ42023,whiletotalrevenueforthefullyear2024decreasedby3.872,000 compared to Q4 2023, while total revenue for the full year 2024 decreased by 3.8% to 302,000 from 314,000in2023[19].CashPositionandAssetsThecompanyhasastrongcashpositionof314,000 in 2023[19]. Cash Position and Assets - The company has a strong cash position of 717.6 million as of December 31, 2024, up from 477.4millionayearearlier,providingacashrunwayintothesecondhalfof2027[11].Cash,cashequivalents,andshortterminvestmentsincreasedsignificantlyto477.4 million a year earlier, providing a cash runway into the second half of 2027[11]. - Cash, cash equivalents, and short-term investments increased significantly to 717,584 in 2024 from 477,370in2023,reflectingagrowthof50.4477,370 in 2023, reflecting a growth of 50.4%[21]. - Total assets rose to 742,403 in 2024, up 51.3% from 490,424in2023[21].Totalstockholdersequityimprovedto490,424 in 2023[21]. - Total stockholders' equity improved to 671,639 in 2024, a 52.0% increase from 442,022in2023[21].ExpensesResearchanddevelopmentexpensesincreasedto442,022 in 2023[21]. Expenses - Research and development expenses increased to 238.3 million for the year ended December 31, 2024, compared to 159.8millionin2023,drivenbyongoingclinicaltrialsandincreasedpersonnelcosts[11].Researchanddevelopmentexpensesincreasedsignificantlyby86.5159.8 million in 2023, driven by ongoing clinical trials and increased personnel costs[11]. - Research and development expenses increased significantly by 86.5% to 71,959 in Q4 2024 from 38,558inQ42023,andforthefullyear,itroseby4938,558 in Q4 2023, and for the full year, it rose by 49% to 238,254 from 159,765[19].Generalandadministrativeexpensesdecreasedto159,765[19]. - General and administrative expenses decreased to 61.1 million in 2024 from 95.0millionin2023,primarilyduetononrecurringseverancecostsinthepreviousyear[16].Generalandadministrativeexpensesdecreasedby52.895.0 million in 2023, primarily due to nonrecurring severance costs in the previous year[16]. - General and administrative expenses decreased by 52.8% to 15,585 in Q4 2024 from 32,993inQ42023,andforthefullyear,itdecreasedby35.932,993 in Q4 2023, and for the full year, it decreased by 35.9% to 61,083 from 94,999[19].ClinicalTrialsandDevelopmentVeligrotugreportedpositivetoplinephase3datainbothTHRIVEandTHRIVE2trialsforactiveandchronicthyroideyedisease(TED),achievingallprimaryandsecondaryendpoints[7].Over400TEDpatientswereenrolledinveligrotugclinicaltrialsduring2024,demonstratingstrongexecutioninthecompanysclinicalprograms[2].TheBLAsubmissionforveligrotugisontrackforthesecondhalfof2025,withaMarketingAuthorizationApplication(MAA)submissionexpectedinthefirsthalfof2026[7].ToplinedatafromtheREVEAL1andREVEAL2trialsforVRDN003isanticipatedinthefirsthalfof2026,enablingaBLAsubmissionbytheendof2026[7].ProofofconceptdataforVRDN006,anFcRninhibitor,isexpectedinQ32025,focusingonIgGreductioninhealthyvolunteers[6].VRDN008,abispecificFcRninhibitor,isexpectedtohaveadditionalpreclinicaldatain2025,withanINDsubmissionplannedforyearend2025[8].LiabilitiesTotalliabilitiesincreasedto94,999[19]. Clinical Trials and Development - Veligrotug reported positive topline phase 3 data in both THRIVE and THRIVE-2 trials for active and chronic thyroid eye disease (TED), achieving all primary and secondary endpoints[7]. - Over 400 TED patients were enrolled in veligrotug clinical trials during 2024, demonstrating strong execution in the company's clinical programs[2]. - The BLA submission for veligrotug is on track for the second half of 2025, with a Marketing Authorization Application (MAA) submission expected in the first half of 2026[7]. - Topline data from the REVEAL-1 and REVEAL-2 trials for VRDN-003 is anticipated in the first half of 2026, enabling a BLA submission by the end of 2026[7]. - Proof-of-concept data for VRDN-006, an FcRn inhibitor, is expected in Q3 2025, focusing on IgG reduction in healthy volunteers[6]. - VRDN-008, a bispecific FcRn inhibitor, is expected to have additional preclinical data in 2025, with an IND submission planned for year-end 2025[8]. Liabilities - Total liabilities increased to 70,764 in 2024 from $48,402 in 2023, marking a rise of 46.2%[21]. - The weighted-average common shares outstanding used to compute basic and diluted loss per share increased to 80,052,123 in Q4 2024 from 49,681,803 in Q4 2023[19].