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Viridian Therapeutics(VRDN) - 2024 Q3 - Quarterly Report
VRDNViridian Therapeutics(VRDN)2024-11-12 12:15

Product Development - The company is developing two product candidates for TED: veligrotug (IV) and VRDN-003 (subcutaneous), with veligrotug showing a 71% proptosis response rate in active TED patients [190]. - The THRIVE study for veligrotug enrolled 113 patients, achieving all primary and secondary endpoints with a statistical significance of p < 0.0001 [191]. - VRDN-003 has a prolonged half-life of 40 to 50 days, which is four to five times that of veligrotug, and is designed for low-volume, self-administration [194]. - The company is prioritizing the development of engineered anti-FcRn inhibitors, including VRDN-006 and VRDN-008, targeting a significant commercial market opportunity [195]. - VRDN-006 demonstrated comparable potency to the current standard of care in FcRn inhibition, with plans to file an IND by the end of 2024 [196]. - The company anticipates filing a Biologics License Application (BLA) for veligrotug in the second half of 2025 and for VRDN-003 by the end of 2026 [191][194]. Financial Performance - Collaboration revenue for the three months ended September 30, 2024, was 86,000,comparedto86,000, compared to 72,000 in 2023, reflecting a 14,000increase[210].−Researchanddevelopmentexpensesincreasedto14,000 increase [210]. - Research and development expenses increased to 69.2 million for the three months ended September 30, 2024, from 30.4millionin2023,ariseof30.4 million in 2023, a rise of 38.8 million [212]. - General and administrative expenses decreased to 14.4millionforthethreemonthsendedSeptember30,2024,downfrom14.4 million for the three months ended September 30, 2024, down from 20.9 million in 2023, a decrease of 6.5million[215].−Otherincome,netwas6.5 million [215]. - Other income, net was 6.8 million for the three months ended September 30, 2024, compared to 3.6millionin2023,anincreaseof3.6 million in 2023, an increase of 3.2 million [216]. - For the nine months ended September 30, 2024, research and development expenses totaled 166.3million,upfrom166.3 million, up from 121.2 million in 2023, an increase of 45.1million[218].−GeneralandadministrativeexpensesfortheninemonthsendedSeptember30,2024,were45.1 million [218]. - General and administrative expenses for the nine months ended September 30, 2024, were 45.5 million, down from 62.0millionin2023,adecreaseof62.0 million in 2023, a decrease of 16.5 million [223]. - Other income, net for the nine months ended September 30, 2024, was 21.3million,comparedto21.3 million, compared to 12.1 million in 2023, an increase of 9.2million[225].−Thecompany’snetlossfortheninemonthsendedSeptember30,2024,was9.2 million [225]. - The company’s net loss for the nine months ended September 30, 2024, was 190.2 million, compared to a net loss of 170.9millionforthesameperiodin2023[248][249].CashFlowandCapitalResources−AsofSeptember30,2024,thecompanyhad170.9 million for the same period in 2023 [248][249]. Cash Flow and Capital Resources - As of September 30, 2024, the company had 753.2 million in cash, cash equivalents, and short-term investments, expected to fund operations into the second half of 2027 [228]. - The company has generated an accumulated deficit of 916.1millionsinceinception,primarilyduetoresearchanddevelopmentexpenses[229].−Thecompanyanticipatesrequiringsubstantialadditionalcapitaltocontinuethedevelopmentofproductcandidatesandfundongoingoperations[230].−ThecompanyenteredintoaloanandsecurityagreementwithHerculesCapital,providingaccesstoatermloanofupto916.1 million since inception, primarily due to research and development expenses [229]. - The company anticipates requiring substantial additional capital to continue the development of product candidates and fund ongoing operations [230]. - The company entered into a loan and security agreement with Hercules Capital, providing access to a term loan of up to 150 million, with an initial tranche of 50milliondrawnatclosing[239].−Thecompanyrecognizedalossondebtextinguishmentof50 million drawn at closing [239]. - The company recognized a loss on debt extinguishment of 0.2 million in August 2023 related to the Hercules Amendment [238]. - Net cash used in operating activities was 159.0millionfortheninemonthsendedSeptember30,2024,comparedto159.0 million for the nine months ended September 30, 2024, compared to 146.2 million for the same period in 2023, reflecting an increase of 12.8million[248][249].−Netcashusedininvestingactivitieswas12.8 million [248][249]. - Net cash used in investing activities was 165.7 million for the nine months ended September 30, 2024, compared to net cash provided of 75.5millioninthesameperiodin2023,indicatingadecreaseof75.5 million in the same period in 2023, indicating a decrease of 241.2 million [250][251]. - Net cash provided by financing activities was 422.2millionduringtheninemonthsendedSeptember30,2024,asignificantincreasefrom422.2 million during the nine months ended September 30, 2024, a significant increase from 26.7 million in the same period in 2023 [253][254]. - The company completed a public offering in January 2024, raising approximately 150millionfromthesaleof7,142,858sharesat150 million from the sale of 7,142,858 shares at 21.00 per share [243]. - In September 2024, the company raised approximately 258.8millionfromthesaleof12,466,600sharesat258.8 million from the sale of 12,466,600 shares at 18.75 per share, including additional shares from underwriters' options [244]. - The company sold 1,561,570 shares under the September 2022 ATM Agreement at a weighted average price of 23.22pershare,generatingapproximately23.22 per share, generating approximately 35.2 million in net proceeds during the nine months ended September 30, 2024 [246]. Market and Economic Conditions - The company expects revenue fluctuations based on the timing of achieving development and commercial milestones [201]. - The global macroeconomic environment presents uncertainties that could negatively affect future operations, including trade disputes and geopolitical tensions [197]. - The company’s Amended Term Loan has a maturity date of October 1, 2026, with an interest rate capped at 8.95% [240][242].