Earnings release
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SOLID BIOSCIENCES Solid Biosciences Provides Second Quarter 2021 Business Update and Financial Results August 16 , 2021 - Clinical activities underway to advance patient dosing in IGNITE DMD ; next patient dosing anticipated in Q4 2021 - - Development activities continue for pipeline initiatives SGT - 003 and Ultragenyx collaboration , next generation gene therapy programs for Duchenne patients - - Company ends Q2 with approximately $ 249 million cash and investments ; cash runway into Q4 2022 - CAMBRIDGE , Mass . , Aug. 16 , 2021 ( GLOBE NEWSWIRE ) -- Solid Biosciences Inc. ( Nasdaq : SLDB ) , a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy ( Duchenne ) , today provided a second quarter 2021 business update as well as financial results for the quarter ended June 30 , 2021 . " We continue on our mission of developing meaningful treatments for patients with Duchenne , " said Ilan Ganot , Chief Executive Officer , President and Co - Founder of Solid Biosciences . “ During the second quarter , we made progress on our key strategic priorities and strengthened our team . Specifically , we advanced clinical activities to prepare for the next patient to be dosed in the IGNITE DMD clinical trial of SGT - 001 , furthered our next generation Duchenne gene therapy program , SGT - 003 , and progressed our Duchenne collaboration with Ultragenyx . We also continue to maintain a strong balance sheet to support further investment into our portfolio of Duchenne programs . " IGNITE DMD Clinical Trial Update As previously reported , in April 2021 , the eighth patient in IGNITE DMD , and fifth patient in the 2E14 vg / kg cohort , was treated with SGT - 001 . The patient experienced an SAE which has since fully resolved . Following dosing of two patients with Solid's second - generation manufacturing process and clinical strategy , Solid conducted an extensive review of all clinical data , resulting in a strengthened risk mitigation plan including new patient management guidance , which has also been submitted to the FDA . Activities are underway to advance IGNITE DMD with the next patient dosing anticipated in the fourth quarter of 2021 . No new drug - related safety findings have been identified in Patients 1 through 8 in post - dosing periods of 90 - days to more than 3 years . The Company continues to follow dosed patients and collect data to support the potential benefit from dosing SGT - 001 . R & D Pipeline Update Preclinical activities progressed on Solid's internally developed next generation Duchenne microdystrophin gene transfer program , SGT - 003 , including proof of concept research ; manufacturing , regulatory and clinical strategies ; and development and validation of screening assays to support clinical dosing . The Company is targeting an IND submission for SGT - 003 in early - 2023 . Solid also continued to work in partnership with Ultragenyx during the quarter to further the companies ' ongoing collaboration , which is focused on optimizing candidate vectors that leverage Solid's proprietary nNOS - containing microdystrophin construct with an AAV8 - like capsid within Ultragenyx's HeLa producer cell line manufacturing approach . Recent Company Developments • Solid strengthened its leadership team with recent additions in the areas of Regulatory Sciences , Clinical Development , Communications & Investor Relations and Legal & Intellectual Property . • Solid established a Technical Advisory Board comprised of leaders with track records of success in biopharmaceutical product development . The advisory board members will provide strategic input on technical and CMC aspects of advancing SGT - 001 and SGT - 003 through clinical development and toward commercialization . Financial Highlights Collaboration revenue for the second quarter of 2021 was $ 3.6 million , compared to no collaboration revenue for the three months ended June 30 , 2020. The increase in collaboration revenue is related to research services and cost reimbursement from our Collaboration Agreement with Ultragenyx , which we entered into in the fourth quarter of 2020 . Research and development expenses for the second quarter of 2021 were $ 15.5 million , compared to $ 13.4 million for the second quarter of 2020 . The increase was primarily attributable to increased costs related to our lead product candidate , SGT - 001 , driven by an increase in manufacturing costs , clinical costs and other research and development costs related to other product candidates . General and administrative expenses for the second quarter of 2021 were $ 6.8 million , compared to $ 5.5 million for the second quarter of 2020. The increase was primarily attributable to increased corporate and personnel - related expenses . Net loss for the second quarter of 2021 was $ 18.7 million , compared to $ 19.0 million for the second quarter of 2020 . Solid had approximately $ 249.0 million in cash , cash equivalents and available - for - sale securities as of June 30 , 2021. The Company expects that its cash , cash equivalents and available - for - sale securities will enable Solid to invest in its Duchenne gene therapy programs and capital expenditures into the fourth quarter of 2022 .