Solid Biosciences Provides First Quarter Business Update and Financial Results
– Company remains on track to submit IND in Q4 2023 for SGT-003, a next-generation gene therapy for patients with Duchenne muscular dystrophy (Duchenne) –
– Company ends first quarter with approximately
“In the first quarter of 2023, we made strong progress across multiple programs in our diversified pipeline of genetic medicines and remain on track to achieve important milestones this year,” said
The Company is on track for an anticipated Investigational New Drug (IND) submission for our Duchenne gene therapy program, SGT-003 in the fourth quarter of 2023 and, subject to IND clearance, the first patient dosing in late-2023. Solid also continues to advance preclinical programs in its other neuromuscular and cardiac indications, including AVB-202-TT for Friedreich’s Ataxia, and AVB-401 for treatment of BAG3 mediated dilated cardiomyopathy.
First Quarter 2023 Financial Highlights
There were no collaboration revenues for the first quarter of 2023, compared to
Research and development expenses for the three months ended
General and administrative expenses were
Net loss for the first quarter of 2023 was
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future expectations, plans and prospects for the company; the ability to successfully achieve and execute on the company’s priorities and achieve key clinical milestones; the company’s plans to present data from its Friedreich’s ataxia program, next-generation Duchenne muscular dystrophy program, novel capsid program, and process development activities; the cash runway of the company and the sufficiency of the company’s cash and investments to fund its operations; the company’s SGT-003 program, including expectations for filing an IND and initiating dosing, and the company’s future development of preclinical and capsid programs; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the ability to recognize the anticipated benefits of Solid’s acquisition of AavantiBio; the company’s ability to advance SGT-003, AVB-202-TT, AVB-401 and other preclinical programs and capsid libraries on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies of the company’s product candidates; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop Duchenne and other neuromuscular and cardiac treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003, AVB-202-TT, AVB-401 and other candidates, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company's views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.
Solid Biosciences Investor Contact:
VP, Investor Relations and Communications
Solid Biosciences Media Contact:
Associate Director, Corporate Communications
Source: Solid Biosciences Inc.