Overview & News:

Press Release

- Completed the acquisition of AavantiBio, creating a precision genetic medicines company with a focus on cardiac and neuromuscular diseases; Closed concurrent $75 million private placement -

- Company remains on track to submit IND for SGT 003, a next-generation gene therapy for patients with Duchenne; Anticipated dosing in late – 2023, subject to IND clearance -

- Company ends 2022 with approximately $213.7 million in cash and investments; Anticipated cash runway into 2025 -

CHARLESTOWN, Mass., March 23, 2023 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing genetic medicines for neuromuscular and cardiac diseases, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.

“Following Solid Biosciences’ merger with AavantiBio and concurrent financing, Solid enters 2023 with an expanded pipeline encompassing both neuromuscular and cardiac indications, a proprietary capsid library and in-house manufacturing with a vector core, an experienced management team, and approximately $214 million of cash and investments.  Our anticipated financial runway goes into 2025, and we are well-positioned to execute on our priorities and achieve key clinical milestones,” said Bo Cumbo, President, and CEO of Solid Biosciences.

The company is on track for an anticipated Investigational New Drug (IND) submission for SGT-003 in the second half of 2023 and, subject to IND clearance, the first patient dosing in late-2023. In addition, preclinical programs continue to progress in other neuromuscular and cardiac indications.

Recent Company Announcements

• On March 19, Solid presented one-year post-treatment data relating to safety, efficacy and microdystrophin expression in muscle biopsies for patients enrolled in the IGNITE DMD Phase I/II clinical trial evaluating SGT-001 in a poster presentation at the Muscular Dystrophy Association Clinical and Scientific Conference. Other than the required ongoing observation of patients in IGNITE DMD and the completion of already in process preclinical experiments, the SGT-001 program has concluded. The Company is advancing SGT-003, a next generation gene therapy for patients with Duchenne.
  
  
• On January 10, 2023, Solid outlined its strategic priorities at the J.P. Morgan Healthcare Conference. The company’s corporate vision is to build an innovation platform enabling the discovery and development of high-value genetic medicines for neuromuscular and cardiac diseases by integrating internal capabilities, including a vector core, validated animal models, optimized expression cassettes, novel capsids, and regulatory elements of target indications, and collaborations with leaders in related clinical and research fields.
  
  
• On January 9, 2023, Solid appointed Kevin Tan, CFA, a seasoned industry professional, as Chief Financial Officer. Mr. Tan brings over 20 years of financial experience to Solid, most recently as CFO at Selecta Biosciences. Before joining Selecta, he served as Treasurer at Sarepta Therapeutics and, before that, had an extensive career in financial services, most recently as Senior Portfolio Manager at CPP Investments.
  
  
• On December 5, 2022, Solid announced the closing of its acquisition of AavantiBio. The combined Company will focus on advancing a portfolio of neuromuscular and cardiac programs. Bo Cumbo, the Chief Executive Officer of AavantiBio, assumed the role of President and CEO of Solid Biosciences.
  
  
  • Concurrent with the merger’s closing, Solid closed the previously announced $75.0 million private placement with a select group of institutional investors and accredited investors.
    
  • To streamline the combined Company’s operating structure, Solid completed a plan to reduce its combined workforce by approximately 18%. The Company incurred a charge in the fourth quarter of 2022 of approximately $5.7 million related to the reduction in force, consisting of severance and other employee termination benefits.

Fourth Quarter and Full-Year 2022 Financial Highlights

There were no collaboration revenues for the fourth quarter of 2022, compared to $3.2 million for the fourth quarter of 2021. Collaboration revenue for the full year ended December 31, 2022, was $8.1 million, compared to $13.6 million for the full year ended December 31, 2021. Collaboration revenue in the 2022 and 2021 periods was related to research services and cost reimbursement from the Collaboration Agreement with Ultragenyx, which the Company entered in the fourth quarter of 2020.

Research and development expenses for the fourth quarter of 2022 were $21.3 million, compared to $14.6 million for the fourth quarter of 2021. Research and development expenses for the full year ended December 31, 2022, were $78.4 million, compared to $58.7 million for the full year ended December 31, 2021. The increase of $19.7 million in research and development expenses was primarily due to an increase in SGT-003 and SGT-001 manufacturing costs.

General and administrative expenses for the fourth quarter of 2022 were $7.6 million, compared to $7.2 million for the fourth quarter of 2021. General and administrative expenses for the full year ended December 31, 2022, were $28.9 million, compared to $27.1 million for the full year ended December 31, 2021.

Net loss for the fourth quarter of 2022 was $15.2 million, compared to $18.6 million for the fourth quarter of 2021. Net loss for the full year ended December 31, 2022 was $86.0 million, compared to $72.2 million for the full year ended December 31, 2021. The increase in net loss was the result of a greater investment in research and development to progress DMD candidates.

Solid had $213.7 million in cash, cash equivalents, and available-for-sale securities as of December 31, 2022, compared to $207.8 million as of December 31, 2021. This financial position resulted from streamlined operating activities, the acquisition of AavantiBio, and a $75.0 million private placement. The Company expects that its cash, cash equivalents, and available-for-sale securities will enable it to fund key strategic priorities into 2025.

About Solid Biosciences

Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene transfer candidate for the treatment of Duchenne, AVB-202-TT, a gene transfer candidate for the treatment of Friedreich’s Ataxia, AVB-401 for the treatment of BAG3 mediated dilated cardiomyopathy, and additional assets for the treatment of undisclosed cardiac diseases. Solid aims to be a center of excellence, bringing together those with expertise in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases. For more information, please visit www.solidbio.com.

Forward-Looking Statements

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 benefits of the merger with AavantiBio; 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; the company’s attempt to build an innovation platform enabling the discovery and development of high-value genetic medicines for neuromuscular and cardiac diseases by integrating internal capabilities, including a vector core, validated animal models, optimized expression cassettes, novel capsids, and regulatory elements of target indications, and collaborations with leaders in related clinical and research fields; 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:
David Carey
FINN Partners
212-867-1768
David.Carey@finnpartners.com

Solid Biosciences Media Contact:
Tim Palmer
Associate Director, Corporate Communications
607-760-4223
Tim@solidbio.com

Source: Solid Biosciences Inc.