Aavantibio, Inc.

CHARLESTOWN, Mass., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it has entered into a securities purchase agreement with a select group of institutional accredited investors for an approximately $108.9 million private placement, which is expected to close on or about January 11, 2024, subject to the satisfaction of customary closing conditions. The private placement is being conducted in accordance with applicable Nasdaq rules and was priced to satisfy the “Minimum Price” requirement (as defined in the Nasdaq rules). The private placement includes new and existing investors, including Perceptive Advisors, Adage Capital Partners LP, Deerfield Management Company, Invus, Janus Henderson Investors, Vestal Point Capital, LP, Bain Capital Life Sciences, RA Capital Management and an undisclosed life sciences investor, among others. Citigroup and Cantor acted as joint lead placement agents to the Company in connection with the private placement. In the private placement, the Company is selling 16,973,103 shares of common stock at a price of $5.53 per share and, in lieu of common stock, pre-funded warrants to purchase up to 2,712,478 shares of common stock at a price of $5.529 per pre-funded warrant. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately and will be exercisable until exercised in full. The Company expects to use net proceeds from the private placement to fund ongoing pipeline development programs, business development activities, and for working capital and other general corporate purposes. The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”) registering the resale of the shares of common stock issued in the private placement and the shares of common stock issuable upon the exercise of the pre-funded warrants issued in the private placement no later than the 30th day after the closing of the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. About Solid Biosciences Solid Biosciences is a life sciences company focused on advancing a portfolio of gene therapy candidates and neuromuscular and cardiac programs, including SGT-003, for the treatment of Duchenne muscular dystrophy (Duchenne), SGT-501 for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT), AVB-401 for the treatment of BAG3-mediated dilated cardiomyopathy, AVB-202-TT for the treatment of Friedreich’s ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid is advancing its diverse pipeline across rare neuromuscular and cardiac diseases, bringing together experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases. Cautionary Note Regarding 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 the anticipated closing of the private placement; the anticipated use of proceeds from the private placement; the filing of a registration statement to register the resale of the shares and pre-funded warrant shares to be issued and sold in the private placement; future expectations, plans and prospects for the Company; 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: whether the conditions for the closing of the private placement will be satisfied; risks associated with the ability to recognize the anticipated benefits of the Company’s acquisition of AavantiBio; the Company’s ability to advance SGT-003, SGT-501, AVB-401, AVB-202-TT 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, SGT-501, AVB-401, AVB-202-TT 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 SEC. 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 Contact:Leah MonteiroVP, Investor Relations and Communications617-766-3430lmonteiro@solidbio.com

– IND submission for SGT-003 for patients with Duchenne muscular dystrophy in Q4 2023 – – Strengthened management team with appointment of Dr. Gabriel Brooks as CMO – – Company ends third quarter with approximately $142.9 million in cash and investments; Anticipated cash runway through multiple important pipeline milestones and into 2025 – CHARLESTOWN, Mass., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today reported financial results for the third quarter ended September 30, 2023, and provided a business update. “We are pleased with the continued advancement of our diversified pipeline of neuromuscular and cardiac gene therapies; including an IND submission in this quarter for SGT-003 for patients with Duchenne,” said Bo Cumbo, President and CEO of Solid Biosciences. “We continue to expand our pipeline and last quarter licensed in a gene transfer program to treat catecholaminergic polymorphic ventricular tachycardia (CPVT). With the addition of Dr. Gabriel Brooks as our Chief Medical Officer and his specialized background in cardiology, we hope to accelerate our multiple cardiac and neuromuscular pipeline assets in preclinical development. Our commitment to bringing transformational therapies to address the severe unmet needs of patients, their caregivers, and families, remains steadfast.” Third Quarter 2023 Business Highlights Solid Biosciences appointed Gabriel Brooks, M.D., as Chief Medical Officer, in October 2023. Dr. Brooks previously directed the translational development of a range of precision AAV gene therapies for dilated, arrhythmogenic, and hypertrophic cardiomyopathies, as Rare Cardiovascular Therapeutic Area Head in the Rare Disease Research Unit at Pfizer. Previous to Pfizer, Dr. Brooks served as the vice president of research and development at 4D Molecular Therapeutics, where he oversaw translational development of AAV gene therapies for Anderson Fabry and first-in-human dosing of AAV gene therapies for two ophthalmologic indications (choroideremia and X-linked retinitis pigmentosa). Third Quarter 2023 Financial Highlights There were no collaboration revenues for the third quarter of 2023 and 2022. Research and development expenses for the three months ended September 30, 2023, were $16.7 million, compared to $14.0 million for the three months ended September 30, 2022. The increase of $2.7 million in research and development expenses was primarily due to a $1.5 million increase in study related costs for SGT-003 for Duchenne advancing the program to IND submission in Q4. General and administrative expenses were $6.4 million for the three months ended September 30, 2023, compared to $7.1 million for the three months ended September 30, 2022. The decrease of $0.7 million was primarily related to a decrease in legal fees related to the acquisition of AavantiBio. Net loss for the third quarter of 2023 was $21.0 million, compared to $20.4 million for the third quarter of 2022. The increase in net loss was the result of higher research and development costs offset by lower general and administrative expenses and an increase in yields on cash equivalents and available-for-sale securities. Solid had $142.9 million in cash, cash equivalents, and available-for-sale securities as of September 30, 2023, compared to $213.7 million as of December 31, 2022. The Company expects that its cash, cash equivalents, and available-for-sale securities will enable it to fund key strategic priorities through multiple important pipeline milestones and into 2025. About Solid Biosciences Solid Biosciences is a life sciences company focused on advancing a portfolio of gene therapy candidates and neuromuscular and cardiac programs, including SGT-003, for the treatment of Duchenne muscular dystrophy (Duchenne), SGT-501 for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT), AVB-401 for the treatment of BAG3-mediated dilated cardiomyopathy, AVB-202-TT for the treatment of Friedreich’s ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid is advancing its diverse pipeline across rare neuromuscular and cardiac diseases, bringing together experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, 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 reach or achieve milestones within projected cash runway; the cash runway of the company and the sufficiency of the Company’s cash, cash equivalents, and available for sale securities to fund its operations; the impact of hiring a CMO; the Company’s SGT-003 program, including expectations for submission of an IND and its success, and the Company’s future development, including the potential acceleration of the Company’s multiple cardiac and neuromuscular pipeline assets in preclinical development; 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, SGT-501, AVB-401, AVB-202-TT 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, SGT-501, AVB-401, AVB-202-TT 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 Contact:Leah MonteiroVP, Investor Relations and Communications617-766-3430lmonteiro@solidbio.com

- 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 . 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