Solid Biosciences Provides Third Quarter 2022 Business Update and Financial Results
- Recently presented preclinical data support potential benefits of next-generation Duchenne gene therapy candidate SGT-003; program on track for mid-2023 Investigational New Drug (IND) submission -
- Company ends Q3 with approximately
- Company expects to close acquisition of AavantiBio and
“Solid made significant strategic advancements in the third quarter, including the prioritization of our next generation Duchenne gene transfer program, SGT-003, and the execution of definitive documents for the acquisition of AavantiBio and a
In September 2022, Solid announced that it had prioritized the development of SGT-003 and would be pausing activities for its first-generation gene therapy candidate, SGT-001. Development activities continued in the quarter for SGT-003, which combines Solid’s differentiated neuronal nitric oxide synthase (nNOS) microdystrophin transgene with the novel capsid AAV-SLB101, a rationally designed muscle-tropic AAV capsid designed to improve transduction to muscle tissue.
The company is on track for an anticipated mid-2023 Investigational New Drug (IND) submission for SGT-003 and, pending IND acceptance, first patient dosing in late-2023.
Recent Company Announcements
- Solid reported additional positive one-year data from the IGNITE DMD Phase I/II clinical trial of its microdystrophin gene therapy, SGT-001, for the functional endpoint of stride velocity 95th centile (SV95C). SV95C is an objective assessment of peak ambulatory performance accepted as a qualified secondary endpoint for Duchenne patients five years of age and older by the
European Medicines Agency(EMA). This assessment represents the fastest spontaneous strides in a patient’s daily life, captured in a real-world setting using the ActiMyo wearable device developed by SYSNAV. In the IGNITE DMD clinical trial, patients receiving SGT-001 in the 2E14 vg/kg cohort improved from baseline in SV95C at one year, whereas a control patient included in the study and natural history data both demonstrated declines over the same period.
September 30, Solid announced that it had entered into a definitive agreement to acquire AavantiBio. The consummation of this transaction will create a genetic medicine company focused on neuromuscular and cardiac diseases. Upon closing of the acquisition, Bo Cumbowill become President & Chief Executive Officer of Solid and there will a leadership team comprised of executives from both companies. Strong synergies are expected by combining key assets, including product candidates for Duchenne (SGT-003), Friedreich’s ataxia, BAG3 mediated dilated cardiomyopathy and other undisclosed cardiac diseases; novel capsid libraries; and personnel. Supported by a securities purchase agreement with a select group of institutional investors and accredited investors for a $75 millionprivate placement of Solid’s common stock, the combined company expects to have approximately $215 millionin cash and investments immediately following closing of the acquisition and private placement, which Solid believes will be sufficient to fund the combined company’s planned operating expenses and capital expenditure requirements into 2025, which includes important milestones for the Company’s pipeline. Solid filed its definitive proxy statement supporting the AavantiBio acquisition on November 7and expects to close in the fourth quarter of 2022, soon after the special meeting of Solid stockholders to be held on December 1.
October 27, Solid announced a reverse stock split of its common stock (Reverse Stock Split) where every fifteen (15) shares of the company’s issued and outstanding common stock were automatically converted to one (1) issued and outstanding share of the common stock, effective on October 27. The Reverse Stock Split, which was approved by shareholders at the company’s Annual Meeting of Stockholders on June 7, 2022, was primarily intended to bring the company into compliance with the minimum bid price requirement for maintaining its listing on the Nasdaq Global Select Market.
Third Quarter 2022 Financial Highlights
There were no collaboration revenues for the third quarter of 2022, compared to
Research and development expenses for the third quarter of 2022 were
General and administrative expenses for the third quarter of 2022 were
Net loss for the third quarter of 2022 was
SGT-003 is Solid's next-generation AAV gene transfer therapy candidate that utilizes a rationally designed, novel muscle-tropic AAV capsid, called AAV-SLB101, to deliver Solid’s proprietary and differentiated nNOS microdystrophin for the treatment of Duchenne. AAV-SLB101 has demonstrated enhanced muscle biodistribution and transgene expression, as well as reduced liver tropism, compared with AAV9 in in vivo mouse models and, utilizing a reporter transgene, non-human primate in vivo models. SGT-003 has correspondingly demonstrated higher levels of microdystrophin expression in vivo in the mdx mouse model of Duchenne and in vitro in human Duchenne cell lines. Solid is targeting an Investigational New Drug submission for SGT-003 in mid-2023.
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 Solid, AavantiBio and the combined company following the anticipated consummation of the acquisition; the anticipated benefits of the acquisition; the anticipated timing of the acquisition and private placement; the anticipated milestones, business focus and pipeline of the combined company; the expected cash and investments of the combined company at closing of the transactions and the cash runway of the combined company; the excepted management team of the combined company; as well as the implication of interim clinical data, the safety or potential treatment benefits of SGT-001 or SGT-003 in patients with Duchenne, the Company’s regulatory plans and discussions, the Company’s SGT-003 program, including the Company’s expectation for filing an IND, timelines, the sufficiency of the Company’s cash, cash equivalents and available-for-sale securities to fund its operations 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 completion of the proposed acquisition and private placement in a timely manner or on the anticipated terms or at all; the satisfaction (or waiver) of closing conditions to the consummation of the acquisition and the private placement, including with respect to the approval of Solid’s stockholders; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement or the private placement; the effect of the announcement or pendency of the acquisition on Solid’s or AavantiBio’s business relationships, operating results and business generally; the ability to recognize the anticipated benefits of the acquisition; the outcome of any legal proceedings that may be instituted against Solid or AavantiBio following any announcement of the proposed acquisition and related transactions; the ability to obtain or maintain the listing of the common stock of the combined company on the
No Offer or Solicitation
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination and shall not constitute an offer to sell or a solicitation of an offer to buy any securities nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Important Additional Information and Where to Find It
In connection with the acquisition and the private placement, Solid has filed with the
Participants in the Solicitation
Solid, AavantiBio and their respective directors and executive officers may be deemed participants in the solicitation of proxies from the stockholders of Solid in connection with the issuance of shares in acquisition and the private placement and any other matters to be voted on at the special meeting. Information about Solid’s directors and executive officers is included in Solid’s most recent definitive proxy statement filed with the
These documents are available free of charge as described above.
Source: Solid Biosciences Inc.