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Solid Biosciences Inc. (Nasdaq: SLDB) is a Cambridge, MA-based biotechnology company focused on developing treatments and cures for Duchenne muscular dystrophy (DMD), a genetic muscle-wasting disease. Solid Biosciences combines commercial acumen with top-tier science to advance promising therapies that address all aspects of DMD. The core of Solid's mission is to improve the daily lives of patients and target the roots of this debilitating condition.
The company's primary focus is on developing gene therapies and other treatments for neuromuscular and cardiac diseases. Their product pipeline includes:
- SGT-003: A next-generation gene therapy candidate for DMD, recently granted FDA clearance for an Investigational New Drug (IND) application. The therapy uses a proprietary capsid (AAV-SLB101) to deliver a microdystrophin transgene to promote muscle function and durability. The planned Phase 1/2 trial aims to evaluate the safety and tolerability of SGT-003 in pediatric patients.
- SGT-501: A treatment for catecholaminergic polymorphic ventricular tachycardia (CPVT), a fatal childhood disease.
- AVB-401: For the treatment of BAG3-mediated dilated cardiomyopathy.
- AVB-202-TT: Aimed at treating Friedreich’s ataxia.
Solid Biosciences has made significant strides in obtaining regulatory milestones. Recently, SGT-003 was granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation by the FDA, enhancing its potential marketability and support for clinical development.
The company has also been involved in strategic collaborations and financing activities. Notably, Solid entered a licensing agreement with Armatus Bio for the use of its AAV-SLB101 capsid, securing a non-exclusive worldwide license and upfront and milestone payments. In January 2024, they raised $108.9 million from a private placement to support ongoing pipeline development and business activities.
Financially, Solid Biosciences reported a net loss of $96.0 million for 2023 but expects its cash reserves and recent financing to fund strategic priorities into 2026. As of December 31, 2023, the company had $123.6 million in cash, cash equivalents, and available-for-sale securities.
For more detailed information, visit www.solidbio.com.
Solid Biosciences Inc. (SLDB) announced participation in the Piper Sandler 34th Annual Healthcare Conference on December 1, 2022, at 10:30 a.m. ET. CEO Ilan Ganot, AavantiBio CEO Bo Cumbo, and CSO Carl Morris will partake in a fireside chat. A live webcast will be accessible on the company's investor relations website with a replay available post-event. Solid Biosciences is dedicated to developing therapies for Duchenne muscular dystrophy and is working on a gene therapy candidate, SGT-003, aimed at addressing the underlying mutation of the disease.
Solid Biosciences (SLDB) recently shared advancements in its gene therapy program for Duchenne muscular dystrophy, focusing on SGT-003, which is set for an Investigational New Drug (IND) submission by mid-2023. The company ended Q3 with $142.2 million in cash, expected to last into Q2 2024. With the planned acquisition of AavantiBio and a $75 million private placement expected by year-end, Solid anticipates a cash reserve of $215 million to support future milestones through 2025.
Solid Biosciences (Nasdaq: SLDB) announced a 1-for-15 reverse stock split effective at 5:00 p.m. ET on October 27, 2022. This action reduces the number of outstanding shares from approximately 113 million to about 7.5 million, aimed at complying with Nasdaq's minimum bid price requirements. Post-split, shares will trade on a split-adjusted basis starting October 28, 2022. The split was approved by shareholders on June 7, 2022, and no fractional shares will be issued; instead, cash payments will be provided for fractional entitlements.
Solid Biosciences presented data on AAV-SLB101, a novel AAV vector for Duchenne gene therapy SGT-003, at the ESGCT Congress in October 2022. The data showed AAV-SLB101's superior transduction efficiency and biodistribution to muscle cells in studies across various models compared to AAV9. Notably, AAV-SLB101 led to significantly higher microdystrophin expression in muscles while reducing liver distribution. The company plans to submit an IND for SGT-003 by mid-2023 and initiate patient dosing in late-2023, aiming for improved safety and efficacy in treatment.
Solid Biosciences has reported promising one-year data from its IGNITE DMD Phase I/II clinical trial evaluating the microdystrophin gene therapy SGT-001. Patients showed an average improvement in stride velocity 95th centile (SV95C) of 8.8%-9.5% compared to baseline, indicating better ambulatory function. As a real-world assessment tool validated by the European Medicines Agency, SV95C revealed significant enhancements over control and natural history patient data. The results are being showcased at the 27th World Muscle Society Congress in Halifax, Nova Scotia.
Solid Biosciences (Nasdaq: SLDB) announced a merger with AavantiBio to create a precision genetic medicine company targeting neuromuscular and cardiac rare diseases. This strategic acquisition aims to leverage synergies from their product candidates, including SGT-003 for Duchenne muscular dystrophy and AVB-202 for Friedreich’s ataxia. The combined company will have approximately $215 million in cash, expected to fund operations into 2025. Leadership will transition to Bo Cumbo, CEO of AavantiBio, post-approval by Solid stockholders.
Solid Biosciences (Nasdaq: SLDB) announced participation in two investor conferences focused on Duchenne muscular dystrophy. Co-Founder and CEO Ilan Ganot, along with Chief Scientific Officer Carl Morris, will hold a fireside chat at the Jefferies Cell and Genetic Medicine Summit on September 30, 2022, at 3:00 PM ET, and at Chardan’s 6th Annual Genetic Medicines Conference on October 4, 2022, at 1:00 PM ET. Live webcasts will be available on the company’s investor relations website, with replays accessible post-event.
Solid Biosciences (Nasdaq: SLDB) reported second-quarter financial results for 2022, indicating a net loss of $25.1 million, up from $18.7 million in the same period in 2021. The company generated $6.2 million in collaboration revenue, a rise from $3.6 million year-over-year. As of June 30, 2022, Solid had $162.9 million in cash, ensuring funding until Q2 2024. The company is advancing its gene therapy programs, SGT-001 and SGT-003, with patient dosing expected to continue in 2023 and an IND submission anticipated for SGT-003 in mid-2023.
Solid Biosciences (Nasdaq: SLDB) announced its participation in two significant conferences focusing on Duchenne muscular dystrophy therapies. At the PPMD 2022 Annual Conference from June 23-26 in Scottsdale, AZ, Chief Scientific Officer Carl Morris will discuss gene therapy approaches on June 24 at 11:30 a.m. EDT. Subsequently, at the ICNMD 2022 in Brussels from July 5-9, Perry Shieh will present selected abstracts on July 7 at 10:30 a.m. ET. Solid Biosciences is dedicated to developing innovative treatments like SGT-001 and SGT-003 to address Duchenne at its genetic source.
Solid Biosciences (Nasdaq: SLDB) announced the grant of inducement awards to Mark Tucker, PhD, as part of his appointment as Senior Vice President, Quality. This was approved by the independent board on April 25, 2022. Dr. Tucker received an option to purchase 120,000 shares of common stock at an exercise price of $0.57, along with a restricted stock unit for 60,000 shares. Both awards will vest over four years based on continued employment. Solid Biosciences focuses on therapies for Duchenne muscular dystrophy, including its gene therapy candidates SGT-001 and SGT-003.
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