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Solid Biosciences Reports Third Quarter 2024 Financial Results and Provides Business Updates

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Solid Biosciences (SLDB) reported Q3 2024 financial results and business updates. The company completed dosing for the first three patients in the INSPIRE DUCHENNE trial, with SGT-003 showing good tolerability and no serious adverse events. Cash position stands at $171.1 million, providing runway into 2026. Q3 net loss increased to $32.7 million ($0.79 per share) from $21.0 million year-over-year. R&D expenses rose to $27.3 million from $16.7 million, while G&A expenses increased to $7.9 million from $6.4 million. The company expanded its study protocol and plans to present initial three-patient data in Q1 2025.

Solid Biosciences (SLDB) ha riportato i risultati finanziari del terzo trimestre 2024 e aggiornamenti aziendali. L'azienda ha completato la somministrazione per i primi tre pazienti nella sperimentazione INSPIRE DUCHENNE, con SGT-003 che ha dimostrato una buona tollerabilità e nessun evento avverso grave. La posizione di cassa è di $171,1 milioni, fornendo un margine fino al 2026. La perdita netta del terzo trimestre è aumentata a $32,7 milioni (0,79 $ per azione) rispetto ai 21,0 milioni dell'anno precedente. Le spese di ricerca e sviluppo sono aumentate a 27,3 milioni rispetto ai 16,7 milioni, mentre le spese generali e amministrative sono cresciute a 7,9 milioni dai 6,4 milioni. L'azienda ha ampliato il protocollo di studio e prevede di presentare i dati iniziali sui tre pazienti nel primo trimestre del 2025.

Solid Biosciences (SLDB) informó sobre los resultados financieros del tercer trimestre de 2024 y actualizaciones comerciales. La compañía completó la dosificación para los primeros tres pacientes en el ensayo INSPIRE DUCHENNE, con SGT-003 mostrando buena tolerancia y sin eventos adversos graves. La posición de efectivo asciende a $171.1 millones, lo que proporciona un margen hasta 2026. La pérdida neta del tercer trimestre aumentó a $32.7 millones ($0.79 por acción) desde los 21.0 millones del año anterior. Los gastos de I+D aumentaron a 27.3 millones desde los 16.7 millones, mientras que los gastos generales y administrativos se incrementaron a 7.9 millones desde los 6.4 millones. La compañía amplió su protocolo de estudio y planea presentar los datos iniciales de tres pacientes en el primer trimestre de 2025.

Solid Biosciences (SLDB)는 2024년 3분기 재무 결과와 비즈니스 업데이트를 보고했습니다. 이 회사는 INSPIRE DUCHENNE 시험에서 첫 번째 세 환자의 투약을 완료했으며, SGT-003는 좋은 내약성과 심각한 이상 반응이 없음을 보여주었습니다. 현금 보유액은 $171.1 백만이며, 2026년까지의 자금을 마련했습니다. 3분기 순손실은 3,270만 달러(주당 0.79달러)로, 전년 대비 2,100만 달러에서 증가했습니다. 연구 및 개발 비용은 1,670만 달러에서 2,730만 달러로 증가했으며, 일반 및 관리 비용은 640만 달러에서 790만 달러로 증가했습니다. 이 회사는 연구 프로토콜을 확장했으며 2025년 1분기에 세 환자의 초기 데이터를 발표할 계획입니다.

Solid Biosciences (SLDB) a annoncé les résultats financiers du troisième trimestre 2024 et des mises à jour commerciales. L'entreprise a terminé le dosage pour les trois premiers patients dans l'essai INSPIRE DUCHENNE, avec SGT-003 montrant une bonne tolérance et aucun événement indésirable grave. Position de trésorerie s'élève à 171,1 millions de dollars, offrant une marge jusqu'en 2026. La perte nette du troisième trimestre a augmenté à 32,7 millions de dollars (0,79 $ par action) contre 21,0 millions de dollars l'année précédente. Les dépenses de R&D sont passées de 16,7 millions de dollars à 27,3 millions de dollars, tandis que les dépenses générales et administratives sont passées de 6,4 millions de dollars à 7,9 millions de dollars. L'entreprise a élargi son protocole d'étude et prévoit de présenter les données initiales de trois patients au premier trimestre 2025.

Solid Biosciences (SLDB) hat die finanziellen Ergebnisse des dritten Quartals 2024 und Unternehmensupdates veröffentlicht. Das Unternehmen hat die Dosis für die ersten drei Patienten in der INSPIRE DUCHENNE-Studie abgeschlossen, wobei SGT-003 eine gute Verträglichkeit und keine schwerwiegenden unerwünschten Ereignisse gezeigt hat. Die Kassensituation beläuft sich auf $171,1 Millionen und bietet finanzielle Ressourcen bis 2026. Der Nettoverlust im dritten Quartal stieg auf $32,7 Millionen (0,79 $ pro Aktie) im Vergleich zu 21,0 Millionen im Vorjahr. Die F&E-Ausgaben stiegen auf 27,3 Millionen von 16,7 Millionen, während die allgemeinen und administrativen Ausgaben auf 7,9 Millionen von 6,4 Millionen erhöht wurden. Das Unternehmen hat sein Studienprotokoll erweitert und plant, die ersten Daten von drei Patienten im ersten Quartal 2025 zu präsentieren.

Positive
  • Strong cash position of $171.1 million providing runway into 2026
  • Successful completion of dosing for first three patients with good tolerability
  • Protocol expansion and additional site activation to accelerate development
Negative
  • Net loss increased 55.7% to $32.7 million in Q3 2024
  • R&D expenses increased 63.5% to $27.3 million
  • G&A expenses rose 23.4% to $7.9 million

Insights

The Q3 2024 results reveal significant financial developments for Solid Biosciences. The company's cash position strengthened to $171.1 million, up from $123.6 million at the end of 2023, providing runway into 2026. However, operational costs have increased substantially, with R&D expenses rising $10.6 million year-over-year to $27.3 million, primarily due to expanded clinical programs and manufacturing costs.

The net loss widened to $32.7 million from $21.0 million year-over-year, with loss per share improving to $0.79 from $1.05. While the increased spending reflects investment in pipeline development, particularly the INSPIRE DUCHENNE trial expansion, the burn rate warrants attention. The cash runway projection suggests quarterly burn of approximately $21-25 million, indicating careful cash management will be crucial.

The INSPIRE DUCHENNE trial progress shows promising early signals, with SGT-003 demonstrating favorable tolerability in the first three patients and no serious adverse events reported. The protocol expansion and addition of new clinical sites indicates confidence in the program's potential. The anticipated Q1 2025 data readout from the initial three patients will be important in validating the therapy's efficacy.

The CPVT program (SGT-501) is advancing toward IND submission in 1H 2025, targeting an underserved market with 50% mortality rate by age 35. The company's proprietary AAV-SLB101 capsid's adoption by 13 academic labs and one validates its platform technology. This diversified pipeline approach in both neuromuscular and cardiac diseases reduces development risk while expanding market opportunities.

- Duchenne: Dosing completed for first three patients in INSPIRE DUCHENNE clinical trial; SGT-003 has been well tolerated in all patients with no SAEs observed; initial three patient data expected Q1 2025 -

- Duchenne: Activities undertaken to accelerate development of SGT-003, including: expansion of study protocol in September 2024, activation of additional clinical sites in Q4 2024, additional manufacturing supply to support expanded trial enrollment -

- CPVT: SGT-501 IND submission for the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT) on track for 1H 2025 -

- Cash: Company ends Q3 2024 with approximately $171.1 million in cash, cash equivalents, and available-for-sale securities; Solid has anticipated cash runway into 2026 -

CHARLESTOWN, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today reported financial results for the third quarter ended September 30, 2024, and provided a business update.

“We are highly encouraged by the progress we have made with the INSPIRE DUCHENNE clinical trial over the past quarter, including the activation of University of California, Davis as a clinical site in October,” said Bo Cumbo, President and CEO, Solid Biosciences. “SGT-003 continues to be well tolerated in the first three patients dosed. As a result of encouraging early results observed in these patients, we have implemented an updated study protocol amending the clinical trial across key parameters, including enrollment size, age range, and clinical endpoint timelines. With these changes, along with other planned studies, we believe our clinical development program provides significant flexibility in pursuing potential regulatory pathways, with the goal of accelerating a new treatment option to this underserved patient community. We are currently enrolling patients under the expanded INSPIRE DUCHENNE protocol and will continue dosing throughout the rest of 2024 and into 2025.”

Mr. Cumbo continued: “We are committed to presenting clinical data in a thoughtful way that will benefit the Duchenne field and community at large, and we will present safety, expression and biomarker data from the first three patients, along with a trial update, in the first quarter of 2025 following the completion and collective assessment of 90-day muscle biopsies.”

“Turning to our cardiac pipeline, we are pleased to share that our IND-enabling, GLP toxicology and proof-of-concept studies for CPVT are progressing as expected, with an anticipated IND submission for SGT-501 in the first half of 2025,” said Gabriel Brooks, M.D., Chief Medical Officer, Solid Biosciences. “Based upon our positive pre-IND meeting with the U.S. Food and Drug Administration (FDA), we are confident that we have a path to rapidly advance this program to the clinic. CPVT is an underdiagnosed and highly malignant, genetic arrhythmia syndrome with historic mortality rates reaching as high as 50% by age 35.1 The treatment landscape has not meaningfully changed in decades, despite the fact that currently available therapies such as beta-blockers and flecainide require a high degree of compliance to be effective, do not treat the underlying cause of the disease, and have multiple unfortunate side effects, including depression, fatigue, weight gain, and impotence. Paradigm-shifting treatments are long overdue for patients and their families, and we believe that our gene therapy has the potential to transform patient care for this disorder for years to come. We look forward to submitting our IND and advancing this program into the clinic, which we believe will mark significant progress toward establishing Solid as a leading cardiac precision genetic medicines company.”

Additional Company Highlights

  • AAV-SLB101, Solid’s proprietary capsid used in SGT-003, continues to be well tolerated in the first three patients dosed in the INSPIRE DUCHENNE study, and was well tolerated in NHP and mouse studies. 13 different academic labs and one corporation have begun utilizing AAV-SLB101.
  • Solid continues to advance preclinical studies for TNNT2, BAG3, and other pipeline programs.

Third Quarter 2024 Financial Highlights

  • Cash Position: Solid had approximately $171.1 million in cash, cash equivalents, and available-for-sale securities as of September 30, 2024, compared to approximately $123.6 million as of December 31, 2023. The Company expects that its cash, cash equivalents, and available-for-sale securities as of September 30, 2024, will enable it to fund its operational runway into 2026, which includes: investment for the expansion of the INSPIRE DUCHENNE clinical trial, additional manufacturing supply and Phase 3 start up activities (pending results from INSPIRE DUCHENNE), as well as ongoing activities related to other pipeline medicines.
  • Research and Development (R&D) Expenses: R&D expenses for the three months ended September 30, 2024, were $27.3 million, compared to $16.7 million for the three months ended September 30, 2023. The increase of $10.6 million was due to a $5.8 million increase in development program expenses and other research costs, a $3.1 million increase in costs for SGT-501 primarily related to manufacturing and research costs, a $1.1 million increase in external expenses, and a $0.6 million increase in costs for SGT-003 primarily related to clinical and manufacturing costs.
  • General and Administrative (G&A) Expenses: G&A expenses for the three months ended September 30, 2024, were $7.9 million, compared to $6.4 million for the three months ended September 30, 2023. The increase of $1.4 million was primarily related to a $1.5 million increase in personnel related costs, and a $0.2 million increase in consulting fees, offset by a $0.3 million decrease in temporary services.
  • Net Loss: Net loss for the three months ended September 30, 2024, was $32.7 million compared to a net loss of $21.0 million for the same period in 2023. Basic and diluted net loss per share was $0.79 and $1.05 for the three-month periods ended September 30, 2024, and September 30, 2023, respectively.

References
1. Abbas M, et al. Catecholaminergic Polymorphic Ventricular Tachycardia. Arrhythm Electrophysiol Rev. 2022; 11:e20.

About Solid Biosciences
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates 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, 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 goals, priorities and achieve key clinical milestones; the company’s SGT-003 program, including expectations for additional CTA filings, site activations, expanded clinical development, accelerated production of multiple GMP batches of SGT-003, initiation and enrollment in clinical trials, dosing, availability of clinical trial data and potential accelerated approval; the company’s expectations for submission of an IND for SGT-501 and to submit additional INDs by the end of 2026; 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; 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 company’s ability to advance SGT-003, SGT-501, 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 and early-stage clinical trials 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 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:
Nicole Anderson
Director, Investor Relations and Corporate Communications
Solid Biosciences Inc.
investors@solidbio.com

Media Contact:
Glenn Silver
FINN Partners
glenn.silver@finnpartners.com

(tables follow)

SELECTED FINANCIAL INFORMATION (UNAUDITED)
    
CONDENSED CONSOLIDATED BALANCE SHEETSSeptember 30, December 31,
(in thousands, except share data)2024 2023
Cash and cash equivalents$64,394 $74,015
Available-for-sale securities 106,723  49,625
Prepaid expenses and other current assets 8,377  6,094
Operating lease, right-of-use assets 24,859  26,539
Property and equipment, net 5,067  6,624
Other non-current assets 475  209
Restricted cash 1,931  1,833
Total Assets$211,826 $164,939
Accounts payable$3,458 $2,032
Accrued expenses and other current liabilities 13,227  10,161
Operating lease liabilities 1,718  1,855
Finance lease liabilities 1,051  469
Derivative liabilities 3,400  
Operating lease liabilities, excluding current portion 21,643  22,707
Finance lease liabilities, excluding current portion 307  1,234
Total stockholders’ equity 167,022  126,481
Total Liabilities and Stockholders’ Equity$211,826 $164,939
    
Common stock outstanding 38,930  20,387
      


CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
       
(in thousands, except per share data) 2024  2023  2024  2023 
Operating expenses:            
Research and development $27,327  $16,702  $65,661  $61,110 
General and administrative  7,855   6,412   24,171   20,940 
Restructuring charges           (63)
Total operating expenses  35,182   23,114   89,832   81,987 
Loss from operations  (35,182)  (23,114)  (89,832)  (81,987)
Other income, net:            
Interest income  2,328   1,962   7,544   5,822 
Interest expense  (82)  (106)  (265)  (339)
Other income, net  211   278   453   825 
Total other income, net  2,457   2,134   7,732   6,308 
Net loss $(32,725) $(20,980) $(82,100) $(75,679)
Net loss per share, basic and diluted $(0.79) $(1.05) $(2.04) $(3.83)
Weighted average shares of common stock outstanding basic and diluted  41,443,317   20,059,641   40,182,303   19,767,174 

FAQ

What were Solid Biosciences (SLDB) Q3 2024 financial results?

SLDB reported a net loss of $32.7 million ($0.79 per share), with R&D expenses of $27.3 million and G&A expenses of $7.9 million. The company had $171.1 million in cash and equivalents as of September 30, 2024.

When will SLDB release initial data from the INSPIRE DUCHENNE trial?

Solid Biosciences plans to present safety, expression, and biomarker data from the first three patients, along with a trial update, in the first quarter of 2025.

What is the cash runway projection for Solid Biosciences (SLDB)?

The company expects its current cash position of $171.1 million to fund operations into 2026, including INSPIRE DUCHENNE trial expansion and manufacturing activities.

Solid Biosciences Inc.

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236.59M
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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
CHARLESTOWN