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Solid Biosciences Inc. (SLDB): Business Model Canvas [Dec-2025 Updated] |
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Solid Biosciences Inc. (SLDB) Bundle
You're digging into a clinical-stage biotech, and honestly, Solid Biosciences Inc. presents that classic high-risk, high-reward profile that keeps analysts busy. As someone who's mapped out these engines for two decades, I see a company pouring significant capital-like the $38.9 million they burned on R&D in Q3 2025-into a single shot at a one-time treatment for Duchenne muscular dystrophy with their SGT-003 program. They are pre-product revenue, relying on that $236.1 million liquidity, but their proprietary AAV-SLB101 capsid is the key differentiator they are building everything around. Check out the full Business Model Canvas below to see the precise structure Solid Biosciences Inc. is using to manage that cash burn and push toward market access.
Solid Biosciences Inc. (SLDB) - Canvas Business Model: Key Partnerships
You're looking at the network of external relationships Solid Biosciences Inc. relies on to push its precision genetic medicines forward. These aren't just names on a slide; they represent critical access to technology, manufacturing capacity, and, most importantly, patients. The strength of these alliances directly impacts the timeline for getting therapies like SGT-003 to market.
Licensing partners like Andelyn Biosciences for AAV-SLB101 capsid
Solid Biosciences has been actively expanding the reach of its proprietary AAV-SLB101 capsid technology through licensing deals. On November 17, 2025, Solid announced a non-exclusive worldwide licensing agreement with Andelyn Biosciences, a Contract Development and Manufacturing Organization (CDMO). This deal lets Andelyn's clients use AAV-SLB101 with their AAV Curator® Platform. Financial terms for this specific agreement were not disclosed. To date, Solid has executed more than 30 agreements and licenses for AAV-SLB101 with various entities. The capsid itself has been tested in 23 pediatric participants in the INSPIRE DUCHENNE trial as of the October 31, 2025, safety cutoff.
Here's a quick look at the partner's scale:
| Partner Metric | Data Point |
| Andelyn Columbus, Ohio Facilities Supported Clinical Batches | More than 450 |
| Andelyn Columbus, Ohio Facilities Supported Global Clinical Trials | 75 |
| Total AAV-SLB101 Agreements/Licenses Executed (as of Nov 2025) | Over 30 |
This strategy of broad licensing helps validate the technology across the industry.
Academic institutions for research and development collaborations
The push for AAV-SLB101 isn't limited to commercial CDMOs. Solid Biosciences explicitly aims to license the capsid broadly to both corporations and academic institutions pursuing treatments for rare diseases. These collaborations are captured within the more than 30 agreements executed for AAV-SLB101, which specifically include licenses with academic laboratories. This type of partnership is defintely key for early-stage validation and exploring new disease applications.
Patient advocacy groups (e.g., CureDuchenne) for trial enrollment and support
Working with patient advocacy groups is crucial for enrollment and maintaining community trust. Updates on the INSPIRE DUCHENNE trial are often shared directly with groups like CureDuchenne. The trial's progress shows the direct result of this community engagement:
- Participants dosed in INSPIRE DUCHENNE trial (as of Oct 31, 2025): 23
- Participants dosed in INSPIRE DUCHENNE trial (as of Aug 12, 2025): 15
- Additional potential participants identified (as of Aug 12, 2025): More than 20
- Projected minimum participants dosed by year-end 2025: 20
- Projected participants dosed by early 2026: 30
The company plans to host educational events/webinars to communicate these results to the broader Duchenne community.
Clinical trial sites across the US, Canada, Italy, and the UK
The INSPIRE DUCHENNE Phase 1/2 trial is a multinational effort, reflecting the global nature of Duchenne muscular dystrophy. As of August 13, 2025, the trial had 10 active sites spread across the U.S., Canada, Italy, and the United Kingdom. Solid Biosciences expected to activate additional sites by the end of 2025. Furthermore, Solid planned to initiate a separate randomized, double-blind, placebo-controlled trial evaluating SGT-003 outside of the U.S. in the fourth quarter of 2025.
Ultragenyx Pharmaceutical Inc. for collaboration and license agreement
The relationship with Ultragenyx Pharmaceutical Inc. is foundational, originating from a strategic collaboration and license agreement announced in October 2020. This deal focused on developing and commercializing new gene therapies for Duchenne, combining Solid's microdystrophin construct with Ultragenyx's HeLa producer cell line (PCL) manufacturing platform.
The initial financial structure of this partnership included significant upfront capital and future potential payments:
- Ultragenyx upfront investment in Solid Biosciences: $40 million (at a 33% premium)
- Cumulative milestone payments per product: Up to $255 million
- Royalties on worldwide net sales: Tiered, from low double digit to mid-teens percentages
Looking at Ultragenyx's own financials as of March 31, 2025, their Condensed Consolidated Balance Sheet included $12.4 million in cash and cash equivalents restricted for use to settle obligations of the consolidated variable interest entity. Solid retains exclusive rights to all uses of its microdystrophin proteins outside of the licensed scope, such as under its SGT-003 program.
Finance: draft 13-week cash view by Friday.
Solid Biosciences Inc. (SLDB) - Canvas Business Model: Key Activities
You're managing a biotech firm in late 2025, and the core of your work is pushing these complex gene therapies through the clinic and preparing for commercial scale. For Solid Biosciences Inc., the Key Activities are centered on execution across three clinical programs and strengthening the underlying technology platform.
Conducting Phase 1/2 INSPIRE DUCHENNE trial for SGT-003
The primary activity here is the continued, diligent dosing and data collection for SGT-003, the Duchenne muscular dystrophy gene therapy. As of the October 31, 2025, safety cutoff, 23 pediatric participants have been dosed in the INSPIRE DUCHENNE trial at the 1E14vg/kg dose level. Solid Biosciences expects to dose a total of 30 participants by early 2026. The trial is running across 15 active clinical sites in the United States, Canada, Italy, and the United Kingdom. Honestly, the Day 90 biopsy data from the first 10 treated participants (ages 5-10) is what really drives the narrative, showing a mean microdystrophin expression of 58% by both western blot and mass spectrometry. That's concrete proof of transduction.
Here's a quick look at those key efficacy markers from the Day 90 biopsies:
| Measurement | Mean Value (N=10) | Assay Type |
|---|---|---|
| Microdystrophin Expression | 58% | Western Blot |
| Microdystrophin Expression | 58% | Mass Spectrometry |
| Microdystrophin Positive Fibers | 51% | Immunofluorescence |
| Beta-Sarcoglycan Positive Fibers | 50% | Immunofluorescence |
Also, they've been tracking safety closely; as of that same date, there were no cases of drug-induced liver injury observed (N=23), and the treatment has been generally well tolerated using a steroid-only prophylactic immunomodulation regimen. If onboarding takes longer than expected, the timeline for that next FDA meeting could slip, but they are pushing for H1 2026.
Advancing next-generation pipeline candidates (SGT-212, SGT-501)
Solid Biosciences Inc. is actively moving its other candidates into the clinic, which is a critical activity to diversify risk beyond Duchenne. For Friedreich's ataxia (FA), the FALCON Phase 1b first-in-human trial for SGT-212 activated its first clinical site and began screening participants in October 2025. To be fair, SGT-212 is notable because it's the first investigational gene therapy for FA using a dual route of administration (intradentate nucleus and intravenous). Furthermore, SGT-501, the CPVT (catecholaminergic polymorphic ventricular tachycardia) gene therapy, was expected to activate its first clinical site for the ARTEMIS Phase 1b trial in the fourth quarter of 2025, following FDA clearance of the IND application on July 8, 2025. The company also secured a significant regulatory win for SGT-212, receiving Rare Pediatric Disease designation from the FDA on December 1, 2025, which carries the potential for a pediatric priority review voucher (PRV).
Key pipeline advancement milestones include:
- SGT-212 (FA): First-in-human trial site activated in October 2025.
- SGT-212 (FA): Received Rare Pediatric Disease designation from FDA on December 1, 2025.
- SGT-501 (CPVT): Phase 1b trial activation expected in Q4 2025.
- SGT-501 (CPVT): Received Fast Track designation from the FDA on July 23, 2025.
Manufacturing and CMC (Chemistry, Manufacturing, and Controls) readiness for SGT-003
This is the unglamorous but essential work of getting ready to actually sell the drug, not just test it. Solid Biosciences has been working on commercial-readiness CMC activities and has aligned with the FDA on the potency assay strategy for SGT-003. The goal here is to have the Process Performance Qualification (PPQ) manufacturing batches completed in 2026. This activity directly supports the planned regulatory discussions in H1 2026.
Developing and licensing proprietary AAV-SLB101 capsid technology
The AAV-SLB101 capsid is a key resource, so licensing it out is a major activity to generate non-dilutive capital and validate the technology. As of November 3, 2025, Solid Biosciences had executed over 30 agreements, including licenses, with corporations, institutions, and academic labs for the use of AAV-SLB101. This is up from over 25 agreements reported in Q2 2025. Recent deals include a non-exclusive worldwide license and collaboration agreement with Andelyn Biosciences in November 2025, and a similar agreement with Kinea Bio. These deals allow early-stage programs to use the next-generation technology, which demonstrates enhanced skeletal muscle and cardiac tropism and decreased liver biodistribution compared to first-generation capsids.
Engaging with regulatory bodies like the FDA and UK MHRA/NHS
Regulatory engagement is a high-stakes activity that dictates market access timelines. Solid Biosciences plans to meet with the U.S. Food and Drug Administration (FDA) in the first half of 2026 to discuss potential registrational pathways, including accelerated approval, for SGT-003. This follows the activation of IMPACT DUCHENNE, a Phase 3 randomized, double-blind, placebo-controlled trial outside the U.S., which started screening participants in October 2025 to support potential ex-U.S. authorizations. On the UK side, SGT-003 received an Innovation Passport designation under the Innovative Licensing and Access Pathway (ILAP), which is designed to accelerate time to market and facilitate patient access by allowing closer engagement with UK regulators. The company ended Q3 2025 with $236.1 million in cash, which they expect will fund operations into H1 2027, giving them the runway to execute these regulatory steps. Research and Development expenses for Q3 2025 were $38.9 million.
Finance: draft 13-week cash view by Friday.
Solid Biosciences Inc. (SLDB) - Canvas Business Model: Key Resources
You're looking at the core assets Solid Biosciences Inc. (SLDB) relies on to execute its strategy as of late 2025. These aren't just line items; they are the engines driving the next phase of their clinical and commercial potential.
The financial foundation is solid for now. Liquidity remains a key resource, providing the necessary runway to hit upcoming milestones. Specifically, Solid Biosciences Inc. (SLDB) reported Cash, cash equivalents, and securities totaling approximately $236.1 million (Q3 2025 liquidity) as of September 30, 2025. Management indicated this funding supports operations into the first half of 2027.
The technology platform is centered around the Proprietary AAV-SLB101 next-generation capsid platform. This is the delivery vehicle for their gene therapies, rationally designed for enhanced skeletal muscle and cardiac tropism while aiming to reduce biodistribution to the liver. This platform is actively being monetized through external partnerships; as of October 31, 2025, Solid Biosciences Inc. (SLDB) had executed over 30 agreements, including licenses, with corporations, institutions, and academic labs for the use of AAV-SLB101.
This platform underpins the company's Intellectual property (IP) portfolio around gene therapies and genetic regulators. The IP extends beyond SGT-003, covering other pipeline assets like SGT-212 for Friedreich's ataxia (FA) and SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT).
The human capital-the Scientific and clinical expertise in rare neuromuscular and cardiac diseases-is crucial for navigating complex regulatory pathways, especially given the planned FDA meeting in the first half of 2026 to discuss registrational pathways for SGT-003.
The most tangible proof of concept comes from the Clinical data from the INSPIRE DUCHENNE trial showing microdystrophin expression. As of October 31, 2025, 23 pediatric participants had been dosed in the Phase 1/2 trial, with plans to dose a total of 30 by early 2026. The data demonstrates molecular restoration translating to functional signals.
Here's a look at the expression data from the trial:
| Data Point (SGT-003) | N (Participants) | Value | Measurement Method |
| Mean Microdystrophin Expression | 10 (Day 90) | 58% | Western Blot / Mass Spectrometry |
| Mean Microdystrophin Positive Fibers | 10 (Day 90) | 51% | Immunofluorescence (IF) |
| Mean Beta-Sarcoglycan Positive Fibers | 10 (Day 90) | 50% | Immunofluorescence (IF) |
| Mean nNOS Activity-Positive Fibers | 10 (Day 90) | 26% | Activity Assay |
| Mean Microdystrophin Expression (Durable) | 2 (Day 360) | 107% (WB) / 100% (MS) | Western Blot (WB) / Mass Spectrometry (MS) |
These results show strong correlations; for instance, the Day 90 microdystrophin expression correlated with beta-sarcoglycan and nNOS restoration with a Pearson correlation coefficient of r = 0.95. Also, there was a correlation with CK (creatine kinase) level reductions of r = -0.78.
The company's pipeline assets, which represent future potential resources, are advancing:
- SGT-003: Dosing ongoing, aiming for 30 total participants by early 2026.
- SGT-212 (FA): First-in-human Phase 1b trial screening underway, anticipated initiation in the second half of 2025.
- SGT-501 (CPVT): Clinical site activation for the ARTEMIS Phase 1b trial expected in the fourth quarter of 2025.
Finance: draft 13-week cash view by Friday.
Solid Biosciences Inc. (SLDB) - Canvas Business Model: Value Propositions
You're looking at the core reasons why Solid Biosciences Inc. (SLDB) believes its pipeline, especially SGT-003, is compelling to patients, prescribers, and partners. The value here is rooted in next-generation technology designed to improve on existing approaches for devastating genetic diseases. It's about precision delivery and durable effect.
Potential One-Time, Systemic Gene Therapy (SGT-003) for DMD
The primary value proposition centers on SGT-003, a one-time intravenous infusion gene therapy candidate for Duchenne muscular dystrophy (DMD). The clinical program, INSPIRE DUCHENNE, is actively enrolling, with 23 participants dosed as of the October 31, 2025, safety cutoff. Solid Biosciences expects to dose a total of 30 participants by early 2026. The therapy is designed to deliver a microdystrophin construct, and the company is moving with urgency, planning to meet with the U.S. Food and Drug Administration (FDA) in H1 2026 to discuss potential registrational pathways. Furthermore, the company is setting up global pathways, expecting to initiate the IMPACT DUCHENNE, an ex-US Phase 3 randomized, double-blind, placebo-controlled trial, in the fourth quarter of 2025.
Potential Best-in-Class Microdystrophin Expression Profile in Early Data
The early clinical data suggests SGT-003 could offer a best-in-class profile, particularly when looking at the expression of the microdystrophin protein and its downstream restoration of muscle components. The data is being tracked across multiple time points and methodologies, showing durability. For instance, Day 360 biopsy data from 2 participants showed a mean microdystrophin expression of 107% by western blot.
Here's a look at the expression and restoration data reported from the INSPIRE DUCHENNE trial:
| Metric (Data Cutoff: Sept 29, 2025) | N | Mean Value | Measurement Method |
|---|---|---|---|
| Microdystrophin Expression | 10 | 58% | Western Blot and Mass Spectrometry |
| Microdystrophin Positive Fibers | 10 | 51% | Immunofluorescence |
| Beta-Sarcoglycan Positive Fibers (DAPC Component) | 10 | 50% | Immunofluorescence |
| nNOS Activity-Positive Fibers (DAPC Component) | 10 | 26% | Activity Assay |
These expression levels correlate strongly with the restoration of key components of the dystrophin-associated protein complex (DAPC), showing a Pearson correlation coefficient of r = 0.95 for both beta-sarcoglycan and nNOS. The therapy has been generally well tolerated using a steroid-only prophylactic immunomodulation regimen, with only one treatment-related serious adverse event reported across the 23 dosed patients as of October 31, 2025.
Next-Generation Capsid (AAV-SLB101) Designed for Reduced Liver Targeting
The delivery vehicle, AAV-SLB101, is a key differentiator. It was rationally designed for enhanced muscle tropism (targeting) and reduced biodistribution to the liver. Preclinical data in non-human primates showed a 4.9x increase in reporter gene expression in skeletal muscle and a reduction to 0.60x in the liver compared to AAV9. This next-generation capsid has been clinically validated in the INSPIRE DUCHENNE trial, where it was well tolerated in the 23 pediatric participants dosed as of October 31, 2025. The value of this platform is also being recognized externally; Solid Biosciences has executed over 30 agreements, including licenses, with corporations, institutions, and academic labs for the use of AAV-SLB101 as of November 3, 2025.
Addressing Multiple Rare Diseases: DMD, Friedreich's Ataxia (FA), and CPVT
Solid Biosciences is applying its gene therapy platform across several high-unmet-need rare diseases. The value proposition extends beyond DMD to include:
- Friedreich's Ataxia (FA): SGT-212, a dual-route gene therapy, aims to restore frataxin protein to both the CNS and cardiac tissue. The Phase 1b FALCON trial is currently screening participants. The FDA cleared the Investigational New Drug (IND) application for SGT-212 on January 7, 2025.
- Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT): SGT-501, a first-in-class gene therapy with no approved therapies currently available, is advancing, with Phase 1b ARTEMIS trial site activation expected in Q4 2025. SGT-501 previously received FDA Fast Track designation on July 23, 2025.
UK ILAP Innovation Passport for SGT-003, Aiming for Accelerated Market Access
The UK government recognized the potential of SGT-003 by granting it an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP) on November 6, 2025. This designation is a direct value driver, as it aims to accelerate time to market and facilitate patient access in the UK. SGT-003 is one of the first three investigational products to join this relaunched program. The passport activates direct engagement with the Medicines and Healthcare products Regulatory Agency (MHRA) and health technology assessment bodies like NICE, SMC, and AWTTC to develop a product-specific roadmap.
For context on the company's ability to fund these value-driving activities, Solid Biosciences ended Q3 2025 with $236.1 million in cash, cash equivalents, and available-for-sale securities, projecting a cash runway into H1 2027. Finance: draft 2026 budget allocation for IMPACT DUCHENNE by end of month.
Solid Biosciences Inc. (SLDB) - Canvas Business Model: Customer Relationships
You're looking at how Solid Biosciences Inc. connects with the people who need its therapies, which is critical for a company in the clinical stage. Their customer relationships are deeply rooted in the patient communities they serve, especially for Duchenne muscular dystrophy.
Direct, high-touch engagement with Duchenne patient communities
Solid Biosciences Inc. focuses heavily on direct engagement through its Phase 1/2 INSPIRE DUCHENNE trial for SGT-003. This isn't just about data collection; it's about building trust with families facing this devastating disease. The commitment to transparency is evident in the ongoing enrollment updates.
Here's the quick math on patient engagement as of late 2025:
| Metric | Value / Status | Date Reference |
|---|---|---|
| Participants Dosed (INSPIRE DUCHENNE) | 23 | As of October 31, 2025 |
| Total Participants Expected by Early 2026 | 30 | Expected |
| Active Clinical Trial Sites (as of Aug 2025) | 10 | |
| Additional Potential Participants Identified (as of Aug 2025) | More than 20 | |
| Total Clinical Trial Sites (as of Oct 2025) | 15 | Across US, Canada, Italy, UK |
The trial has expanded its footprint, moving from six active sites in the US and Canada as of February 2025 to 15 active sites by late 2025. Also, the company has regulatory approvals to conduct the ex-U.S. Phase 3 trial, IMPACT DUCHENNE, in Canada and Australia.
Collaborative relationships with clinical investigators and key opinion leaders
Working closely with clinical investigators is how Solid Biosciences Inc. validates its science. You see this collaboration in the presentation schedules and advisory roles. For instance, data from the INSPIRE DUCHENNE trial was presented by Kevin Flanigan, MD, an Advisor Consultant & Researcher at Nationwide Children's Hospital, at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting in May 2025. This level of engagement with external experts is key to advancing the science.
The company actively shares its platform technology, AAV-SLB101, which is used in SGT-003, through external partnerships:
- Agreements/licenses executed for AAV-SLB101: Over 30 as of November 2025.
- Agreements/licenses executed for AAV-SLB101 as of August 2025: Over 25.
Managed access programs (MAPs) for investigational therapies post-approval
While specific financial details on a formal Managed Access Program are not public, the groundwork for future patient access is being laid through global trial expansion. Solid Biosciences Inc. expects to initiate a separate randomized, double-blind, placebo-controlled trial evaluating SGT-003 outside of the United States in the fourth quarter of 2025 to support potential global regulatory authorizations. Furthermore, the company received an Innovation Passport Designation under the New UK Innovative Licensing and Access Pathway for SGT-003 in November 2025. This suggests a proactive approach to navigating different reimbursement and access landscapes.
Investor relations and communication via earnings calls and conferences
Keeping the financial community informed is a structured, regular process. You can track their communication cadence through their earnings reports in 2025:
- Q1 2025 Financial Results reported: May 15, 2025.
- Q2 2025 Financial Results reported: August 12, 2025.
- Q3 2025 Financial Results reported: November 3, 2025.
The company also actively engages at industry events. They presented data at the World Muscle Society (WMS) Annual Congress and the European Society of Gene & Cell Therapy (ESGCT) Annual Congress in October 2025. They also announced plans to participate at 'Upcoming Investor Conferences' in November 2025.
Providing educational resources on genetic medicines and clinical trials
Solid Biosciences Inc. supports the broader scientific understanding of its technology. They presented data on the mechanism of action of AAV-SLB101 at the ASGCT meeting in May 2025. The company also received regulatory designations that serve as external validation and educational milestones, such as receiving Fast Track designation from the FDA for SGT-501 in July 2025 and receiving Rare Pediatric Disease designation for SGT-212 in December 2025.
The financial commitment to this external engagement and resource sharing is reflected in the R&D spend, which was $38.9 million for the third quarter of 2025. Finance: draft 13-week cash view by Friday.
Solid Biosciences Inc. (SLDB) - Canvas Business Model: Channels
You're hiring before product-market fit, so your channels for reaching patients, regulators, and partners are everything right now. For Solid Biosciences Inc., these channels are heavily weighted toward clinical execution and strategic technology out-licensing.
Global network of specialized clinical trial sites (US, Europe)
The primary channel for validating the science is the ongoing Phase 1/2 INSPIRE DUCHENNE clinical trial for SGT-003. This effort relies on a geographically expanding network of specialized centers. As of the August 12, 2025, update, the INSPIRE DUCHENNE trial had 10 active clinical sites spanning the United States, Canada, Italy, and the United Kingdom. This represented growth from the 8 active sites reported in May 2025. The company expected to dose a total of 30 participants by early 2026, showing a clear channel focus on patient enrollment velocity.
Direct communication via patient advocacy organizations
Direct engagement with patient communities serves as a critical channel for trial recruitment and building trust. The company noted receiving overwhelming interest in the INSPIRE DUCHENNE trial from families and the clinical community. This interest is the direct result of consistent communication and the encouraging safety profile of SGT-003, which has been generally well tolerated in the 23 participants dosed as of the October 31, 2025, safety cutoff.
Scientific publications and presentations at medical conferences
Disseminating clinical data through peer-reviewed channels and major medical forums is essential for establishing scientific credibility. Solid Biosciences Inc. presented data from its neuromuscular and cardiac programs at the World Muscle Society 2025 Annual International Congress in Vienna, Austria (October 7-11), and the European Society of Gene & Cell Therapy 2025 Annual Congress in Seville, Spain (October 7-12). These presentations are the direct channel to the broader scientific and medical community.
Licensing agreements to distribute AAV-SLB101 technology to other biotechs
A key channel for monetizing the platform technology, AAV-SLB101, is through non-exclusive licensing. Solid Biosciences Inc. continues to execute these deals to expand the capsid's application. As of November 17, 2025, the company reported expanding collaborative efforts for AAV-SLB101 with over 30 agreements including licenses executed. A recent example is the non-exclusive worldwide license announced with Andelyn Biosciences on November 17, 2025. Another was with Kinea Bio on September 23, 2025. Specific financial terms for these agreements have not been disclosed.
Regulatory pathways (FDA, EMA, MHRA) for eventual product commercialization
Navigating regulatory bodies is the ultimate channel to market access. The company was on track to discuss accelerated pathways with the U.S. FDA later in 2025, with the meeting expected to occur in the fourth quarter of 2025 for SGT-003. Furthermore, the company achieved several key regulatory milestones for its pipeline candidates in 2025:
- SGT-212 (FA): Received Fast Track designation on January 21, 2025.
- SGT-501 (CPVT): FDA cleared the Investigational New Drug (IND) application on July 8, 2025.
- SGT-212 (FA): Received Rare Pediatric Disease designation on December 1, 2025.
- SGT-212 (FA) and SGT-501 (CPVT): Phase 1b trial initiation expected in Q4 2025.
The investment into these channels is reflected in the financials; Research and Development (R&D) Expenses for the third quarter of 2025 totaled $38.9 million.
Here's a look at the channel expansion and key milestones through late 2025:
| Channel/Program | Metric/Event | Date/Value |
| Clinical Sites (INSPIRE DUCHENNE) | Active Sites (Latest Reported) | 10 (US, Canada, Italy, UK) as of August 12, 2025 |
| Clinical Sites (INSPIRE DUCHENNE) | Participants Dosed (Latest Reported) | 23 as of October 31, 2025 |
| Licensing Channel | Total AAV-SLB101 Agreements Executed | Over 30 as of November 17, 2025 |
| Regulatory (SGT-003) | Planned FDA Meeting for Accelerated Pathway | Q4 2025 |
| Regulatory (SGT-212) | Fast Track Designation Date | January 21, 2025 |
| Regulatory (SGT-501) | FDA IND Clearance Date | July 8, 2025 |
Solid Biosciences Inc. (SLDB) - Canvas Business Model: Customer Segments
You're hiring before product-market fit, so knowing exactly who you are building for-and who is funding the build-is the first step in mapping your business.
Solid Biosciences Inc. targets distinct patient populations for its pipeline candidates, alongside strategic partners for its delivery technology and the financial community that underwrites its research and development (R&D).
The primary patient segments are defined by the rare genetic diseases they suffer from, with clinical trial enrollment numbers serving as a proxy for the immediate customer base being engaged.
- Duchenne muscular dystrophy (DMD) patients enrolled in the INSPIRE DUCHENNE trial.
- Friedreich's ataxia (FA) participants for the SGT-212 FALCON trial.
- Adult participants with Catecholaminergic polymorphic ventricular tachycardia (CPVT) for the ARTEMIS trial.
As of October 31, 2025, 23 participants have been dosed in the Phase 1/2 INSPIRE DUCHENNE trial for SGT-003, with the company expecting to dose 30 participants in total by early 2026.
For the Friedreich's ataxia program (SGT-212), the first clinical site for the FALCON Phase 1b trial was activated in October 2025, with participant screening underway.
For the CPVT program (SGT-501), site activation for the ARTEMIS Phase 1b trial was expected in the fourth quarter of 2025.
The table below summarizes the key patient and partner segments with relevant operational and financial data as of late 2025.
| Customer Segment | Product/Program Focus | Key Metric (as of late 2025) | Status/Target |
| DMD Patients | SGT-003 (INSPIRE DUCHENNE trial) | 23 participants dosed (as of Oct 31, 2025) | FDA discussion on registrational pathways planned for H1 2026. |
| FA Patients | SGT-212 (FALCON trial) | First site activated in October 2025 | First-in-human dosing anticipated in Q4 2025. |
| CPVT Patients | SGT-501 (ARTEMIS trial) | Phase 1b trial site activation expected in Q4 2025 | IND submission for the trial was anticipated in 1H 2025. |
| Pharma/Biotech Companies | AAV-SLB101 Capsid Technology | Over 30 agreements/licenses executed | Technology licensing for gene therapy delivery. |
| Institutional Investors/Shareholders | R&D Funding | $236.1 million in cash reserves (as of Q3 2025) | Cash runway anticipated into H1 2027. |
The financial backers are a concentrated group, showing strong conviction in the platform. Solid Biosciences Inc. has a total of 18 institutional investors.
The analyst sentiment reflects this conviction; the average brokerage recommendation (ABR) is 1.14 on a scale of 1 to 5 (Strong Buy to Strong Sell), based on recommendations from 14 brokerage firms. Of those, 13 are Strong Buy recommendations, representing 92.86% of all current ratings.
To fuel operations, Solid Biosciences Inc. closed a significant offering in February 2025, generating approximately $200.0 million in gross proceeds. This capital infusion is key to supporting the concurrent advancement of the three clinical-stage programs. That's how you fund a pipeline. The company ended the third quarter of 2025 with $236.1 million in cash, cash equivalents and available-for-sale securities.
The licensing segment, focused on the AAV-SLB101 capsid, shows traction beyond the company's internal pipeline. Solid Biosciences Inc. has executed over 30 agreements, including licenses, with various corporations, institutions, and academic labs for the use of AAV-SLB101 as of November 3, 2025.
- The February 2025 offering involved 35,739,810 shares of common stock at $4.03 per share.
- Pre-funded warrants were offered at $4.029 per warrant.
- The company has 101 employees as of December 31, 2022, though this number is likely higher given the late 2025 R&D spend.
Solid Biosciences Inc. (SLDB) - Canvas Business Model: Cost Structure
You're looking at where Solid Biosciences Inc. is putting its capital to work, which is almost entirely focused on advancing its pipeline, especially SGT-003. The cost structure is dominated by the heavy lift of clinical development and manufacturing prep for a gene therapy.
Here's a quick look at the major operating expenses for the third quarter of 2025, which really shows where the burn rate is coming from:
| Expense Category | Q3 2025 Amount (USD Millions) | Q3 2024 Amount (USD Millions) |
| Research and Development (R&D) Expenses | $38.9 million | $27.3 million |
| General and Administrative (G&A) Expenses | $9.2 million | $7.9 million |
| Total Operating Expenses | $48.1 million | $35.2 million |
The Research and Development (R&D) expenses hit $38.9 million in Q3 2025, a significant jump from $27.3 million in the same quarter last year. This acceleration reflects the active clinical execution across the pipeline.
The primary cost drivers within R&D are tied directly to your lead assets. You see the costs associated with the INSPIRE DUCHENNE trial for SGT-003 ramping up as enrollment continues. For instance, in Q2 2025, the R&D increase was largely due to a $9.9 million rise in SGT-003 costs related to manufacturing, regulatory, and clinical activities.
Manufacturing and process development costs are a major component, particularly for SGT-003. While the FDA meeting was pushed to H1 2026, the company is still pushing forward with commercial-readiness CMC activities, with the expectation that the Process Performance Qualification (PPQ) manufacturing batches for SGT-003 will be completed in 2026. This prep work is expensive, even before commercial launch.
General and Administrative (G&A) expenses were approximately $9.2 million in Q3 2025, up from $7.9 million the prior year. This increase is often tied to personnel costs needed to support the growing clinical and regulatory complexity of advancing multiple programs simultaneously.
When you look at other specific costs, you can see the ebb and flow of program-specific spending. For example, in Q3 2025, costs for SGT-212 saw a decrease of $3.3 million, partially due to lower license and milestone related costs. Still, intellectual property maintenance and licensing fees are an ongoing, necessary cost of doing business in this space, as evidenced by prior periods showing increases in license fees for development programs.
The major buckets of spending look like this:
- Costs for SGT-003: Primarily manufacturing, regulatory, and clinical costs.
- Costs for SGT-601: Including manufacturing costs.
- Costs for SGT-212: Including clinical and research costs, and license/milestone payments.
- Personnel related expenses across R&D and G&A.
Finance: draft 13-week cash view by Friday.
Solid Biosciences Inc. (SLDB) - Canvas Business Model: Revenue Streams
You're looking at the revenue side of Solid Biosciences Inc. (SLDB) as of late 2025, and honestly, it looks exactly like what you'd expect from a company deep in clinical development. The revenue streams aren't from selling a drug yet; they are about future potential and non-product income sources that keep the lights on while the science matures.
Currently $0.0 in product revenue (pre-revenue clinical-stage company)
For the trailing twelve months ending September 30, 2025, Solid Biosciences revenue was reported as $0.00. This is the reality for a clinical-stage company focused on bringing a novel gene therapy to market. The Q3 2025 reported revenue was also $0.0.
Potential future revenue from sales of approved gene therapies (e.g., SGT-003)
The primary long-term revenue driver is the potential commercialization of SGT-003 for Duchenne muscular dystrophy. As of the October 31, 2025, safety cutoff, 23 participants had been dosed in the Phase 1/2 INSPIRE DUCHENNE trial. Solid Biosciences expects to dose 30 participants in total by early 2026 and plans to meet with the U.S. Food and Drug Administration (FDA) in the first half of 2026 to discuss potential registrational pathways. This is the inflection point that unlocks potential blockbuster sales, but until then, it's zero product revenue.
Upfront payments and milestones from AAV-SLB101 capsid licensing agreements
This is a key near-term, non-product revenue stream. Solid Biosciences is actively licensing its proprietary AAV-SLB101 capsid technology broadly. As of November 17, 2025, Solid Biosciences had executed over 30 agreements, including licenses, with corporations, institutions, and academic labs. For instance, the agreement with Kinea Bio confirms Solid receives an upfront fee and is eligible for development/sales milestones and tiered royalties, though the specific upfront amount wasn't disclosed. Similarly, financial terms for the non-exclusive license with Andelyn Biosciences were not disclosed.
Potential non-dilutive funding from government grants for rare disease research
While Solid Biosciences is pursuing multiple rare disease indications (Friedreich's ataxia with SGT-212, CPVT with SGT-501), specific dollar amounts received from government grants as of late 2025 aren't detailed in the latest public updates. This funding source is a crucial, non-dilutive component that supports the high Research and Development (R&D) spend.
Equity financing and public offerings to fund operations
Since product sales are absent, financing is the lifeblood. The company ended Q3 2025 with $236.1 million in cash, cash equivalents, and available-for-sale securities. Management projects this cash position will fund the operational runway into the first half of 2027. This is a critical metric to watch, especially given R&D expenses for Q3 2025 were $38.9 million. The company previously announced a Series C Financing of up to $50 Million in 2017, which, along with subsequent financing, built this current war chest.
Here's a quick snapshot of the key financial and operational data points underpinning these revenue expectations:
| Metric | Value as of Late 2025 | Context/Date |
| Trailing 12-Month Product Revenue | $0.00 | TTM ending September 30, 2025 |
| Cash Position | $236.1 million | As of September 30, 2025 |
| Projected Cash Runway | Into the first half of 2027 | Based on September 30, 2025 cash |
| SGT-003 Dosed Participants | 23 | As of October 31, 2025 |
| AAV-SLB101 Licensing Agreements Executed | Over 30 | As of November 17, 2025 |
| Q3 2025 R&D Expense | $38.9 million | For the quarter ended September 30, 2025 |
The revenue model right now is entirely dependent on successfully executing these non-dilutive licensing deals and managing the cash burn until SGT-003 can potentially generate sales, which hinges on the planned H1 2026 FDA discussions.
You should keep an eye on the pace of new AAV-SLB101 deals, as these upfront payments directly offset the operating loss. The current non-product revenue streams are structured around:
- Upfront fees from new capsid licenses.
- Future milestone payments tied to partners advancing their AAV-SLB101 programs.
- Tiered royalties on net sales from commercialized partner products.
- Non-dilutive grant funding for pipeline programs.
The company's liquidity, sitting at $236.1 million as of the end of Q3 2025, is the buffer that allows them to pursue these revenue-generating milestones without immediate reliance on public offerings, though that remains a fallback option.
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