Solid Biosciences Inc. (SLDB): PESTLE Analysis [Nov-2025 Updated]

You're looking at Solid Biosciences Inc. (SLDB), a classic high-stakes biotech play where the outcome is defintely binary. The company is sitting on a Q3 2025 cash position of $236.1 million, but with a Q2 2025 net loss of $39.5 million, the cash runway runs out by H1 2027 without a major catalyst. That catalyst is SGT-003, their gene therapy for Duchenne Muscular Dystrophy, which showed promising early 2025 data with a mean microdystrophin expression of 58%. The entire investment thesis hinges on the H1 2026 U.S. FDA meeting to discuss accelerated approval; miss that timeline, and the need for a capital raise becomes immediate. This PESTLE analysis maps out exactly how Political, Economic, and Technological forces are creating this critical near-term inflection point, so you can make an informed decision.

Solid Biosciences Inc. (SLDB) - PESTLE Analysis: Political factors

U.S. FDA Meeting Planned for H1 2026 to Discuss Accelerated Approval Pathways for SGT-003

The regulatory landscape for gene therapies remains a critical political factor, and Solid Biosciences has a clear, near-term milestone here. The company plans to meet with the U.S. Food and Drug Administration (FDA) in the first half of 2026 to discuss a potential registrational pathway for SGT-003, their gene therapy candidate for Duchenne muscular dystrophy. This meeting will specifically explore accelerated approval options, which is a major political and regulatory lever.

Accelerated approval allows the FDA to approve drugs for serious conditions based on a surrogate endpoint-a measure thought to predict clinical benefit-rather than waiting for definitive long-term outcomes. For Solid Biosciences, a positive discussion could significantly shorten the time to market, providing a massive advantage over competitors. To be fair, this is a high-stakes discussion; the FDA has been under political pressure to both speed up rare disease approvals and maintain rigorous safety standards, especially after recent events in the gene therapy space. The company's interim data as of October 31, 2025, shows 23 participants have been dosed in the INSPIRE DUCHENNE trial, which provides the clinical basis for this regulatory dialogue.

Global Regulatory Approvals Secured for the Phase 3 IMPACT DUCHENNE Trial in Canada and Australia

Solid Biosciences is smartly de-risking its global regulatory strategy by securing early approvals for its Phase 3 IMPACT DUCHENNE trial outside the U.S. The company has already received the necessary regulatory approvals to conduct this multinational trial in both Canada and Australia.

This is a clear action: initiating a separate, randomized, double-blind, placebo-controlled trial outside the U.S. is designed to support potential ex-U.S. regulatory authorizations. This strategy diversifies the political and regulatory risk away from a single jurisdiction like the U.S. FDA, which is defintely a smart move. Plus, multinational trials help build a more robust, globally accepted data package, which is essential for a product with global sales potential.

Government Focus on Rare Disease (Orphan Drug) Incentives Provides a Favorable Regulatory Tailwind

The U.S. government's policy framework, specifically the Orphan Drug Act (ODA) of 1983, provides a strong, favorable political tailwind for companies like Solid Biosciences. SGT-003 has already been granted Orphan Drug Designation and Fast Track Designation by the FDA.

The financial incentives are substantial and directly impact the company's bottom line and market position. Here's the quick math on the core ODA benefits:

• Market Exclusivity: Seven years of U.S. market exclusivity post-approval, protecting against direct competition.
• Tax Credit: A 25% federal tax credit for qualified clinical trial expenses conducted in the U.S.
• Fee Waiver: Waiver of Prescription Drug User Fee Act (PDUFA) fees, which can save millions on the application process.

The overall U.S. orphan drugs market was valued at $84.70 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 12.3%, showing that the political will to incentivize this sector translates into massive market growth.

Potential for Political Scrutiny on the High Cost of Approved Gene Therapies for Single-Dose Treatments

This is the biggest political risk on the horizon. While the rare disease designation is a tailwind, the ultra-high price of single-dose gene therapies is a major political lightning rod. Prices for approved gene therapies are now cresting above $3 million per patient, which has drawn significant scrutiny from policymakers and payers.

The political pressure is real, and it's translating into policy action. The Trump administration's focus on 'most favored nation' (MFN) drug pricing-aiming to bring U.S. drug costs in line with other developed countries-is a policy that cell and gene therapy makers are actively preparing for as of late 2025.

This scrutiny creates a reimbursement hurdle for any approved gene therapy, including SGT-003. Payers are struggling to design reimbursement pathways for one-time, multi-million-dollar treatments. This means that even with FDA approval, the political environment could force intense negotiations and scrutiny on the therapy's cost-effectiveness.

Here is a snapshot of the price scrutiny Solid Biosciences will face:

The political climate demands that Solid Biosciences not only proves SGT-003 is safe and effective but also that its price represents a clear, long-term value compared to the lifetime cost of care for Duchenne muscular dystrophy. Finance: draft a pricing strategy that maps to a 5-year cost-effectiveness model by year-end.

Solid Biosciences Inc. (SLDB) - PESTLE Analysis: Economic factors

Ended Q3 2025 with a cash position of $236.1 million, providing a runway into H1 2027.

You need to see the cash position not just as a number, but as a time buffer for critical development. Solid Biosciences Inc. ended the third quarter of 2025 with a strong liquidity position, reporting $236.1 million in cash, cash equivalents, and available-for-sale securities as of September 30, 2025. This capital, significantly boosted by a $189.6 million public offering in February 2025, is projected to fund the company's operational runway into the first half of 2027. That's a solid 18-month cushion, which is essential for a clinical-stage biotech company navigating the costly and time-consuming path to market. The financial stability buys time for the SGT-003 gene therapy program to advance through regulatory discussions with the FDA, which are planned for the first half of 2026.

High R&D expenses, totaling $38.9 million in Q3 2025, driven by clinical and manufacturing costs.

The core economic reality for a gene therapy company is the burn rate, and for Solid Biosciences Inc., that burn is driven by Research and Development (R&D). R&D expenses for the third quarter of 2025 were $38.9 million, a significant increase from the $27.3 million reported in Q3 2024, reflecting a 42.2% year-over-year rise. This spending is concentrated on advancing the pipeline, particularly the lead candidate, SGT-003, for Duchenne muscular dystrophy (Duchenne), which accounted for $39.7 million of the R&D expenses year-to-date (YTD) 2025. High R&D is a necessary expense, but it's still the primary financial risk.

The total R&D expenses for the first nine months of 2025 reached $102.2 million, a 55.6% jump from the same period in 2024. This expenditure is tied directly to clinical trial costs, like dosing participants in the INSPIRE DUCHENNE trial, and the complex, high-cost manufacturing scale-up required for gene therapies.

Analyst average 2025 revenue forecast is $19,867,111, reflecting licensing revenue, not product sales.

The revenue picture for 2025 is largely symbolic of the company's pre-commercial stage. The average 2025 revenue forecast from Wall Street analysts is $19,867,111. Importantly, this revenue is expected to come from licensing agreements or collaboration milestones, not from the sale of a commercialized product like SGT-003. The lowest revenue forecast is $0, underscoring the high-risk nature of milestone-dependent revenue. This means the company's valuation is almost entirely based on pipeline success, not current sales performance.

Here's the quick math on the pre-commercial financial state:

Continued net losses; Q3 2025 net loss was $45.8 million, underscoring pre-commercial financial risk.

Solid Biosciences Inc. continues to operate at a net loss, which is typical for a clinical-stage biotechnology company. The net loss for the third quarter of 2025 was $45.8 million, which is a significant increase from the $32.7 million net loss in Q3 2024. This widening loss is a direct consequence of the increased R&D spending as the clinical programs, particularly SGT-003, accelerate.

The cumulative net loss for the first nine months of 2025 reached $124.5 million, a 51.7% increase from the $82.1 million loss for the same period in 2024. This sustained, and defintely growing, operational deficit highlights the pre-commercial financial risk. The company's economic viability hinges entirely on positive clinical data and subsequent regulatory approvals, which would then trigger the shift from a high-burn R&D model to a potential revenue-generating commercial model. Until then, the risk of needing to raise additional capital, which could dilute existing shareholder value, remains high.

• Operating cash use for the first nine months of 2025 was $102.7 million.
• The average analyst forecast for 2025 earnings is a loss of -$158,726,530.
• Future cash needs are significant, supporting clinical development, manufacturing scale-up, and potential commercialization.

Solid Biosciences Inc. (SLDB) - PESTLE Analysis: Social factors

You're looking at Solid Biosciences Inc. (SLDB) and its gene therapy candidate, SGT-003, and the social factors here are not just a soft metric; they are a hard, material risk and opportunity. The company operates in the rare disease space, where patient groups wield significant, direct influence over regulatory and commercial success. Simply put, the social license to operate is as critical as the clinical data.

Focus on Duchenne Muscular Dystrophy (DMD), a Rare Pediatric Disease

Duchenne Muscular Dystrophy (DMD) is the core of Solid Biosciences' mission, and it's a devastating, X-linked genetic disorder. It is a classic example of a high-unmet-need pediatric disease. The disease is progressive, irreversible, and ultimately fatal, with a median age of survival for males historically around 23.7 years. This creates an intense social pressure for a curative or disease-modifying therapy.

The disease is rare, but the affected population is clearly defined and highly visible. The estimated prevalence in the United States alone is significant, ranging from 5,000 to 15,000 cases, with some 2024 estimates suggesting up to 17,000 cases. This patient pool is small enough to be considered a rare disease (affecting approximately 1 in every 3,500 to 5,000 male births), but large enough to drive a multi-billion dollar market. The race for a one-time treatment is not just scientific; it's a massive social and emotional imperative for these families.

Strong Influence of Patient Advocacy Groups

The Duchenne patient advocacy ecosystem is one of the most organized and influential in rare disease. Groups like Parent Project Muscular Dystrophy (PPMD), CureDuchenne, and the Muscular Dystrophy Association (MDA) are deeply embedded in the research and regulatory process. They don't just raise money; they actively shape the dialogue.

These groups work directly with the FDA and companies like Solid Biosciences, influencing everything from the selection of clinical endpoints to the speed of the regulatory review. For example, the MDA's 2025 Advocacy Agenda includes a push to add DMD to the Recommended Uniform Screening Panel (RUSP) for newborns, which would drastically accelerate early diagnosis and, consequently, the market for a gene therapy like SGT-003. Solid Biosciences has already engaged directly with PPMD to share updates on the INSPIRE DUCHENNE trial, showing a direct line of communication with the patient community.

• Advocacy groups drive policy, including pushing for the Rare Pediatric Disease Priority Review Voucher Program extension.
• They ensure access to approved therapies, a crucial post-approval factor.
• Their collaboration can accelerate trial enrollment and acceptance.

The Promise of a One-Time Intravenous Gene Therapy (SGT-003)

The emotional and social value of a one-time intravenous gene therapy is immense. For a fatal, progressive disease, the promise of a single infusion that could halt or significantly slow the disease progression is a life-changing prospect. SGT-003 is a one-time treatment, and the initial data from the Phase 1/2 INSPIRE DUCHENNE trial has created a strong positive social signal.

Here's the quick math on the early clinical impact that drives this social excitement:

Achieving microdystrophin expression at 110% of normal levels in the first three participants is defintely a headline number that fuels optimism in the community and among investors. This kind of data translates directly into a social mandate for the company to move quickly toward an accelerated approval pathway, which Solid Biosciences is planning to discuss with the FDA in mid-2025.

Public Perception of Gene Therapy Safety is Critical

The social acceptance of SGT-003 is highly sensitive to the broader gene therapy sector's safety record, especially within the Duchenne community. The recent turbulence and safety events involving other AAV-based gene therapies for muscular dystrophies have raised alarms. For instance, the sector saw fatalities in 2025 in trials using the same AAV vector (AAVrh74) for Duchenne and related diseases, leading to increased scrutiny of liver and cardiac safety.

This means Solid Biosciences' safety data is under a social microscope. While SGT-003 uses a proprietary, next-generation capsid (AAV-SLB101) designed for enhanced muscle targeting and decreased liver targeting, the public perception remains cautious. Surveys from October 2025 indicate that 66% of patients still view Cell and Gene Therapies (CGTs) as 'too experimental or risky.' The company's positive interim safety update, noting SGT-003 was 'generally well tolerated' in 23 participants as of October 31, 2025, with only one treatment-related serious adverse event (SAE), is crucial for managing this perception and maintaining patient trust. The social risk is that a single adverse event in the broader sector could negatively impact the enrollment and public confidence in SGT-003, regardless of its differentiated safety profile.

Solid Biosciences Inc. (SLDB) - PESTLE Analysis: Technological factors

Lead candidate SGT-003 showed a mean microdystrophin expression of 110% by western blot in early 2025 data.

You're looking at a gene therapy company, so the technology is the product. Solid Biosciences Inc.'s core strength is its proprietary gene therapy platform, anchored by the lead candidate SGT-003 for Duchenne muscular dystrophy (Duchenne). The technology is showing real promise, which is the key to future value.

The Phase 1/2 INSPIRE DUCHENNE trial delivered compelling initial data in early 2025. Specifically, the interim 90-day biopsy data from the first three participants showed an average microdystrophin expression of 110% of normal, as measured by western blot. This is a critical metric for efficacy, and frankly, a very strong number that exceeded expectations. Plus, the data showed a mean of 78% dystrophin-positive fibers by immunofluorescence, along with significant reductions in muscle damage biomarkers.

The safety profile is also favorable, with SGT-003 being well-tolerated in the first six participants dosed as of February 2025, with no serious adverse events (SAEs) observed. They plan to dose approximately 20 total participants by the fourth quarter of 2025, and were on track to meet with the U.S. FDA in late 2025 to discuss a potential accelerated approval pathway, though that meeting was later moved to the first half of 2026 to generate a more fulsome data set.

Proprietary, next-generation AAV-SLB101 capsid is designed for enhanced muscle and cardiac targeting.

The engine behind SGT-003, and the whole pipeline, is the proprietary, next-generation adeno-associated virus (AAV) capsid, AAV-SLB101. This is a rationally designed delivery vehicle, not just a repurposed one, and that's a big deal for gene therapy. This capsid is engineered for enhanced skeletal muscle and cardiac tropism-meaning it targets the muscles and heart more effectively-while reducing biodistribution to the liver.

AAV-SLB101 is the core technological asset. It's what makes their gene therapy a potential best-in-class option. Preclinical and early clinical data from the INSPIRE DUCHENNE trial, which utilizes AAV-SLB101, have demonstrated robust cardiac and skeletal muscle transduction.

Pipeline expansion includes SGT-212 for Friedreich's ataxia and SGT-501 for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT).

Solid Biosciences is defintely diversifying its bets beyond Duchenne, which is a smart strategic move. They are leveraging the AAV-SLB101 technology to address other devastating neuromuscular and cardiac diseases, rapidly expanding their clinical-stage pipeline to three unique candidates in 2025.

The pipeline includes SGT-212 for Friedreich's ataxia (FA) and SGT-501 for Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). SGT-212 is particularly innovative because it's the first gene therapy for FA to use a dual route of administration-systemic and bilateral intradentate nucleus (IDN) infusion-to target both neurologic and systemic manifestations.

Here's the quick status map for the pipeline as of late 2025:

Over 30 agreements executed for licensing the AAV-SLB101 capsid technology to other entities.

The true measure of a platform technology is its external validation and adoption. Solid Biosciences has successfully established AAV-SLB101 as a sought-after technology, not just for their own pipeline. They are actively licensing it out.

As of November 2025, the company has executed over 30 agreements, including licenses, for the use of the AAV-SLB101 capsid technology with academic labs, institutions, and corporations. This broad licensing strategy generates non-dilutive revenue streams through upfront payments, milestones, and potential royalties, which helps fund their internal programs.

Recent agreements include a non-exclusive worldwide license granted to Andelyn Biosciences in November 2025, and a non-exclusive worldwide license to Kinea Bio in September 2025 for their gene therapy targeting dysferlin-related limb-girdle muscular dystrophy. This shows the technology's versatility and market acceptance across multiple rare diseases.

• 30+ agreements validate the capsid's commercial value.
• Licensing provides a key non-dilutive funding source.
• The capsid is being used in other gene therapy programs like Kinea Bio's KNA-155.

Solid Biosciences Inc. (SLDB) - PESTLE Analysis: Legal factors

Need to secure and defend intellectual property (IP) for the AAV-SLB101 capsid and SGT-003 microdystrophin construct.

In the gene therapy space, your core value is your intellectual property (IP), and for Solid Biosciences Inc., this centers on the proprietary next-generation capsid, AAV-SLB101, and the differentiated SGT-003 microdystrophin construct. The legal challenge isn't just securing patents, but defintely defending them against competitors in a crowded field like Duchenne muscular dystrophy (DMD).

The company has been proactive in monetizing and validating this IP through licensing. As of November 2025, Solid Biosciences has executed more than 30 agreements, including licenses, with corporations, institutions, and academic labs for the use of AAV-SLB101. This includes a non-exclusive worldwide license announced with Andelyn Biosciences in November 2025. This strategy brings in non-dilutive capital and validates the technology, but also increases the complexity of managing and enforcing licenses globally. Any successful IP challenge could severely impact the company's valuation, which is currently underpinned by its cash runway into the first half of 2027 (based on a cash position of $236.1 million as of September 30, 2025).

Here's the quick math: protecting a differentiated construct, which uniquely includes the R16/17 binding domain to localize nNOS, is a non-negotiable legal cost that drives a portion of the Q3 2025 General and Administrative (G&A) expenses, which were $9.3 million in Q2 2025.

Compliance with stringent global clinical trial regulations across the U.S., Canada, Australia, and Europe.

Running a global gene therapy trial means navigating a patchwork of stringent regulations, and any misstep can trigger a costly clinical hold. Solid Biosciences is currently executing its Phase 1/2 INSPIRE DUCHENNE trial across multiple jurisdictions, including the United States, Canada, Italy, and the United Kingdom. They are also expanding their Phase 3 IMPACT DUCHENNE trial outside the U.S., having already received regulatory approvals in Canada and Australia.

Compliance is a moving target, especially in Europe. For instance, the UK's Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 were signed into law in April 2025, with an effective date of April 28, 2026. This requires immediate procedural and documentation updates to ensure a smooth transition. Also, India's regulatory framework saw updates in April 2025, requiring all Contract Research Organizations (CROs) to register with the Drug Controller General of India (DCGI). This global regulatory complexity increases the legal and consulting fees component of G&A expenses.

• Manage trial master files (TMF) across 4+ continents.
• Monitor new UK and EU Clinical Trial Regulations (CTRs) effective April 2026.
• Maintain approvals in the 15 active clinical sites across the INSPIRE DUCHENNE trial.

Potential for product liability litigation if the one-time gene therapy has long-term, unforeseen side effects.

The nature of a one-time gene therapy, like SGT-003, creates a unique and significant product liability risk. Unlike chronic medication, a single infusion means any unforeseen, long-term side effects are irreversible, leading to the potential for large-scale litigation. This is a risk that doesn't go away, even with promising early data.

To be fair, the safety profile has been encouraging in the Phase 1/2 trial. As of the October 31, 2025, data cutoff, 23 participants have been dosed, and SGT-003 was generally well tolerated using a steroid-only prophylactic regimen. Crucially, there were no cases of drug-induced liver injury (DILI) observed. Still, the company did report one treatment-related serious adverse event (SAE) as of that same date. The legal risk here is a long tail one, extending decades after commercialization, requiring substantial insurance coverage and detailed post-market surveillance. What this estimate hides is the potential for a single, high-profile adverse event to trigger a massive legal and financial crisis.

Ongoing regulatory risk tied to the FDA's evolving standards for accelerated approval of gene therapies.

The path to market for SGT-003 hinges on the U.S. Food and Drug Administration's (FDA) willingness to grant accelerated approval, a regulatory mechanism that is under intense scrutiny and constantly evolving. Solid Biosciences is actively working toward this, with plans to meet with the FDA in the first half of 2026 to discuss potential registrational pathways, including accelerated approval.

The company is strategically gathering a robust data package to support this discussion, with 23 pediatric participants dosed as of October 31, 2025. The risk is tied to the FDA's evolving interpretation of surrogate endpoints (like microdystrophin expression) and the requirement for confirmatory trials. Any delay in the planned 2026 meeting or an unfavorable FDA stance could materially impact the stock price, which already has a high beta of 3.71. Also, external factors like FDA disruptions due to funding cuts or personnel losses, as seen in late 2025, introduce a systemic risk of delayed guidance and approvals.

Solid Biosciences Inc. (SLDB) - PESTLE Analysis: Environmental factors

Here's the quick math: The company's cash burn rate (Q2 2025 net loss of $39.5 million) means they need a major catalyst, like a clear regulatory path or a significant partnership, before the H1 2027 cash runway deadline. You need to watch the H1 2026 FDA meeting defintely.

Management of Hazardous Biological Waste

Solid Biosciences Inc.'s core business of developing adeno-associated virus (AAV) gene therapies inherently involves the use of hazardous materials, including chemicals, viruses, and other biologic materials. This is a critical risk area, especially as the lead candidate, SGT-003, moves through its Phase 1/2 INSPIRE DUCHENNE trial and towards potential commercial scale. The company's operations, centered in Charlestown, Massachusetts, and through its Contract Development and Manufacturing Organization (CDMO) partner, Forge Biologics, in Columbus, Ohio, generate regulated hazardous waste.

The primary environmental risk is liability from accidental contamination, which could lead to significant fines or, worse, the suspension of clinical trials. Since the company does not carry specific biological or hazardous waste insurance coverage, as noted in its SEC filings, the financial burden of a major incident would fall directly on the balance sheet. They manage this risk by contracting with specialized third parties for disposal, but the ultimate liability remains with Solid Biosciences Inc. This is a costly, non-negotiable part of the gene therapy business.

Energy Consumption and Carbon Footprint

Gene therapy manufacturing is an energy-intensive process, largely due to the need for cGMP (Current Good Manufacturing Practice) cleanrooms. The Hearth, Forge Biologics' facility where SGT-003 is manufactured, is a massive, over 200,000 square foot site housing 20 cGMP suites with bioreactors up to 5,000L capacity. Maintaining the required ISO 7 (Class 10,000) and ISO 8 (Class 100,000) air quality conditions in such a large space demands continuous, high-volume air filtration and conditioning, driving up energy use.

While Solid Biosciences Inc. does not publicly disclose its specific 2025 energy consumption or carbon footprint data, the industry benchmark is clear: manufacturing costs for a single gene therapy dose can exceed $100,000 per patient, with a significant portion allocated to facility overhead and utility costs. The company's reliance on a centralized, large-scale CDMO means its carbon footprint is concentrated in a single, high-draw location. Any future push for lower-cost, commercial-scale production will require energy-efficient facility design and process optimization to reduce this environmental burden.

Need for Sustainable Sourcing

The complexity of biologic drug production creates a significant sustainability challenge in the supply chain for raw materials and reagents. The global gene therapy starting materials market was valued at an estimated $1.90 billion in 2024 and is projected to grow at a CAGR of 19.24% through 2030, underscoring a rapidly increasing demand for high-purity components like plasmids, cell culture media, and chromatography resins. This growth puts pressure on sustainable sourcing.

The industry is moving toward single-use bioreactors (SUBs) for AAV production, which are efficient for batch changeover and reducing cross-contamination risk, but they generate enormous volumes of plastic waste. Solid Biosciences Inc.'s focus on a proprietary next-generation capsid, AAV-SLB101, is a positive step toward efficiency, as optimizing the vector can reduce the required dose and, consequently, the overall manufacturing scale and raw material input. However, the reliance on single-use components remains a major environmental hurdle.

• Demand for cGMP-grade raw materials is intensifying, requiring greater traceability.
• Use of single-use plastic systems in manufacturing increases non-hazardous solid waste volume.
• Optimizing AAV-SLB101 yield is a key leverage point to reduce raw material consumption per patient dose.

Compliance with Environmental Regulations

Compliance is a baseline requirement, not a competitive advantage, but failure to comply is a catastrophic risk. Solid Biosciences Inc. must adhere to a complex matrix of local, state, and federal environmental, health, and safety (EHS) laws, including the Resource Conservation and Recovery Act (RCRA) for hazardous waste and the Occupational Safety and Health Act (OSHA) for laboratory safety. The company's R&D operations in Massachusetts and its CDMO operations in Ohio face stringent state-level EHS oversight.

The critical factor is that EHS compliance costs are non-discretionary. They are built into the cost of goods sold (COGS) for future commercial products and the current R&D budget. The risk is not just the fine, but the operational disruption. A non-compliance event could trigger an inspection, leading to a temporary shutdown of a cGMP suite at Forge Biologics, which would directly impact the SGT-003 clinical supply timeline and valuation.

Next step: Finance: Model a scenario where SGT-003 approval is delayed by 12 months past the H1 2026 meeting and assess the required capital raise size by the end of Q1 2026.