Executive Summary / Key Takeaways

• NeuroSense Therapeutics ($NRSNW) is a clinical-stage biotechnology company poised at a critical juncture, advancing its lead drug candidate, PrimeC, an oral fixed-dose combination, through late-stage clinical trials for debilitating neurodegenerative diseases like ALS and Alzheimer's.
• PrimeC has demonstrated compelling disease-modifying potential in Phase 2b ALS trials, showing a 58% improvement in survival rates and a 40% slower functional decline, positioning it as a significant differentiator in a market with immense unmet medical needs.
• The company is strategically pursuing early commercialization in Canada for ALS, targeting an estimated $100 million to $150 million in peak annual revenues, alongside preparing for a multinational Phase 3 ALS study and finalizing a strategic partnership with a global pharmaceutical company.
• Despite consistent net losses and a reliance on equity financing, recent capital raises, including a $500,000 private placement at a 40% premium in September 2025, have strengthened the balance sheet and underscore investor confidence ahead of key clinical and regulatory milestones.
• While facing significant liquidity challenges and intense competition from larger, more established players, NeuroSense's innovative oral formulation and strong clinical data for PrimeC present a highly asymmetric risk-reward profile for discerning investors.

The Urgent Call: Addressing Neurodegenerative Diseases with Innovation

NeuroSense Therapeutics Ltd. is an Israeli-headquartered clinical-stage biotechnology company dedicated to discovering and developing treatments for some of the most challenging neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS), Alzheimer's disease, and Parkinson's disease. These conditions represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available. The global precision medicine market, which aligns with NeuroSense's targeted therapeutic approach, is projected to expand significantly, from $102.17 billion in 2024 to $470.53 billion by 2034, underscoring the vast potential for innovative treatments.

NeuroSense's overarching strategy is to develop disease-modifying therapies that can slow or halt the progression of these devastating conditions. The company's foundational strength lies in its differentiated technology, particularly its lead product candidate, PrimeC. This extended-release oral formulation combines ciprofloxacin and celecoxib, offering a unique approach to targeting the complex pathologies of neurodegeneration. The oral delivery mechanism itself provides a tangible benefit of improved patient convenience and adherence compared to more complex administration routes, which can be a critical factor in long-term treatment success and market adoption.

PrimeC: A Differentiated Approach to Debilitating Diseases

PrimeC stands as the cornerstone of NeuroSense's pipeline, representing a significant technological differentiator. This proprietary oral formulation of ciprofloxacin and celecoxib is designed to address multiple pathways implicated in neurodegenerative diseases. The tangible benefits of PrimeC have been highlighted in its clinical development, particularly in ALS. In the Phase 2b PARADIGM study for ALS, PrimeC achieved primary and secondary clinical endpoints, demonstrating a statistically significant 36% reduction in ALS progression (p=0.009). The study also showed a 43% improvement in survival rates versus placebo and a remarkable 58% better survival at 18 months (p=0.007). Further long-term data from this study, reported in February 2025, revealed that in the per-protocol population, treatment with PrimeC slowed functional decline by approximately 40%, improved overall survival by 74%, and complication-free survival by 79%. Patients also experienced a 26% slower decline in slow vital capacity, reinforcing the disease-modifying potential of PrimeC.

Beyond ALS, PrimeC has completed Phase 2 clinical trials for Alzheimer's disease, with a recent press release on September 10, 2025, reporting early signals of benefit in Alzheimer's patient-derived neurons. Initial Phase 2 RoAD trial results demonstrated improvements in brain-cell connectivity and health with a favorable safety profile. The drug is also under preclinical studies for Parkinson's disease. This multi-indication approach, leveraging a single core technology, enhances the potential market opportunity and de-risks the pipeline. The company has also secured Orphan Drug Designation from both the FDA and European Medicines Agency, which provides potential market exclusivity and regulatory advantages.

NeuroSense's preclinical pipeline further includes StabiliC for Parkinson's disease and CogniC for Alzheimer's disease, indicating a broader commitment to addressing these conditions. The successful scaling of PrimeC production to a commercial level in May 2025, along with the selection of a global contract development and manufacturing organization (CDMO), validates the manufacturing process and demonstrates product stability for a 36-month shelf-life, ensuring supply chain readiness for potential commercialization. This operational achievement is crucial for a clinical-stage company aiming for market entry.

Strategic Initiatives and Market Expansion

The coming months are pivotal for NeuroSense as it advances several strategic initiatives. Following positive regulatory feedback from the FDA, the company plans to begin a multinational Phase 3 study of PrimeC in ALS in the second half of 2025. This is a critical step towards potential broad market approval.

Concurrently, NeuroSense is pursuing an expedited path to market in Canada. In June 2025, the company completed its pre-New Drug Submission (pre-NDS) meeting with Health Canada regarding the potential early approval of PrimeC for ALS under the Notice of Compliance with Conditions (NOC/c) pathway. NeuroSense plans to file for early commercialization in Canada in Q3 2025, with a potential regulatory decision expected in early 2026. This initiative targets an estimated potential market opportunity of $100 million to $150 million in peak annual revenues.

Furthermore, discussions are ongoing for a definitive partnership agreement with a global pharmaceutical partner, following a binding term sheet executed in Q4 2024. Such a partnership could provide significant non-dilutive funding, commercialization expertise, and broader market reach, substantially de-risking the company's future.

Financial Performance and Liquidity: Fueling Innovation

As a clinical-stage biotechnology company, NeuroSense Therapeutics has consistently reported net losses, reflecting its intensive research and development phase. The company reported net losses from continuing operations of -$10.21 million in 2024, -$10.11 million in 2023, -$10.49 million in 2022, and -$4.04 million in 2021. The company has generated no revenue from 2020 to 2024.

Operating expenses, while still substantial, have shown some moderation. Research and development expenses decreased by 21.9% ($1.6 million) in 2024, primarily due to reduced expenses for subcontractors, consultants, and share-based payments. General and administrative expenses also decreased by 12.5% ($0.6 million) in 2024, mainly attributed to lower share-based compensation, insurance costs, and a decrease in employee salaries and social benefits, partially offset by increased professional services expenses. For the first half of 2025, R&D expenses were reduced to $2.5 million (down 32.9% year-over-year), while G&A expenses remained stable at $2.2 million.

Liquidity remains a critical factor for NeuroSense. The company's cash and cash equivalents have shown a declining trend, from $11.06 million in 2021 to $3.38 million in 2024, and further to $666,000 as of September 23, 2025. NeuroSense has consistently reported negative free cash flow, indicating that its operations and investments consume more cash than they generate. As of September 23, 2025, the company's current ratio was 0.71 and its quick ratio was 0.69, suggesting potential short-term liquidity constraints.

To fund its operations and extensive R&D, NeuroSense has relied on equity financing. Significant capital stock issuances include $11.30 million in 2024, $4.33 million in 2023, and $9.86 million in 2021. In January 2025, the company regained compliance with Nasdaq's stockholders' equity requirement after completing a $5 million private placement in December 2024, which strengthened its balance sheet. Further demonstrating investor confidence, in September 2025, NeuroSense announced a $500,000 private placement of ordinary shares at a purchase price of $1.50 per share, representing a 40% premium to the closing price on September 3, 2025. Alon Ben-Noon, CEO of NeuroSense, commented on this, stating, "This ordinary share only investment serves as a short-term bridge as we continue to advance our activities and prepare for our next stage of growth. This is our third financing which is with private investors at a premium to market. This enables us to strengthen our balance sheet as the Company advances toward key upcoming milestones, while minimizing dilution for our shareholders".

Competitive Landscape: Carving a Niche

NeuroSense Therapeutics operates in a highly competitive biotechnology landscape, particularly within the neurodegenerative disease space. Key direct competitors include established players like Biogen Inc. (BIIB), Amylyx Pharmaceuticals Inc. (AMLX), and Ionis Pharmaceuticals Inc. (IONS), all of whom have significant investments in neurological treatments.

Biogen, a large, established biotechnology company, boasts a broad portfolio and global distribution networks, with treatments for ALS such as Tofersen. Its financial strength, consistent revenue growth, and higher profitability margins, driven by marketed products, provide a significant scale advantage. NeuroSense's PrimeC, with its oral formulation, offers a qualitative edge in patient convenience compared to Biogen's often injectable or infusion-based treatments. However, Biogen's superior resources for clinical trial execution and market reach allow it to capture a larger market share.

Amylyx Pharmaceuticals, with its approved ALS product Relyvrio, also presents direct competition. Amylyx has shown promising revenue growth and improving profitability as it scales. While Amylyx benefits from approved products and established partnerships, NeuroSense's PrimeC aims to differentiate through potentially superior long-term efficacy, as evidenced by its disease-modifying data. NeuroSense's focused pipeline for multiple neurodegenerative diseases could offer more flexibility in emerging markets, but it lags Amylyx in terms of current revenue generation and cash flow.

Ionis Pharmaceuticals, focused on RNA-targeted therapies, represents another formidable competitor with its cutting-edge technology and partnerships with larger pharma firms. Ionis has demonstrated steady revenue growth through licensing deals. NeuroSense's oral formulations could offer patient convenience benefits over Ionis's more complex delivery methods. While Ionis's advanced platform enables faster development in certain areas, NeuroSense's strength lies in its focused, cost-efficient R&D for early-stage treatments.

NeuroSense's current valuation metrics, including a negative Price-to-Book (P/B) Ratio (-20 as of September 23, 2025) and a negative Book Value (-0.02), reflect its accumulated losses and clinical-stage status. However, this also contributes to its "asymmetric risk-reward profile". Analyst price targets, with an average of $10.75 and forecasts ranging up to $14.00, suggest a potential increase of over 788% from recent prices, indicating Wall Street's recognition of PrimeC's potential.

Indirect competition also arises from non-pharmaceutical interventions and advancements in AI-driven drug discovery. While AI could accelerate drug development across the industry, larger competitors with greater resources may be better positioned to leverage these trends. NeuroSense's competitive advantages are rooted in its proprietary oral formulation technology and the compelling clinical data for PrimeC, which could lead to stronger customer loyalty and recurring revenue from partnerships, ultimately enhancing pricing power and market share in patient-centric segments.

Risks and Challenges

Investing in a clinical-stage biotechnology company like NeuroSense Therapeutics inherently involves significant risks. The company faces uncertainties related to ongoing partnership discussions, which may not lead to a definitive agreement or yield anticipated benefits. There is also a risk of delays or changes in the scope of the planned Phase 3 study for PrimeC in ALS, which could impact timelines and capital requirements.

The potential market opportunity for PrimeC in Canada and other territories could be lower than anticipated, affecting future revenue projections. NeuroSense may need to raise additional capital earlier than currently anticipated, and there is a risk that regulatory approvals for PrimeC could be delayed or not obtained at all. Other risks include unexpected R&D costs or operating expenses, insufficient capital to complete PrimeC's development, and general uncertainties regarding the outcomes and timing of current and future clinical trials. The company's ability to maintain its listing on Nasdaq is also a continuous consideration.

Conclusion

NeuroSense Therapeutics stands at a pivotal moment, with its lead candidate PrimeC demonstrating compelling disease-modifying potential in the challenging landscape of neurodegenerative diseases. The company's strategic focus on an innovative oral formulation, coupled with strong Phase 2b ALS data and a clear path towards Canadian commercialization and a multinational Phase 3 study, underpins a compelling investment thesis. While current financial performance reflects its clinical-stage nature, marked by consistent losses and a reliance on equity financing, recent capital raises at a premium signal growing investor confidence in its future.

The ability to successfully execute its Phase 3 trial, secure regulatory approvals, and finalize a strategic partnership will be critical determinants of its long-term success. NeuroSense's technological differentiation with PrimeC's efficacy and patient-friendly oral delivery positions it to carve out a significant niche against larger competitors. For investors with a high-risk tolerance and a long-term view, NeuroSense Therapeutics offers a unique opportunity to participate in the potential transformation of treatment paradigms for debilitating neurodegenerative conditions.