Capital Raise, Next-Gen Neuropathy Solution, Pennsylvania, USA

Neuropathix, Inc. is pioneering a novel synthetic cannabinoid platform with KLS-13019, a groundbreaking therapeutic designed to prevent and reverse neuropathic pain and neuroinflammation, starting with Chemotherapy-Induced Peripheral Neuropathy (CIPN). Led by an experienced team with deep roots in pharmaceuticals, the mission is to address the root causes of neuropathy, offering a safer, more effective alternative to opioids. With a robust intellectual property portfolio, peer-reviewed science, and a $1.5M grant from The Michael J. Fox Foundation, Neuropathix is poised to transform the $32.3B pain management market.

Investment Opportunity

Neuropathix is raising $30M USD to advance KLS-13019 through clinical trials (Phase 1a, 1b, and 2a) and achieve commercialization by 2028. This capital will fund completion of the IND package by Q4 2025, first-in-human trials by Q4 2026, and Phase 2a trials by Q4 2027. With a highly efficient trial design and a de-risked path to market, investors are offered a compelling opportunity to enter a high-growth sector at a discount to comparable exits (e.g., Inflazome/Roche: $447M cash, $2.4B total deal value).
The goal is an early exit or strategic partnership post-Phase 2a, leveraging a $1.5M commitment from Prevail Partners and interest from HNW investors and funds like Medical Excellence Capital.

Revenue Model & Market Potential

• Initial Market (CIPN): Targeting 360,614 U.S. patients, with a $684.9M TAM. Year 3 target: $34.2M at 5% penetration.
• Broader Neuropathy Market: 73.3M U.S. patients across diabetic neuropathy, COVID-19-related PN, and more, with a $13.2B TAM. Year 3 target: $659.8M at 5% penetration.
• Revenue Streams: Direct sales to healthcare providers, licensing deals with pharma giants, and potential buyouts, mirroring recent exits (e.g., Merck/Caraway: $60M cash, $550M milestones).

Use of Funds ($30M, 2025–2028)

• Year 1 (2025–2026, $4.35M): Completing the IND package ($2.5M for biomarker studies, CMC optimization, GMP material, GLP toxicology) and G&A ($1.35M for 8 employees, consultants).
• Year 2 (2026–2027, $7M): Phase 1a ($1.47M, 42 patients) and 1b ($3.78M, 42 patients) trials, plus G&A ($1.45M).
• Year 3 (2027–2028, $12.95M): Phase 2a trials ($11.3M, 252 patients) and G&A ($1.65M).
  Outcome: Clinical validation by Q4 2027, positioning Neuropathix for commercialization or exit.

Go-to-Market Strategy

Neuropathix plans to scale KLS-13019 across the U.S. with a focused strategy targeting healthcare providers and pharma partners:

• Initial Focus: Launch with oncologists and pain specialists treating 360,614 CIPN patients, leveraging clinical trial data to secure early adoption in cancer care settings.

• Strategic Partnerships: Collaborate with 3–5 major pharmaceutical firms (e.g., Roche, Merck) for licensing or co-development, building on $1.5M Prevail Partners’ commitment and NIH funding history.

• Broader Reach: Expand to 73.3M patients with diabetic neuropathy and other conditions by Year 3, using direct sales to clinics and hospitals, supported by industry events showcasing efficacy (e.g., ASPET conferences).

• Milestones: Achieve IND approval by Q4 2025, onboard 500+ providers post-Phase 1b (2026), and penetrate 5% of the TAM by 2028, driving $34.2M (CIPN) and $659.8M (other neuropathies).

Key Highlights

• Innovative Solution: KLS-13019 is a fresh, powerful drug that turns off a pain-causing switch in the body called GPR55, preventing and reversing CIPN while calming nerve inflammation; it works in tiny amounts, avoids opioid risks, and could be a safer, smarter way to stop pain in its tracks.

• Validated Science: Backed by 8 peer-reviewed publications, including a 2024 study in Journal of Pharmacology & Experimental Therapeutics, and demonstrated efficacy in two animal species, KLS-13019’s scientific foundation is robust, with third-party validation from leading journals and research collaborators.

• Strong IP Portfolio: Secured by 4 patent families with global protection extending to 2035 for composition of matter and 2041 for method of use, Neuropathix holds a defensible position, ensuring long-term exclusivity and freedom to operate in major pharmaceutical markets worldwide.

• Experienced Leadership: Guided by CEO Dean Petkanas and a team with proven expertise from industry giants like J&J, Pfizer, Wyeth, and Novartis, Neuropathix benefits from decades of pharmaceutical knowledge and is supported by top-tier scientific advisors and collaborators.

• Sizable Market Opportunity: Targeting a $32.3B total addressable market, with an initial $0.8B CIPN segment and potential expansion into diabetic neuropathy, HIV-related PN, and other conditions, Neuropathix addresses a critical and growing need in a lucrative, underserved sector.

Investment Highlights

• Addressing a Global Crisis: Neuropathic pain impacts millions globally, with CIPN affecting 360,614 U.S. cancer patients yearly; KLS-13019 provides a non-opioid alternative, unlocking a $684M CIPN market and a $13.2B broader neuropathy market within three years post-commercialization, meeting urgent demand for safer treatments.

• High Growth Potential: With a projected 5% TAM penetration by Year 3, Neuropathix targets $34.2M in CIPN revenue and $659.8M across other neuropathies, fueled by rising prevalence of chronic pain conditions and a shift away from opioids, positioning the company for exponential growth.

• Proven Product Potential: Peer-reviewed studies, such as the 2024 ASPET publication, confirm KLS-13019’s ability to reverse CIPN in rats, supported by clean toxicology, low abuse liability, and no morphine substitution in behavioral models, indicating a safe, effective, and market-ready therapeutic profile.

• Efficient Capital Deployment: The $30M raise funds a streamlined path through Phase 2a with small, cost-effective trials (e.g., 42 patients in Phase 1a), enhanced by $12.9M in prior NIH grants and a $1.5M VC commitment, minimizing risk while maximizing progress toward clinical and commercial milestones.

• Attractive Exit Strategy: Recent deals like Roche/Inflazome ($447M upfront, $2B milestones) and Merck/Caraway ($60M cash, $550M milestones) suggest a potential exit valuation of $60M–$447M upfront cash and up to $550M–$2B in milestones, achievable post-Phase 2a, offering investors significant upside potential.

Neuropathix combines cutting-edge science, a seasoned team, and a de-risked capital plan to deliver a transformative pain management solution. With a clear path to clinical success, strong IP, and a massive market opportunity, the company is positioned for rapid growth and a lucrative exit. Investors can join in redefining neuropathy treatment and capitalizing on a $32.3B market.