Carnyx Therapeutics

About the offering

Overview Carnyx Therapeutics is developing proprietary oral and topical versions of Epitalon—a peptide that was effectively banned by the FDA in September 2023 despite 40+ years of use overseas. While the FDA didn't declare Epitalon unsafe, they halted its sale due to insufficient safety data from formal trials. Led by Dr. Patrick Gunning, whose last two biotech startups resulted in multi-billion dollar deals, Carnyx aims to engineer FDA-approvable Epitalon analogs that solve the original safety concerns while improving delivery methods—transforming injections into convenient pills and eye drops. The Problem & Opportunity Epitalon was discovered in the 1980s at Russia's St. Petersburg Institute of Bioregulation and Gerontology. For decades, it was the "open secret" of elite athletes, A-list celebrities, and wealthy biohackers who reported sleeping like teenagers again. Studies showed the peptide activated telomerase (lengthening telomeres to potentially slow cellular aging), improved melatonin production by up to 160%, and in elderly patient cohorts followed for 10+ years, demonstrated 27-36% lower death rates. By 2020, Epitalon became the #3 best-selling research peptide in the US. However, no company had ever provided the safety, dosing, or stability data needed for FDA approval. In September 2023, the FDA placed Epitalon on a "Category 2" list, citing concerns about immunogenicity risks and lack of sufficient safety information. The agency didn't ban it for being dangerous—they simply required formal trials proving safety and efficacy before legal usage could continue. Technology & Product Pipeline Carnyx has created two lead Epitalon analogs that differ significantly from the original compound: CNYX-005 (Sleep): An oral formulation targeting the $31 billion sleep market. Unlike Ambien (which creates dangerous addiction) or straight Epitalon (which requires injection and leaves the body in under 10 minutes), CNYX-005 aims to provide sustained therapeutic levels for 24+ hours through a simple pill. In rat EEG models, the analog added 2+ hours of mostly non-REM restorative sleep per night, with effects lasting 1-1.5 weeks after the last dose—potentially eliminating the need for daily use. The drug works by restoring circadian rhythms and enhancing natural melatonin production from the pineal gland, rather than sedating patients. CNYX-001 (Vision): An eye drop formulation targeting Retinitis Pigmentosa (RP)—a disease affecting 1 in 3,000 children that leads to blindness, with zero approved treatments. Under FDA "Orphan Drug Designation," approval for a rare disease drug grants a 7-year market monopoly. Over a 7-day dosage period, CNYX-001 delivered 500x-1,000x higher ocular levels compared to Epitalon injections directly into the eyeball. Preliminary studies showed electrical activity in rat eyes was preferentially preserved, potentially delaying degeneration by multiple years. The $14 billion RP market represents significant revenue potential. Future Pipeline: Carnyx is conducting preliminary cell-based testing for longevity applications, aiming to reduce telomere shortening and DNA damage—targeting the projected $314 billion longevity market by 2030. Competitive Advantages Carnyx's analogs offer five key improvements over raw Epitalon: Oral pill + eye drop delivery vs. injection-only 500-1,000x higher ocular levels for eye disease treatment Sustained 24+ hour therapeutic levels vs. cleared from blood in under 10 minutes New composition-of-matter patents providing potentially decades-long monopoly vs. zero active US patents for Epitalon Dual IND-enabling studies targeted mid-2026 vs. no FDA approval pathway to date Market Context: The Peptide Boom The global peptide therapeutics market is projected to hit $260 billion by 2030. Ozempic (semaglutide) alone turned Novo Nordisk into one of Europe's most valuable companies, proving a single peptide can become a cultural phenomenon worth hundreds of billions. Google search traffic for "peptides" is at all-time highs. Dr. Andrew Huberman (3rd most popular podcast in the US) states: "A lot of the bodies you see in Hollywood films are on peptides." Currently, 80 peptide products are FDA-approved with 200+ in clinical trials. Global peptide sales hit $50B+ in 2024. However, nearly all require injections because peptides are fragile—stomach enzymes destroy them before absorption. Carnyx's oral delivery breakthrough could unlock mass-market adoption. Leadership & Track Record Dr. Patrick Gunning (CEO/Co-Founder): "Chemist-first, businessman-second" with proven exits. Co-founded Janpix Therapeutics (acquired by Centessa Pharmaceuticals, which later IPO'd at $2 billion) and Dunad Therapeutics (raised $70M, secured partnership with Novartis worth up to $1.3 billion)—both exited at the pre-clinical stage. Also founded the Centre for Medicinal Chemistry, publishing 100+ papers and attracting $40M+ in donations/grants. Gunning states: "Carnyx [may be] easier than the other companies I've founded because Epitalon has already been around since the 1980s. I don't have to reinvent the wheel—I'm just making targeted variations." Dr. Mark Lindsay (CMO): 35 years working with elite athletes, Olympians, and World Champions including Super Bowl, Stanley Cup, and World Series winners. Observed professional athletes using peptide stacks including Epitalon for recovery, reduced fatigue, and sleep enhancement. Traction & Timeline Current Stage: Pre-clinical, 1.5 years into project Provisional Patents: Filed for CNYX-001 and CNYX-005 (composition of matter and formulation) Q4 2025 – Q1 2026: Two additional composition-of-matter patents filed Mid-2026: Dual IND-enabling studies initiated (sleep + RP orphan designation) End-2026/Q1 2027: Phase I trials, topline data (sleep first) 2027: Potential Big Pharma partnership or acquisition Valuation Context Studies of 1,000+ biotech deals from 2005-2020 showed average valuation inflection points: Preclinical (Pre-IND) averaged $88M; Phase I completion averaged $399M (4.5x multiple); Phase II completion averaged $734M (8.3x multiple). Carnyx is currently valued at $45M in the pre-clinical stage. Notably, both of Gunning's previous companies (Janpix and Dunad) were acquired/partnered at the pre-clinical stage before IND filing. Investment Terms Platform: Equifund (Regulation Crowdfunding) Security Type: Common stock Price per Share: $1.87 Minimum Investment: $501.16 (268 shares) Valuation: $44.7M Raising: $5M maximum Previously Raised: Approximately $4M

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