Regentis Biomaterials Ltd. · AMEX:RGNT
Regentis Biomaterials — Investor Presentation (September 2026)
23 slides from Regentis Biomaterials's investor presentation, September 2026
Slide 1: Investor Presentation
Investor Presentation September 2026 NYSE American: RGNT
Slide 2: Forward Looking Statements
Forward Looking Statements RGNT This presentation contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements con
Slide 3: Overview
Overview RGNT There is currently no approved, ready-to-use, off-the-shelf product in the United States market for cartilage repair. Knee cartilage repair U.S. market: 472,500+ procedures annually large market with Limitations: Microfracture (MFx) the current gold standard of care unmet need • Short-
Slide 4: Company at a Glance
Company at a Glance RGNT Regenerative medicine company developing GelrinC for knee cartilage injuries Ready-to-use hydrogel technology offering cost-effective, restorative tissue repair, sustained pain relief and improved function Phase II success with approximately 100% greater KOOS (1) and VAS (2)
Slide 5: Strategic & Clinical Milestones Since IPO
Strategic & Clinical Milestones Since IPO RGNT June 2026 April 2026 March 2026 Runway Commercialization Manufacturing Cash and equivalents of $9M as of June European commercial strategy Breakthrough in GelrinC manufacturing 30 with no debt, to fund U.S. Phase III luanches with European Centers of pr
Slide 6: Operational Progress & Commercial Readiness
Operational Progress & Commercial RGNT Readiness Clinical & Regulatory Technology & Scale-Up Commercial Readiness • Network Scaling: Rapidly • IP Protection: New U.S. patent • Market Entry: Engaging expanding U.S. Phase III sites granted in Dec. ‘25 secures regional distributors to map and EU footpr
Slide 7: Initial U.S. Addressable Market
Initial U.S. Addressable Market (1) 60-66% (~472,500) have cartilage damage RGNT 750,000 arthroscopic knee procedures 60-66% (~472,500) have cartilage damage Estimated $3 Billion Annual U.S. Market ~472,500 procedures ü Estimated ~$3 billion total addressable market for GelrinC following market intr
Slide 8: Advantages of GelrinC®
RGNT Off-the-shelf product for cartilage repair New class of acellular solution leveraging: • Polyethylene glycol (PEG) hydrogel implant to drive new cartilage formation • Denatured fibrinogen-controlled erosion enabling hyaline-like cartilage regeneration Advantages Liquid form for optimal defect f
Slide 9: Testimonial: Dr. Brian Cole
Testimonial: Dr. Brian Cole Leading orthopaedic surgeon at Rush Hospital Center, Chicago RGNT 9
Slide 10: Testimonial: Jason M. Scopp, MD
Testimonial: Jason M. Scopp, MD. Orthopaedic surgeon – Director Peninsula Orthopaedic Associates, Maryland RGNT How soon after GelrinC surgery Can I go back to normal activities? 10
Slide 11: How is GelrinC working for your patients?
ow is GelrinC working _ for your patients?
Slide 12: GelrinC vs Competition in Cartilage Repair
GelrinC vs Competition in Cartilage Repair Pre-formed RGNT f, Resorbable Hydrogel Cell-based Products Bi-phasic plugs f f-th e-shel (AgiliC of Cartiheal) O iate GelrinC (Maci of Vericel) immed ent treatm All Types – involving multiple areas of Limited - small, well-defined region Limited - small, we
Slide 13: Unique FDA approved IDE Clinical Protocol
Unique FDA approved IDE Clinical Protocol RGNT Phase II Phase III Study Design Highlights • 80 patients needed for submission Historical Control Data Package • Over 50% of patients (owned by Regentis) recruited and treated to date • FDA allowed the use of Historical Control in the FDA Allowed use of
Slide 14: Clinical Phase II Pilot Study
Clinical Phase II Pilot Study RGNT Study Design and Results KOOS & VAS Results 56 patients treated with GelrinC Near- and long-term improvements Study Size • • Followed for up to 4 years in Northern Europe and Israel superior to microfracture. KOOS scores ~100% greater pain reduction Primary Changes
Slide 15: Improvement in KOOS score
RGNT EU Phase II - Clinical Results EU Phase II Study Data KOOS 35 Measurement – 4 Year Efficacy GelrinC 30 n=56 Improvement in KOOS score Data demonstrated P<0.05(1) for 6-24 25 months compared to microfracture Approx. 100% • Safe - Low incidence of Adverse 20 better than Microfracture Events (equi
Slide 16: EU Phase II - Clinical Results
RGNT EU Phase II - Clinical Results GelrinC MRI Quantitative Score Healthy Cartilage 100 MOCART Scores(1) 90 P<0.05 80 MOCART (Magnetic resonance Observation of Cartilage Repair Tissue) 70 is a recognized nine-part assessment of cartilage repair based on MRI 60 images Mocart 50 Data from GelrinC MRI
Slide 17: GelrinC Phase III Pivotal Trial Protocol Summary
GelrinC Phase III Pivotal Trial RGNT Protocol Summary Progress 50%+ of 80 patients already Trial Scope FDA-approved IDE trial in the U.S., recruited and treated with 24- Europe, and Israel month follow-up No serious adverse events observed Control Microfracture historical data (TiGenix NV1) Data app
Slide 18: Gelrin Technology Platform Potential Additional Applications
RGNT GelrinP™ Gelrin Technology • A paste form of GelrinC, cured with UV light • Designed for treating injuries in smaller joints Platform (ankle, wrist, elbow) Potential Additional Applications GelrinV™ May address osteoarthritis and other • A novel intra-articular injectable gel with pro-healing c
Slide 19: Comprehensive Intellectual Property Portfolio
Comprehensive Intellectual Property Portfolio RGNT Patents for Composition of Matter and treatment • Claims protein-polymer conjugates of extracellular matrix proteins (e.g., fibrinogen) or serum proteins (e.g., albumin) • Conjugates are covalently bound to synthetic polymers (e.g., polyethylene gly
Slide 20: Management Team
Management Team RGNT Ehud Geller, PhD, MBA Dr. Galit Reske, PhD Raz Simon Ori Gon, CPA Nadya Lisovoder, MD Liora Sklair – Tavron, Orly Amiran, M.Sc. CEO & Chairman Chief Medical Officer VP Product & CFO and CBO Director of Clinical Ops PhD VP Quality & Regulatory Applications VP R&D Affairs • Former
Slide 21: Board of Directors
Board of Directors RGNT Successful track record of healthcare product development and life sciences operating expertise Ehud Geller, PhD, MBA Jeff Dykan, CPA Chairman Director • Former President & CEO of Interpharm Laboratories and EVP of Teva Group • Served on Board of Directors since 2005, appoint
Slide 22: The Only Restorative Solution for Cartilage Repair
The Only Restorative Solution for Cartilage Repair RGNT Multiple upcoming value-driving clinical and commercial milestones Knee cartilage repair GelrinC® Development & Platform technology IP Portfolio large market with Acellular hydrogel for commercial with multiple unmet need off-the-shelf knee mil
Slide 23: Thank you
ee RE q entis Thank you
Regentis Biomaterials — Investor Presentation (September 2026) on 6ix