Regentis Biomaterials Ltd. · AMEX:RGNT
Regentis Biomaterials — IPO Roadshow (July 2025)
25 slides from Regentis Biomaterials's IPO roadshow presentation, Jul 7, 2025
Slide 1: Investor Presentation June 2025
Investor Presentation June 2025 Filed Pursuant to Rule 433 Issuer Free Writing Prospectus June [___], 2025 Relating to Preliminary Prospectus Dated June [___], 2025 Registration No. 333 - 285692
Slide 2: Disclaimer
2 Disclaimer This presentation highlights information about Regentis Biomaterials Ltd . (“ Regentis ,” “we,” “us,” or the “Company”) and the proposed public offering to which this presentation relates . Because this presentation is a summary, it does not contain all of the information that you shoul
Slide 3: Forward Looking Statements
3 Forward Looking Statements This presentation contains forward - looking statements concerning our business, operations and financial performance and conditio n, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements con
Slide 4: Offering Summary
4 Offering Summary NYSE American: RGNT Symbol Regentis Biomaterials Ltd. Issuer 1,000,000 Ordinary Shares (1) (15% Over - allotment Option) Expected Offering Size • Approx. $ 4.5 million for clinical development and PMA submission; • Approx. $ 1.0 million for operations (manufacturing, regulatory af
Slide 5: Knee cartilage repair large market with unmet need
5 Knee cartilage repair large market with unmet need U.S. market: 472,500+ procedures annually Limitations: Microfracture ( MFx ) the current gold standard of care • Short - term relief • Often requires repeat surgical intervention GelrinC ® Acellular, unique hydrogel for off - the - shelf knee cart
Slide 6: Company at a Glance
6 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 , Approx. 1 00% greater KOOS (1) and VAS (2) improvement vs.
Slide 7: US addressable market: ~472,500 procedures with cartilage damage
7 750,000 arthroscopic knee procedures 60 - 66% (~472,500) have cartilage damage ~472,500 procedures (1) Minimal market to further grow when Gelrin is introduced. 7 US Addressable (1) Market 60 - 66% (~472,500) have cartilage damage
Slide 8: Advantages of GelrinC
8 Advantages of GelrinC (further supported by the Phase II - study) 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
Slide 9: Competitive comparison of cartilage repair products
9 Pre - formed Bi - phasic plugs ( AgiliC of Cartiheal ) Cell - based Products (Maci of Vericel ) Resorbable Hydrogel GelrinC Limited - small, well - defined region of the cartilage Limited - small, well - defined region of the cartilage All Types – involving multiple areas of the cartilage Type of
Slide 10: Testimonial: Dr. Brian Cole
10 Testimonial: Dr. Brian Cole Leading orthopaedic surgeon at Rush Hospital Center, Chicago
Slide 11: Testimonial: Jason M. Scopp, MD
11 11 Testimonial: Jason M. Scopp , MD Orthopaedic surgeon – Director Peninsula Orthopaedic Associates, Maryland
Slide 12: Testimonial: Solomon Wilcots
12 Testimonial : Solomon Wilcots Former NFL Defensive Back – Bengals, Vikings, Steelers, and TV Broadcaster
Slide 13: Unique, FDA approved IDE Clinical Protocol
13 Unique, FDA approved IDE Clinical Protocol Phase II Phase III CE Mark EU Approved FDA Allowed use of Historical Control Tigenix for PMA Clinical Study Study Design Highlights • 80 patients for submission • 47 patients recruited and treated • Balance to follow post - IPO • FDA allowed the use of H
Slide 14: KOOS & VAS Results
14 KOOS & VAS Results Near - and long - term improvements superior to microfracture. KOOS scores ~100% greater pain reduction at 2 years. KOOS Scores ( Aprrox .) GelrinC : 28 at 2 years, vs. Microfracture: 14 . MRI MOCART Scores GelrinC scores reached 80+ within 24 months. Study Size • 56 patients t
Slide 15: EU (Phase II) - Clinical Results: KOOS
15 EU (Phase II) - Clinical Results KOOS Measurement – 4 Year Efficacy Data demonstrated P<0.05 (1) for 6 - 24 months compared to microfracture • Safe - Low incidence of Adverse Events (equivalent to microfracture alone) • Efficacy – Approx. 100% superiority improvement of Overall KOOS (2) score cha
Slide 16: EU (Phase II) - Clinical Results: MOCART Scores
16 EU (Phase II) - Clinical Results MOCART Scores (1) MOCART (Magnetic resonance Observation of Cartilage Repair Tissue) is a recognized nine - part assessment of cartilage repair based on MRI images Data from GelrinC MRI results P<0.05 in MOCART continues ( 2) 0 10 20 30 40 50 60 70 80 90 100 0 6 1
Slide 17: GelrinC Phase III (Pivotal) Trial Protocol Summary
17 17 Progress 41 of 80 patients already recruited and treated with 24 - month follow - up. No serious adverse events observed. Timelines Recruitment by 2025 ; PMA submission by 2027 . Patient Match First 40 patients closely match control group; high likelihood of efficacy in future readouts. Trial
Slide 18: Gelrin Technology Platform
18 Gelrin Technology Platform Potential Additional Applications May address osteoarthritis and other cartilage injuries in the ankle, wrist, and elbow, based on animal studies. 18 GelrinP • A paste form of GelrinC , cured with UV light. • Designed for treating injuries in smaller joints (ankle, wris
Slide 19: Granted & issued patents
19 34 Granted & issued patents 8: U.S. patents 26: Foreign patents (1) 4 Pending patent applications 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 covalentl
Slide 20: Management team
20 Ehud Geller, PhD, MBA Executive Chairman • Former President & CEO of Interpharm Laboratories and EVP of Teva Group • Former head of the Israeli Pharmaceutical Manufacturers Association • Board member of the Tel Aviv Stock Exchange • National Industry award for contribution to biotech industry and
Slide 21: Board of directors
21 Ehud Geller, PhD, MBA Executive Chairman • Former President & CEO of Interpharm Laboratories and EVP of Teva Group • Former head of the Israeli Pharmaceutical Manufacturers Association • Board member of the Tel Aviv Stock Exchange • National Industry award for contribution to biotech industry and
Slide 22: Pre-Offering Capitalization Table
Pre - Offering Capitalization Table Fully Diluted Shares Outstanding 5,014,744 Warrants (3) 349,070 Options ( WAEP: $0.44 ) (2) 736,296 Shares Outstanding (1) 3,929,378 (1) Assumes or gives effect to ( i ) the automatic conversion of all outstanding preferred shares, no par value, of the Company, or
Slide 23: Summary Balance Sheet
Summary Balance Sheet As of December 31, 2024 Summary Balance Sheet ( In USD Thousands ) 229 Cash and Cash Equivalents 482 Total Assets 6,488 Total Liabilities 35,098 Total temporary equity (41,104) Total Shareholders’ Equity (deficit)
Slide 24: The Only Restorative Solution for Cartilage Repair
24 The Only Restorative Solution for Cartilage Repair Knee cartilage repair large market with unmet need US market: 472,500 + procedures annually Limitations: Microfracture ( MFx ) the current gold standard of care • Short - term relief • Often requires repeat surgical intervention GelrinC ® Acellul
Slide 25: Thank you
Regentis Thank you