Announcement PDF ASX:RNV Transforming Nerve Repair Through Science Quarterly investor update | May 2025 Important Notice & Disclaimer Nature of Document: This presentation has been prepared and issued by ReNerve Ltd (Company) to provide general information about the Company. The information in this document is in summary form and should not be relied upon as a complete and accurate representation of any matters that a reader should consider in evaluating the Company. While management has taken every effort to ensure the accuracy of the material in this presentation, the Company have not verified the accuracy or completeness of the material contained in this presentation. Not an offer: this presentation should not be distributed, transmitted, or viewed by any person in any jurisdiction where the distribution, transmission or viewing of this document would be unlawful under the securities or other laws of that or any other jurisdiction. 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An offer of Shares in ReNerve Ltd (ABN 23 614 848 216) is being made in or accompanied by a prospectus dated at a date to be confirmed. Anyone who wants to acquire Shares pursuant to the offer will need to complete the application form that accompanies the prospectus. A person should consider and rely only on the prospectus in deciding whether to invest. A copy of the prospectus is available by contacting the Company or by downloading from the Company’s website (www.renerve.com.au). Speculative nature of investment: Any potential investor should be aware that subscribing for Shares involves various risks. The Shares to be issued pursuant to the Prospectus lodged with ASIC by ReNerve Ltd carry no guarantee with respect to the payment of dividends, returns of capital or the market value of those Shares. An investment in Shares of the Company should therefore be considered very speculative. ReNerve Ltd ABN 23 614 848 216 Executive Summary Development of Novel Nerve Repair & Regeneration Products ReNerve is focused on developing a portfolio of products for the nerve repair and regeneration markets, with clearly defined commercial demand. Significant Product Portfolio ReNerve currently has one product in market with a clear commercial pathway for FDA approval of 3+ products over the next 4 years. Strong Sales & Distribution Presence ReNerve have established logistics, warehouse and invoicing infrastructure with a strong focus on building a sales distribution network for all products. Global Expansion & Commercialisation Successful ongoing expansion within the first year of listing into major surgical markets throughout Asia, The Middle East, and The Americas. Clinical & Professional Validation Improved patient outcomes for post-surgical measures of pain and surgery satisfaction, as well as proven ease of use for surgeons. Global Market by Segment $8.0Bn 16% 32% $6.0Bn USD $Bn Global Nerve Repair Biomaterial Market Global Nerve Repair Biomaterial Market $4.0Bn 52% $2.0Bn - Nerve Wrap 2024 2025 2026 2027 2028 North America 2029 Europe 2030 2031 Nerve Conduit Nerve Grafts USD$1.69Bn ~900k Nerve Compression Three products already developed with an additional two currently under development. Three products already developed with an additional two currently under development. Three products already developed with an additional two currently under development. Global Nerve Repair Biomaterials Market Research Report (2020 – 2031) ReNerve’s Opportunity Nerve Conduit Nerve Cuff Product Nerve Guide Matrix Bionic Nerve • Used on damaged or transected nerves with no gaps or gap closure • Improved Nerve Cuff developed from scCO2 tissue, offering better product profile • An ‘off-the-shelf’, ready to use nerve graft replacement with internal guidance infrastructure • An ‘off-the-shelf’, continuous nerve replacement, in a ready to use nerve structure • • Protecting injured nerve repairs • Replaces damaged nerve section instead of using donor or harvested tissue • The Bionic Nerve is a nerve guide matrix with ionic polymers designed to replace injured and damaged nerves for lengths from 1cm to 20cm • • • • Trauma Craniotomy Spinal cord injury Spinal cord surgery • Enable production of nerves of bespoke dimension Procedure Use • End to end suturing covered with a wrap/cuff Protective cuff for grafts Application • • • • Trauma Breast reconstruction Orthopaedics Oral & maxillofacial surgery • • • • Trauma Breast reconstruction Orthopaedics Foot and ankle • • • • Trauma Breast reconstruction Orthopaedics Hand & wrist • Bio-absorbed removing need for additional surgery Pliable and conforms • Improved product profile to Nerve Cuff Stronger patient reimbursement • • Can be cut to ideal length Off-the-shelf, reducing logistics issues Simple to use and cost effective Benefit • FDA Status TAM (USD) Approved • Targeting Q4 CY25 filing • Targeting Q2 CY27 filing $3219m $314m 2024 $975m $1015m 2030 2024 $1991m >$400m $635m 2030 Targeting Q3 CY28 filing 2024 2030 2023 Company quarterly highlights Sales Highlights Sales for Q3 FY25 of A$75K represented a ~40% increase from the previous quarter. ReNerve Quarterly Sales $100,000.00 $80,000.00 $60,000.00 $40,000.00 $20,000.00 ReNerve Global Expansion & Distribution United States Middle East Established sales presence in target states with a focus on key hospital systems in each region. Entered into exclusive partnership with Union Mediscience B.S.C in the Middle East. Hong Kong East Asia Entered into partnership with Accession Medical Supplies Co in Hong Kong and achieved first sale Confirmed first hospital sales in Hong Kong, establishing clinical presence in a key Asian market. Latin America Indian Subcontinent Executed exclusive distribution agreement with Imbiomex in Mexico, targeting a USD$74 million nerve repair biomaterials market growing at 17% annually. Southeast Asia Formed strategic partnership with NetCentrix Ventures to pursue regulatory approval in India's rapidly expanding nerve repair market (USD$115 million per annum, projected to reach USD$270+ million by 2030 at 18.5% CAGR). Secured commercial marketing approval in Thailand, enabling access to a population of 70+ million and the region's medical tourism market. $- Key Hire ReNerve has appointed Mr Eric Feliciano as its VP of Sales & Marketing Eric Feliciano, a seasoned medical technology sales expert, has worked with Skeletal Dynamics, Medartis, and Smith & Nephew. Based in the Midwest U.S., he enhances ReNerve’s distribution and sales reach. NervAlign® Nerve Cuff 01 Key Features Clinical Use Patient Results Product • The NervAlign® Nerve Cuff is an FDA cleared product used on damaged or transected nerves with no gaps or gap closure achieved by flexion. • The product is used as a barrier between the repaired nerve and surrounding tissue. • Majority of cases to date have been focused on hand and wrist. • Clinical cases have: ‒ All reported positive outcomes; and ‒ Shown better than expected outcomes for patients Clinical Use Patient Benefit Bio-absorbed within 6-months. Produced using a non-toxic method. Terminally sterilised with no residual chemicals. Covered under procedural reimbursement rather than individual product reimbursement. • Promotes vascular tissue formation on surrounding fascia tissue post-implant. • • • • Surgeon Benefit • Requires no change to surgical technique or procedures. • Available in various sizes and thickness with ability to be trimmed to required shape. • Is pliable and conforms. • Received positive feedback from surgeons stating it handles well, is pliable and conforms and has resulted in strong patient outcomes. • ReNerve has started to explore podiatry, breast and urology as areas beyond hand and wrist. • Has been used with attachment methods including sutures, glue, micro clips and ‘nothing’. Clinical Study • ReNerve has completed an initial clinical study to explore the benefits of using the NervAlign® Nerve Cuff in the repair of injured nerves. • The data will be presented late March at the American College of Foot and Ankle Surgeons conference in Phoenix. Clinical Study Design • Two Cohorts Two cohorts (blinded to ReNerve). • One undergoing the ‘standard of care’ for neurectomies (nerve repairs). • The second having the neurectomy repair wrapped with the NervAlign® Nerve Cuff. • This includes repairs to both sensory and motor nerves. • A range of nerve injuries included in the study. Study Outcome to be Assessed • Primarily looking at pain evaluations before and after surgery. – • Pain is independently assessed. Statistical advantage of using the NervAlign® Nerve Cuff. Clinical Validation Clinical Study on the NervAlign® Nerve Cuff At the American College of Foot and Ankle Surgeons Conference (27–30 March 2025), ReNerve presented a comparative clinical study showing statistically significant improvements in patient outcomes using the NervAlign® Nerve Cuff for peripheral nerve repair. Comparison of Patient Pre & Post Surgery Pain Score 7.1 7.1 54% Improvement Study Design: Two patient cohorts • Control Group: Standard neurectomy repair • Test Group: Neurectomy repair with NervAlign® Nerve Cuff 3.3 Key Outcomes: • Pain Reduction: 96% Improvement ‒ Control: 7.1 ➝ 3.3 ‒ NervAlign : 7.1 ➝ 0.4 • Satisfaction & Recovery: 0.4 ‒ Higher satisfaction and improved recovery in the NervAlign group ‒ Pain assessment conducted independently Standard of Care NervAlign® Nerve Cuff significantly reduces post-operative pain and enhances patient satisfaction compared to standard surgical methods. NervAlign® Nerve Cuff Protected Figure 1. The comparison of pain scores between the two cohorts of patients Efficacy of a Porcine Pericardium Nerve Wrap in Peripheral Nerve Surgery” March 2025 Namany et al. ACFAS 2025, (https://imis.acfas.org/ACFAS2025/ACFAS2025/Abstracts.aspx?hkey=5209f2e8-69fc-4935-8823-799c8f5c2922) Abstract Ref ID Sci-743 Clinical Use Damaged nerve removed from the right thumb Removed gap filled with a conduit NervAlign® Nerve Cuff used to protect the cuff conduit implant Completed repair held in place with micro clips NervAlign® Conduit 02 Key Features • ReNerve is focused on developing a conduit from scCO2 tissue from the Nerve Cuff. • Project remains on track and working through commercial manufacturing • ReNerve will be able to leverage existing data from the Nerve Cuff FDA application to accelerate FDA approval. • Offers the followings benefits: ‒ Expands the ReNerve product range and portfolio; ‒ Better reimbursement for the conduit; and ‒ Same outcome and better product profile as the Nerve Cuff. • ReNerve are targeting a Q4 CY25 FDA filing. NervAlign® Nerve Guide Matrix (Graft) 03 Key Features & Guide Matrix Product • The NervAlign® Neve Guide Matrix is an ‘off-the-shelf’, ready to use nerve graft replacement with internal guidance infrastructure. • ReNerve is developing three product options: ‒ Initial ‘wet’ prep nerve graft; ‒ Dry version that's hydrated within 10 minutes; and ‒ Longer lengths out to 7cms+. Current Options • Harvesting patients own nerves. • Donor tissue graft. • Conduits (for smaller repairs). Benefit • ReNerve Nerve Guide Matrix offers many benefits, including: ‒ Doesn’t create secondary surgical site; ‒ Stored at room temperature, removing storing issues; ‒ Doesn’t go through Wallerian degradation; ‒ Ease of use allows for immediate repairs; ‒ Longer lengths enables surgical revisions; ‒ More cost effective to existing options; and ‒ Positive outcomes post-surgery. Near Term Milestones - 2025 1H 2025 27 February 2025 Partnership Signed for Mexico Market 7 March 2025 R&D Tax Incentive Refund Received 11 March 2025 Thailand Approval & First Hong Kong Sale 28 March 2025 Clinical Study Results Presented 10 April 2025 Partnership for Indian Market Announced 29 April 2025 Q3 FY25 Results: Revenue Growth & Clinical Validation 2H 2025 NervAlign® Nerve Conduit into Market (Q4 2025/Q1 2026) Initial Clinical Cases for the Nerve Conduit Additional NervAlign® Nerve Cuff Clinical Data Starting GMP manufacturing runs of the Nerve Guide Matrix NervAlign® Nerve Cuff Approvals in New Countries & Territories Near Term Progression of the Nerve Guide Matrix to Stage 3 of Development H2 2025 (Estimated) — India: Regulatory Approval Pathway Initiated First clinical cases using the nerve guide matrix NervAlign® Nerve Cuff filing for European approval Investment Highlights In Market Product Immediate Market Need Growing Market Nerve Cuff transitioned from R&D to commercial sales post FDA market clearance, achieving strong initial product margins. Product offering promotes nerve injury recovery and regrowth leading to faster patient recovery and better outcomes. Nerve repair biomaterials market is forecasted to grow by >17% pa, estimated to be worth >US$6.19Bn by 2031. Diverse Product Portfolio Growing Distribution Board & Management Three products already developed with an additional two currently under development. Continuing to build sales representation with a targeted-direct sales approach. Highly accomplished executive team with a proven track record in the development & commercialisation of medical opportunities. ASX:RNV Contact ReNerve Limited +61 (03) 9482 3940 info@renerve.com.au Level 10/99 Queen St, Melbourne, Victoria 3000 Australia Board & Management STEPHEN COOPER CHAIRMAN DR JULIAN CHICK CEO & MANAGING DIRECTOR DR MICHAEL PANACCIO NON-EXECUTIVE DIRECTOR DR DAVID RHODES EXECUTIVE DIRECTOR & CSO DR ALEX ADAMIDES CHIEF MEDICAL OFFICER Stephen was previously Managing Director at Grant Samuel, a leading Australian investment bank. Dr Julian Chick is an experienced healthcare executive with over 20 years’ experience in senior management including in ASX listed companies Avexa and Admedus, and is currently NonExecutive Director at LTR Pharma (ASX:LTP). Dr Michael Panaccio is one of the founders of Starfish Ventures, a venture capital firm that invests in early-stage technology companies and plays an active role in the management of its portfolio. Dr David Rhodes has more than 20 years’ experience in healthcare and biotechnology industries, where he has held numerous senior management roles and developed technologies through to market approval. Dr Alex Adamides studied medicine at the University of Nottingham, UK, and completed his basic surgical training in Edinburgh before undertaking his neurosurgical training in Australia. Michael has been a director of numerous technology businesses in Australia and the USA including SIRTeX Medical Ltd, Engana Pty Ltd (now part of Finisar Corporation), Energy Response (sold to EnerNoc Inc), ImpediMed Ltd, and Protagonist Therapeutics Inc. David has been involved in obtaining several FDA USA and European marketing authorisation approvals for medical devices. Stephen has over twenty-five years of experience in Investment Banking and has been responsible for numerous corporate advisory assignments including public company takeovers, mergers, business sales and acquisitions, schemes of arrangement, capital raisings and business valuations. Stephen has previously served as Chairman of Avexa, an ASX-listed biotechnology company. Julian’s previous roles include Chief Executive Officer, COO and Head of Business Development, as well as running early and latestage R&D projects and launching medical devices into the global markets. Julian has been involved in developing and obtaining FDA USA clearance for four tissue based medical devices. Julian, while COO at Admedus Ltd was involved in the R&D development, regulatory approval and launch of several tissue products in North America, Europe and Asia. Julian has eight years’ investment banker experience focused on healthcare and biotechnology. Julian has a PhD in Muscle Physiology. Michael currently serves on the boards of Armaron Bio Ltd and Cylite Pty Ltd And ASX listed dorsaVi Ltd (ASX:DVL). Previous roles include senior researcher at Amrad, Chief Scientific Officer of the medical devices company Admedus Ltd, COO of AdAlta Ltd and senior executive and Head of Drug Discovery and Senior Vice President Biology at Avexa Ltd. David has successfully led multiple technology development programs attracting significant levels of funding from many State and Federal Government initiatives and research institute programs. Dr Adamides became a fellow of the Royal Australasian College of Surgeons in 2012 and has since been a consultant neurosurgeon at the Royal Melbourne Hospital. Dr Adamides is an honorary clinical senior lecturer at Melbourne University and a reviewer for the Journal of Clinical Neuroscience. Working with ReNerve, Dr Adamides has developed preclinical models testing the safety and efficacy of surgical implants for the repair of peripheral nerves and dura. David has a PhD in Biochemistry. 19