Announcement PDF Sales & Marketing Update ReNerve Board meeting | July 2025 Annual Report 2025 ASX:RNV www.renerve.com.au Contents About ReNerve 3 Chairman’s Letter 4 Corporate Directory 7 Directors’ Report 8 Auditors’ Independent Declaration 20 Statement of Profit or Loss and Other Income 22 Statement of Financial Position 23 Statement of Changes in Equity 24 Statement of Cash flows 25 Directors’ Declaration 44 Independent Auditors’ Report 45 Shareholder Information 50 About ReNerve Limited ReNerve Limited aims to transform nerve repair and improve lives through breakthrough medical technology. Founded by a neurosurgeon and MedTech researchers, ReNerve is a rapidly growing medical device company that aims to revolutionise peripheral nerve surgery with it innovative, ready-to-use solutions for peripheral nerve injury repairs (PNI). Proven Clinical Success A clinical study announced in March 2025 has demonstrated remarkable results, showing that patients treated with the NervAlign® Nerve Cuff experienced post-surgical pain scores dropping from 7.1 to just 0.4, compared to from 7.1 to 3.3 without the device being used – a statistically significant improvement for patients. Comprehensive Product Portfolio ReNerve is advancing a complete suite of nerve repair solutions: • NervAlign® Nerve Cuff – Our bioabsorbable protective wrap, naturally absorbed within six months of surgery. • Deep Dermal tissue product -- A deep dermal product used in the repair of reconstructive and cosmetic surgical cases. • Amniotic tissue product ranges -- Three amniotic tissue product ranges used to aid the healing of wounds. • NervAlign® Nerve Conduit Range – Next-generation nerve conduit leveraging advantages of eCOO technology and designed to facilitate nerve growth over short gaps between nerve ends. • NervAlign® Nerve Guide Matrix – Focused on the nerve graft market for treating more severe nerve injuries, but eliminating the need for patients to undergo additional sural nerve harvesting. • NervAlign® Bionic Nerve – Next-generation combination technology for the most challenging nerve repairs. Growth With demonstrated market traction since the Company’s 2022 product launch, ReNerve achieved 53% revenue growth in FY25, reaching $271k in sales. Our high-margin products are providing solutions for surgeons seeking superior patient outcomes in the rapidly expanding global nerve repair market, valued at US$1.96 billion in 2024 and is projected to reach $6.2 billion by 2031.1 Vision and Values We're not just developing medical devices – we're engineering hope. By creating the ideal healing environment for nerve repair and regeneration, ReNerve bridges critical gaps in healthcare while empowering the human body's natural healing process. Our cleaner, safer, and more effective solutions represent the future of peripheral nerve surgery. 1 Global Nerve Repair Biomaterials Market Research Report (2020 – 2031) Chairman’s Letter Dear Shareholders, It gives me great pleasure to present ReNerve Limited’s Annual Report for the year ended 30 June 2025 — a year that marks a defining chapter for our Company. The past year has been transformational for the Company. In November 2024, ReNerve successfully completed its Initial Public Offering and listed on the Australian Securities Exchange (ASX:RNV). This important milestone has provided us with the capital strength and visibility required to pursue our mission: delivering world‑class medical solutions that address significant unmet clinical needs in the area of nerve repair and related regenerative therapies. Our listing was met with strong support from institutional and retail investors, reflecting broad confidence in the promise of our proprietary technologies. This vote of confidence has enabled us to accelerate several strategic initiatives: • Advancement of our core nerve repair platforms, where our tissue derived scaffolds aim to redefine standards of care in peripheral nerve injury and related conditions. • Clinical Validation of NervAlign® products where during the year we saw the publication of strong clinical data demonstrating the superior effectiveness of our NervAlign® Nerve Cuff compared to the standard of care, with patients receiving our Nerve Cuff benefiting from materially reduced pain and improved surgical outcomes. • Building sales and marketing capabilities. Over the past 12 months ReNerve has continued to develop its sales and marketing capabilities, with a focus on the US market. In addition, we have entered into distribution arrangements across a number of other markets, including in Mexico, India, Hong Kong and the Middle East. • Growing our product range: during the year ReNerve entered into a partnership with Berkeley Biologics in the USA to bring several human tissue products to market. These products are complementary to ReNerve’s nerve repair product portfolio, with applications across the main surgery cases that ReNerve is already targeting, and can be sold through the same distribution networks and to the same surgeon and hospital customer base. In addition, they provide access to other related regenerative medicine areas, including wound care, reconstruction and plastic surgeries. They provide a broader product range that delivers benefits both to our distributors and our hospital customers and should therefore support our sales efforts, as well as potentially lifting the returns per procedure for our Company. These achievements underscore our focus: bringing safe, efficacious, and accessible nerve repair and related regenerative therapies to patients whose options today remain limited. Chairman’s Letter Globally, regenerative medicine continues to capture significant attention and investment, as demographic shifts and medical advances converge to increase demand for novel therapies. ReNerve is strongly positioned within this trend — addressing conditions where nerve repair and tissue regeneration can have profound effects on quality of life. Our competitive edge is built on years of foundational research, combined with scalable manufacturing capabilities that allow us to look beyond proof‑of‑concept toward real clinical and commercial impact. A successful IPO brings heightened responsibility to all stakeholders. The Board and management remain committed to the highest standards of governance, transparency, and capital discipline as we progress from research to development and ultimately to market delivery. In the coming year, ReNerve will continue to: • grow company revenue as we bring more products to market and expand our commercial offering, with the company anticipating having four product ranges on market by the end of calendar 2025 • progress the ReNerve NervAlign® Nerve Conduit range of products to market • progress the ReNerve NervAlign® Nerve Guide Matrix through the development stages ahead of the regulatory submission • steward investor capital carefully as we build toward long‑term, sustainable value creation. We recognise that the journey ahead is ambitious. Yet it is precisely this ambition — to restore function, mobility, and dignity to patients through science — that defines ReNerve’s purpose and unites us as a team. On behalf of the Board, I thank our dedicated employees, our scientific and clinical partners, and our shareholders for your trust and support through this pivotal year. The enthusiasm and confidence shown during our IPO were humbling, and we are determined to deliver disciplined execution and continual innovation as the company grows. We are excited by what lies ahead and look forward to sharing our progress with you as we build ReNerve into a leader in nerve repair and related regenerative medicine. Yours sincerely, Mr Stephen Cooper Chairman ReNerve Limited ABN 23 614 848 216 Annual Report - 30 June 2025 ReNerve Limited Corporate directory 30 June 2025 Directors Mr Reginald Stephen Cooper – Independent Chairman & Director Dr Michael Panaccio – Independent Non-Executive Director Dr Julian Chick – Director & Chief Executive Officer Dr David Rhodes – Executive Director & Chief Scientific Office Company secretary Mr David Lilja Notice of annual general meeting The details of the annual general meeting of ReNerve Limited are: Date: Wednesday 5th November 2025 Time: 10.00AM (AEDT) Location: To be confirmed Registered office DLK Advisory Pty Ltd, Level 10, 99 Queen Street Melbourne, 3000, Australia Principal place of business 157 Heidelberg Road Northcote VIC 3070, Australia Auditor William Buck Level 20, 181 William Street Melbourne VIC 3000, Australia Solicitors Cornwalls Level 4, 380 Collins Street Melbourne VIC 3000, Australia Bankers ANZ Ground Floor, 55 Collins Street Melbourne VIC 3000, Australia Bendigo Bank The Bendigo Centre Bendigo VIC 3550, Australia Stock exchange listing ReNerve Limited shares are listed on the Australian Securities Exchange (ASX code: RNV) Website https://renerve.com.au Corporate Governance Statement The directors and management are committed to conducting the business of ReNerve Limited in an ethical manner and in accordance with the highest standards of corporate governance. ReNerve Limited has adopted and has substantially complied with the ASX Corporate Governance Principles and Recommendations (Fourth Edition) (‘Recommendations’) to the extent appropriate to the size and nature of its operations. The company’s 2024 Corporate Governance Statement that sets out the corporate governance practices that were in operation during the financial year and identifies and explains any Recommendations that have not been followed, which is approved at the same time as the Annual Report, can be found at: https://renerve.com.au/company-policies/ 1 ReNerve Limited Directors' report 30 June 2025 The directors of ReNerve Limited (referred to hereafter as the 'company') present their report, together with the financial statements for the year ended 30 June 2025. Directors The following persons were directors of the company during the whole of the financial year and up to the date of this report, unless otherwise stated: Mr Reginald Stephen Cooper – Independent Chairman & Director Dr Michael Panaccio – Independent Non-Executive Director Dr Julian Chick – Director & Chief Executive Officer Dr David Rhodes – Executive Director & Chief Scientific Officer Principal activities ReNerve has FDA market clearance and is selling its NervAlign® Nerve Cuff product in the US market. ReNerve aims to develop its portfolio of medical devices used in the repair and/or replacement of damaged peripheral nerves, with three further product ranges at various stages of development: a) The NervAlign® Nerve Conduit range b) The NervAlign® Nerve Guide Matrix c) The NervAlign® Bionic Replacement Nerve In addition, ReNerve is bringing to market two ranges of tissue-based products (deep dermal tissue and amniotic tissue products) that are expected to be complementary to ReNerve’s nerve repair products, sold through ReNerve’s existing distribution channels, and used by the same target customer surgeons in procedures in which ReNerve’s nerve repair products are commonly used. In addition, these tissue-based products are expected to have further surgical applications, particularly in reconstructive and cosmetic surgical cases. Dividends There were no dividends paid, recommended or declared during the current or previous financial year. Review of operations The loss for the company after providing for income tax amounted to $3,733,918 (30 June 2024: $2,984,945). During the year the company has continued to build its US sales infrastructure through partnerships with sales agents and distributors, with a focus on developing channels that will not only be effective in selling the NervAlign® Nerve Cuff but will also support the sale of additional products in due course. ReNerve’s efforts to work more closely with sales agents and distributors resulted in much stronger sales for the year compared to the prior year. ReNerve now has two full time sales and marketing executives in the USA who are focussed on expanding and supporting ReNerve’s distribution network, facilitating hospital approvals for ReNerve products and developing and delivering distributor and surgeon education and marketing materials. The company has continued to work with surgeons, with surgeon feedback confirming the unique characteristics of the NervAlign® Nerve Cuff in terms of surgical convenience, patient safety and efficacy. The NervAlign® Nerve Cuff is produced using a proprietary, non-toxic process and is designed to protect the repaired nerve, whilst facilitating remodelling and therefore nerve regeneration. The product is easily used and can be fixed in place through a number of methods. The Nerve Cuff is ultimately safely absorbed within six months into the surrounding fascial tissue post the healing of the repaired nerve. In addition, during the year ReNerve furthered clinical programs to explore the utility and benefit of the NervAlign® Nerve Cuff. In particular, a clinical study from an Indianapolis based surgical team compared the recovery of repaired nerves that have been protected with the NervAlign® Nerve Cuff with the recovery of nerves repaired using the current standard of care. The data for this study was presented in late March 2025 at the American College of Foot and Ankle Surgeons scientific conference, demonstrating material benefits for patients using the NervAlign® Nerve Cuff. ReNerve will continue to explore clinical studies to illustrate the clinical utility and benefits of its products for surgeons and patients. 2 ReNerve Limited Directors' report 30 June 2025 In June 2025, ReNerve announced a strategic partnership with Berkeley Biologics to develop and commercialise two tissuebased product ranges. ReNerve achieved first sale and surgical use of a deep dermal product after year end, in August 2025. The second range, comprising amniotic tissue products is expected to be launched before the end of 2025, with both products approved in the US. Access to these tissue-based products through the partnership enhances ReNerve’s suite of surgical solutions in peripheral nerve injury repairs and related surgeries. During the year ReNerve continued to explore markets outside the US. The company signed four distribution partnerships during the year, covering Hong Kong, Mexico, India and six countries in the Middle East. The company also achieved market approval in Hong Kong and Bahrain and has seen its first sales in Hong Kong. These new partnerships complement the existing partnerships in New Zealand and Taiwan and are part of a broader program by the company to open additional markets outside the US. The partnerships will also benefit from the clinical and patient data accumulated and presented in the US. During the 2024/25 financial year, ReNerve continued to work with its commercial development partners on the NervAlign® Nerve Conduit and NervAlign® Nerve Guide Matrix programs. During the year ReNerve successfully showed that its Nerve Guide Matrix was able to re-establish functioning nerves in an animal model that replicated the procedures common in patients, where an injured nerve is replaced with an autologous nerve, such as the sural nerve. The study was designed to investigate the performance of the NervAlign® Nerve Guide Matrix as an alternative to using an autologous nerve. The very positive results showed that animal gait was restored to normal, and an electrophysiological stimulus was detected through the length of the nerve, on a basis comparable to the performance of the autologous nerve graft. ReNerve is actively continuing the development of the NervAlign® Nerve Guide Matrix product with its partner Collagen Solutions (EvergenTM) based in the US. Key risks and uncertainties The company is subject to risks specific to its business activities, as well as general risks. The major risks and uncertainties are summarised below. Successful Commercialisation of Assets The nature of medical device research and development is inherently uncertain at times. There are substantial risks including that clinical studies may fail to achieve acceptable endpoints for efficacy or safety, or the products may not secure acceptance from surgeons and clinicians. Failure in any of these areas would have a material impact on the company’s prospects. ReNerve seeks to mitigate risk through a diversified product pipeline, a maturing portfolio of products some of which are on market, continuous engagement with surgeons, careful design of its clinical studies, and collaboration with reputable and experienced partners. Research and Development Risk ReNerve’s ongoing and future projects require research and development. It is possible that the development of its product portfolio may be more costly or take more time than expected, or may not achieve the expected clinical endpoints. Delays or increased costs could materially impact the company’s ability to bring products to market or achieve commercial milestones. Regulatory and Product Approval Risks As a medical device company, ReNerve’s products are subject to stringent regulatory approval processes in each jurisdiction. The loss, delay or failure to secure required approvals (such as FDA clearance or comparable authorities in other markets) may prevent the commercialisation of its products or expose the company to additional costs and delays. The withdrawal or suspension of existing approvals could significantly affect operations and financial performance. ReNerve monitors regulatory developments and maintains relationships with regulatory consultants and agencies to manage this risk. Product Acceptance and Commercial Risks ReNerve relies on acceptance of its products by surgeons. If products are not accepted by surgeons or fail to generate repeat usage, commercial uptake may be limited. The company mitigates this risk through active engagement with opinion leaders, development of clinical data, and education initiatives. Intellectual Property and Competitive Risk ReNerve’s strategy is to rely on a combination of proprietary know-how, trade secrets, and, to a lesser extent, patents. There is a material risk that competitors could seek to reverse-engineer or copy the company’s products, or develop superior alternatives. If ReNerve’s trade secrets are not adequately protected, or if key intellectual property is lost or circumvented, it could harm the company’s market position. The company proactively manages confidentiality but acknowledges some risks are outside its control. 3 ReNerve Limited Directors' report 30 June 2025 Manufacturing, Supply Chain, and Dependency on Key Partners ReNerve’s lead products are currently manufactured by a single supplier (EMCM) under an exclusivity agreement that depends on meeting certain obligations. Loss of exclusivity or termination of the supply agreement - whether through default, insolvency, or operational disruption—would require rapid transition to alternative suppliers, which may not be feasible without significant disruption and cost, although ReNerve has identified an alternative manufacturer. Key raw materials (porcine tissue) are sourced from the Netherlands and could be subject to disruption by disease outbreaks or export restrictions although can be sourced from other jurisdictions. Funding and Liquidity Risk ReNerve is an early stage company that is currently loss-making and requires substantial additional funding to progress its R&D pipeline and commercial plans. There is a risk that future capital raisings may not be available on acceptable terms, or at all, which could affect the company’s ability to continue as a going concern or delay its growth and development objectives. Market, Economic, and Industry Risk Broader economic factors and industry dynamics may adversely affect the company. These include changes in healthcare spending, hospital procurement behaviour, reimbursement policy changes, currency fluctuations, and competitive product launches. The company regularly reviews strategy in light of current industry developments. Reliance on Key Personnel The success of ReNerve depends in large part on the continued involvement of its executive and scientific management team. The loss of one or more key employees, or inability to attract and retain appropriately qualified personnel as the business grows, may have a material adverse effect on the company’s performance. Reputational and Product Liability Risk Though none have been experienced, a significant adverse event from the use of ReNerve’s products, such as patient injury or product recalls, could result in reputational damage, litigation or regulatory investigations, all of which could materially harm the company’s business and financial results. Activity Levels and Demand Risk The company’s products are sold to hospital and surgeon customers. Any reduction in activity levels - whether due to shifts in surgical practice, economic conditions in the healthcare sector, adverse industry trends, or the emergence of competing products - may reduce demand for ReNerve’s products and adversely impact financial performance. 4 ReNerve Limited Directors' report 30 June 2025 Significant changes in the state of affairs In July 2024, a total pool of 150,000 options were granted to several employees at an exercise price of $0.35 per option, for an estimated fair value of $20,667, which was determined using a Black-Scholes option valuation model. Further, in July 2024, the company issued 300,000 shares in lieu of cash payment to four Scientific Advisory Board members, as part payment for their services and consultancy activities. Per a sales agent and market development agreement entered into in March 2024 with Emerging Surgical, the company issued a second tranche of 272,725 shares to Emerging Surgical on 1 July 2024. In August 2024, the company issued 150,000 shares in lieu of cash payment to a new Scientific Advisory Board member, as part payment for their services and consultancy activities. In September 2024, a total pool of 600,000 options were granted to several employees at an exercise price of $0.35 per option, for an estimated fair value of $82,297, which was determined using a Black-Scholes option valuation model. In September 2024, ReNerve raised $755,000 before costs via the issue of convertible notes, to fund the progression of the Nerve Guide Matrix project, support the company’s marketing program for the NervAlign® Nerve Cuff and address working capital requirements. The terms of the convertible notes provided that the convertible notes would convert into shares on an initial public offer (“IPO”) of shares in ReNerve. Pursuant to the terms of the convertible notes, the conversion price was a 20% discount to the IPO Offer Price. During the year, ReNerve successfully completed an IPO of new shares in the company, raising $7 million (before costs) through the issue of 35,000,000 shares. ReNerve shares were listed on the Australian Stock Exchange (ASX) on 26 November 2024. Upon the successful completion of the IPO, the company granted Lead Manager Options to Alpine Capital Pty Ltd, representing 2% of the fully diluted share capital post completion of the Offer. These options have an exercise price of $0.30 and a three year expiry from the date of issue. Based on the maximum subscription of $7 million, a total of 2,951,594 Lead Manager Options were granted. At the time of the IPO, the convertible notes were converted into 10,984,847 ordinary shares in the company. In March 2025, the company issued 300,000 shares in lieu of cash payment to four Scientific Advisory Board members, as part payment for their services and consultancy activities. In March 2025, per the sales agent and market development agreement, the company issued a third tranche of 366,212 shares to Emerging Surgical. In April 2025, a total pool of 400,000 options were granted to a new US-based employee at varying exercise prices of $0.12, $0.15, $0.20 and $0.30 per option, for an estimated fair value of $31,758, which was determined using a Black-Scholes option valuation model. There were no other significant changes in the state of affairs of the company during the financial year. Matters subsequent to the end of the financial year Non-adjusting Events: On 14 July 2025, the company issued 300,000 shares in lieu of cash payment to four Scientific Advisory Board members, as part payment for their services and consultancy activities. The shares were issued as consideration with a total value of $32,222. Per the sales agent and market development agreement with Emerging Surgical, the company issued a fourth tranche of 473,260 shares on 14 July 2025.The shares were issued as consideration with a total value of $50,831. No other matter or circumstance has arisen since 30 June 2025 that has significantly affected, or may significantly affect the company's operations, the results of those operations, or the company's state of affairs in future financial years. 5 ReNerve Limited Directors' report 30 June 2025 Likely developments and expected results of operations The company’s key milestones in the coming 12 to 24 months are expected to be: ● ● ● ● ● ● ● Growth in sales of the NervAlign® Nerve Cuff in the USA . First sales of the amniotic tissue products New sales and marketing partnerships outside the US for the Nerve Cuff NervAlign® Nerve Cuff clinical case publications Market clearance of the NervAlign® Nerve Conduit Progression of the NervAlign® Nerve Guide Matrix (NGM) project into formal studies for FDA filing Further research and development in relation to the NervAlign® Bionic Replacement Nerve During the 2024/25 financial year the company successfully progressed the development of both manufacturing processes for the scale production of the NervAlign® Nerve Conduit and packaging solutions for the product. The company intends to further progress its NervAlign® Nerve Conduit program during the year, including: ● ● ● ● ● Finalisation of the manufacturing process for the NervAlign® Nerve Conduit Finalisation of packaging development and validations Bench testing of products from validation batches including for strength and suture holding Animal (rat) study in gap repair FDA filing The company will continue to progress its NervAlign® Nerve Guide Matrix program. The technology is based on proprietary methods for preparation of novel nerve scaffolds and will initially target repair of discontinuities in nerves with diameters in the 1mm to 5mm range. In partnership with Collagen Solutions, ReNerve has successfully transferred its development process and completed an initial product production run. It has also held a meeting with its surgeon advisory group on the final product, resulting in a clear understanding of the characteristics of the final product. The next step for ReNerve will be to progress the project to the manufacture of clinical grade product and scale manufacturing of the nerve guide matrix. ReNerve will continue to aim to grow its commercial business through revenue growth of its NervAlign® Nerve Cuff product as well as building out its product portfolio. In the coming 12 months the company anticipates having four product ranges in market, which it will sell through its existing relationships with US distributors Environmental regulation The company is not subject to any significant environmental regulation under Australian Commonwealth or State law. Information on directors Name: Title: Qualifications: Experience and expertise: Other current directorships: Former directorships (last 3 years): Interests in shares: Interests in options: Reginald Stephen Cooper Independent Chairman & Non-Executive Director BCom (Hons) Mr Stephen Cooper is a director of Grant Samuel, a leading independent Australian investment banking business. Stephen has over 26 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. He has served as the chairman of an ASX-listed biotechnology company Avexa. N/A N/A 10,643,434 ordinary shares NIL 6 ReNerve Limited Directors' report 30 June 2025 Name: Title: Qualifications: Experience and expertise: Dr Michael Panaccio Independent Non-Executive Director BSc (Hons), MBA, PhD Michael 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. 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, Protagonist Therapeutics Inc, and dorsaVi Ltd. Other current directorships: N/A Former directorships (last 3 years): Interests in shares: Interests in options: DorsaVi (ASX:DVL) 3,662,250 ordinary shares NIL Name: Title: Qualifications: Experience and expertise: Dr Julian Chick Director & Chief Executive Officer BSc, PhD Julian is an experienced healthcare executive with over 26 years of experience in senior management and board positions including in ASX listed companies Avexa and Admedus. His roles have included Chief Executive Officer, COO, Head of Business Development, as well as running early and late-stage R&D projects. Julian has launched medical devices into the global markets. 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. He has 10 years of investment banking experience and has also held a role as an analyst reviewing healthcare and biotechnology investment opportunities for private