Announcement PDF CEO Presentation ASX:RCE | FSE:R9Q November 2023 Disclaimer DISCLAIMER This presentation has been prepared by Recce Pharmaceuticals Ltd (the “Company”). It does not purport to contain all the information that a prospective investor may require in connection with any potential investment in the Company. You should not treat the contents of this presentation, or any information provided in connection with it, as financial advice, financial product advice or advice relating to legal, taxation or investment matters. No representation or warranty (whether express or implied) is made by the Company or any of its officers, advisers, agents or employees as to the accuracy, completeness or reasonableness of the information, statements, opinions or matters (express or implied) arising out of, contained in or derived from this presentation or provided in connection with it, or any omission from this presentation, nor as to the attainability of any estimates, forecasts or projections set out in this presentation. This presentation is provided expressly on the basis that you will carry out your own independent inquiries into the matters contained in the presentation and make your own independent decisions about the affairs, financial position or prospects of the Company. The Company reserves the right to update, amend or supplement the information at any time in its absolute discretion (without incurring any obligation to do so). Neither the Company, nor its related bodies corporate, officers, their advisers, agents and employees accept any responsibility or liability to you or to any other person or entity arising out of this presentation including pursuant to the general law (whether for negligence, under statute or otherwise), or under the Australian Securities and Investments Commission Act 2001, Corporations Act 2001, Competition and Consumer Act 2010 or any corresponding provision of any Australian state or territory legislation (or the law of any similar legislation in any other jurisdiction), or similar provision under any applicable law. Any such responsibility or liability is, to the maximum extent permitted by law, expressly disclaimed and excluded. Nothing in this material should be construed as either an offer to sell or a solicitation of an offer to buy or sell securities. It does not include all available information and should not be used in isolation as a basis to invest in the Company. FUTURE MATTERS This presentation contains reference to certain intentions, expectations, future plans, strategy and prospects of the Company. Those intentions, expectations, future plans, strategy and prospects may or may not be achieved. They are based on certain assumptions, which may not be met or on which views may differ and may be affected by known and unknown risks. The performance and operations of the Company may be influenced by a number of factors, many of which are outside the control of the Company. No representation or warranty, express or implied, is made by the Company, or any of its directors, officers, employees, advisers or agents that any intentions, expectations or plans will be achieved either totally or partially or that any particular rate of return will be achieved. Given the risks and uncertainties that may cause the Company’s actual future results, performance or achievements to be materially different from those expected, planned or intended, recipients should not place undue reliance on these intentions, expectations, future plans, strategy and prospects. The Company does not warrant or represent that the actual results, performance or achievements will be as expected, planned or intended. US DISCLOSURE This document does not constitute any part of any offer to sell, or the solicitation of an offer to buy, any securities in the United States or to, or for the account or benefit of any “US person” as defined in Regulation S under the US Securities Act of 1993 (“Securities Act”). The Company’s shares have not been, and will not be, registered under the Securities Act or the securities laws of any state or other jurisdiction of the United States, and may not be offered or sold in the United States or to any US person without being so registered or pursuant to an exemption from registration including an exemption for qualified institutional buyers. About Recce Pharmaceuticals Ltd • Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a new class of Synthetic Anti-Infectives, protected by Composition of Matter Patent • Australian clinical-stage biotech company, with a United States presence • Strong pre-clinical data package demonstrating high bactericidal activity combined with very good safety at expected human therapeutic range • Qualified Infectious Disease Product designation • 10 years market exclusivity plus fast track approval* • RECCE® 327 (main product candidate) has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer, sepsis drug candidate in development • Multiple clinical indications and formulations in Phase I and II addressing unmet medical needs *Awarded by the US FDA in 2017 for R327 bacteraemia (broad-spectrum bacterial sepsis). Time starts only from potential market approval. 2 Board and Management Structure Dr John Prendergast – Chairman BSc (Hons), MSc (UNSW), PhD (UNSW), CSS (HU) US-based, current Chairman and Co-founder of Palatin Technologies, Inc. (NYSE: PTN) and Lead Director of Nighthawk Biosciences (NYSE: HHWK). With extensive experience in the international commercialisation of pharmaceutical technologies, Dr Prendergast has been responsible for the approval of three new drug applications. James Graham – Managing Director & Chief Executive Officer BCom (Entrepreneurship), GAICD Six years as former Executive Director and extensive experience in marketing, business development and commercialisation of early-stage technologies with global potential. Mr Graham has served on Recce’s Board of Directors for six years and has invested in almost every capital raise to date with a focus on expanding Recce’s commercial opportunities and clinical initiatives. Michele Dilizia – Executive Director & Chief Scientific Officer BSc (Med Sci), Grad Dip Bus (Mkting), BA (Journ), GAICD, MASM Co-inventor and qualified medical scientist with a specialisation in medical microbiology and regulatory affairs. Ms Dilizia successfully co-led the research and development of Recce’s suite of anti-infective compounds, resulting in a portfolio of granted patents across the globe, including a Qualified Infectious Disease Product designation with the U.S. FDA. Dr Justin Ward – Executive Director & Principal Quality Chemist BSc (Chem), PhD (Chem), M Pharm, MRACI, CChem A quality control expert who has worked with leading pharmaceutical companies. He previously held a technical role with Pfizer, involving providing data for the regulatory submissions to the FDA and TGA. Dr Ward is bringing Recce’s research and development, and manufacturing up to US FDA requirements Dr Alan Dunton – Chief Medical Advisor & Non-Executive Director BSc (BioChem) Hons, M.D. (NYU) US based, Director of Palatin Technologies. Over three decades of senior pharmaceutical experience incl. President and MD of Janssen Research Foundation (Johnson & Johnson). Dr Dunton has advanced a number of blockbuster antibiotics through regulatory review and commercialisation at Fortune 500 companies including Roche. Dr Dunton has been responsible for the approval of approximately 20 New Drug Applications; an amalgamation of prescription and OTC products. Alistair McKeough – Non-Executive Director Alistair is a qualified lawyer and specialises in complex commercial matters that require careful and strategic planning. Mr McKeough has extensive experience advising ASX-listed companies and their directors and is a member of the University of New South Wales Law Advisory Council. 3 Since our last AGM We’ve announced and achieved the following: ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ Received HREC Approval to start Phase I/II DFU Study Anti-Infective Research Unit Established at Murdoch Children’s Australian Patent to be Granted for RECCE Anti-infectives Presented at LifeSci Corporate Access Event during the JP Morgan Health Care Conference Received AUD $6.21m from R&D Rebate Payments RECCE trademark Registered – Hong Kong Selected CMAX for Phase I/II UTI clinical Trial Corporate Presentations in Sydney and London for the Wholesale Investor Emergence Conference Series Received a further AUD $973k R&D advance New Australian Family 4 Patent to be granted for RECCE anti-infectives RECCE trademark Registered – Israel HREC Approval to start Phase I/II UTI/Urosepsis clinical trial WA Government Sponsorship for BIO Korea 2023 Appointed Outpatient Nurses to Phase I/II DFI Clinical Trial HREC Approval for Phase I/II UTI/Urosepsis Trial Site Expansion (Scientia) First Cohort Dosed in Faster Infusion Phase I/II UTI/Urosepsis Study Received an additional AUD $801k R&D Rebate Phase I Clinical Trial Data Complete Review Scientia Doses Ahead of Schedule in Phase I/II UTI/Urosepsis Trial Abstract & Poster Presentation at US Military Symposium Scientia Completes Cohort Dosing in Phase I/II UTI/Urosepsis Trial Bonus Canadian R&D Rebate Received Australian Patent Granted for RECCE Anti-Infectives Positive Patients Update – Special Access Scheme Phase I/II Burn Wound Infection Trial Stage 1 Complete 39 announcements ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ Patients Dosed in R327 DFI Trial Safety Committee Approved Dose of 3,000mg faster infusion rate at 30 mins Additional Patients dosed in Special Access Scheme RECCE trademark Registered – Vietnam Delivered Opening R&D Address at World AMR Congress Placement and Entitlement Offer – Capital Raise FIL becomes Substantial Holder R327 safe and well tolerated in male and female subjects at a faster infusion rate of 30 minutes of 3,000mg Entitlement Offer – Announcement of Capital Raise Results Recce Pharmaceuticals Annual Report 2023 Placement of Entitlement Offer Shortfall Safety Committee Approves Dose Faster Infusion rate of 15-minutes of 3,000mg Presented at the Ord Minnett Health Care Forum Subjects Dosed Over 15 mins in UTI/Urosepsis Clinical Trial Breakdown by Category – 2023 Announcements Clinical 18 46% Operational 13 33% Financial 8 21% Breakdown by Category – 2022 Announcements Clinical 15 71% Operational 5 5% Financial 1 24% 2022 Corporate Goals New Clinical Data Sets ✓ Phase I Intravenous Study data sets to be released Global Strategy - Partnerships ✓ Continued engagement in partnership opportunities with both domestic and international organisations Strengthen Intellectual Property ✓ Including internationally recognised drug designations Peer-Reviewed Publications – Ongoing Recognition of R327’s Unique Mechanism of Action unique with clinical context Publication Location Title Abstract and Poster Presentation Military Health System Research Symposium R327: A Novel Synthetic AntiInfective for the Treatment of AMR Bacterial Sepsis Infections Abstract ESCMID/ASM R327 Demonstrates Bactericidal Activity Against Several Microbial Species 5 2023/2024 Corporate Goals Data Review and Completion of Clinical Trials Successfully streamline and accelerate current clinical trial processes in chosen indications and routes of administration Government/Private Enterprise Partnerships Funding, research partnerships, licensing, grant submissions, military areas of interest Submit Investigational New Drug (IND) application Build Out Presence in the USA Further expand capabilities in USA supporting FDA strategy 6 Company Overview Recce Pharmaceuticals Ltd is a clinical-stage biotech company with a new class of novel synthetic anti-infectives Capital Structure – 6th November 2023 RCE Share Price and Volume Chart – 12 Months ASX & FSE Code RCE, R9Q Share Price AUD $0.43 3-Month Average Volume $0.80 $0.70 253.4k $0.60 Shares on Issue 203 million $0.50 Unlisted Options (Avg $1.54) 13.9 million $0.40 AUD $87 million $0.30 AUD $8.36 million* $0.20 51% $0.10 Nil $0.00 Market Capitalisation Cash at Bank Top 20 Shareholders Debt *Before 43.5% R&D Rebate submitted - net benefit from anticipated receipt during present quarter 6,000,000.00 5,000,000.00 4,000,000.00 3,000,000.00 2,000,000.00 1,000,000.00 - Volume Close $ Multiple near-term clinical readouts The global antibiotics market was US$38.08 billion in 2021 projected to grow to US$45.30 billion in 2028 at a CAGR of 2.5% Multiple clinical indications and formulations in Phase I and Phase II addressing unmet medical needs: Sepsis, UTI,recce.com.au Burn Wounds and Diabetic Foot Ulcer Infections Proprietary first-in-class, broad-spectrum anti-infectives against bacteria Successful Capital Raise – AUD $11 million • The Company announced it successfully completed a strongly supported raise of AUD $11 million (before costs) through a placement to institutional, sophisticated and professional investors completed on 18 September 2023 and an Entitlement Offer which completed on 29 September 2023. Fidelity International Ltd (FIL) are now a substantial shareholder of Recce Pharmaceuticals Ltd owning 7.69% • James Graham, CEO, took up his full entitlement, investing a further AUD $102.7k into the Company. Capital Raise Snapshot Total Raised AUD $11m • Directors of the Company took a portion of the Shortfall (AUD $0.3m), representing approximately 250,000 shares (AUD $110k). Placement AUD $8.0m Entitlement Offer AUD $3.0m • Recce received major institutional support in capital raise from FIL (Fidelity) Limited FIL Limited Increased Holding 7.69% New Shares Issued 6.171m • Funds raised will be used to fund various clinical trials, build out RCE’s infectious disease portfolio, geographical expansion and general working capital. recce.com.au Director Shortfall Participation 250,000 Shares (AUD $110k) Top 20 Shareholders Movements since last AGM – Increased Support 6-Nov-23 Balance Issued Capital (%) 6 Nov 23 Holding Movement Total % Increase Since Last AGM G & O Melrose 37,028,311 18.20% - - 2 HSBC Custody Nominees (Australia) Limited 13,348,988 6.56% 6,844,408 105.22% 3 4 M Rogers and A Veliss Mr James Graham 8,500,000 7,593,932 4.18% 3.73% 3,500,000 1,562,000 70.00% 25.90% 5 Acuity Capital Investment Management Pty Ltd <Acuity Capital Holdings A/C> 4,500,000 2.21% - - 6 Ms Michele Keryn Dilizia 3,543,485 1.74% - - 7 Acewood Investments Pty Ltd <Chivers Super Fund A/C> 3,307,101 1.63% 122,485 3.85% 8 Mr John James Liddelow <John Liddelow A/C> 3,040,000 1.49% 610,000 25.10% 9 10 Pejay Pty Limited Citicorp Nominees Pty Limited 3,000,000 2,675,183 1.47% 1.31% 750,000 1,639,798 33.33% 158.38% 11 BNP Paribas Nominees Pty Ltd ACF Clearstream 2,637,254 1.30% 1,437,859 119.88% 12 Querion Pty Ltd 2,100,000 1.03% - - 13 Haultrans Management Pty Limited <Successful Super Fund A/C> 1,870,000 0.92% 1,410,000 306.52% 14 15 BNP Paribas Noms Pty Ltd LDU Pty Ltd 1,734,359 1,484,882 0.85% 0.73% 95,908 -1,739,510 5.85% -53.95% 16 Mr Michael Noel Aarons & Mrs Mami Aarons <The Aarons Superfund A/C> 1,437,498 0.71% - - 17 Mark David Swinn 1,314,720 0.65% 97,718 8.03% 18 BNPP Noms Pty Ltd HUB24 Custodial Serv Ltd 1,273,198 0.63% 142,032 12.56% 19 Mr Nikolai Shirobokov & Mrs Svetlana Shirobokov 1,260,036 0.62% 148,062 13.32% 20 Mr Peter McCray 1,083,661 102,730,233 0.53% 50.49% 53,500 17,091,000 5.19% - Position Holder/Group Name 1 Total Top 20 Holder Increase Top 20 Shareholding as of 2022 – 48.74% recce.com.au Top 20 Shareholding as of 2023 – 50.49% (increase 1.75%) Platform Technology Recce’s products will treat systemic and local infections caused by ESKAPE pathogens, other resistant organisms or when the etiology of the infection is unknown • Very broad-spectrum coverage of bacteria with no signs of resistance • Extremely rapid onset of effect – measured in minutes as compared to hours for typical antibiotics • Multiple formulations available – intravenous, topical liquid, topical gel and aerosol for inhalation or intranasal • Manufacturing – fast and economical • Readily available raw materials • Prolonged stability of product(s) Strong Pipeline Over Various Indications and Upcoming Inflection Points *AIR – Anti infective Research Unit 11 Phase I Human Clinical Trial - Complete 120x dose amount* 6,000 mg ✓ subjects as a single ascending dose. 80x dose amount* 4,000 mg ✓ Randomized, double-blind, placebo-controlled, safety, tolerability and pharmacokinetics study. 60x dose amount* 3,000 mg ✓ • Single dose of a 1-hour via IV infusion at a uniform rate in hospital setting. 40x dose amount* 2,000 mg ✓ • In concurrence with the Therapeutic Goods Administration clinical trial regulatory procedures, the recruitment for the study is closed and marked ‘Complete’ with no ‘Serious Adverse Events’ reported. 20x dose amount* 1,000 mg ✓ 10x dose amount* 500 mg ✓ 3x dose amount* 150 mg ✓ 1x dose amount 50 mg ✓ • • • Study to assess IV infusion of RECCE® 327 in healthy male Safe up to and including 6,000mg using a 1-hour infusion – • 60 subjects received R327, 20 subjects received placebo Plasma concentrations are linear vs. dose and “predictable” *Dose increase fold based off 50mg RECCE® 327 - Intravenous formulation – Phase I Summary of Results – All Primary Endpoints Achieved ✓ No serious adverse events (SAEs) or deaths were reported in this study. ✓ No clinically significant changes were noted in any hematology parameter(s) in any cohort during the course of the study. ✓ No clinically significant changes were noted in any chemistry parameter(s) in any cohort during the course of the study (Kidney and Liver functions all normal – no change in parameters). ✓ All coagulation parameters remained within normal limits or were deemed not clinically significant (Normal blood clotting properties were maintained). ✓ No clinically significant changes were noted in any urinalysis parameter(s) in any cohort during the course of the study (i.e. no adverse event/side effect). ✓ No clinically significant changes were noted in any vital sign (included systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and body temperature) parameter(s) in any cohort during the course of the study. ✓ No clinically significant changes were noted in any 12-lead ECG parameter(s) in any subject in any cohort during the course of the study (no cardiac event). ✓ No clinically significant changes were noted in any cardiac telemetry parameter(s) in any subject in any cohort during the course of the study (no cardiac abnormalities during continuous heart monitoring whilst under observation). 13 RECCE® 327 Concentrates Safely in the Urine Concentration of R327 in Urine Compared to Plasma In over 60 healthy subjects – R327 primary route of elimination appears to be through the kidney to the ureters and bladder. – High concentrations of R327 noted in the urine of Phase I healthy subjects. – Insight consistent with pre-clinical in-vivo kidney and UTI bacterial infection studies. Ratio Urine/Plasma 16x 17x 14x 9x 21x 16x – Opportunities for therapeutic in array of UTIs (uncomplicated UTI - single dose, complicated UTI, recurrent UTI, treatment resistant etc.) – Suggests broader anti-infective treatment model in pre-sepsis. Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial High Dose – 15 minutes • Assessing R327 at faster administration rates (<1 hour) • Trial aimed at positioning R327 as first patient presentation Cohort 4 TBD mg (?) ‘fast-infusion’ designed to stop any bacterial infection in its tracks in any medical setting • Male and female subjects dosed • Results from this trial will pave the way for R327 as a potential ✓ Dosing commenced first-line treatment for patients suffering from UTI/Urosepsis • Awarded by the US FDA in 2017 for R327 bacteraemia (broad-spectrum bacterial sepsis). 3,000mg Low Dose – 30 minutes Qualified Infectious Disease Product designation • Cohort 3 ✓ Safe and well tolerated UTI’s are responsible for about 30% of all sepsis infections, defined as ‘Urosepsis’ ✓ Safe and well tolerated Cohort 2 3,000mg Cohort 1 2,500mg ✓ Topical Clinical Programs Phase I/II Clinical Trial – Treatment of Burn Wound Infections • Stage 1 Complete • Patients treated with R327 showed good indications of safety and tolerability • No serious adverse events reported among patients • Clinical investigators are preparing a new protocol of next stage • Stage 2 clinical trial expected to be a randomised ‘head-to-head’ in patients with infected burn wounds, where R327G treatment is compared to existing treatment standard of care Phase I/II Clinical Trial – Diabetic Foot Infections • Ongoing and dosing patients • Patients supported by in-home (out-patient) nurses trained in R327 treatment protocols • Appointment of leading out-patient nursing group sees broadening of DFI patient trial population – increased probability of dosing completion • Study across South Western Sydney health district – one of the highest prevalence rates of diabetes in NSW • Largest DFU study underway in Australia at this time For illustrative purposes only – not final product 16 TGA Special Access Scheme Case Studies 17 Robust Worldwide Intellectual Property Portfolio Recce’s patent portfolio contains over 40 patents and patent applications in the world’s major markets. Patent Family 1 Expiry Patent Family 2 Expiry Patent Family 3 Expiry Patent Family 4 Expiry Australia ✓ 2028 ✓ 2037 ✓ 2037 ✓ 2041 USA ✓ 2029 ✓ 2037 ✓ 2037 Pending - Europe ✓ 2028 ✓ 2037 ✓ 2037 Pending - Germany ✓ 2028 ✓ 2037 ✓ 2037 - - Spain ✓ 2028 ✓ 2037 ✓ 2037 - - France ✓ 2029 ✓ 2037 ✓ 2037 - - UK ✓ 2028 ✓ 2037 ✓ 2037 - - Italy ✓ 2028 ✓ 2037 ✓ 2037 - - Sweden ✓ 2028 ✓ 2037 ✓ 2037 - - Japan ✓ 2028 ✓ 2037 ✓ 2037 Pending - China ✓ 2028 Pending 2037 ✓ 2037 Pending - HK Pending 2028 Pending 2037 ✓ 2037 Pending - Israel - - - - - - Allowed 2041 Canada - - - - - - Allowed 2041 Filed Family 1 group relates to the Company’s Unique and Highly Economical Manufacturing Process and use of the Polymer in Treatment of Diseases. Family 2 relates to the Method of Manufacture, Administration and Application to Treat a Broad Range of Common Human Infections. Family 3 relates to a Method of Treatment of a Broad Range of Viral Infections, particularly Parenteral Viral Infection. Family 4 relates to Process for Preparation of Biologically Active Copolymer, other Patent Cooperation Treaty countries pending/allowed) 18 Multiple Upcoming Clinical Milestones Topical R327 Key inflection points Burn Wounds Burn Wounds H1: Initiate Phase I/II Burn Wound Infection Clinical Trial- Initiated Q4 23: Readout of Phase I/II Burn Wound Infection Trial DFU DFU Q4 23: Readout of Phase I/II DFU Trial H1: Initiate Phase I/II DFU Clinical - Initiated CY23 Mid 23: Rapid IV Infusion Study Pre-UTI HREC Approved UTI Present H2 23: Multidose Safety/PK Mid 2023 start UTI CY24 CY25 Q4 23/Q1 24: Readout of Phase I/II UTI Trial H2 24: Initiate Phase III UTI Trial UTI UTI H2 22: Phase I Safety/PK – Completed H2 23: Initiate Phase II sepsis trial Mid 24: Readout of Phase II sepsis trial Sepsis Urosepsis Urosepsis H2 24: Initiate Phase III sepsis trial H2 25: Initiate 2025 I.V. R327 Urosepsis Urosepsis Displayed as calendar years Milestones are indicative only 19 Thank you James Graham Managing Director and Chief Executive Officer Recce Pharmaceuticals Ltd ASX:RCE; FSE:R9Q +61 2 9256 2505 james.graham@recce.com.au recce.com.au