Announcement PDF ASX Announcement Recce to Present at MST Access Investor Conference Sydney Australia, 17 June 2021: Recce Pharmaceuticals Ltd (ASX:RCE) (FSE:R9Q) (Company), is pleased to announce that it has been invited to present at the MST Access Australian Micro & Small Caps Conference 2021. Presentation is to be given by CEO Mr James Graham today, Thursday 17 June at 12.30pm AEST. Please find attached the presentation. To join, please click the webinar link below: https://mstfinancial-au.zoom.us/j/82826045695 This announcement has been approved for release by Recce Pharmaceuticals CEO About Recce Pharmaceuticals Ltd Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialisation of New Classes of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic resistant superbugs and emerging viral pathogens. Recce’s anti-infective pipeline is unique and comprised of broad-spectrum synthetic polymer antibiotics RECCE® 327, RECCE® 435, and RECCE® 529 for viral infections with unique mechanisms of action against hyper-mutation on bacteria and viruses, respectively. Patented lead candidate RECCE® 327 as an intravenous therapy, is being developed for treatment of serious and potentially life-threatening infections including sepsis due to Gram-positive and Gram-negative bacteria including their superbug forms. Recce’s new antibiotic compound, RECCE® 435, has been formulated for oral use. The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate in development. Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of RECCE® technologies targeting synergistic, unmet medical needs. MST Access Presentation ASX:RCE, FSE:R9Q June 2021 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. 1 Management Structure Dr John Prendergast – Chairman James Graham – Chief Executive Officer Michele Dilizia – Chief Scientific Officer US based, current Chairman and Co-founder of Palatin Technologies, Inc. (NYSE: PTN) and Lead Director of Heat Biologics, Inc. (NASDAQ: HTBX) – extensive experience in the international commercialisation of pharmaceutical technologies. 5 years as former Executive Director. Invested along-side shareholders in most capital rounds since inception. Background in marketing, business development and commercialisation of early-stage technologies. Co-inventor and qualified medical scientist; specialisation in medical microbiology and regulatory affairs requirements. BSc (Hons), MSc (UNSW), PhD (UNSW), CSS (HU) BCom (Entrepreneurship), GAICD BSc (Med Sci), Grad Dip Bus (Mkting), BA (Journ), GAICD, MASM 2 A Versatile Technology Platform Anti-infective focused Biotech company targeting both bacterial and viral indications Burn Wound Burn Wound RECCE® 327 Strong IP and own manufacturing capability and spray formulations for a range of usecases Designed to safely provide treatment without Unique and universal Mechanism of Action on Viruses and Bacteria Proprietary manufacturing facility, producing to Phase I & II volumes | Versatile platform delivering oral, intravenous developing resistance over time Multiple opportunities with RECCE® 327 interim first in human data expected in 2021 Strong Intellectual Protection 10 years market exclusivity IN USA post approval Fast track 3 327 Strong Pipeline 435 529 Over Various Indications and Upcoming Inflection Points Asset Indications Discovery Preclinical Phase I Phase II Phase III Anti-bacterial programs Indication Discovery Preclinical Phase 1 Phase 2 Phase 3 Route of administration R327 Intravenous & Intranasal Serious/life threatening bacterial infections including sepsis Pre-sepsis - kidney & UTI infections R327 Wound infections including infected burns R435 Helicobacter pylori in stomach ulcers Topical Oral R529 Next data readout Next inflection point Market Size Market Size EU/US/AU Phase I interim data readout Q4 2021 47-50 million cases worldwide Phase I/II readout Q4 2021 11 million burn wound cases requiring medical intervention. Majority of which escalate to infection To start post Phase II in sepsis Up to 4.4 billion worldwide Anti-viral programs R327 COVID & Influenza R529 COVID Nasal IV and Intranasal 4 RECCE® 327 as an Antibiotic Natural Antibiotics vs Synthetic Antibiotics 327 435 529 Pre-formed natural superbugs All Fungi or Bacteria based ‒ “Penicillin allergy is the most common drug allergy and is reported in up to 15 percent of hospitalized patients” 1 Only as good as what’s found in nature Natural Antibiotics Has always had naturally occurring superbugs, now multiplying out of control! NO pre-formed natural superbugs Entirely man-made and designed with purpose Universal Mechanism of Action - detailed experimentation demonstrates it does not succumb to superbugs Contains only what we want - not reliant on what’s found in nature Synthetic Antibiotics Broad Spectrum capability and maintains its activity even with repeated use! 1- Lee, C E et al. “The incidence of antimicrobial allergies in hospitalized patients: implications regarding prescribing patterns and emerging bacterial resistance.” Archives of internal medicine vol. 160,18 (2000): 2819-22. doi:10.1001/archinte.160.18.2819 6 327 Sepsis – it’s a big problem! 48.9 million incident cases of sepsis recorded worldwide 1 11 million sepsis related deaths recorded 2 435 529 One in three patients who die in hospital have sepsis 3 Sepsis is a life-threatening inflammatory response to infection that has spread in the body. 4 ‒ Kills more people in the US than prostate, breast cancer and HIV/AIDS combined. Has been the most expensive condition to treat in the last 8 years - double the average cost per stay across all other conditions. 5 Currently no drug therapies specifically for the treatment of sepsis.6 1,2,3 – The Lancet 4 – BioMed Central 5 – University of Texas 6 – International Medicine Journal RACP 7 327 Treatment Paradigm 435 529 Impact of delayed antibiotic treatment on odds ratio for mortality1 Current treatment paradigm relies on: Introducing broad spectrum antibiotic(s) Running antibiograms Adjusting antibiotics based on antibiogram results Early treatment with the correct antibiotic is key to patients’ outcome ~1/3 of patients present unspecific symptoms, leading to delayed treatment and high mortality rate Mortality from sepsis increases by as much as 8% for every hour that treatment is delayed2 1 – Vincent X. Liu et al. The Timing of Early Antibiotics and Hospital Mortality in Sepsis - Am J Respir Crit Care Med. 2017 Oct 1; 196(7): 856–863. 8 2 – https://www.sepsis.org/wp-content/uploads/2017/05/Sepsis-Fact-Sheet-2018.pdf Hypothesized Mechanism of Action 327 435 529 Stage 2 Stage 1 R327 interrupts bacterial cellular energetics via ATP Synthesis R327 permeabilizes cell membrane & enters the cell Stage 4 Stage 3 Cellular division & non-dividing cell functions are disrupted R327 rapidly & irreversibly bactericidal & at high concentrations cell lysis 9 RECCE® 327 Mechanism of Action in practice 327 435 00 minutes 20 minutes 180 minutes Before application of R327, the E. coli bacteria cells are healthy, smooth and intact After application of R327, the E. coli bacteria cell membrane begins to weaken and is disrupted E. coli bacteria cells (10e6 cfu/ml) having their outer membrane weakened – and bursting from treatment with R327 (1000 ppm) This is a high-definition electron microscope image generated in February 2017 by Dr Peta Clode and Lyn Kirilak of the Centre for Microscopy, Characterisation and Analysis, University of Western Australia. It was taken to demonstrate RECCE® 327’s unique mechanism of action 529 10 327 Phase I Human Clinical Trial 435 Safety and Tolerability Interim Data Expected Late 2021 Study to assess IV infusion of RECCE® 327 in 80 healthy male subjects as a single ascending dose Formal subject recruitment expected to open for enrolments shortly 16,000 mg 8,000 mg High Dose 10 subjects in each cohort: 2 control, 8 R327 4,000 mg 2,000 mg Randomized, double blind, placebo controlled, safety, tolerability and pharmacokinetics study Single dose of a 1-hour via IV infusion at a uniform rate in hospital setting Primary endpoint: vital signs, 12-lead ECG parameters, clinical chemistry, hematology, and urinalysis. Interim data expected late-2021 Full data expected early-2022 1,000 mg 500 mg Low Dose 10 subjects in each cohort: 2 control, 10 R327 150 mg 50 mg Day -28 Pre-administration 0 screening Safety follow up 28 11 529 327 Topical RECCE® 327 - Phase I/II 435 529 Burn wound infections – Interim Data expected in Q3 2021 Phase I/II to assess Topical RECCE® 327 Topical in burn wound infections 20 patients – dosing 3 times/week for 2 weeks duration Sponsored by the South Metropolitan Health Service, Department of Health, Government of Western Australia Primary outcome at 14 days post dosing Trial Investigators: o Dr Edward Raby (Clinical Microbiologist and Infectious Diseases expert at Royal Perth and Fiona Stanley Hospitals) o Professor Fiona Wood (Head of Burns) – world-renowned burns specialist and sprayon skin pioneer o Dr Chris Diseases) Heath (Head of 30 patients Infection status of wound1 Infectious 10 patients – daily dosing for 2 weeks duration Full data expected in Q4 2021 1 - Using the consensus clinical criteria of the International Wound Infection Institute Burn Wound Infections Affects ~60%1 of Patients 327 435 529 11 million cases requiring medical intervention annually2 MRSA one of the leading organisms causing invasive infection in burns across the world, burn units reporting rates of infection greater than 50%3 Multiple studies over the last decade have shown that 42%–65% of deaths in burn victims are attributable to infection4 1 - https://pubmed.ncbi.nlm.nih.gov/27246641/ 2 - https://www.who.int/news-room/fact-sheets/detail/burns 3 - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4790211/#:~:text=aureus%20now%20is%20one%20of,%25%20%5B9%2C10%5D 4 - https://academic.oup.com/cid/article/65/12/2130/4372276 13 RECCE® 435 - Targeting Helicobacter pylori R435 in Helicobacter pylori (H. pylori) infection 327 435 529 Potency as an Oral Formulation H. pylori is a common type of bacteria that grows in the digestive tract and has a tendency to attack the stomach lining It is estimated to affect 4.4 billion people worldwide (over half of the global population) Approximately 89% of all gastric cancers are attributed to H. pylori infection and the eradication of this infection has known to reduce gastric cancer incidence Global unmet medical need for the treatment of H. pylori with no first-line therapy curative in all patients Recce in agreement with Murdoch Children’s Research Institute to conduct pre-clinical studies to tackle this deadly pathogen RECCE® 435’s potential as an oral formulation to be assessed for the treatment of H. pylori infections Helicobacter pylori 15 RECCE® 435 Efficacy 327 435 529 Efficacious at Reducing H. pylori Colonisation Dose-dependent efficacy was seen at all doses with significant reduction in bacterial load High solubility and antibacterial effect supportive of a ‘targeted’ oral therapy for stomach infection Two weeks post infection with bacteria isolated from a duodenal ulcer patient, rats were treated twice a day for 7 days with: 10 rats Control No treatment 10 rats Control Amoxicillin + Clarithromycin 10 rats Treatment 1 RECCE® 435 250 mg/kg 10 rats Treatment 2 RECCE® 435 500 mg/kg 10 rats Treatment 3 RECCE® 435 1,000 mg/kg 16 RECCE® 435 Safety Oral Study in Rats 327 435 529 RECCE® 435 / Vehicle were administered twice daily for 7 days Data indicates their feeding habits, which contributes to weight gain RECCE® 435 had no impact on weight gain/loss vs control Supports overall general and gastrointestinal health 17 R435 Pre-clinical Studies 327 435 529 Further Pre-clinical Studies planned with R435 against H. pylori Murdoch Children’s Research Institute (MCRI) to evaluate in-vivo antimicrobial activity of RECCE® 435 oral formulation against H. pylori in pre-clinical studies program Study led by H. pylori infectious disease expert Prof. Philip Sutton Using mice as a highly validated animal model for H. pylori MCRI is one of the top three children's health research institutes worldwide for research quality and impact Recce and MCRI will work together on the oral antibiotic dosing program with a particular focus on optimal dosing and the effect of RECCE® 435 Anticipated completion at approximately mid-2022, at which time Recce may pursue a human clinical trial second half of 2022 18 RECCE® 327 and RECCE® 529 as Anti-virals against COVID-19 327 SARS-CoV-2 Antiviral Program 435 529 Despite vaccinations availability, an effective pharmaceutical treatment against all current and future strains of COVID-19 is needed to gain control over the global pandemic RECCE® 327 was selected as priority 1 test candidate for testing against COVID-19 - in the Australian government SARS-CoV-2 Antiviral program Therapeutic anti-viral treatment focus with added potential benefit against secondary bacterial infections Studies in mammalian cells showed safety and efficacy in preclinical studies RECCE® 327 and RECCE® 529 have shown concentration-dependent reduction of SARS-CoV-2 virus in Vero (monkey) cells 20 SARS-CoV-2 Antiviral Program At 4,000ppm, RECCE® 327 demonstrated in-vitro: 327 435 529 RECCE 327 RT-PCR and Cell Viability Data 99.9% efficacious with a 3-log drop in viral genome copies No virus detectable by virus titration Some cytotoxicity detected at 4,000ppm but not at lower concentration International in-vivo studies expanded to include new UK and South African COVID strains. 21 327 Nasal administration 435 529 RECCE® 327 and RECCE® 529 in Hamsters 5 groups with 8 hamsters each, administrated with: Saline nasal wash R327 200 mg/kg R327 400 mg/kg R529 100 mg/kg R529 200 mg/kg Drug administrated twice daily for 5 days qPCR of samples from nasal wash at day 2,4,6 RECCE® 327 and RECCE® 529 demonstrated dose-dependent activity in-vivo against SARSCoV-2 virus in Syrian golden hamsters Understanding logs* A 1-log kill is a 90% reduction A 2-log kill is a 99% reduction A 3-log kill is a 99.9% reduction Data conveyed a mean log reduction within groups on Day 4 where low R529 dose achieved a log reduction in the order of 1.5 logs and a high dose of R327 achieved log reduction of 1.25 logs *https://halosil.com/what-are-logs-and-why-do-they-matter-in-preventing-infections/ **Statistical significance was not assessed in this study 22 Full Control through Strong IP and Manufacturing Patents Three families across all major markets Recce’s patent portfolio includes more than 20 issued patents and patent applications in the world’s major markets, including the United States, Europe, Japan, China and Australia. Filed Australia USA Europe Japan China ✓ Granted Patent Family 1 Expiry Patent Family 2 Expiry Patent Family 3 Expiry ✓ 2028 ✓ 2035 Pending 2037 2035 Allowed 2037 2035 ✓ 2037 ✓ ✓ ✓ ✓ 2029 2028 ✓ ✓ 2028 ✓ 2035 ✓ 2037 2028 Pending 2035 Allowed 2037 Patent Family 1 – Antimicrobial Polymers and their Compositions Family 1 group relates to the Company’s unique and highly economical manufacturing process and use of the polymer in treatment of diseases Patent Family 2 – Copolymer for use in Method of Treatment of a Parenteral Infection Family 2 relates to the method of manufacture, administration and application to treat a broad range of common human infections. Patent Family 3 – Anti-Virus Agent and Method for Treatment of Viral Infection Family 3 relates to a method of treatment of a broad range of viral infections, particularly parenteral viral infection 24 Insourced Manufacturing Capabilities Wholly owned, automated manufacturing facility in Sydney’s Macquarie Park Raw materials plentiful and cheap – few $/Kg No expensive waste – 99.9% product yield Automated manufacture process taking approximately 1 hour 500 doses per fully automated run Currently producing in volumes to support planned Phase I & II clinical trials. Facility built to pharmaceutical specification. Packaging and labelling to international ‘tamper-proof’ standards Recce Pharmaceuticals Ltd – Capital Structure Top 20 Shareholders Distribution* Snapshot Tickers ASX:RCE, FSE:R9Q Amount Raised to Date AUD $46 million Market Cap (approx.) AUD $185 million Cash and deposits AUD $22.9 million 15 June 2021 31 March 2021 7% 26% 56% 11% Outstanding shares 173.8 million Average daily volume 265.8K 3 months RCE Institution Retail Other *Top 20 as of 16 June 2021 26 Investment Summary Proprietary new class of anti-infectives against bacteria and viruses, protected by Composition of Matter Patent. Fast development plans initially targeting: Sepsis, Burn wounds, Helicobacter Pylori and COVID-19. Strong pre-clinical data package demonstrating high bactericidal activity combined with very good safety at expected human therapeutic range. State of the Art manufacturing capacities ensuring highly attractive manufacturing costs and scalability. R327 Phase I clinical trial patient dosing in Q3 2021 delivering interim data by late 2021. Topical Phase I/II human clinical study of R327 is underway delivering full data Q4 2021 with interim data throughout. Robust financial position to deliver clinical data. 28 Thank you James Graham Chief Executive Officer Recce Pharmaceuticals ASX:RCE; FSE:R9Q +61 2 9256 2572 james.graham@recce.com.au recce.com.au