Announcement PDF Corporate Presentation ASX:RCE 10th Annual Corporate Access Event January 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. 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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 About Recce Pharmaceuticals Ltd Recce Pharmaceuticals (ASX:RCE) is commercialising a New Class of Synthetic Anti-Infectives to address the global health issue of antibiotic resistant superbugs and emerging viral pathogens. Listed on ASX 2016 (ASX:RCE) Unique and universal Mechanism of Action Water soluble over a broad range of pH levels New Class of Synthetic Anti-Infectives that kill emerging viral pathogens as well as Gram + & Gram – bacteria, including their superbug forms - even with repeated use! RECCE® 327 & RECCE® 435 – bacterial indications RECCE® 529 – viral indications RECCE® 327 awarded Qualified Infectious Disease Product designation under GAIN Act 10 years market exclusivity (post approval) Patented manufacturing, producing to Phase I & II volumes Fast track (life of regulatory process) 2 Recce Pharmaceuticals Ltd - Capital Structure Major Shareholders – 6 January 2021 G & O Melrose* HSBC Nominees LDU Pty Ltd J Graham** Acuity Capital JP Morgan Nominees Aus. M Dilizia** Acewood Investments Querion Citicorp Nominees 23.6% 4.0% 4.0% 3.4% 2.6% 2.6% 2.1% 1.8% 1.2% 1.2% Snapshot ASX code RCE Shares on issue 173.71 million Share price USD $0.82 Market Cap (approx.) USD $144 million*** Cash and deposits USD $20.1 million*** Trading range USD 0.16c - $1.45 Average daily volume 336.61K Debt Nil 6 January 2021 6 January 2021 6 January 2021 30 September 2020 AUD $1.065 AUD $185 million AUD $25.7 million ASX:RCE 6 months 52 week 3 months AUD 0.21c-$1.875 * Inventor & Former Head of J&J Research (Australasia) ** Held by Executive Directors *** Price converted to USD 7 January 2021: 1 AUD = 0.77 USD 3 Board and Management Structure Dr John Prendergast – Non-Executive 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 Heat Biologics, Inc. (NASDAQ: HTBX) – extensive experience in the international commercialisation of pharmaceutical technologies James Graham – Managing Director & Chief Executive Officer BCom (Entrepreneurship), GAICD 5 years as former Executive Director Invested along-side shareholders in most capital rounds since inception. Background in marketing, business development and commercialisation of earlystage technologies. Dr Alan Dunton – 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 (J&J Research). Dr Dunton has advanced a number of blockbuster antibiotics through regulatory review and commercialization at fortune 500 companies including J&J and Roche. Michele Dilizia – Executive Director & Chief Scientific Officer BSc (Med Sci), Grad Dip Bus (Mkting), BA (Journ), GAICD, MASM Co-inventor and qualified medical scientist; specialisation in medical microbiology and regulatory affairs Dr Justin Ward – Executive Director & Principal Quality Chemist BSc (Chem), PhD (Chem), MRACI, CChem Alistair McKeough – Company Secretary (Outsourced – Automic Group) Alistair is a qualified lawyer and Principal of Automic Legal Pty Ltd, Alistair has broad experience as a commercial litigator and Company Secretary to ASX Listed companies Justin Reynolds – CFO (Outsourced - Pitcher Partners Sydney) Justin is a qualified accountant and Partner of Pitcher Partners Sydney, Justin has broad experience covering all areas of accounting, taxation and assurance. Particularly, Justin’s areas of expertise are business services and outsourced accounting Arthur Kollaras – Principal Engineer & Head of Manufacturing BSc Beng (Chem), PhilEng (Enviro), MIEAust, MISPE Highly qualified in chemical engineering and microbiology, has significant experience taking a new technology concept to pilot plant and full-scale FDA standards and production internationally Dr David Bowers – Chair of Clinical Advisory Committee Leading spinal injury physician at Royal North Shore Hospital. Dr Bowers has a specialist interest in the treatment of complex and life-threatening antibiotic resistant infections, particularly among patients with severe spinal cord injuries. Professor Philip Sutton – Head of H. pylori Development Program Global infectious disease expert with over 30 years of research and industry experience, having served as former Head of Immunology at CSL Ltd in Melbourne. Chief Editor of textbook “Helicobacter pylori in the 21st Century” and has co-authored 92 manuscripts published in peerreviewed journals. Professor Sutton currently leads Mucosal Immunology Group at Murdoch Children’s Research Institute. A quality control expert who has worked with leading pharmaceutical companies, he is bringing Recce’s research and development, and manufacturing up to US FDA requirements 4 RECCE® – Multiple Anti-Infective Applications Recce’s technology enjoys the added opportunity of multiple markets and product categories. *FIH – First-in-human Estimated timelines/indications are subject to change in development plans and regulatory requirements/clarifications 5 Natural Antibiotics vs Synthetic Antibiotics 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 https://www.uptodate.com/contents/choice-of-antibiotics-in-penicillin-allergic-hospitalized-patients/abstract/1 6 Sepsis – it’s a big problem! 48.9 million incident cases of sepsis recorded worldwide 1 11 million sepsis related deaths recorded One in three patients who die in hospital have sepsis 2 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 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 RECCE® 327 Phase I Human Clinical Trial Human safety and tolerability study to assess IV infusion of RECCE® 327 in 48 healthy subjects as a single ascending dose Phase I trial agreement with leading clinical research organization PAREXEL Trial will be held at CMAX Clinical Research – an independent trial facility Facility meets international regulatory authority data entry and quality requirements including European Medicines Agency and US FDA Dispatched to Clinical Trial Facility (CMAX) Placebo and RECCE 327 (I.V.) via Recce’s Manufacturing facility (Sydney) Formal subject recruitment to open for enrolments shortly CMAX has more than 30,000 registered patient volunteers on file Patient screened Q1, 2021 CMAX Phase I Clinical Unit 8 RECCE® Antibiotics – Curative & Preventative IV Studies* Number of mice that survived Sepsis from S. aureus (superbug) RECCE® 327 132 mg/kg Oxacillin 500 mg/kg Infection in mice from S. pyogenes No treatment All ten mice treated with RECCE® antibiotic survived Nine mice treated with efficacious dose of Oxacillin (500 mg/kg) survived Four mice that had no treatment at all, survived * Results from an independent laboratory in USA One group of ten mice were administered a 167 mg/kg dose of RECCE® 327 at 0 hours. Second group received no antibiotic. Both groups inoculated with the S. pyogenes burden into the bloodstream. Mice results first monitored after 12 hours allowing bacteria to develop and establish an infection. Bacteria in the blood were rapidly killed and unable to establish an 9 infection in the kidneys of mice who received RECCE® 327. Single Dose and Range-Finding Repeat Dosing - Rats No Observed Adverse Effect Level (NOAEL) of 24-hour 500mg/kg (10x indicated efficacious dose) Phase Ia (24-hour), Phase Ib (24-hour over 7 days) A separate single 24-hour intravenous infusion administration of RECCE® 327 up to 12,000 mg/kg over the course of 7-days was carried out. Results of up 12,000 mg/kg/day was well tolerated from Days 1 to 4 (inclusive); with no mortalities or clinical signs. 24-hour dosing up to 4,000 mg/kg (80x indicated efficacious dose) in Dogs well tolerated. RECCE® 327 is indicated to be efficacious from as little as 50mg/kg and here shows tolerability can be sustained over at least 7 days of continuous daily exposure at doses up to and including 500 mg/kg. 10 Single Dose and Range-Finding Repeat Dosing - Dogs No Observed Adverse Effect Level (NOAEL) of 24-hour 500mg/kg (10x indicated efficacious dose) Phase Ia (24-hour), Phase Ib (24-hour over 7 days) A single 24-hour intravenous infusion administration of RECCE® 327 up to 4000 mg/kg and 7-day continuous intravenous infusion administration of RECCE® 327 up to 500 mg/kg/day were well tolerated; with no mortalities, clinical signs, changes in body weight, coagulation, clinical chemistry or salient macroscopic abnormalities. RECCE® 327 is indicated to be efficacious from as little as 50mg/kg Therapeutic dose window appears considerably wider than Vancomycin and other antibiotics. 11 RECCE® 327 Phase I/II Topical Human Trial in burn wound infections The topical study will assess RECCE® 327 as a broadspectrum antibiotic for patients with Gram-positive and Gram-negative bacterial burn wound infections Sponsored by the South Metropolitan Health Service, Department of Health, Government of Western Australia Fiona Stanley Hospital nominated as the study site Principal Investigator Professor Fiona Wood Dr Wood pioneered the innovative the worlds-first ‘sprayon skin’ technique, which greatly reduces permanent scarring in burns victims. Over 14 days, 10 patients will receive RECCE® 327 daily while a further 20 receive treatment 3 times per week Phase I/II clinical trial approved by Human Research Ethics Committee 12 Topical Efficacy – Wound Infection & Contraction Superbug Methicillin-Resistant S. aureus (MRSA) The Study Director noted: “RECCE® 327 (100 µl (19.15 mg/ml), topical, once daily, over three days), and Soframycin (30 mg, topical, twice daily, Q=12hr, over three days) showed a significant reduction wound on day four (p<0.05) when compared to day one, when compared to the vehicle control.” The Study Director noted: “RECCE® 327 (100 µl (19.15 mg/ml), topical, once daily over three days) showed significant reduction in bacterial load on day four when compared to day one. Soframycin (30 mg, topical, twice daily, Q=12hr, over three days), the current standard of care antibiotic did not show significant efficacy on day four...” *Significantly different from vehicle control (p<0.05, 1-way ANOVA) Results from an independent laboratory in USA 13 RECCE® 435 Pre-clinical Studies Program with H. pylori Murdoch Children’s Research Institute (MCRI) to evaluate in-vivo antimicrobial activity of RECCE® 435 oral formulation against Helicobacter pylori (H. pylori) in pre-clinical studies program RECCE® 435 is a new broad-spectrum synthetic polymer antibiotic formulated for oral use Study led by H. pylori infectious disease expert Professor Philip Sutton Research program will be carried out by Mucosal Immunology Group at the MCRI Royal Children’s Hospital MCRI is one of the top three child 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 in approximately 12 months, at which time Recce will pursue a human clinical trial 14 RECCE® 435 Efficacy Against H. pylori New RECCE® 435 oral showed dose-dependent and significant efficacy against Helicobacter pylori (H. pylori) bacteria Bacteria isolated from a patient with a duodenal ulcer compared to control vehicle in independent study model in rats Five groups of 10 rats each were observed. Three groups were treated with varying doses of RECCE® 435 (250, 500, 1,000 mg/kg) 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 Study assessed a combination of two broad spectrum antibiotics being used – Amoxicillin and Clarithromycin. 15 RECCE® 435 Safety Oral Study Additional independent study was undertaken Purpose of the study examined the safety oral dosing of RECCE® 435 up to 500 mg/kg Compound was administered to groups of five mice each twice daily for seven days compared to water-only administration Data indicates their feeding habits, which contributes to weight gain No negative impact Supports overall general and gastrointestinal health 16 SARS-CoV-2 Antiviral Program RECCE® 327 compound selected as Priority 1 candidate group for testing in SARS-CoV-2 Antiviral Program. The program is run by CSIRO and The Peter Doherty Institute for Infection and Immunology. Compounds were chosen by a Science Selection Panel including field experts in the areas of: Virology, Antivirals, Medicinal Chemistry & Clinical Trials of Antiviral drugs. Therapeutic anti-viral treatment focus with added potential benefit against secondary bacterial infections. All intellectual property rights are retained by the Company 17 SARS-CoV-2 International Study RECCE® 327 and RECCE® 529 have shown concentration-dependent reductions in the SARS-CoV-2 virus Concentrations of R327 and R529 tested, further indicated an excellent toxicity profile (<0.25%) on Vero (monkey) cells, in a separately related study COVID-19 studies will be advancing to goldstandard animal in-vivo models (e.g. ferret) Method of administration will be via intranasal to target viral infection in the airways/lungs Ferret international study expected to begin September and be completed prior to end of 2020 18 SARS-CoV-2 Intranasal Study** RECCE® 327 and RECCE® 529 demonstrated dosedependent activity in-vivo against SARS-CoV-2 virus in Syrian golden hamsters Intranasal administration of both compounds supports multiple potential modes of administration against SARS-CoV-2 Study consisted of five groups of eight hamsters, each receiving a different treatment Placebo control of saline nasal wash, low dose of R327 (200mg/kg), high dose of R327 (400mg/kg), low dose of R529 (100mg/kg), and high dose of R529 (200mg/kg) 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 This hamster study is the first indication of the potential for nasal administration of Recce’s anti-infective compounds, specifically when used against viruses Understanding logs (example of a small colony of 1 million MRSA bacteria)* A 1-log kill reduces the colony to 100,000 MRSA bacteria after a 90% reduction A 2-log kill reduces the colony to 10,000 bacteria after a 99% reduction A 3-log kill reduces the colony to 1,000 bacteria after a 99.9% reduction A 4-log kill reduces the colony to 100 bacteria after a 99.99% reduction A 5-log kill reduces the colony to 10 bacteria after a 99.999% reduction A 6-log kill reduces the colony to 1 MRSA bacterium after a 99.9999% reduction *https://halosil.com/what-are-logs-and-why-do-they-matter-in-preventing-infections/ **Statistical significance was not assessed in this study 19 RECCE® 327 kills at practical speeds Standard Bacteria S. aureus E. coli P. aeruginosa S. pyogenes C. difficile 20-60 minutes 20-60 minutes 3-24 hours 20-60 minutes 20-60 minutes S. aureus E. coli P. aeruginosa 20-60 minutes 20-60 minutes 3-24 hours Superbugs The same kill-rates for standard bacteria and their superbugs All concentrations of bacteria (germ) were 10 cfu/ml Concentration of RECCE antibiotic was 1,000 ppm against all bacteria except P. aeruginosa 2,000 ppm was used against P. aeruginosa 20 RECCE® 327 Does Not Lose Activity! 1 Number of repetitive uses before displaying loss of antibiotic activity RECCE® 327 1 After repetitive use, the commercial antibiotic loses activity; >25 repeats RECCE® 327 DOES NOT *‘Commercial Antibiotic’ generates over US $10bn in revenue 21 RECCE® 327 Mechanism of Action in practice 00:00 minutes Before application of RECCE® 327, the E.coli bacteria cells are healthy, smooth and intact E.coli Facts 1 • Part of the Enterobacteriaceae family • $1.2bn USD estimated attributable healthcare costs in 2017 • CDC labels this bacteria as a Serious Threat • 50% increase in cases since 2012 1 CDC Antibiotic Resistance Report 2019 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 22 RECCE® 327 Mechanism of Action in practice 20 minutes After application of RECCE® 327, the E.coli bacteria cell membrane begins to weaken and is disrupted Burst! – others already redundant and breaking down 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 23 RECCE® 327 Mechanism of Action in practice 180 minutes Bacteria compromised – now consumable by healthy blood cells E. coli bacteria cells (10e6 cfu/ml) having their outer membrane weakened – and bursting from treatment with RECCE® 327 (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 24 Patents and trademarks Recce’s patent portfolio includes more than 15 issued patents and patent applications in the world’s major markets, including the United States, Europe, Japan, China and Australia. 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 Filed Australia USA Europe Germany Spain France Patent Family 1 Granted Expiry Patent Family 2 Expiry Patent Family 3 Expiry Patent Family 4 Trademarks registered ✓ 2028 ✓ 2035 Pending 2037 Pending ✓ 2035 Pending 2037 Pending 2035 Pending 2037 Pending ✓ 2035 Pending 2037 Pending - 2035 Pending 2037 Pending - 2035 Pending 2037 Pending - ✓ ✓ ✓ ✓ ✓ 2029 2028 2028 2028 2029 ✓ ✓ ✓ ✓ ✓ ✓ United Kingdom ✓ 2028 ✓ 2035 Pending 2037 Pending - Italy ✓ 2028 ✓ 2035 Pending 2037 Pending - 2035 Pending 2037 Pending ✓ Sweden Japan China ✓ ✓ ✓ 2028 ✓ 2028 ✓ 2035 ✓ 2037 Pending 2028 Pending 2035 Pending 2037 Pending ✓ 25 Manufacturing and Production 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 ¼ hours. 500 doses per automated manufacture output in less than 1 hour/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’ Investment summary R327 Qualified Infectious Disease Product (QIDP) Designation R327 Generating Antibiotics Incentive Now (GAIN) Act approved Proprietary technology as a new class of synthetic anti-infectives R327 addressing the most expensive condition faced by hospitals worldwide Early commercialisation potential R327 initial focus on sepsispotentially the first treatment for sepsis Favourable legislative and financial landscape Experienced commercial management and board Creating value by meeting key milestones Established manufacturing (volumes suitable for Ph I/II) 27 Thank you James Graham Managing Director and Chief Executive Officer Recce Pharmaceuticals ASX:RCE +61 2 9256 2572 james.graham@recce.com.au recce.com.au