Announcement PDF James Graham - Executive Director Finance News Network Investor Event, Sydney September 2019 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 About Recce Pharmaceuticals Ltd Recce Pharmaceuticals is commercialising a New Class of Broad Spectrum antibiotics to address the global health issue of antibiotic resistant superbugs. Listed on ASX 2016 (ASX:RCE) recce.com.au New Class of Broad Spectrum antibiotics that kill Gram + and Gram – bacteria, including their superbug forms - even with repeated use! Lead indication for treatment of sepsis – #1 most expensive condition. 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 31 July 2019 1. G. & O. Melrose* 2. R. Gustafson 3. Acuity Capital Investment 4. J. Graham* 5. Foord Asset Management ASX:RCE 3 months Snapshot 28.3% 4.2% 4.2% 4.0% 3.9% ASX code RCE Shares on issue 107.13 million Share price AUD 21.5 cents Market Cap (approx.) AUD $23 million Cash and deposits* AUD $403K Trading range AUD 13-26.5 cents August 2019 52 week Average daily volume 117.94K 3 months * Held by Executive Directors *R&D rebate to further offset this amount 3 Tackling superbugs – RECCE® 327 (video) 4 Sepsis – it’s a big problem! Sepsis affects 30 million+ people worldwide* $24bn in annual costs treated in US hospitals 270K deaths recorded in the US yearly 1 Sepsis is a life threatening inflammatory response to infection that has spread in the body. 2 ‒ Kills more people in the US than prostate, breast and lung cancer combined. Most expensive condition to treat - double the average cost per stay across all other conditions.3 Over 750,000 cases of severe sepsis reported in the US alone.4 5 Currently no drug therapies specifically for the treatment of sepsis. 1 – Mayo Clinic 2 – Sepsis Alliance 3,4,5 – National Centre for Biotechnology Information *growing at an annual rate of 8-13% 5 Natural antibiotics vs synthetic antibiotics 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 Has always had naturally occurring superbugs, now multiplying out of control! 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 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 RECCE® Antibiotics – Curative study* Three groups of 10 mice were each infected with MRSA (S. aureus superbug) Number of mice that survived Sepsis from S. aureus (superbug) All ten mice treated with RECCE® antibiotic survived Nine mice treated with current antibiotic (Oxacillin) survived Four mice that had no treatment at all, survived Note: Oxacillin was chosen for its known activity against MRSA. It is however a ‘narrow-spectrum’ antibiotic. In a clinical context, where diagnostics cannot immediately determine bacterial type, use in combatting any number of other bacteria, may likely see a less favorable patient outcome… RECCE® 327, with its proven ‘broad-spectrum’ activity, has shown strength against a range of bacteria including superbug forms, delivering rapid kill of deadly germs. * Results from an independent laboratory in USA 7 RECCE® Antibiotics – Preventative study* Controlled study with two groups of mice: Sepsis in mice from Streptococcus pyogenes Blue group represent mice with RECCE® 327 already flowing through blood stream Grey group represent mice with no treatment At 0 hours both groups were introduced with significant S. pyogenes bacterial burden to the blood stream Due to RECCE® 327 already present in a preventative role, introduction of bacteria to the blue group DID NOT lead to established infection Results were monitored at 12th hour (per industry standard) to allow bacterial infection to develop in host After the 12th hour, S. pyogenes appears to be clearing naturally from the blood – WRONG ‒ Bacteria in grey group rapidly colonising in the kidneys – commonly resulting in catastrophic organ failure ‒ NOT in RECCE’s case. Bacteria in blood rapidly killed and unable to establish infection in kidneys * Results from an independent laboratory in USA 8 Toxicity Study* – Sprague Dawley Rats A dose-range-finding and 7-day repeat dose intravenous infusion toxicity study with RECCE® 327 in Sprague Dawley Rats. 1-hour infusion - Rat plasma concentration of RECCE® 327 is dose Following the 1-hour infusion – quickly cleared from the blood dependent.  ‘Dose Dependent’ = drug concentration in blood can be well controlled to efficaciously kill pathogenic bacteria;  ‘Cleared from blood quickly’ = drug does it job in the bloodstream, then exits quickly so as not to remain and cause toxicity. recce.com.au *Results from an independent laboratory in USA 9 Toxicity Study* – Beagle Dogs A dose-range-finding and intravenous infusion toxicity study with RECCE® 327 in Beagle Dogs. Dogs administered RECCE® 327 (70mg/kg) over 4-hour IV infusion protocol Numerous studies (in-vitro & in-vivo) indicate broad spectrum efficacy at 70mg/kg dose recce.com.au Even at highly zoomed level of analysis: 1. Compound again well identified in the blood; 2. High correlation between dose level and plasma concentration *Results from an independent laboratory in USA 10 RECCE® antibiotics kill at practical speeds Rates of kill of standard bacteria S. aureus E. coli P. aeruginosa S. pyogenes C. difficile 20-60 20-60 3-24 20-60 20-60 minutes minutes hours minutes minutes Rates of kill of Superbugs S. aureus E. coli P. aeruginosa 20-60 20-60 3-24 minutes minutes hours The same kill-rates for standard bacteria and their superbugs 6 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 11 RECCE® antibiotics do not Fail 1 Number of repetitive uses before displaying loss of antibiotic activity 1 After repetitive use, the commercial antibiotic loses activity; >25 repeats RECCE® antibiotic DOES NOT *‘Commercial Antibiotic’ generates over US $10bn in revenue 12 RECCE® 327 – how it works (in more detail) RECCE® antibiotics attracted to the bacteria plasma membrane through hydrophobic attraction An interaction occurs within the bacterial plasma membrane proteins via hydrophilic interactions Subsequent narrowing of bacterial cell wall and the natural, unique high metabolic pressure in bacteria results in bacteria cell lysis (BURST!) Outer protein can mutate as much as it likes (superbug) - RECCE® antibiotic will still kill it! 13 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 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 14 RECCE® 327 Mechanism of Action in practice 20 minutes Burst! – others already redundant and breaking down After application of RECCE® 327, the E.coli bacteria cell membrane begins to weaken and is disrupted 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 15 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 16 New Antibiotic Checklist – Snapshot for RECCE® 327  Efficacy – Performs as a broad spectrum antibiotic – active against Gram-negative, Gram-Positive and drug resistant Superbugs  Safety – Toxicology & Dose Escalation studies in four animal species (2 small, 2 large) - Escalating dose, Maximum dose, Repeat Dosing  Haemolysis – Selective toxicity against bacteria in the bloodstream  Genotox & Mutagenicity cleared – multiple studies confirm does not cause cell mutation  Pharmacokinetics – RECCE® 327 clears rapidly from blood stream after dosing  Allergenicity – Unlike most existing antibiotics, anaphylactic reactions not evident  Mechanism of Action – Unique (MoA) always works, unable to be overcome by bacterial mutation (superbugs) – even with repeated use!  100% Soluble at all pH’s – 100% soluble at all pH’s – even to the very acidic (low) pH of the stomach  Chemistry, Manufacturing & Controls (CMC) – Established (wholly owned) to human clinical specification (GLP/GMP)  First-in-human applications in advanced stages 17 What is Qualified Infectious Disease Product? Qualified Infectious Disease Product (QIDP) designation is awarded if FDA considers the drug to treat “serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen.” Legal status awarded under US Generating Antibiotic Incentives Now (GAIN) Act Labeled for fast track designation – speed the FDA’s review process 10 years market exclusivity, starting from the date of New Drug Application approval Anticipated further five year exclusivity under New Chemical Entity (NCE) policy* QIDP designated drugs to treat serious or life-threatening conditions and fill an unmet medical need 50% loading… *A New Chemical Entity (NCE) can be defined as "a compound which, previously, hasn't been described in scientific literature” Patents and trademarks Patent portfolio covers all key geographies, manufacturing and modes of use Filed Australia USA Europe Germany Spain France United Kingdom Italy Sweden Japan China Patent Family 1 Granted ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ Expiry Patent Family 2/3 Expiry Trademarks registered 2028 ✓ 2035 ✓ 2029 2028 2028 2028 2029 2028 2028 ✓ ✓ ✓ ✓ ✓ ✓ ✓ 2035 ✓ 2035 ✓ 2035 - 2035 - 2035 - 2035 - 2035 - 2028 ✓ 2035 - 2028 Pending 2035 ✓ 2028 Pending 2035 ✓ Patent Family 1 – granted Unique and highly economical manufacturing process Patent Family 2 – pending Applications (Multi-drug delivery) Patent Family 3 – pending Anti-viral uses Trademarks RECCE® for use on pharmaceutical products and services 19 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’ Board and management structure Dr Justin Ward – Executive Director & Principal Quality Chemist 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 Dr Graham Melrose – Executive Director & CRO BSc (Hons), PhD (UWA), MBA (Macq), FRACI, C Chem, FAICD Founder and inventor. Former Executive Director and Chief Research at Johnson & Johnson (Aust) Pty Ltd in Sydney, with global responsibilities, particularly in Asia-Pacific Michele Dilizia – Executive Director BSc (Med Sci), Grad Dip Bus (Mkting), BA (Journ), GAICD, MASM Co-inventor and qualified medical scientist; specialisation in medical microbiology and regulatory affairs James Graham – Executive Director BCom (Entrepreneurship), GAICD Extensive experience in marketing, business development and commercialisation of early stage technologies with global potential BSc (Chem), PhD (Chem), MRACI, CChem 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 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 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. 21 TGA Special Access Scheme The Special Access Scheme (SAS) refers to arrangements that provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. 3 categories Category A Category C • • Notification of use of specific therapeutic goods; allows certain types of health practitioners to supply therapeutic goods deemed to have an established history of use. Pathway that may be accessed by a prescribing medical practitioner or by a health practitioner acting on behalf of that medical practitioner, for a patient, who is seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment. Category B • Application pathway that can be accessed by health practitioners if patients do not fit the Category A definition. World Anti-Microbial Resistance Congress 2019 • Sole commercially focussed AMR conference globally • Recce Opening R&D Address - Chairman Dr John Prendergast – “How synthetic antibiotic development can change the antibiotic treatment model” • More than 600 attendees from over 40 countries • Congress General Manager on Recce: – “We are proud to provide this platform for promising antibiotic programs to be introduced to the AMR community, such as Recce Pharmaceuticals’ synthetic polymer program which has the potential of transforming the way superbugs are targeted, through a new class of broad-spectrum antibiotics.” World Anti-Microbial Resistance Congress 2018 Left to right: Dr Prendergast, Ms Dilizia, Mr Graham 23 RECCE® 327 development program Recce’s technology enjoys the added opportunity of multiple markets and product categories. SEPSIS (IV – S. AUREUS, E. COLI) GASTRITIS (ORAL – H. PYLORI) INTESTINAL (ORAL – E. COLI) Estimated timelines/indications are subject to change in development plans and regulatory requirements/clarifications FIH – First-inhuman *Testing for RECCE ® antibiotic Safety and Efficacy **Date submissions to regulators for permission to market 24 Investment summary Qualified Infectious Disease Product (QIDP) Designation Generating Antibiotics Incentive Now (GAIN) Act approved Proprietary technology as a new class of antibiotics Lead compound addressing the most expensive condition faced by hospitals worldwide Early commercialisation potential 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) 25 Thank you James Graham Executive Director – Recce Pharmaceuticals +61 2 8075 4585 +61 431 978 682 james.graham@recce.com.au Chad South Director Corporate Finance – ShawandPartners +61 427 361 041 chad.south@shawandpartners.com.au recce.com.au