Ascend Biopharmaceuticals Limited Corporate Overview October 2016 ASCEND BIOPHARMACEUTICALS LIMITED
Disclaimer This presentation is being provided for the sole purpose of providing the recipients with background information about Ascend Biopharmaceuticals Limited’s (“Ascend”) business. This presentation, including the information contained in this disclaimer, does not constitute an offer, invitation or recommendation to subscribe for or purchase any security, and neither the presentation, disclaimer nor anything contained in them forms the basis of any contract or commitment. This presentation does not purport to summarize all information that an investor should consider when making an investment decision. Before making an investment decision you should consider whether it is suitable for you in light of your own investment profile and objectives and financial circumstances and the merits and risk involved. No representation, express or implied, is made as to the fairness, accuracy, completeness or correctness of information, opinions and conclusions contained in this presentation, including the accuracy, likelihood of achievement or reasonableness of any forecasts, prospects, returns or statements in relation to future matters contained in the presentation (“forward -looking statements”) . Such forward- looking statements are by their nature subject to significant uncertainties and contingencies and are based on a number of estimates and assumptions that are subject to change (and in many cases are outside the control of Ascend and its Directors) which may cause the actual results or performance of Ascend to be materially different from any future results or performance expressed or implied by such forward-looking statements. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. To the maximum extent permitted by law, neither Ascend nor its related corporations, directors, employees or agents, nor any other person, accepts any liability, including, without limitation, any liability arising from fault or negligence, for any loss arising from the use of this presentation or its contents or otherwise arising in connection with it. You represent and confirm by attending and/or retaining this presentation, that you accept the above conditions. This presentation does not constitute an offer to sell or a solicitation of an offer to buy securities in the United States. 2 ASCEND BIOPHARMACEUTICALS LIMITED
Ascend Company Highlights Ascend is an immuno-oncology company targeting regulated cell death and immune pathways with: a high value lead opportunity: lead candidate addresses a major high-value clinical need in nodular BCC patients considered to be poor candidates for surgery a clinically de-risked lead with prospects of an expedited pivotal program: lead candidate has good safety and clinical benefit results in 3 different skin cancers phase 2 data available shortly: current Phase 2 study in nodular BCC will have top-line interim data in November 2016 and final data in 1H, 2017 lead candidate with multiple follow-on opportunities: potential to address multiple high- value follow-on indications in recurrent ovarian cancer and recurrent cutaneous squamous cell carcinoma *Based on regulatory precedence for Aldara in Superficial BCC patients who were not good surgery candidates 3 ASCEND BIOPHARMACEUTICALS LIMITED
Board & Management • Dr Clement Leong, PhD, Over 20 years of biotech, pharma and venture capital experience in Australia and United States • MBA Commercial and development roles with Schering Plough, Entelos, SciVentures; lead investor on multiple CEO private/public biotech and med. tech transactions • PhD from University of Western Australia; MBA from the Australian Graduate School of Management • Dr. Richard Stead, MD. Over 25 years directing clinical trials in Industry and licensing transactions • Non-executive Director Formerly Med. Director at Amgen & VP Clinical Res at Immunex; involved in approval of Epogen & Neupogen • MD from Stanford University; Postdoc training at the Brigham and Woman’s Hospital, Harvard Medical School • Over 30 years’ experience in funds management Mr George Tsiamis • Non-executive Director Formerly Head of Operations for ANZ Asset Management, $15B in Funds under Management. • Formerly Chief Financial Officer of the publicly listed McMillan Shakespeare Ltd (ASX: MMS). • Dr. Paul Weiden MD Over 30 years as medical oncologists and directing/assisting with clinical trials • Chief Medical Officer Formerly a member of the University of Washington, Fred Hutchinson and Virginia Mason Medical Center • MD from Harvard Medical School. • Dr. Satish Menon, PhD Over 26-years of experience in protein based therapeutics R&D and manufacture • CMC Director Directed process and bioprocess development for Schering Plough, DNAX, Genitope and Allergan • Ph.D. from the Indian Institute of Science, Bangalore and Postdoc at Harvard Medical School. • Dr Geoffrey Pietersz, PhD Over 30 years as an organic chemist working in cancer & infectious diseases • Director of Technology Formerly a Professor at the Burnet Institute, expert in bio-conjugation of therapeutics (e.g., vaccine; antibody Development drug conjugates) and inventor of the ASN-004 technology • Ph.D. from the University of Melbourne. 4 ASCEND BIOPHARMACEUTICALS LIMITED
Pipeline Product Composition Indication Preclinical Phase 1 Phase 2 Phase 3 ASN-002 ASN-002 Monotherapy Cutaneous BCL Completed Bladder ASN-002 ASN-002 Monotherapy Nodular BCC H1, 2017 complete Cutaneo ASN-002/small molecule ASN-002 Chemo-immuno therapy Head & Neck SCC H2 2017 start ASN-002/small molecule H2, 2017/2018 start ASN-002 Chemo-immuno therapy Recurrent OC ASN-002/small molecule Planned ASN-002 Chemo-immuno therapy Nevoid BCC H2, 2017/2018 start H2, 2017 ASN-006 Mannan-genetic adjuvant Peritoneal Cancer Breast ASN-008 Replicon vector - RCD genes* Refractory cancers on-going Replicon vector - Neoantigens Refractory cancers on-going * Preclinical work performed in collaboration with Fox Chase Cancer Centre in Philadelphia, USA Addressing high-value clinical opportunities CBCL Cutaneous B cell lymphoma; BCC Basal Cell Carcinoma; H&N SCC Head and Neck Squamous Cell Carcinoma; RCD induction of multiple regulated cell death pathways; IT Immunotherapy; OC Ovarian Cancer; PC Peritoneal Cancer 5 ASCEND BIOPHARMACEUTICALS LIMITED
The Opportunity: nodular Basal Cell Carcinoma Basal cell carcinoma is the most common cancer worldwide arising in ~3 Million patients annually (~2 million with nodular BCC and ~1 million with superficial BCC) Prognosis is good if excised but if untreated can cause Most nBCC lesions occur If untreated BCCs on the face, head and become locally invasive significant morbidity/disfigurement neck, making excision and and can cause extensive wound closure more disfigurement difficult Surgical excision is the main treatment option for nBCC It is estimated that around 25-30% of nBCC patients (over 500,000 patients annually) can be considered poor candidates for surgery Excision margins of 2 to 5 mm (all around the whole of the outer tumour mass) are appropriate for most BCC resections A significant clinical and commercial opportunity in high-risk nBCC The risk of recurrence is determined by the patients age, immune status, and the location and subtype (histology) of the tumour 6 ASCEND BIOPHARMACEUTICALS LIMITED
Current Non-surgical Treatment Options High-risk nBCC Small Lesion Large Lesion Comments Photodynamic Therapy Generally a poor choice Generally a poor choice Poor efficacy for High-risk nBCC 5-FU Poor choice Poor choice Poor efficacy for High-risk nBCC Radiotherapy Generally good clinical Generally good clinical Risk of radiation induced secondary clearance clearance cancers Aldara Generally a poor choice Should not be used Poor efficacy for High-risk nBCC Cryosurgery Generally fair choice Generally a poor choice Poor efficacy for High-risk nBCC Vismodegib/Sonidigib Not recommended Recommended for Locally Major adverse effects (hair loss, (Smoothened advanced basal cell skin muscle cramps, taste disturbance) inhibitors) cancer patients with residual Secondary resistance disease in whom surgery and radiation are contraindicated Existing options have major disadvantages or are clinically inadequate Telfer NR Br J Dermatol 2008 159(1) 35-48 Guidelines for the management of basal cell carcinoma; Arch Dermatol August 2012 7 ASCEND BIOPHARMACEUTICALS LIMITED
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