Level 2, 6 66 Hunter Str reet Syd dney NSW 2 2000 Tel: (61-2) 9300 3 344 Fax: (61-2) 9221 6 6333 E-mail: p pnightingale@ @biotron.com m.au W Website: www w.biotron.com m.au 20 Novemb ber 2017 The Manag ger Compan nies ASX Limit ted 20 Bridge S Street SYDNEY NSW 2000 0 (19 p pages by em mail) Dear Mada am, PRESENT TATION TO O ANNUAL L GENERA AL MEETI ING I attach an n address by y the Chair rman and a a PowerPoin nt presentat tion which are to be d delivered to o the shareholder rs present at t today’s An nnual Gener ral Meeting which is co onvened to b be held at 1 1.30 am. Yours faith hfully Peter J. Nig ghtingale Company S Secretary pjn9169
Level 2, 6 66 Hunter Str reet Syd dney NSW 2 2000 Tel: (61-2) 9300 3 344 Fax: (61-2) 9221 6 6333 E-mail: info@ E @biotron.com m.au W Website: www w.biotron.com m.au 20 Novemb ber 2017 My Fellow w Shareholde ers CH HAIRMAN’ S ADDRES SS TO THE E AGM In recent w weeks, Biotro on has taken n a giant ste ep towards d demonstratin ng that erad dication of H HIV is possi ible. The 36 th a and final pa atient in th he Company y's Phase 2 2 HIV trial completed treatment. The trial w was designed to o demonstra ate the Com mpany's lea ad compoun nd, BIT225, , benefits p atients abov ve and bey ond current ant ti-HIV treat tments. Ana alysis of tria al data is, b by necessity y, frustrating gly slow so o we have li ittle choice but to impatien ntly await fi nal results. Neverthele ess, we rem main confiden nt. For the many milli ions of patients destined to o live with th his disease, there is ho ope, and for the thousan nds of share eholders of this Company m maybe, just maybe, ther re is light at t the end of a very long tunnel. 9 th clinical This is the trial condu ucted by Bio otron. The p previous eig ght trials su uccessfully p provided sou und stepping st tones along g the clinic cal developm ment pathw way for BIT T225. The e latest tria al caps off our determinati ion to dem monstrate so ound scienc ce and prov ven results add crede ence to our r belief in the significanc e of the Co ompany's pl latform. Th he only wa ay to achiev ve the comm mercial out comes that are desired by shareholder rs is by patie ently delive ering quality y data from c clinical trial ls and suppo orting studie es. Much has b been achiev ed during th he past 12 m months, as w will be outlin ned in the C CEO’s presen ntation. Looking ah head, we ha ave every re ason to be o optimistic. Close focus s on our cor re assets is p presenting n new opportuniti ies. Biotron n should no ot be viewe d as a singl le asset com mpany. Ou ur diversity offers a str rong portfolio of f possibilitie es capable o of delivering g sustainabl e sharehold der value. Importantly y, BIT225 i is only one of hundreds s of Biotron n compound ds. A subst tantial volum me of evide ence now suppo orts the belie ef that many y opportuni ities reside i in the Comp pany's comp pound libra ary, likely to o be beneficial a against addi itional viral targets. A disciplin ned and focu used approa ach to capit tal managem ment is emb bedded in o our operatin ng model. O Our priority is t to retain fle exibility in t the developm ment of gro owth opport tunities align ned, of cour rse, to our l lead product. I would lik ke to take th his opportun nity to than nk our smal ll but dedica ated staff fo or their dete ermination and productive efforts dur ring the pas st12 months s. I would also like to o thank my y fellow dire ectors for th heir equally ded dicated parti icipation an nd support.
In particular, I should single out Denis Wade for his enduring contribution and dedication to the Company since he joined the Board in 2010. For personal reasons, Denis steps down from the Board today. Denis' advice and insight have been of enormous value to me personally and to the entire Board. He departs with a mix of our regret and gratitude. I am relieved to report he won't be going far. Denis will retain an ongoing advisory role with the Company. I would now like to invite our CEO, Michelle Miller, to address the meeting. Michael J. Hoy Chairman
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Forward Looking Statements This presenta'on may contain forward looking statements with respect to the financial condi'on, results and business achievements/performance of Biotron Limited (ACN 086 399 144) and certain of the plans and objec'ves of its management. These statements are statements that are not historical facts. Words such as “should”, “expects”, “an'cipates”, “es'mates”, “believes” or similar expressions, as they relate to Biotron Limited, are intended to iden'fy forward looking statements. By their nature, forward looking statements involve risk and uncertainty because they reflect Biotron’s current expecta'ons and assump'ons as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assump'ons or expecta'ons could cause actual results to differ materially from current expecta'ons.
Investment Highlights • Biotron is designing, developing and commercialising a plaUorm of an'viral drugs with a novel mode of ac'on – able to target a wide variety of viral infec'ons • Pipeline of programs in high value, high need markets • Progress in clinical lead program (BIT225) provides strong valida'on for en're plaUorm
Biotron Limited – Snap Shot BROAD PLATFORM WITH NEW CLASS OF ANTIVIRAL DRUGS HIV-1 ERADICATION HEPATITIS C VIRUS (HCV) HBV & EARLY STAGE PROGRAMS - New class of HCV drug - Targe'ng HIV-1 in long-lived - Pipeline of early stage reservoirs programs, including: - Phase 2 completed - Phase 2 trial in progress - Hepa''s B virus - Seeking partnerships in during 2017; dosing China - Respiratory viruses complete - Flaviviruses (e.g. Dengue) ROBUST CLINICAL VALIDATION – COMPLETED 8 CLINICAL TRIALS WITH STRONG SAFETY & EFFICACY OUTCOMES
Key Achievements FY 2017 • Commenced Phase 2 clinical trial of BIT225 and Combina'on An'retroviral Therapy (cART) in Feb’17 • Fully recruited in July ‘17; Dosing with BIT225/placebo completed; data pending • Demonstrated significant and accelerated reduc'on in HIV-1 viral load following addi'on of BIT225 in humanised mouse study in Feb ‘17 • Independent Nature publica'on validated Biotron’s approach of targe'ng HIV-1 in macrophages as a key step in HIV-1 eradica'on in May ’17 • Appointed Lynx Financial as Corporate Advisor for China – assis'ng with execu'ng HCV regional partnering strategy in June ‘17 • Raised $1.56 million via rights issue in June ‘17 • Received $1.6 million R&D tax refund in Nov ‘17 (post-end of FY)
CommercialisaUon – Key Focus • Three tac'cal priori'es: • Partnering lead clinical program - BIT225 for HIV-1 eradica'on • Partnering one or more preclinical programs – e.g. HBV • Execute a regional licensing deal in China - HCV program remains a great opportunity
HIV-1 EradicaUon Current drugs do not eradicate HIV-1 virus • HIV-1 remains hidden in reservoirs, leading to chronic, life-long infec'on • Invisible to body’s immune defenses • Not sensi've to an'-HIV-1 drugs • New mode of ac'ons drugs are needed to eradicate or cure HIV-1 infec'on Why is HIV-1 eradicaUon necessary? • Long-term health implica'ons e.g. HAND, immune ac'va'on, etc • Cost of treatment • ~ $20 billion p.a. world wide • Major burden on healthcare systems BIT225 has potenUal to be used in combinaUon with other drugs to eradicate HIV-1 reservoirs Mario Stevenson Scien.fic American 299 , 78 - 83 (2008)
HIV-1 EradicaUon: BIT225-009 Trial BIT225 or placebo added to ART 36 HIV-1 +ve , treatment-naïve subjects commencing ART • Randomised 2:1 (drug:placebo) • BIT225 or placebo added to ART for first 12 weeks of treatment • Read-out • Impact on virus levels; reduc'on of immune ac'va'on markers • Fully recruited; completed dosing with BIT225/placebo; in follow-up period (ART alone) •
HIV-1 EradicaUon: BIT225-009 Trial • Fully recruited July; last pa'ent, last dose in mid-October • Three month follow-up period post-dosing with BIT225/placebo • Addi'onal samples collected from pa'ents throughout this next 3 month period • Post-trial laboratory analyses on samples from treatment period are in progress: • Virological Outcomes • Immunological Outcomes • Post-dosing sample data also required to complete the analyses • E.g. Any rebound or change in parameters once drug ceased? • All data is necessary to determine outcome of the trial
CommercialisaUon: BIT225 HIV-1 EradicaUon • Several pharmaceu'cal companies have ac've HIV-1 “Cure” Programs • Iden'fied and qualified poten'al partners • Posi've outcomes – BIT225 clinical trial - key to progressing commercialisa'on discussions • Poten'al partners have defined their success criteria – we are aligned! • Communica'ng trial data as soon as available • Follow up mee'ngs with poten'al partners con'nue
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