Noxopharm Ltd. · ASX:NOX
Noxopharm — Investor Presentation (November 2018)
38 slides from Noxopharm's investor presentation, Nov 8, 2018
Slide 1: NOX releases latest corporate presentation
Date: 8 November 2018 Sydney, Australia For personal use only ASX Limited ASX: NOX 20 Bridge Street Noxopharm Limited SYDNEY NSW 2000 ABN 50 608 966 123 Registered Office NOX releases latest corporate presentation and Operational Office: • Highlighting Veyonda as a radio-enhancer Suite 3, Level 4 •
Slide 2: For personal use only
made by Noxopharm about circumstances and events that have not yet taken place. Although Noxopharm believes the forward-looking statements to be reasonable, they are not certain. Forward-looking statements involve known and unknown risks, uncertainties and other factors that are in some cases beyond
Slide 3: Discover Develop Deliver
For personal use only DISCOVER DEVELOP DELIVER ASX: NOX 1
Slide 4: Disclaimer
Disclaimer For personal use only This presentation has been prepared by Noxopharm Limited (NOX or the Company). It should not be considered as an offer or invitation to subscribe for or purchase any shares in NOX or as an inducement to purchase any shares in NOX. No agreement to subscribe for securi
Slide 5: Noxopharm At-a-Glance
Noxopharm At-a-Glance For personal use only • Australian biotechnology company • Offices Sydney, Hong Kong, New York • Aim to bring Veyonda® to market in 2022 as first-in-class dual-ac'on radio-enhancing/immuno-oncology drug • Listed Aug 2016: ASX (NOX) • Market cap: AUD$53 million Cash: AUD$9.6 • PIPE
Slide 6: Investment Highlights
Investment Highlights For personal use only § Leader in the development of isoflavonoid-based therapeutics, an emerging field of drug development § Novel family of G-protein inhibitors blocking key signaling pathways § Key proprietary know-how on maximizing drug-like activity § Targeted applications
Slide 7: Pipeline
Pipeline For personal use only PRECLINICAL PHASE 1 PHASE 2 ONCOLOGY Veyonda® Chemo-enhancement Veyonda® Radio-enhancement DARRT Veyonda® Radio-enhancement LuPIN NON-ONCOLOGY NYX-330 LDL Lowering NYX-104 Neuro-protection NYX-205 Peripheral neuropathy 5
Slide 8: Overall Drug Development Strategy
Overall Drug Development Strategy For personal use only Ø NOX to take Veyonda® through the registra6on process to marke6ng approval Ø Final registra6on study to start H2 2019 as an enhancer of radiotherapy in late-stage prostate cancer (DARRT program). Objec6ve = marke6ng approval by 2022 Ø In 2019
Slide 9: Overall Commercial Strategy
Overall Commercial Strategy For personal use only Ø NOX to remain an independent biopharma company based on proprietary IP enabling the development of a new class of drugs across a range of degenerative diseases Ø Establish marketing collaborations with larger companies for larger markets Ø NOX to r
Slide 10: Oncology Pipeline
Oncology Pipeline For personal use only PRECLINICAL PHASE 1 PHASE 2 ONCOLOGY Veyonda® Chemo-enhancement Veyonda® Radio-enhancement DARRT Veyonda® Radio-enhancement LuPIN NON-ONCOLOGY NYX-330 LDL Lowering NYX-104 Neuro-protecHon NYX-205 Peripheral neuropathies 8
Slide 11: Standard Radiotherapy – good but needs help
Standard Radiotherapy – good but needs help …. For personal use only § Pros: § Radiotherapy is an effec2ve an2-cancer treatment that is poten2ally cura2ve if used sufficiently early § Short course, usually well tolerated, rela2vely inexpensive § Cons: § Radia2on sickness caps amount and number of cours
Slide 12: Abscopal Response
… that help now on offer in the form of a phenomenon For personal use only known as an Abscopal Response An ABSCOPAL RESPONSE is a response to radiation in tumors outside the field of radiation An abscopal response refers to an anti-cancer effect on non- irradiated lesions involving the following res
Slide 13: Abscopal Responses Now Can Be Deliberately Induced
Abscopal Responses Now Can Be Deliberately Induced For personal use only Abscopal responses now recognized as a likely quantum Cancer cell damaged by leap forward in the treatment of cancer. radiation and dies ….. Up to 2005, very rare phenomenon The introduc8on of immuno-oncology (i-o) drugs includ
Slide 14: Idronoxil: a multi-acting immuno-oncology drug
IDRONOXIL: a mul.-ac.ng immuno-oncology drug For personal use only Idronoxil (Veyonda®ac-ve ingredient) works in 3 ways: 1. Idronoxil kills cancer cells on its own (ac#vates apopto#c pathways) 2. Idronoxil enhances the cancer-killing effect of radiotherapy: • By increasing chromosomal damage from rad
Slide 15: Idronoxil: Cancer-specific Inhibitor of Sphingosine Kinase
IDRONOXIL: Cancer-specific Inhibitor of Sphingosine Kinase For personal use only Ø Sphingosine kinase is a primary regulator of pro- survival and growth signaling pathways Ø Sphingosine kinase highly expressed in most cancers Ø Idronoxil specifically inhibits sphingosine kinase, resul>ng in downstream
Slide 16: Idronoxil: Additional Immuno-oncology Mechanism
Veyonda® For personal use only Idronoxil: Addi,onal Immuno-oncology Mechanism In addi*on to its radio-enhancing ac*vity, idronoxil also works through an addi*onal immuno-oncology mechanism Idronoxil ac*vates the innate immune system (monocytes and natural killer cells) Natural killer (NK) cells are
Slide 17: Veyonda - A Proprietary Formulation of Idronoxil
Veyonda® For personal use only Veyonda® - A Proprietary Formula5on of Idronoxil Veyonda® delivers a proprietary pro-drug form of idronoxil that… Protects idronoxil from being inac=vated by the body’s detox enzymes Increases the half-life of idronoxil from 45 minutes to >10 hours Veyonda® is a conven
Slide 18: Veyonda - A First-in-Class Radio-Enhancer and Immuno-Oncology Drug
Veyonda® Veyonda® - A First-in-Class Radio-Enhancer For personal use only AND Immuno-Oncology Drug Veyonda®: Selec?vely enhancing radia/on only in cancer cells, sparing healthy normal /ssue Increasing the cancer cell-killing effect of radia/on 2-3 /mes Working effec?vely across a broad spectrum of can
Slide 19: Make Veyonda a standard co-treatment with radiotherapy
Veyonda® Objec8ve is to make Veyonda® a standard co- For personal use only treatment with radiotherapy Well tolerated: Combina*on (Veyonda® + radiotherapy) tested to date in 38 pa*ents with no dose- limi*ng toxicity Short course of treatment for increased safety and reduced cost: 5 days of radiother
Slide 20: Veyonda Being Evaluated in Two Clinical Programs
Veyonda® - Currently Being Evaluated as a Veyonda® For personal use only Radio-enhancer in Two Clinical Programs DARRT - Direct and Abscopal Response to RadioTherapy LuPIN - 177Lute4um-PSMA-617 In Combina4on with Veyonda 18-Month Development Plan Non-small cell lung cancer Sarcomas 18
Slide 21: DARRT treatment regimen
DARRT – A treatment regimen intended for pa8ents Veyonda® For personal use only 9 with late-stage solid cancers who are eligible for DARRT pallia8ve radiotherapy Maximising death of Prepares cancer cell cancer cells by blocking DNA for maximum repair of DNA. Blocking post-radia8on radia8on damage. D
Slide 22: DARRT – Anticipated Clinical Benefits
DAART – An(cipated Clinical Benefits Veyonda® For personal use only DARRT DIRECT RESPONSE ABSCOPAL RESPONSE At a minimum, Veyonda® is expected to lead to The best expected outcome would be an improved better DIRECT responses to radiotherapy by DIRECT response, plus and ABSCOPAL response functioning a
Slide 23: Veyonda projected to provide meaningful survival benefits
Veyonda® projected to provide meaningful Veyonda® For personal use only 9 survival benefits DARRT + Veyonda® + Veyonda® PalliaFve Effect limited to Effect on irradiated + radiotherapy irradiated tumors non-irradiated tumors only Symptoms (pain) + +++ +++ CLINICAL Quality of Life + ++ +++ BENEFIT Time
Slide 24: DARRT-1: Phase 1b clinical trial
DARRT-1: Phase 1b clinical trial evalua<ng the safety and efficacy of Veyonda® For personal use only Veyonda® in men with late-stage prostate cancer eligible for pallia<ve 9 DARRT radia<on for pain and symptom management Combining Veyonda® with palliative radiotherapy to determine: • Safety across thr
Slide 25: DARRT-1 Prostate Cancer: Early Clinical Evidence of Veyonda
DARRT-1 Prostate Cancer: Early clinical Evidence of Veyonda® For personal use only Halt to Disease Progression 9 DARRT Cohort 1: 400 mg Veyonda® 12 weeks: • 4 pa,ents • 3 pa,ents with stable disease • 1 pa,ent disease progression Cohort 2: 800 mg Veyonda® 12 weeks: + • 2 pa,ents • (+ 2 replacement p
Slide 26: Case Study: Example of a Complete Abscopal Response
Case Study: Example of a Complete Abscopal Response Veyonda® For personal use only Pa3ent with metastaDc castrate-resistant DARRT prostate cancer. Being treated with pallia3ve radiotherapy for spinal lesions. Combined with Veyonda® produced a complete abscopal response within 2 months. AHer 4 years
Slide 27: DARRT-1 Prostate Cancer: Data Read-outs
Veyonda® DARRT-1 Prostate Cancer: Data Read-outs For personal use only 9 DARRT Cohorts 1, 2 and 3 Cohorts 1, 2 and 3 Cohort 4 6- & 12-week assessments 24-week assessments 12-week assessments End Q1 End of Dec 2018 2019 Q2 2019 Company planning to report 6-week and interim 12- and 24-weeks data from
Slide 28: DARRT: Broad Potential Utility In Solid Tumors
Veyonda® DARRT: Broad PotenIal UIlity In Solid Tumors For personal use only DARRT PROGRAM STRATEGY 2018/2019 DARRT DARRT-1 DARRT-2 DARRT-3 DARRT-4 Prostate cancer Lung cancer Sarcomas Brain cancer (GBM) (current) Q1 2019 Q1 2019 Q3 2019 26
Slide 29: Endocyte's Lutetium-PSMA-617
Endocyte’s Lutetium-PSMA-617 Veyonda® For personal use only 9 Targeted Brachytherapy for Prostate Cancer LuPIN PSMA-617 is a pep2de that recognizes and targets prostate specific membrane an2gen (PSMA). 85-90% cases pf prostate cancer are PSMA +ve Lu-PSMA-617 links radioac2ve lute2um isotope to PSMA-
Slide 30: NVS-ECYT Deal Shows Growing Interest in Targeted Radiotherapy
NVS-ECYT Deal Shows Growing Interest in Targeted For personal use only Radiotherapy and Lu-PSMA Novar(s pending acquisi(on of EndoCyte for $2.1 billion Provides Novar(s access to 177 Lu-PSMA-617 (Lu-PSMA) currently being evaluated by Endocyte in a Phase 3 Significant posi-ve poten-al registra(onal st
Slide 31: LuPIN: Phase 1b investigator-initiated dose finding study
LuPIN: Phase 1b inves5gator-ini5ated dose finding study evalua5ng Veyonda® For personal use only the safety and efficacy of Veyonda® in combina5on with Lu-PSMA-617 9 LuPIN in men with advanced, metasta5c prostate cancer Ra&onale: That combining Veyonda® with Lu-PSMA-617 will: • Boost the cancer cell-ki
Slide 32: LuPIN-1 Study Design
LuPIN-1 Study Design Veyonda® For personal use only LuPIN Enrollment: Late-stage prostate cancer -metasta3c castrate-resistant disease Trial Design: 6 x 6-weekly IV injec3ons of 177Lute3um-PSMA-617 + 10 days Veyonda® with each injec3on Two dosing cohorts: 8 pa3ents 400 mg Veyonda®; 24 pa3ents 800 mg
Slide 33: Non-Oncology Pipeline
Non-Oncology Pipeline For personal use only PRECLINICAL PHASE 1 PHASE 2 ONCOLOGY Veyonda® Chemo-enhancement Veyonda® Radio-enhancement DARRT Veyonda® Radio-enhancement LuPIN NON-ONCOLOGY NYX-330 LDL Lowering NYX-104 Neuro-protecHon NYX-205 Peripheral neuropathies 31
Slide 34: Three first-in-class drug candidates aiming to meet significant unmet medical needs
Three first-in-class drug candidates aiming to meet significant For personal use only unmet medical needs NYX-104 NYX-205 NYX-330 STATUS: Lead optimization Lead confirmed Lead op/miza/on First-in-class neuro-protectant First-in-class anti-inflammatory First-in-class small molecule PCSK9 for peripheral
Slide 35: Expected Upcoming Milestones
Expected Upcoming Milestones For personal use only Dec 2018 DARRT 12-week assessments (Cohorts 1,2,3) 1Q 2019 DARRT 24-week assessments (Cohorts 1,2,3) 1Q 2019 Initiation of DARRT-2 (lung cancer) 1Q 2019 DARRT 12-week assessment (Cohort 4) 1Q 2019 Completion of LuPIN-1 enrollment 1Q 2019 Commence pl
Slide 36: Experienced Leadership Team
Experienced Leadership Team For personal use only Executive Title Prior Experience Novogen, Marshall Graham Kelly, PhD Founder and CEO Edwards Inc (MEIP) Greg van Wyk, MD Chief Medical Officer Eli Lilly Chief Scientific Officer John Wilkinson PhD Biotron (Oncology) Chief Scientific Officer James Bon
Slide 37: Key metrics
Key metrics For personal use only 24 Number of Shares 121.9M : Free float 66.8% Market Cap (1 Nov 2018) AU$73M CEO IPO price 20 cents Directors 12 month high/low $1.80/0.48 Other founders8 Others Average daily turnover $0.54M Cash position AU$ 9.6 (30 Sept 2018) 35
Slide 38: Dr. Graham Kelly, Chief Executive Officer
For personal use only Dr. Graham Kelly Chief Executive Officer graham.kelly@noxopharm.com DISCOVER DEVELOP DELIVER ASX: NOX 36