Noxopharm Ltd. · ASX:NOX
Noxopharm — Investor Presentation (June 2019)
25 slides from Noxopharm's investor presentation, Jun 6, 2019
Slide 1: Noxopharm Corporate Presentation June 2019
Date: June 6, 2019 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 and NOXOPHARM CORPORATE PRESENTATION Operational Office: Suite 3, Level 4 828 Pacific Highway June 2019 Gordon NSW 2072 Australia SY
Slide 2: About Noxopharm and Forward Looking Statements
About CEP The Company’s CEP Program (Chemotherapy Enhancement Program) is testing the ability of Veyonda to restore sensitivity of cancer cells to carboplatin in patients whose late-stage cancers have stopped responding to chemotherapy, and to do that to the extent that the dosage of carboplatin ca
Slide 3: Noxopharm Limited Veyonda
For personal use only June 2019 Noxopharm Limited Veyonda® DISCOVER DEVELOP DELIVER ASX: NOX © 2019 Noxopharm Ltd. All rights reserved.
Slide 4: Disclaimer
Disclaimer 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 securities in the NOX will b
Slide 5: Metastatic disease challenges
Metastatic disease typically involves multiple tumors including Ø A primary tumor Ø A number of visible (on scanning) secondary tumors, and Ø Multiple less visible secondaries (micro-metastases) For personal use only The challenges in the treatment of metastatic disease are: Ø Extensive tumor load Ø
Slide 6: History of Veyonda and the active ingredient idronoxil
History of Veyonda® and the active ingredient idronoxil (IDX) For personal use only 1999 2000 ENOX2 target identified Inhibitory effect on pro- 2000 1994 survival signaling via S-1-P Enters clinical program as Purdue Uni identified intravenous dosage form Idronoxil (IDX) discovered and pan-anticance
Slide 7: Veyonda
Veyonda® Active ingredient IDRONOXIL (IDX) For personal use only Ø Oral and IV formulations previously known as phenoxodiol Ø Over 20 years of pre-clinical and clinical research Ø 61 PubMed publications Minimized Cmax peak while keeping a therapeutic concentration for >12 hours to allow for twice-da
Slide 8: Veyonda - First in Class
Veyonda® - First in Class Ø Inhibitor of pro-survival mechanisms in cancer cells Ø Activator of STING mechanisms For personal use only No known off-target TARGET: Ecto-NADH oxidase disulfide-thiol exchanger Type 2 (ENOX2) activity in most body Human genome has two genes (ENOX1 and ENOX2) controlling
Slide 9: Veyonda - First in Class
Veyonda® - First in Class Ø Inhibitor of pro-survival mechanisms in cancer cells Ø Activator of STING mechanisms For personal use only TARGET: Ecto-NADH oxidase disulfide-thiol exchanger Type 2 (ENOX2) Human genome has two genes (ENOX1 and ENOX2) controlling expression of externally-located enzyme (
Slide 10: Veyonda - First in Class
Veyonda® - First in Class Ø Inhibitor of pro-survival mechanisms in cancer cells Ø Activator of STING mechanisms For personal use only Multiple anti-cancer biologies able to attack metastatic disease Monotherapy effect: Ø Cytostasis Ø Cytotoxicity Chemo-enhancing effect: Ø Inhibit DNA repair Ø Inhib
Slide 11: Safety of Veyonda and IDX in >400 Patients
Safety of Veyonda® and IDX in >400 Pa_ents Authors/Study/SAS Formulation Combination Patients Cancer type(s) Safety related to Veyonda®/idronoxil/phenoxodiol (N) Howes, 2011 IV M 6 Breast, prostate No AEs For personal use only De Souza, 2006 IV M 21 Various solid TUs Lymphocytopenia (Gr3 n=9); hyper
Slide 12: Veyonda - Clinical Program
Veyonda® - Clinical Program Ø Inhibitor of pro-survival mechanisms in cancer cells * Ø Activator of STING mechanisms For personal use only Multiple anti-cancer biologies able to offer 4 ways to attack metastatic disease CEP Chemo-enhancement effect: Chemo-Enhancement Program - Inhibit DNA repair - I
Slide 13: CEP: Chemo-Enhancement Program
CEP For personal use only CEP: Chemo-Enhancement Program Chemo-Enhancement Program Noxopharm is pursuing a combination of Veyonda® + cytotoxic chemotherapy as a treatment for late-stage metastatic disease burden because: Ø Chemotherapy is the mainstay treatment of most forms of cancer1 Ø Off-target
Slide 14: CEP-1: Chemo-Enhancement Program
CEP 1 For personal use only CEP-1: Chemo-Enhancement Program Chemo-Enhancement Program CEP-1 Phase 1b Study (Completed) Ø Open label study; 19 patients with end-stage solid cancers (breast, lung, prostate, ovarian) Ø Dose-finding (400 mg/800 mg Veyonda®) with low-dose carboplatin Assessment Count Pa
Slide 15: DARRT: Radio-Enhancement Program
DARRT DARRT: Radio-Enhancement Program Direct and Abscopal Response to Radiotherapy Rationale: Single course of Veyonda® + palliative external beam RT to a For personal use only single lesion Ø DNA repair inhibition boosts effect of RT on irradiated lesion Ø STING agonist effect produces anti-cancer
Slide 16: DARRT: Radio-enhancement Program
1 DARRT DARRT: Radio-enhancement Program Direct and Abscopal Response to Radiotherapy DARRT-1 Phase 1b Study (Current) For personal use only Ø Open label study; 24 patients with mCRPC post-taxane and abiraterone/enzalutamide Ø Treatment regimen = 10 days Veyonda®: palliative EBRT (20-25 Gy) in 5 fra
Slide 17: LuPIN: Radio-enhancement Program
LuPIN LuPIN: Radio-enhancement Program Lutetium-PSMA in Combination with NOX66 Ra_onale: To boost effec_veness of most radiopharmaceu_cals which is limited For personal use only by degree of expression of target receptor on cancer cells via ØDNA repair inhibieon to boost DNA-damaging effect of isotope
Slide 18: LuPIN interim data PSA response by Veyonda dose
LuPIN For personal use only LuPIN: Radio-enhancement Program Lutetium-PSMA in Combination with NOX66 1 Interim data PSA response by Veyonda® dose First 16 subjects: 8 Ø All of whom have received ≥ 2 doses of Number of patients 177Lu-PSMA-617 6 Ø 4/16 have already completed the planned 4 6 cycles 75.
Slide 19: Clinical Strategy
Clinical Strategy Ø Considered likely quickest way to achieve NDA Ø Select cancer type with poor therapeuec opeons (e.g. CEP sarcomas) For personal use only Ø Opportunity for Accelerated Approval, Orphan Drug Chemo-Enhancement Program designaeon, Pediatric Review Voucher Ø Timetable: Commence Phase
Slide 20: CEP-2: Chemo-enhancement Program
CEP 2 CEP-2: Chemo-enhancement Program Chemo-Enhancement Program Phase 1b, open label; Veyonda® + doxorubicin; metastatic soft tissue For personal use only sarcomas Ø Design: Dose escalation and dose expansion study ― Dose escalation: 400, 600, 800, 1200, 1800 mg Veyonda® (up to 30 patients) ― Dose
Slide 21: Intellectual Property
Intellectual Property For personal use only Ø Family of 5 PCT patents; final specifications lodged with USPO in 2017 Ø Based on LIPROSE drug delivery technology involving proprietary suppository formulation Ø Key claims relate to protection of IDX from Phase 2 metabolism and sustained half-life Ø Ot
Slide 22: Multiple anticipated milestones
Multiple anticipated milestones For personal use only TIMING STUDY MILESTONE 3Q 19 CEP-2 File IND CEP 4Q 19 CEP-2 Initiate study 3Q19 DARRT-1 Data: Interim results DARRT 4Q 19 DARRT-1 Data: Interim results 1Q 20 DARRT-1 Data: Interim results 3Q 19 LuPIN-1 Data: Interim results LuPIN 2Q 20 LuPIN-1 Da
Slide 23: Senior Management
Senior Management For personal use only Graham Kelly Executive Chairman BSc, BVSc, PhD Graham has 25 years’ experience in founding and leading biotech companies. He founded Novogen Ltd (ASX:NRT. NASDAQ: NVGN)(now Kazia Therapeutics, KZA) in 1994; Marshall Edwards Inc (NASDAQ:MEI) (now MEI Pharma, ME
Slide 24: Key Metrics
Key Metrics For personal use only Number of Shares 121,902,310 shares outstanding Free float 66.8% 25,282,956 options (expiring 2020-22) Market Cap (13 March AU$74M 2019) IPO price 20 cents 12 month high/low $1.64/0.36 Cash position • AU$ 6.2M (31 March 2019) • AU$4M anticipated July 2019 (Aust CEO
Slide 25: Noxopharm Limited Veyonda
For personal use only May 2019 Noxopharm Limited Veyonda® DISCOVER DEVELOP DELIVER ASX: NOX © 2019 Noxopharm Ltd. All rights reserved.