Noxopharm Ltd. · ASX:NOX
Noxopharm — Investor Presentation (August 2019)
41 slides from Noxopharm's investor presentation, Aug 7, 2019
Slide 1: Noxopharm August 2019 Corporate Presentation
Date: 7 August 2019 Sydney, Australia ASX Limited 20 Bridge Street SYDNEY NSW 2000 NOXOPHARM AUGUST 2019 CORPORATE PRESENTATION • Current clinical programs and therapeutic indications strategy remain ongoing • Primary focus on use of Veyonda® and radiotherapy as first-in-class treatments for late-st
Slide 2: Investor & Corporate Enquiries; Forward Looking Statements
Investor & Corporate Enquiries: Company Secretary: Prue Kelly David Franks M: 0459 022 445 T: +61 2 9299 9690 E: info@noxopharm.com E: David.Franks@automicgroup.com.au Media Contact: Frank de Maria Purposeful Communications T: +1 347 647 0284 E: frank.demaria@purposefulcommunications.com Forward Loo
Slide 3: Noxopharm Limited Roadshow Presentation
August 2019 Noxopharm Limited Roadshow PresentaDon DISCOVER DEVELOP DELIVER ASX: NOX © 2019 Noxopharm Ltd. All rights reserved.
Slide 4: Disclaimer
Disclaimer This presenta<on has been prepared by Noxopharm Limited (NOX or the Company). It should not be considered as an offer or invita<on 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<es in the NOX will be en
Slide 5: Our Vision for Veyonda
OUR VISION for Veyonda® A first-in-class, dual-acting cytotoxic and immuno- oncology molecule in a novel proprietary formulation Putting cGAS-STING into the Tale we believe that Veyonda ® has the poten<al to transform the survival and quality of life for a high propor<on of cancer pa<ents © 2019 Nox
Slide 6: Relevance of STING
Relevance of STING …….. Why the pharmaceu<cal industry has STING in their sights There are many different approaches to killing cancer cells, but one of the most recent ones is also one of the most elegant and rational ones: killing cancer cells with our own immune cells! An immune technology known
Slide 7: STING: Converting COLD tumours into HOT tumours
Relevance of STING …….. Why the pharmaceu<cal industry has STING in their sights The proposed soluDon…… Conver<ng COLD tumours into HOT tumours In the case of the current i-o (checkpoint-inhibi<ng drugs), this conversion has been predicted to substan<ally boost their current US$15 billion p.a. sales
Slide 8: Switching STING back on
Relevance of STING …….. Why the pharmaceutical industry has STING in their sights STING (SDmulaDon of Interferon Genes) is a fundamental first-line defense mechanism designed to eliminate cancer cells STING involves the detecDon by the compound cGAS of damaged DNA in the cell’s cytoplasm, a hallmark
Slide 9: Relevance of STING: STING agonists
Relevance of STING …….. Why the pharmaceutical industry has STING in their sights MulDple companies are working in the field of STING triggering (STING agonists) Their efforts are based on acDvaDng STING through the introducDon of foreign DNA into the cancer cells. This is done with bacterial or viral
Slide 10: Veyonda®
Veyonda® (previously known as NOX66; suppository dosage form of idronoxil (IDX)) A first-in-class cGAS-STING modulating agent IDX switches STING on! It amplifies STING where it already exists © 2019 Noxopharm Ltd. All rights reserved.
Slide 11: Competitive advantages
Veyonda® Ac3ve ingredient idronoxil (IDX) CompeDDve advantages IDX does not trigger STING. It amplifies STING where it already exists IDX relies on the presence of ‘self DNA’ to amplify STING, not on foreign DNA, thereby limiting its effect to cancer cells IDX is not a bacterial or viral cyclic nucl
Slide 12: Contents; Strategic priorities
Contents Strategic prioriDes 1. Establish Veyonda® as an essen<al adjunct to radiotherapy in the treatment of prostate cancer. 2. Broaden the clinical value of Veyonda® by improving outcomes in sarcoma and increasing response-rates with immuno-oncology agents 1 1. Clinical Program In progressing tow
Slide 13: Veyonda Clinical Development Program Summary
1 Veyonda® Clinical Development * Program Summary © 2019 Noxopharm Ltd. All rights reserved.
Slide 14: Impact of IDX-STING discovery on Veyonda development strategy
Impact of IDX-STING discovery on Veyonda® development strategy DARRT, LuPIN and CEP programs to remain on-track STING amplifica3on now considered a key mechanism of ac3on in the DARRT program. Radiotherapy also known to ac3vate STING, with Veyonda® now believed to be boos3ng this effect to yield the a
Slide 15: Veyonda - Clinical Program
1 Veyonda® - Clinical Program * Unique 4-way development program 4-way use of a STING agonist to a_ack metastaDc disease CEP Chemo-enhancement: Chemo-Enhancement Program Soj Dssue sarcoma: Veyonda + doxorubicin DARRT Radio-enhancement: Direct and Abscopal Response to Radiotherapy Prostate Cancer: Ve
Slide 16: Veyonda - Clinical Program Strategy
1 Veyonda® - Clinical Program * STRATEGY CEP • Demonstrate the value of Veyonda by improving outcomes in under-served cancers e.g. Sarcoma Chemo-Enhancement Program • Likely quickest way to achieve NDA (2025/26) • Prostate cancer is large market opportunity DARRT • PotenDal future use in early-stage
Slide 17: DARRT-1 DARRT-2
2 DARRT-1 DARRT-2 © 2019 Noxopharm Ltd. All rights reserved.
Slide 18: DARRT-1 (Current)
DARRT 2 Direct and Abscopal Response to Radiotherapy DARRT-1 (Current) Ø Late-stage mCRPC ; no remaining approved Rx op<ons Ø Progressive disease; post-taxane; post-androgen-abla<on; eligible for pallia<ve RT for symptoma<c relief Ø DARRT Regimen: Single course of pallia<ve (20-25 Gy) EBRT to a sing
Slide 19: DARRT-1 (Cont)
1 DARRT 2 Direct and Abscopal Response to Radiotherapy DARRT-1 (Cont) 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 fractionated doses to a single lesion ― Dose escalation arm: 12 patients:
Slide 20: DARRT-2 (planned)
1 DARRT 2 Direct and Abscopal Response to Radiotherapy DARRT-2 (planned) Ø Prostate Cancer Ø Double-blind, randomized, controlled trial Ø Phase 2 with possible Phase 3 adaptaDon Ø Veyonda plus radiotherapy Ø Repeat courses of 1200 mg Veyonda® daily/7 days each month for 6 months Ø Expected commencem
Slide 21: LuPIN
2 LuPIN © 2019 Noxopharm Ltd. All rights reserved.
Slide 22: LuPIN
2 LuPIN 177Lutetium-PSMA-617 is a radiopharmaceutical comprising the radionuclide177lutetium (a beta emitter) attached to the monoclonal antibody peptide (617) against the prostate surface membrane antigen (PSMA). Enabling the access of a low dose of radiation to all prostate cancer cells within the
Slide 23: LuPIN Aim and Rationale
2 LuPIN AIM To show that Veyonda® boosts the efficacy of radiopharmaceuDcal treatment which is limited by the degree of expression of the target receptor on cancer cells RATIONALE To do so through v DNA repair inhibi<on to boost DNA-damaging effect of isotope on cancer cell v STING agonist effect to s<m
Slide 24: LuPIN-1 (Current)
2 LuPIN LuPIN-1 (Current) InvesDgator-iniDated, open-label, Phase 1 study to determine if Veyonda® increases the response to 177Lu-PSMA-617 in men with mCRPC1 PATIENTS* (N=56) Endpoints Cohort 1 (n=8) • mCRPC previously treated with Veyonda® 400mg abiraterone and/or • Toxicity (primary) enzalutamide
Slide 25: LuPIN-1 Interim Safety data
2 LuPIN LuPIN-1 (Current) Interim Safety data on first 16 patients1 ➢ All 16 patients received at least 2 doses; 4 (25%) patients received 6 cycles ➢ Treatment was well tolerated; 1 patient (6.3%) reported an SAE due to pneumonitis and continued on trial without Veyonda® AEs ≥ Grade 2, n (%) Cohort
Slide 26: LuPIN-1 Interim Efficacy data
2 LuPIN LuPIN-1 (Current) Interim Efficacy data on first 16 patients PSA% response by Veyonda® dose First 16 subjects: 8 ✓ All of whom have received ≥ 2 doses of 177Lu- Number of paDents 6 PSMA-617 ✓ 4/16 have already completed the planned 6 cycles 4 75.0% ✓ Pa<ents 1-8 received 400 mg of Veyonda® 6
Slide 27: CEP-1 CEP-2
3 CEP-1 CEP-2 © 2019 Noxopharm Ltd. All rights reserved.
Slide 28: Why Chemo-Enhancement?
3 CEP Chemo-Enhancement Program Why Chemo-Enhancement? Because: Chemotherapy remains the mainstay treatment of most types of cancer in all stages of the disease1 However, toxicity and the development of drug resistance make chemotherapy less practical and less attractive in late-stage disease1,2 IDX
Slide 29: CEP-1 (Completed)
1 3 CEP CEP-1 (Completed) Chemo-Enhancement Program Phase 1, open label, first in human study of Veyonda® in combination with carboplatin in heavily pre-treated patients with end-stage metastatic disease N=19: multiple tumour types: breast, prostate, lung, ovarian ● Locally or metasta<c advanced sol
Slide 30: CEP-1 (Completed) Results
1 CEP 3 Chemo-Enhancement Program CEP-1 (Completed) Dose cohort Assessment Count Partial Stable Progressive time point* (n) response disease disease Cohort 1 Cycle 3 5 0 (0.0) 4 (80.0) 1 (20.0) Veyonda® 400mg, Cycle 6 2 0 (0.0) 1 (50.0) 1 (50.0) n (%) Cohort 2 Cycle 3 9 0 (0.0) 7 (77.8) 2 (22.2) Vey
Slide 31: CEP-2 (Proposed)
CEP 3 Chemo-Enhancement Program CEP-2 (Proposed) ● Soft tissue sarcomas: cancer type with poor therapeutic options ● Opportunity for Accelerated Approval, Orphan Drug designation, Pediatric Review Voucher ● Timetable: • Submit IND to FDA Q3/4 2019 • NDA grant 2025/26 assuming accelerated approval Pr
Slide 32: CEP-2 Study Design
2 CEP 3 Chemo-Enhancement Program CEP-2 (Proposed) Phase 1b, open label; Veyonda® + doxorubicin; metastatic soft tissue sarcomas ✓ Design: Dose escalation and dose expansion arms ― Dose escalation: 400, 600, 800, 1200, 1800 mg Veyonda® (6 patients per dose) ― Dose expansion: MTD Veyonda® dose (16 pa
Slide 33: Timetable and News Flow
4 - Timetable - News Flow © 2019 Noxopharm Ltd. All rights reserved.
Slide 34: Clinical Timetable 2019-2020
4 Clinical Dmetable 2019 - 2020 2019 July-Dec 2020 Jan-Dec CEP-2 DARRT-1 DARRT-2 LuPIN IONIC-1 © 2019 Noxopharm Ltd. All rights reserved.
Slide 35: Anticipated clinical news flow
4 AnDcipated clinical news flow H2 2019 H1 2020 H2 2020 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 LuPIN LuPIN LuPIN Interim data Interim data Final data CEP-2 CEP-2 IND grant Study start DARRT-1 DARRT-1 DARRT-1 DARRT-2 Interim data Interim data Final data Starts IONIC-1 Starts © 2019 Noxopharm Ltd. A
Slide 36: Cash position, Interim funding, IPO
5 - Cash posiDon - Interim funding - IPO © 2019 Noxopharm Ltd. All rights reserved.
Slide 37: Current cash position
5 Current cash posiDon Capital raisings since ASX listing August 2016 IPO AU$6.0 M Aug 2017 AU$5.5 M April 2018 AU$11.5 M TOTAL US$23.0 M Cash position at 31 July 2019 = US$6.5 M Current monthly burn rate = US$800K An<cipated Australian Govt 43% R&D cash rebate. August 2019 = US$3.6 M © 2019 Noxopha
Slide 38: Key Metrics
5 Key Metrics Number of Shares 125.6 million shares outstanding 30.5 million options (expiring 2020-22) Market Cap (3 August AU$56.6M 2019) IPO price 20 cents 12 month high/low $1.64/0.36 Cash position • AU$ 6.2M (31 July 2019) • AU$3.6M anticipated (Aust Govt R&D Rebate) CEO Directors General share
Slide 39: Our People
Our People 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, MEIP) in 2001; Noxopharm (ASX:N
Slide 40: Our People
Our People John Wilkinson Chief ScienDfic Officer BSc Hons, PhD John brings over 30 years of experience from both pharmaceu<cal and research se•ngs in Australia and the United Kingdom. His research interests include Drug Development, Virology, Oncology and Immunology, transla<ng novel laboratory finding
Slide 41: Noxopharm Limited Veyonda®
August 2019 Noxopharm Limited Veyonda® DISCOVER DEVELOP DELIVER ASX: NOX © 2019 Noxopharm Ltd. All rights reserved.