Noxopharm Ltd. · ASX:NOX
Noxopharm — Shareholder Meeting (November 2019)
54 slides from Noxopharm's shareholder meeting presentation, Nov 20, 2019
Slide 1: Noxopharm 2019 Annual General Meeting Corporate Presentations
Date: 20 November 2019 Sydney, Australia For personal use only ASX Limited 20 Bridge Street SYDNEY NSW 2000 Noxopharm 2019 Annual General Meeting Corporate Presentations Sydney, 20 November 2019: Noxopharm (ASX: NOX) is pleased to provide shareholders and the market generally the corporate presentat
Slide 2: Forward Looking Statements
Media Contact USA: Frank de Maria For personal use only Purposeful Communications T: +1 347 647 0284 E: frank.demaria@purposefulcommunications.com Forward Looking Statements This announcement may contain forward-looking statements. You can identify these statements by the fact they use words such as
Slide 3: Noxopharm Limited AGM Presentation
20 November 2019 For personal use only Noxopharm Limited AGM PresentaEon 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 For personal u
Slide 5: Agenda
AGENDA For personal use only 1. What we see as our future Graham Kelly CEO/Exec Chairman 2. Turning Veyonda® into a reality Gisela Mautner CMO 3. How we intend to pay for the reality Alex Hunter CCO © 2019 Noxopharm Ltd. All rights reserved.
Slide 6: Corporate Overview
For personal use only Corporate Overview © 2019 Noxopharm Ltd. All rights reserved.
Slide 7: Veyonda (idronoxil): A sphingosine-1-phosphate inhibitor
For personal use only Veyonda® (idronoxil) A sphingosine-1-phosphate inhibitor v First in class v Selective for cancer cells …. that we see having the poten<al to become a commonly-used an<-cancer drug within a few years © 2019 Noxopharm Ltd. All rights reserved.
Slide 8: Sphingosine-1-phosphate (S1P) story
sphingosine-1-phosphate (S1P) story S1P is a vital pro- For personal use only survival factor S1P exits cell in order produced in the cell to activate 5x S1P membrane of all cells receptors on external cell surface S1P1 S1P2 S1P3 S1P4 S1P5 Promote: • cell survival • cell growth • cell migra<on • cel
Slide 9: S1P – major driver of cancer cell misbehaviour
S1P – major driver of cancer cell misbehaviour S1P is over- For personal use only expressed All five S1P receptors by most cancer over-ac<vated cells Cancer • Increased growth • Increased migra<on S1P1 S1P2 S1P3 S1P4 S1P5 Cancer • Resistance to chemotherapy • Resistance to radiotherapy Cancer • Reduc
Slide 10: Idronoxil blocks S1P production in cancer cells
Idronoxil blocks S1P production in cancer cells S1P is over- For personal use only expressed All five S1P receptors by most cancer over-activated cells Cancer • less growth • Less migration S1P1 S1P2 S1P3 S1P4 S1P5 Cancer Less resistant to • chemotherapy • Less resistant to radiotherapy Cancer • Inc
Slide 11: Veyonda first-in-class S1P inhibitor
For personal use only Veyonda® first-in-class S1P inhibitor Distinct from any other S1P inhibitor in that inhibitory effect is on an oncogene upstream of S1P Only inhibits S1P in cancer cells and some high turn- over cells Well-tolerated S1P inhibitor © 2019 Noxopharm Ltd. All rights reserved.
Slide 12: Providing Veyonda with potential methods of use
Providing Veyonda® with 3 potenEal methods of use For personal use only Monotherapy 1 • Slow cancer growth • Slow cancer spread Combination therapy S1P1 S1P2 S1P3 S1P4 S1P5 • Increase response to chemotherapy 2 • Increase response to radiotherapy Immunotherapy • Combine with radiotherapy 3 or i-0 dr
Slide 13: Determining the most assured path to market for Veyonda
With multiple options for use, Years 1-3 have been about determining most assured path to market for Veyonda® For personal use only On its own? With chemotherapy? Which I-O drug? Which Which cancer cancer type? stage? Which chemotherapy? Compe<tors? Regulatory landscape? With I-O drug? With external
Slide 14: Clinical Development Program
For personal use only Clinical Development * Program © 2019 Noxopharm Ltd. All rights reserved.
Slide 15: Veyonda path to market now set
YEAR 4 …… Veyonda® path to market now set For personal use only DARRT and mCRPC Combination therapy Monotherapy Immunotherapy radiotherapy 1. Repeat Rx cycles to 2. Combine with 3. Increase sEmulatory effect of block cancer growth radiotherapy to boost radiaEon on immune acEvity number of cancer cell
Slide 16: Selection of DARRT
Selection of DARRT based on …… For personal use only • Posi<ve clinical signals in DARRT-1 • Absence of disease progression at 6-months in >50% of men sugges<ve of ability to achieve OS outcome • No safety issues observed • Advice of Company’s U.S. Prostate Cancer Med Advisory Board • Large unmet ne
Slide 17: Veyonda - Clinical Program
Veyonda® - Clinical Program * For personal use only Clinical development priorities Priority Indication ObjecEve 10 DARRT-2 Late-stage mCRPC Path to NDA 20 LuPIN Late-stage mCRPC Potential strategic alliance 30 CEP-2 Soft tissue sarcomas + DOX Orphan drug grant 40 IONIC-1 NSCLC non-responding to i-o
Slide 18: Veyonda - Clinical Program: LuPIN
Veyonda® - Clinical Program * For personal use only 20 LuPIN • 56-man Phase study St Vincent’s Hospital, Sydney - Garvan Inst of Med Res - Kinghorn Cancer Centre • NOX66 + 177Lu-PSMA -617 • Full recruitment expected end-2019 • Final read-out Q1 2021 • Compassionate use scheme • Providing valuable si
Slide 19: Clinical Timetable 2020-2021
Clinical Emetable 2020-2021 * For personal use only 2020 Jan-Dec 2021 Jan-Dec DARRT-2 P R I LuPIN O R I T IONIC-1 Y CEP-2 © 2019 Noxopharm Ltd. All rights reserved.
Slide 20: Drug Pipeline Program
For personal use only Drug Pipeline Program © 2019 Noxopharm Ltd. All rights reserved.
Slide 21: Pipeline Program
Pipeline Program For personal use only Build Company value IndicaEon Glutamate receptor Glioblastoma mul<forme inhibitor NOX66 Nasopharyneal cancer Cancer stem cell Various cancers cytotoxic IRAK4 inhibitor Various cancers © 2019 Noxopharm Ltd. All rights reserved.
Slide 22: Pipeline Program: Glutamate receptor inhibitor
Pipeline Program Glutamate receptor inhibitor For personal use only GBM cancer cells form GBM does not grow in connec<ons with neurons the brain in isolation Glutamate neurotransmitter drives growth of GBM cells Aim is to be first In-licence existing glutamate-inhibitor in Developing world-first gluta
Slide 23: NOX66 for nasopharyngeal cancer
Pipeline Program NOX66 for nasopharyngeal cancer For personal use only • Incidence 25x rest of world • Responsible for 18% of cancers in Southern China • Associated with EBV infec<on Cancer upper throat/back of nasal cavity High incidence in ethnic Chinese in southern China and SE Asia © 2019 Noxoph
Slide 24: NOX66 for nasopharyngeal cancer
Pipeline Program NOX66 for nasopharyngeal cancer For personal use only • Collabora<on with Hong Kong University (NPC KOL) • Recently awarded $50,000 bridging grant from Australian Academy of Technology and Science • Idronoxil highly ac<ve against NPC cells in vitro. New study to determine role of NO
Slide 25: Commercial and Financial Perspective
For personal use only Commercial and Financial Perspective Alex Hunter, Chief Commercial Officer © 2019 Noxopharm Ltd. All rights reserved.
Slide 26: Commercial & financial perspective
Commercial & financial perspective For personal use only My key focus as Chief Commercial Officer is to work with Noxopharm’s highly experienced scien<fic and management team to: Finesse commercial Ø ensure Noxopharm has the necessary commercial structure structure and business systems and business sys
Slide 27: Next nine months
Next nine months For personal use only Next nine months cri<cal focus: Business readiness Ø Work with NOX management team to prepare business for for clinical plan optimal implementation of clinical development plan implementaHon Profile raising Ø Undertake investor roadshows in Australia & USA to ra
Slide 28: Beyond nine months
Beyond nine months For personal use only Beyond nine months critical focus: Finalise DARRT 2 Ø Finalise DARRT 2 clinical plan in prepara<on for clinical plan submission of applica<ons Enter commercial Ø Enter mul<tude of commercial agreements required agreements & to implement DARRT 2 contacts Submi
Slide 29: Noxopharm Limited AGM Presentation
20 November 2019 For personal use only Noxopharm Limited AGM PresentaEon DISCOVER DEVELOP DELIVER ASX: NOX © 2019 Noxopharm Ltd. All rights reserved.
Slide 30: Noxopharm AGM, November 2019 in Sydney
For personal use only Noxopharm AGM, 20 November 2019 in Sydney www.noxopharm.com Veyonda® DISCOVER DEVELOP DELIVER ASX: NOX © 2019 Noxopharm Ltd. All rights reserved.
Slide 31: 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 32: Did you know?
Did you know? EACH DAY For personal use only in Australia 50 MEN are diagnosed with PROSTATE CANCER © 2019 Noxopharm Ltd. All rights reserved.
Slide 33: For personal use only
For personal use only 1 in 5 men develop prostate cancer before they turn 85 © 2019 Noxopharm Ltd. All rights reserved.
Slide 34: Prostate Cancer – four main stages
Prostate Cancer – four main stages For personal use only Stage I Stage II The cancer is small and confined to the The cancer is still confined to the prostate but is large prostate. enough to be detected by physical examination. Stage III Stage IV The cancer has spread beyond the prostate into The c
Slide 35: Prostate Cancer Therapy
Prostate Cancer Therapy For personal use only © 2019 Noxopharm Ltd. All rights reserved.
Slide 36: Prostate Cancer Therapy – Side Effects
Prostate Cancer Therapy – Side Effects For personal use only © 2019 Noxopharm Ltd. All rights reserved.
Slide 37: Our Goal is to Revolutionise Cancer Therapy
Our Goal is to Revolutionise Cancer Therapy For personal use only © 2019 Noxopharm Ltd. All rights reserved.
Slide 38: Prostate Cancer and Treatment Options
Prostate Cancer and Treatment Options use only Course of Disease and Treatment Journey for Stage I - IV Prostate Cancer Surgery Chemical Androgen Palliative therapy Chemo- and/or local castration & receptor Rising PSA levels in blood therapy radiotherapy therapy inhibitors For personal DARRT-1 Hormo
Slide 39: Veyonda – Clinical Study DARRT-1
1 Veyonda® – Clinical Study DARRT-1 For personal use only ➢ 26 men enrolled with late-stage prostate cancer ➢ Metastatic castration-resistant prostate cancer (mCRPC) ➢ Progressive disease ➢ No remaining standard treatment options ➢ Eligible for palliative RT for symptomatic relief ➢ Treatment with l
Slide 40: DARRT-1: Study Design
11 DARRT-1: Study Design1 ➢ Phase 1b, open label, non-randomised study of NOX66 in combination with For personal use only palliative radiotherapy in patients with mCRPC Cohort 1 (n=4) Primary Endpoints NOX66 400 mg on Days 1-16 • Safety (TEAEs, laboratory + radiation on Days 2-9 results, ECG) PATIEN
Slide 41: DARRT-1: Interim Data
11 DARRT-1: Interim Data ➢ Veyonda® in combination with radiation therapy For personal use only appeared to be well-tolerated1 ➢ In the 22* patients who were evaluable at 3 months1 * 4 patients lost to follow-up DARRT = Direct and Abscopal Response to RadioTherapy; PSA = prostate specific antigen 1.
Slide 42: DARRT-1: Interim Data
11 DARRT-1: Interim Data ➢ Veyonda® in combination with radiation therapy For personal use only appeared to be well-tolerated1 ➢ In the 22* patients who were evaluable at 3 months1 ―The PSA levels fell in 7 patients (7/22 patients achieved >50% reduction in PSA at 3 months) * 4 patients lost to foll
Slide 43: DARRT-1: Interim Data
11 DARRT-1: Interim Data ➢ Veyonda® in combination with radiation therapy For personal use only appeared to be well-tolerated1 ➢ In the 22* patients who were evaluable at 3 months1 ―The PSA levels fell in 7 patients (7/22 patients achieved >50% reduction in PSA at 3 months) ―The Pain levels fell in
Slide 44: DARRT-1: Interim Data
11 DARRT-1: Interim Data ➢ Veyonda® in combination with radiation therapy For personal use only appeared to be well-tolerated1 ➢ In the 22* patients who were evaluable at 3 months1 ―The PSA levels fell in 7 patients (7/22 patients achieved >50% reduction in PSA at 3 months) ―The Pain levels fell in
Slide 45: DARRT-2 – In Planning
2 DARRT-2 – In Planning For personal use only Late-stage Prostate Cancer, symptomatic lesion Randomisation Low-dose RT Low-dose RT + + Placebo NOX66 1200 mg Treatment: Up to 6 cycles of NOX66 © 2019 Noxopharm Ltd. All rights reserved.
Slide 46: For personal use only
For personal use only © 2019 Noxopharm Ltd. All rights reserved.
Slide 47: Sarcoma – Two main Types
Sarcoma – Two main Types For personal use only © 2019 Noxopharm Ltd. All rights reserved.
Slide 48: For personal use only
For personal use only © 2019 Noxopharm Ltd. All rights reserved.
Slide 49: Synovial Sarcoma
Synovial Sarcoma For personal use only © 2019 Noxopharm Ltd. All rights reserved.
Slide 50: Sarcomas
Sarcomas For personal use only ➢ A heterogeneous group of malignant tumours in connective tissue such as bone, cartilage, muscle, fat, blood vessel and lymphoid tissue ➢ Divided into two major groups: Osteosarcomas (bone sarcomas) and Soft Tissue Sarcomas – each have multiple subtypes ➢ Two thirds o
Slide 51: FDA – Orphan Drug Designation
FDA – Orphan Drug Designation For personal use only ➢ Seven-year exclusivity ➢ Protocol assistance by FDA ➢ Tax credits of 50% of the clinical drug testing cost ➢ Research grants awarded by FDA ➢ Waiver of NDA application fee © 2019 Noxopharm Ltd. All rights reserved.
Slide 52: Veyonda - Clinical Program
Veyonda® - Clinical Program For personal use only In preparation Ongoing Completed Become standard Veyonda® + EBRT1 in mCRPC2 DARRT-1 of care adjunct to radiotherapy Veyonda® + 177Lutetium-PSMA-6173 in mCRPC2 LuPIN in prostate Veyonda® + EBRT1 in cancer DARRT-2 mCRPC (phase II/III) Combined with Vey
Slide 53: Drug Development Process
Drug Development Process For personal use only © 2019 Noxopharm Ltd. All rights reserved.
Slide 54: For further information please visit www.noxopharm.com
For personal use only For further information please visit www.noxopharm.com Veyonda® DISCOVER DEVELOP DELIVER ASX: NOX © 2019 Noxopharm Ltd. All rights reserved.