Noxopharm Ltd. · ASX:NOX
Noxopharm — Investor Presentation (March 2019)
25 slides from Noxopharm's investor presentation, Mar 5, 2019
Slide 1: New Corporate Presentation Released
Date: 5 March 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 NEW CORPORATE PRESENTATION RELEASED Operational Office: Suite 3, Level 4 828 Pacific Highway Gordon NSW 2072 SYDNEY, 5 March 201
Slide 2: Discover Develop Deliver - March 2019
March 2019 For personal use only DISCOVER DEVELOP DELIVER ASX: NOX 1 ©2019 Noxopharm
Slide 3: 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 4: We have a single objective
We have a single objective: For personal use only To make Veyonda (a radio-enhancing/immune-enhancing drug) ® a standard companion drug → for all forms of radiotherapy → across most forms of solid cancer in order to deliver → more potent and more curative responses to radiotherapy → at lower, better
Slide 5: Veyonda - A New Improved Formulation of Idronoxil
For personal use only Veyonda® - A New Improved Formulation of Idronoxil Veyonda® delivers a proprietary pro-drug form of idronoxil* that delivers continuous anti-cancer activity for 12 hours Veyonda® provides clinical benefit where earlier formulations did not Veyonda® is a convenient-to-use, self-
Slide 6: Examples of how a radio-enhancer might be used in prostate cancer
Examples of how a radio-enhancer might be used in prostate cancer For personal use only Stage of cancer Veyonda® + Radiotherapy (RT) Potential benefits Avoidance of surgery and Early-stage, operable attendant side-effects • Reduction in RT dosage to Early-stage, inoperable minimise pelvic tissue dam
Slide 7: How radiotherapy works
How radiotherapy works For personal use only High energy Cell Too much damage » particles attempts to Repair unsuccessful » damage DNA repair DNA CELL DIES damage Damaged DNA triggers release of Repair successful » interferon from neighboring CELL SURVIVES healthy cells SURVIVING CELLS killed by imm
Slide 8: How Veyonda radio-enhances
How Veyonda® radio-enhances BLOCKS DNA REPAIR MECHANISMS For personal use only Cell Repair unsuccessful attempts to CELL DIES repair DNA damage Damaged DNA triggers release of Repair successful FEWER CELLS SURVIVE CELL SURVIVES interferon from neighboring healthy cells SURVIVING CELLS more effective
Slide 9: Veyonda MoA
Veyonda® MoA For personal use only S1P is a key pro-survival secondary H+ H+ H+ Normal cell S1P messenger. S1P leaves the cell where it activates 5 different S1P receptors on the external surface ENOX of the cell S1P 1 S1P 2 S1P 3 S1P 4 S1P 5 H+ H+ S1P receptors activate wide range of pro-survival s
Slide 10: Veyonda MoA
Veyonda® MoA Cancer cell For personal use only Human cells express RNA for two Declining S1P levels deprive forms of ENOX - ENOX1 and ENOX2. S1P S1P receptors of activation ENOX2 protein only expressed on cancer cells where it dominates over ENOX2 ENOX1 S1P 1 S1P 2 S1P 3 S1P 4 S1P 5 H+ H+ H+ H+ Idro
Slide 11: Veyonda + Radiotherapy: potential use across broad range of radiotherapy practice
Veyonda® + Radiotherapy Potential use across broad range of radiotherapy practice For personal use only Externally-delivered radiotherapy Internally-delivered radiopharmaceuticals 10 ©2019 Noxopharm
Slide 12: Clinical Programs
Clinical Programs For personal use only DARRT Direct and Abscopal Response to Radio-Therapy 177Lutetium-PSMA In Combination With VeyoNda LuPIN Initial focus on late-stage prostate cancer • Metastatic, castrate-resistant disease • Post-docetaxel and abiraterone/enzalutamide • No remaining standard tr
Slide 13: DARRT: Direct and Abscopal Response to Radio-Therapy
DARRT Direct and Abscopal Response to Radio-Therapy For personal use only 1. Use of palliative (low) dose of radiation minimizes damage to innate Rationale immune cells within the irradiated lesion. 2. Veyonda® amplifies radiation-induced DNA damage in cancer cell by: • blocking cell division, there
Slide 14: DARRT study design
DARRT Direct and Abscopal Response to Radio-Therapy For personal use only Ø Patients with multiple lesions and at least 2 measurable lesions Ø Irradiate 1 lesion* (20-25 Gy in 5 fractionated doses) External Beam RT or Ø Veyonda® (600 mg bid) 10 days beginning Day -5 Stereotactic Body RT Ø Assessment
Slide 15: DARRT direct and abscopal response
DARRT Direct and Abscopal Response to Radio-Therapy For personal use only DIRECT RESPONSE ABSCOPAL RESPONSE At a minimum, Veyonda® is expected to lead to The best expected outcome would be an improved better DIRECT response to radiotherapy by DIRECT response, plus shrinkage of non-targeted lesions f
Slide 16: DARRT-1 Study
DARRT-1 Study For personal use only Details: v Phase 1b multi-national study (Australia, NZ, Georgia) v Open label, single-arm study v 24 patients; metastatic, castrate-resistant prostate cancer v Veyonda® + external beam RT to 1 lesion* v Part 1: Dose-finding (constant RT dose) § 400 mg Veyonda (4
Slide 17: DARRT-1 Study 12-week data
DARRT-1 Study For personal use only 12-week data for Part 1 patients: 400 mg 800 mg 1200mg n=4 n=4 n=4 (3 evaluable) PSA response* 0 2 2 Pain response** 2 3 2 RECIST response*** 4 SD 1 PR 3SD 2 SD 1 PD * > 50% decline ** > 30% decline *** aggregate of all measurable lesions 24-week data Part 1 patie
Slide 18: DARRT-1 Study interim conclusions
DARRT-1 Study For personal use only Interim conclusions: v Veyonda® + palliative dosages of radiotherapy well tolerated v 400 mg dose of Veyonda® sub-therapeutic v No notable difference between 800 and 1200 mg doses v In the 7 evaluable patients in the 800 and 1200 mg cohorts* • 4/7 achieved PSA fal
Slide 19: LuPIN: 177Lutetium-PSMA-617 in combination with Veyonda
LuPIN 177Lutetium-PSMA-617 In Combination With VeyoNda For personal use only Aim of 177lutetium-PSMA-617 therapy is to deliver a low dose of radiation to all cancer cells within the body 68-Gallium 177-Lutetium PSMA-617 Prostate peptide* cancer cell * PSMA-617 is owned by 18 ©2019 Noxopharm
Slide 20: LuPIN rationale and objectives
LuPIN 177Lutetium-PSMA-617 In Combination With For personal use only VeyoNda 1. Use of radiopharmaceutical maximises interaction between Veyonda® and Rationale radiation in the broad spread of cancer cells throughout the body. 2. Veyonda® amplifies radiation-induced DNA damage in cancer cell by: • b
Slide 21: LuPIN-1 Study
LuPIN-1 Study For personal use only Ø Phase 1/2 study; investigator-initiated; Australia Ø Open label, single arm Ø PSMA-positive, late-stage mCRPC patients Ø 6 courses of 177 lutetium-PSMA-617 administered intravenously every 6 weeks Ø Veyonda® administered for 10 days starting Day-2 each course Ø
Slide 22: Planned Expanded Clinical Study Program 2019-2020
Planned Expanded Clinical Study Program 2019-2020 For personal use only DARRT - mCRPC • Late-stage mCRPC patients eligible for palliative therapy Priority • Phase 2 (adaptive), USA High • Double-blind, 2-arm study • End-points: PSA response, pain response, QoL, PFS DARRT – rare cancers • Rare cancer
Slide 23: External radiotherapy in cancer treatment
External radiotherapy in cancer (all forms) treatment* For personal use only Africa Asia Pacific Europe Latin America North America Population 1070 4108 893 601 350 No. radiation 140 2590 1430 620 2790 centres No. radiotherapy 0.4M 3.3M 1.9M 0.6M 0.9M courses Cost per course 1,300 2,120 3,490 2,080
Slide 24: Key metrics
Key metrics For personal use only Number of Shares 121.9M : Free float 66.8% Market Cap (1 March 2019) AU$53M IPO price 20 cents CEO Directors 12 month high/low $1.64/0.36 Others Cash position AU$ 9.6M (31 Dec 2018) 23 ©2019 Noxopharm
Slide 25: Discover Develop Deliver
For personal use only DISCOVER DEVELOP DELIVER ASX: NOX 24 ©2019 Noxopharm