Noxopharm Ltd. · ASX:NOX
Noxopharm — Investor Presentation (March 2019)
24 slides from Noxopharm's investor presentation, March 2019
Slide 1: March 2019 Corporate Presentation
March 2019 DISCOVER DEVELOP DELIVER ASX: NOX 1 ©2019 Noxopharm
Slide 2: 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 3: We have a single objective
We have a single objective: ® 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, life‐prolonging responses to radiotherapy → at lower, be er tolerated dosages of ra
Slide 4: Veyonda - A New Improved Formulation of Idronoxil
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‐administered dosage fo
Slide 5: Examples of how a radio-enhancer might be used in prostate cancer
Examples of how a radio‐enhancer might be used in prostate cancer Stage of cancer Veyonda® + Radiotherapy (RT) Potential benefits Avoidance of surgery and Early‐stage, operable attendant side‐effects Early‐stage, inoperable Reduction in RT dosage to or recurrence post‐ minimise pelvic tissue damage
Slide 6: How radiotherapy works
How radiotherapy works 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 immune cells Interferon a
Slide 7: How Veyonda radio-enhances
How Veyonda® radio‐enhances BLOCKS DNA REPAIR MECHANISMS 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 effectively Veyonda® BOOSTS INT
Slide 8: Veyonda MoA
Veyonda® MoA S1P is a key pro‐survival secondary messenger. S1P leaves the cell H+ H+ H+ Normal cell S1P 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 signaling pathways, Ext
Slide 9: Veyonda MoA
Veyonda® MoA Cancer cell 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+ Idronoxil (Veyonda active
Slide 10: Veyonda + Radiotherapy
Veyonda® + Radiotherapy Potential use across broad range of radiotherapy practice Externally‐delivered radiotherapy Internally‐delivered radiopharmaceuticals 10 ©2019 Noxopharm
Slide 11: Clinical Programs
Clinical Programs 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 treatment options • Prog
Slide 12: DARRT: Direct and Abscopal Response to Radio-Therapy
Direct and Abscopal Response to Radio‐Therapy DARRT 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, thereby exposing the DNA to
Slide 13: DARRT study design
Direct and Abscopal Response to Radio‐Therapy DARRT Patients with multiple lesions requiring palliative radiotherapy Irradiate one lesion(20‐25 Gy in 5 fractionated doses) Veyonda® 13‐16 days External Beam RT or Stereotactic Body RT Assessments at 6 , 12 and 24 weeks • PSA • Pain Score • QoL
Slide 14: DARRT direct and abscopal response
Direct and Abscopal Response to Radio‐Therapy DARRT 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 functioning as a radio‐
Slide 15: DARRT-1 Study
DARRT‐1 Study Details: Phase 1b multi‐national study (Australia, NZ, Georgia) Open label, single‐arm study 24 patients; metastatic, castrate‐resistant prostate cancer Veyonda® + external beam RT to 1 lesion* Part 1: Dose‐finding (constant RT dose) 400 mg Veyonda (4 patients) 800 mg Vey
Slide 16: DARRT-1 Study 12-week data
DARRT‐1 Study 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 3 SD 2 SD 1 PD * > 50% decline ** > 30% decline *** aggregate of all measurable lesions PD = Progressive disease 24‐week data Part 1 p
Slide 17: DARRT-1 Study interim conclusions
DARRT‐1 Study Interim conclusions: Veyonda® + palliative dosages of radiotherapy well tolerated 400 mg dose of Veyonda® sub‐therapeutic No notable difference between 800 and 1200 mg doses In the 7 evaluable patients in the 800 and 1200 mg cohorts* • 4/7 achieved PSA falls >50% • 5/7 achieved
Slide 18: LuPIN: 177Lutetium-PSMA-617 In Combination With Veyonda
LuPIN 177Lutetium‐PSMA‐617 In Combination With VeyoNda 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 19: LuPIN rationale and objectives
LuPIN 177Lutetium‐PSMA‐617 In Combination With VeyoNda 1. Use of radiopharmaceutical maximises synergy 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: • blocking cell division, the
Slide 20: LuPIN-1 Study
LuPIN‐1 Study Phase 1/2 study; investigator‐initiated; Australia Open label, single arm PSMA‐positive, late‐stage mCRPC patients 6 courses of 177 lutetium‐PSMA‐617 administered intravenously every 6 weeks Veyonda® administered for 10 days, starting day 1 of every course 8 patients 400 mg
Slide 21: Planned Expanded Clinical Study Program 2019-2020
Planned Expanded Clinical Study Program 2019‐2020 DARRT ‐ mCRPC • Late‐stage mCRPC patients eligible for palliative radiotherapy therapy Priority • Phase 2 (Proof‐of‐concept), Global including US • Double‐blind, 2‐arm study Highest • End‐points: PSA response, pain response, QoL, rPFS, OS CEP – sarco
Slide 22: External radiotherapy in cancer treatment
External radiotherapy in cancer (all forms) treatment* 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 7,050 (US$) RADIO‐ENHA
Slide 23: Key metrics
Key metrics 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 24: ASX: NOX
DISCOVER DEVELOP DELIVER ASX: NOX 24 ©2019 Noxopharm