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NOXOPHARM LIMITED — AGM Information 2017
Nov 26, 2017
65437_rns_2017-11-26_837b661c-6781-44f8-912e-043c136edfc1.pdf
AGM Information
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Date: 27 November, 2017 Sydney, Australia
ASX Limited
20 Bridge Street NOX AGM CORPORATE PRESENTATION SYDNEY NSW 2000
ASX: NOX
Noxopharm Limited
Sydney, 27[th] November 2017 : Noxopharm Limited (ASX:NOX) is pleased to provide to the market and shareholders the Corporate Presentation for today’s 2017 Annual General Meeting.
ABN 50 608 966 123
Registered Office:
Suite 1 Level 6 50 Queen St Melbourne VIC 3000 Australia
Operational Office:
Suite 3, Level 4 828 Pacific Highway Gordon NSW 2072 Australia
Board of Directors Mr Peter Marks
Chairman Non-Executive Director
To be held at 2.00 pm at the Sydney Sofitel Wentworth Hotel, Adelaide Room, Level 4, 61-101 Phillip Street, Sydney.
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About Noxopharm
Noxopharm is an Australian drug development company with offices in Sydney and Hong Kong. The Company has a primary focus on the development of drugs to address the problem of drug-resistance in cancer cells, the major hurdle facing improved survival prospects for cancer patients. NOX66 is the first pipeline product, with later generation drug candidates under development. The Company also has initiated a pipeline of non-oncology drugs.
Investor & Corporate Enquiries: Company Secretary : Prue Kelly David Franks M: 0459 022 445 T: +61 2 9299 9690 E: [email protected] E: [email protected] www.noxopharm.com
Forward Looking Statements
Dr Graham Kelly Chief Executive Officer Managing Director
Dr Ian Dixon Non-Executive Director
This announcement may contain forward-looking statements. You can identify these statements by the fact they use words such as “aim”, “anticipate”, “assume”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “plan”, “should”, “target”, “will” or “would” or the negative of such terms or other similar expressions. Forward-looking statements are based on estimates, projections and assumptions made by Noxopharm about circumstances and events that have not yet taken place. Although Noxopharm believes the forward-looking statements to be reasonable, they are not certain. Forward-looking statements involve known and unknown risks, uncertainties and other factors that are in some cases beyond the Company’s control that could cause the actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statement. No representation, warranty or assurance (express or implied) is given or made by Noxopharm that the forward-looking statements contained in this announcement are accurate and undue reliance should not be placed upon such statements.
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Noxopharm
CEO REVIEW 2017 AGM
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Noxopharm
Our objectives
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For the doctor: 🔵 Drugs that boost the effectiveness of radiotherapy (and chemotherapy) ONCOLOGY …. with lower (better tolerated) treatment dosages For the patient: 🔵 Better survival outcomes without fewer side-effects
For the investor: 🔵 A technology platform with the potential to become standard of care …. with an aim of generating revenue in 2022 2
Radiotherapy … the best anti-cancer treatment we have
Noxopharm
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Limitation of radiotherapy 1. Dose-limiting toxicity
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Noxopharm
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Limitation of radiotherapy 2. Metastatic cancer too extensive for radiation
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Noxopharm
DARRT
Direct and Abscopal Response to Radio-Therapy
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DIRECT Sensitisation of Radio-Therapy
Noxopharm 7
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DNA damaged. Cell attempts to repair the damage.
Extensive damage .. beyond repair……cell dies. Modest damage … repairable …. cell lives.
Most dosages of radiotherapy not high enough to deliver extensive damage to all cancer cells .… tumour survives.
NOX66
v Blocks ability of cancer cell to repair damage …. even modest damage becomes un-repairable …. cell dies v Does NOT increase extent of damage v No effect on healthy cells
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DIRECT Response to Radio-Therapy
Noxopharm
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Shrinkage of irradiated
Radiotherapy applied to large
Direct radio-sensitising effect
tumours
tumours for pain relief 8
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DIRECT Response to Radio-Therapy
Noxopharm
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NOX66
Shrinkage of irradiated Complete remission of
Radiotherapy applied to large
Direct radio-sensitising effect Direct radio-sensitising effect
tumours irradiated tumours
tumours for pain relief 9
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ABSCOPAL Response to Radio-Therapy
Noxopharm 10
Exposed tumours respond
Non-exposed tumours respond
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Low-dose radiotherapy Direct radio-sensitising effectRemission of irradiated tumours Abscopal response
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Noxopharm
Features of an abscopal response
Rare – very rare phenomenon Complete – primary AND secondary tumours disappear Durable – potentially permanent Unrestricted – range of cancers reportedly involved Short treatment – single course of treatment (7-14 days) Low toxicity – low-grade radiation sickness
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How might an abscopal response/bystander effect work?
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Noxopharm
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DARRT
Noxopharm
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Direct Effect Abscopal Effect
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External Beam RT
Ø Patients with multiple (>3) tumours Ø Irradiate 1-2 tumours (5 days) Ø NOX66 14 days
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Ø Scan + 2 months and 4 months
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DARRT
Noxopharm
Direct Effect Abscopal Effect
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External Beam RT
Ø Prostate cancer (metastatic castrate-resistant) Ø Solid common cancers (eg. lung, breast, melanoma) Ø Rare cancers (eg. sarcomas)
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DARRT
Noxopharm
Direct Effect Abscopal Effect
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Brachytherapy
Ø[177] Lutetium-PSMA-617
Ø 4 x monthly intravenous injections of LuPSMA/10 days NOX66
Ø Prostate cancer (metastatic castrate-resistant)
Ø ? Kidney cancer
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DARRT
Noxopharm
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Where NOX66 + Radiotherapy needs a boost ……… NOX66-001 Phase 1b Study Georgia
- Low-dose carboplatin (AUC4 – monthly)
400 mg NOX66 800 mg NOX66
5 patients: 1 progressive; 4 non-progressive
6 patients: 5 non-progressive; 1 partial response
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Noxopharm
NOX66
+ external beam radiotherapy + brachytherapy + chemotherapy (carboplatin)
Idronoxil
+ intravenous dosage form + pessary dosage form
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Noxopharm
Ian Minns
Director, Clinical Development and Medical Affairs
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NOX66 Clinical Development
Noxopharm 19
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Review of 2017 – Where are we now?
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Looking forward to 2018 – Where are we heading?
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Moving NOX66 towards first registration - Radiotherapy
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Chemotherapy and other research with NOX66
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Sharing our progress
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Communicating data in 2018 and beyond
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Noxopharm
Review of 2017 – Where are we now?
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Mid Year update Studies planned:
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Chemotherapy (Carboplatin): Study Commenced (Georgia)
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Radiotherapy: External Beam RT in prostate cancer (Australia)
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Radiotherapy: Stereotactic RT in prostate cancer (Investigator) 4. Radiotherapy: Brachytherapy in prostate cancer (Investigator) 5. Radiotherapy: External Beam RT in solid cancers (Hong Kong) 6. Rare Cancers: collect evidence in rare cancer population 7. Chemo-radiotherapy: in solid cancers (ANZ, Georgia)
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Review of 2017 – Where are we now?
Noxopharm 21
Mid Year update à 6 months later
Studies planned:
- Chemotherapy (Carboplatin): Study Commenced
Recruitment completed, interim data presented
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Radiotherapy: External Beam RT in prostate cancer
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Radiotherapy: Stereotactic RT in prostate cancer
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Radiotherapy: Brachytherapy in prostate cancer
Open for Recruitment Open for Recruitment Open for Recruitment
5. Radiotherapy: External Beam RT in solid cancers
6. Rare Cancers: collect evidence in rare cancers
- Chemo-radiotherapy: in solid cancers
Studies combined: multinational study in radiotherapy (all tumours) - Ethics submission (Aust) planned December De-prioritised, following discussions with oncologists
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Noxopharm
Review of 2017 – Where are we now?
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Mid Year update à 6 months later à Moving to first registration Studies planned:
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Chemotherapy (Carboplatin): Study Commenced
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Radiotherapy: External Beam RT in prostate cancer
Open for Recruitment
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Radiotherapy: Stereotactic RT in prostate cancer
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Radiotherapy: Brachytherapy in prostate cancer
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Radiotherapy: External Beam RT in solid cancers
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Rare Cancers: collect evidence in rare cancers
Open for Recruitment
Studies combined: Multinational study in Radiotherapy (all tumours) - Ethics submission (Aus) in December
- Chemo-radiotherapy: in solid cancers
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Moving towards first registration study
Target Indication: NOX66 in combination with Radiotherapy for the treatment of patients with metastatic cancer
Studies:
NOX66-002A: Determine Dose of NOX66 (Prostate Cancer)
NOX66-006: Open Label, all tumours. safety and efficacy
NOX66-007: Randomised, common tumours. Efficacy in comparison to standard care
LuPIN Study:[177] Lu-PSMA and NOX66 (Prostate Cancer)
Expansion of[177] Lu-PSMA research
Other Radiotherapy Research (supportive data, for expanded indication in future) – e.g. brain, paediatrics, stereotactic, brachytherapy etc.
Noxopharm 23
Notes:
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Different Global Regulators may modify indication for specific tumour types
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• Indication may also list when treatment can be used
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Indication will discuss how to use Radiotherapy with NOX66
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Rare cancers may not be included in indication, however evidence is important
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• Reimbursement is as important as Registration
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Noxopharm
Moving towards first registration
Target Indication: NOX66 in combination with Radiotherapy for the treatment of patients with metastatic cancer
Studies:
NOX66-002A: Determine Dose of NOX66 (Prostate Cancer)
NOX66-006: Open Label, all tumours. Safety and efficacy
NOX66-007: Randomised, 2-3 tumours. Efficacy in comparison to standard care
LuPIN Study:[177] Lu-PSMA and NOX66 (Prostate Cancer): Supporting registration
Expansion of[177] Lu-PSMA research
Other Radiotherapy Research (supportive data, for expanded indication in future) – e.g. brain, paediatrics, stereotactic, brachytherapy etc.
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Notes:
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Different Global Regulators may modify indication for specific tumour types
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• Indication may also list when treatment can be used
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Indication will discuss how to use Radiotherapy with NOX66
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Rare cancers may not be included in indication, however evidence is important
Reimbursement is as important as Registration
2020/21
2017
2018
242019
Noxopharm
Beyond the trials to reach registration
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Manufacturing and formulation: Optimise NOX66 formulation; GMP Manufacturing
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Pre-clinical / non-clinical : in vitro and animal studies to meet regulatory and other requirements for registration and marketing
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Medical Affairs: Liaison with oncologists, advisory boards, congress attendance and presentation
NEW!!
- Marketing: Develop Noxopharm presence, brand-naming, commercialization (including pricing) strategy
NEW!!
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Noxopharm
Chemotherapy with NOX66
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Which Combination(s)?
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Which tumour type(s)?
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When in disease pathway?
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For how long?
https://en.wikipedia.org/wiki/Chemotherapy_regimen
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Noxopharm
Chemotherapy with NOX66
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Radiotherapy prioritised for pathway to registration
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Duration of therapy and of trials
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Clarity of treatment (i.e. combination with RT) across all tumours
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Chemotherapy remains important to development
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NOX66-001 study to complete in Q2 2018
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Next study, to be a randomised trial ± NOX66, planned for H2 2018
- Cancer type(s) and chemo to follow from advisory meetings with doctors
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Further studies
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Other tumour types, chemotherapy regimen and dosing
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Led by medical need, in discussion with doctors
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NOX66 alone (monotherapy) to be investigated
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Communicating Trials Progress 2018
Noxopharm
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Progress – based on Data Safety Monitoring Committee Review
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Independent body – researchers and statisticians
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Regular meetings during trials – expect ~6 across trials in 2018
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Review overall progress à decisions on continuation
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Findings of DSMBs will be communicated
• Trial Data at conferences
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Contingent on significant milestones in trials (end of study, all patients through a pre-defined time point) – expect ~4 in 2018
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Requires considerable planning (e.g. ASCO – meeting June, submit presentation in February)
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Requirement that data are embargoed until presented
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Where significant outcomes, top line result may be released as per ASX requirements prior to conference
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Noxopharm
What will ‘good response’ look like ???
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Looking at a new breakthrough cancer treatment:
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In Non-Small Cell Lung Cancer trial (582 patients evaluated)
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Compared with a standard Chemotherapy
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Median (50% of patients) overall Survival - 12.2 months compared with 9.4 months
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Median Progression Free Survival (time before disease worsened) – 2.3 months v 4.2 months (not statistically significant)
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Overall Response Rate (patients who had at least partial response) – 19% v 12%
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Four Complete Responses v One
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Mean (average) duration of Response 17 months v 6 months
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Common Adverse Reactions (>20% of patients) - fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite
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http://www.opdivohcp.com/metastatic-nsclc/efficacy/clinical-trial-results
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Noxopharm
- 🔵 NOX66 clinical studies in Asian-centric cancers
• Hepatocellular carcinoma (liver cancer)
- Gastric carcinoma
🔵 Identify KOLs and form collaborations
🔵 Identify potential partners.
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NYX-205
NYX-104
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Peripheral
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neuropathy
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• Ulcerative colitis
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Sclerosing cholangitis
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Stroke
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Concussion
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• Head trauma
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• Hearing loss
NYX-330
Noxopharm
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• High cholesterol
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Noxopharm
Key Messages
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WE EXPECT TO KNOW BY END OF 2017 OF THE SUCCESS OF OUR MISSION
WE AIM TO BE IN A REGISTRATION STUDY BY END OF 2018
WE AIM TO HAVE MARKETING APPROVAL BY 2022
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A SUCCESSFUL OUTCOME IS A MAJOR SHARE OF THE $100 BILLION ONCOLOGY DRUG MARKET REALISTIC POTENTIAL TO BECOME STANDARD OF CARE DRUG IN MANY CANCERS
ü Lean operation ü Experienced team
ü A number of key inflection points anticipated within next 12 months
ü Several potential blockbuster drugs candidates
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Disclaimer
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This presentation has been prepared by Noxopharm Limited a company proposed to be listed as [ASX:NOX] (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 make an offer or invitation to subscribe for or purchase any shares in NOX. No agreement to subscribe for securities in the NOX will be entered into on the basis of this presentation or any information, opinions or conclusions expressed in the course of this presentation.
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This presentation is not a prospectus, product disclosure document or other offering document under Australian law or under the law of any other jurisdiction. It has been prepared for information purposes only. This presentation contains general summary information and does not take into account the investment objectives, financial situation and particular needs of an individual investor. It is not a financial product advice and the Company is not licenced to, and does not provide, financial advice.
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This presentation may contain forward-looking statements which are identified by words such as ‘may’, ‘could’, ‘believes’, ‘estimates’, ‘targets’, ‘expects’, or ‘intends’ and other similar words that involve risks and uncertainties. These statements are based on an assessment of past and present economic and operating conditions, and on a number of assumptions regarding future events and actions that, as at the date of this presentation, are expected to take place. Such forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions and other important factors many of which are beyond the control of the Company, its Directors and management.
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Although the Company believes that the expectations reflected in the forward looking statements included in this presentation are reasonable, none of the Company, its Directors or officers can give, or gives, any assurance that the results, performance or achievements expressed or implied by the forward-looking statements contained in this document will actually occur or that the assumptions on which those statements are based are exhaustive or will prove to be correct beyond the date of its making. Readers are cautioned not to place undue reliance on these forward-looking statements. Except to the extent required by law, the Company has no intention to update or revise forward-looking statements, or to publish prospective financial information in the future, regardless of whether new information, future events or any other factors affect the information contained in this presentation.
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Readers should make their own independent assessment of the information and take their own independent professional advice in relation to the information and any proposed action to be taken on the basis of the information. To the maximum extent permitted by law, the Company and its professional advisors and their related bodies corporate, affiliates and each of their respective directors, officers, management, employees, advisers and agents and any other person involved in the preparation of this presentation disclaim all liability and responsibility (including without limitation and liability arising from fault or negligence) for any direct or indirect loss or damage which may arise or be suffered through use of or reliance on anything contained in, or omitted from, this presentation. Neither the Company nor its advisors have any responsibility or obligation to update this presentation or inform the reader of any matter arising or coming to their notice after the date of this presentation document which may affect any matter referred to in the presentation.
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Contact
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