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Novogen Limited
(Registrant)
Kate Hill
Kate Hill
Company Secretary
Date 11 September 2017
ASX:NRT
NASDAQ:NVGN
Novogen Ltd
(Company)
ABN 37 063 259 754
Capital Structure
Ordinary Shares on issue:
483 M
Board of Directors
Mr Iain Ross
Chairman
Non-Executive Director
Mr Bryce Carmine
Non-Executive Director
Mr Steven Coffey
Non-Executive Director
Dr James Garner
Chief Executive Officer
Managing Director
MARKET RELEASE
11 September 2017
NOVOGEN PRESENTS AT
RODMAN & RENSHAW CONFERENCE
Sydney, 11 September 2017 Australian oncology-focused biotechnology company Novogen Ltd (ASX: NRT;
NASDAQ: NVGN) is pleased to release the presentation that CEO, Dr James Garner will be presenting at the Rodman & Renshaw 19th Annual Global Investment Conference being held in New York.
Dr James Garner will be presenting in New York at the Lotte New York Palace Hotel on Monday 11 September at 9:35 am, EDT.
ENDS
About Novogen Limited
Novogen Limited (ASX: NRT; NASDAQ: NVGN) is an emerging oncology-focused biotechnology company, based in Sydney, Australia. Novogen has a portfolio of
development candidates, diversified across several distinct technologies, with the potential to yield
first-in-class
and best-
in-class
agents in a range of oncology indications.
The lead program is
GDC-0084,
a small molecule inhibitor of the PI3K / AKT / mTOR pathway, which is being developed to treat glioblastoma multiforme. Licensed from Genentech in late 2016,
GDC-0084
is anticipated to enter phase II clinical trials in 2017. A second clinical program,
TRXE-002-01
(Cantrixil) commenced a
phase I clinical trial in ovarian cancer in December 2016. In addition, the company has several preclinical programs in active development, the largest of which is substantially funded by a
CRC-P
grant from
the Australian Federal Government.
For more information, please visit:
www.novogen.com
An emerging oncology drug developer with two clinical-stage programs Novogen Limited September 2017 NRT NVGN
Forward-Looking Statements 1 This presentation contains forward-looking statements within the
meaning of the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Company to differ
materially from the results expressed or implied by such statements, including changes from anticipated levels of customer acceptance of existing and new products and services and other factors. Accordingly, although the Company believes that the
expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to sales, future international, national or regional economic and
competitive conditions, changes in relationships with customers, access to capital, difficulties in developing and marketing new products and services, marketing existing products and services update the forward-looking information contained in this
presentation.
Executive Summary Novogen is an oncology-focused biotechnology company, listed on ASX and NASDAQ
Lead asset is
GDC-0084
for GBM, an orally-administered small molecule PI3K inhibitor licensed from Genentech PI3K class is well-validated, with one commercial product on market: Zydelig
(idelalisib) from Gilead PI3K / Akt / mTOR pathway shown to be upregulated in
85-90%
of GBM tumours
GDC-0084
well differentiated from class; able to cross
blood-brain barrier Genentech has successfully completed a large (n=47) phase I study in recurrent GBM patients, demonstrative a favourable safety profile and promising indications of clinical efficacy
GDC-0084
is ready to begin phase II studies in first-line GBM, with protocol concept developed, experienced clinical sites enthusiastic to participate, and 45kg of drug substance already manufactured and
on hand Cantrixil, lead asset from
in-house
discovery programs, is currently in a phase I clinical trial in ovarian cancer in United States and Australia Company strategy is to build a diversified
pipeline over the medium term by
in-licensing
undervalued assets that have been deprioritised by pharmaceutical companies and developing them to value inflection 2
Agenda Corporate Overview
GDC-0084
Cantrixil
Investment Hypothesis 3
Novogen has a well-diversified portfolio of assets, stretching from preclinical to
mid-stage
clinical 4 Lead Optimisation Preclinical
Proof-of-Concept
IND-Enabling
Tox &
CMC Phase I Clinical Trials Phase II Clinical Trials Patent Expiry SBP
TRXE-002-1
Cantrixil 2035 SBP
TRXE-009
Trilexium 2035 PI3K
GDC-0084
2032 Ovarian Cancer Solid Tumours Glioblastoma Multiforme Phase II 2H 2017 CLINICAL DEVELOPMENT Data 1H 2018 PRECLINICAL DEVELOPMENT & DISCOVERY ATM
Next-Gen
ATM Solid Tumours TBD Pipeline Licensed from Genentech in late 2016 after completion of phase I clinical trial Derived from historical
in-house
discovery
program Discovery program largely
co-funded
by Australian Government grant of AU$ 3 million over three years
A strong team brings international experience in big pharma and biotech 5 Board Management Team Scientific
Advisory Board Board & Management Dr James Garner Chief Executive Officer & Executive Director Physician / MBA; Extensive drug development experience Dr Gordon Hirsch Chief Medical Officer Physician / MBA; 20 years of pharma
industry experience Dr Peng Leong Chief Business Officer 18 years of BD and investment banking experience Kate Hill Company Secretary Chartered accountant, and former audit partner at Deloitte Iain Ross Chairman Executive and Board roles in pharma
and small biotech Bryce Carmine Deputy Chairman 36 years executive experience in Eli Lilly Steven Coffey
Non-Executive
Director Chartered accountant with extensive governance experience Dr James Garner Chief
Executive Officer & Executive Director Physician / MBA; Extensive drug development experience Professor Sir Murray Brennan Emeritus Chairman of Cancer Surgery at Memorial Sloan Kettering Hospital, New York Dr Karen Ferrante Former Chief
Medical Officer at Millennium Pharmaceuticals Professor Peter Gunning Head of School of Medical Sciences at University of New South Wales Professor Alex Matter Former Global Head of Oncology Research at Novartis
Agenda Corporate Overview
GDC-0084
Cantrixil
Investment Hypothesis 6
Glioblastoma Multiforme (GBM) is the most common form of primary brain cancer 7
GDC-0084
Lung 14 million cancer cases per annum Breast Colon Prostate Stomach No clear cause or strong risk factors
3-4
months untreated survival
12-15
months average survival with treatment Any age, but most common in 60s Five-year survival 3 5% ( breast cancer: 90%) Most common drug treatment is temozolomide (Temodar®), used after surgery and
radiotherapy Ineffective in approximately
two-thirds
of patients Glioblastoma Multiforme 133,000 cases per annum worldwide Indicative Market Opportunity US$ 1 billion
Current GBM standard of care is ineffective in ~65% of patients 8 Source: ME Hegi,
A-C
Diserens, T Gorlia, et al. (2005). N Engl J Med
352:997-1003
Standard of Care (Stupp Regimen) Debulking surgery where possible Radiotherapy + temozolomide
Temozolomide maintenance therapy 6 weeks 4w 6 x
28-day
cycles Temozolomide is clearly efficacious
but only in ~35% with a methylated MGMT promotor
GDC-0084
The PI3K pathway is highly relevant to GBM;
GDC-0084
is differentiated
within the class 9 1CW Brennan et al, Cell (2013),
155(2):462-477;
2Y Suzuki, et al. J Radiat Res (2010), 51(3):343 PI3K Activation in GBM PI3K Inhibitor Class is Diverse
GDC-0084
PI3K dysregulation is associated with a worse prognosis2 PI3K pathway upregulated in ~90% of GBM cases per Cancer Genome Atlas1 0% 24% 0% 10% 20% 30% pAkt positive pAkt negative
2-Year
Survival Rate
GDC-0084
is a
pan-PI3K
inhibitor, active against all four isoforms (a b g d) Idelalisib (Gilead) d
IPI-549
(Infinity) g Umbalisib (TG)d a & b isoforms likely more relevant to solid tumors Differentiation Comparators Relevance
GDC-0084
is a dual PI3K /
mTOR inhibitor Taselisib (Genentech) PI3K only Dual mechanism reduces bypass signalling
GDC-0084
penetrates the blood-brain barrier (1:1 brain / plasma ratio) Buparsilib (Novartis) also
brain-penetrant but mood disturbances Brain / plasma ratio
³
1 necessary, given diffuse nature of GBM Rich preclinical data set supporting clinical development in GBM Buparsilib (Novartis) lead
indication is breast cancer
GDC-0084
developed from ground up as a GBM drug
Previous GBM failures are understood and can inform development of new therapies 10
GDC-0084
Pharmacokinetic Failure Many small-molecule kinase inhibitors are not well brain-penetrant, and so reach insufficient concentration at the tumour Tumour Genetics &
Heterogeneity Many driver mutations for GBM, but few constitutive (e.g. EGFR disordered in ~40% of cases) Profound heterogeneity in the tumour, and rapid evolution Immunological Environment Brain is immunologically
privileged, with profoundly different set of immunological responses, so immuno-oncology therapies and cancer vaccines are likely to face hurdles Clinical Trial Design Positioning in advanced treatment failures
entails an extremely
hard-to-treat
group with limited life expectancy, creating very high bar for new therapies Combination therapy tends to be limited
by significant toxicity, and some monotherapies can be impeded by higher levels of toxicity in this population Compensatory Mechanisms Inhibition of some downstream targets may lead to upregulation elsewhere (e.g. pure
mTOR inhibitors have been associated with worse clinical outcomes)
Genentechs phase I study established a dose of 45mg and demonstrated acceptable safety 11
GDC-0084
Efficacy Signals Safety Phase I safety trial conducted by Genentech 47 patients enrolled with advanced glioma (grade 3/4) Most common adverse events were oral mucositis and hyperglycemia
(common effects of PI3K inhibitors) No evidence of liver, bone marrow, kidney toxicity, or mood disturbances Data presented at American Society for Clinical Oncology annual meeting in Chicago, June 2016
GDC-0084
40% Achieved stable disease Arresting Tumour Growth 21% Remained on study for >3 months Potentially Delaying Progression 26% Showed metabolic partial response on
FDG-PET
Slowing Tumour Metabolism
40% of patients achieved stable disease, with response increasing in higher doses 12 Best % change from
baseline of target lesions CR / PR: 0 SD: 19 (40%) PD: 26 (55%)
GDC-0084
Disease stabilisation is consistent with a primarily cytostatic mechanism, and highly relevant for use in post-resection setting
First-line phase II study design is supported by preclinical data and KOL consultation 13
GDC-0084
Debulking surgery prior to study entry Radiotherapy + temozolomide Maintenance temozolomide Maintenance
GDC-0084
R Approximately 60 sites in
5-6
countries Will target patients who are resistant to temozolomide (approximately
two-thirds
of glioblastoma patients) Duration: 18 months recruitment 12 months
follow-up
Number of patients: approx. 228 (114 per arm) prior to entering study during study Regulatory Strategy Designed to provide robust evidence of clinical efficacy, using an endpoint, progression-free
survival (PFS), that could potentially be approvable Goal is to seek accelerated approval prior to completion of a definitive phase III study. Avastin (bevacizumab) was approved for recurrent GBM in this way In the interim, Novogen aims
special designations (ODD, FTD, etc.) to provide enhanced opportunities for regulatory engagement n = 114 n = 114
Brain metastases from
non-CNS
tumors represent long-term upside
potential 14 Source: E Lim & N Lim (2012). Oncology.
26(7):652-9;
PK Brastianos, SL Carter, S Santagata, et al. (2015). Discovery 5:1164 Estimated 100,000200,000 cases/year in US
~10-25%
adult cancer patients develop symptomatic brain mets Lung, breast and melanoma represent the majority of brain mets Frequency of brain mets increasing with better systemic control and
longer survival Few (if any) drugs available to treat brain metastasis Use GBM as a gateway indication, with the potential to explore registration post-phase II via accelerated approval / breakthrough
designation, subject to clinical results Meanwhile, conduct preclinical exploration of brain metastases in partnership with identified researchers to demonstrate preclinical
proof-of-concept
and augment economic value of the
asset ~30-44%
of metastatic HER2-positive
metastatic breast cancer patients have brain metastases Brain metastases represent the cause of death in ~50% of HER2-positive breast cancer patients
~40-50%
of breast cancer brain metastases have
disordered PI3K pathway Therapies that are effective for the primary tumor (e.g. Herceptin) are often ineffective for brain metastases Overview Example: Breast Cancer Next Steps
GDC-0084
Agenda Corporate Overview
GDC-0084
Cantrixil
Investment Hypothesis 15
Ovarian cancer remains a disease of high unmet medical need 16 Source: GLOBOCAN; Holschneider & Berek
(2000), Sem Surg Onc
19(1):3-10;
Decision Resources Cantrixil Cause of death for 1 in 100 women 10% of cases are primarily genetic in origin Lung 14 million cancer cases per annum Breast Colon Prostate
Stomach >60% of patients have disease spread at diagnosis 80% of patients are over 50 years of age Five-year survival 45% ( breast cancer: 90%) Chemotherapy only curative in ~20% of ovarian cancers More than half of patients with advanced disease
will recur within
1-4
years Ovarian Cancer 239,000 cases per annum worldwide Indicative Market Opportunity US$ 1.5 billion
Cantrixil
(TRX-E-002-1)
is a novel small molecule optimized to kill tumor-initiating cells 17
First-in-class
agent that kills the tumor-initiating cells thought to be responsible for tumor recurrence and metastasis Prevents recurrence post-chemotherapy Combination treatment of
TRX-E-002-
1 and paclitaxel reduces tumour recurrence in a model of disseminated, chemoresistant ovarian cancer Potentiates the
destruction of ovarian cancer stem cell spheroids which are linked to migration and enhanced chemo-resistance Survival benefit over 47 days of treatment compared with the respective monotherapy controls Ref: Mol Can Ther; 15(6) June 2016 Spheroid
Degraded 0 20 40 60 80 100 Number per image Control TRX 0.245 μM TRX 2.45 μM Number of spheroids after 48 hours of treatment with Cantrixil Cantrixil kills chemo-resistant cancer cells resulting in improved survival compared
to cisplatin alone in tumour-bearing athymic nude mice Cantrixil
Phase I study is designed to establish safety and tolerability, and explore potential efficacy 18 Trial Sites
~6 hospitals in United States and Australia Investigators are generally specialist gynaecological oncologists with clinical trial experience Patient Population Women with confirmed ovarian cancer
Resistant or refractory to at least one prior line of therapy (generally a platinum compound) Study Design Standard dose escalation to establish maximally tolerated dose (MTD) Expansion phase at MTD to
explore signals of clinical activity Completion Forecast 18 month study duration Actual duration will depend on how many dose cohorts are required to establish MTD Study performed under Investigational New Drug
(IND) application with United States Food & Drug Administration (FDA) provides careful validation and supports eventual product approval in United States In addition to standard efficacy measures (via CT scan), study will measure
exploratory biomarkers to seek signals of clinical activity Cantrixil
Agenda Corporate Overview
GDC-0084
Cantrixil
Investment Hypothesis 19
20 2017 2018 2019 2020
GDC-0084
Other Programs 2H Phase I study
publication 2H FDA meeting re: GBM phase II program 2H Initiation of GBM study 2H Maximum Tolerated Dose (MTD) from
TRXE-002-1
phase I study in ovarian cancer 1H Planned
FDA ODD approval 1H Potential exploratory clinical studies with partners 1H Completion of
TRXE-002-1
phase I study in ovarian cancer 1H Initital data from GBM study 1H
Data from
FDG-PET
subgroup of GBM study 2H Completion of ATM discovery program and potential progression to clinic Calendar Year Basis Milestones and Newsflow
Financial Overview 21 * Adjusted for change in ASX / NASDAQ consolidation ratio on 14 July 2017 Market
Capitalisation 0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00
Mar-17
May-17
Jul-17
Sep-17
NVGN US$ 16.2 million Shares on Issue 483 million (35% US, 65% Australia) Cash at Bank ~US$ 11.1 million Listing ASX: NRT NASDAQ: NVGN (1:100 ratio) Share Price (US$)* Outstanding Options / Warrants ~60 million Average Daily
Volume ASX: 0.1% /day NASDAQ: 0.2% /day Debt Nil Average Daily Value ASX: AU$ 44K /day NASDAQ: US$ 54K /day As at 30 June 2017
Multiple value-driving catalysts between now and 2Q 2019 Two active clinical
programs providing diversification Board and management brings international big pharma experience Ambition to source additional assets and to aggressively seek partnering opportunities with
big pharma Lead asset
in-licensed
from Genentech after successful phase I Investment Summary 22 High-Quality Pipeline Clear Development Plans Careful Risk Management Proven Team
Sustainable Corporate Strategy
NOVOGEN