Report of Foreign Issuer (6-k)
October 31 2016 - 7:07AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of October, 2016
Commission File Number
Novogen
Limited
(Translation of registrants name into English)
Level 5, 20 George Street, Hornsby, NSW 2077, Australia
(Address of principal executive office)
Indicate by check mark whether
the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F
þ
Form 40-F
¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
¨
Note
: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted
solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as
permitted by Regulation S-T Rule 101(b)(7):
¨
Note
: Regulation S-T Rule 101(b)(7) only
permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated,
domiciled or legally organized (the registrants home country), or under the rules of the home country exchange on which the registrants securities are traded, as long as the report or other document is not a press release, is
not required to be and has not been distributed to the registrants security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark if the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission
pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes
¨
No
þ
If yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b)
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
Novogen Limited
(Registrant)
Kate Hill
Kate Hill
Interim Company Secretary
Date 31 October 2016
NOVOGEN
Novogen Limited
Investor Presentation
In-licensing of phase II ready molecule (GDC-0084) from
Genentech for treatment of brain cancer (Glioblastoma)
31st October 2016
Version 1.0
Forward-Looking Statements
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.
NOVOGEN
1
Novogen now has a diversified portfolio and is positioned for growth
Focus on unmet need: pipeline of novel therapies, targeting oncology patients, poorly served by existing treatment options
Building a sustainable model: leveraging oncology expertise, developing commercially attractive, in-house and external assets
Diversified portfolio:
Multiple assets in various stages of development
from pre-clinical through to phase II-ready
Across technologies / development platforms
Strong management and board: lean team of internationally-experienced pharma executives
Financially sound: listed on ASX and NASDAQ, with cash runway
News flow: substantial flow of value-driving milestones over 12-18 months
NOVOGEN
2
Novogen is listed on ASX and NASDAQ (via ADRs) and is well-funded for current operations
Share Price (US$)
3.00
NVGN
NASDAQ Biotech Index
2.50
2.00
1.50
1.00
Volume
0.50
0.00
Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16
Market Capitalisation*A$ 41 million
Listing ASX: NRT
NASDAQ: NVGN (1:25 ratio)
Average Daily Volume ASX: ~570,000 /day
NASDAQ: ~50,000 ADRs /day
Shares on Issue* 450 million
(40% US, 60% Australia)
Outstanding
Options / Warrants* 74 million
Cash at Bank**
A$ 33.5 million
* Data current as at 26 October 2016 ** Cash balance as at
30 June 2016
NOVOGEN
3
In-licensing of GDC-0084, a promising phase II-ready, well-differentiated drug candidate for the treatment of
advanced brain cancer
GDC-0084 has been in-licensed from Genentech
Being developed to treat the most common form of primary brain cancer, Glioblastoma Multiforme (GBM)
Pan-PI3 Kinase inhibitor with some mTOR activity
Sound rationale for inhibitors
of PI3 Kinase as a target for treating GBM: 80-90% of GBM cases have disordered PI3 Kinase
Designed to cross the blood-brain barrier: a critical success
factor for GBM therapies, and not true of other drug candidates
Clinical data suggestive of activity in a very treatment-resistant Phase I clinical trial
population; safety profile consistent with other agents in the class
NOVOGEN
4
GDC-0084: transaction deal terms
Exclusive worldwide development and commercialisation agreement for all uses
US
$5M upfront, payable at time of contract signing
Performance-related consideration linked to regulatory and commercial outcomes
Royalty payments as a percentage of net sales, in-line with industry benchmarks
Novogen assumes full responsibility for development, commercialisation and maintenance of intellectual property
NOVOGEN
5
GDC-0084 has successfully completed a phase I study which established dose and safety profile
Phase I Study
47 patients enrolled at 4 centres (MD Anderson, UCLA, Dana-Farber, and
Vall dHebron)
Patients were grade 3 or 4 gliomas with at least one (and in most cases, several) lines of prior therapy
45mg established as Maximally Tolerated Dose (MTD) for phase II study
Pharmacokinetic profile consistent with daily dosing
Safety profile consistent with other PI3K inhibitors, with hyperglycemia and mucositis / stomatitis the
most common adverse events
Promising signals of pharmacodynamic response on FDG-PET, an exploratory radiological marker
NOVOGEN
6
Strong strategic rationale for in-licensing GDC-0084
Novogens strategy includes
GDC-0084 is highly complementary to existing pipeline
augmentation of our pipeline
Validated mechanism (1x commercial
product) and clinical data
through prudent in-licensing
Strengthens
Novogens position as an innovative oncology company
Designed by Genentech, specifically to address brain cancer which
GDC-0084 is an attractive
has >$1b market potential
opportunity, phase II-ready
Completed phase I studies and ready to commence phase II
Potential to improve survival for advanced brain cancer that with
and
with a validated
current standard of care has expected survival of only 12 - 15 months
mechanism
from time of diagnosis
Strong intellectual property protection
Experienced management team, with
intl big pharma background
Strong scientific networks, including in glioblastoma through Glioblast
Novogen is ready and able to
acquisition; key thought leaders in neuro-oncology field are
highly
execute on the GDC-0084
engaged
program
Manufactured drug substance for phase II clinical trial included in
transaction
Strong cash position
NOVOGEN
7
Novogen is oncology-focused, with a robust in-house pipeline and strong partnering aspirations
Assets from internal
discovery engines
Programs taken through
Molecules partnered with
preclinical and clinical
pharma / large biotech for
development, generally to
phase III development and
completion of phase II
commercialization
Assets in-licensed from
external partners
NOVOGEN
8
Post transaction pipeline
Lead
Preclinical
IND-Enabling
Phase I
Phase II
Optimisation
Proof-of-Concept
Tox & CMC
Clinical Trials
Clinical Trials
PI3K
GDC-0084
Glioblastoma
Phase II
2017
SBP
TRXE-002-1
Ovarian Cancer
Phase I
4Q 2016
ATM
ATM-3507
Solid Tumours
IND
2017
SBP
TRXE-009
Solid Tumours
PI3K Inhibitor Module
Brain-penetrant PI3 Kinase inhibitor with some mTOR activity, targeting
PI3K / Akt / mTOR pathway,
which is shown to be upregulated in majority of GBM cases and many other tumour types
First-in-class program targeting cancer-specific tropomyosin isoform in cytoskeletal microfilaments of
ATM Platform
cancer cells, leading to apoptosis
SBP Platform
First-in-class program based on proprietary isoflavone chemistry effective in
killing tumour-initiating
cells
NOVOGEN
9
Novogen anticipates a rich news flow of value-driving events over the next 12-18 months
Key Milestones
1Q
2016
Granting of patent for SBP technology ?
2Q
2016
Granting of patent for ATM technology ?
3Q 2016 Submission of IND for
Cantrixil ? 4Q 2016 In-licensing of GDC-0084 ? Start of phase I trial for Cantrixil 2017 Submission of IND for Anisina Start of phase II trial for GDC-0084 Start of phase I trial for Anisina NOVOGEN 10
Recap: diversified portfolio, positioned for growth
Focus on unmet need: pipeline of novel therapies, targeting oncology patients, poorly served by existing treatment options
Building a sustainable model: leveraging oncology expertise, developing commercially attractive, in-house and external assets
Diversified portfolio:
Multiple assets in various stages of development
from pre-clinical through to phase II-ready
Across technologies / development platforms
Strong management and board: lean team of internationally-experienced pharma executives
Financially sound: listed on ASX and NASDAQ, with cash runway
News flow: substantial flow of value-driving milestones over 12-18 months
NOVOGEN
11
NOVOGEN
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