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 March, 2016
Commission File Number
Novogen
Limited
(Translation of registrants name into English)
16-20 Edgeworth David Ave, 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)
Lionel Mateo
Lionel Mateo
Company Secretary
Date 17 March 2016
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ASX:NRT
NASDAQ:NVGN
Novogen Ltd (Company)
ABN 37 063 259 754
Capital Structure
Ordinary Shares on issue:
429 M
Board of Directors
Mr John OConnor
Chairman Non-Executive Director
Mr Bryce Carmine
Deputy Chairman Non-Executive Director
Dr James Garner
Chief Executive Officer Managing Director
Mr Ian Phillips MNZM
Non-Executive Director
Mr Iain Ross Non-Executive Director
Mr Steven Coffey
Non-Executive Director
Prof Peter Gunning Non-Executive Director |
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ASX RELEASE 17 March 2016
NOVOGEN RECEIVES R&D TAX INCENTIVE CASH REFUND
Sydney, 17 March 2016 US-Australian drug
discovery company, Novogen Limited (ASX:NRT; NASDAQ:NVGN) today announced that it has received a cash refund of $2.8M from the Australian Taxation Office under the R&D Tax Incentive Program for the financial year ending 30 June 2015. This
will support the Companys preparations to progress Cantrixil (TRXE-002-1), its lead superbenzopyran (SBP) drug candidate, to Phase 1 clinical trial in 2016.
According to Novogen CEO, Dr James Garner, it was expected that the Company would continue to comply with the internationally competitive Australian Government
tax incentive scheme and receive commensurate cash benefits in future years, enabling Novogen to continue to reinvest in early stage drug initiatives and product development opportunities.
These funds reinforce the Companys strong financial position as we move
towards commencing a Phase 1 clinical trial for Cantrixil in the second half of 2016, Dr Garner said.
We have completed the necessary GLP toxicology program on Cantrixil to enable a first-in-human study. The final results of that program have been
accepted for presentation at the Annual Meeting of the American Association for Cancer Research (AACR) in April 2016. The accepted abstract will be available to view on the Novogen and AACR websites on 15 April 2016. We have also completed
large-scale GMP manufacture of the API and the production of sterile drug product for clinical studies is well advanced. The Company continues to expect that these data provide a sound basis to move forward into the clinic. We are currently working
with experienced clinicians and expert consultants to finalise the study design, he added.
[ENDS]
About the Cantrixil (TRXE-002-1) drug candidate
Cantrixil is a cyclodextrin-based formulation of the active ingredient, TRXE-002-1, which has shown in vitro and in vivo anti-cancer activity in
a range of tumor types. The Company anticipates that, if approved, the drug product would be used as an intra-peritoneal chemotherapy, either alone or in combination with other agents, and in one or more cancers of the abdominal cavity (eg ovarian,
uterine, colorectal and gastric carcinomas). A first-in-human clinical study is planned to commence in the second half of 2016. |
About Novogen Limited
Novogen is an oncology-focused, Australian-US drug development company, traded on both the Australian Securities Exchange (NRT) and on NASDAQ (NVGN). Novogen
has two proprietary drug discovery platforms, the superbenzopyrans (SBPs) and the anti-tropomyosins (ATMs), which have provided first-in-class agents with potential application across a range of oncology indications. The Company has three lead
molecules Cantrixil, Anisina, and Trilexium, which are in advanced preclinical development for various cancer types, with the most advanced molecule, Cantrixil, slated to enter clinical trials in the second half of 2016. For more information, please
visit www.novogen.com.
Media Enquiries
Kym
Robins
Marketing and Communications Director, Novogen Group
E: kym.robins@novogen.com / +61 (0) 2 9472 4109
Forward Looking Statement
This press release
contains forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by
use of such words as expects, appear, intends, hopes, anticipates, believes, could, should, would, may, target,
evidences and estimates, and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Companys
drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Companys drug development program, including, but not limited to Cantrixil, Anisina, Trilexium, and any other statements
that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production
and marketing of the Companys drug components, including, but not limited to, Cantrixil, Anisina, Trilexium, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate
therapeutic efficacy of the Companys drug compounds, including, but not limited to, Cantrixil, Anisina, Trilexium, that could slow or prevent products coming to market, the uncertainty of patent protection for the Companys intellectual
property or trade secrets, including, but not limited to, the intellectual property relating to Cantrixil, Anisina, Trilexium, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission
including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on managements current expectations, but actual results may differ materially due to various factions including those risks and
uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.
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