UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 20-F

(Mark One)

OR

For the fiscal year ended June 30, 20152016

OR

OR

Date of event requiring this shell company report                    

For the transition period from                    to                    

Commission file number 0-29962

Novogen Limited

ACN 063 259 754

(Exact name of Registrant as specified in its charter)

Not Applicable

(Translation of Registrant’s name into English)

New South Wales, Australia

(Jurisdiction of incorporation or organization)

Level 1, 16-20 Edgeworth David Avenue,5, 20 George Street, Hornsby, New South Wales 2077, Australia

(Address of principal executive offices)

Mr Lionel MateoMs Cristyn Humphreys

(e)Lionel.Mateo@novogen.comCristyn.Humphreys@novogen.com (t) +61-2-9472-4104+61-2-9472-4101

Level 1, 16-20 Edgeworth David Avenue,5, 20 George Street, Hornsby, New South Wales 2077, Australia

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Securities registered or to be registered pursuant to Section 12(g) of the Act.

None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.

Not Applicable

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report.

The number of outstanding Ordinary Shares of the issuer as at June 30, 20152016 was 423,116,465.429,733,982.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes  ¨             No  x

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

Yes  ¨            No  x

Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes  x             No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes  ¨            No  ¨

Indicate by check mark if the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check one):

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing

If ‘Other’ has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

Item 17  ¨        Item 18¨

If this is an annual report, indicate by a check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes  ¨             No  x

TABLE OF CONTENTS

FORWARD-LOOKING STATEMENTS

This Annual Report on Form 20-F includes forward-looking statements, which involve a number of risks and uncertainties. These forward-looking statements can generally be identified as such because the context of the statement will include words such as “may,” “will,” “intend,” “plan,” “believe,” “anticipate,” “expect,” “estimate,” “predict,” “potential,” “continue,” “likely,” or “opportunity,” the negative of these words or other similar words. Similarly, statements that describe our future plans, strategies, intentions, expectations, objectives, goals or prospects and other statements that are not historical facts are also forward-looking statements. Discussions containing these forward-looking statements may be found, among other places, in “Business Overview” and “Operating and Financial Review and Prospects” in this Annual Report on Form 20-F. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995 and section 27A of the Securities Act and Section 21E of the Exchange Act. Readers of this Annual Report on Form 20-F are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the time this Annual Report on Form 20-F was filed with the Securities and Exchange Commission, or SEC. These forward-looking statements are based largely on our expectations and projections about future events and future trends affecting our business, and are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. These risks and uncertainties include, without limitation, those discussed in “Risk Factors” and in “Operating and Financial Review and Prospects” of this Annual Report on Form 20-F. In addition, past financial or operating performance is not necessarily a reliable indicator of future performance, and you should not use our historical performance to anticipate results or future period trends. We can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them do, what impact they will have on our results of operations and financial condition. Except as required by law, we undertake no obligation to update publicly or revise our forward-looking statements to reflect events or circumstances that arise after the filing of this Annual Report on Form 20-F.

In this Annual Report on Form 20-F, “Consolidated entity”, “Novogen,” “Company,” “we,” “us” and “our” refer to Novogen Limited and its wholly owned subsidiaries on a consolidated basis, unless the context otherwise provides.

PART I

Item 1 details are not required to be disclosed as part of the Annual Report.

Item 2 details are not required to be disclosed as part of the Annual Report.

Selected financial data

The selected financial data at June 30, 20152016 and 20142015 and for the years ended June 30, 2016, 2015 2014 and 20132014 have been derived from the consolidated financial statements of the Company included in this Annual Report and should be read in conjunction with, and are qualified in their entirety by, reference to those statements and the notes thereto.

This financial report complies with International Financial Reporting Standards (‘IFRS’(“IFRS”) as adopted by the International Accounting Standards Board (‘IASB’(“IASB”).

The consolidated financial statements have been audited in accordance with the Public Company Accounting Oversight Board (‘PCAOB’(“PCAOB”) auditing standards in the United States by the Company’s independent registered public accounting firm.

The Company’s fiscal year ends on June 30. As used throughout this Annual Report, the word “fiscal” followed by a year refers to the 12-month period ended on June 30 of that year. For example, the term “fiscal 2015”2016” refers to the 12 months ended June 30, 2015.2016. Except as otherwise indicated, all dollar amounts referred to in this Annual Report are at the consolidated level and exclude inter-company amounts.

At the Company’s Annual General Meeting on November 12, 2012, shareholders approved the demerger of Novogen Limited and MEI Pharma, Inc. (‘MEI’). On November 27, 2012, a dividend of $24,775,000 was paid via anin-specie distribution of shares in MEI representing 23.87 cents per ordinary share. No other dividends have been declared by the Company in the fiscal years included in this report.

The Company publishes its consolidated financial statements expressed in Australian dollars. In this Annual Report, references to “U.S. dollars” or “US$” are to the currency of the United States of America (‘(“U.S.’”) and references to “Australian dollars” or “A$” are to the currency of Australia. For the convenience of the reader, this Annual Report contains translations of certain Australian dollar amounts into U.S. dollars at specified rates. These translations should not be construed as representations that the Australian dollar amounts actually represent such U.S. dollar amounts or could be converted into U.S. dollars at the rate indicated. Unless otherwise stated, the translations of Australian dollars into U.S. dollars have been made at the rate of US$0.77040.7432 = A$1.00, the foreign exchange rate as issued weekly by the Board of Governors of the Federal Reserve System (www.federalreserve.gov/releases) on June 30, 2015.2016. The rate on September 30, 20152016 was US$0.70200.7667 = A$1.001.00.

Exchange rates for the six months to September 2015

2016 A$ versus1.00 per US$

Exchange rates for the last five fiscal years

A$ versus1.00 per US$

As mentioned above, the Company paid an in-specie distribution of the shares of MEI held by Novogen Limited, on November 27, 2012 following shareholders’ approval at the Annual General Meeting held on November 17, 2012. This report has been prepared on the basis of the current business structure which excludes MEI and any other businesses or assets disposed of during the previous fiscal year. MEI and the Consumer Business show as discontinued operations.

Risk factors

Investment in our securities involves a high degree of risk. You should consider carefully the risks described below, together with other information in this Annual Report on Form 20-F and our other public filings, before making investment decisions regarding our securities. If any of the following events actually occur, our business, operating results, prospects or financial condition could be materially and adversely affected. This could cause the trading price of our common stock to decline and you may lose all or part of your investment. Moreover, the risks described below are not the only ones that we face. Additional risks not presently known to us or that we currently deem immaterial may also affect our business, operating results, prospects or financial condition.

The Company currently is exploring the development of anti-cancer drugs based on two unproven drug technology platforms. Failure of either or both of these platforms to prove suitable for drug candidate selection, may have a material adverse effect on our business and our financial conditioncondition.

The Company is committed to the identification ofdeveloping lead candidate anti-cancer drugs from two drug technology platforms, super-benzopyrans (‘SBP’(“SBP”) and anti-tropomyosins. Although earlyanti-tropomyosins (“ATM”). Early pre-clinical studies have confirmed the utility of both drug technology platforms in the generation of compounds with novel and potent cytotoxicity against various human cancer cell lines in vitro and in vivo, there arevivo. The Company was successful in gaining Investigational New Drug (“IND”) status from the U.S. Food and Drug Administration (“FDA”) for our lead SBP. While we have addressed early stage risk associated with toxicity, significant risks and uncertainties remain in translating those early laboratory results into drugs that will have meaningful clinical application and meetin the market place given the stringent requirementsclinical trial process that is required to achieve market approval. We are in the process of regulatory authorities such as the United States Food and Drug Administration (‘FDA’), who review Investigational New Drug (‘IND’) Applications to enable the conductour IND-enabling safety evaluation of first in man clinical trials.our lead ATM drug candidate so significant safety risk remains with this technology platform. The Company plans to submit an IND to the FDA to obtain the appropriate approvalsapproval to enable the trials.a Phase I trial of our lead ATM drug candidate.

Factors that have a negative impact on early drug candidate selection may include:

The Company’s ability to continue as a going concern is dependent on a continuing positive news flow from its pre-clinical Research & Development (‘(“R&D’&D”) programs, and its ability to raise capital to support those programsprograms.

The Company has limited cash resources and will need substantial additional funds to maintain the planned level of R&D. We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates. The impact on cash resources and results from operations will vary with the extent and timing of the future clinical trial program. While it is not possible to make accurate predictions of future operating results, we expect existing cash and cash equivalents will be sufficient to enable us to continue our research and development activities until approximately second quarter 2018.

The factors that will determine the actual amount of additional capital required may include the following:

If the Company is unable to obtain additional funds on favourablefavorable terms or at all, it may be required to cease or reduce its operations. Also, if the Company raises more funds by selling additional securities, the ownership interests of holders of its securities will be diluted.

We receive Australian government research and development grants. If we lose funding from these research and development grants, we may encounter difficulties in the funding of future research and development projects, which could harm our operating results.

We have historically received, and expect to continue to receive, grants through the Australian federal government’s Research and Development Tax Incentive program, under which the government provides a cash refund for the 45% of eligible research and development expenditures by small Australian entities, which are defined as Australian entities with less than A$20 million in revenue, having a tax loss. The Australian federal government’s Research and Development Tax incentive program cash refund changes from 45% to 43.5% from July 2016. The Research and Development Tax Incentive grant is made by the Australian federal government for eligible research and development purposes based on the filing of an annual application. We received Research and Development Tax Incentive grants in fiscal 2015 and 2016 of A$1.5 million and A$2.9 million, respectively. This grant is available for our research and development activities in Australia, as well as activities in the United States to the extent such U.S. based expenses relate to our activities in Australia, do not exceed half the expenses for the relevant activities and are approved by the Australian government. To the extent our research and development expenditures are deemed to be “ineligible,” then our grants would decrease. In addition, the Australian government may in the future decide to modify the requirements of, reduce the amounts of the grants available under, or discontinue the Research and Development Tax Incentive program. For instance, the Australian government recently received a recommendation from a review panel recommending a reduction of the amount of the grants available to small entities such as Novogen to a maximum of A$2 million per annum. Any such change in the Research and Development Tax Incentive program could have a material adverse effect on our future cash flows and financial position.

The Company is at an early stage of drug development and is in the process of applying for patents over composition and matter and use for both of its drug technology platforms. There is no certainty that patent protection will be grantedgranted.

The Company’sCompany has an extensive patent portfolio to protect its key assets. The patent strategy is adapted for each technology platform and the sub-sections of each platform. The over-arching strategy in a development stage. It comprises a certain numberthe IP portfolio is to cover the three critical corner stones of provisionalpharmaceutical patent: composition of matter (the breadth structures covered in the patent), method of manufacture (the chemical processes used to manufacture the compounds disclosed in the patent) and method of use. Our key patents thatcovering lead assets have been lodgedgranted in Australia and others that are at different stages of entering national phase in jurisdictions covering ~95% of the process of being lodged. The patents usually have worldwideglobal market as measured by sales. Consequently, the risk to our patent coverage with a particular focus on U.S., European Union (‘EU’), Asia and Australia.for our lead assets has been substantially reduced. While the Company’s patent strategy is closely supervised by experienced patent attorneys and every effort made to ensure the likely success of achieving approval of patent claims in all major territories, there is no guarantee that any or all territories will grant such claims.

Negative global economic conditions may pose challenges to the Company’s business strategy, which relies on access to capital from the markets or collaborators. Failure to obtain sufficient funding on acceptable terms could have a material adverse effect on our business, results of operations and financial conditioncondition.

Negative conditions in the global economy, including credit markets and the financial services industry, have generally made equity and debt financing more difficult to obtain, and may negatively impact the Company’s ability to complete financing transactions. The duration and severity of these conditions is uncertain, as is the extent to which they may adversely affect the Company’s business and the business of current and prospective vendors and collaborators. If negative global economic conditions persist or worsen, the Company may be unable to secure additional funding to sustain its operations or to find suitable collaborators to advance its internal programs, even if positive results are achieved from research and development efforts.

If we are unable to raise sufficient funding on acceptable terms, we may be unable to continue to operate. There is no assurance that we will be successful in obtaining sufficient financing on acceptable terms and conditions to fund continuing operations, if at all. Our failure to obtain sufficient funds on acceptable terms when needed could have a material adverse effect on our business, results of operations and financial condition.

Our Company has a history of incurring losses. The extent of any future losses, and whether or not the Company can generate profits, remains uncertainuncertain.

With the acquisition of Triaxial Pharmaceuticals Pty LtdThe Company is involved in 2012 and ongoingearly stage research and development the companyand has had a history of incurring losses andlosses. The Company is likely to continue to incur operating losses in the near future, until such time as any possible commercial breakthrough occurs.

The companyCompany incurred net losses of A$785,000 for year ended June 30, 2013, net losses of A$7,569,0007.6 million for year ended June 30, 2014, and net losses of A$7,306,0007.3 million for the year ended June 30, 2015.2015 and net losses of A$12.2 million for year ended June 30, 2016. As of June 30, 2015,2016, we have accumulated losses of A$148,445,000 (USD114,360,000)160.5 million (US$119.3 million) and the extent of any future losses and whether or not the Company can generate profits remains uncertain.

Final approval by regulatory authorities of the Company’s drug candidates for commercial use may be delayed, limited or prevented, any of which would adversely affect its ability to generate operating revenuesrevenues.

The Company will not generate any operating revenue until it, or its subsidiaries, successfully commercializes one of its drug candidates.candidates via Royalty and license agreements. Currently, the Company’s drug candidates are at an early stage of development, and each will need to successfully proceed through a number of steps in order to obtain regulatory approval before potential commercialization.

For example, any of the following factors may serve to delay, limit or prevent the final approval by regulatory authorities of the Company’s drug candidates for commercial use:

The successful development of any of these drug candidates is uncertain and, accordingly, the Company may never commercialise any of these drug candidates or generate revenue.

Even if the Company receives regulatory approval to commercialize its drug candidates, the ability to generate revenues from any resulting products will be subject to a variety of risks, many of which are out of the Company’s controlcontrol.

Even if the drug candidates obtainRegardless of regulatory approval, resulting products arising from the development process may not gain market acceptance among physicians, patients, healthcare payers or the medical community. The Company believes that the degree of market acceptance and its ability to generate revenues from such products will depend on a number of factors, including, but not limited to:

If any of the Company’s drugs are approved and fail to achieve market acceptance, the Company may not be able to generate significant revenue to achieve or sustain profitability.

The Company may not be able to establish the contractual arrangements necessary to develop, market and distribute the product candidates. Our failure to do so may adversely affect our business, results of operations and financial conditioncondition.

AThe Company has been successful in executing contractual agreements with strategic partners. This remains a key part of the Company’s business plan is to establish contractual relationships with strategic partners. Theand the Company must successfully contractcontinue to partner with third parties to package,manufacture clinical grade drug product, and conduct key pre-clinical and clinical investigations. Strategic agreements around packaging, branding, market access and distributedistribution for its product candidates.drug products will also eventually be required.

Potential partners maycould be discouraged by the Company’s limited operating history.

There is no assurance that the Company will be able to negotiate commercially acceptable licensing or other agreements for the future exploitation of its drug product candidates including continued clinical development, manufacture or marketing. If the Company is unable to successfully contract for these services, or if arrangements for these services are terminated, itthe Company may have to delay the commercialization program which will adversely affect its ability to generate operating revenues.

The Company’s commercial opportunity will be reduced or eliminated if competitors develop and market products that are more effective, have fewer side effects or are less expensive than its drug candidatescandidates.

The development of drug candidates is highly competitive.competitive and is high risk. A number of other companies have products or drug candidates in various stages of pre-clinical or clinical development that are intended for the same therapeutic indications for which the Company’s drug candidates are being developed. Some of these potential competing drugs are further advanced in development than the Company’s drug candidates and may be commercialized sooner. Even if the Company is successful in developing effective drugs, its compounds may not compete successfully with products produced by its competitors.

The Company’s competitors include pharmaceutical companies and biotechnology companies, as well as universities and public and private research institutions. In addition, companies active in different but related fields represent substantial competition. Many of the Company’s competitors developing oncology drugs have significantly greater capital resources, larger R&D staff and facilities and greater experience in drug development, regulation, manufacturing and marketing. These organizations also compete with the Company and its service providers, to recruit qualified personnel, and to attract partners for joint ventures and to license technologies. As a result, the Company’s competitors may be able to more easily develop technologies and products that would render the Company’s technologies or its drug candidates obsolete or non-competitive.

The Company relies on third parties to conduct its pre-clinical studies. If those parties do not successfully carry out their contractual duties or meet expected deadlines, the Company’s drug candidates may not advance in a timely manner or at allall.

In the course of discovery, pre-clinical testing and clinical trials, the Company relies on third parties, including laboratories, investigators, clinical contract research organizations (‘CROs’(“CROs”), and manufacturers, to perform critical services. For example, the Company relies on third parties to conduct all of its pre-clinical studies. These third parties may not be available when the Company needs them or, if they are available, may not comply with all regulatory and contractual requirements or may not otherwise perform their services in a timely or acceptable manner, and the Company may need to enter into new arrangements with alternative third parties and the studies may be extended, delayed or terminated. These independent third parties may also have relationships with other commercial entities, some of which may compete with the Company. As a result of the Company’s dependence on third parties, it may face delays or failures outside of its direct control. These risks also apply to the development activities of collaborators, and the Company does not control their research and development, clinical trial or regulatory activities.

The Company has no direct control over the cost of manufacturing its drug candidates. Increases in the cost of manufacturing the Company’s drug candidates would increase the costs of conducting clinical trials and could adversely affect future profitabilityprofitability.

The Company does not intend to manufacture the drug product candidates in-house, and it will rely on third parties for drug supplies both for clinical trials and for commercial quantities in the future. The Company has taken the strategic decision not to manufacture active pharmaceutical ingredients (‘API’(“API”) for the drug candidates, as these can be more economically supplied by third parties with particular expertise in this area. The Company plans to outsourceoutsources the manufacture of its drug product and testtesting of it to FDA requirements. The Company has identifieduses contract facilities that are registered with the FDA, have a track record of large scale API manufacture, and have already invested in capital and equipment. The Company has no direct control over the cost of manufacturing its product candidates. If the cost of manufacturing increases, or if the cost of the materials used increases, these costs may be passed on, making the cost of conducting clinical trials more expensive. Increases in manufacturing costs could adversely affect the Company’s future profitability if it was unable to pass all of the increased costs along to its customers.

The Company may face a risk of product liability claims and may not be able to obtain adequate insuranceinsurance.

The Company’s business exposes it to the risk of product liability claims. This risk is inherent in the manufacturing, testing and marketing of human therapeutic products. The Company has product liability insurance. The coverage is subject to deductibles and coverage limitations. The Company is in the process of identifying lead candidate compounds. When identified, and INDs are obtained they will be taken into the clinic. The Company may not be able to obtain or maintain adequate protection against potential liabilities, or claims may exceed the insurance limits. If the Company cannot or does not sufficiently insure against potential product liability claims, it may be exposed to significant liabilities, which may materially and adversely affect our business, results of operations and financial condition.

Enforceability of civil liabilities under the federal securities laws against the Company or the Company’s officers and directors may be difficultdifficult.

The Company is a public company limited by shares and is registered and operates under the Australian Corporations Act 2001. Some of the Company’s directors and officers reside outside of the United States. In addition, a substantial portion of the directly owned assets of the Company are located outside of the United States. As a result, it may be difficult or impossible for investors to effect service of process within the United States against the Company or its directors and officers or to enforce against them any of the judgments, including those obtained in original actions or in actions to enforce judgments of the U.S. courts, predicated upon the civil liability provisions of the federal or state securities laws of the United States. There is doubt as to the enforceability in the Commonwealth of Australia, in original actions or in actions for enforcement of judgments of U.S. courts, of civil liabilities predicated solely upon federal or state securities laws of the U.S., especially in the case of enforcement of judgments of U.S. courts where the defendant has not been properly served in Australia.

The trading price of the Company’s ordinary shares and American Depositary Receipts (‘ADRs’(“ADRs”) is highly volatile. Your investment could decline in value and the Company may incur significant costs from class action litigation and its securities may be delisted from NASDAQNASDAQ.

The trading price of the Company’s ordinary shares and ADRs is highly volatile in response to various factors, many of which are beyond the Company’s control, including:

In addition, equity markets in general and the market for biotechnology and life sciences companies in particular, have experienced substantial price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the companies traded in those markets. Further changes in economic conditions in Australia, the U.S., EU, or globally, could impact the Company’s ability to grow profitably. Adverse economic changes are outside the Company’s control and may result in material adverse effects on the Company’s business or results of operations. These broad market and industry factors may materially affect the market price of the Company’s ordinary shares and ADRs regardless of its development and operating performance. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against that company. Such litigation, if instituted against the Company, could cause it to incur substantial costs and divert management’s attention and resources.

If the market price of the Company’s ADRs remains below US$5.00 per share, under stock exchange rules, the Company’s stockholders will not be able to use such ADRs as collateral for borrowing in margin accounts. This inability to use ADRs as collateral may depress demand as certain institutional investors are restricted from investing in securities priced below US$5.00 and may lead to sales of such ADRs, creating downward pressure on and increased volatility in the market price of the Company’s ordinary shares and ADRs.

In addition, under NASDAQ rules, companies listed on the NASDAQ Capital Market are required to maintain a share price of at least US$1.00 per share and if the share price declines below US$1.00 for a period of 30 consecutive business days, then that listed company would have 180 days to regain compliance with the US$1.00 per share minimum. In the event that the Company’s share price declines below US$1.00, it may be required to take action, such as a reverse stock split, in order to comply with the NASDAQ rules that may be in effect at the time.

Because we are not necessarily required to provide you with the same information as an issuer of securities based in the United States, you may not be afforded the same protection or information you would have if you had invested in a public corporation based in the United States.

We are exempt from certain provisions of the Securities Exchange Act of 1934, as amended, commonly referred to as the Exchange Act, that are applicable to U.S. public companies, including (i) the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q or current reports on Form 8-K; (ii) the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; and (iii) the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time. The exempt provisions would be available to you if you had invested in a U.S. corporation.

However, in line with the Australian Securities Exchange regulations, we disclose our financial results on a semi-annual basis which are required to have a limited review semi-annually and to be fully audited annually. The information, which may have an effect on our stock price on the Australian Securities Exchange, will also be disclosed to the Australian Securities Exchange and the Securities Exchange Commission. Other relevant information pertaining to our Company will also be disclosed in line with the Australian Securities Exchange regulations and information dissemination requirements for listed companies. We will provide our semi-annual results and other material information that we make public in Australia in the U.S. under the cover of an SEC Form 6-K. Nevertheless, you may not be afforded the same protection or information, which would be made available to you, were you investing in a United States public corporation because the requirements of a Form 10-Q and Form 8-K are not applicable to us.

In certain circumstances, holders of ADSs may have limited rights relative to holders of ordinary shares.

An ADS refers to the individual share represented by the ADR program. The rights of holders of ADSs with respect to the voting of ordinary shares and the right to receive certain distributions may be limited in certain respects by the deposit agreement entered into by us and The Bank of New York Mellon. For example, although ADS holders are entitled under the deposit agreement, subject to any applicable provisions of Australian law and of our Constitution, to instruct the depositary as to the exercise of the voting rights pertaining to the ordinary shares represented by the ADSs, and the depositary has agreed that it will try, as far as practical, to vote the ordinary shares so represented in accordance with such instructions, ADS holders may not receive notices sent by the depositary in time to ensure that the depositary will vote the ordinary shares. This means that, from a practical point of view, the holders of ADRs may not be able to exercise their right to vote. In addition, under the deposit agreement, the depositary has the right to restrict distributions to holders of the ADSs in the event that it is unlawful or impractical to make such distributions. We have no obligation to take any action to permit distributions to holders of our ADSs. As a result, holders of ADSs may not receive distributions.

There is a substantial risk that we are, or will become, a passive foreign investment company, or PFIC, which will subject our U.S. investors to adverse tax rules

Holders of our ADSs who are U.S. residents face income tax risks. There is a substantial risk that we are, or will become, a passive foreign investment company, commonly referred to as a PFIC. Our treatment as a PFIC could result in a reduction in the after-tax return to the holders of our ADSs and would likely cause a reduction in the value of such ADSs. For U.S. federal income tax purposes, we will be classified as a PFIC for any taxable year in which either (i) 75% or more of our gross income is passive income, or (ii) at least 50% of the average value of all of our assets for the taxable year produce or are held for the production of passive income. For this purpose, cash is considered to be an asset that produces passive income. We believe that there is a risk we will be classified as a PFIC for the taxable year ended June 30, 2015.2016. If we are classified as a PFIC for U.S. federal income tax purposes, highly complex rules will apply to U.S. holders owning ADSs. Accordingly, you are urged to consult your tax advisors regarding the application of such rules.

United States residents should carefully read “Item 10.E. See Item 10 - Additional Information –- Taxation, United States

Federal Income Tax Consequences” in this Annual Report, for a more complete discussion of the U.S. federal income tax risks related to owning and disposing of our ADSs.

History and development of the Company

Novogen Limited, a public company limited by shares, was incorporated in March 1994 under the jurisdiction of the laws of New South Wales, Australia. Novogen is registered and operates under the Australian Corporations Act 2001 (Cth).2001. Novogen has its registered office at Level 1, 16-20 Edgeworth David Avenue,5, 20 George Street, Hornsby, New South Wales NSW 2077, Australia. Its telephone number and other contact details are: Phone +61-2-9472 4100; Fax +61-2-9476-0388; and website,www.novogen.com (the information contained in the website does not form part of the Annual Report). The Company’s Ordinary Shares are listed on the Australian Securities Exchange (‘ASX’(“ASX”) under the symbol ‘NRT’ and its ADRs, each representing twenty-five Ordinary Shares, trade on the NASDAQ Capital Market under the symbol ‘NVGN’. The Company’s Depositary infor the U.S. forCompany’s ADRs is The Bank of New York Mellon, 101 Barclay Street 22W New York, N.Y. 10286.

Business overview

Nature of the Business

Since its inception in 1994, the principal business of the Company has been pharmaceutical drug development. With the acquisition of Triaxial onin December 5, 2012, the Company continuedincreased its pharmaceutical drug research and development.

Corporate developments

Novogen

Board of Directors

The Company directors as at the date of this report are as follows:

Note 1 – Ian Phillips was appointed Interim Chairman on 1 July 2015

Note 2 – Iain Ross was re-appointed as Director and Acting CEO on 22 July 2015

Former directors who served during the financial year ended June 30, 2015:

More information on each of the current Directors is contained under item 6 “Directors, Senior Management and Employees” commencing on page 31.

Triaxial Pharmaceuticals Pty Ltd

OnIn December 5, 2012, the Company acquired the biotechnology company Triaxial Pharmaceuticals Pty Ltd (‘Triaxial’(“Triaxial”). Triaxial developed a novel technology platform allowing the design and construction of a novel family of compounds that Triaxial refers to as super-benzopyrans. The Company acquired the outstanding shares of Triaxial Pharmaceuticals Pty Ltd, including those of its shareholders Dr Graham Kelly, Dr Andrew Heaton and Robert Birch, who became directors of Novogen as a result of this transaction. 15.4 million Novogen shares were issued at a fair value of $0.09A$0.09 per share as part of the acquisition, the purchase price of which included a $1.5A$1.5 million loan, payable to the Triaxial shareholders.

OnIn December 4, 2014, the companyCompany and the convertible note holders, former shareholders of Triaxial, signed an amendment to the Convertible Note Deed Poll (‘Deed’(“Deed”) which superseded the precedent Loan Agreement between Triaxial shareholders and the Company.TheCompany. The amendment to the Deed extinguishes the liability created by the Loan Agreement, which was carried over to the original version of the Deed.

The amendment allowed the Company to convert the liability attached to the transaction into ordinary shares instead by removing the clauses allowing redemption in cash. The conditions of conversion into ordinary shares regarding the convertible notes are still dependent of the achievement of defined milestones established in the schedule of the Deed. Accordingly, the convertible notes have been reclassified as an equity instrument rather than debt instrument.

In August 2016, the Company announced the submission of an IND application with the FDA and, in September 2016, the Company received a letter from the FDA advising that the study may proceed. Accordingly, the Company advised the note holders of this conversion event and 20,000,000 ordinary shares were issued to the noteholders in September 2016.

CanTx Inc.

On November 4, 2013,CanTx, Inc., a subsidiary in which a wholly-owned subsidiary of the Company entered intoheld an 85% interest, was dissolved in May 2016. The dissolution was completed following a joint venture arrangement with Yale University (‘Yale’) and Prof Gil Mor. Novogen owns 85%decision to stop funding the operations of CanTx, and Prof Gil Mor and Yale own respectively 7.5%. The purpose of the joint venture company, CanTx Inc., (‘CanTx’) was to pool the resources of both parties in order to develop drugs for the treatment of ovarian cancer. A series of agreements underpin this joint venture. The first of those is a licensing agreement from the Company to CanTx that allows CanTx to access the Company patent portfolio of super-benzopyrans drugs in order to identify a lead candidate compound for its objective of developing an intra-abdominal product capable of treating any intra-abdominal cancer, but with a particular focus on ovarian cancer. A corporate sponsored research agreement between Yale and CanTx gave CanTx access to certain Yale cell culture technology and animal models and facilities and resources. This agreement between CanTx and Yale identified the appropriate research plan to be undertaken by Yale, and a shareholders’ agreement between all parties comprised a commitment from the Company to fund CanTx for up to three years for up to a maximum of $2 million. Yale and CanTx devised a construct comprising Trx-1 in a guided drug delivery system and commenced animal studies to investigate its utility both as an intra-peritoneal and intravenous product for the treatment of ovarian cancer.

Other

On October 8, 2013, the Company announced the acquisition of the anti-tropomyosin technology from Genscreen Pty Ltd.

On May 2, 2014, the Company announced a partnership with Genea Biocells Pty Ltd to investigate promising new approaches using the super-benzopyrans technology to treat neurodegenerative and musculodegenerative diseases.

On May 5, 2014, the Company joined CODA (the Children’s Oncology Drug Alliance) to facilitate the development of treatments for childhood cancers, using both the super-benzopyran and anti-tropomyosin drug technology platforms.

On May 27, 2014, the Company announced that it had a key milestone with its SBP drug program, having identified a number of SBP compounds with potent anti-cancer activity against human prostate cancer cellsin vitro.

On June 17 2014, the Company announced the success of proof-of-concept pre-clinical studies confirming the potency of experimental drug TRX-1, in the treatment of primary of ovarian cancer when delivered into the peritoneal cavity.

On October 1, 2014, the Company announced that it had received guidance from the US Food and Drug Administration (FDA) on the process to bring the experimental drug product, Cantrixil, into the clinic in the US for the treatment of late-stage ovarian cancer.

On October 22, 2014, the Company announced results of two completed studies of one of its lead candidate compounds, TRX-E-009-1, confirming its ability to kill paediatric brain cancer cells – diffuse intrinsic pontine glioma (DIPG) and paediatric neuroblastoma cells – and clearing the way for the compound to come into the clinic as a potential treatment of childhood cancers.

On November 21, 2014 the Company announced that it had identified its lead anti-tropomyosin (ATM) drug candidate.

On December 16, 2014, the Company announced that it had confirmed that its lead candidate product, TRXE-009, originally developed for the treatment of brain cancers, had shown in pre-clinical studies to be highly active against melanoma.

On January 16, 2015, the Company announced an important discovery in its regenerative medicine program that had delivered a key proof-of-concept step forward in the quest to develop drugs capable of stimulating the function of brain tissue stem cells.

On February 11, 2015, the Company announced the lodgement of final specifications of a patent that covers the Company’s first family of super-benzopyran compounds, which yielded leading drug candidates, TRXE-002, TRXE-009 and TRXE-0025.

On March 4, 2015, the Company announced that it had confirmed that one of its lead candidate products, TRXE-009, was showing the potential to become an important new therapy in the fight against adult and paediatric brain cancer.

On April 9, 2015, the Company announced that studies conducted at The University of Queensland Diamantina Institute revealed that Anisina killed melanoma cells irrespective of their mutational status.

On April 17, 2015, the Company announced that it had signed a Memorandum of Understanding with the Feinstein Institute for Medical Research of New York to collaborate with the objective of developing effective treatments for brain cancers.

On April 22, 2015, the Company announced that it had received notification from the U.S. Food and Drug Administration (FDA) that its chemotherapy candidate drug, Cantrixil, had been granted Orphan Drug Designation for ovarian cancer.

On May 8, 2015, the Company announced that TRXE-009 confirmed its potential to become an important new therapy against an incurable paediatric brain cancer, DIPG (diffuse intrinsic pontine glioma).

On May 15,July 16, 2015, the Company announced that it had confirmed that itshas received orphan drug candidate, Anisina, was an effective monotherapy against human melanoma in an animal model.status designation from the FDA for Anisina.

On May 28, 2015,February 19, 2016, the Company announced the lodgement with the US Patent Office of a key patent covering a novel family of compounds within the Company’s anti-tropomyosin (ATM) drug technology platform.Cantrixil and Trilexium has proceeded to grant.

On June 5, 2015, the Company announced that a lipid formulation of TRXE-009 dosed intravenously to animals was able to deliver therapeutic concentrations of TRXE-009 to brain tissue, confirming that the drug was able to cross the blood brain barrier.

On June 24, 2015, the Company announced that its candidate cytotoxic chemotherapy drug, Anisina, has proved an effective anti-cancer agent in animals, the result of which it now has been fast-tracked by the Company to come into the clinic

On July 14, 2015, the Company announced details of an in vivo proof of concept study that demonstrates their lead anti-tropomyosin drug candidate, Anisina, has the potential to improve the effectiveness of chemotherapy in children and reduce life-long side-effects.

On July 22, 20152016, the Company announced the resignation of CEO and the appointment of new Director and Acting CEO.patent covering Anisina has proceeded to grant.

On July, 30, 2015,September 12, 2016, the Company confirmed its commitment to progressing its ground-breaking technology platforms to Phase 1 clinical trials as soon as practicable.

On October 21, 2015,announced the Company disclosed key pre-clinical data generated in an animal model of recurrent ovarian cancer suggesting thatFDA approved the experimental anti-cancer drug, Cantrixil, may have utility as an adjuvant therapy when dosed in combination with platinum-based drugs.IND application for Cantrixil.

Capital raising

In June 2014, the Board adopted a strategy intended to provide the Company with sufficient funding for the foreseeable future and to sustain the Company as a going concern. The strategy was to raise capital in several tranches through the placement of new securities to underwrite Company plans for an active R&D program, with the goal of bringing at least two and possibly a third new drug into clinical testing by the end of 2015.

During the financial year the Company raised cash amounting to approximately A$50,356,000 and issued 254,558,631 ordinary shares.

See Item 5 – Operating and Financial Review and Prospects – Fundraising campaigns.

Research and developmentDevelopment

The Company has two drug technology platforms –- Superbenzopyran (SBP) and Anti-tropomyosin (ATM) –- around which the Company has established very strong patent positions, and made considerable advances overin fiscal 2016.

Cantrixil: From an operational perspective we successfully prepared and lodged our IND Application for our lead drug candidate Cantrixil (TRXE-002-1) with the last 12 months.FDA. This application consisted of the pharmacology, toxicology, Chemistry, Manufacturing Controls and Clinical protocol documentation considered requisite for an IND submission. The medicinal chemistry programs have identified two promising drug candidates, oneTRXE-002-1 pharmacology data was published in the prestigious American Association for Cancer Research (“AACR”) journal “Molecular Cancer Therapeutics” and the Toxicology data was presented at the 2016 Annual Conference of the American Association for Cancer Research. The Company successfully gained IND status from each platform (Cantrixilthe FDA for TRXE-002-1 enabling us to execute our Phase I trial, and Anisina), whichfinalised agreements with Quintiles, the Clinical Research Organisation contracted to oversee the TRXE-002-1 Phase I clinical trial and identify hospital trial sites to conduct the Phase I trial.

Anisina: The Company is progressing down the translational development path in concert.

The proprietary SBP technology was incorporated into Novogen after its acquisitioncurrently preparing Anisina (ATM-3507) pharmacology proof-of-concept reports and identifying target cancer indication(s) and completing scale up manufacture of Triaxial Pharmaceuticals Pty Ltd in December 2012. Cantrixil, the Company’s first lead SBP drug candidate is being developed by its partially owned subsidiary CanTx (a joint venture between Yale University and Novogen). The planned route of administration for the Cantrixil drug-candidate is via injection into the peritoneal cavity. Pre-clinical studies have confirmed that Cantrixil induces cell death in both differentiated cancer cells and tumour initiating cells, those cells thought to be primarily responsible for cancer recurrence post chemotherapy. At a pre-IND meeting with the US Food and Drug Administration (FDA), the FDA agreed with our strategy on manufacturing and toxicology evaluation. Subsequent to this meeting, the Company has been able to produce both the activeATM-3507 drug substance and drug product to a quality that conforms to Good Laboratory Practice (GLP) standards. Critically the drug has shown an excellent stability profileGLP standards for formal safety pharmacology and all manufacturing processes have proven robust and scalable.toxicity studies. The Company has initiated the requisite IND-enabling safety studies and commenced a safety evaluation program ofdocument preparation for the Cantrixil drug candidate with the aim of gaining Investigational New Drug (IND) status with the Food and Drug Administrations (FDA). This evaluation will characterize the toxicology signals associated with the experimental drug and correlate any toxicities with drug concentrations achieved in mammalian models. ResultsATM-3507 IND submission to date indicate that the drug is associated with gastrointestinal toxicity manifest as diarrhoea and some haematological toxicity (anaemia) and potential cardiovascular signals in in vitro studies. The Company anticipates completing the Cantrixil toxicology evaluation by the end of 2015. This information will enable regulators, such as the FDA and clinical investigators to assess the drug’s safety, ascribe a starting dose in humans, and establish AE/SAE monitoring criteria in humans.

The Company has assembled a Medical Study Committee for Cantrixil and commenced writing theahead of commencing our Phase I clinical trial protocol where it will assess the safety and tolerability of Cantrixil in late stage cancer patients. The Company is also planning to conduct a second trial in women with late-stage ovarian cancer who have become unresponsive to standard of care therapy once it has received IND status for Cantrixil from the FDA. The FDA recently granted Cantrixil Orphanon this drug status for ovarian cancer. Progress and timing of these clinical studies will depend upon the outcome of the toxicology program and therefore it is not possible at this stage to be precise as to when clinical studies will commence. However the Company continues to aim to start the trials in 2016.

Pre-clinical studies have demonstrated that Anisina, a first-in-class ATM small molecule drug candidate, is able to target a protein component of the actin microfilaments, tropomyosin Tpm3.1, which is essential for tumor cell survival. In vitro studies confirm that inhibition of Tpm3.1 function impacts the structural integrity of the cancer cells cytoskeleton causing the cancer cell to die. In addition to having anti-cancer properties, these ATM compounds are also novel in that when administered to tumour-bearing nude mice and used in combination they enhance the anti-proliferative effect of one of the most widely used classes of chemotherapy drugs in cancer – the anti-microtubules. Preclinical studies are underway to validate the effectiveness of Anisina in animal models of adult and pediatric cancers both on its own and in combination with standard of care microtubule inhibitors. Importantly, a proof of concept study done in an animal cancer model as part of the Children’s Oncology Drug Alliance (CODA) has confirmed that Anisina is not only effective on its own in reducing neuroblastoma tumor growth but also enhances the sensitivity of cancer cells to microtubule targeting compounds.candidate. The Company has successfully optimizedalso completed manufacture of cGMP drug substance to be used in the Anisina manufacturing process using a process that is scalable, and meets GLP standards.ATM-3507 Phase I trial.

Trilexium: The Company has identified the Trilexium (TRXE-009-1) drug target, mechanism of action and target cancer indication(s); generated proof-of-concept data in animal models of cancer, and are currently in the process of optimising drug product formulation to be used intake forward into safety-pharmacology and toxicity studies ahead of progressing into the clinic which enabled the initiation of an Anisina toxicology program with a view to filing an IND with the FDA.this molecule.

Discovery: The Company has assembledidentified a Medical Advisory Boardseries of pipeline molecules from the second-generation super-benzopyran technology platform (AD-HET system) and a series of pipeline molecules from the next generation N-terminal targeting anti-tropomyosin family (termed 6500).

Intellectual Property: The Company has substantially strengthened the IP estate around the SBP and ATM technology platforms and has begun national phase roll out into international jurisdictions for Anisina and, based on its pharmacology package, anticipates initially taking Anisina through to the clinic, pending successful completion if the safety assessment, as an IV delivered drug in combination with taxanes or vinca alkaloids. Further studies are ongoing to identify the adult cancer indication for Anisina. The FDA recentlycurrent granted Anisina Orphan drug status for neuroblastoma. Pending the outcome of the Anisina toxicology program and discussions with the FDA, the first-in-human studies are predicted to start in 2016.

Trilexium (TRXE-009), the Company’s second lead SBP drug candidate, is behind the development timeline of Anisina and Cantrixil. Pre-clinical studies have shown that Trilexium induces cell death in a panel of cancer cells via caspase-mediated apoptosis. Researchers have also demonstrated tumor growth inhibition in several other animal models of cancer. Further pre-clinical studies are current to identify the optimal formulation and target indication. Once the optimal drug product has been identified, the Company will commence the requisite toxicology program prior to the conduct of a first-in-human trial in 2016/2017.

Jacob Hope research consists of three discovery programs: Regenerative Medicine Program, Facioscapulohumeral muscular dystrophy (FSHD) program and Lysosomal Storage Disorder (LSD). Given the data achieved to date inOther technologies: Results from the Regenerative Medicine, and FSHDLysosomal storage disorder research programs did not justify further R&D expenditure. However, we did observe some positive data from the Company intends to pursue patent protection around the discrete SBP pharmacophores that are attributable to either potentiating neurogenesis in the Regenerative Medicine Program, or normalizing the myotube phenotype in the FSHD program. The Company will also endeavour to protect any SBP pharmacophore that is active in the LSD setting. This patent protection strategy will increase the intrinsic value of eachFacioscapulohumeral muscular dystrophy (“FSHD”) program and establish a priority date from anwe are currently pursuing several development opportunities. Our decision to focus on Oncology drug development has allowed us to meet key development, intellectual property perspective thereby enabling the Company to re-visit each program that has promise when funds and time permits.regulatory milestones for our lead oncology assets.

Patent Protection

The companyCompany has an aggressive global Intellectual Property (IP)(“IP”) strategy to protect its key assets and we have partnered with a global patent law firm to lodge patents that offer the best possible protection for our assets. The patent strategy is adapted for each technology platform and the principle mode of protection is through the patenting procedure, seeking to obtain exclusive licences for all its key inventions and drug pipeline. The company’sover-arching strategy in the IP portfolio is to cover the three critical corner stones of pharmaceutical patent: composition of matter (the breadth structures covered in the patent), method of manufacture (the chemical processes used to manufacture the compounds disclosed in the patent) and method of use. The Company’s IP is centredcentered around two key technology platforms; the super benzopyrans (SBP’s)super-benzopyrans (SBPs) and the anti tropomyosins (ATM’s). Each of these technology platforms is delivering hit and lead drug candidates; as part of the companies drug discovery/development pipeline. As the research programs reveal new discoveries these are protected through lodging patents. The company has partnered with the global patent law firm, K & L Gates, to lodge patents that offer the best possible protection of our IP assets. The patent philosophy is to protect the three key cornerstones of the invention of a drug: composition of matter (the drug itself), method of manufacture (capturing new manufacturing methods) and method of use (covering the use of the drug to treat certain diseases)anti-tropomyosins (ATMs). Patents are submitted initially as provisional applications and after 12 monthsmonths’ progress through to a Patent Cooperation Treaty (‘PCT’(“PCT”) application. The company hasOur key patents covering lead assets, Cantrixil, Trilexium (both SBP assets) and Anisina (ATM asset) have been successful in lodging several provisional applications covering the SBP technology platform, one of which has progressed through to PCT status and has been accepted in Australia. This patent covers the key SBP assets of Cantrixil and Trilexium and is expected to be fully granted in Australia and are at different stages of entering national phase in Feb 2016. The ATM technology platform has also been the subject of significant IP protection, with severaljurisdictions covering approximately 95% of the key ATM provisional patent applications having movedglobal market as measured by sales.

Drug discovery/development efforts are contributing to PCT. The key PCT coveringour pipeline with our other technology platforms also delivering hit and lead drug candidates. As the lead ATM Anisina being granted “pending-acceptance” status in Australia with this patent expected to be fully granted in May 2016.research programs reveal new hit molecules, these are protected through lodging patents. The Company pursueswill continue to pursue a broad patent filing strategy based on multiple jurisdictions with particular attention paid toa focus on those member countries offering the most significant market opportunities for its future products.development.

Australian GovernmentKey developments during fiscal 2016 include:

Regulatory requirements

Australian Regulatory Requirements

TheTherapeutic Goods Act 1989 (‘(“1989 Act’Act”), sets out the legal requirements for the import, export, manufacture and supply of pharmaceutical products in Australia. The 1989 Act requires that all pharmaceutical products to be imported into, supplied in, manufactured in or exported from Australia be included in the Australian Register of Therapeutic Goods (‘ARTG’(“ARTG”), unless specifically exempted under the Act.

Medicines with a higher level of risk (prescription medicines, some non-prescription medicines) are evaluated for quality, safety and efficacy and are registered on the ARTG. Medicines with a lower risk (many over the counter medicines including vitamins) are assessed only for quality and safety. Medicines included in the ARTG can be identified by the AUST R number (for registered medicines) or an AUST L number (for listed medicines) which appears on the packaging of the medicine.

In order to ensure that a product can be included in the ARTG, a sponsoring company must make an application to the Therapeutic Goods Administration (‘TGA’(“TGA”). The application usually consists of a form accompanied by data (based on the EU requirements) to support the quality, safety and efficacy of the product for its intended use and payment of a fee. Application details are available on the TGA websitewww.tga.gov.au.

The first phase of evaluation, known as the Application Entry Process, is usually a short period during which an application is assessed at an administrative level to ensure that it complies with the basic guidelines. The TGA may request further details from the applicant, and may agree with sponsors that additional data (which while not actually required by the application, could enhance the assessment outcome) may be submitted later at an agreed time. The TGA must decide within at least 40 working days whether it will accept the application for evaluation.

Once an application is accepted for evaluation, aspects of the data provided are allocated to evaluators within the different relevant sections, who prepare clinical evaluation reports. Following evaluation, the chemistry, quality control bioavailability and pharmacokinetics aspects of a product may be referred to a Pharmaceutical Sub-Committee (‘PSC’(“PSC”), which is a sub-committee of the TGA prescription medicine expert advisory committee, the Advisory Committee on Prescriptive Medicines (‘ACPM’(“ACPM”) to review the relevant clinical evaluation reports.

The clinical evaluation reports (along with any resolutions of the ACPM sub-committee) are then sent to the sponsoring company who then has the opportunity to comment on the views expressed within the evaluation report, provide corrections and to submit supplementary data to address any issues raised in the evaluation reports.

Once the evaluations are complete, the TGA prepares a summary document on the key issues on which advice will be sought from either the ACPM (for new medicines) or from the Peer Review Committee (‘PRC’(“PRC”) for extensions to products which are already registered. This summary is sent to the sponsoring company, which is able to submit a response to the ACPM or PRC dealing with issues raised in the summary and those not previously addressed in the evaluation report. The ACPM/PRC provide independent advice on the quality, risk-benefit, effectiveness and access of the product and conduct medical and scientific evaluations of the application. The ACPM meets every two months to examine the applications referred by the TGA and its resolutions are provided to the sponsoring company after five working days after the ACPM meeting.

The TGA takes into account the advice of the ACPM or PRC in reaching a decision to approve or reject a product. Any approval for registration on the ARTG may have conditions associated with it.

From the time that the TGA accepts the initial application for evaluation, the TGA must complete the evaluation and make a decision on the registration of the product within at least 255 working days. If not completed within 255 working days, the TGA forfeits 25% of the evaluation fee otherwise payable by the sponsor, but any time spent waiting for a response from the sponsor is not included in the 255 working days. The TGA also has a system of priority evaluation for products that meet certain criteria, including where the product is a new chemical entity that it is not otherwise available on the market as an approved product, and is for the treatment of a serious, life-threatening illness for which other therapies are either ineffective or not available.

U.S. Regulatory Requirements

The FDA regulates and imposes substantial requirements upon the research, development, pre-clinical and clinical testing, labelling, manufacture, quality control, storage, approval, advertising, promotion, marketing, distribution, import and export of pharmaceutical products including drugs and biologics, as well as significant reporting and record-keeping obligations. State governments may also impose obligations in these areas.

In the U.S., pharmaceutical products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (‘FDCA’(“FDCA”), and other laws in the case of biologics, the Public Health Service Act and other acts that implement regulations. The Company believes that the FDA will regulate its products as drugs. The process required by the FDA before drugs may be marketed in the U.S. generally involves the following:

The testing and approval process requires substantial time, effort, and financial resources, and the Company cannot be certain that any approval will be granted on a timely basis, if at all.

The results of the pre-clinical studies, clinical experience together with initial specified manufacturing information, the proposed clinical trial protocol, and information about the participating investigators are submitted to the FDA as part of an IND, which must become effective before the Company may begin human clinical trials in the U.S. Additionally, an independent IRB must review and approve each study protocol and oversee conduct of the trial. An IND becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises concerns or questions about the conduct of the trials as outlined in the IND and imposes a clinical hold. If the FDA imposes a clinical hold, the IND sponsor must resolve the FDA’s concerns before clinical trials can begin. Pre-clinical tests and studies can take several years to complete, and there is no guarantee that an IND submitted, based on such tests and studies, will become effective within any specific time period, if at all.

Human clinical trials are typically conducted in three sequential phases that may overlap, which are:

The Company cannot be certain that it will successfully complete Phase I, Phase II or Phase III testing of its products within any specific time period, if at all. Furthermore, the FDA, the IRB or the Company may suspend or terminate clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

Results of pre-clinical studies and clinical trials, as well as detailed information about the manufacturing process, quality control methods, and product composition, among other things, are submitted to the FDA as part of an NDA seeking approval to market and commercially distribute the product on the basis of a determination that the product is safe and effective for its intended use. Before approving an NDA, the FDA will inspect the facilities at which the product is manufactured and will not approve the product unless GMP compliance is satisfactory. If applicable regulatory criteria are not satisfied, the FDA may deny the NDA or require additional testing or information. As a condition of approval, the FDA also may require post-marketing testing or surveillance to monitor the product’s safety or efficacy. Even after an NDA is approved, the FDA may impose additional obligations or restrictions (such as labelling changes), or even suspend or withdraw a product approval on the basis of data that arise after the product reaches the market, or if compliance with regulatory standards is not maintained. The Company cannot be certain that the FDA on a timely basis, if at all will approve any NDA it submits. Also, any such approval may limit the indicated uses for which the product may be marketed. Any refusal to approve, delay in approval, suspension or withdrawal of approval, or restrictions on indicated uses could have a material adverse impact on the Company’s business prospects.

A user fee, pursuant to the requirements of the Prescription Drug User Fee Act (‘PDUFA’(“PDUFA”), and its amendments, must accompany each NDA. According to the FDA’s fee schedule, effective on October 1, 2015, for the fiscal year 2016,2017, the user fee for an application requiring clinical data, such as an NDA, is US$2,374,200.2,038,100. The FDA adjusts the PDUFA user fees on an annual basis. PDUFA also imposes an annual product fee for prescription drugs and biologics (US$114,450)97,750), and an annual establishment fee (US$585,200)512,200) on facilities used to manufacture prescription drugs and biologics. A written request can be submitted for a waiver under certain circumstances. Waivers may be possible for the application fee for the first human drug application that is filed by a small business, as defined by the FDCA, but there are no small business waivers for product or establishment fees. Waivers may also be possible for one or more fees, upon written request, when a waiver or reduction is necessary to protect the public health, the user fees would present a significant barrier to innovation, or the fees are anticipated to exceed the present or future costs incurred by FDA. The Company is not at the stage of development with its products where it is subject to these fees, but they are significant expenditures that may be incurred in the future and must be paid at the time of application submissions to FDA.

Satisfaction of FDA requirements typically takes several years. The actual time required varies substantially, based upon the type, complexity, and novelty of the pharmaceutical product, among other things. Government regulation imposes costly and time-consuming requirements and restrictions throughout the product life cycle and may delay product marketing for a considerable period of time, limit product marketing, or prevent marketing altogether. Success in pre-clinical or early stage clinical trials does not ensure success in later stage clinical trials. Data obtained from pre-clinical and clinical activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit, or prevent marketing approval. Even if a product receives marketing approval, the approval is limited to specific clinical indications. Further, even after marketing approval is obtained, the discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.

After product approval, there are continuing significant regulatory requirements imposed by the FDA, including record-keeping requirements, obligations to report adverse events in patients using the products, and restrictions on advertising and promotional activities. Quality control and manufacturing procedures must continue to conform to GMPs, and the FDA periodically inspects facilities to assess GMP compliance. Additionally, post-approval changes in ingredient composition, manufacturing processes or facilities, product labelling, or other areas may require submission of a NDA Supplement to the FDA for review and approval. New indications will require additional clinical studies and submission of a NDA Supplement. Failure to comply with FDA regulatory requirements may result in an enforcement action by the FDA, including warning letters, product recalls, suspension or revocation of product approval, seizure of product to prevent distribution, impositions of injunctions prohibiting product manufacture or distribution, and civil and criminal penalties. Maintaining compliance is costly and time-consuming. The Company cannot be certain that it, or its present or future suppliers or third-party manufacturers, will be able to comply with all FDA regulatory requirements, and potential consequences of non-compliance could have a material adverse impact on its business prospects.

The FDA’s policies may change, and additional governmental regulations may be enacted that could delay, limit, or prevent regulatory approval of the Company’s products or affect its ability to manufacture, market, or distribute its products after approval. Moreover, increased attention to the containment of healthcare costs in the U.S. and in foreign markets could result in new government regulations that could have a material adverse effect on the business. The Company’s failure to obtain coverage, an adequate level of reimbursement, or acceptable prices for future products could diminish any revenues the Company may be able to generate. The Company’s ability to commercialize future products will depend in part on the extent to which coverage and reimbursement for the products will be available from government and health administration authorities, private health insurers, and other third-party payers. EU member states and U.S. government and other third-party payers increasingly are attempting to contain healthcare costs by consideration of new laws and regulations limiting both coverage and the level of reimbursement for new drugs. The Company cannot predict the likelihood, nature or extent of adverse governmental regulation that might arise from future legislative or administrative action, either in the U.S. or abroad.

The Company’s activities may also be subject to state laws and regulations that affect its ability to develop and sell products. The Company is also subject to numerous federal, state, and local laws relating to such matters as safe working conditions, clinical, laboratory, and manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. The Company may incur significant costs to comply with such laws and regulations now or in the future, and the failure to comply may have a material adverse impact on the Company.

The FDCA includes provisions designed to facilitate the development and expedite the review of drugs and biological products intended for treatment of serious or life-threatening conditions that demonstrate the potential to address unmet medical needs for such conditions. These provisions set forth a procedure for designation of a drug as a “fast track product”. The fast track designation applies to the combination of the product and specific indication for which it is being studied. A product designated as fast track is ordinarily eligible for additional programs for expediting development and review, but products that are not in fast-track drug development programs may also be able to take advantage of these programs if they meet the necessary requirements. These programs include priority review of NDAs and accelerated approval. Drug approval under the accelerated approval regulations may be based on evidence of clinical effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. A post-marketing clinical study will be required to verify clinical benefit, and other restrictions to assure safe use may be imposed.

Under the Drug Price Competition and Patent Term Restoration Act of 1984, a sponsor may obtain marketing exclusivity for a period of time following FDA approval of certain drug applications, regardless of patent status, if the drug is a new chemical entity or if new clinical studies were required to support the marketing application for the drug. This marketing exclusivity prevents a third party from obtaining FDA approval for an identical or nearly identical drug under an Abbreviated New Drug Application or a “505(b)(2) New Drug Application”. The statute also allows a patent owner to obtain an extension of applicable patent terms for a period equal to one-half the period of time elapsed between the filing of an IND and the filing of the corresponding NDA plus the period of time between the filing of the NDA and FDA approval, with reductions taken for any time an applicant did not act with due diligence. There is a five yearfive-year maximum patent extension and a maximum of 14 years protection from product approval. The Company cannot be certain that it will be able to take advantage of either the patent term extension or marketing exclusivity provisions of these laws.

The Best Pharmaceuticals for Children Act (‘BPCA’(“BPCA”), signed into law on January 4, 2002, was reauthorized and amended by the FDA Amendments Act of 2007 (‘FDAAA’(“FDAAA”). The reauthorization of BPCA provides an additional six months of exclusivity to NDA applicants that conduct and file acceptable paediatric studies of new and currently marketed drug products for which paediatric information would be beneficial, as identified by FDA in a Paediatric Written Request. The Paediatric Research Equity Act (‘PREA’(“PREA”), signed into law on December 3, 2003, also was reauthorized and amended by FDAAA. The reauthorization of PREA requires that most applications for drugs and biologics include a paediatric assessment (unless waived or deferred) to ensure the drugs’ and biologics’ safety and effectiveness in children. Such paediatric assessment must contain data, gathered using appropriate formulations for each age group for which the assessment is required, that are adequate to assess the safety and effectiveness of the drug or the biological product for the claimed indications in all relevant paediatric subpopulations, and to support dosing and administration for each paediatric subpopulation for which the drug or the biological product is safe and effective. The paediatric assessments can only be deferred provided there is a timeline for the completion of such studies. The FDA may partially waive or fully waive the paediatric assessment requirement for several reasons, including if the applicant can demonstrate that necessary studies are impossible or highly impracticable. The FDA Safety and Innovation Act permanently renewed and strengthened BPCA and PREA.

European Union Regulatory Requirements

Outside the U.S., the Company’s ability to market its products will also be contingent upon receiving marketing authorizations from the appropriate regulatory authorities and compliance with applicable post-approval regulatory requirements. Although the specific requirements and restrictions vary from country to country, as a general matter, foreign regulatory systems include risks similar to those associated with FDA regulation, described above. Under EU regulatory systems, marketing authorizations may be submitted either under a centralized or a national procedure. Under the centralized procedure, a single application to the European Medicines Agency (‘EMA’(“EMA”) leads to an approval granted by the European Commission that permits the marketing of the product throughout the EU. The centralized procedure is mandatory for certain classes of medicinal products, but optional for others. For example, all medicinal products developed by certain biotechnological means, and those developed for cancer and other specified diseases and disorders, must be authorized via the centralized procedure. The Company assumes that the centralized procedure will apply to its products that are developed by means of a biotechnology process. The national procedure is used for products not requiring authorization by the centralized procedure. Under the national procedure, an application for a marketing authorization is submitted to the competent authority of one memberone-member state of the EU. The holders of a national marketing authorization may submit further applications to the competent authorities of the remaining member states via either the decentralized or mutual recognition procedure. The decentralized procedure enables applicants to submit an identical application to the competent authorities of all member states where approval is sought at the same time as the first application, while under the mutual recognition procedure, products are authorized initially in one memberone-member state, and other member states where approval is sought are then requested to recognize the original authorization based upon an assessment report prepared by the original authorizing competent authority. Both the decentralized and mutual recognition procedures should take no longer than 90 days, but if one memberone-member state makes an objection, which under the legislation can only be based on a possible risk to human health, the application will be automatically referred to the Committee for Medicinal Products for Human Use (‘CHMP’(“CHMP”) of the EMA. If a referral for arbitration is made, the procedure is suspended. However, member states that have already approved the application may, at the request of the applicant, authorize the product in question without waiting for the result of the arbitration. Such authorizations will be without prejudice to the outcome of the arbitration. For all other concerned member states, the opinion of the CHMP, which is binding, could support or reject the objection or alternatively could reach a compromise position acceptable to all EU countries concerned. The arbitration procedure may take an additional year before a final decision is reached and may require the delivery of additional data.

As with FDA approval, the Company may not be able to secure regulatory approvals in the EU in a timely manner, if at all. Additionally, as in the U.S., post-approval regulatory requirements, such as those regarding product manufacture, marketing, or distribution, would apply to any product that is approved in the EU, and failure to comply with such obligations could have a material adverse effect on the Company’s ability to successfully commercialize any product.

The conduct of clinical trials in the EU is governed by the European Clinical Trials Directive (2001/20/EC), which was implemented in May 2004. This Directive governs how regulatory bodies in member states control clinical trials. No clinical trial may be started without a clinical trial authorization granted by the national competent authority and favorable ethics approval.

Accordingly, there is a marked degree of change and uncertainty both in the regulation of clinical trials and in respect of marketing authorizations that face the Company or its products in the EU.

Stock market listing compliance

On November 7, 2014, NASDAQ notified the Company that it did not comply with Listing Rule 5550(b) (Rule), which requires a minimum $2,500,000 stockholders’ equity, $35,000,000 market value of listed securities, or $500,000 net income from continuing operations.

The Company submitted a plan to regain compliance on December 18, 2014 and January 19, 2015 (‘Submission’(“Submission”).

Following the Submission, NASDAQ granted on January 26, 2015 an extension to regain compliance with the Rule.

On April 28, 2015, NASDAQ advised the Company that it had regainregained full compliance with the Rule.

The Company has met the compliance requirements for ASX listings and accordingly has not been in breach of those requirements.

Organizational structure

Corporate structure

Novogen Limited is a public company limited by sharesincorporated in Australia and is incorporated and domiciled in Australia. Novogen Limited and its controlled entities have prepared a consolidated financial report incorporating the entities that Novogen Limited controlled as at the end of fiscal year 2015, which includedhas the following controlled entities:wholly-owned subsidiaries:

On 31 May 2016, the Company merged its U.S. fully owned subsidiary Novogen, Inc. with Novogen North America, Inc. The merger was completed to simplify the group’s structure. The Company also approved the dissolution of Cantx, Inc., a subsidiary in which Novogen North America, Inc. held an 85% interest. The dissolution of Cantx, Inc. was completed on 31 May 2016.

Property, plant and equipment

The Company leases moderate office space in Hornsby, New South Wales, Australia, which is used as its corporate headquarters. The Company has entered into two short term leases on this property which expires in May 2016. On renewal, the terms of the lease are renegotiated. To accommodate its constant growth, the consolidated entityCompany has entered into a new 3-year lease, starting in November 2015. The office lease contains two renewal options, each for a three-year period. These renewal options may be cancelled by the Company. The Company at this stage intends to exercise the two remaining options. In order to exercise an option, the Company must inform the lessor no later than 6 months prior to the end of the lease, by which time it must commit to the term of the option.

None.

The following discussion and analysis should be read in conjunction with Item 18. “Financial Statements” included below. Operating results are not necessarily indicative of results that may occur in future periods. This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in the forward-looking statements as a result of many factors including, but not limited to, those set forth under “Forward-Looking Statements” and “Risk Factors” in Item 3.3 “Key Information” included above in this Annual Report onForm 20-F. All forward-looking statements included in this document are based on the information available to the Company on the date of this document and the Company assumes no obligation to update any forward-looking statements contained in this Annual Report on Form 20-F.

Application of criticalCritical accounting policies

We prepare our financial statements in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). As such, we are required to make certain estimates, judgments, and assumptions that management believes are reasonable based upon the information available. These estimates, judgments and assumptions affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the periods presented. The significant accounting policies are summarized in Item 18. “Financial Statements –- Note 2 –- Significant Accounting Policies”.

Income taxes

The groupCompany has not recognized deferred tax assets relating to carried forward tax losses and taxable temporary differences since the groupCompany is currently in a loss making position and unable to generate taxable income to utilize the carried forward tax losses and taxable temporary differences. The utilization of the tax losses also depends on the ability of the entity to satisfy certain tests at the time the losses are recouped. Significant judgment is required in determining the worldwide provision for income taxes. There are certain transactions and calculations undertaken during the ordinary course of business for which the ultimate tax determination is uncertain. The groupCompany estimates its tax liabilities based on the group’sCompany’s understanding of the tax law. Where the final tax outcome of these matters is different from the amounts that were initially recorded, such differences will impact the current and deferred income tax assets and liabilities in the period in which such determination is made.

Share-based Payment Transactions

The consolidated entityCompany measures the cost of equity-settled transactions with employees by reference to the fair value of the equity instruments at the date at which they are granted. The fair value is determined by using the Black-Scholes model taking into account the terms and conditions upon which the instruments were granted. The accounting estimates and assumptions relating to equity-settled share-based payments would have no impact on the carrying amounts of assets and liabilities within the next Annual Reporting period but may impact profit or loss and equity.

Research and Development

We have expensedexpense all internal research and development expenditures incurred during the year as the costs relate to the initial expenditure for research and development of biopharmaceutical products and the generation of future economic benefits is not considered probable given the stage of development. It was considered appropriate to expense the research and development costs as they did not meet the criteria to be capitalized under IAS 38.

The R&DAustralian Research and Development Tax Incentive is a government run program which helps to offset some of the costs of R&D. Annually, the consolidated entityCompany claims a refundable tax offset and has disclosed this as other income in the statement of profit or loss and other comprehensive income. The groupCompany currently accounts for R&D Tax Incentive on a cash basis due to the difficulty of making reasonable estimation as at year end.

Impairment of Assets

We assess impairment of non-financial assets at each reporting date by evaluating conditions specific to the consolidated entityCompany and parent entity and to the particular asset that may lead to impairment. If an impairment trigger exists, the recoverable amount of the asset is determined. This involves fair value less costs to sell or value- in-usevalue-in-use calculations, which incorporate a number of key estimates and assumptions.assumptions such as cash flow projections and discount rate.

For additional information on significant accounting policies refer to Item 18. “Financial Statements –- Note 2 –- Significant Accounting Policies”.

Discontinued operations

On November 27, 2012, the Company disposed of the operations of MEI Pharma, Inc. (‘MEI’) and its subsidiary MEI Pharma Pty Limited in which it held majority ownership, via an in-specie distribution to its shareholders. MEI held the intellectual property originally developed by Novogen in the field of isoflavonoid drugs. The net gain on disposal was A$5.0 million. This has been classified as a discontinued operation for the purpose of this report.

For additional information on discontinued operations refer to Item 18. “Financial Statements – Note 10 – Discontinued operations”.

Results of operationsOperating results

The following table provides a summary of revenues and expenses to supplementincome for the more detailed discussions below:

Statements of profit or loss and other comprehensive income

For the year ended 30 June 2015past three fiscal years:

Restatement of comparatives

Comparative information in the profit and loss statement has been restated to correct an immaterial error in classification of expenses. The profit and loss for Fiscal 2014 and Fiscal 2013, included salary and related general expenses of scientists totalling A$853,000 and A$1,101,000 respectively in general and administrative expenses. These expenses have been reclassified from general and administrative expenses to research and development expenses. The restatement is to reflect the nature of the expense in a more accurate manner. A third balance sheet has not been presented as the reclassification is immaterial and has no impact on the financial results for the year ended June 30, 2014, and June 30, 2013, or the closing financial position at that date.

Operating results – Fiscal 20152016 compared to Fiscal 2014fiscal 2015

Revenue and other income

The consolidated entity’sCompany’s revenue, which is solely interest income derived from interest bearing bank account, increased from A$89,000 in 2015 to A$406,000 in 2016 as a result of capital raisings in April and June 2015 that raised aggregate gross proceeds of A$33.2 million, thus providing for higher interest returns on increased bank account cash balances in fiscal 2016.

Net foreign exchange gain decreased 30% from A$1.1 million in fiscal 2015 to A$0.8 million in fiscal 2016 due to less volatility in the exchange rate.

Research and development grant (rebate) increased 86% from A$1.5 million in fiscal 2015 to A$2.9 million in fiscal 2016 due to higher level of eligible research and development expense in fiscal 2016. The Australian federal government’s Research and Development Tax incentive program cash refund changes from 45% to 43.5% from July 2016. We note that the Australian government recently received a recommendation from a review panel recommending a reduction of the amount of the grants available to small entities such as Novogen to a maximum of A$2 million per annum commencing fiscal year 2018. Any such change in the Research and Development Tax Incentive program could have a material adverse affect on the Company’s research and development grant (rebate) as well as on our future cash flows and financial position.

Expenses

Research and development expenses increased A$4.0 million from A$5.9 million in fiscal 2015 to A$9.9 million in fiscal 2016 due to higher research and development activity in fiscal 2016, including the completion of necessary Chemistry, Manufacturing and Controls activity in relation to the Cantrixil program, as required by the FDA and finalization of the first-in-human Phase I clinical protocol. In relation to Anisina, the Company has manufactured both the active candidate drug substance and candidate drug product. The Company has also manufactured the candidate drug substance to cGMP in preparation for first-in-human clinical trials.

General and administrative costs increased A$2.0 million (53%) from A$3.8 million in fiscal 2015 to A$5.8 million in fiscal 2016 due, in large part, to a rental increase arising from a relocation of our headquarters in November 2015 as well as higher legal and consultancy fees.

There were no finance costs in fiscal 2016, representing a decrease of A$370,000 in comparison with fiscal 2015, with the A$370,000 consisting of A$69,000 finance costs and A$301,000 loss in fair value of convertible notes. There was no borrowing during fiscal 2016 as a result of the additional funds raised through the issue of equity securities in fiscal 2015.

Net loss

As a result of the above and particularly the higher research and development expenses, the Company’s loss after income tax increased A$4.9 million (67%) from A$7.3 million in fiscal 2015 to A$12.2 million in fiscal 2016.

Fiscal 2015 compared to fiscal 2014

Revenue and other income

The Company’s revenue, which is solely interest income derived from interest bearing bank account, increased marginally from A$87,000 in fiscal 2014 to A$89,000 in fiscal 2015.

Net foreign exchange gain increased from none in fiscal 2014 to A$1.1 million in fiscal 2015 due to an increase in the foreign currency balances and transactions.

Research and development grant increased from A$342,000 in fiscal 2014 to A$1.5 million in fiscal 2015 due to higher level of eligible research and development expense in fiscal 2015.

Net lossExpenses

The consolidated entity incurred a loss after income tax of $7,306,000 (2014: $7,569,000), was in a net current asset position of $42,871,000 (2014: net current liability position of $609,000) and had net cash outflows from operating activities of $5,760,000 (2014: $5,709,000) for fiscal 2015.

Research and development expenses increased A$2.6 million (79%) from continuing operations forA$3.3 million in fiscal 2014 to A$5.9 million in fiscal 2015 was A$5,935,000 representing an increase of A$2,607,000 in comparison with fiscal 2014. This increase is due to ongoing implementation of research and development programs, in line with our Corporate Developments as noted on page 11.programs.

General and administrative costs from continuing operations for fiscal 2015 amounted towere A$3,844,0003.8 million, representing an increase of A$428,000 in comparison with fiscal 2014. This increase is due to increased overheads with employment of more staff as a result of the significant growth of the Company’s operations.

Finance costs from continuing operations were A$370,000 in fiscal 2015, representing a decrease of A$885,000 in comparison with fiscal 2014. This decrease is due to the repayment of borrowings during the yearfiscal as a result of the additional funds raised through the issue of equity securities.

Operating results – Fiscal 2014 compared to Fiscal 2013

Revenue

The consolidated entity’s revenue declined from A$1,112,000 in 2013 to $87,000 in 2014, due to change of operations.

Revenue from royalties in 2013 ceased following the changes in operations in 2012.

Net loss

The consolidated entity incurredAs a result of the above, the Company’s loss after income tax ofdecreased 4% from A$7,569,000 (2013: A$785,000), was7.6 million in a net current liability position of A$609,000 (2013: net asset position of A$1,439,000) and had net cash outflows from operating activities of A$5,709,000 (2013: A$8,795,000) for fiscal 2014.

Research and development expenses from continuing operations for fiscal 2014 was A$3,328,000 representing an increase of A$1,971,000 in comparison with Fiscal 2013. This increase is due to ongoing implementation of research and development programs.

General and administrative costs from continuing operations for fiscal 2014 amounted to A$3,415,000 representing an increase of A$1,666,0007.3 million in comparison with Fiscal 2013. This increase is due to amortisation of intellectual property and employment related expenses.

Finance costs from continuing operations were A$1,255,000 representing an increase of A$1,123,000 in comparison with fiscal 2013 due to costs associated with the Hudson Bay Master Fund Convertible Note transaction.2015.

Liquidity and capital resources

Cash resources

AtWe have incurred cumulative losses and negative cash flows from operations since our inception and, as of June 30, 2015,2016, we had accumulated losses of A$161.5 million. We anticipate that we will continue to incur losses for at least the consolidated entitynext several years. We expect that our research and development and general and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding and other collaborations, strategic alliances and licensing arrangements.

We had total fundsno borrowings in fiscal 2016 and do not currently have a credit facility.

As of A$44,371,000 compared to A$2,502,000 as at June 30, 2014.

During fiscal 2015, the consolidated entity2016, we had net cash outflows from operating activities of A$5,760,000 compared to cash outflows of A$5,709,000 in fiscal 2014.

The consolidated entity invests its cash and cash equivalents of A$33.5 million. Cash in interest bearing facilitiesexcess of immediate requirements is invested in accordance with variousour investment policy, primarily with a view to liquidity and capital preservation. Currently, our cash and cash equivalents are held in bank accounts. Our short-term investments consist of term deposits with maturity dates.within 90 days. At the end of fiscal 2015,June 30, 2016, term deposits amounting to A$15,00013.0 million had a weighted average interest rate of 2.4%2.60% and cash deposits of A$44,356,00020.4 million had a weighted average interest rate of 0.86%0.31%.

We expect to consume cash and incur operating losses for the foreseeable future as the Company continues developing its oncology drug candidates. The impact on cash resources and results from operations will vary with the extent and timing of the future clinical trial program. While it is not possible to make accurate predictions of future operating results, we expect existing cash and cash equivalents will be sufficient to enable us to continue or research and development activities until approximately second quarter fiscal 2018.

Cash flows

The following table set forth the sources and uses of cash for the past three fiscal years:

Operating activities.Net cash used in operating activities for fiscal 2016, fiscal 2015 and fiscal 2014 was A$12.0 million, A$5.8 million and A$5.7 million, respectively. The use of net cash in all periods resulted primarily from our net losses.

Investing activities.Net cash used in investing activities in fiscal 2016, 2015 and 2014 was A$522,000, A$89,000 and A$27,000, respectively, and mostly related to purchases of equipment.

Financing activities.Net cash provided by financing activities of A$782,000 in fiscal 2016 related to the exercise of options, A$47.4 million in fiscal 2015 related to the issuance of ordinary shares in private placements and a rights issue and A$5.5 million in fiscal 2014 related to the issuance of convertible notes.

At June 30, 2015,2016, the consolidatedCompany entity did not hold any derivative financial instruments for managing its foreign currency; however, the consolidated entityCompany may from time to time enter into hedging arrangements where circumstances are deemed appropriate.

The Company believes that its future ability to fund its operations will be dependent on deriving sufficient cash from investors through successful capital raising and return from government grants as part of the Research and Development Tax Incentive Program available in Australia. The R&D Tax Incentive is an Australian government run program which helps to offset some of the costs of R&D. Annually, the consolidated entityCompany claims a refundable tax offset and has disclosed this as other income in the statement of profit or loss and other comprehensive income. The groupCompany currently accounts for R&D Tax Incentive on a cash basis due to the difficulty of making a reasonable estimation as at year end.

There areThe Company had no commitments for capital expenditure outstanding at the end of the financial year.fiscal 2016.

The Company continuously pursues opportunityopportunities for non-dilutive funding, such as grant applications.

The Company cannot provide assurance that it or its subsidiaries will be able to raise the funds necessary to complete the planned clinical trial programs, or find appropriate collaboration or licensing opportunities. For more information on future funding requirements of the subsidiaries please refer to the disclosure contained in the Risk Factors section of this report.

Financing activities

The Company has historically financed its operations primarily from issuing equity capital.capital and, to a lesser extent, convertible notes.

Fundraising campaignsPrivate Equity Placement – November 2014

On April 24, 2013,November 12, 2014, the Company raisedissued ordinary shares in a private placement to institutional and professional investors at A$2,400,000 through0.11 per share along with an option (for no consideration), exercisable at A$0.125 per share. In the issueaggregate, the Company issued 16,859,988 ordinary shares and 16,859,988 unlisted options. The gross proceeds of 14,425,150the private placement were approximately A$1.9 million. In addition, during fiscal 2015, the Company received approximately A$1.4 million from the proceeds of the exercise of options issued as part of the private placement.

Private Equity Placement – December 2014

In December 2014, the Company issued to institutional and professional investors an aggregate of 46,900,800 ordinary shares at a purchase price of 16.5 centsA$0.125 per share.

On May 28, 2013, Following the approval of shareholders in March 2015, the Company raisedissued 50,652,864 options with an exercise price of A$790,000 through0.15 per option exercisable by December 2019. As consideration for the issue of 4,645,207ordinary shares, the Company received gross proceeds of approximately A$5.9 million. In addition, the Company received approximately A$6.8 million from the proceeds of the exercise of options issued as part of this private placement.

Private Equity Placement – April 2015

In April 2015, the Company issued to institutional investors in a private placement 51,750,000 ordinary shares at a purchase price of 17.0 centsA$0.30 and, following shareholders’ approval received on June 24, 2015:

Rights Issue – June 2015

On June 4, 2015, the Company issued as part of a Share Purchase Plan.rights offer to eligible shareholders 58,971,151 ordinary shares at a purchase price of A$0.30 and:

The Company received gross proceeds of approximately A$17.7 million from the rights offer.

During fiscal 2016, the Company issued 6,617,517 ordinary shares, all following the exercise of options. The details of these options is as follows:

Foreign currency fluctuations were not material for the Company in fiscal 2016. See Item 18. “Financial Statements - Note 27 – Financial Instruments” for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk.

Convertible notes

Convertible note (Triaxial) carrying value of A$1,500,000

A convertible note was issued in November 2013 with a face value of A$1,500,000. The convertible note was exercisable at the holder’s discretion as follows:

Convertible note (Hudson Bay)

In July 3, 2013 the Company entered into a Convertible Securities Agreement with HBMF pursuant to which HBMF agreed to invest, at the Company’s option, up to an aggregate amount of A$5,000,000 in return for the Company issuing HBMF up to five convertible securities having an aggregate face value of up to A$5,500,000 (the “Convertible Securities Agreement”). The Convertible Securities Agreement was amended on November 15, 2013 to among other things increase the total amount which HBMF agreed to invest to A$8,000,000. Under the Convertible Securities Agreement, the Company also issued to HBMF an option to purchase 4,000,000 ordinary shares (the “2013 HBMF Option”), at an option exercise price of A$0.237 per ordinary share and having an expiration date of July 4, 2016. On July 4, 2013, the Company also issued 822,369 ordinary shares to HBMF in satisfaction of our obligation to pay a commencement fee under the Convertible Securities Agreement. Between July 3, 2013 and February 10, 2015, we issued four convertible promissory notes to HBMF having an aggregate face value of A$6,050,000. HBMF or its nominees have converted all of these convertible promissory notes and were issued a further 47,173,141 ordinary shares. On January 16, 2015, we terminated the Convertible Securities Agreement, therefore no further Notes will be issued under the Convertible Securities Agreement.

ASX Bookbuild – November 12, 2014

On November 12, 2014, the consolidated entity conducted a capital raising with sophisticated investors in Australia and some qualified U.S. investors, which gave the opportunity to these investors to purchase ordinary shares at A$0.11 per share and included an option for no consideration, exercisable at A$0.125 per share. The consolidated entity issued 16,859,988 ordinary shares and 16,859,988 unlisted options. The gross proceeds of the placement was approximately A$1,855,000.

At June 30, 2015, the consolidated entity received approximately A$1,406,000 from the proceeds of the exercise of options issued as part of the capital raise.

Private Equity Placement – December 16 & 18, 2014

On December 16 and 18, 2014, the consolidated entity issued 46,900,800 ordinary shares at a purchase price of A$0.125. Following shareholders’ approval received on March 4, 2015, the consolidated entity issued 50,652,864 options with an exercise price of A$0.15 per option exercisable by December 16 & 18, 2019, to U.S. based private investment funds (‘December PIPE’). As consideration for the issue of securities, the consolidated entity received gross proceeds of approximately A$5,850,000.

At June 30, 2015, the consolidated entity received approximately A$6,800,000 from the proceeds of the exercise of options issued as part of the December PIPE.

Private Equity Placement – April 27, 2015

On April 27, 2015, the consolidated entity issued 51,750,000 ordinary shares at a purchase price of A$0.30 and, following shareholders’ approval received on June 24, 2015:

to U.S. based private investments funds (‘April PIPE’).

As consideration for the issue of securities, the consolidated entity received gross proceeds of A$15,525,000.

Rights Issue – June 4, 2015

On June 4, 2015, the consolidated entity issued 58,971,151 ordinary shares at a purchase price of A$0.30 and:

to Australian and qualified U.S. shareholders as part of the rights entitlement offer announced on April 21, 2015 (‘Rights Issue’).

The consolidated entity received gross proceeds of approximately A$17,691,000 from the Rights Issue. The consolidated entity released a prospectus in support of the Rights Issue.

See Item 18. “Financial Statements – Note 28 – Financial Instruments” for disclosures about financial risk management including interest rate risk, foreign currency risk and liquidity risk.

Research and Development

Research and development policy

Expenditure during the research phase of a project is recognized as an expense when incurred. Development costs are capitalized only when technical feasibility studies identify that the project will deliver future economic benefits and these benefits can be measured reliably.

The Company spent A$5,935,000,9.9 million, A$3,328,0005.9 million and A$3,648,0003.3 million on research and development expenditure from both continuing and discontinued operations during fiscal 2016, 2015 2014 and 20132014 respectively. All of these costs have been recognised as an expense in the statement of profit or loss in the respective periods. The profit and loss for Fiscalfiscal 2014 and Fiscal 2013 included salary and related general expenses of scientists totalling $853,000 and A$1,101,000 respectively in general and administrative expenses. These expenses have been reclassified from general and administrative expenses to research and development expenses. Please refer to Note 4 for details.

It is not possible to reasonably estimate the cost and timing of project completion due to the uncertainty of the research and development projects being undertaken by the Company and the nature of the research being early phase and the product being pre-clinical. The costs of research and development projects are not estimated on a project by project basis. An analysis of costs between projects may only be performed on an arbitrary and subjective basis.

Trend information

The Company expects to consume cash and incur operating losses for the foreseeable future. The Company intends to continue its expenditure on the development of its oncology drug candidates.

The impact on cash resources and results from operations will vary with the extent and timing of the future clinical trial program. It is not possible to make accurate predictions of future operating results.

Off-balance sheet arrangements

The Company does not have any off-balance sheet arrangements.

Tabular disclosure of contractual obligations

The following table sets forth the Company’s contractual obligations for the periods as at June 30, 20152016:

Operating lease commitments include contracted amounts for leases of premises and plant and equipment under non-cancellable operating leases expiring within three years. Leases for premises include an annual review for CPI increases.

The office lease contains two renewal options, each for a three-year period. These renewal options are not included in the commitments as they may be cancelled by the Company. The Company at this stage intends to exercise the two remaining options. In order to exercise an option, the Company must inform the lessor no later than 6 months prior to the end of the lease, by which time it must commit to the term of the option.

Item 6.

Directors, Senior Management and Employees

Directors

The names and details of the Company’s Directors at the date of this report are as follows:

Note 1 - Ian Phillips was appointed Interim Chairman on 1 July 2015

Note 2 - Iain Ross was re-appointed as Director and Acting CEO on 22 July 2015

Former directors who served during the financial year ended June 30, 2015:fiscal 2016:

Directors were in office for the entire period unless otherwise stated.

Names, qualifications, experience and special responsibilities

Name:		MrSteven Coffey
Title:		Non-Executive Director
Qualifications:		B. Comm., CA
Experience and expertise:		Steven Coffey is a chartered accountant, having spent his career in public practice since graduating from University of New South Wales, Australia in 1983. He has been a partner in the chartered accounting firm Watkins Coffey Martin since 1993. He is a registered company auditor and audits a number of large private companies as well as a number of not-for-profit entities. Steven has previously served on the board of an Australian listed public company. He is currently a board member of private family foundation.
Other current directorships:		None

Former directorships
(last 3 years):		None
Special responsibilities:		Chairman of the Remuneration and Nomination Committee
Name:		MrDr John O’ConnorJames Garner
Title:		Non-ExecutiveExecutive Director
Qualifications:		BEc, MAICD and Chief Executive Officer
Experience and expertise:		John O’ConnorDr Garner is an internationally experienced life sciences executive who has spent his working life in the financial industry. In this time hepreviously worked with companies ranging from small biotechs to multinational pharmaceutical companies such as Biogen and Takeda. His career has worked both in funds managementfocused on regional and as a stockbroker. He has worked in the UK, U.S. and in Australia. He has held management roles and been a partner in securities businesses. He served on the Boardglobal development of Lonsec Securities, a Zurich Insurance owned business, for several years. John has been a consultantnew medicines from preclinical to several biotech businesses, including Novogen Limited and MEI Pharma, Inc. assisting with fundraising.
Other current directorships:		None
Former directorships (last 3 years):		NuSep Holdings Limited (appointed October 10, 2011, resigned February 19, 2012)
Special responsibilities:		Deputy Chairman, Chair of the Audit, Risk and Governance Committeecommercialisation.
Name:		Prof Peter Gunning
Title:		Non-Executive Director
Qualifications:		B.Sc (Hons), Ph.D
ExperienceDr Garner is a physician by training and expertise:		Peter Gunning is the Head of the Oncology Research Unit in the School of Medical Sciences and Associate Dean (Research) in the Faculty of Medicine atholds an MBA from the University of New South Wales, Australia. His research is focused onQueensland. He began his career in hospital medicine and worked for a number of years as a corporate strategy consultant with Bain & Company before entering the pharmaceutical industry. From 2013 to 2016, he led R&D strategy for Sanofi in Asia-Pacific and was based in Singapore. Prior to that, he was regional Vice President of R&D for Takeda, from 2009-2013, where he had responsibility for a multinational team of approximately 60 people, and oversight of all development of new therapeutic strategies foractivities in the treatment of childhood cancer. These strategies target the skeleton of the cancer cell and build on the principles of cell architecture that Professor Gunning’s group has discovered over the last 20 years. Peter has published over 100 primary research articles and has recently edited the first book devoted to his field of research. Previous appointments have included leadership roles as Chair of the Division of Research at The Children’s Hospital at Westmead, Chair of the Westmead Research Hub Executive and Chair, Board of Bio-Link, a company established by the NSW Government to support commercialisation of biomedical intellectual property.Asia-Pacific region.
Other current directorships:		None
Former directorships (last 3 years):		None
Special responsibilities:		Member of the Audit, Risk and GovernanceScientific Committee and memberMember of the ScientificStrategy and Innovation Committee
Name:		MrIan M. Phillips MNZM (appointed 3 June 2015)
Title:		Non-Executive Director Interim Chairman (appointed 1 July 2015)
Experience and expertise:		Ian M. Phillips has been involved with International Banking, global financial markets and Corporate Finance for over 30 years having worked in New York, (20 years plus), London, (5 years), Singapore, (6 months), Sydney (5 years) and Wellington (4 years).Wellington. Ian is the President of KUMARA, Chairman of NNP, Deputy Chairman of the American Australian Association, Immediate past President of the American Friends of the NGA, Chairman of ANZA, an Advisory Board of the US-NZ Council and a Board member of the American friends of Christchurch. As Regional Head of Commonwealth Bank North and South America between 1996 and 2002 and then 2006 to 2013, Ian was responsible to the US regulators, the OCC, as well as taking overall responsibility for compliance with accounting standards. He also chaired the New York based Broker Dealer of CBA Americas during this period. Ian studied at Otago University, University of Colorado and London School of economics. He holds dual citizenship in the USA & NZ.New Zealand. In 2013, Ian was awarded the NZNew Zealand Order of Merit.
Other current directorships:		None
Special responsibilities:		Chair of Strategy and Innovation Committee, Member of Remuneration and Nomination Committee and Member of the Audit, Risk and Governance Committee.

Former directorships (last 3 years):		None
Special responsibilities:		Chair of Strategic Planning Committee
Name:		MrIain Ross
Title:		Director, Acting CEO (appointed July 2015 - retired January 2016)
Qualifications:		B.Sc. (Hons), C.DirNon-Executive Director (from February 2016)
Experience and expertise:		Based in the UK, Iain Ross is an experienced directorDirector on a number of Australian company boards. He is also currently Executive Chairman of Ark Therapeutics Group Plc and a director of a number of other European based technology companies.e-Therapeutics plc. In his career he has held senior positions at Coms Plc,in Sandoz AG, Fisons Plc, Hoffmann-La Roche AG and Celltech Group Plc and also undertaken a number of start-ups and turnarounds on behalf of banks and private equity groups. His track record includes multiple financing transactions having raised in excess of £300 million, both publicly and privately, as well as extensive experience of divestments and strategic restructurings and has manyover 20 years in cross-border management as a Chairman and CEO. IainHe has led and participated in four London Stock Exchange (‘LSE’(“LSE”) Initial Public Offerings, and has direct experience of mergers and acquisitions transactions in Europe, U.S.USA and the Pacific Rim.
Other current directorships:		Benitec Biopharma Limited, Anatara Lifesciences Limited, and Premier Veterinary Group Plc (LSE)(LSE: PVG), e-Therapeutics plc (LSE: ETX) and Biomer Technology Limited
Former directorships
(last 3 years):		Tissue therapies Limited, Coms Plc, and Ark Therapeutics Group Plc(LSE)Tissue Therapies Limited, Benitec Biopharma Limited
Special responsibilities:		Member of Strategic PlanningRemuneration and Nomination Committee, Member of Scientific Committee and memberMember of Scientific Committeethe Audit, Risk and Governance Committee.
Executive officers’ profiles
Name:		DrDavid Brown
Title:		Chief Scientific Officer
Qualifications:		B.Sc. (Hons) Ph.D
Experience and expertise:		David Brown was in charge of preclinical testing for Novogen’s oncology drugs between 2000 and 2010. In his new role, he oversees2010 and was appointed CSO in 2009. David left Novogen in 2010 and re-joined the company in May 2013 as Chief Science Officer, overseeing the entire portfolio of Research and Development programs, and is responsible for developing evidence of the Company’s drug technology platforms.
Name:		DrAndrew Heaton
Title:		CEO & President of Novogen North America
Qualifications:		B.Sc (Hons) Ph.D
Experience and expertise:		Andrew Heaton has an extensive drug discovery background. He was one of the founders and former CEO of Triaxial Pharmaceuticals Pty Ltd. BasedAndrew re-joined Novogen in the U.S., he2013 as CEO & President of Novogen North America and oversees the formulation, patent and manufacture of the Company’s drug technology platforms.
Name:		MrLionel Mateo
Title:		Company Secretary
Qualifications:		BCL, MCL
Experience and expertise:		Lionel Mateo was appointed Company Secretary on 8 October 2013. He has a Bachelor’s degree in Civil Law and a Master’s Degree in Civil Law, Economics and Business from the University of Aix-en-Provence, France. Prior to specialising in corporate governance, he worked in Criminal Law. He previously worked for R.M. Williams Agricultural Holdings Pty Ltd, initially as Corporate Governance Officer and then Company Secretary. Lionel completed the Graduate Diploma of Applied Corporate Governance with the Governance Institute of Australia in 2015.

Name:		MsCristyn Humphreys
Title:		Chief Financial Officer (appointed on 1 January 2015)
Qualifications:		B.Bus (Acc), DIPPOL, FTI, CA
Experience and expertise:		Cristyn Humphreys has 20 yearsyears’ commercial experience working for private industries including heading up finance, marketing and strategy departments for businesses with a global presence. Cristyn’s commercial experience is broad including founding a registered charity in Australia and working in the NSW Police Service. She is a Chartered Accountant and a Fellow of the Tax Institute in Australia. Cristyn commenced as Novogen CFO on January 1, 2015. Between 2012 and 2014, Cristyn was Head of Finance and Chief Strategic Officer of a privately held global manufacturing and design company.

Directors’ and KMPKey Management Personnel (“KMP”) interests in the shares and options of the company for fiscal 2015:2016:

Shareholding

The number of shares in the consolidated entityCompany held during the financial yearfiscal 2016 by each Director and other members of Key Management Personnel of the consolidated entity,Company, including their personally related parties, is set out below:

Option holding

The number of options over ordinary shares in the consolidated entityCompany held during the financial yearfiscal 2016 by each Director and other members of Key Management Personnel of the consolidated entity,Company, including their personally related parties, is set out below:

For all other KMPs, no options were vested at year end.

In addition to Director’s fees, one-off consultancy fees of A$266,000 for interim executive duties while Mr Iain Ross was Acting CEO were paid in fiscal 2016 to Gladstone Consultancy Partnership, a UK based consulting partnership in which he has a beneficial interest. These fees were paid between July 2015 and February 2016. No such consultancy fees will be paid in fiscal 2017.

In addition to Director’s fees, one-off consultancy fees of A$120,000 for interim duties were paid in fiscal 2016 to Kumara Inc, a corporation in which Mr Ian Phillips is a Director and has a beneficial interest. These fees were paid between July 2015 and March 2016. No such consultancy fees will be paid in fiscal 2017.

In addition to Director’s fees, consultancy fees of A$7,000 were paid to Watkins Coffey Martin, a partnership in which Steven Coffey is a partner.

Share-based compensation

There were no shares issued to Directors or other KMP as part of compensation during fiscal 2016

Options

The terms and conditions of each grant of options over ordinary shares affecting remuneration of Directors and other Key Management Personnel in fiscal 2016 or future reporting years are as follows;

Further disclosures regarding KMPs options