Form 6-K GENETIC TECHNOLOGIES For: Feb 27

FORM 6-K

U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

dated February 27, 2015

Commission File Number 0-51504

GENETIC TECHNOLOGIES LIMITED

(Exact Name as Specified in its Charter)

N/A

(Translation of Registrant’s Name)

60-66 Hanover Street

Fitzroy

Victoria 3065 Australia

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F   x            Form 40-F   o

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes  o                          No  x

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):  Not applicable.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused the Report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date:  February 27, 2015

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EXHIBIT INDEX

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Exhibit 99.1

GENETIC TECHNOLOGIES LIMITED

A.B.N. 17 009 212 328

Half-Year Financial Report

for the period ended

31 DECEMBER 2014

DIRECTORS’ REPORT

The Directors submit the financial report of Genetic Technologies Limited (“GTG” and the “Company”) and the entities it controlled for the half-year ended 31 December 2014.

Directors

The names of the Directors of the Company in office at the date of this Report are stated below.  All Directors were in office for the entire period, except as noted below.

Dr. Malcolm R. Brandon (Non-Executive Chairman)

Grahame J. Leonard AM (Non-Executive Director)

Dr. Paul A. Kasian (Non-Executive Director)

Dr. Lindsay Wakefield (Non-Executive Director)

Dr. Mervyn Cass served as a Director of the Company from 1 July 2014 until 25 November 2014.  Prof. Ian McKenzie served as a Director of the Company from 1 July 2014 until 25 November 2014. Mr. David Carter served as a Director of the Company from 23 September 2014 until 27 January 2015. Dr. Lindsay Wakefield was appointed a Director of the Company on 23 September 2014.

Review and results of operations

Financial overview

During the period under review, the consolidated entity continued to operate in the molecular diagnostics sector, focussing its energies and resources on the further expansion of its US-based business and the distribution of its proprietary breast cancer risk assessment test BREVAGen™.  The total comprehensive loss of the consolidated entity for the financial half-year ended 31 December 2014 was $4,774,751 (2013: $5,087,286).  The net cash flows used in operations during the half-year were 11.9% higher than the previous corresponding period ($5,820,310 as compared to $5,199,847).  Net cash flows from investing activities were $2,001,903 as compared to ($198,296) due to the sale of the Australian heritage business , while a total of $2,407,500 was raised during the period from the issue of shares and convertible debt notes (see below), before the payment of associated expenses.

Overall, total cash and cash equivalents for the half-year ended 31 December 2014 decreased by $1,556,277 to $1,274,808 at balance date.

The first half of the 2015 financial year saw the Company deliver gross revenues from its domestic genetic testing operations which were in line with budget.  In November, the Company completed the divestiture of its heritage Australian Genetics $2,100,894 (net of employee entitlements and inclusive of GST).

Financing

On 15 September 2014, the Company announced plans to restructure and realign its group activities. The changes proposed would enable the Company to focus its strategy on the U.S. molecular diagnostics (“MDx”) market and commercialisation of the Company’s lead breast cancer risk test BREVAGen. The aim being to provide investors with a focused MDx company and refined US commercialisation strategy for BREVAGen, with a significantly reduced operating cost base.

In support of these plans, the Company finalised the raising of $2,150,000 via the issue of unlisted secured (debt) notes, with a face value of $1.00, to existing and new Australian institutional and wholesale investors during September 2014. The debt notes carried a 10.0% coupon rate, and as approved at the Annual General Meeting, held on 25 November 2014, became convertible notes, which can be converted into ordinary shares (at a 10.0% discount to the 5 day VWAP). The convertible notes also carry free attached options to purchase further shares in the Company.

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As at 31 December 2014, $650,000 of the convertible notes, together with the capitalised interest, had been converted into 50,837,784 ordinary shares in the Company.

Subsequent to 31 December 2014, a further $1,475,000 of convertible notes plus capitalised interest has been converted into 100,123,257 ordinary shares in the Company.  As at the date of this report, there are $25,000 convertible notes still remaining to be converted.

On 30 December 2014, the Company advised its shareholders that the Share Purchase Plan (“SPP”) announced on 3 December 2014, closed at 5:00pm (AEDT) on Monday, 22 December 2014, with applications received for 19,074,112 new shares raising $257,500.

In accordance with the previously published indicative timetable for the SPP, the new shares were issued on 30 December 2014.

Convertible notes

On 10 September 2013, the Company announced that it had executed documents with Ironridge BioPharma Co., a division of institutional investor Ironridge Global IV, Ltd. (“Ironridge”), in respect of redeemable convertible notes to raise USD 5,000,000 (the “Notes”).  The details of the Notes were provided to all shareholders in a Notice of Extraordinary General Meeting at which approval for the issue of the Notes was sought from shareholders.  This approval was subsequently received on 29 November 2013.

On 23 December 2013, the Notes were drawn down and the Company received $5,627,462 (being the Australian dollar equivalent of USD 5,000,000) from Ironridge, before the payment of associated costs.

During the current half year, conversion notices were received from Ironridge in respect of Notes with a face value of USD 1,750,000. These Notes were converted in return for which Ironridge received 164,771,370 ordinary shares (including ordinary shares issued in lieu of interest payment and interest true-up adjustments). As a result of the above conversions, there are no further Notes remaining to be converted. The last conversion notice was received by the Company on 27 November 2014.

With respect to the unlisted secured (debt) notes that were issued to existing and new Australian institutional and wholesale investors in September 2014, and subsequently became convertible notes, following approval at the Annual General Meeting, held on 25 November 2014, $650,000 of the convertible notes, together with the capitalised interest, had been converted into 50,837,784 ordinary shares in the Company, as at 31 December 2014.

Subsequent to 31 December 2014, a further $1,475,000 of convertible notes plus capitalised interest has been converted into 100,123,257 ordinary shares in the Company, leaving $25,000 convertible notes still remaining to be converted.

BREVAGen™ breast cancer risk test

Launch of BREVAGenplus® and Test samples received

In October 2014, the Company announced the US release of BREVAGenplus, an easy-to-use predictive risk test for the millions of women at risk of developing sporadic, or non-hereditary, breast cancer, representing a marked enhancement in accuracy and broader patient applicability, over the Company’s first generation BREVAGen product. Results from BREVAGenplus provide physicians with valuable information to assist in developing a patient-specific Breast Cancer Risk Reduction and Screening Plan based on professional medical society guidelines, such as the American Cancer Society (ACS) (www.cancer.org) and The National Comprehensive Cancer Network (NCCN) (www.nccn.org).

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Clinical support for BREVAGenplus was further enhanced with the release of findings from a new research study show that adding a panel of 77 single-nucleotide polymorphisms (“SNPs”) improves the predictive accuracy of four commonly used breast cancer risk assessment models. This same panel of 77 SNPs is used in the Company’s recently released BREVAGenplus. Results of the study were presented at the 2014 San Antonio Breast Cancer Symposium, on 13 December, 2014.

For the December 2014 quarter, 779 BREVAGen/BREVAGenplus test samples were received, subsequent to the launch of the second generation test in October 2014. (YTD 1,721 BREVAGen/BREVAGenplus test samples were received).

Prior to the release of BREVAGenplus, the Company revised its sales strategy to focus on large comprehensive breast treatment and imaging centres, in concert with its ongoing approach to independent physician and women’s healthcare providers. This recent pivotal change of sales and marketing emphasis towards large breast centres, which are more complex entities with a longer sales cycle, but with higher potential, is expected to lead to significant acceleration in growth and less volatile test volumes than the Company has experienced to date. However, this revised sales model involving the promotion of BREVAGenplus to comprehensive breast imaging and breast diagnosis/treatment centres, has resulted in a plateau in sales uptake and growth during this interim transition period. Sales growth is expected to accelerate as this transition is completed and these new breast centres, with their attendant large number of at-risk and appropriate patients adopt BREVAGenplus..

Reimbursement:

Up until the end of the 2012 calendar year, insurance claims for BREVAGen were submitted using the so-called “code stack” of CPT methodology codes.  Reimbursement under this regime was positive, with a low percentage of denials and appeals.  However, effective 1 January 2013, the AMA removed the code stack claim process, requiring tests without a specific CPT code to be claimed via an “Unlisted or Miscellaneous Code”.

As a result of the above changes the Company now uses a miscellaneous code when submitting claims for reimbursement from insurers.  As part of this transition, the list price for the BREVAGen test and subsequently the BREVAGenplus test was increased to enable the Company to receive payment for aspects of the test that were not previously available under the code stack.  With the launch of the BREVAGenplus test, the Company increased the maximum out-of-pocket amount that a given patient is required to pay for a BREVAGenplus test, under its “Patient Protection Program,” to $275, up from $250 previously.

Though the Company’s reimbursement per test (including write-offs and denials for non-coverage) has increased by more than 30%, the use of a miscellaneous code requires more administration and time by the Insurance Company to adjudicate and process the claim, thus increasing the time taken to receive reimbursement.

Cost effectiveness studies to improve reimbursement outcomes:

Further to the publication in the journal of Cancer Prevention Research Vol 6 (12), dated 5 December 2013: pp 1328-36, demonstrating the cost effectiveness of the BREVAGenplus test to guide MRI screening, an additional paper has been published demonstrating the cost effectiveness of the BREVAGenplus test to direct chemoprevention.

On 7 March 2014, the Company announced the publication in the journal Applied Health Economics and Health Policy Vol 12 (2): pp 203-17, of a study entitled “Economic Evaluation of Using a Genetic Test to Direct Breast Cancer Chemoprevention in White Women with a Previous Breast Biopsy”.

This study was a collaborative project between the Company and Archimedes Inc. of San Francisco, a healthcare modelling and analytics organisation. The study examined the cost-effectiveness of utilising BREVAGenplus to direct tamoxifen chemoprevention.

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An in-silico (computer) model of breast cancer and health care processes was used to simulate a population of white women aged 40-69, who were at elevated risk for breast cancer due to a history of benign breast biopsy, in a virtual clinical trial. Women were assessed for risk of developing breast cancer using the BREVAGenplus test to determine eligibility for five years of tamoxifen therapy. The BREVAGenplus test was most cost-effective when given to patients at an intermediate risk of developing breast cancer (1.20-1.66%, 5-year risk).

The results demonstrated that adding genetic information about breast cancer susceptibility loci to current decision models for breast cancer chemoprevention not only improves clinical outcomes (with an average of 15 breast cancer cases prevented per 1,000 women), but is also cost-effective, with an incremental cost-effectiveness ratio below the benchmark number used by U.S. payers of $50,000 per quality-adjusted life year saved.

Clinical utility studies have been designed and are currently proceeding through the Institutional Review Board process at a US breast cancer research institute. The data obtained from these studies will be utilised in direct contracting discussions with insurers and self-insured employer groups.

Licensing and IP

Non-Coding Assertion Program

At the end of the September 2014 Quarter, the Company reported that it was asserting actions against a number of different companies including large pharmaceutical companies in 4 different states in the US and had pleasingly overcome two “101 Motions to Dismiss” based on ‘179 patent invalidity raised in the Northern District of California and District of North Carolina.

At the time, a further “101 Motion to Dismiss” was still pending in the District of Delaware. On the 30 October 2014, Judge Stark issued a Memorandum Opinion finding Claim 1 of the ‘179 patent ineligible and granted that Motion to Dismiss. The Company’s Legal Counsel has prepared an appeal to the decision in the Federal Circuit and has sought stay of all commercially relevant pending actions.

There are no updates to report relating to the remaining U.S or European cases.

Further, during the half-year, the Company announced that it had executed an agreement with Histogenetics LLC, of Ossining, New York, USA.

Other commercial assets

As part of the Company’s strategy to focus on the expansion of its cancer diagnostic franchise, work continues to sell, out-license or co-develop other assets and technologies in which the Group has an interest.

Significant changes in the state of affairs

In addition to the matters discussed above in the Review and results of operations, the following events occurred during the half-year ended 31 December 2014.

Sale of heritage Australian Genetics business

On 19 November 2014, the Company announced that it had completed the sale of its heritage Australian Genetics business to Specialist Diagnostics Services Ltd (“SDS”), the wholly owned pathology subsidiary of Primary Health Care Ltd. Under the terms of sale, SDS acquired the Australian Genetics business for $2,100,894 (net of employee entitlements and inclusive of GST).

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NASDAQ Notices

On 3 September 2014, the Company announced that it had received a letter dated 29 August 2014, from the NASDAQ Stock Market, notifying the Company that for the last 30 consecutive business days, prior to 28 August, the bid price for the Company’s common stock (ADRs), listed on the Nasdaq Stock Market, had closed below the minimum USD 1.00 per share requirement for continued inclusion under NASDAQ Marketplace Listing Rules.

This letter stated that, in accordance with the Listing Rules, the Company had 180 calendar days, or until 25 February 2015, to regain compliance.

To regain compliance, the Company undertook a reverse stock split (consolidation) which, when actioned, has the effect of resetting the existing ratio of 1 ADR representing 30 Ordinary shares to 1 ADR representing 150 Ordinary shares. The target date for the ratio change was Monday 19 January, 2015. From January 20 to February 2, 2015, the closing bid price of the Company’s common stock has been at USD 1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a) (2), and as notified by Nasdaq on 4 February 2015, this matter is now closed.

On 6 November 2014, the Company announced that it had also received a letter dated 5 November 2014, from the Nasdaq Stock Market notifying the Company that, companies listed on the Nasdaq Capital market are required to maintain a minimum of USD 2.5 million in stockholder’ equity for continued listing. Since the Company’s Form 20-F, for the fiscal year ended June 30 2014, reported stockholders’ equity of approximately USD 1.7 million, the Company does not meet the alternatives of market value of listed securities or net income from continuing operations, the Company no longer complies with the Nasdaq Marketplace Listing Rules (the “Rules”).

The letter stated that in accordance with the Rules the Company has 45 calendar days, or until 22 December 2014, to submit a plan to regain compliance. If the plan is accepted, Nasdaq can grant the Company an extension of up to 180 calendar days from November 5, 2014 to evidence compliance.

On 28 January 2015, the Company received a letter from Nasdaq, dated 27 January 2015, advising that it had been granted an extension of time (on or before May 4, 2015) to regain compliance with the minimum stockholders’ equity requirement.

Note that these rules only apply to the Company’s common stock trading on the Nasdaq Capital Market and not the Company’s share trading on the Australian Securities Exchange, the Company’s home exchange.

Key Managerial Changes

As announced on 25 November 2014, following the resignation of Ms. Alison Mew as Chief Executive Officer, for personal-health related reasons, Mr. Eutillio Buccilli, the then Chief Financial Officer, was appointed to the dual role of Chief Operating Officer and Chief Financial Officer and Mr. Mark Ostrowski, previously Senior VP Sales and Marketing was appointed to the position of President, Phenogen Sciences Inc., based in the US, with both appointments to have immediate effect.

Subsequent to the above announcement, on the 26 February 2015, the Company announced that Mr. Eutillio Buccilli has been appointed to the position of Chief Executive Officer, with immediate effect.

Tribute to Mr. David Carter

On 29 January 2015, the Company announced the early passing of Mr. David Carter.

David will always be remembered fondly and we feel privileged to have had the pleasure of working with such a learned and warm person. In the short time with the Company his contribution was invaluable.

Our most heartfelt sympathy is with his family at this difficult time.

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Options

On 31 July 2014, the Company granted a total of 6,875,000 options over ordinary shares in the Company to the Company’s U.S. employees.  The options, which were granted at no cost, entitle the holders to acquire one ordinary share, at a strike price of $0.04, at any time up to, and including 31 May 2019, subject to certain vesting conditions.

There were no other significant changes in the state of affairs that are not described elsewhere in this Report.

Significant events after balance date

On 4 February, 2015 the Company released a Notice for an Extraordinary General Meeting of shareholders that is to be held at 10.00 am on Friday, 6 March 2015, at the Company’s offices.  Shareholders will be asked to consider and, if thought fit, to pass the following resolutions:

Resolution 1 — Ratification of prior Placement of Shares to Ironridge Global IV Ltd

Resolution 2 — Ratification of prior Placement of Shares to Kentgrove Capital Growth Fund

Resolution 3 — Approval of Standby Equity Placement Facility (Kentgrove Capital Growth Fund)

Resolution 4 - Approval of proposed new placement of Shares to sophisticated investors

Subsequent to 31 December 2014, the Company announced that it had entered into a A$24 million Standby Equity Placement Facility Agreement with the Kentgrove Capital Growth Fund, an investment fund managed by Kentgrove Capital Pty Ltd, a Melbourne-based investment and advisory firm, to strengthen the Company’s funding position.

Under the Agreement, Kentgrove Capital may provide the Company with up to A$24 million of equity capital via placements over the next 24 months. Proceeds from the Facility will be used to fund the growth of the Company’s flagship lead breast cancer risk test, BREVAGenplus and for general working capital.

Under the Agreement, the Company can determine whether or not it will request a subscription from Kentgrove Capital, can set the time period of the placements, the maximum amount of the placements and the minimum issue price. For each placement made via the Facility, shares will be issued at a 5% discount to a volume weighted average price (VWAP) over the placement time period.

At the date of this report, the Company has received $2,603,111 (before associated costs) via the issue of equity placements by Kentgrove Capital Growth Fund (“Kentgrove Capital”) as part of the standby Equity Placement Facility Agreement.

The Company has also received $1,844,500 from the exercise of options to purchase more shares which were attached to the unlisted secure debt note issued in October 2014.

On 26 February 2015, the Company advised that Mr. Eutillio Buccilli has been appointed Chief Executive Officer of the Company.

Apart from the above, there have been no events which have occurred after balance date.

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Further information

Further information concerning the operations and financial condition of the consolidated entity can be found in the reports and releases made by the Company to the Australian Securities Exchange during the half-year.

Signed in accordance with a resolution of the Directors.

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CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

The above consolidated statement of comprehensive income should be read in conjunction with the accompanying notes.

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CONSOLIDATED BALANCE SHEET

The above consolidated balance sheet should be read in conjunction with the accompanying notes.

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CONSOLIDATED STATEMENT OF CASH FLOWS

The above consolidated statement of cash flows should be read in conjunction with the accompanying notes.

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CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

The above consolidated statement of changes in equity should be read in conjunction with the accompanying notes.

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NOTES TO THE HALF-YEAR FINANCIAL STATEMENTS

Half-year ended 31 December 2014

1.                  BASIS OF PREPARATION OF HALF-YEAR REPORT

This condensed consolidated interim financial report for the half-year reporting period ended 31 December 2014 has been prepared in accordance with AASB 134 Interim Financial Reporting and the Corporations Act 2001.

This condensed consolidated interim financial report does not include all the notes of the type normally included in an annual financial report.  Accordingly, this Report is to be read in conjunction with the annual report for the year ended 30 June 2014 and any public announcements made by Genetic Technologies Limited during the interim reporting period in accordance with the continuous disclosure requirements of the Corporations Act 2001.

The accounting policies adopted are consistent with those of the previous financial year and corresponding interim reporting period.

Going concern

During the financial half-year, the consolidated entity incurred a total comprehensive loss after income tax of $4,774,751 (2013: $5,087,286) and net cash outflows from operations of $5,820,310 (2013: $5,199,847).  As at 31 December 2014, the consolidated entity held cash reserves of $1,274,808.

Subsequent to balance date, the Company has raised $4,447,611 before the payment of associated costs, through:

·                  $2,603,111 of new finance via the issue of equity placements by Kentgrove Capital Growth Fund (“Kentgrove Capital”) as part of the Standby Equity Placement Facility Agreement; and

·                  $1,844,500 from options attached to the issue of unlisted secured debt in October 2014, exercised by note holders.

As at the date of this Report, the Company held cash reserves of approximately $4,305,435.

The cash raised from the above two transactions, combined with its existing cash reserves, will enable the Company to fund its operations over the next 4 to 6 months.

The continuing viability of the Company and the group’s ability to continue as a going concern and meet its debts and commitments as and when they fall due is wholly dependent on the Company being successful in raising additional funds via the issuance of new equity.  The cash reserves will be used to fund the growth of the Company’s breast cancer risk test, BREVAGenplus and for general working capital.

The issuance of new equity will be subject to shareholder approval, which will be sought at the EGM on 6 March 2015.

Due to the significant uncertainty surrounding the timing and quantum of the above event, there is a material uncertainty that may cast significant doubt on the Company’s ability to continue as a going concern and, therefore, that it may be unable to realise its assets and discharge its liabilities in the normal course of business.  However, the Directors believe that the Company will be successful in raising new funds, in the timeframe required, and accordingly, have prepared the financial report on a going concern basis.

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2.                  COST OF SALES

3.                  OTHER REVENUE

4.                  OTHER INCOME AND EXPENSES

5.                  GAIN ON DECONSOLIDATION OF SUBSIDIARY

Note:        During the half-year ended 31 December 2013, the Group deconsolidated its former Canadian-listed subsidiary, Gtech International Resources Limited.  As a result, the net liabilities, the foreign currency reserve and non-controlling interest of the formerly-consolidated subsidiary were derecognised from the Group at the carrying amounts on the date that control was lost.  The retained equity interest has been recorded as an available for sale financial asset.

6.                  GAIN ON DISPOSAL OF BUSINESS

On 19 November 2014, the Company announced that it had completed the sale of its heritage Australian Genetics business to Specialist Diagnostics Services Ltd (“SDS”), the wholly owned pathology subsidiary of Primary Health Care Ltd. Under the terms of sale, SDS acquired the Australian Genetics business for $2,100,894 (net of employee entitlements and inclusive of GST), in cash. The gain on disposal as recognised in the Consolidated Statement of Comprehensive Income is $1,480,811. Goodwill of $315,387 attributable to the heritage business disposed of has been included in the net assets disposed.

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7.                  EXPENSES

8.                  LOSS PER SHARE

The following reflects the income and share data used in the calculations of basic and diluted loss per share:

Note:        None of the 14,025,000 (30 June 2014: 7,775,000) options outstanding as at the reporting date are considered to be dilutive for the purposes of calculating diluted earnings per share and have therefore been excluded from the weighted average number of shares.

9.                  CASH AND CASH EQUIVALENTS

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10.                               FAIR VALUE MEASUREMENT OF FINANCIAL INSTRUMENTS

Fair value hierarchy

AASB requires disclosure of fair value measurements by level of the following fair value measurement hierarchy:

(a)             quoted prices (unadjusted) in active markets for identical assets or liabilities (level 1);

(b)             inputs other than prices included within level 1 that are observable for the asset or liability, either directly or indirectly (level 2); and

(c)              inputs for the asset or liability that are not based on observable market data (unobservable inputs) (level 3).

The following table presents the Group’s financial assets and financial liabilities measured and recognised at fair value as at 31 December 2014.

(1)Management has recognised a fair value of $NIL for the ImmunAid financial asset as at 31 December 2014.