Form 6-K GENETIC TECHNOLOGIES For: Nov 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 November 27, 2015
Commission File Number 0-51504
GENETIC TECHNOLOGIES LIMITED
(Exact Name as Specified in its Charter)
N/A
(Translation of Registrants 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: November 27, 2015 |
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GENETIC TECHNOLOGIES LIMITED | ||
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By: |
/s/ Kevin Fischer | |
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Name: |
Kevin Fischer |
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Title: |
Company Secretary |
EXHIBIT INDEX
Exhibit |
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Description of Exhibit |
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99.1 |
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ASX Announcement, November 25, 2015 |
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99.2 |
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ASX Announcement, November 25, 2015 |
Exhibit 99.1
ASX ANNOUNCEMENT
25 November 2015
2015 Annual General Meeting
Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) is pleased to release the attached slide show presentation which will be delivered by its Chief Executive Officer, Mr. Eutillio Buccilli, at the Companys 2015 Annual General Meeting to be held at approximately 10.30 am this morning in the Treetops Room at Melbourne Museum, 11 Nicholson Street, Carlton, Victoria, Australia.
FOR FURTHER INFORMATION PLEASE CONTACT
Mr. Eutillio Buccilli |
Candice Knoll (USA) |
Executive Director & Chief Executive Officer |
Blueprint Life Science Group |
Genetic Technologies Limited |
+1 (415) 375 3340, Ext. 4 |
+ 61 3 8412 7050 |
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About Genetic Technologies Limited
Genetic Technologies is a molecular diagnostics company that offers predictive testing and assessment tools to help physicians proactively manage womens health. The Companys lead product, BREVAGenplus®, is a clinically validated risk assessment test for non-hereditary breast cancer and is first in its class. BREVAGenplus® improves upon the predictive power of the first generation BREVAGen test and is designed to facilitate better informed decisions about breast cancer screening and preventive treatment plans. BREVAGenplus® expands the application of BREVAGen from Caucasian women to include African-Americans and Hispanics, and is directed towards women aged 35 years or above, who have not had breast cancer and have one or more risk factors for developing breast cancer.
The Company has successfully launched the first generation BREVAGen test across the U.S. via its U.S. subsidiary Phenogen Sciences Inc. and the addition of BREVAGenplus®, launched in October 2014, significantly expands the applicable market. The Company markets BREVAGenplus® to healthcare professionals in comprehensive breast health care and imaging centres, as well as to obstetricians/gynaecologists (OBGYNs) and breast cancer risk assessment specialists (such as breast surgeons).
For more information, please visit www.brevagenplus.com and www.phenogensciences.com.
Safe Harbor Statement
Any statements in this press release that relate to the Companys expectations are forward-looking statements, within the meaning of the Private Securities Litigation Reform Act. The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees. Since this information may involve risks and uncertainties and are subject to change at any time, the Companys actual results may differ materially from expected results. Additional risks associated with Genetic Technologies business can be found in its periodic filings with the SEC.
Genetic Technologies Limited Annual General Meeting Wednesday, 25 November 2015
Forward Looking Statements This presentation may contain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S. Securities Exchange Act of 1934 with respect to the financial condition, results and business achievements/performance of Genetic Technologies Limited and certain of the plans and objectives of its management. These statements are statements that are not historical facts. Words such as should, expects, anticipates, estimates, believes or similar expressions, as they relate to Genetic Technologies Limited, are intended to identify forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect Genetic Technologies current expectations and assumptions as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assumptions or expectations could cause actual results to differ materially from current expectations.
Major Achievements Since Last AGM Secured $24.0M Standby Equity Placement Facility Completed $18.6M capital raise Continued roll out of the 2nd generation BREVAGenplus test across the U.S. Revised sales and marketing strategy to target large comprehensive breast health centres and imaging centres Completed divestiture of the heritage Australian Genetics business Launched an initiative to reinvigorate the pathway to Peer-Reviewed Publications Granted U.S. Patent No. 9,051,617 and 9,068,229 covering three of the core genetic markers included in the BREVAGenplus risk assessment test Significant reduction in cost base, with annualised June 15 quarter cash spend down 34%, expressed in constant currency terms Successfully remediated two separate Nasdaq deficiencies Securing sufficient capital resources to enable proper execution of our next generation plan was a top priority
Operational Review Board and Management operational review, commenced at start of the fiscal year Strategic decision to shift the Companys entire focus to the U.S. molecular diagnostics market Streamlined operations and focused on executing an ambitious commercial strategy for BREVAGenplus Decision to divest non-core assets - Heritage businesses little opportunity for growth, sample numbers trending downwards - RareCellect technology being superseded, patent portfolio costly, time limit on divestment activities - Other non-core assets Simavita shares and Immunaid options Licensing program changing landscape in U.S. courts, patents at the end of life, expected within the next 6-12 months Realigned corporate spending and restructured Board of Directors 4 The past fiscal year has been a period of refinement while continuing to build capacity for growth
What is BREVAGenplus? Simple swab-based test that helps determine a womans risk of developing breast cancer Single nucleotide polymorphisms (SNPs) are the most common type of genetic variation among people. The SNPs used in BREVAGenplus have been confirmed to be associated with Breast Cancer Molecular panel of 77 SNPs combined with clinical risk factors from the NCIs Breast Cancer Risk Assessment Tool (BCRAT) to provide an integrated risk score First test of its kind to be clinically validated to assess both 5-year and lifetime risk for sporadic breast cancer: both hormone-dependent and triple negative subtypes Validated and CLIA-approved for use in Caucasian, Hispanic and African-American women aged ≥ 35 Provides a >20% increase in accuracy over first generation BREVAGen BREVAGenplus - Our flagship first-in-class risk assessment test for non-hereditary breast cancer
TV Segment 6
Market Opportunity Total number of women in target age range for BREVAGenplus: 54.3 million Potential market size reduced by: Ethnicities not covered by BREVAGenplus ~10% Women on Medicaid ~20% Of which ~33% are Women of intermediate risk, based on GAIL score Total target population ~12.9 million BUT: the Centre for Disease Control (CDC) data shows only 67% compliance for mammography in eligible age groups Potential target market size ~8.6 million women
Key Market Drivers Scientific validation and clinical utility studies Further scientific validation results/publications expected by end Q2 FY16 Evidence from clinical utility studies will secure wider payer coverage, increase current reimbursement levels and speed product uptake first of three trials to begin Q2 FY16, completion expected end FY16 Market awareness KOL speaker program Integrated web/social media Targeted regional media features Key accounts Focus on breast/imaging centers Find, establish, grow Reimbursement Commence discussions with insurer groups once clinical utility studies provide evidence that demonstrate test impact on treatment decision-making that is aligned with payer evidence requirements
Market Progress BREVAGenplus now available in all 50 U.S. states Samples received from 18 high population density territories 8,558 Samples received since launch of BREVAGen, in June 2011, BREVAGenplus released in October 2014 Key Opinion Leaders (KOLs) act as BREVAGenplus Ambassadors to: Highlight the utility and value of BREVAGenplus in the clinical setting Provide templates for clinic adoption, patient selection and logistics Drive increased adoption of the BREVAGenplus test High prescribing users and KOLs on U.S. regional TV aim to: Introduce BREVAGenplus to the general public Integrate PR with new speakers in the various sales markets
Geographical Cluster of Samples Cumulative U.S. Samples cluster - July 2011 to June 2015 U.S. sales team focus on territories with high volume, demonstrating strong growth potential
Priorities for FY2016 SALES, SALES, SALES Complete scientific validation end Q2 FY16 and first of three clinical trials by end FY16, while commencing two other longer-term clinical trials in FY16 Strengthen the U.S. sales team, focus on improving scalability and creating market awareness of BREVAGenplus Find, establish and grow key accounts (breast health centres and imaging centres) in the U.S. market Monitor BREVAGenplus roll out to improve performance, expand market reach, increase market acceptance and brand awareness Continue to work with payers (insurers) to improve reimbursement outcomes Manage operating cost base and cash flow with the aim of maximising re-investment in product development and top line growth R & D: push to develop additional products for different disease states eg. Colon Cancer Ensure adequate funding is available to meet objectives
Financial Snapshot Shares outstanding 1,714 MM ADRs (@150:1 ratio) 8.9 MM Top 20 shareholders 86.4% Total shareholders 3,165 Unlisted Options outstanding 24.2MM As at 30 Jun 2015 - Market cap (@$0.028) AUD48.0 MM Fiscal Year Ended June 30 Financials Revenue (AUD millions) 2015 2014 2013 BREVAGen/ BREVAGenplus 1.3 1.7 0.3 Shares as at 30 June 2015 As at 24 Nov 2015 - Market cap (@$0.029) AUD49.7 MM As at 30 Jun 2014 - Market cap (@$0.036) AUD22.1 MM
Exhibit 99.2
ASX ANNOUNCEMENT
25 November, 2015
Results from 2015 Annual General Meeting
Melbourne, Australia; 25 November 2015: Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, Company) advises that the 2015 Annual General Meeting of shareholders was held at 10.30 am today (Melbourne time).
All seven (7) resolutions that were put before the shareholders were passed on a show of hands. Details of the proxy votes received by the Company in respect of all seven resolutions is contained in Table 1 to this announcement on the attached page.
FOR FURTHER INFORMATION PLEASE CONTACT
Mr. Eutillio Buccilli |
Candice Knoll (USA) |
Executive Director & Chief Executive Officer |
Blueprint Life Science Group |
Genetic Technologies Limited |
+1 (415) 375 3340, Ext. 4 |
+ 61 3 8412 7050 |
|
About Genetic Technologies Limited
Genetic Technologies is a molecular diagnostics company that offers predictive testing and assessment tools to help physicians proactively manage womens health. The Companys lead product, BREVAGenplus®, is a clinically validated risk assessment test for non-hereditary breast cancer and is first in its class. BREVAGenplus® improves upon the predictive power of the first generation BREVAGen test and is designed to facilitate better informed decisions about breast cancer screening and preventive treatment plans. BREVAGenplus® expands the application of BREVAGen from Caucasian women to include African-Americans and Hispanics, and is directed towards women aged 35 years or above, who have not had breast cancer and have one or more risk factors for developing breast cancer.
The Company has successfully launched the first generation BREVAGen test across the U.S. via its U.S. subsidiary Phenogen Sciences Inc. and the addition of BREVAGenplus®, launched in October 2014, significantly expands the applicable market. The Company markets BREVAGenplus® to healthcare professionals in comprehensive breast health care and imaging centres, as well as to obstetricians/gynaecologists (OBGYNs) and breast cancer risk assessment specialists (such as breast surgeons).
For more information, please visit www.brevagenplus.com and www.phenogensciences.com.
Safe Harbor Statement
Any statements in this press release that relate to the Companys expectations are forward-looking statements, within the meaning of the Private Securities Litigation Reform Act. The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees. Since this information may involve risks and uncertainties and are subject to change at any time, the Companys actual results may differ materially from expected results. Additional risks associated with Genetic Technologies business can be found in its periodic filings with the SEC.
Table 1 - Proxy results for 2015 Annual General Meeting
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Manner in which the securityholder directed the proxy vote |
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Description of Resolution |
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Votes |
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Votes |
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Votes |
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Votes |
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Consideration of financial statements |
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NO VOTE REQUIRED | |||||||
1. Adoption of Remuneration Report |
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Numbers of votes received |
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20,387,416 |
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3,292,279 |
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17,175 |
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31,874,738 |
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Percentage of votes cast |
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36.7 |
% |
5.9 |
% |
0.0 |
% |
57.4 |
% |
2. Re-election of Dr. Malcom Brandon |
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Numbers of votes received |
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39,303,354 |
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3,136,279 |
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12,000 |
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31,874,738 |
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Percentage of votes cast |
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52.9 |
% |
4.2 |
% |
0.0 |
% |
42.9 |
% |
3. Election of Mr. Eutillio Buccilli |
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Numbers of votes received |
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39,304,354 |
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3,135,279 |
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12,000 |
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31,874,738 |
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Percentage of votes cast |
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52.9 |
% |
4.2 |
% |
0.0 |
% |
42.9 |
% |
4. Ratification of prior placement of shares to sophisticated investors |
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|
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|
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Numbers of votes received |
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38,834,479 |
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3,609,154 |
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8,000 |
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31,874,738 |
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Percentage of votes cast |
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52.2 |
% |
4.9 |
% |
0.0 |
% |
42.9 |
% |
5. Ratification of prior placement of shares to Kentgrove Capital Growth Fund |
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Numbers of votes received |
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25,643,179 |
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3,300,454 |
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8,000 |
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31,874,738 |
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Percentage of votes cast |
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42.2 |
% |
5.4 |
% |
0.0 |
% |
52.4 |
% |
6. Refresh of existing Kentgrove standby equity placement facility |
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Numbers of votes received |
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25,643,179 |
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3,291,279 |
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17,175 |
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31,874,738 |
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Percentage of votes cast |
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42.2 |
% |
5.4 |
% |
0.0 |
% |
52.4 |
% |
7. Issue of Options to Mr. Eutillio Buccilli |
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Numbers of votes received |
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38,782,479 |
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3,661,154 |
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8,000 |
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31,874,738 |
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Percentage of votes cast |
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52.2 |
% |
4.9 |
% |
0.0 |
% |
42.9 |
% |
* Discretionary votes in favour of the Chair of the meeting - voted in favour of the resolution
Note: The Company currently has a total of 1,715,282,724 ordinary shares on issue and 3,177 registered shareholders.
Genetic Technologies Limited · Website: www.gtglabs.com · Email: [email protected] ABN 17 009 212 328
Registered Office · 60-66 Hanover Street Fitzroy Victoria 3065 Australia · Postal Address P.O. Box 115 Fitzroy Victoria 3065 Australia
Phone +61 3 8412 7000 · Fax +61 3 8412 7040
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