0001104659-15-005655.txt : 20150130 0001104659-15-005655.hdr.sgml : 20150130 20150130143823 ACCESSION NUMBER: 0001104659-15-005655 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20150130 FILED AS OF DATE: 20150130 DATE AS OF CHANGE: 20150130 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENETIC TECHNOLOGIES LTD CENTRAL INDEX KEY: 0001166272 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51504 FILM NUMBER: 15562535 BUSINESS ADDRESS: STREET 1: 60-66 HANOVER STREET CITY: FITZROY, VICTORIA STATE: C3 ZIP: 3065 BUSINESS PHONE: 011613-9415-1135 MAIL ADDRESS: STREET 1: 60-66 HANOVER STREET CITY: FITZROY, VICTORIA STATE: C3 ZIP: 3065 6-K 1 a15-3467_16k.htm 6-K

 

 

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 January 30, 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:  January 30, 2015

 

 

GENETIC TECHNOLOGIES LIMITED

 

 

 

 

 

 

 

By:

/s/ Bronwyn Christie

 

 

Name:

Bronwyn Christie

 

 

Title:

Company Secretary

 

2



 

EXHIBIT INDEX

 

Exhibit

 

Description of Exhibit

 

 

 

99.1

 

Appendix 3B, January 30, 2015

 

 

 

99.2

 

Quarterly Activities Report and Appendix 4C of the ASX Listing Rules for the quarter ended 31 December 2014

 

3


EX-99.1 2 a15-3467_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Rule 2.7, 3.10.3, 3.10.4, 3.10.5

 

Appendix 3B

 

New issue announcement,

application for quotation of additional securities

and agreement

 

Information or documents not available now must be given to ASX as soon as available.  Information and documents given to ASX become ASX’s property and may be made public.

 

Introduced 01/07/96  Origin: Appendix 5  Amended 01/07/98, 01/09/99, 01/07/00, 30/09/01, 11/03/02, 01/01/03, 24/10/05, 01/08/12

 

Name of entity

 

GENETIC TECHNOLOGIES LIMITED

 

ABN

 

17 009 212 238

 

We (the entity) give ASX the following information.

 

Part 1 - All issues

 

You must complete the relevant sections (attach sheets if there is not enough space).

 

1

 

+Class of +securities issued or to be issued

 

Ordinary shares

 

 

 

 

 

2

 

Number of +securities issued or to be issued (if known) or maximum number which may be issued

 

68,599,858

 

 

 

 

 

3

 

Principal terms of the +securities (eg, if options, exercise price and expiry date; if partly paid +securities, the amount outstanding and due dates for payment; if +convertible securities, the conversion price and dates for conversion)

 

Fully paid ordinary shares

 

41,933,191 in respect of the drawdown, under the standby equity placement facility.

 

26,666,667 in respect to exercise of options approved at the Annual General Meeting on 25th November 2014.

 



 

4

 

Do the +securities rank equally in all respects from the date of allotment with an existing +class of quoted +securities?

 

If the additional securities do not rank equally, please state:

 

·    the date from which they do

·    the extent to which they participate for the next dividend, (in the case of a trust, distribution) or interest payment

·    the extent to which they do not rank equally, other than in relation to the next dividend, distribution or interest payment

 

Yes

 

 

 

 

 

5

 

Issue price or consideration

 

41,933,191 at $0.01407

 

26,666,667 at $0.015

 

 

 

 

 

6

 

Purpose of the issue

(If issued as consideration for the acquisition of assets, clearly identify those assets)

 

41,933,191 - The drawdown of funds pursuant to an allotment request submitted to Kentgrove Capital Growth Fund under the standby equity placement facility, details of which were announced to the market on 22nd January 2015.

 

26,666,667 — Exercise of options

 

 

 

 

 

6a

 

Is the entity an +eligible entity that has obtained security holder approval under rule 7.1A?

 

If Yes, complete sections 6b — 6h in relation to the +securities the subject of this Appendix 3B, and comply with section 6i

 

No

 

 

 

 

 

6b

 

The date the security holder resolution under rule 7.1A was passed

 

Not applicable

 

 

 

 

 

6c

 

Number of +securities issued without security holder approval under rule 7.1

 

Not applicable

 

 

 

 

 

6d

 

Number of +securities issued with security holder approval under rule 7.1A

 

Not applicable

 


+ See chapter 19 for defined terms.

 

2



 

6e

 

Number of +securities issued with security holder approval under rule 7.3, or another specific security holder approval (specify date of meeting)

 

Not applicable

 

 

 

 

 

6f

 

Number of securities issued under an exception in rule 7.2

 

Not applicable

 

 

 

 

 

6g

 

If securities issued under rule 7.1A, was issue price at least 75% of 15 day VWAP as calculated under rule 7.1A.3?  Include the issue date and both values.  Include the source of the VWAP calculation.

 

Not applicable

 

 

 

 

 

6h

 

If securities were issued under rule 7.1A for non-cash consideration, state date on which valuation of consideration was released to ASX Market Announcements

 

Not applicable

 

 

 

 

 

6i

 

Calculate the entity’s remaining issue capacity under rule 7.1 and rule 7.1A — complete Annexure 1 and release to ASX Market Announcements

 

38,424,914

 

 

 

 

 

7

 

Dates of entering +securities into uncertificated holdings or despatch of certificates

 

30 January 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Number

 

+Class

8

 

Number and +class of all +securities quoted on ASX (including the securities in section 2 if applicable)

 

965,460,112

 

Ordinary shares

 


+ See chapter 19 for defined terms.

 

3



 

 

 

 

 

Number

 

+Class

9

 

Number and +class of all +securities not quoted on ASX (including the securities in section 2 if applicable)

 

1,875,000

 

Options at $0.19, exp.
31/3/2016 (GTGAW)

 

 

 

 

 

 

 

 

 

 

 

1,000,000

 

Options at $0.20, exp.
31/7/2016 (GTGAM)

 

 

 

 

 

 

 

 

 

 

 

750,000

 

Options at $0.12, exp.
20/2/2017 (GTGAK)

 

 

 

 

 

 

 

 

 

 

 

2,650,000

 

Options at $0.14, exp.
29/8/2017 (GTGAO)

 

 

 

 

 

 

 

 

 

 

 

250,000

 

Options at $0.10, exp.
1/12/17 (GTGAQ)

 

 

 

 

 

 

 

 

 

 

 

500,000

 

Options at $0.10, exp.
25/1/18 (GTGAS)

 

 

 

 

 

 

 

 

 

 

 

750,000

 

Options at $0.105, exp.
11/7/18 (GTGAY)

 

 

 

 

 

 

 

 

 

 

 

6,875,000

 

Options at $0.04, exp.
31/5/19 (GTGAA)

 

 

 

 

 

 

 

 

 

 

 

1,390,000

 

Convertible Notes issued on 3 December 2014 (GTGAB)

 

 

 

 

 

 

 

 

 

 

 

116,666,666

 

Options at $0.015, exp.
2/12/2018 (GTGAC)

 


+ See chapter 19 for defined terms.

 

4



 

Part 2 - Bonus issue or pro rata issue

 

10

 

Dividend policy (in the case of a trust, distribution policy) on the increased capital (interests)

 

 

 

 

 

 

 

11

 

Is security holder approval required?

 

 

 

 

 

 

 

12

 

Is the issue renounceable or non-renounceable?

 

 

 

 

 

 

 

13

 

Ratio in which the +securities will be offered

 

 

 

 

 

 

 

14

 

+Class of +securities to which the offer relates

 

 

 

 

 

 

 

15

 

+Record date to determine entitlements

 

 

 

 

 

 

 

16

 

Will holdings on different registers (or subregisters) be aggregated for calculating entitlements?

 

 

 

 

 

 

 

17

 

Policy for deciding entitlements in relation to fractions

 

 

 

 

 

 

 

18

 

Names of countries in which the entity has +security holders who will not be sent new issue documents

 

Note: Security holders must be told how their entitlements are to be dealt with.

 

Cross reference: rule 7.7.

 

 

 

 

 

 

 

19

 

Closing date for receipt of acceptances or renunciations

 

 

 

 

 

 

 

20

 

Names of any underwriters

 

 

 

 

 

 

 

21

 

Amount of any underwriting fee or commission

 

 

 

 

 

 

 

22

 

Names of any brokers to the issue

 

 

 

 

 

 

 

23

 

Fee or commission payable to the broker to the issue

 

 

 

 

 

 

 

24

 

Amount of any handling fee payable to brokers who lodge acceptances or renunciations on behalf of +security holders

 

 

 


+ See chapter 19 for defined terms.

 

5



 

25

 

If the issue is contingent on +security holders’ approval, the date of the meeting

 

 

 

 

 

 

 

26

 

Date entitlement and acceptance form and prospectus or Product Disclosure Statement will be sent to persons entitled

 

 

 

 

 

 

 

27

 

If the entity has issued options, and the terms entitle option holders to participate on exercise, the date on which notices will be sent to option holders

 

 

 

 

 

 

 

28

 

Date rights trading will begin (if applicable)

 

 

 

 

 

 

 

29

 

Date rights trading will end (if applicable)

 

 

 

 

 

 

 

30

 

How do +security holders sell their entitlements in full through a broker?

 

 

 

 

 

 

 

31

 

How do +security holders sell part of their entitlements through a broker and accept for the balance?

 

 

 

 

 

 

 

32

 

How do +security holders dispose of their entitlements (except by sale through a broker)?

 

 

 

 

 

 

 

33

 

+Despatch date

 

 

 

Part 3 - Quotation of securities

 

You need only complete this section if you are applying for quotation of securities

 

34

 

Type of securities

(tick one)

 

 

 

 

 

(a)

 

x

 

Securities described in Part 1

 

 

 

 

 

(b)

 

o

 

All other securities

 

Example: restricted securities at the end of the escrowed period, partly paid securities that become fully paid, employee incentive share securities when restriction ends, securities issued on expiry or conversion of convertible securities

 


+ See chapter 19 for defined terms.

 

6



 

Entities that have ticked box 34(a)

 

Additional securities forming a new class of securities

 

Tick to indicate you are providing the information or documents

 

35

 

o

 

If the +securities are +equity securities, the names of the 20 largest holders of the additional +securities, and the number and percentage of additional +securities held by those holders

 

 

 

 

 

36

 

o

 

If the +securities are +equity securities, a distribution schedule of the additional +securities setting out the number of holders in the categories

1 - 1,000

1,001 - 5,000

5,001 - 10,000

10,001 - 100,000

100,001 and over

 

 

 

 

 

37

 

o

 

A copy of any trust deed for the additional +securities

 

Entities that have ticked box 34(b)

 

38

 

Number of securities for which +quotation is sought

 

 

 

 

 

 

 

39

 

Class of +securities for which quotation is sought

 

 

 

 

 

 

 

40

 

Do the +securities rank equally in all respects from the date of allotment with an existing +class of quoted +securities?

 

If the additional securities do not rank equally, please state:

 

·                  the date from which they do

·                  the extent to which they participate for the next dividend, (in the case of a trust, distribution) or interest payment

·                  the extent to which they do not rank equally, other than in relation to the next dividend, distribution or interest payment

 

 

 

 

 

 

 

41

 

Reason for request for quotation now

 

Example: In the case of restricted securities, end of restriction period

 

(if issued upon conversion of another security, clearly identify that other security)

 

 

 

 

 

 

 

 

 

 

 

Number

 

+Class

42

 

Number and +class of all +securities quoted on ASX (including the securities in clause 38)

 

 

 

 

 


+ See chapter 19 for defined terms.

 

7



 

Quotation agreement

 

1                                        +Quotation of our additional +securities is in ASX’s absolute discretion.  ASX may quote the +securities on any conditions it decides.

 

2                                        We warrant the following to ASX.

 

·                                          The issue of the +securities to be quoted complies with the law and is not for an illegal purpose.

 

·                                          There is no reason why those +securities should not be granted +quotation.

 

·                                          An offer of the +securities for sale within 12 months after their issue will not require disclosure under section 707(3) or section 1012C(6) of the Corporations Act.

 

Note: An entity may need to obtain appropriate warranties from subscribers for the securities in order to be able to give this warranty

 

·                                          Section 724 or section 1016E of the Corporations Act does not apply to any applications received by us in relation to any +securities to be quoted and that no-one has any right to return any +securities to be quoted under sections 737, 738 or 1016F of the Corporations Act at the time that we request that the +securities be quoted.

 

·                                          If we are a trust, we warrant that no person has the right to return the +securities to be quoted under section 1019B of the Corporations Act at the time that we request that the +securities be quoted.

 

3                                        We will indemnify ASX to the fullest extent permitted by law in respect of any claim, action or expense arising from or connected with any breach of the warranties in this agreement.

 

4                                        We give ASX the information and documents required by this form.  If any information or document not available now, will give it to ASX before +quotation of the +securities begins.  We acknowledge that ASX is relying on the information and documents.  We warrant that they are (will be) true and complete.

 

 

Sign here:

 

 

Date: 30 January 2015

 

Chief Operating Officer & Chief Financial Officer

 

 

 

 

 

 

 

 

 

 

Print name:

Eutillio Buccilli

 

 

 

== == == == ==

 


+ See chapter 19 for defined terms.

 

8



 

Appendix 3B — Annexure 1

 

Calculation of placement capacity under rule 7.1 and rule 7.1A for +eligible entities

 

Introduced 01/08/12

 

Part 1

 

Rule 7.1 — Issues exceeding 15% of capital

 

Step 1: Calculate “A”, the base figure from which the placement capacity is calculated

 

Insert number of fully paid ordinary securities on issue 12 months before date of issue or agreement to issue

 

597,926,082

 

 

 

Add the following:

 

 

 

 

 

·      Number of fully paid ordinary securities issued in that 12 month period under an exception in rule 7.2

 

19,074,112

 

 

 

·      Number of fully paid ordinary securities issued in that 12 month period with shareholder approval

 

331,880,807

 

 

 

·      Number of partly paid ordinary securities that became fully paid in that 12 month period

 

 

 

 

 

Note:

 

·    Include only ordinary securities here — other classes of equity securities cannot be added

·    Include here (if applicable) the securities the subject of the Appendix 3B to which this form is annexed

·    It may be useful to set out issues of securities on different dates as separate line items

 

 

 

 

 

Subtract the number of fully paid ordinary securities cancelled during that 12 month period

 

75,937,500

 

 

 

“A”

 

872,943,501

 

 

 

Step 2: Calculate 15% of “A”

 

 

 

 

 

“B”

 

0.15

[Note: this value cannot be changed]

 

 

 

Multiply “A” by 0.15

 

130,941,525

 


+ See chapter 19 for defined terms.

 

9



 

Step 3: Calculate “C”, the amount of placement capacity under rule 7.1 that has already been used

 

 

 

Insert number of equity securities issued or agreed to be issued in that 12 month period not counting those issued:

 

·    Under an exception in rule 7.2

 

·    Under rule 7.1A

 

·    With security holder approval under rule 7.1 or rule 7.4

 

Note:

 

·    This applies to equity securities, unless specifically excluded — not just ordinary securities

·    Include here (if applicable) the securities the subject of the Appendix 3B to which this form is annexed

·    It may be useful to set out issues of securities on different dates as separate line items

 

 

 

 

 

“C”

 

92,516,611

 

 

 

Step 4: Subtract “C” from [“A” x “B”] to calculate remaining placement capacity under rule 7.1

 

 

 

“A” x 0.15

Note: number must be same as shown in Step 2

 

130,941,525

 

 

 

Subtract “C”

Note: number must be same as shown in Step 3

 

92,516,611

 

 

 

Total [“A” x 0.15] – “C”

 

38,424,914

[Note: this is the remaining placement capacity under rule 7.1]

 


+ See chapter 19 for defined terms.

 

10



 

Part 2

 

Rule 7.1A — Additional placement capacity for eligible entities

 

Step 1: Calculate “A”, the base figure from which the placement capacity is calculated

 

“A”

 

Note: number must be same as shown in Step 1 of Part 1

 

 

 

 

 

Step 2: Calculate 10% of “A”

 

 

 

 

 

“D”

 

0.10

 

Note: this value cannot be changed

 

 

 

Multiply “A” by 0.10

 

 

 

 

 

Step 3: Calculate “E”, the amount of placement capacity under rule 7.1A that has already been used

 

 

 

Insert number of equity securities issued or agreed to be issued in that 12 month period under rule 7.1A

 

Notes:

 

·      This applies to equity securities — not just ordinary securities

·      Include here — if applicable — the securities the subject of the Appendix 3B to which this form is annexed

·      Do not include equity securities issued under rule 7.1 (they must be dealt with in Part 1), or for which specific security holder approval has been obtained

·      It may be useful to set out issues of securities on different dates as separate line items

 

 

 

 

 

“E”

 

 

 


+ See chapter 19 for defined terms.

 

11



 

Step 4: Subtract “E” from [“A” x “D”] to calculate remaining placement capacity under rule 7.1A

 

“A” x 0.10

 

Note: number must be same as shown in Step 2

 

 

 

 

 

Subtract “E”

 

Note: number must be same as shown in Step 3

 

 

 

 

 

Total [“A” x 0.10] – “E”

 

 

 

Note: this is the remaining placement capacity under rule 7.1A

 


+ See chapter 19 for defined terms.

 

12


EX-99.2 3 a15-3467_1ex99d2.htm EX-99.2

Exhibit 99.2

 

 

GENETIC TECHNOLOGIES LIMITED

A.B.N. 17 009 212 328

 

Quarterly Activities Report

and

Appendix 4C of the ASX Listing Rules

for the quarter ended

31 December 2014

 



 

GENETIC TECHNOLOGIES LIMITED

 

QUARTERLY ACTIVITIES REPORT

FOR THE QUARTER ENDED 31 December 2014

 

Highlights

 

·                  Launches 2nd generation BREVAGenTM, BREVAGenplus® breast cancer risk assessment test, in the U.S. market

·                  Up to 6 new Breast Centres to begin offering BREVAGenplus

·                  Secures $24.0M Standby Equity Placement Facility

·                  Completes divestiture its heritage Australian Genetics business for $2.0M, in cash

·                  New research study supporting the use of BREVAGenplus in breast cancer risk assessment

 

Melbourne, Australia, 30 January 2015: Molecular diagnostics company Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”) is pleased to report that up to 6 new breast diagnosis/treatment centres are expected to begin offering BREVAGenplus to their at-risk patients in a systematic broad fashion in the January to March timeframe, with a growing number of additional new breast and imaging centre customers expected to follow later in calendar year 2015. As a result, the Company expects sales growth to accelerate in the second half 2015 and beyond. In addition, the Company has entered into a A$24 million Standby Equity Placement Facility Agreement to strengthen the Company’s funding position. The Facility will assist the Company with its funding requirements, over the coming years, as the BREVAGenplus test roll out continues across the United States.

 

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).

 

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 December 13, 2014.

 

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

 

1



 

OPERATIONS

 

Financial summary

 

Total cash receipts from customers during the quarter ended 31 December 2014 were $0.8 million, taking the equivalent figure to $1.8 million for the half year ended on that date (previous corresponding period: $2.3 million).

 

BREVAGenplus breast cancer risk test

 

Test Samples received for the December quarter:

 

For the December 2014 quarter, 779 BREVAGenplus test samples were received, subsequent to the launch of the second generation test in October 2014. (YTD 1,721 BREVAGen/BREVAGenplus test samples received). The 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 was increased to enable the Company to receive payment for aspects of the test that were not previously available under the code stack.  Importantly, notwithstanding this, the Company did not seek to increase the maximum out-of-pocket amount that a given patient is required to pay for a BREVAGen test under its “Patient Protection Program.”

 

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 BREVAGen test to guide MRI screening, an additional paper has been published demonstrating the cost effectiveness of the BREVAGen 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 BREVAGen to direct tamoxifen chemoprevention.

 

2



 

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 BREVAGen test to determine eligibility for five years of tamoxifen therapy. The BREVAGen 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

 

As reported by the CEO at the 25 Nov 2014 Annual General Meeting, the Licensing program has recently been faced with numerous challenges including the changing landscape in US courts, European up-front costs as well as the nearing end of the core non-coding patents’ lives. Despite these, during the 2014 Financial Year, there were 6 new licenses granted, and the fourth re-examination of the ‘179 patent was successfully defended with the USPTO upholding all challenged claims.

 

At the end of the September Quarter, we reported that the company 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. Legal Counsel is currently preparing 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.

 

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.

 

CORPORATE MATTERS

 

Convertible Notes

 

On 29 November 2013, the Company received approval, from its shareholders, for the issue to Ironridge BioPharma Co., a division of institutional investor Ironridge Global IV, Ltd. (“Ironridge”), redeemable convertible notes to raise USD 5,000,000 (the “Notes”).

 

3



 

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.

 

As at 30 September 2014, Notes with a face value of USD 4,150,000 had been converted by Ironridge in return for which Ironridge received 171,349,821 ordinary shares (including ordinary shares issued in lieu of interest payment and interest true-up adjustments).

 

During the current quarter, further conversion notices were received from Ironridge in respect of Notes with a face value of USD 850,000. These Notes were converted in return for which Ironridge received 110,583,420 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.

 

Notice and Results of 2014 Annual General Meeting

 

On 27 October 2014, the Company released the Notice for the 2014 Annual General Meeting of shareholders that was subsequently held at 10.30 am on Tuesday, 25 November 2014, at “Treetops”, Melbourne Museum. Shareholders were asked to consider and, if thought fit, to pass nine (9) resolutions.

 

All nine (9) resolutions that were put before the shareholders were passed on a show of hands.

 

NASDAQ Notices

 

On 3 September 2014, the Company announced that it 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 ordinary shares had closed below the minimum $US1.00 per share requirement for continued inclusion under NASDAQ Marketplace Listing Rules.

 

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

 

To regain compliance, the Company undertook a reverse stock split which, when actioned, has the effect of resetting the existing ratio from 1 ADS representing 30 Ordinary shares to 1 ADS representing 150 Ordinary shares. The target date for the ratio change was Monday 19 January, 2015. From the 20 January 2015, the Company’s stock price, on the Nasdaq market, was once again trading above the $1.00 required bid price.

 

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 the Company that it had been granted an extension of time (on or before May 4, 2015) to regain compliance with the minimum stockholders’ equity requirement.

 

4



 

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

 

Financing

 

On 15 September 2014, the Company announced plans to restructure and realign its group activities. The changes proposed will 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 $2.15M via the issue of unlisted secured (debt) notes to existing and new Australian institutional and wholesale investors. The debt notes carried a 10.0% coupon rate, and as approved at the Annual General Meeting, held on 25 November 2014, will become convertible notes, which can convert into ordinary shares (at a 10.0% discount to the 5 day VWAP). The convertible notes will also carry free attached options to purchase further shares in the Company.

 

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

 

Subsequent to 31 December 2014, a further $110,000 of convertible notes plus capitalised interest has been converted into 8,258,496 ordinary shares in the Company.

 

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.

 

Subsequent to 31 December 2014, the Company announced that it has 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.

 

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

 

5



 

pathology subsidiary of Primary Health Care Ltd. Under the terms of sale, SDS acquired the Australian Genetics business for $2.0M, in cash.

 

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.

 

Annual Report

 

The Company published its Annual Report on 27 October 2014. The Annual Report is available on the company’s website at www.gtglabs.com

 

Signed on behalf of Genetic Technologies Limited

 

 

/s/ Eutillio Buccilli

 

Dated this 30th day of January, 2014

Eutillio Buccilli

 

 

Chief Operating Officer and Chief Financial Officer

 

 

 

6



 

Appendix 4C

Quarterly report for entities

admitted on the basis of commitments

 

Rule 4.7B

 

Appendix 4C

 

Quarterly report

for entities admitted

on the basis of commitments

 

Introduced 31/3/2000.  Amended 30/9/2001, 24/10/2005.

 

Name of entity

GENETIC TECHNOLOGIES LIMITED

 

ABN

Quarter ended (“current quarter”)

17 009 212 328

31 DECEMBER 2014

 

Consolidated statement of cash flows

 

 

 

 

 

Current quarter
(December 2014)
A$

 

Year to date
(six months)
A$

 

 

 

Cash flows related to operating activities

 

 

 

 

 

 

 

 

 

 

 

 

 

1.1

 

Receipts from customers

 

749,885

 

1,754,261

 

1.2

 

Payments for

(a)

staff costs

 

(2,020,323

)

(3,854,968

)

 

 

 

(b)

advertising and marketing

 

(341,076

)

(531,766

)

 

 

 

(c)

research and development

 

(28,122

)

(197,506

)

 

 

 

(d)

leased assets

 

 

 

 

 

 

(e)

other working capital

 

(1,287,339

)

(2,968,602

)

1.3

 

Dividends received

 

 

 

1.4

 

Interest and items of a similar nature received

 

6,830

 

15,898

 

1.5

 

Interest and other costs of finance paid

 

(11,284

)

(22,964

)

1.6

 

Income taxes paid

 

 

 

1.7

 

Grant and other income

 

 

 

 

 

 

 

 

 

 

 

 

 

Net operating cash flows

 

(2,931,429

)

(5,805,647

)

 


+ See chapter 19 for defined terms.

 

1



 

Consolidated statement of cash flows (cont.)

 

 

 

 

 

Current quarter
(December 2014)
A$

 

Year to date
(six months)
A$

 

1.8

Net operating cash flows (carried forward)

 

(2,931,429

)

(5,805,647

)

 

 

 

 

 

 

 

 

Cash flows related to investing activities

 

 

 

 

 

 

 

 

 

 

 

 

1.9

Payment for the acquisition of:

 

 

 

 

 

 

a)

businesses (item 5)

 

 

 

 

b)

equity investments

 

 

 

 

c)

intellectual property

 

 

 

 

d)

physical non-current assets

 

(5,480

)

(152,267

)

 

e)

other non-current assets

 

 

 

 

 

 

 

 

 

 

 

1.10

Proceeds from the disposal of:

 

 

 

 

 

 

a)

businesses (item 5)

 

 

 

 

b)

equity investments

 

 

 

 

c)

intellectual property

 

 

 

 

d)

physical non-current assets

 

 

53,276

 

 

e)

joint venture interest

 

 

 

 

f)

other assets

 

2,100,895

 

2,100,895

 

 

 

 

 

 

 

 

 

1.11

Loans to other entities

 

 

 

1.12

Loans repaid by other entities (refer note below)

 

 

 

1.13

Other (provide details if material)

 

 

 

 

 

 

 

 

 

 

 

Net investing cash flows

 

2,095,415

 

2,001,904

 

 

 

 

 

 

 

 

1.14

Total operating and investing cash flows

 

(836,014

)

(3,803,743

)

 

 

 

 

 

 

 

 

Cash flows related to financing activities

 

 

 

 

 

 

 

 

 

 

 

 

1.15

Net proceeds from the issue of shares

 

241,093

 

241,093

 

1.16

Equity transaction costs

 

 

 

1.17

Net proceeds from borrowings

 

 

 

1.18

Net proceeds from the issue of unlisted secured debt notes

 

(130,500

)

1,999,500

 

1.19

Dividends paid

 

 

 

 

 

 

 

 

 

 

 

Net financing cash flows

 

110,593

 

2,240,593

 

 

 

 

 

 

 

 

 

Net increase / (decrease) in cash held

 

(725,421

)

(1,563,150

)

 

 

 

 

 

 

 

1.20

Cash at beginning of quarter / year to date

 

1,995,985

 

2,831,085

 

1.21

Exchange rate adjustments

 

4,244

 

6,873

 

1.22

Cash at end of quarter

 

1,274,808

 

1,274,808

 

 


+ See chapter 19 for defined terms.

 

2



 

Payments to directors of the entity and associates of the directors

Payments to related entities of the entity and associates of the related entities

 

 

 

 

 

 

Current quarter
$A

 

1.23

Aggregate amount of payments to the parties included in item 1.2

 

 

 

121,445

 

1.24

Aggregate amount of loans to the parties included in item 1.11

 

 

 

 

1.25

Explanation necessary for an understanding of the transactions

 

 

 

 

 

 

 

 

 

 

 

 

 

The amount included at Item 1.24 includes $98,751 paid to Directors during the quarter in respect of fees and superannuation.  The amount also includes $22,694 in commissions and consulting fees paid to a former Director and substantial shareholder in respect of services rendered to the Company by that individual and parties associated with him.

 

Non-cash financing and investing activities

 

2.1

Details of financing and investing transactions which have had a material effect on consolidated assets and liabilities but did not involve cash flows

 

 

 

None during the quarter under review

 

 

2.2

Details of outlays made by other entities to establish or increase their share in businesses in which the reporting entity has an interest

 

 

 

None during the quarter under review

 

Financing facilities available

 

Add notes as necessary for an understanding of the position. (See AASB 1026 paragraph 12.2).

 

 

 

 

Amount available
$A

 

Amount used
$A

 

3.1

Loan facilities

 

 

 

3.2

Credit standby arrangements

 

 

 

 

 

 

Hire purchase facility

 

 

 

 


+ See chapter 19 for defined terms.

 

3



 

Reconciliation of cash

 

Reconciliation of cash at the end of the quarter

(as shown in the consolidated statement of cash flows) to the related items in the accounts is as follows:

 

 

 

Current quarter
(December 2014)
$A

 

Previous quarter
(September 2014)
$A

 

4.1

Cash on hand and at bank

 

1,274,808

 

1,995,985

 

4.2

Term deposits

 

 

 

4.3

Bank overdraft

 

 

 

4.4

Commercial Bills of Exchange

 

 

 

 

Total cash at end of quarter (item 1.23)

 

1,274,808

 

1,995,985

 

 

Acquisitions and disposals of business entities

 

 

 

Acquisitions
(Item 1.9(a))

 

Disposals
(Item 1.10(a))

 

5.1

Name of entity

 

Not applicable

 

Not applicable

 

5.2

Place of incorporation or registration

 

 

 

 

 

5.3

Consideration for acquisition or disposal

 

 

 

 

 

5.4

Total net liabilities

 

 

 

 

 

5.5

Nature of business

 

 

 

 

 

 

Compliance statement

 

1                     This statement has been prepared under accounting policies which comply with accounting standards as defined in the Corporations Act (except to the extent that information is not required because of note 2) or other standards acceptable to ASX.

 

2                     This statement does give a true and fair view of the matters disclosed.

 

Sign here:

/s/ Eutillio Buccilli

 

Date:

30 January 2015

 

Chief Operating Officer and Chief Financial Officer

 

 

 

 

 

 

 

 

 

 

 

 

 

Print name:

Eutillio Buccilli

 

 

 

 


+ See chapter 19 for defined terms.

 

4



 

Notes

 

1.                            The quarterly report provides a basis for informing the market how the entity’s activities have been financed for the past quarter and the effect on its cash position.  An entity wanting to disclose additional information is encouraged to do so, in a note or notes attached to this report.

 

2.                            The definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report except for any additional disclosure requested by AASB 107 that are not already itemised in this report.

 

3.                            Accounting Standards.  ASX will accept, for example, the use of International Financial Reporting Standards for foreign entities.  If the standards used do not address a topic, the Australian standard on that topic (if any) must be complied with.

 


+ See chapter 19 for defined terms.

 

5


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