0001213900-19-014078.txt : 20190731 0001213900-19-014078.hdr.sgml : 20190731 20190731060329 ACCESSION NUMBER: 0001213900-19-014078 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20190731 FILED AS OF DATE: 20190731 DATE AS OF CHANGE: 20190731 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ALTERITY THERAPEUTICS LTD CENTRAL INDEX KEY: 0001131343 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: C3 FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-49843 FILM NUMBER: 19987221 BUSINESS ADDRESS: STREET 1: LEVEL 3, 460 BOURKE STREET CITY: MELBOURNE STATE: C3 ZIP: VIC 3000 BUSINESS PHONE: 61 3 9349 4906 MAIL ADDRESS: STREET 1: LEVEL 3, 460 BOURKE STREET CITY: MELBOURNE STATE: C3 ZIP: VIC 3000 FORMER COMPANY: FORMER CONFORMED NAME: PRANA BIOTECHNOLOGY LTD DATE OF NAME CHANGE: 20010105 6-K 1 f6k073119_alteritytherap.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

  

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of July 2019

 

Alterity Therapeutics Limited

(Name of Registrant)

 

Level 3, 460 Bourke Street, Melbourne, VIC 3000, Australia

(Address of Principal Executive Office)

 

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

 

Form 20-F ☒    Form 40-F ☐

 

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

 

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): __

 

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 ☐     No ☒

 

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _____

 

This Form 6-K is being incorporated by reference into the Registrant’s Registration Statements on Form F-3 (File No. 333-220886) and Form S-8 (File No. 333-228671).

 

 

 

 

 

 

Alterity Therapeutics Limited

 

6-K Items

 

1.

Appendix 4C – quarterly report

 

 

 

 

SIGNATURES

 

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

  

  ALTERITY THERAPEUTICS LIMITED
    (Registrant)
     
  By: /s/ Geoffrey Kempler
    Geoffrey Kempler,
    Executive Chairman

  

July 31, 2019

 

 

 

 

EX-99.1 2 f6k073119ex99-1_alterity.htm APPENDIX 4C - QUARTERLY REPORT

Exhibit 1

 

 

 

Appendix 4C – Q4 FY19 Quarterly Cash Flow Report

 

Highlights:

 

Completion of Phase 1 Clinical Trial; PBT434 found to be safe and well-tolerated; clinically tested doses achieve concentrations in the brain comparable with other test results

 

Presentation of clinical trial data at the American Academy of Neurology

 

Life Biosciences leads investment round raising an initial A$11.44M during the quarter

 

Name change to Alterity Therapeutics Limited, reflecting an important reset and new direction

 

Strong cash balance of $14.4M

 

MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – Wednesday 31 July 2019. Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), releases its Appendix 4C Quarterly Cash Flow report and update on company activities for the quarter ending 30 June 2019 (Q4 FY19).

 

This past quarter saw important milestones achieved as the Company enters into its next phase of development, the most significant being finalization and reporting of its Phase 1 Clinical Trial for its lead compound PBT434.

 

The completed trial includes data from elderly and healthy volunteers who received repeated doses, and demonstrated that the drug was safe and well-tolerated, with adverse event rates comparable to placebo. It builds on the data presented in May 2019 at the American Academy of Neurology Annual Meeting in the US.

 

Systemic exposure to the drug was comparable between elderly and healthy volunteers. This information, along with previous results in the Phase 1 study, indicate that clinically-tested doses achieve concentrations in the brain that are comparable with other test results. No serious adverse event or an adverse event that led to discontinuation of the study drug was reported.

 

The findings showed that PBT434 passed the blood-brain barrier and inhibited the alpha-synuclein protein which when aggregated in the brain is a pathological hallmark of Parkinsonian conditions and is considered an important biologic target for treating these neurodegenerative diseases.

 

The Company launched a new name moving from Prana Biotechnology to Alterity Therapeutics. The name change aligns with the new direction for the Company and followed a major strategic investment by Life Biosciences. A$11.44M has so far been received as part of this investment. Shareholders approved a resolution to allow the investment by Life Biosciences and the name change at an Extraordinary General Meeting on 5th April.

 

Alterity reported a strong cash balance of A$14.4M, up from A$8.9M in Q3 FY19 with the contribution of investment funds.

 

 

 

 

Mr Geoffrey Kempler, CEO of Alterity, said: “The final quarter of Alterity’s financial year has ended on a high note with the recent completion of the Phase 1 trial for PBT434. The clinical data for the Phase 1 trial was well-received at the American Academy of Neurology Annual Meeting in Philadelphia, a key audience for Alterity. We thank Life Biosciences for its investment.”

 

END

 

Investor enquiries IR@alteritytherapeutics.com

 

Contact:

 

Investor Relations

Rebecca Wilson or Dylan Mark

E: alterity@we-buchan.com

Tp: +61 3 9866 4722

 

About Alterity Therapeutics Limited

 

Alterity’s lead candidate, PBT434, is the first of a new generation of small molecules designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. PBT434 has been shown to reduce abnormal accumulation of α-synuclein and tau proteins in animal models of disease by restoring normal iron balance in the brain. In this way, it has excellent potential to treat various forms of atypical Parkinsonism such as Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP).

 

For further information please visit the Company’s web site at www.alteritytherapeutics.com

 

Forward Looking Statements

 

This press release contains “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as “expects,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “may,” “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements.

 

Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described in the sections titled “Risk Factors” in the Company’s filings with the SEC, including its most recent Annual Report on Form 20-F as well as reports on Form 6-K, including, but not limited to the following: statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, PBT434, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to, PBT434, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, PBT434, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to PBT434.

 

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly updated any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

 

 

 

Appendix 4C

Quarterly report for entities subject to Listing Rule 4.7B

 

 

+Rule 4.7B

 

Appendix 4C

 

Quarterly report for entities subject to Listing Rule 4.7B

 

Introduced 31/03/00 Amended 30/09/01, 24/10/05, 17/12/10, 01/09/16

 

Name of entity
Alterity Therapeutics Limited
 
ABN   Quarter ended (“current quarter”)
37 080 699 065   30 June 2019

 

Consolidated statement of cash flows  Current quarter $A’000  

Year to date

(12 months)
$A’000

 
1.  Cash flows from operating activities        
1.1  Receipts from customers   -    - 
1.2  Payments for      
   (a) research and development    (3,295   (10,295)
   (b) product manufacturing and operating costs   -    - 
   (c) advertising and marketing   (133)   (193)
   (d) leased assets   -    - 
   (e) staff costs   (999)   (3,812)
   (f) administration and corporate costs   (1,538)   (3,100)
1.3  Dividends received (see note 3)   -    - 
1.4  Interest received   22    119 
1.5  Interest and other costs of finance paid   -    - 
1.6  Income taxes paid   -    - 
1.7  Government grants and tax incentives   -    3,252 
1.8  Other (provide details if material)   -    - 
1.9  Net cash from / (used in) operating activities   (5,943)   (14,029)

 

+ See chapter 19 for defined terms

1 September 2016

 

Page 1

 

 

Appendix 4C

Quarterly report for entities subject to Listing Rule 4.7B

 

 

Consolidated statement of cash flows  Current quarter $A’000  

Year to date

(12 months) $A’000

 
2.  Cash flows from investing activities          
2.1  Payments to acquire:          
   (a) property, plant and equipment   (4)   (4)
   (b) businesses (see item 10)   -    - 
   (c) investments   -    - 
   (d) intellectual property   -    - 
   (e) other non-current assets   -    - 
2.2  Proceeds from disposal of:        
   (a) property, plant and equipment   -    - 
   (b) businesses (see item 10)   -    - 
   (c) investments   -    - 
   (d) intellectual property   -    - 
   (e) other non-current assets   -    - 
2.3  Cash flows from loans to other entities   -    - 
2.4  Dividends received (see note 3)   -    - 
2.5  Other (provide details if material)   -    - 
2.6  Net cash from / (used in) investing activities   (4)   (4)

 

Consolidated statement of cash flows  Current quarter $A’000  

Year to date

(12 months) $A’000 

 
3.  Cash flows from financing activities        
3.1  Proceeds from issues of shares    11,440     13,084 
3.2  Proceeds from issue of convertible notes   -    - 
3.3  Proceeds from exercise of share options   -    - 
3.4  Transaction costs related to issues of shares, convertible notes or options   (203)   (277)
3.5  Proceeds from borrowings   -    - 
3.6  Repayment of borrowings   -    - 
3.7  Transaction costs related to loans and borrowings   -    - 
3.8  Dividends paid   -    - 
3.9  Other (receipt of funds upon expiry of term deposit towards rental guarantee)   -    - 
3.10  Net cash from / (used in) financing activities   11,237    12,807 

 

+ See chapter 19 for defined terms

1 September 2016

 

Page 2

 

 

Appendix 4C

Quarterly report for entities subject to Listing Rule 4.7B

 

 

Consolidated statement of cash flows  Current quarter $A’000  

Year to date

(12 months) $A’000

 
4.  Net increase / (decrease) in cash and cash equivalents for the period        
4.1  Cash and cash equivalents at beginning of quarter/year to date    8,910    15,236 
4.2  Net cash from / (used in) operating activities (item 1.9 above)   (5,943)   (14,029)
4.3  Net cash from / (used in) investing activities (item 2.6 above)   (4)   (4)
4.4  Net cash from / (used in) financing activities (item 3.10 above)   11,237    12,807 
4.5  Effect of movement in exchange rates on cash held   200    390 
4.6  Cash and cash equivalents at end of quarter   14,400    14,400 

  

5.  Reconciliation of cash and cash equivalents
at the end of the quarter (as shown in the consolidated statement of cash flows) to the related items in the accounts
  Current quarter
$A’000
   Previous quarter
$A’000
 
5.1  Bank balances   11,388    4,910 
5.2  Call deposits   3,012    4,000 
5.3  Bank overdrafts   -    - 
5.4  Other (provide details)   -    - 
5.5  Cash and cash equivalents at end of quarter (should equal item 4.6 above)   14,400    8,910 

 

6.   Payments to directors of the entity and their associates   Current quarter
$A'000
 
6.1   Aggregate amount of payments to these parties included in item 1.2     545  
6.2   Aggregate amount of cash flow from loans to these parties included in item 2.3     -  
6.3   Include below any explanation necessary to understand the transactions included in items 6.1 and 6.2        

 

Salaries, director’s fees and consulting fees at normal commercial rates.
Excludes GST where applicable.

 

+ See chapter 19 for defined terms

1 September 2016

 

Page 3

 

 

Appendix 4C

Quarterly report for entities subject to Listing Rule 4.7B

 

 

7.  Payments to related entities of the entity and their associates  Current quarter
$A'000
 
7.1  Aggregate amount of payments to these parties included in item 1.2           - 
   Aggregate amount of cash flow from loans to these parties included in item 2.3   - 
7.3  Include below any explanation necessary to understand the transactions included in items 7.1 and 7.2     

 

8.  Financing facilities available
Add notes as necessary for an understanding of the position
  Total facility amount at quarter end
$A’000
   Amount drawn at quarter end
$A’000
 
8.1  Loan facilities   -    - 
8.2  Credit standby arrangements   -    - 
8.3  Other (please specify)   -    - 
8.4  Include below a description of each facility above, including the lender, interest rate and whether it is secured or unsecured. If any additional facilities have been entered into or are proposed to be entered into after quarter end, include details of those facilities as well. 

  

9.  Estimated cash outflows for next quarter  $A’000 
9.1  Research and development   3,500 
9.2  Product manufacturing and operating costs   - 
9.3  advertising and marketing   40 
9.4  Leased assets   - 
9.5  Staff costs   1,000 
9.6  Administration and corporate costs   600 
9.7  Other (provide details if material)   - 
9.8  Total estimated cash outflows   5,140 

 

+ See chapter 19 for defined terms

1 September 2016

 

Page 4

 

 

Appendix 4C

Quarterly report for entities subject to Listing Rule 4.7B

 

 

10.  Acquisitions and disposals of business entities
(items 2.1(b) and 2.2(b) above)
  Acquisitions   Disposals 
10.1  Name of entity             -             - 
10.2  Place of incorporation or registration   -    - 
10.3  Consideration for acquisition or disposal   -    - 
10.4  Total net assets   -    - 
10.5  Nature of business   -    - 

 

Compliance statement

 

1This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A.

 

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

 

Sign here: /s/ Phillip Hains   Date: 31 July 2019
  Company Secretary    
Print name: Phillip Hains    

  

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 that wishes to disclose additional information is encouraged to do so, in a note or notes included in or attached to this report.

 

2.If this quarterly report has been prepared in accordance with Australian Accounting Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows apply to this report. If this quarterly report has been prepared in accordance with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding equivalent standard applies to this report.

 

3.Dividends received may be classified either as cash flows from operating activities or cash flows from investing activities, depending on the accounting policy of the entity.

 

 

+ See chapter 19 for defined terms

1 September 2016

 

Page 5

 

 

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