Alterity Therapeutics Ltd 6-K, filed Jul 30, 2020
Alterity Therapeutics Ltd (ATHE)
About this 6-K
Alterity Therapeutics Ltd filed this 6-K on July 30, 2020.
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 2020
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 our Registration Statement on Form S-8 (File No. 333-228671) and our Registration Statements on Form F-3 (Files No. 333-220886 and 333-231417).
INFORMATION CONTAINED IN THIS FORM 6-K REPORT
This Report on Form 6-K includes a copy of the Appendix 4C and Quarterly Cash Flow Report filed on the 30th of July 2020.
On July 15, 2020, NASDAQ notified the Company that it has regained compliance with the minimum bid price requirement of Listing Rule 5550(a)(2). On February 5, 2020, the NASDAQ Staff had notified the Company that its ADSs failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by the Listing Rules of The Nasdaq Stock Market and that the Company had 180 days to regain compliance
Alterity Therapeutics Limited
| 6-K | Items | |
| 99.1 | Appendix 4C and Quarterly Cash Flow Report | |
1
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 30, 2020
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Exhibit 99.1
Appendix 4C – Q4 FY20 Quarterly Cash Flow Report
Highlights:
| ● | FDA provides guidance for ATH434 development pathway |
| ● | Company compliant with minimum NASDAQ price |
| ● | End of period cash balance of $9.2M bolstered by $1.5M following issue of shares on 2 July |
MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – 30 July 2020. 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 2020 (Q4 FY20).
Development pathway for ATH434
On June 30th, Alterity announced that it had received guidance from the US Food and Drug Administration (FDA) in relation to the development pathway for ATH434 (previously PBT434), the company’s lead compound for the treatment of Multiple System Atrophy (MSA).
ATH434 is an orally bioavailable, brain penetrant, small molecule inhibitor of α-synuclein aggregation, and is being developed for the treatment of MSA, a Parkinsonian disorder. Alpha-synuclein aggregation is implicated in the pathology of MSA and Parkinson’s disease.
The company recently met with the FDA following the successful completion of its Phase 1 clinical trial last year and further data analysis. The pre-IND (Investigational New Drug) meeting was to obtain input on the clinical development plan for ATH434, including feedback on the Phase 2 study design.
Alterity reached agreement with the FDA on the non-clinical investigations required to support the Phase 2 study. In addition, the FDA agreed to key aspects of the Company’s Phase 2 study design including the proposed patient population, safety monitoring plan, and strategy for evaluating drug exposure during the study.
In parallel with the US strategy, Alterity is also pursuing a regulatory pathway in Europe and Australia. Given the uncertainty of study conduct and recruitment in the COVID-19 era, and with the need to target sites that are minimally impacted, it is prudent for the Company to be flexible in identifying and recruiting sites around the world and maintaining optionality. Planning is underway to meet with European authorities.
Corporate update
The Company’s $9.2M cash balance was bolstered by the receipt of $1.5M following the issue of shares as part of the company’s previously approved “At the Market or ATM” facility and issued in accordance with ASX Listing Rules 7.1 and 7.1A (enabling share issues up to a maximum of 25% of the issued capital of the company).
In February the company received notification from the Listing Qualifications Department of Nasdaq advising the Company it was non-compliant with Nasdaq’s requirement that listed securities maintain a minimum bid price of $US1.00 per share on NASDAQ as outlined in the Nasdaq Listing Rules. This was resolved naturally through improved trading conditions and company performance, and as the closing bid price exceeded $US1.00 per Approved Depositary Share for at least 10 business days, Nasdaq has confirmed re-compliance.
In accordance with ASX Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1. of the Appendix 4C incorporates directors’ fees, remuneration and superannuation at commercial rates.
END
Authorisation & Additional information
This announcement was authorised by Geoffrey Kempler, CEO and Chairman of Alterity Therapeutics Limited.
Contact:
Investor Relations
Rebecca Wilson, WE Communications
E: WE-AUAlterity@we-worldwide.com
Tp: +61 3 8866 1216
About Alterity Therapeutics Limited and ATH434
Alterity’s lead candidate, ATH434 (formerly PBT434), is the first of a new generation of small molecules designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown to reduce abnormal accumulation of α-synuclein and tau proteins in animal models of disease by redistributing labile iron in the brain. In this way, it has potential to treat Parkinson’s disease and atypical forms of Parkinsonism such as Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP).
ATH434 has been granted Orphan designation for the treatment of MSA by the US FDA and the European Commission.
For further information please visit the Company’s web site at www.alteritytherapeutics.com.
About Multiple System Atrophy
Multiple System Atrophy (MSA) is a rare and rapidly progressive neurological disorder affecting adults. It has no known cause. In addition to presenting with motor symptoms like those in Parkinson’s disease, individuals with MSA may also experience loss of ability to coordinate voluntary movements and impaired regulation of involuntary body functions such as blood pressure, bowel and bladder control. Most of these symptoms are not addressed by available drugs for patients with Parkinson’s disease. As the condition progresses, daily activities become increasingly difficult and complications such as increased difficulty swallowing, vocal cord paralysis, progressive immobility, and poor balance become more prominent. Symptoms tend to appear after age 50 and rapidly advance, leading to profound disability.
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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, ATH434 (formerly 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, ATH434, uncertainties relating to the impact of the novel coronavirus (COVID-19) pandemic on the company’s business, operations and employees, 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, ATH434, 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 ATH434.
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.
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Appendix 4C
Quarterly
cash flow report for entities
subject to Listing Rule 4.7B
Name of entity | ||
| Alterity Therapeutics Limited | ||
| ABN | Quarter ended (“current quarter”) | |
| 37 080 699 065 | 30 June 2020 | |
| Consolidated statement of cash flows | Current quarter $A’000 |
Year to date | |
| 1. | Cash flows from operating activities | ||
| 1.1 | Receipts from customers | - | - |
| 1.2 | Payments for | ||
| (a) research and development | (2,140) | (8,606) | |
| (b) product manufacturing and operating costs | - | - | |
| (c) advertising and marketing | (34) | (112) | |
| (d) leased assets | - | - | |
| (e) staff costs | (926) | (3,815) | |
| (f) administration and corporate costs | (858) | (1,871) | |
| 1.3 | Dividends received (see note 3) | - | - |
| 1.4 | Interest received | 1 | 18 |
| 1.5 | Interest and other costs of finance paid | - | - |
| 1.6 | Income taxes paid | - | - |
| 1.7 | Government grants and tax incentives | 50 | 4,875 |
| 1.8 | Other (provide details if material) | - | - |
| 1.9 | Net cash from / (used in) operating activities | (3,907) | (9,511) |
| 2. | Cash flows from investing activities | ||
| 2.1 | Payments to acquire: | ||
| (a) entities | - | - | |
| (b) businesses | - | - | |
| (c) property, plant and equipment | - | - | |
| (d) investments | - | - | |
| (e) intellectual property | - | - | |
| (f) other non-current assets | - | - |
ASX Listing Rules Appendix 4C (01/12/19) | Page 1 |
Appendix 4C
Quarterly cash flow 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 | |
| 2.2 | Proceeds from disposal of: | ||
| (a) entities | - | - | |
| (b) businesses | - | - | |
| (c) property, plant and equipment | - | - | |
| (d) investments | - | - | |
| (e) intellectual property | - | - | |
| (f) 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 | - | - |
| 3. | Cash flows from financing activities | ||
| 3.1 | Proceeds from issues of equity securities (excluding convertible debt securities) | 3,484 | 4,364 |
| 3.2 | Proceeds from issue of convertible debt securities | - | - |
| 3.3 | Proceeds from exercise of options | - | - |
| 3.4 | Transaction costs related to issues of equity securities or convertible debt securities | (182) | (301) |
| 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 (provide details if material) | - | - |
| 3.10 | Net cash from / (used in) financing activities | 3,302 | 4,063 |
| 4. | Net increase / (decrease) in cash and cash equivalents for the period | ||
| 4.1 | Cash and cash equivalents at beginning of period | 10,391 | 14,400 |
| 4.2 | Net cash from / (used in) operating activities (item 1.9 above) | (3,907) | (9,511) |
| 4.3 | Net cash from / (used in) investing activities (item 2.6 above) | - | - |
ASX Listing Rules Appendix 4C (01/12/19) | Page 2 |
Appendix 4C
Quarterly cash flow 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 | |
| 4.4 | Net cash from / (used in) financing activities (item 3.10 above) | 3,302 | 4,063 |
| 4.5 | Effect of movement in exchange rates on cash held | (589) | 245 |
| 4.6 | Cash and cash equivalents at end of period | 9,197 | 9,197 |
| 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 | 9,197 | 10,391 |
| 5.2 | Call deposits | - | - |
| 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) | 9,197 | 10,391 |
| 6. | Payments to related parties of the entity and their associates | Current
quarter $A'000 |
| 6.1 | Aggregate amount of payments to related parties and their associates included in item 1 | 183 |
| 6.2 | Aggregate amount of payments to related parties and their associates included in item 2 | - |
Note: if any amounts are shown in items 6.1 or 6.2, your quarterly activity report must include a description of, and an explanation for, such payments
The amount at 6.1 includes payment of director’s fees and salaries, excluding GST where applicable.
ASX Listing Rules Appendix 4C (01/12/19) | Page 3 |
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
| 7. | Financing
facilities Add notes as necessary for an understanding of the sources of finance available to the entity. |
Total
facility amount at quarter end $A’000 |
Amount
drawn at quarter end $A’000 |
| 7.1 | Loan facilities | - | - |
| 7.2 | Credit standby arrangements | - | - |
| 7.3 | Other (please specify) | - | - |
| 7.4 | Total financing facilities | - | - |
| 7.5 | Unused financing facilities available at quarter end | - | |
| 7.6 | Include in the box below a description of each facility above, including the lender, interest rate, maturity date and whether it is secured or unsecured. If any additional financing facilities have been entered into or are proposed to be entered into after quarter end, include a note providing details of those facilities as well. | ||
-
| |||
| 8. | Estimated cash available for future operating activities | $A’000 |
| 8.1 | Net cash from / (used in) operating activities (Item 1.9) | (3,907) |
| 8.2 | Cash and cash equivalents at quarter end (Item 4.6) | 9,197 |
| 8.3 | Unused finance facilities available at quarter end (Item 7.5) | - |
| 8.4 | Total available funding (Item 8.2 + Item 8.3) | 9,197 |
| 8.5 | Estimated quarters of funding available (Item 8.4 divided by Item 8.1) | 2.3 |
| 8.6 | If Item 8.5 is less than 2 quarters, please provide answers to the following questions: |
| 1. | Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not? |
| Answer: N/A |
| 2. | Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful? |
| Answer: N/A |
| 3. | Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis? |
| Answer: N/A |
ASX Listing Rules Appendix 4C (01/12/19) | Page 4 |
Appendix 4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Compliance statement
| 1 | This statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A. |
| 2 | This statement gives a true and fair view of the matters disclosed. |
| Date: | 30 July 2020 |
Authorised by:
 |
||
| Phillip Hains – Company Secretary | ||
| (Name of body or officer authorising release – see note 4) |
Notes
| 1. | This quarterly cash flow report and the accompanying activity report provide a basis for informing the market about the entity’s activities for the past quarter, how they have been financed and the effect this has had on its cash position. An entity that wishes to disclose additional information over and above the minimum required under the Listing Rules is encouraged to do so. |
| 2. | If this quarterly cash flow 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 cash flow 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. |
| 4. | If this report has been authorised for release to the market by your board of directors, you can insert here: “By the board”. If it has been authorised for release to the market by a committee of your board of directors, you can insert here: “By the [name of board committee – eg Audit and Risk Committee]”. If it has been authorised for release to the market by a disclosure committee, you can insert here: “By the Disclosure Committee”. |
| 5. | If this report has been authorised for release to the market by your board of directors and you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate Governance Council’s Corporate Governance Principles and Recommendations, the board should have received a declaration from its CEO and CFO that, in their opinion, the financial records of the entity have been properly maintained, that this report complies with the appropriate accounting standards and gives a true and fair view of the cash flows of the entity, and that their opinion has been formed on the basis of a sound system of risk management and internal control which is operating effectively. |
| ASX Listing Rules Appendix 4C (01/12/19) + See chapter 19 of the ASX Listing Rules for defined terms. |
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