Full Press Release Details
Appendix 4C - Q3 FY21
Quarterly Cash Flow Report
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA - 29th April 2021. 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 31 March 2021 (Q3 FY21).
The company's cash position
was $32.8M with operational cash outflows of $5.1M, in line with company expectations and reflecting ongoing preparation for the Phase
2 clinical trial for Alterity's lead drug candidate ATH434 in Multiple System Atrophy (MSA) patients.
In accordance with ASX Listing Rule
4.7C, payments made to related parties and their associates included at item 6.1 of the Appendix 4C incorporates directors' fees,
consulting fees, remuneration and superannuation at commercial rates.
Operational Activities
During the quarter, Alterity continued
to make important advances in its Phase 2 program.
Most of the company's efforts
were focused on the bioMUSE Natural History study in MSA patients being conducted at Vanderbilt University Medical Center. This study
will provide important information and insights to inform patient selection and design of the Phase 2 trial, which is scheduled to begin
later this year. The study has now recruited 80% of the original target population and the company is evaluating the feasibility to expand
The Michael J. Fox Foundation awarded
Alterity US$495,000 to evaluate the pharmacologic profile of ATH434 to determine the optimal dose of the drug in future Parkinson's
disease clinical trials. It was the second grant the company has received from the Michael J. Fox Foundation for ATH434.
The profile of Alterity continues
to strengthen with the company regularly invited to present at investor conferences and the leading clinical and scientific events around
the world. In January and then again in March, Alterity CEO Dr David Stamler presented at life science and healthcare conferences hosted
by HC Wainwright attended by institutional fund managers, HNW and other investors. Alterity also participated in the Biotech Showcase,
a satellite event at the world's largest healthcare conference hosted by JP Morgan.
In February, the company presented
at the 7th Annual International Congress of Multiple System Atrophy, the pre-eminent conference for scientists and clinicians
focused on MSA. Alterity's presentation featured as part of the Congress' poster presentation and provided further data on
ATH434. The new results included data on blood pressure following change in body position which demonstrated that ATH434 does not lower
blood pressure when people move to the standing position. This is an important safety finding considering impaired maintenance of blood
pressure is a key issue with MSA.
In January, Alterity announced the
appointment of Dr David Stamler to the role of Chief Executive Officer. Dr Stamler is based in San Francisco and joined the Company in
June 2017 as Chief Medical Officer and Senior Vice President Clinical Development. Mr. Geoffrey Kempler, who founded the company in November
1997, has stepped down from the role of CEO and continues as Non-Executive Chairman.
Authorisation & Additional information
This announcement was authorised by David
Stamler, CEO of Alterity Therapeutics Limited.
Greig King, WE Communications
About Alterity Therapeutics Limited
lead candidate, ATH434, 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 -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).
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.
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.
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, 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
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 update 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.
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 | 31 March 2021 |
| Consolidated statement of cash flows | Current quarter $A'000 | Year to date (9 months) $A'000 | |||||||||
| 1. | Cash flows from operating activities | ||||||||||
| 1.1 | Receipts from customers | - | - | ||||||||
| 1.2 | Payments for | ||||||||||
| (a) | research and development | (2,950 | ) | (7,789 | ) | ||||||
| (b) | product manufacturing and operating costs | - | - | ||||||||
| (c) | advertising and marketing | (10 | ) | (101 | ) | ||||||
| (d) | leased assets | - | - | ||||||||
| (e) | staff costs | (2,022 | ) | (3,667 | ) | ||||||
| (f) | administration and corporate costs | (322 | ) | (1,356 | ) | ||||||
| 1.3 | Dividends received (see note 3) | - | - | ||||||||
| 1.4 | Interest received | 17 | 19 | ||||||||
| 1.5 | Interest and other costs of finance paid | - | - | ||||||||
| 1.6 | Income taxes paid | - | - | ||||||||
| 1.7 | Government grants and tax incentives | - | 50 | ||||||||
| 1.8 | Other (provide details if material) - Michael J. Fox Foundation Grant | 213 | 213 | ||||||||
| 1.9 | Net cash from / (used in) operating activities | (5,074 | ) | (12,631 | ) | ||||||
| 2. | Cash flows from investing activities | ||||||||||
| 2.1 | Payments to acquire or for: | ||||||||||
| (a) | entities | - | - | ||||||||
| (b) | businesses | - | - | ||||||||
| (c) | property, plant and equipment | (3 | ) | (3 | ) | ||||||
| (d) | investments | - | - | ||||||||
| (e) | intellectual property | - | - | ||||||||
| (f) | other non-current assets | - | - |
flow report for entities subject to Listing Rule 4.7B
| Consolidated statement of cash flows | Current quarter $A'000 | Year to date (9 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 | ) | (3 | ) | ||||||
| 3. | Cash flows from financing activities | ||||||||||
| 3.1 | Proceeds from issues of equity securities (excluding convertible debt securities) | 2,675 | 39,237 | ||||||||
| 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 | (226 | ) | (2,423 | ) | ||||||
| 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 | 2,449 | 36,814 | ||||||||
| 4. | Net increase / (decrease) in cash and cash equivalents for the period | ||||||||||
| 4.1 | Cash and cash equivalents at beginning of period | 35,042 | 9,197 | ||||||||
| 4.2 | Net cash from / (used in) operating activities (item 1.9 above) | (5,074 | ) | (12,631 | ) | ||||||
| 4.3 | Net cash from / (used in) investing activities (item 2.6 above) | (3 | ) | (3 | ) |
flow report for entities subject to Listing Rule 4.7B
| Consolidated statement of cash flows | Current quarter $A'000 | Year to date (9 months) $A'000 | ||||||||
| 4.4 | Net cash from / (used in) financing activities (item 3.10 above) | 2,449 | 36,814 | |||||||
| 4.5 | Effect of movement in exchange rates on cash held | 348 | (615 | ) | ||||||
| 4.6 | Cash and cash equivalents at end of period | 32,762 | 32,762 |
| Current quarter $A'000 | Previous quarter $A'000 | |||||||||
| 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 | |||||||||
| 5.1 | Bank balances | 29,762 | 16,042 | |||||||
| 5.2 | Call deposits | 3,000 | 19,000 | |||||||
| 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) | 32,762 | 35,042 |
| Current quarter $A'000 | ||||||
| 6. | Payments to related parties of the entity and their associates | |||||
| 6.1 | Aggregate amount of payments to related parties and their associates included in item 1 | 1,362 | ||||
| 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,
salaries and consulting fees at normal commercial rates excluding GST where applicable.
flow report for entities subject to Listing Rule 4.7B
| Total facility amount at quarter end $A'000 | Amount drawn at quarter end $A'000 | |||||||||
| 7. | Financing facilities Note: the term "facility' includes all forms of financing arrangements available to the entity. Add notes as necessary for an understanding of the sources of finance available to the entity. | |||||||||
| 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. |
| $A'000 | ||||||
| 8. | Estimated cash available for future operating activities | |||||
| 8.1 | Net cash from / (used in) operating activities (item 1.9) | (5,074) | ||||
| 8.2 | Cash and cash equivalents at quarter end (item 4.6) | 32,762 | ||||
| 8.3 | Unused finance facilities available at quarter end (item 7.5) | - | ||||
| 8.4 | Total available funding (item 8.2 + item 8.3) | 32,762 | ||||
| 8.5 | Estimated quarters of funding available (item 8.4 divided by item 8.1) | 6.5 | ||||
| Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as "N/A". Otherwise, a figure for the estimated quarters of funding available must be included in item 8.5. | ||||||
| 8.6 | If item 8.5 is less than 2 quarters, please provide answers to the following questions: |
| 8.6.1 | 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 | |||
| 8.6.2 | 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 | |||
| 8.6.3 | 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 | |||
| Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered. |
flow report for entities subject to Listing Rule 4.7B
Compliance statement
| /s/ Phillip Hains | |
| Phillip Hains - Company Secretary | |
| (Name of body or officer authorising release - see note 4) |