Full Press Release Details
FY22 Quarterly Cash Flow Report
MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA -
29 October 2021. Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology
company dedicated to developing disease modifying treatments for neurodegenerative conditions, releases its Appendix 4C Quarterly Cash
Flow Report and update on company activities for the quarter ending 30 September 2021 (Q1 FY22).
The Company's cash position
as of 30 September 2021 of $41.3M includes A$17.2M proceeds from the issue of shares via the approved ATM ("At the Market")
facility in July 2021 issued in accordance with ASX Listing Rules 7.1 and 7.1A.
Operating cash outflows were A$4.9M, which was in line
with company expectations and largely due to the preparation for the Phase 2 clinical trial for Alterity's lead drug candidate ATH434
in Multiple System Atrophy (MSA) and the bioMUSE (Biomarkers of Progression in Multiple Systems Atrophy) natural history.
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, consulting fees, remuneration
and superannuation at commercial rates.
Operational Activities
During the quarter, the company progressed
the Phase 2 development program for ATH434. In September, data from the bioMUSE natural history study was presented at the
International Parkinson and Movement Disorder Society Congress reporting that advanced MRI methods employed in the study, referred
to as quantitative susceptibility mapping (QSM), demonstrated pathological iron accumulation in multiple areas of the brain in
patients with early MSA. The study investigators, led by Dr. Daniel Claassen, Associate Professor of Neurology at Vanderbilt
University Medical center, concluded that advanced MRI methods for measuring iron may improve patient selection in clinical trials
of disease modifying therapy and has potential to serve as a biomarker for assessing treatment induced changes.
Most recently, and after the reporting period, Alterity
announced that bioMUSE has reached its original enrollment goal and will be expanded to a total of 20 patients with MSA. The study has
proved to be invaluable in generating data to inform and de-risk the Phase 2 trial design, and it will continue to provide longitudinal
biomarker and clinical data to characterize disease progression in a patient population that mirrors those to be enrolled in the Phase
Alterity also announced the expansion of
the clinical development program for ATH434. The planned Phase 2 clinical trial is a randomized, double-blind, placebo-controlled
investigation of ATH434 in patients with early-stage MSA. The study will explore the effect of ATH434 treatment on imaging and
protein biomarkers such as aggregating -synuclein and excess iron, which are important contributors to MSA pathology. Several
other biomarkers and clinical endpoints will permit comprehensive assessment of ATH434 efficacy along with characterization of its
safety and pharmacokinetics. Based on consultation with the U.S. Food and Drug Administration (FDA), the European Medicines Agency
(EMA) and clinical experts in MSA, Alterity has established that patients will receive treatment for 12 months. The longer treatment
duration will provide an improved opportunity to detect changes in biomarkers and clinical endpoints to optimize design of a
definitive Phase 3 study.
During the period, significant progress was
made on two important new patents that places Alterity in a commanding position with respect to its iron chaperone technology. These
novel molecules are designed to redistribute the excess iron implicated in many neurodegenerative diseases. In July, we announced that
the United States Patent and Trademark Office (USPTO) granted US patent No. 10/941,143 relating to claims on a group of 150 novel compounds
that act as iron chaperones. This was followed, in August, by a second composition of matter patent (No. 17/239,375) which was allowed
by the USPTO securing exclusivity for a new group of iron chaperones and covers more than 80 novel compounds.
Authorisation & Additional information
This announcement was authorised by David Stamler, CEO of
Alterity Therapeutics Limited.
Contact: Investor Relations
| Australia | US |
| Greig King | Remy Bernarda |
| E: WE-AUAlterity@we-worldwide.com | E: remy.bernarda@iradvisory.com |
| Tp: +61 452 041 261 | Tp: +1 (415) 203-6386 |
About Alterity Therapeutics Limited
Alterity Therapeutics is a clinical
stage biotechnology company dedicated to creating an alternate future for people living with neurodegenerative diseases. The Company's
lead asset, ATH434, has the potential to treat various forms of Parkinsonian disorders. Alterity also has a broad drug discovery platform
generating patentable chemical to intercede in disease processes. The Company is based in Melbourne, Australia, and San Francisco, California,
USA. 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.
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 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 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 | 30 September 2021 |
| Consolidated statement of cash flows | Current quarter $A'000 | Year to date (3 months) $A'000 | |
| 1. | Cash flows from operating activities | ||
| 1.1 | Receipts from customers | - | - |
| 1.2 | Payments for | ||
| (a) research and development | (3,300) | (3,300) | |
| (b) product manufacturing and operating costs | - | - | |
| (c) advertising and marketing | (81) | (81) | |
| (d) leased assets | - | - | |
| (e) staff costs | (803) | (803) | |
| (f) administration and corporate costs | (936) | (936) | |
| 1.3 | Dividends received (see note 3) | - | - |
| 1.4 | Interest received | - | - |
| 1.5 | Interest and other costs of finance paid | - | - |
| 1.6 | Income taxes paid | - | - |
| 1.7 | Government grants and tax incentives | 226 | 226 |
| 1.8 | Other (provide details if material) | - | - |
| 1.9 | Net cash from / (used in) operating activities | (4,894) | (4,894) |
| 2. | Cash flows from investing activities | ||
| 2.1 | Payments to acquire or for: | ||
| (a) entities | - | - | |
| (b) businesses | - | - | |
| (c) property, plant and equipment | - | - | |
| (d) investments | - | - | |
| (e) intellectual property | - | - | |
| (f) other non-current assets | - | - |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 1 |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
| 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 (3 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) | 17,176 | 17,176 |
| 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 | (564) | (564) |
| 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 | 16,612 | 16,612 |
| 4. | Net increase / (decrease) in cash and cash equivalents for the period | ||
| 4.1 | Cash and cash equivalents at beginning of period | 28,116 | 28,116 |
| 4.2 | Net cash from / (used in) operating activities (item 1.9 above) | (4,894) | (4,894) |
| 4.3 | Net cash from / (used in) investing activities (item 2.6 above) | - | - |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 2 |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
| 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 (3 months) $A'000 | |
| 4.4 | Net cash from / (used in) financing activities (item 3.10 above) | 16,612 | 16,612 |
| 4.5 | Effect of movement in exchange rates on cash held | 1,502 | 1,502 |
| 4.6 | Cash and cash equivalents at end of period | 41,335 | 41 ,335 |
| 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 | 38,335 | 25 ,116 |
| 5.2 | Call deposits | 3,000 | 3,000 |
| 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) | 41,335 | 28,116 |
| 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 | 201 |
| 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. |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 3 |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
| Appendix 4C |
| Quarterly cash flow report for entities subject to Listing Rule 4.7B |
| 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. | 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) | (4,894) |
| 8.2 | Cash and cash equivalents at quarter end (item 4.6) | 41,335 |
| 8.3 | Unused finance facilities available at quarter end (item 7.5) | - |
| 8.4 | Total available funding (item 8.2 + item 8.3) | 41,335 |
| 8.5 | Estimated quarters of funding available (item 8.4 divided by item 8.1) | 8.4 |
| 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. |
| ASX Listing Rules Appendix 4C (17/07/20) | Page 4 |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
| Appendix 4C |
| Quarterly cash flow report for entities subject to Listing Rule 4.7B |
Compliance statement
Phillip Hains - Company Secretary
(Name of body or officer authorising release - see
| ASX Listing Rules Appendix 4C (17/07/20) | Page 5 |
| + See chapter 19 of the ASX Listing Rules for defined terms. |