Full Press Release Details
Appendix 4C - Q1 FY24 Quarterly Cash Flow Report
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA - 30 October 2023. Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"),
a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, releases its Appendix 4C
Quarterly Cash Flow Report and update on company activities for the quarter ending 30 September 2023 (Q1 FY24).
"Alterity had a great start to
the 2024 financial year with significant developments in the first quarter," said David Stamler, M.D., Chief Executive Officer of
Alterity. "Our two Phase 2 clinical trials in Multiple System Atrophy (MSA) are on track as we look to develop a new treatment for
this devastating rare disease. Of note, we have closed screening in the ATH434-201 study and expect to close enrollment imminently. In
addition, an independent Data Monitoring Committee (DMC) recommended that the trial continue as planned and they expressed no concerns
about safety. These events are important milestones in the development of ATH434 for the treatment of early-stage MSA."
"While the ATH434-201 trial is
evaluating individuals with early-stage MSA, we are also conducting a second Phase 2 trial in individuals with more advanced disease.
This open label, biomarker study will give us the opportunity to assess the effect of ATH434 in multiple populations and we also expect
it to provide preliminary data in the first cohort of participants in the first half of next year," concluded Dr. Stamler.
The Company's cash position on
30 September 2023 was A$16.7M with operating cash outflows for the quarter of A$4.1M, offset by a refund of $4.7M from the Australian
Taxation Office under the Australian Government's Research and Development Tax Incentive (R&DTI) Scheme for eligible activities
conducted during the financial year ending 30 June 2022.
ATH434-201: Randomized, Double-Blind
Phase 2 Clinical Trial in MSA
Today, Alterity announced that screening
has closed for its ATH434-201 Phase 2 clinical trial, an important step to completing enrollment in the study. On 26 July, Alterity announced
that an independent DMC recommended the trial continue as planned. The DMC conducted a prespecified review of unblinded clinical data
from an initial cohort of study participants. The DMC expressed no concerns about safety and recommended that the study continue without
double blind, placebo controlled clinical trial continues to progress with early-stage MSA participants enrolled in seven countries
globally. The trial has been well received by the study investigators as they implement Alterity's state of the art methods to
diagnose, treat and track the disease.
ATH434-202: Open-label, Biomarker Phase 2 Clinical
The ATH434-202 trial is enrolling
according to plan. The study is assessing the effect of ATH434 treatment on neuroimaging and protein biomarkers to evaluate target engagement,
in addition to clinical measures, safety, and pharmacokinetics. The primary objective of this study is to evaluate the impact of 12 months
treatment with ATH434 on brain iron by MRI in a more advanced patient population than is being studied in Alterity's double blind
Phase 2 trial. Preliminary data from the first cohort in this study is expected in the first half of 2024.
bioMUSE Natural History Study
Alterity's bioMUSE natural history
study continues to produce meaningful data to address the need for novel approaches to the evaluation of individuals with MSA. The diagnosis
of early MSA can be challenging as individuals often present similarly to Parkinson's disease. On 31 August, presentations from
bioMUSE were delivered at the prominent International Congress of Parkinson's Disease and Movement Disorders (MDS). The presentations
addressed the importance of incorporating biomarkers in diagnosis of MSA and support the need for a timely and accurate diagnosis to ensure
that the right treatment can be delivered to patients.
Findings from the bioMUSE study are
being incorporated into the Company's Phase 2 studies. Alterity's unique protocol designs help to ensure they are enrolling
the right patient population with confirmed MSA, thus giving ATH434 the best chance at success. Based on the collaboration with clinical
and neuroimaging experts from Vanderbilt University Medical Center in the U.S., Alterity is in a unique position to implement this strategy
in its development programs.
Composition of Matter Patent Granted in Europe
The European Patent Office granted
Alterity a new composition of matter patent. The patent secures broad protection over a new class of iron chaperone drug candidates for
treating major neurodegenerative diseases. It is well established that excess iron in the brain is implicated in the pathology of many
important neurodegenerative diseases, including Alzheimer's and Parkinson's diseasesi.
The composition of matter patent,
entitled, "Compounds for and Methods of Treating Diseases", Patent No. 3938364 covers more than 150 novel pharmaceutical compositions
that are designed to redistribute the excess iron implicated in neurodegenerative diseases. The patent will confer on Alterity 20 years
of exclusivity over the compounds claimed in the patent, thus providing a strong basis for drug development and commercialization.
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 Parkinsonian disorders. Alterity also has a broad drug discovery platform generating
patentable chemical compounds 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.
| i | Dusek, P. et al. Cerebral Iron Deposition in Neurodegeneration. Biomolecules 2022, 12, 714. |
| | https://doi.org/10.3390/biom12050714. |
Authorisation & Additional information
This announcement was authorised by David Stamler, CEO
of Alterity Therapeutics Limited.
Investor and Media Contacts:
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, 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, 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 obtaining patent
protection for the Company's intellectual property or trade secrets, the uncertainty of successfully enforcing the Company's patent
rights and the uncertainty of the Company freedom to operate.
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 2023 |
| 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 | | | (2,951 | ) | | | (2,951 | ) |
| | | (b) product manufacturing and operating costs | | | - | | | | - | |
| | | (c) advertising and marketing | | | (45 | ) | | | (45 | ) |
| | | (d) leased assets | | | - | | | | - | |
| | | (e) staff costs | | | (830 | ) | | | (830 | ) |
| | | (f) administration and corporate costs | | | (369 | ) | | | (369 | ) |
| 1.3 | | Dividends received (see note 3) | | | - | | | | - | |
| 1.4 | | Interest received | | | 82 | | | | 82 | |
| 1.5 | | Interest and other costs of finance paid | | | - | | | | - | |
| 1.6 | | Income taxes paid | | | - | | | | - | |
| 1.7 | | Government grants and tax incentives | | | 4,679 | | | | 4,679 | |
| 1.8 | | Other (provide details if material) | | | (17 | ) | | | (17 | ) |
| 1.9 | | Net cash from / (used in) operating activities | | | 549 | | | | 549 | |
| 2. | | Cash flows from investing activities | | | | | | | | |
| 2.1 | | Payments to acquire or for: | | | | | | | | |
| | | (a) entities | | | - | | | | - | |
| | | (b) businesses | | | - | | | | - | |
| | | (c) property, plant and equipment | | | (4 | ) | | | (4 | ) |
| | | (d) investments | | | - | | | | - | |
| | | (e) intellectual property | | | - | | | | - | |
| | | (f) other non-current assets | | | - | | | | - | |
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 | | | (4 | ) | | | (4 | ) |
| 3. | | Cash flows from financing activities | | | | | | |
| 3.1 | | Proceeds from issues of equity securities (excluding convertible debt securities) | | | - | | | | - | |
| 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 | | | 1 | | | | 1 | |
| 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) | | | (18 | ) | | | (18 | ) |
| 3.10 | | Net cash from / (used in) financing activities | | | (17 | ) | | | (17 | ) |
| 4. | | Net increase / (decrease) in cash and cash equivalents for the period | | | | | | |
| 4.1 | | Cash and cash equivalents at beginning of period | | | 15,773 | | | 15,773 |
| 4.2 | | Net cash from / (used in) operating activities (item 1.9 above) | | | 549 | | | 549 |
| 4.3 | | Net cash from / (used in) investing activities (item 2.6 above) | | | (4 | ) | | | (4 | ) |
Quarterly cash flow report
for entities subject to Listing Rule 4.7B