Full Press Release Details
Appendix 4C - Q4 FY23
Quarterly Cash Flow Report
AUSTRALIA AND SAN FRANCISCO, USA - 31 July 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 June 2023 (Q4 FY23).
"The last several months
have been extremely productive for Alterity as we hit several milestones and made significant progress advancing ATH434," said David
Stamler, M.D., Chief Executive Officer, Alterity. "With the clearance by the Data Monitoring Committee to continue the ATH434-201
trial as planned and the enthusiasm for the trial from physicians around the world, the trial remains on track to complete enrollment
in the third quarter of 2023 with top-line data expected by the end of 2024."
Dr. Stamler, continued, "We
also initiated a second Phase 2 study, ATH434-202, in participants with more advanced MSA. Importantly, this Biomarker study gives us
the opportunity to get an early indication of efficacy before the ATH434-201 Phase 2 study reads out. Individuals with more advanced MSA
may also benefit from ATH434 and measuring key biomarkers will permit us to evaluate drug activity in this population. The data derived
from the Biomarker study have the potential to accelerate the overall development program."
"An important element of
our ATH434-201 trial is the use of wearable sensors to determine the impact of ATH434 on motor impairment and gait stability. During the
quarter, data from the bioMUSE natural history study reinforced this measure by showing that wearable sensors can be used to assess disease
progression that may not be captured by neurological examination," concluded Dr. Stamler.
The Company's cash position
on 30 June 2023 was A$15.8M with operating cash outflows for the quarter of A$6.2M. The company anticipates the cash position will be
boosted in the coming weeks with the receipt of the A$4.7M R&D Tax incentive for the 2022 fiscal year.
Operational Activities
ATH434-201 Phase 2 Clinical
Subsequent to the quarter, on 26
July, Alterity announced that the independent Data Monitoring Committee (DMC) for the ATH434-201 Phase 2 study 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 modification.
This randomized, double blind,
placebo controlled clinical trial continues to progress with participants in both Australia and the United Kingdom now being treated.
The trial is enrolling participants with early stage MSA at over 15 sites in three regions - Australia/New Zealand, the United States,
and Europe. The trial is being well received by physicians across the board with feedback positive as they implement Alterity's
state of the art methods to diagnose and track the disease.
ATH434-202 Phase 2 Clinical
initiated enrollment in a second Phase 2 trial of ATH434 during the quarter in participants with MSA. This open label, single arm study,
entitled "A Biomarker Study of ATH434 in participants with MSA" (ATH434-202), allows Alterity to evaluate the effect of ATH434
on a MSA population more advanced than that being investigated in the randomized study. The design of the Biomarker study will allow the
Company to perform interim analyses of biomarker data during conduct, with potential to provide early indications of efficacy before the
randomized study reads out.
The key aim of the study is to
assess the efficacy of ATH434 on objective biomarkers that measure target engagement and are relevant to the underlying pathology of disease.
Clinical measures important in MSA will also be assessed.
Promising wearable sensor data
from the bioMUSE Natural History Study
quarter, analysis from the Biomarkers of Progression in Multiple System Atrophy (bioMUSE) natural history study demonstrated that wearable
sensors can quantify motor impairment in individuals with MSA that is not captured by neurological examination. This means that wearable
sensors can be used to assess disease progression and inform clinical trials. These data were presented at the American Academy of Neurology
Annual Meeting. As a result of the study, Alterity has incorporated wearable sensor data into its Phase 2 clinical trial for ATH434 as
one of its secondary endpoints to determine the effect of treatment on gait parameters.
The ongoing bioMUSE study will
continue to provide vital information on early stage MSA, inform the selection of biomarkers suitable to evaluate target engagement and
preliminary efficacy, and deliver clinical data to characterize disease progression in a population that mirrors those being studied in
Alterity's ATH434-201 trial.
About Alterity Therapeutics
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.
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.
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 June 2023 |
| 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 | (4,180 | ) | (13,253 | ) | ||||||
| (b) product manufacturing and operating costs | - | - | ||||||||
| (c) advertising and marketing | (98 | ) | (449 | ) | ||||||
| (d) leased assets | - | - | ||||||||
| (e) staff costs | (832 | ) | (3,867 | ) | ||||||
| (f) administration and corporate costs | (1,116 | ) | (2,403 | ) | ||||||
| 1.3 | Dividends received (see note 3) | - | - | |||||||
| 1.4 | Interest received | 1 | 9 | |||||||
| 1.5 | Interest and other costs of finance paid | - | - | |||||||
| 1.6 | Income taxes paid | - | (102 | ) | ||||||
| 1.7 | Government grants and tax incentives | - | - | |||||||
| 1.8 | Other (provide details if material) | - | - | |||||||
| 1.9 | Net cash from / (used in) operating activities | (6,225 | ) | (20,065 | ) | |||||
| 2. | Cash flows from investing activities | |||||||||
| 2.1 | Payments to acquire or for: | |||||||||
| (a) entities | - | - | ||||||||
| (b) businesses | - | - | ||||||||
| (c) property, plant and equipment | - | (5 | ) | |||||||
| (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 (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 | - | (5 | ) | ||||||
| 3. | Cash flows from financing activities | |||||||||
| 3.1 | Proceeds from issues of equity securities (excluding convertible debt securities) | - | 311 | |||||||
| 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 | (40 | ) | (133 | ) | |||||
| 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 | (40 | ) | 178 | ||||||
| 4. | Net increase / (decrease) in cash and cash equivalents for the period | |||||||||
| 4.1 | Cash and cash equivalents at beginning of period | 21,944 | 34,807 | |||||||
| 4.2 | Net cash from / (used in) operating activities (item 1.9 above) | (6,225 | ) | (20,065 | ) | |||||
| 4.3 | Net cash from / (used in) investing activities (item 2.6 above) | - | (5 | ) |
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) | (40 | ) | 178 | ||||||
| 4.5 | Effect of movement in exchange rates on cash held | 94 | 858 | |||||||
| 4.6 | Cash and cash equivalents at end of period | 15,773 | 15,773 |
| 5. | Reconciliation of cash and cash equivalents | Current quarter $A'000 | Previous quarter $A'000 | |||||||
| 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 | 15,773 | 21,944 | |||||||
| 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) | 15,773 | 21,944 |
| 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 | 132 | ||||
| 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. |
Quarterly cash 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. |