Full Press Release Details
Appendix 4C - Q2 FY23
Quarterly Cash Flow Report
MELBOURNE, AUSTRALIA AND
SAN FRANCISCO, USA - 31 January 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 31st December 2022 (Q2 FY23).
Alterity continued to focus its efforts on running and expanding the Phase 2 clinical trial (the "Trial" or "Study")
for its lead drug candidate ATH434 in Multiple System Atrophy (MSA), now enrolling patients across the globe. The Company's cash
position on 31 December 2022 was A$25.3M with operating cash outflows of A$5.2M.
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.
M.D., Chief Executive Officer, Alterity, commented, "We are excited about the progress of our Phase 2 clinical trial which is now
actively recruiting participants with early-stage MSA in three regions globally. We remain committed to bringing our potential disease
modifying therapy to individuals living with this devastating condition. During the quarter, we also presented key bioMUSE data, grew
our intellectual property portfolio, and published preclinical data giving us the opportunity to expand our pipeline into other neurodegenerative
Operational Activities
ATH434 Phase 2 Clinical Trial
second quarter of FY23, Alterity launched in its Phase 2 clinical trial of ATH434 in Sydney, Australia after successfully securing ethics
approval from the Human Research Ethics Committee (HREC) at St. Vincent's Hospital, Melbourne.
quarter closed, in January 2023, the Company also announced further expansion of the trial with sites now open form enrollment in the
United States and Italy. With these additions, the Company is now actively enrolling patients for the Study in three regions (Europe,
Asia-Pacific, and North America), and five countries (New Zealand, Australia, United Kingdom, U.S., and Italy). Alterity's clinical
team is providing ongoing support to the investigators at each site working toward the goal of recruiting 60 patients globally.
bioMUSE (Biomarkers of progression in Multiple System
The bioMUSE Natural History study continues to
deliver valuable data to de-risk Alterity's Phase 2 trial by providing insight into the diagnosis and biomarkers of MSA to characterize
disease progression.
and in conjunction with collaborators at Vanderbilt University Medical Center, the Company gave a poster presentation at the 147th Annual
Meeting of the American Neurological Association (ANA) on different methods of measuring the volume of brain structures affected in individuals
with MSA, Parkinson's disease, and healthy controls. The poster, Deep Learning Segmentation Improves Precision of Volume Assessment
of Subcortical Structures in early MSA, found meaningful differences in the accuracy of three different techniques for measuring the
volume of subcortical brain structures on MRI scans of patients with MSA and Parkinson's disease. The Deep Learning method provides
the basis for measuring brain iron with high precision in the Phase 2 study.
In November, Alterity also presented
data from bioMUSE at the American Autonomic Society (AAS) 2022 Annual Conference. This poster, entitled Urinary Symptom Profile in
Early Multiple System Atrophy, evaluated early stage MSA patients urinary symptoms with the Urinary Symptom Profile (USP). The study
results indicate that the USP can be used for comprehensive evaluation of urinary complaints, a symptom which can have a profound negative
impact on quality of life, in a group of patients similar to those being studied in the Phase 2 trial.
2022, a preclinical investigation of ATH434 was published in the journal Neurotherapeutics and demonstrated efficacy in an animal
model of Parkinson's disease. The publication, entitled, "ATH434 Rescues Pre-motor
Hyposmia in a Mouse Model of Parkinsonism" assessed the impact of ATH434 on motor and non-motor manifestations in experimentally
induced Parkinson's disease. The investigation showed that treatment with ATH434 prevented the development of motor impairment,
which was associated with a reduction in iron levels and preservation of nerve cells in the brain region affected in Parkinson's.
This study adds to the weight of evidence regarding ATH434 as a potential disease modifying therapy for Parkinsonian disorders.
Intellectual Property
Strengthening its IP portfolio,
Alterity secured a new composition of matter patent from the United States Patent and Trademark Office (USPTO) in December. The patent,
entitled, "Compounds for and methods of treating diseases", is based on a new scaffold that includes more than 100
novel compounds, at least one of which has demonstrated efficacy in an animal model of dementia.
The new patent covers iron chaperones,
small molecules capable of binding and redistributing excess iron in the central nervous system, implicated in the pathology of many important
neurodegenerative diseases, including Alzheimer's and Parkinson's diseases. Alterity will have 20 years of exclusivity for
these compounds, expanding the company's intellectual property estate for treating major neurodegenerative diseases.
Subsequent to the end of the
quarter on 24 January 2023, Alterity received formal notification from The Nasdaq Stock Market LLC confirming that the Company had regained
compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Rule"), which
requires that the Company's American Depositary Shares ("ADS") maintain a minimum bid price of at least US$1.00 per
ADS, and that the matter is now closed.
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.
Authorization & 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, 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 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
subject to Listing Rule 4.7B
Alterity Therapeutics Limited
| ABN | Quarter ended ("current quarter") |
| 37 080 699 065 | 31 December 2022 |
| Consolidated statement of cash flows | Current quarter $A'000 | Year to date (6 months) $A'000 | ||||||
| 1. Cash flows from operating activities | ||||||||
| 1.1 Receipts from customers | - | - | ||||||
| 1.2 Payments for | ||||||||
| (a) research and development | (3,604 | ) | (6,784 | ) | ||||
| (b) product manufacturing and operating costs | - | - | ||||||
| (c) advertising and marketing | (173 | ) | (253 | ) | ||||
| (d) leased assets | - | - | ||||||
| (e) staff costs | (955 | ) | (1,863 | ) | ||||
| (f) administration and corporate costs | (444 | ) | (940 | ) | ||||
| 1.3 Dividends received (see note 3) | - | - | ||||||
| 1.4 Interest received | 6 | 6 | ||||||
| 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 | (5,170 | ) | (9,936 | ) | ||||
| 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 | - | - |
Quarterly cash flow report for entities subject to Listing Rule 4.7B
| Consolidated statement of cash flows | Current quarter $A'000 | Year to date (6 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) | - | 129 | ||||||
| 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 | (28 | ) | (36 | ) | ||||
| 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 | (28 | ) | 93 |