Full Press Release Details
Appendix 4C - Q1 FY21 Quarterly
AUSTRALIA AND SAN FRANCISCO, USA - 30 October 2020. 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 30 September 2020 (Q1 FY21).
Alterity continues to progress
its clinical program for lead compound ATH434 for the treatment of Parkinsonian diseases, with growing international scientific
and clinical interest. The potential of Alterity's therapeutic pipeline was validated with the company securing $35M funding
from institutional investors in Australia, the US and UK as part of a placement to wholesale and sophisticated investors that occurred
after the reporting period.
During the period, Alterity
announced that new clinical and experimental pharmacology data were selected for presentation at the 2020 International Congress
of Parkinson's Disease and Movement Disorders and the American Neurological Association's 2020 Annual Meeting. The
new data were generated from experiments testing ATH434 in an animal model of Multiple System Atrophy (MSA) in the laboratory of
Dr. Nadia Stefanova, Professor of Translational Neurodegeneration Research at the Medical University of Innsbruck. They independently
confirmed and extended previous findings demonstrating that ATH434 reduces -synuclein pathology, preserves neurons and improves
The company also presented
new cardiac safety data evaluating electrical activity in the heart as measured by the QT interval. The data reinforce previous
safety findings from the Phase 1 clinical study that ATH434 was generally well tolerated at all doses and had an adverse event
profile comparable to placebo in adult and older adult volunteers. The new data indicate that there is no evidence of cardiac liability
at clinically tested doses.
Post the reporting period, Alterity
announced it has commenced enrolling patients with MSA in its bioMUSE Study in the United States. BioMUSE is a natural history
study that aims to track the progression of patients with MSA, a Parkinsonian disorder without approved therapy. The study is being
conducted in collaboration with Vanderbilt University Medical Center in the US under the direction of Daniel Claassen, MD, Associate
Professor of Neurology and Principal Investigator.
Natural history studies
such as bioMUSE are important for characterizing disease progression in selected patient populations. The study will provide vital
information on early stage MSA patients to optimize the design of Alterity's Phase 2 study in MSA. The study will also inform
the selection of biomarkers suitable to evaluate target engagement and preliminary efficacy in the upcoming Phase 2 study.
The Company's $7.4M cash
balance was bolstered after the reporting period with the receipt of Tranche 1 funds of $10M forming part of a larger $35M Placement
to Australian and International institutions and other unrelated sophisticated, professional or exempt investors. A further $25M
in committed funds are subject to shareholder approval at the company's AGM on 18th November.
The proceeds will enable Alterity to
continue advancing its clinical development program for ATH434, including the bioMUSE Natural History study and Phase 2 trial,
both in MSA patients, ongoing research and discovery, and working capital.
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, remuneration
and superannuation at commercial rates.
Authorisation & Additional information
This announcement was authorised by Geoffrey Kempler,
CEO and Chairman of Alterity Therapeutics Limited.
Rebecca Wilson, WE Communications
About Alterity Therapeutics
Alterity's lead candidate,
ATH434 (Formerly PBT434), 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 potential to treat Parkinson's
disease and atypical forms of 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.
About Multiple System
Multiple System Atrophy
(MSA) is a rare and rapidly progressive neurological disorder affecting adults. It has no known cause. In addition to
presenting with motor symptoms like those in Parkinson's disease, individuals with MSA may also experience loss of
ability to coordinate voluntary movements and impaired regulation of involuntary body functions such as blood pressure, bowel
and bladder control. Most of these symptoms are not addressed by available drugs for patients with Parkinson's disease.
As the condition progresses, daily activities become increasingly difficult and complications such as increased difficulty
swallowing, vocal cord paralysis, progressive immobility, and poor balance become more prominent. Symptoms tend to appear
after age 50 and rapidly advance, leading to profound disability and death.
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, ATH34, 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.
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
| Name of entity | ||
| Alterity Therapeutics Limited | ||
| ABN | Quarter ended ("current quarter") | |
| 37 080 699 065 | 30 September 2020 |
| 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 | (1,828 | ) | (1,828 | ) | ||||||
| (b) product manufacturing and operating costs | - | - | ||||||||
| (c) advertising and marketing | (39 | ) | (39 | ) | ||||||
| (d) leased assets | - | - | ||||||||
| (e) staff costs | (808 | ) | (808 | ) | ||||||
| (f) administration and corporate costs | (377 | ) | (377 | ) | ||||||
| 1.3 | Dividends received (see note 3) | - | - | |||||||
| 1.4 | Interest received | 1 | 1 | |||||||
| 1.5 | Interest and other costs of finance paid | - | - | |||||||
| 1.6 | Income taxes paid | - | - | |||||||
| 1.7 | Government grants and tax incentives | 12 | 12 | |||||||
| 1.8 | Other (provide details if material) | - | - | |||||||
| 1.9 | Net cash from / (used in) operating activities | (3,039 | ) | (3,039 | ) | |||||
| 2. | Cash flows from investing activities | |||||||||
| 2.1 | Payments to acquire: | |||||||||
| (a) entities | - | - | ||||||||
| (b) businesses | - | - | ||||||||
| (c) property, plant and equipment | - | - | ||||||||
| (d) investments | - | - | ||||||||
| (e) intellectual property | - | - | ||||||||
| (f) other non-current assets | - | - |
| ASX Listing Rules Appendix 4C (01/12/19) | Page 1 |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
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) | 1,562 | 1,562 | |||||||
| 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 | (63 | ) | (63 | ) | |||||
| 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 | 1,499 | 1,499 | |||||||
| 4. | Net increase / (decrease) in cash and cash equivalents for the period | |||||||||
| 4.1 | Cash and cash equivalents at beginning of period | 9,197 | 9,197 | |||||||
| 4.2 | Net cash from / (used in) operating activities (item 1.9 above) | (3,039 | ) | (3,039 | ) | |||||
| 4.3 | Net cash from / (used in) investing activities (item 2.6 above) | - | - |
| ASX Listing Rules Appendix 4C (01/12/19) | Page 2 |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
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) | 1,499 | 1,499 | |||||||
| 4.5 | Effect of movement in exchange rates on cash held | (259 | ) | (259 | ) | |||||
| 4.6 | Cash and cash equivalents at end of period | 7,398 | 7,398 |
| 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 | 7,398 | 9,197 | |||||||
| 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) | 7,398 | 9,197 |
| 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 | 183 | ||||
| 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 (01/12/19) | Page 3 |
| + See chapter 19 of the ASX Listing Rules for defined terms. |
Quarterly cash flow report for entities subject to Listing Rule 4.7B