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Appendix 4C - Q3 FY23 Quarterly Cash Flow Report Highlights: Continued expansion of ATH434 Phase 2 Clinical Trial with sites open for recruitment in five countries Participants in the US and Europe received first dose as

Key Takeaway: Alterity Therapeutics Limited reported significant updates in their Q3 FY23 cash flow report, emphasizing the progress of the ATH434 Phase 2 clinical trial for Multiple System Atrophy (MSA). The trial has opened recruitment in five countries, including the U.S. and Italy, with initial participants already dosed. The company also highlighted encouraging data from an independent study suggesting ATH434's neuroprotective potential. In addition, Alterity secured a new patent for novel compounds related to neurodegenerative treatments.

Market Sentiment Analysis

POSITIVE FACTORS

  • ATH434 Phase 2 clinical trial is gaining momentum with active recruitment in five countries.
  • Independent study suggests ATH434 may have neuroprotective effects, supporting its potential as a treatment.
  • Alterity has received regulatory approval in multiple European countries for the trial.

Full Press Release Details

Appendix 4C - Q3 FY23
Quarterly Cash Flow Report
MELBOURNE, AUSTRALIA AND SAN
FRANCISCO, USA - 27 April 2023. Alterity Therapeutics Limited (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the
Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, released
its Appendix 4C Quarterly Cash Flow Report and update on company activities for the quarter ending 31st March 2023 (Q3 FY23).
"We continue to make excellent
progress with our ATH434 Phase 2 clinical trial in participants with early-stage Multiple System Atrophy, a rapidly progressing Parkinsonian
disorder with no approved treatment." said David Stamler, M.D., Chief Executive Officer, Alterity. "The Phase 2 trial is gaining
momentum with active recruitment in five countries, including the United States. We were pleased that an independent study was published
providing further evidence that ATH434 has potential to be neuroprotective in humans."
The Company's cash position on 31 March 2023 was
A$21.9M with operating cash outflows of A$4M.
Operational Activities
ATH434 Phase 2 Clinical Trial
During the quarter, Alterity's Phase 2 clinical trial
of ATH434 for the treatment of participants with Multiple System Atrophy (MSA) opened several new clinical trial sites. The trial is now
actively recruiting participants in three regions: Europe, Asia-Pacific and the U.S. as the Company looks to bring a potential new treatment
option to individuals living with MSA.
In the US, the Phase 2 clinical
trial of ATH434 opened for enrollment and enrolled the first participant at Vanderbilt University Medical Center in Nashville, Tennessee.
Vanderbilt University has been an important partner for the clinical development of ATH434 and initiating the trial in the
U.S. is a major milestone for Alterity.
Alterity also expanded enrollment
in Europe with the dosing of the first participant in Italy. In addition, Alterity received regulatory authority in France and Austria
to proceed with the Phase 2 trial.
In an independent study published in the journal Neurotherapeutics
during the quarter, it was reported that ATH434 prevented the onset of motor and non-motor symptoms in animals with genetically induced
Parkinson's disease. The study found that ATH434 prevented the development of motor impairment in older animals that was associated
with a reduction in iron levels and preservation of neurons in the substantia nigra, the brain region affected in Parkinson's. The
authors also demonstrated that ATH434 prevented an early non-motor symptom (loss of smell) in younger mice and rescued it in older mice.
These data support other studies indicating that ATH434 has a beneficial effect on the motor and non-motor symptoms in animal models of
PD. The publication provides further evidence that ATH434 has the potential to address the underlying pathology of Parkinson's disease
and related disorders such as MSA.
Intellectual Property and Business Development
Alterity was granted a new composition of matter patent,
entitled "Compounds for and methods of treating diseases" (No. 11,603,364). The patent covers more than 100 novel compounds
with an acyl hydrazone (AH) structure and provides 20 years of exclusivity. The new patent is a testament to the ongoing success of Alterity's
discovery team as they continue to generate novel small molecules with potential to treat important neurodegenerative diseases.
Alterity also entered into a Licensing Agreement for
the new patent and a sub-licensing agreement for PBT2 to Professor Colin Masters, M.D., A.O., to advance the compounds for the treatment
of Alzheimer's and related diseases. Professor Masters is a preeminent researcher in the field of Alzheimer's disease whose
work has provided the foundation for recently approved disease modifying treatments for Alzheimer's disease. Under the license agreement,
Alterity grants the entire rights to the AH patents as well as an exclusive worldwide license to develop and commercialise both AH and
PBT2 in Alzheimer's disease. In exchange, Alterity is entitled to future royalties of net sales from the assets.
On 9 January 2023, the company effected a ratio change
of its American Depository Shares (ADSs) to Ordinary Shares from the previous ratio of 1 ADS representing 60 Ordinary Shares to 1 ADS
representing 600 Ordinary Shares and has regained compliance with NASDAQ's minimum bid price requirement.
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.
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
for entities subject to Listing Rule 4.7B
Name of entity
Alterity Therapeutics Limited
ABN Quarter ended ("current quarter")
37 080 699 065 31 March 2023
Consolidated statement of cash flows Current quarter $A'000 Year to date (9 months) $A'000
1. Cash flows from operating activities
1.1 Receipts from customers - -
1.2 Payments for
(a) research and development (2,289 ) (9,073 )
(b) product manufacturing and operating costs - -
(c) advertising and marketing (98 ) (351 )
(d) leased assets - -
(e) staff costs (1,172 ) (3,035 )
(f) administration and corporate costs (347 ) (1,287 )
1.3 Dividends received (see note 3) - -
1.4 Interest received 2 8
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 (3,904 ) (13,840 )
2. Cash flows from investing activities
2.1 Payments to acquire or for:
(a) entities - -
(b) businesses - -
(c) property, plant and equipment (5 ) (5 )
(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.
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Consolidated statement of cash flows Current quarter $A'000 Year to date (9 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 ) (5 )
3. Cash flows from financing activities
3.1 Proceeds from issues of equity securities (excluding convertible debt securities) 182 311
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 (57 ) (93 )
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 125 218
4. Net increase / (decrease) in cash and cash equivalents for the period
4.1 Cash and cash equivalents at beginning of period 25,350 34,807
4.2 Net cash from / (used in) operating activities (item 1.9 above) (3,904 ) (13,840 )
4.3 Net cash from / (used in) investing activities (item 2.6 above) (5 ) (5)
ASX Listing Rules Appendix 4C (17/07/20) 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 (9 months) $A'000
4.4 Net cash from / (used in) financing activities (item 3.10 above) 125 218
4.5 Effect of movement in exchange rates on cash held 378 764
4.6 Cash and cash equivalents at end of period 21,944 21,944
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 21,944 25,350
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) 21,944 25,350
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 1 131
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.
Quarterly cash flow report for entities subject to Listing Rule 4.7B

Frequently Asked Questions

What is Alterity Therapeutics focused on?

Alterity Therapeutics develops treatments for neurodegenerative diseases.

What is the status of the ATH434 trial?

The Phase 2 trial for ATH434 is actively recruiting participants across five countries.

What recent patent did Alterity receive?

Alterity was granted a patent for over 100 novel compounds for treating diseases.

Where is Alterity Therapeutics located?

Alterity has offices in Melbourne, Australia, and San Francisco, USA.

What were Alterity's cash flows for Q3 FY23?

Their cash position was A$21.9M with operating cash outflows of A$4M.

Last updated: Apr 27, 2023