SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-163
UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For
the month of July 2024
Alterity
Therapeutics Limited
(Name
of Registrant)
Level 14, 350 Collins Street,
Melbourne, Victoria 3000 Australia
(Address
of Principal Executive Office)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form
20-F ☒ Form 40-F ☐
This
Form 6-K is being incorporated by reference into our Registration Statement on Form S-8 (Files No. 333-251073, 333-248980
and 333-228671) and our
Registration Statements on Form F-3 (Files No. 333-274816, 333-251647, 333-231417
and 333-250076)
ALTERITY
THERAPEUTICS LIMITED
(a
development stage enterprise)
The
following exhibits are submitted:
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
Alterity Therapeutics Limited |
|
|
|
|
By: |
/s/ Geoffrey P. Kempler |
|
|
Geoffrey P. Kempler |
|
|
Chairman |
Date:
July 31, 2024
2
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1131343/000101376224002902/ex99-1_002.jpg)
Appendix 4C – Q4 FY24 Quarterly Cash Flow
Report
Highlights
| ● | Positive interim data reported from ATH434-202 Phase 2 clinical trial showing improvement on the UMSARS
Activities of Daily Living Scale and stable or improved neurological symptoms in some patients |
| | |
| ● | Data from the bioMUSE Natural History Study continues to characterize early stage MSA and inform Alterity’s
Phase 2 clinical trials |
| | |
| ● | Multiple data presentations at the World Orphan Drug Congress and the American Academy of Neurology
(AAN) Annual Meeting |
| | |
| ● | Cash balance on 30 June 2024 of A$12.6M |
MELBOURNE, AUSTRALIA AND SAN FRANCISCO, USA – 31 July
2024: Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology
company dedicated to developing disease modifying treatments for neurodegenerative diseases, today released its Appendix 4C
Quarterly Cash Flow Report and update on company activities for the quarter ending 30 June 2024 (Q4 FY24).
“We have made great strides over
the last two months with the positive interim data readout from our ATH434-202 Phase 2 clinical trial and the important observations from
our bioMUSE Natural History Study that continue to guide development of ATH434,” said, David Stamler, M.D., Chief Executive Officer
of Alterity. “I am very encouraged by the results from our 202 study in patients with advanced Multiple System Atrophy (MSA) where
we saw favorable clinical and biomarker outcomes in some patients suggesting that ATH434 has the potential to modify the course of this
devastating condition. We were also very pleased to see that the clinical responders had biomarker evidence of stable disease as this
provides an objective indication of potential efficacy.”
“Our bioMUSE study continues to provide
valuable information to inform our patient selection criteria and choose endpoints for our Phase 2 clinical trials. This
observational study has allowed us to monitor the progression of MSA in earlier stage patients and further characterize this
devastating disease. Working with our colleagues at Vanderbilt University, we have employed novel MRI technology and machine
learning to precisely analyze brain iron content and brain volumes in these patients over time. The results from the study have
guided us to modify our endpoints in the ATH434-202 study. The data from our 202 and bioMUSE studies increases my overall confidence
in the ATH434 development program,” concluded, Dr. Stamler. Alterity’s cash position on 30 June 2024 was A$12.6M with
operating cash outflows for the quarter of A$5.6M.
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, consulting
fees, remuneration and superannuation at commercial rates.
Operational Activities
ATH434–201: Randomized, Double-Blind Phase 2 Clinical
Trial in Early-State MSA
On 8 May 2024, Alterity announced that
an independent Data Monitoring Committee (DMC) completed its third prespecified review of unblinded clinical trial data from the ATH434-201
Phase 2 study. The DMC expressed no concerns about safety and recommended that the study continue as planned without modification. This
recommendation is an important milestone as participants are able to safely tolerate ATH434 as their time on study increases.
In April 2024, important new data on ATH434
was presented at the World Orphan Drug Congress in a poster presentation, entitled, “Biophysical Characteristics of ATH434, a Unique
Iron- Targeting Drug for Treating Friedreich’s Ataxia.” The study evaluated the ability of ATH434 to target the toxic form
of iron that drives the pathology of Friedreich’s Ataxia, a rare neurodegenerative disease that affects young children to young
adults. The investigation provides important insights into the mechanism of action of ATH434, namely that it selectively targets the labile
iron implicated in the pathology of important neurodegenerative diseases. In this way, ATH434 behaves like a chaperone to redistribute
iron within the body.
In April 2024, a poster was presented
at the American Academy of Neurology (AAN) 2024 Annual Meeting, entitled, “A Phase 2 Study of ATH434, a Novel Inhibitor of α-Synuclein
Aggregation, for the Treatment of Multiple System Atrophy”. The poster described the baseline characteristics for the 65 evaluable
participants from the ATH434-201 with a focus on baseline fluid biomarkers, neuroimaging and clinical data. The participants met strict
selection criteria designed to confirm they had early-stage MSA. Overall, the participants had a mean duration of motor symptoms of two
years. The data showed increased iron in areas of pathology and elevated plasma Neurofilament Light Chain (NfL) levels at baseline that
correlated significantly with disease severity.
The trial remains on track to complete
in November 2024. The data from the trial will then be analyzed and the Company expects to report topline results by January 2025.
ATH434–202: Open-label, Biomarker Phase 2 Clinical Trial
in More Advanced MSA
Subsequent to the quarter end, on 17 July
2024, Alterity reported positive interim data from the ATH434-202 trial in participants with advanced MSA. The interim analysis included
clinical and biomarker data on 7 participants treated with ATH434 for 6 months and neuroimaging data on 3 participants who were treated
for 12 months. After 6 months of treatment, 43% of participants showed improvement on the UMSARS1, indicating reduced disability
on activities of daily living. Over the same period, 29% of participants had stable or improved neurological symptoms (clinical responders)
as assessed by the global impression of change by both the treating physician and the patient. Importantly, the clinical responders on
average had reduced accumulation of iron on MRI in the substantia nigra, putamen and globus pallidus and stable levels of NFL, a marker
of axonal injury, when compared to participants who declined.
bioMUSE Natural History Study
On 30 May 2024 Alterity hosted a webinar
to discuss data from the bioMUSE Natural History Study. The goal of the observational bioMUSE study is to optimize patient selection and
choose endpoints for the Company’s Phase 2 clinical trials. This study enrolled 21 individuals who were observed for 12 months to
characterize early-stage MSA in terms of various biomarkers. In particular, the focus is on brain iron, brain volume, and the pathology
in glial support cells. Utilizing novel MRI technology, Alterity’s partners at Vanderbilt University have optimized specialized
MRI methods, including machine learning (a form of artificial intelligence), to establish standardized methods to analyze brain iron and
brain volumes with precision. Importantly, they developed a new, novel imaging biomarker to assess brain volume in MSA affected regions.
The bioMUSE data showed a statistically significant increase in iron over 12 months in the substantia nigra, and statistically significant
decreases in brain volume observed in affected regions at 12 months.
Also at AAN, a poster was presented at
the AAN 2024 Annual Meeting, entitled, “Neurofilament Light Chain and Clinical Progression in Early Multiple System Atrophy”.
The poster described results from bioMUSE in which changes in clinical severity of 15 patients across a span of 12 months were compared
with plasma biomarkers with a goal of establishing meaningful correlations. Importantly, the observational data suggest the fluid biomarker
NfL may be used as a marker of disease severity in studies of MSA as it holds promise for measuring the extent of disease, tracking its
progression, and forecasting the onset of clinical manifestations associated with MSA.
ATH434 for the Treatment of Parkinson’s
Disease
A poster was also presented at
AAN entitled, “Effects of ATH434, a Clinical-Phase Small Molecule with Moderate Affinity for Iron, in Hemiparkinsonian
Macaques”. The presentation showed that ATH434 can reduce Parkinsonism in a higher order animal, the monkey, with symptoms
that closely parallel human disease. Importantly, the improvements in motor skills and general functioning that parallel human
parkinsonism were associated with reductions in abnormal iron in affected brain regions. These favorable parkinsonian outcomes
observed in the ATH434- treated monkeys were also associated with increased levels of striatal synaptophysin, a protein marker that
reflects functional connections between neurons, suggesting functional recovery of nerve endings in this critical motor pathway.
Taken together, the findings in this study increase the Company’s confidence in their approach in the ongoing Phase 2 program
in MSA.
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 and is currently being evaluated in two Phase 2 clinical
trials in Multiple System Atrophy. Alterity also has a broad drug discovery platform generating patentable chemical compounds to treat
the underlying pathology of neurological diseases. 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 authorized by David Stamler, CEO of Alterity
Therapeutics Limited.
Investor and Media Contacts:
Australia
Hannah Howlett
we-aualteritytherapeutics@we-worldwide.com
+61 450 648 064
U.S.
Remy Bernarda remy.bernarda@iradvisory.com
+1 (415) 203-6386
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.
Rule
4.7B
Appendix
4C
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 2024 |
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 |
(3,933) |
(15,303) |
|
(b)
|
product
manufacturing and operating costs |
- |
- |
|
(c) |
advertising
and marketing |
(56) |
(261) |
|
(d) |
leased
assets |
- |
- |
|
(e) |
staff
costs |
(746) |
(3,370) |
|
(f) |
administration
and corporate costs |
(1,008) |
(2,409) |
1.3 |
Dividends
received (see note 3) |
- |
- |
1.4 |
Interest
received |
126 |
268 |
1.5 |
Interest
and other costs of finance paid |
- |
- |
1.6 |
Income
taxes paid |
(57) |
(57) |
1.7 |
Government
grants and tax incentives |
- |
8,584 |
1.8 |
Other
(provide details if material) |
- |
(17) |
1.9 |
Net
cash from / (used in) operating activities |
(5,674) |
(12,565) |
2. |
Cash
flows from investing activities |
|
|
2.1 |
Payments
to acquire or for: |
|
|
|
(a) |
entities |
- |
- |
|
(b) |
businesses |
- |
- |
|
(c) |
property, plant and equipment |
- |
(6) |
|
(d) |
investments |
- |
- |
|
(e) |
intellectual property |
- |
- |
|
(f) |
other non-current assets |
- |
- |
ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. | | Page 1 |
Appendix
4C
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 |
- |
1 |
|
(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) |
45 |
10,095 |
3.2 |
Proceeds
from issue of convertible debt securities |
50 |
50 |
3.3 |
Proceeds
from exercise of options |
- |
- |
3.4 |
Transaction
costs related to issues of equity securities or convertible debt securities |
(23) |
(904) |
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) |
(15) |
20 |
3.10 |
Net
cash from / (used in) financing activities |
57 |
9,261 |
4. |
Net
increase / (decrease) in cash and cash equivalents for the period |
|
|
4.1 |
Cash
and cash equivalents at beginning of period |
18,301 |
15,773 |
4.2 |
Net
cash from / (used in) operating activities (item 1.9 above) |
(5,674) |
(12,565) |
4.3 |
Net
cash from / (used in) investing activities (item 2.6 above) |
- |
(5) |
ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. | | Page 2 |
Appendix
4C
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) |
57 |
9,261 |
4.5 |
Effect
of movement in exchange rates on cash held |
(45) |
175 |
4.6 |
Cash
and cash equivalents at end of period |
12,639 |
12,639 |
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 |
Current
quarter
$A’000 |
Previous
quarter
$A’000 |
5.1 |
Bank
balances |
12,639 |
18,301 |
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) |
12,639 |
18,301 |
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 |
107 |
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. |
The amount at 6.1 includes payment of director’s
fees and salaries and consulting fees, excluding GST where applicable.
ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. | | Page 3 |
Appendix
4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
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. |
Total
facility
amount at quarter
end
$A’000 |
Amount
drawn at
quarter end
$A’000 |
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. |
|
|
8. |
Estimated cash available for future operating activities |
$A’000 |
8.1 |
Net cash from / (used in) operating activities (item 1.9) |
(5,674) |
8.2 |
Cash and cash equivalents at quarter end (item 4.6) |
12,639 |
8.3 |
Unused finance facilities available at quarter end (item 7.5) |
- |
8.4 |
Total available funding (item 8.2 + item 8.3) |
12,639 |
|
8.5 |
Estimated quarters of funding available (item 8.4 divided by item 8.1) |
2.2 |
Note: if the entity has reported positive net operating cash flows in item 1.9, answer item 8.5 as “N/A”. Otherwise, a figure for the estimated quarters of funding available must be included in item 8.5. |
8.6 |
If item 8.5 is less than 2 quarters, please provide answers to the following questions: |
|
8.6.1 Does the entity expect that it will continue to have the current level of net operating cash flows for the time being and, if not, why not? |
|
Answer: N/A |
|
|
8.6.2 Has the entity taken any steps, or does it propose to take any steps, to raise further cash to fund its operations and, if so, what are those steps and how likely does it believe that they will be successful? |
|
Answer: N/A |
|
|
8.6.3 Does the entity expect to be able to continue its operations and to meet its business objectives and, if so, on what basis? |
|
Answer: N/A |
Note: where item 8.5 is less than 2 quarters, all of questions 8.6.1, 8.6.2 and 8.6.3 above must be answered. |
ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. | | Page 4 |
Appendix
4C
Quarterly cash flow report for entities subject to Listing Rule 4.7B
Compliance
statement
| 1 | This
statement has been prepared in accordance with accounting standards and policies which comply with Listing Rule 19.11A. |
| 2 | This
statement gives a true and fair view of the matters disclosed. |
Date: |
31
July 2024 |
|
|
|
![](https://www.sec.gov/Archives/edgar/data/1131343/000101376224002902/ex99-1_003.jpg) |
|
|
Authorised
by: |
Phillip
Hains – Company Secretary |
|
(Name
of body or officer authorising release – see note 4) |
Notes
| 1. | This
quarterly cash flow report and the accompanying activity report provide a basis for informing
the market about the entity’s activities for the past quarter, how they have been financed
and the effect this has had on its cash position. An entity that wishes to disclose additional
information over and above the minimum required under the Listing Rules is encouraged to
do so. |
| 2. | If
this quarterly cash flow report has been prepared in accordance with Australian Accounting
Standards, the definitions in, and provisions of, AASB 107: Statement of Cash Flows
apply to this report. If this quarterly cash flow report has been prepared in accordance
with other accounting standards agreed by ASX pursuant to Listing Rule 19.11A, the corresponding
equivalent standard applies to this report. |
| 3. | Dividends
received may be classified either as cash flows from operating activities or cash flows from
investing activities, depending on the accounting policy of the entity. |
| 4. | If
this report has been authorised for release to the market by your board of directors, you
can insert here: “By the board”. If it has been authorised for release to the
market by a committee of your board of directors, you can insert here: “By the [name
of board committee – eg Audit and Risk Committee]”. If it has been
authorised for release to the market by a disclosure committee, you can insert here: “By
the Disclosure Committee”. |
| 5. | If
this report has been authorised for release to the market by your board of directors and
you wish to hold yourself out as complying with recommendation 4.2 of the ASX Corporate Governance
Council’s Corporate Governance Principles and Recommendations, the board should
have received a declaration from its CEO and CFO that, in their opinion, the financial records
of the entity have been properly maintained, that this report complies with the appropriate
accounting standards and gives a true and fair view of the cash flows of the entity, and
that their opinion has been formed on the basis of a sound system of risk management and
internal control which is operating effectively. |
ASX Listing Rules Appendix 4C (17/07/20) + See chapter 19 of the ASX Listing Rules for defined terms. | | Page 5 |
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