Full Press Release Details
Appendix 4C - Q1 FY20 Quarterly
| Results of Phase 1 Clinical Trials for lead compound PBT434 announced | ||
| Presentation of clinical trial data at the 2019 International Congress of Parkinson's Disease and Movement Disorders (MDS Congress) in France | ||
| Presentation at the Janney Healthcare conference in New York | ||
| Cash balance of $10.7M |
MELBOURNE, AUSTRALIA AND SAN FRANCISCO,
USA - 30 October 2019. 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 2019 (Q1
Phase 1 clinical trial results for Alterity's
lead compound PBT434 were announced this past quarter in July. PBT434 was found to be safe and well-tolerated in its human subjects
with an adverse event profile comparable to placebo. The clinically tested doses achieved concentrations in brain that are potentially
clinically relevant.
PBT434 looks to treat Parkinsonian disorders
such as Parkinson's disease (PD) and Multiple System Atrophy (MSA). These neurodegenerative diseases result from accumulation
of aggregated alpha-synuclein protein. PBT434 was found to inhibit the alpha-synuclein aggregation, preserve neurons and improve
motor function in animal models of PD and MSA.
Alterity presented the Phase 1 results
at the MDS Congress in France on the 24th of September and at the Janney Healthcare Conference in New York City on the
10th of September. The conferences provided opportunities for the Company to network with other leaders in the industry
along with global healthcare investors.
Cash at the end of the quarter was $10.7M
compared to $14.4M in the previous quarter. Expenses predominantly related to completion of the PBT434 Phase 1 clinical trial and
pre-clinical studies for future trials into PBT434. The Company anticipates receipt of $4.8M from the Australian Taxation Office
relating to the R&D tax incentive for the 2019 financial year before the end of 2019.
Geoffrey Kempler, CEO of Alterity, said:
"Completing the Phase 1 trials for PBT434 and having positive results from the study has helped Alterity raise its profile
in the industry through events such as the MDS Congress and Janney Healthcare Conference. The Company now looks forward to updating
investors and the industry on further trials into PBT434, which will occur in due course."
Investor enquiries IR@alteritytherapeutics.com
About Alterity Therapeutics Limited
Alterity's lead candidate, PBT434,
is the first of a new generation of small molecules designed to inhibit the aggregation of pathological proteins implicated in
neurodegeneration. PBT434 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 excellent potential to treat various forms of atypical
Parkinsonism such as Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP).
For further information please visit the
Company's web site at www.alteritytherapeutics.com
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, PBT434, 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, PBT434,
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, PBT434, 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 PBT434.
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 updated 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 report for entities subject
to Listing Rule 4.7B
Quarterly report for entities subject
to Listing Rule 4.7B
Introduced 31/03/00 Amended 30/09/01, 24/10/05, 17/12/10, 01/09/16
| Name of entity | ||
| Alterity Therapeutics Limited | ||
| ABN | Quarter ended ("current quarter") | |
| 37 080 699 065 | 30 September 2019 |
| 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 | (2,964) | (2,964) | |||
| (b) | product manufacturing and operating costs | - | - | |||
| (c) | advertising and marketing | (20) | (20) | |||
| (d) | leased assets | - | - | |||
| (e) | staff costs | (978) | (978) | |||
| (f) | administration and corporate costs | (378) | (378) | |||
| 1.3 | Dividends received (see note 3) | - | - | |||
| 1.4 | Interest received | 10 | 10 | |||
| 1.5 | Interest and other costs of finance paid | - | - | |||
| 1.6 | Income taxes paid | - | - | |||
| 1.7 | Government grants and tax incentives | - | - | |||
| 1.8 | Other (provide details if material) | - | - | |||
| 1.9 | Net cash from / (used in) operating activities | (4,330) | (4,330) |
| + See chapter 19 for defined terms | ||
| 1 September 2016 | Page 1 |
Quarterly 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. | Cash flows from investing activities | |||||
| 2.1 | Payments to acquire: | |||||
| (a) | property, plant and equipment | - | - | |||
| (b) | businesses (see item 10) | - | - | |||
| (c) | investments | - | - | |||
| (d) | intellectual property | - | - | |||
| (e) | other non-current assets | - | - | |||
| 2.2 | Proceeds from disposal of: | |||||
| (a) | property, plant and equipment | - | - | |||
| (b) | businesses (see item 10) | - | - | |||
| (c) | investments | - | - | |||
| (d) | intellectual property | - | - | |||
| (e) | 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 | - | - |
| Current quarter | Year to date (3 months) | ||||
| Consolidated statement of cash flows | $A'000 | $A'000 | |||
| 3. | Cash flows from financing activities | ||||
| 3.1 | Proceeds from issues of shares | 278 | 278 | ||
| 3.2 | Proceeds from issue of convertible notes | - | - | ||
| 3.3 | Proceeds from exercise of share options | - | - | ||
| 3.4 | Transaction costs related to issues of shares, convertible notes or options | (12) | (12) | ||
| 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 (receipt of funds upon expiry of term deposit towards rental guarantee) | - | - | ||
| 3.10 | Net cash from / (used in) financing activities | 266 | 266 |
| + See chapter 19 for defined terms | ||
| 1 September 2016 | Page 2 |
Quarterly 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. | Net increase / (decrease) in cash and cash equivalents for the period | ||||
| 4.1 | Cash and cash equivalents at beginning of quarter/year to date | 14,400 | 14,400 | ||
| 4.2 | Net cash from / (used in) operating activities (item 1.9 above) | (4,330) | (4,330) | ||
| 4.3 | Net cash from / (used in) investing activities (item 2.6 above) | - | - | ||
| 4.4 | Net cash from / (used in) financing activities (item 3.10 above) | 266 | 266 | ||
| 4.5 | Effect of movement in exchange rates on cash held | 357 | 357 | ||
| 4.6 | Cash and cash equivalents at end of quarter | 10,693 | 10,693 |
| 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 | 8,688 | 11,388 | ||
| 5.2 | Call deposits | 2,005 | 3,012 | ||
| 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) | 10,693 | 14,400 |
| 6. | Payments to directors of the entity and their associates | Current quarter $A'000 | |
| 6.1 | Aggregate amount of payments to these parties included in item 1.2 | 182 | |
| 6.2 | Aggregate amount of cash flow from loans to these parties included in item 2.3 | - | |
| 6.3 | Include below any explanation necessary to understand the transactions included in items 6.1 and 6.2 |
| + See chapter 19 for defined terms | ||
| 1 September 2016 | Page 3 |
Quarterly report for entities subject
to Listing Rule 4.7B
| 7. | Payments to related entities of the entity and their associates | Current quarter $A'000 | |
| 7.1 | Aggregate amount of payments to these parties included in item 1.2 | - | |
| Aggregate amount of cash flow from loans to these parties included in item 2.3 | - | ||
| 7.3 | Include below any explanation necessary to understand the transactions included in items 7.1 and 7.2 |
| 8. | Financing facilities available Add notes as necessary for an understanding of the position | Total facility amount at quarter end $A'000 | Amount drawn at quarter end $A'000 | ||
| 8.1 | Loan facilities | - | - | ||
| 8.2 | Credit standby arrangements | - | - | ||
| 8.3 | Other (please specify) | - | - | ||
| 8.4 | Include below a description of each facility above, including the lender, interest rate and whether it is secured or unsecured. If any additional facilities have been entered into or are proposed to be entered into after quarter end, include details of those facilities as well. |
| 9. | Estimated cash outflows for next quarter | $A'000 | |
| 9.1 | Research and development | 3,000 | |
| 9.2 | Product manufacturing and operating costs | - | |
| 9.3 | advertising and marketing | 40 | |
| 9.4 | Leased assets | - | |
| 9.5 | Staff costs | 1,000 | |
| 9.6 | Administration and corporate costs | 600 | |
| 9.7 | Other (provide details if material) | - | |
| 9.8 | Total estimated cash outflows | 4,640 |
| + See chapter 19 for defined terms | ||
| 1 September 2016 | Page 4 |
Quarterly report for entities subject
to Listing Rule 4.7B
| 10. | Acquisitions and disposals of business entities (items 2.1(b) and 2.2(b) above) | Acquisitions | Disposals | ||
| 10.1 | Name of entity | - | - | ||
| 10.2 | Place of incorporation or registration | - | - | ||
| 10.3 | Consideration for acquisition or disposal | - | - | ||
| 10.4 | Total net assets | - | - | ||
| 10.5 | Nature of business | - | - |
Compliance statement
| Sign here: | |||
| Company Secretary | Date: 30 October 2019 | ||
| Print name: | Phillip Hains |
| + See chapter 19 for defined terms | ||
| 1 September 2016 | Page 5 |