Full Press Release Details
Therapeutics Limited
year ended 31 December 2019
| Name of entity: | Alterity Therapeutics Limited |
| ABN: | 37 080 699 065 |
| Half-year ended: | 31 December 2019 |
| Previous period: | 31 December 2018 |
| Results for announcement to the market | ||||||||||||||||
| A$ | ||||||||||||||||
| Revenue from ordinary activities* | Down | 78.7 | % | to | 14,133 | |||||||||||
| Net loss after tax (from ordinary activities) for the period attributable to members | Up | 5.6 | % | to | 5,640,258 | |||||||||||
| Net loss after tax for the period attributable to members | Up | 5.6 | % | to | 5,640,258 |
| Net tangible assets per security | ||||||||
| 31 December | 31 December | |||||||
| 2019 A$ | 2018 A$ | |||||||
| Net tangible asset backing (cents per share) | 1.27 | 2.03 |
Therapeutics Limited recorded income of $14,133 for the half year ended 31 December 2019 (2018: 66,364) which is interest received
on the Group's bank accounts. Alterity Therapeutics Limited has incurred a loss of 5,640,258 for the half year ended 31
December 2019 (2018: 5,340,227).
explanation of the key financial elements contributing to the revenue and result above can be found in the review of operations
included within the directors' report.
dividends have been paid or declared by the Group for the current financial period. No dividends were paid for the previous financial
in controlled entities
have been no changes in controlled entities during the period ending 31 December 2019.
information required by Listing Rule 4.2A
interim financial statements have been reviewed by the Group's independent auditor which includes a paragraph regarding
a material uncertainty in relation to going concern.
Therapeutics Limited
the half-year 31 December 2019
| Contents | Page |
| Corporate directory | 1 |
| Directors' report | 2 |
| Consolidated statement of profit or loss and other comprehensive income | 5 |
| Consolidated statement of financial position | 6 |
| Consolidated statement of changes in equity | 7 |
| Consolidated statement of cash flows | 8 |
| Notes to the consolidated financial statements | 9 |
| Directors' declaration | 19 |
| Independent auditor's report to the members | 20 |
Therapeutics Limited
| Directors | Mr. Geoffrey Kempler |
| Chairman & CEO | |
| Mr. Brian Meltzer | |
| Independent Non-Executive Director | |
| Mr. Peter Marks | |
| Independent Non-Executive Director | |
| Mr. Lawrence Gozlan | |
| Non-Executive Director | |
| Dr. David Sinclair | |
| Non-Executive Director | |
| Mr. Tristan Edwards | |
| Non-Executive Director | |
| Secretary | Mr. Phillip Hains |
| Principal registered office in Australia | Level 3, 62 Lygon Street |
| Carlton Victoria 3053 | |
| Australia | |
| +61 3 9824 5254 | |
| Share register | Computershare Investor Services Pty Ltd |
| Yarra Falls, 452 Johnston Street | |
| Abbotsford Victoria 3067 | |
| 1300 85 05 05 (within Australia) & +61 3 9414 4000 (overseas) | |
| Auditor | PricewaterhouseCoopers |
| 2 Riverside Quay | |
| Southbank Victoria 3006 | |
| Solicitors | Quinert Rodda & Associates |
| Level 6/400 Collins St Melbourne Victoria 3000 | |
| Website | www.alteritytherapeutics.com |
Therapeutics Limited
directors present their report on the Consolidated Entity (referred to hereafter as the group) consisting of Alterity Therapeutics
Limited and the entities it controlled at the end of, or during, the half-year ended 31 December 2019.
following persons were directors of Alterity Therapeutics Limited during the whole of the half-year and up to the date of this
of operations - 31 December 2019
below is an update on the status of the Group's research and development projects and overall operations for the half-year
ended 31 December 2019.
Group's 30 June 2019 Annual Report contains detailed background information relating to its operations including its research
and development projects and collaboration partners and should be read in conjunction with this report.
Therapeutics' lead drug candidate PBT434, a novel, small molecule targeting pathological alpha-synuclein protein, achieved
significant clinical and regulatory developments over the period.
Company's Phase 1 Clinical trial found PBT434 was considered safe and well-tolerated in adult and older adult ( 65 years)
volunteers, with an adverse event profile comparable to placebo.
the results, PBT434 looks to treat neurodegenerative diseases resulting from accumulation and aggregation of alpha-synuclein protein,
such as Multiple Systems Atrophy (MSA) and Parkinson's disease (PD). By inhibiting the alpha-synuclein aggregation, PBT434
was found to preserve neurons and improve motor function in pre-clinical models of MSA and PD.
the results also indicated that PBT434 not only crosses the blood brain barrier in humans, confirming previous observations in
animal studies, but that the clinically tested doses achieve concentrations in the brain that exceed those associated with the
reported efficacy in animal models.
has presented the findings to the scientific, MSA, and PD research communities at the 2019 International Congress of Parkinson's
disease and Movement Disorders (MDS Congress), further enhancing the Company and its drug, as a potential leader in this treatment
Therapeutics Limited
of operations - 31 December 2019 (continued)
Company is already in the preparatory phase of planning its Phase 2 clinical trial of PBT434 in MSA, and will provide further
updates in the coming months.
developments over the period saw PBT434 receive a positive opinion from the Committee for Orphan Medicinal Products (COMP) on
recommending the designation of the drug for the treatment of MSA as an orphan medicinal product to the European Commission (EC).
Subsequent to the end of the period, in January 2020, the Company announced the EC had granted Orphan Drug designation. The designation
of PBT434 as an Orphan Drug by the EC entitles Alterity to ten years of market exclusivity in the European Union for the use of
PBT434 in the treatment of MSA. The designation also grants access to other benefits including assistance in developing clinical
protocols, reduced fees and access to EU-funded research grants. The designation follows granting of orphan drug status by the
US Food and Drug Administration (FDA) early in 2019.
update for Alterity's Translational Research program
Alterity research team continues to evaluate new chemical scaffolds that have potential to intercede in various disease processes.
Promising candidates arising from the Translational Research program will be tested in relevant animal models of Parkinsonian
diseases, other neurodegenerative diseases, and potential applications outside of neurodegeneration.
Therapeutics continues to pursue inbound interest for the application of PBT2 in diseases outside of neurological disease.
changes in the state of affairs
have been no significant changes in the state of affairs of the Company during the period.
since the end of the financial year
matter or circumstance has arisen since 31 December 2019 that has significantly affected the Group's operations, results
or state of affairs, or may do so in future periods.
auditor has included an "emphasis of matter" paragraph in the review report relating to our ability to continue as
a going concern (refer note 1b).
independence declaration
copy of the auditor's independence declaration as required under section 307C of the Corporations Act 2001 is set
report is made in accordance with a resolution of directors.
| /s/ Geoffrey Kempler | |
| Mr. Geoffrey Kempler | |
| Chairman & CEO | |
| Melbourne | |
| 27 February 2020 |
Independence Declaration
lead auditor for the review of Alterity Therapeutics Limited for the half-year ended 31 December 2019, I declare that to the best
of my knowledge and belief, there have been:
declaration is in respect of Alterity Therapeutics Limited and the entities it controlled during the period.
| /s/ Jon Roberts | |
| Jon Roberts | Melbourne |
| Partner | 27 February 2020 |
| PricewaterhouseCoopers |
PricewaterhouseCoopers,
Riverside Quay, SOUTHBANK VIC 3006, GPO Box 1331 MELBOURNE VIC 3001
+61 3 8603 1000, F: +61 3 8603 1999, www.pwc.com.au
limited by a scheme approved under Professional Standards Legislation.
Therapeutics Limited
statement of profit or loss and other comprehensive income
the half-year 31 December 2019
| 31 December | 31 December | |||||||||
| 2019 | 2018 | |||||||||
| Notes | A$ | A$ | ||||||||
| Income | ||||||||||
| Interest income | 6 | 14,133 | 66,364 | |||||||
| Other income | 6 | 1,855,172 | 2,426,518 | |||||||
| Expenses | ||||||||||
| Intellectual property expenses | (102,232 | ) | (82,667 | ) | ||||||
| General and administration expenses | 7 | (1,747,986 | ) | (2,031,326 | ) | |||||
| Research and development expenses | 7 | (5,747,034 | ) | (5,890,241 | ) | |||||
| Other operating expenses | (40,136 | ) | (28,162 | ) | ||||||
| Other gains/(losses) | 7 | 127,825 | 199,287 | |||||||
| Loss for the period | (5,640,258 | ) | (5,340,227 | ) | ||||||
| Loss before income tax | (5,640,258 | ) | (5,340,227 | ) | ||||||
| Income tax expense | - | - | ||||||||
| Other comprehensive loss | ||||||||||
| Other comprehensive income for the period, net of tax | - | - | ||||||||
| Total comprehensive loss for the period | (5,640,258 | ) | (5,340,227 | ) |
| Cents | Cents | |||||||||
| Loss per share for profit attributable to the ordinary equity holders of the Group: | ||||||||||
| Basic loss per share | 5 | 0.65 | 0.99 | |||||||
| Diluted loss per share | 5 | 0.65 | 0.99 |
above consolidated statement of profit or loss and other comprehensive income should be read in conjunction with the accompanying
Therapeutics Limited
statement of financial position
| 31 December | 30 June | |||||||||
| 2019 | 2019 | |||||||||
| Notes | A$ | A$ | ||||||||
| ASSETS | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 12,178,695 | 14,399,904 | ||||||||
| Trade and other receivables | 8(a) | 1,879,958 | 4,829,497 | |||||||
| Other current assets | 309,733 | 631,769 | ||||||||
| Total current assets | 14,368,386 | 19,861,170 | ||||||||
| Non-current assets | ||||||||||
| Property, plant and equipment | 117,334 | 48,748 | ||||||||
| Total non-current assets | 117,334 | 48,748 | ||||||||
| Total assets | 14,485,720 | 19,909,918 | ||||||||
| LIABILITIES | ||||||||||
| Current liabilities | ||||||||||
| Trade and other payables | 2,624,398 | 2,718,174 | ||||||||
| Provisions | 545,398 | 601,995 | ||||||||
| Other current liabilities | 70,344 | - | ||||||||
| Total current liabilities | 3,240,140 | 3,320,169 | ||||||||
| Non-current liabilities | ||||||||||
| Provisions | 37,126 | 34,976 | ||||||||
| Other non-current liabilities | 10,784 | - | ||||||||
| Total non-current liabilities | 47,910 | 34,976 | ||||||||
| Total liabilities | 3,288,050 | 3,355,145 | ||||||||
| Net assets | 11,197,670 | 16,554,773 | ||||||||
| EQUITY | ||||||||||
| Contributed equity | 9(a) | 156,922,052 | 156,632,636 | |||||||
| Reserves | 9(c) | 1,158,975 | 1,158,975 | |||||||
| Accumulated losses | 9(b) | (146,883,357 | ) | (141,236,838 | ) | |||||
| Total equity | 11,197,670 | 16,554,773 |
above consolidated statement of financial position should be read in conjunction with the accompanying notes.
Therapeutics Limited
statement of changes in equity
the half-year 31 December 2019
| Attributable to owners of | ||||||||||||||||||
| Alterity Therapeutics Limited | ||||||||||||||||||
| Contributed | Accumulated | |||||||||||||||||
| equity | Reserves | losses | Total | |||||||||||||||
| Notes | A$ | A$ | A$ | A$ | ||||||||||||||
| Balance at 1 July 2018 | 143,910,328 | 1,753,954 | (129,583,125 | ) | 16,081,157 | |||||||||||||
| Loss for the period | - | - | (5,340,227 | ) | (5,340,227 | ) | ||||||||||||
| Total comprehensive income for the period | - | - | (5,340,227 | ) | (5,340,227 | ) | ||||||||||||
| Transactions with owners in their capacity as owners: | ||||||||||||||||||
| Issue of ordinary shares | 9 | 166,086 | - | - | 166,086 | |||||||||||||
| Share-based payment expenses | - | 79,090 | - | 79,090 | ||||||||||||||
| Transaction costs | 9 | (63,140 | ) | - | - | (63,140 | ) | |||||||||||
| Expired options | - | (620,323 | ) | 620,323 | - | |||||||||||||
| 102,946 | (541,233 | ) | 620,323 | 182,036 | ||||||||||||||
| Balance at 31 December 2018 | 144,013,274 | 1,212,721 | (134,303,029 | ) | 10,922,966 | |||||||||||||
| Balance at 1 July 2019 | 156,632,636 | 1,158,975 | (141,236,838 | ) | 16,554,773 | |||||||||||||
| Initial adoption of AASB 16* | - | - | (6,261 | ) | (6,261 | ) | ||||||||||||
| Restated total equity at the beginning of the financial period | 156,632,636 | 1,158,975 | (141,243,099 | ) | 16,548,512 | |||||||||||||
| Loss for the period | - | - | (5,640,258 | ) | (5,640,258 | ) | ||||||||||||
| Total comprehensive income for the period | - | - | (5,640,258 | ) | (5,640,258 | ) | ||||||||||||
| Transactions with owners in their capacity as owners: | ||||||||||||||||||
| Issue of ordinary shares | 9 | 372,506 | - | - | 372,506 | |||||||||||||
| Transaction costs | 9 | (83,090 | ) | - | - | (83,090 | ) | |||||||||||
| 289,416 | - | - | 289,416 | |||||||||||||||
| Balance at 31 December 2019 | 156,922,052 | 1,158,975 | (146,883,357 | ) | 11,197,670 |
above consolidated statement of cash flows should be read in conjunction with the accompanying notes.
Therapeutics Limited
statement of cash flows
the half-year 31 December 2019
| 31 December | 31 December | |||||||||
| 2019 | 2018 | |||||||||
| Notes | A$ | A$ | ||||||||
| Cash flows from operating activities | ||||||||||
| Payments to suppliers and employees | (7,424,156 | ) | (7,290,291 | ) | ||||||
| R&D tax incentive refund | 4,824,880 | - | ||||||||
| Interest paid | (2,474 | ) | - | |||||||
| Interest received | 16,124 | 68,526 | ||||||||
| Net cash (outflow) from operating activities | 10 | (2,585,626 | ) | (7,221,765 | ) | |||||
| Cash flows from investing activities | ||||||||||
| Payments for property, plant and equipment | (7,499 | ) | (3,273 | ) | ||||||
| Net cash (outflow) from investing activities | (7,499 | ) | (3,273 | ) | ||||||
| Cash flows from financing activities | ||||||||||
| Proceeds from issues of shares and other equity securities | 372,506 | 166,086 | ||||||||
| Transaction costs relating to issue of equity | (83,090 | ) | (23,140 | ) | ||||||
| Principle elements of lease payments | (45,325 | ) | - | |||||||
| Net cash inflow from financing activities | 244,091 | 142,946 | ||||||||
| Net (decrease) in cash and cash equivalents | (2,349,034 | ) | (7,082,092 | ) | ||||||
| Cash and cash equivalents at the beginning of the financial year | 14,399,904 | 15,235,556 | ||||||||
| Effects of exchange rate changes on cash and cash equivalents | 127,825 | 229,797 | ||||||||
| Cash and cash equivalents at end of period | 12,178,695 | 8,383,261 |
above consolidated statement of cash flows should be read in conjunction with the accompanying notes.
Therapeutics Limited
to the consolidated financial statements