TALI DIGITAL LIMITED ASX Announcement | 31 January 2022 |
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ASX Release
TALi PRODUCT AND CLINICAL PROGRAM, INTERNATIONAL DISCUSSIONS,
APPENDIX 4C
HIGHLIGHTS
- U.S. Clinical Development Phase, part of Akili license agreement, on schedule
- First co-development payment from Akili expected next quarter (Q3 FY22)
- Marketing activities in India recommenced after COVID-driven delay
- International discussions on additional agreements continued
- Key management roles filled, and new board member added, strengthening capabilities
- Digital health and digital therapeutics (DTx) markets growing, according to report
TALi Digital Ltd (ASX: TD1, "TALi" or "the Company"), a leading global digital health business is pleased to provide the following quarterly activities report, together with its Appendix 4C for the quarter ended 31 December 2021 (Q2 FY2022).
COMMERCIALISATION AND OPERATIONS UPDATE
US Market - Akili Partnership1
TALi executed a Strategic Licensing Agreement with Akili, a global peer in the digital therapeutics segment, in Q1 FY22. The agreement will see TALi, in partnership with Akili, bring to market a digital therapeutic for the treatment of ADHD in early childhood in the United States.
The first stage of this Agreement, a program of Clinical Development, was initiated and is on-schedule. TALi expects to receive the first co-development payment from Akili during the coming quarter (Q3 FY22), per the terms of the Agreement.
TALi expects to receive approximately AUD $250,000 in co-development payments from Akili during FY22 and Q1 FY23 as part of this Clinical Development phase, leading to a submission to the U.S. Food and Drug Administration (FDA) seeking approval to market the solution in FY23.
A payment of USD $2 million is payable to TALi on receipt of FDA approval, anticipated during FY23.
1 May be subject to change based on clinical development program endpoints, partner product requirements, US regulator advice, force majeure and other unforeseen events
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ASX Announcement | 31 January 2022 |
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The Akili agreement is transformational and highly strategic for TALi and is estimated to represent AU$51 million (US$37.5 million) in total future contingent milestone payments plus royalties on potential revenues.
India - Times of India Partnership
In Q2 FY21 TALi announced an investment agreement and an advertising agreement with Brand Capital International (BCI), the strategic investment arm of Bennett, Coleman and Company Ltd (The Times Group) to bring the TALi technology to consumers in India.
The initial rollout was impacted by the surge of COVID-19 India encountered in late FY21. Approximately US$1.37 million of the US$2.0 million pre-paid advertising credits with our advertising partner, The Times Group of India, remains for use in this market.
In Q2 FY22, TALi and the Times of India recommenced formal marketing activities. In December 2021, TALi appointed a new Head of Marketing (see below) whose responsibilities will include maximising the value of this key relationship.
International
TALi also continued to engage with potential partners to enable development and deployment of the TALi technology into more jurisdictions. These mainly focused on the Asia-Pacific region. However, TALi has also commenced initial market research and resource allocation to the UK/Europe.
Market Growth
According to a report by market intelligence firm CB Insights: "Digital health investment around the world hit an all-time high of USD$57.2 billion in funding in 2021, fueled by the growing need to provide digital solutions and delivery models to patients during the pandemic. The record-breaking funding marks a 79% jump from the USD$32 billion raised globally in 2020. That record amount was raised in 2,930 deals, compared to 2,518 deals in 20202".
2 https://www.fiercehealthcare.com/digital-health/digital-health-startups-around-world-raked-57-2b-2021-up-79-from-2020
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ASX Announcement | 31 January 2022 |
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The report continues: "Digital therapeutics and mental health startups both had banner years in 2021, raking in sky-high funding. Digital therapeutics (DTx) start-ups secured a record-breaking USD$3.4 billion across 122 deals in 2021, up 133% from the prior year. DTx enables the treatment of chronic conditions at scale and is demonstrating improved patient outcomes in clinical trials. This is driving investor interest in the technology's future".
Personnel
A number of roles were filled during the quarter:
- New Board member: Mr David Williams, a former senior executive with Cochlear Limited, joined the Board as a Non-Executive Director (see announcement dated 15th December 2021).
- New Advisory Board member: Ms Sara Pantzer former Head, Gov't Relations and Policy for Amgen and Associate Director, Policy at Merck.
- Senior management roles:
- VP, Engineering, Simon Bond (Ex Director, Ballarat Health)
-
Director of Product Marketing, Rehana Nathwani (ex ResMed) o Head of Digital Marketing, Matthew Shaw (ex ResMed)
o Investor and Public Relations Manager, Mr Paul McKeon (ex ResMed, Intel)
In combination with the recruitment of Mary Colt to the leadership team (see announcement dated 29th October 2021) these additions continue to build resource capability in TALi.
FINANCE UPDATE
COVID-19 impact statement
As per previous quarterly reports the Company confirms that the COVID-19 pandemic has had a material impact on the commercialisation activities of the Company. As examples, the severe COVID-19 crisis in India delayed the launch of TALi with our in market partner the Times Group and the interim shift to home-schooling on a global basis restricted marketing and sales opportunities in that segment.
The Company has sought to proactively manage the financial and operational impacts on the businesses during the COVID-19 pandemic and welcomes the changing health and economic environments in key markets for the Company.
Outlook - a year of milestones ahead
The Company recognises revenues during quarter appear on the surface as disappointing. However, this was primarily driven by a shift to the marketing approach in India and Australia by the new TALi management team. Improvements in the macro environment in India and Australia combined with deployment of targeted marketing initiatives under the guidance of the new management group show promise, with indicators in January pointing towards improved quarterly metrics for the Company.
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This targeted marketing approach combined with the sharp focus by the Company on delivering to the development milestones under the agreement with Akili, should see forecast significant milestone payments and sales to TALi in forward quarters.
TALi reported a net operating cash outflow for Q2 FY22 of $1.18 million, an increase from the net operating cash outflows of $0.49 million in the prior quarter (Q1 FY22) which included an inflow of $0.8 million from the receipt of the FY21 R&D tax incentive.
TALi reported an overall net outflow of $0.97 million, aided by the receipt of $0.30 million from Tranche 1 of the Victorian Government non-dilutive R&D tax financing facility.
As at 31 December 2021, TALi had a closing cash balance of $1.28 million, and expects to receive up to a further $0.20 million of cash inflows via Tranche 2 of the non-dilutive financing facility with the Victoria Government during Q3 FY22.
In accordance with Listing Rule 4.7C, payments made to related parties and their associates included in item 6.1 of the Appendix 4C ($105,270) includes Director fees and salary (including superannuation) for the CEO and Managing Director and related parties.
The Company looks forward to providing the market further updates on commercialisation activities of the Company as appropriate and in future quarterly activities reports.
Release authorised by: | |
The Board of TALi Digital Limited | |
CONTACT | |
Corporate | Investors |
Glenn Smith | Paul McKeon |
Managing Director | Investor Relations Manager |
TALi Digital | TALi Digital |
1300 082 013 | 1300 082 013 |
investors@talidigital.com | investors@talidigital.com |
About TALi Digital |
TALi [TALi Digital Limited (ASX: TD1)] is a digital health company delivering diagnostic and therapeutic solutions to enhance cognitive function and behaviour. The Company has built a patented platform technology with our first solution targeting cognitive attention skills during early childhood via the evidence and game-based screening (DETECT®) and training (TRAIN®) modules. This program is complementary to existing diagnosis and therapy and places TALi at the forefront of patient experience and early intervention for attention related conditions. We believe in healthy, happier minds - they start here with TALi.
A continuous innovation focus will see the Company deliver a series of product developments in ADHD (Attention Deficit Hyperactivity Disorder) and ASD (Autism Spectrum Disorder) along with a core research program exploring applications for at populations afflicted with Mild Cognitive Decline (MCI has been found to often been a precursor to recognizing Alzheimer's disease and other forms of dementia). At TALi, our vision is to deliver a personalised digital experience to enhance cognitive care. Learn more at talidigtial.com.
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ASX Announcement | 31 January 2022 |
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Appendix 4C
Quarterly cash flow report for entities
subject to Listing Rule 4.7B
Name of entity
TALi DIGITAL LIMITED
ABN | Quarter ended ("current quarter") |
53 108 150 750 | 31 December 2021 |
Consolidated statement of cash flows | Current quarter | Year to date | ||
$A'000 | (6 months) | |||
$A'000 | ||||
1. | Cash flows from operating activities | |||
1.1 | Receipts from customers | 3 | 7 | |
1.2 | Payments for | |||
(a) | research and development | (71) | (100) | |
(b) product manufacturing and operating | - | - | ||
costs | ||||
(c) | advertising and marketing | (51) | (107) | |
(d) | leased assets | - | - | |
(e) | staff costs | (640) | (1,356) | |
(f) administration and corporate costs | (414) | (903) | ||
1.3 | Dividends received (see note 3) | - | - | |
1.4 | Interest received | - | - | |
1.5 | Interest and other costs of finance paid | (3) | (6) | |
1.6 | Income taxes paid | - | - | |
1.7 | Government grants and tax incentives | - | 796 | |
1.8 | Other (provide details if material) | - | - | |
1.9 | Net cash from / (used in) operating | (1,176) | (1,669) | |
activities | ||||
2. | Cash flows from investing activities | |||
2.1 | Payments to acquire or for: | |||
(a) | entities | - | - | |
(b) | businesses | - | - | |
(c) property, plant and equipment | (7) | (11) |
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Tali Digital Ltd. published this content on 31 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 31 January 2022 07:48:06 UTC.
