CYNATA THERAPEUTICS LIMITED ASX ANNOUNCEMENT16 November 2021
onlyGood morning everyone and welcome to the 2021 Annual General Meeting of Cynata Therapeutics Ltd. I am Geoff Brooke, the Non-Executive Chairman, and I am joined today by Dr Ross Macdonald, the Managing Director and Chief Executive Officer of Cynata, as well as our Non-Executive Directors including Drs Paul Wotton, Stewart Washer and Darryl Maher. I would also like to acknowledge our Chief Operating Officer, Dr Kilian Kelly, Chief Medical Officer, Dr Jolanta Airey, and Company Secretary, Peter Webse, who are also present with us today.
I am delighted to address you all and provide an update on Cynata's exciting achievements over the last twelve months. Following my address, Ross and Kilian will present a more detailed overview of Cynata's clinical program and upcoming catalysts.
While the impact of COVID-19 continued to dominate headlines globally, it was encouraging to see Cynata flourish | ||
and achieve multiple clinical development milestones this year, demonstrating meaningful progress and | ||
cementing our position in the regenerative medicine sector. In what has been an exciting FY21, Cynata has | ||
useachieved many significant highlights: | ||
personal | 1. | the company has commenced and advanced recruitment in the Phase 3 osteoarthritis trial in association |
with the University of Sydney; | ||
2. | similarly commenced and expanded recruitment in its MEND trial in respiratory distress; | |
3. | received ethics approval to begin a clinical trial in patients with diabetic foot ulcers (DFU); | |
4. | signed a worldwide exclusive licence agreement with TekCyte Pty Ltd to utilise its advanced wound | |
dressing technology for the planned DFU trial; | ||
5. | and raised approximately $18.3m in capital via an institutional placement and non-renounceable | |
entitlement offer, led by a $10m cornerstone investment from renowned healthcare investor, BioScience | ||
Managers. The funds raised place the company in a strong position going forward, with a robust pipeline | ||
across multiple therapeutic targets. |
The market for mesenchymal stem cell (MSC) products continues to be highly attractive, with a growing body of evidence supporting the role of MSCs in modulating the immune system and in tissue repair and regeneration in a range of devastating diseases. We are focused on generating pre-clinical and clinical data to drive value and inform our target indications, and this year our further studies demonstrated that Cynata's proprietary Cymerus™
ForMSCs to be efficacious in preclinical rodent models of idiopathic pulmonary fibrosis and myocardial infarction ( therwise known as heart attack). Currently, Cynata's ongoing, planned and potential future clinical trials amount to a ~$46bn market opportunity, due to the broad applicability of MSCs. MSC products are now on the market in Japan and in Europe and as more MSC-based therapies approach commercialisation, concern continues to turn towards the production challenges associated with manufacturing commercially viable quantities of MSCs. This concern was amply demonstrated in recent commentary from the US FDA.
Pleasingly, Cynata's technology addresses these manufacturing challenges with the most advanced technology in the therapeutic MSC space. Through the considered strategic investment in the Cymerus™ technology, the Company is well placed to advance its clinical studies with a unique manufacturing platform that can produce essentially unlimited quantities of consistent, potent MSCs from a single donor from a single blood donation. Our distinctive technology leverages Nobel Prize winning iPSCs as a starting material which can then be developed
Cynata Therapeutics Limited
Level 3, 100 Cubitt Street, Cremorne, Victoria, 3121, Australia
PO Box 7165, Hawthorn North, Victoria 3122
- +613 7067 6940 E:info@cynata.comABN - 98 104 037 372
into virtually any cell in the human body. The Cymerus™ MSC manufacturing process actively addresses current challenges associated with conventional methods of producing MSC-based therapies that have been identified by the US FDA, including cell heterogeneity arising from a reliance on multiple donors and manufacturing quantity
onlylimits. Accordingly, Cynata's consistent and scalable MSC manufacturing process provides a unique competitive advantage, facilitating a pathway to robust commercial scale MSC production.
Further deepening our commercial relationships, we recently entered into a new strategic partnership agreement with our long-standing partner Fujifilm. Under the agreement, Cynata will be able to leverage Fujifilm's world- leading cell therapy production capabilities to provide clinical and commercial manufacturing services for the pr duction of our Cymerus™ MSCs at scale. Fujifilm's credibility as a proven cell therapy manufacturer will bring significant long-term benefits to Cynata and our shareholders, and they've demonstrated a strong commitment to the Company by agreeing to a further voluntary escrow over their shares. We have also regained the
usecommercial rights to CYP-001 in GvHD, which presents a compelling opportunity to pursue a US development strategy and conduct a Phase 2 GvHD trial in the US, which will be an exciting and very valuable late-stage addition to our growing and diverse portfolio.
Cynata is well placed to progress development across existing clinical programs and drive shareholder value, with approximately $24m in cash at the close of the most recent quarter, in addition to $5m received from Fujifilm as part of the new strategic partnership agreement subsequent to the September quarter.
As a final note, on behalf of the Board, I would like to thank all our shareholders and partners for your personalcontinued support as we advance our Cymerus™ technology to develop breakthrough cell therapy products to
treat serious and debilitating diseases. I would like to extend my gratitude to our staff for their commitment to the Company and I acknowledge that the achievements this year are a testament to our exceptional team that has managed to prudently navigate through such unforeseeable circumstances. I would finally like to thank Ross, for his leadership, which allowed us to progress our pipeline and commercial initiatives through such tumultuous times. I am confident that the team will continue to execute on our strategic priorities and kick
g als for the year ahead. I would now like to pass on to Ross and Kilian to provide a comprehensive update on Cynata's clinical development and outlook.
Dr Geoff Brooke
Cynata Chairman
CONTACTS:
ForAbout Cynata Therapeutics (ASX: CYP)
Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors.
Cynata's lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. Planning for a Phase 2 clinical trial in GvHD is presently underway. Clinical trials of Cymerus products in osteoarthritis (Phase 3) and in patients with respiratory failure are currently ongoing. In addition, Cynata has demonstrated utility of its Cymerus technology in preclinical
Cynata Therapeutics Limited
Level 3, 100 Cubitt Street, Cremorne, Victoria, 3121, Australia
PO Box 7165, Hawthorn North, Victoria 3122
- +613 7067 6940 E:info@cynata.comABN - 98 104 037 372
models of numerous diseases, including the clinical targets mentioned above, as well as asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome.
onlyC nata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service provider, Automic Group.
For usepersonal
Cynata Therapeutics Limited
Level 3, 100 Cubitt Street, Cremorne, Victoria, 3121, Australia
PO Box 7165, Hawthorn North, Victoria 3122
- +613 7067 6940 E:info@cynata.comABN - 98 104 037 372
onlyuseA Next Generation Stem Cell Therapeutics Company
ersonalAGM Presentation 16 November 2021
Important information
Summary information
This Presentation contains summary information about Cynata Therapeutics Limited and its subsidiaries (CYP) which is current at 16 November 2021. This Presentation should be read in conjunction with CYP's other periodic and continuous disclosure information lodged with the Australian Securities Exchange (ASX), which are available at www.asx.com.au.
onlyNot an offer
This Presentation is not a prospectus, product disclosure statement or other offering document under Australian law (and will not be lodged with the ASIC) or any other law. This Presentation is for information purposes only and is not an invitation or offer of securities for subscription, purchase or sale in any jurisdiction. The release, publication or distribution of this Presentation (including an electronic copy) outside Australia may be restricted by law. If you come into possession of this Presentation, you should observe such restrictions. Any non-compliance with these restrictions may contravene applicable securities laws.
N t investment advice
This Presentation does not constitute investment or financial product advice (nor tax, accounting or legal advice) or any recommendation by CYP or its advisers to acquire CYP securities. This Presentation has been prepared without taking account of any person's individual investment objectives, financial situation or useparticular needs. Before making an investment decision, prospective investors should consider the appropriateness of the information having regard to their own investment objectives, financial situation and needs and seek legal, accounting and taxation advice appropriate to their jurisdiction. CYP is not licensed to
provide financial product advice in respect of CYP securities.
Investment risk and past performance
An investment in CYP securities is subject to known and unknown risks, some of which are beyond the control of CYP and its directors. CYP does not guarantee any particular rate of return or performance of CYP. Past performance cannot be relied upon as an indicator of (and provides no guidance as to) future CYP performance including future share price performance.
ersonalFinancial data
All financial information in this Presentation is in Australian currency (A$) unless otherwise stated.
This Presentation contains historical financial information based on the Company's results for the quarter to September 2021. This information is disclosed in the 4C report lodged with ASX on 28 October 2021. Any discrepancies between totals and sums of components in tables and figures in this Presentation are due to r unding.
F rward-looking statements
This Presentation contains certain 'forward looking statements', which can generally be identified by the use of forward looking words such as 'expect', 'anticipate', 'likely', 'intend', 'should', 'could', 'may', 'predict', 'plan',
'propose', 'will', 'believe', 'forecast', 'estimate', 'target', 'outlook', 'guidance', 'potential' and other similar expressions. The forward looking statements contained in this Presentation are not guarantees or predictions of future performance and involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of CYP, its directors and management, and may involve significant elements of subjective judgment and assumptions as to future events which may or may not be correct. There can be no assurance that actual outcomes will not differ materially from these forward looking statements. A number of important factors could cause actual results or performance to differ materially from the forward looking statements. No representation or warranty, express or implied, is made as to the accuracy, likelihood of achievement or reasonableness of any forecasts, prospects, returns or statements in relation to future matters contained in this Presentation. The forward looking statements are based on information available to CYP as at the date of this Presentation. Except as required by law or regulation (including the ASX Listing Rules), CYP and its directors, officers, employees, advisers, agents and intermediaries undertake no obligation to provide any additional or updated information whether as a result of new information, future events or results or otherwise. You are strongly cautioned not to place undue reliance on forward-looking statements, particularly in light of the current economic climate and the significant volatility, uncertainty and disruption caused by the outbreak of COVID-19.
Industry and Market data
Certain market and industry data used in connection with this Presentation may have been obtained from research, surveys or studies conducted by third parties, including industry or general publications. Neither CYP nor its representatives have independently verified any such market or industry data provided by third parties or industry or general publications.
Disclaimer
To the maximum extent permitted by law, CYP and its advisers, affiliates, related bodies corporate, directors, officers, partners, employees and agents (Related Persons) exclude and disclaim all liability, including without limitation for negligence, for any expenses, losses, damages or costs arising from this Presentation or reliance on anything contained in or omitted from it. To the maximum extent permitted by law, CYP and its Related Persons make no representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this Presentation and disclaim any obligation or undertaking to release any update or revision to the information in this Presentation to reflect any change in expectations or assumptions.
Statements made in this Presentation are made only as at the date of this Presentation. The information in this Presentation remains subject to change without notice.
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