Happy NewYear everyone! A new year, century, but most of all -...

Happy NewYear everyone! A new year, century, but most of all - opportunity.

There is somuch potential in this stock this year, with multiple events to take place(that we know of), other events (over) due and many more possibilities on thecards.

A brief summary below. Please feel free to add to it

The 3confirmed II’s:

P2 trialsto commence for:

· Critical limb ischemia (US $1.4bn market opportunity),expected to commence in early 2020

· Osteoarthritis (US $11.6bn market opportunity),one of the largest MSC trials yet and by far THE largest iPSC trial (448patients), led by the University of Sydney and substantially funded by theNHMRC – with full commercial rights retained by Cynata, expected to commence inQ1 CY2020
- A perfect opportunity to showcase the Cymerus next generation MSC manufacturingcapability

· Graft vs. Host Disease (US $0.3bn), with costs fully borneby our Japanese partner FujiFilm, expected to commence before the end of 2020

Thepossibilities:

Pre-Clinicaltest completed and P2 ready:

· Heart Attack (US $18.2bn market opportunity):
“Dr Kilian Kelly, Cynata’s Vice President, Product Development, said: ‘These very encouraging results add to a growing body of evidence showing that Cymerus MSCs may have an important role to play in the treatment of a wide range of diseases. There is still a huge unmet medical need associated with heart attacks, which cause over 8,000 deaths and more than 50,000 hospitalisations each year in Australia alone. We are optimistic about the potential benefits that Cymerus MSCs could bring to patients who experience these life-changing events.’”
http://files.cynata.com/364/18.07.31.Cymerus-MSCs-improve-cardiac-recovery-in-preclinical-study.pdf

· Brain Cancer/Glioblastoma (US $3.3bn market opportunity by2024):
“Professor Shah commented, ‘Our results validate the use of this cell-based approach, as it provides a continuous pool of therapeutic protein around the tumour cells, circumventing the protein short half-lives. Overall, the study outcomes support the use of engineered Cymerus MSCs for cell therapy to target various malignancies.’”
http://files.cynata.com/386/18.10.18.MSCs-Demonstrate-Anti-Cancer-Effects-in-Pre-Clinical-Studies.pdf

· Diabetic Wounds (US $4.9bn market opportunity by2024):
“Dr Leanna Read, CTM CRC’s Chair and CEO, said, ‘Rapid wound closure reduces the risk of infection and wound management costs, and improves health outcomes for patients. Our studies show that delivery of Cymerus MSCs via CTM CRC’s proprietary polymer-coated dressing can accelerate reepithelialisation and wound closure when compared to the dressing alone or treatment with commercially produced bone marrow-derived MSCs. We need only a small number of MSCs to seed the dressing, so we expect that this product could be produced at a low cost and positioned very competitively against existing treatment options.’”
http://files.cynata.com/348/18.05.31.Cynatas-MSCs-Effective-in-Model-of-Diabetic-Wounds.pdf

· Cytokine Release Syndrome (market opportunity TBD):
“Dr Kilian Kelly, Cynata’s Vice President, Product Development, said, ‘Cancer immunotherapy is one of the most exciting fields in medicine today, offering a potentially curative treatment option to patients with otherwise intractable and advanced disease. However, CRS is a common, unpredictable and potentially fatal complication that may limit treatment uptake. These results suggest that administering a single dose of Cymerus MSCs before, during or even shortly after cancer immunotherapy treatment may provide significant therapeutic benefit and a straightforward way of limiting adverse CRS reactions. We look forward to continuing to explore the benefits of our MSCs in humans through partnerships with companies commercialising cancer immunotherapies, such as CART.’”
http://files.cynata.com/374/18.09.19.Cynata-MSCs-Ameliorate-CRS-in-Preclinical-Study.pdf

· Asthma (US $25.6bn market opportunity by 2024):
Standalone treatment – “‘The combination of Cymerus MSCs and dexamethasone resulted in maximal improvement for each endpoint measured. Hence, it can be concluded that such a combination therapy has the potential to improve treatment outcomes in asthmatic patients,’ said Associate Professor Samuel.
[…]
Dr Kilian Kelly, Cynata’s Vice President, Product Development commented: ‘These findings further strengthen the body of evidence supporting the use of Cymerus MSCs as a potential asthma treatment. In addition to confirming that Cymerus MSCs had a greater effect than corticosteroid treatment on several key manifestations of asthma in this model, these results provide clear evidence that Cymerus MSCs can work in synergy with corticosteroids. Overall, the resultssuggest that Cymerus MSCs could be used as a standalone treatment, for example in patients who are unable to tolerate corticosteroids, or as an add-on therapy in patients who are unable to gain control of their condition with existing medications’.”
http://files.cynata.com/307/17.12.11.Final-Preclinical-Asthma-Study-Confirms-Efficacy.pdf
Combo treatment – “Results suggest that the combination of Cymerus MSCs with corticosteroids may be a viable treatment option offering the potential of superior asthma control”
http://files.cynata.com/463/19.02.25.Further-Cynata-Asthma-Study-Published.pdf

· Organ Transplant Rejection (market opportunity TBD):
“Dr Khan commented, ‘We are very excited by these results. Based on our findings, we believe that a clinical trial of Cymerus MSCs is warranted, as a potential option for immunosuppression in organ transplant recipients.’”
http://files.cynata.com/506/19.09.04.Cynata-transplant-rejection-study-accepted-for-publication.pdf

· Sepsis (US $5.9bn market opportunity by 2026):
“Professor Curley said, ‘There is a critical need for new therapies to treat sepsis, which is a devastating condition that can affect people at any stage of life without warning. These exciting results give us grounds for optimism that Cymerus MSCs could provide a new treatment option for these patients.’”
http://files.cynata.com/541/19.12.05.Cymerus-MSCs-Effective-in-Preclinical-Model-of-Sepsis.pdf

(see CynataASX announcement dated 01 November 2018 for more details
http://files.cynata.com/390/18.11.01.Cynata-Outlook-and-Investor-Presentation.pdf)

Pre-Clinical tests with possible positive outcomes:

· Coronary Artery Disease, with an Australian GovernmentGrant awarded to progress the development:
“The additional project, which is expected to complete by the end of 2020, seeks to build on the previous findings by profiling the pro-angiogenic factors released from the primed MSCs, establish the ability of primed cells to promote new blood vessel formation in vivo, followed by in vivo safety and efficacy in a preclinical model.”
http://files.cynata.com/527/19.10.28.Cynata-Awarded-Grant-for-Coronary-Artery-Disease-Study.pdf

· Acute Respiratory Distress Syndrome, funded by a group of bodiesincluding the Queensland State Government:
“’We are very optimistic about the potential benefit that MSC therapy can bring to these critically ill patients, and this study in combination with ECMO is a crucial step towards clinical trials. We are delighted that Cynata has joined this collaborative project. Their manufacturing process has the potential to overcome some of the challenges that we have previously identified with donor-derived MSCs,4 including batch to batch inconsistency and problems with scalability, so we look forward to evaluating their cells in our model’, said Professor Fraser.”
http://files.cynata.com/260/17.04.11.CYP-in-Collaboration-on-Acute-Respiratory-Distress-Syndrome.pdf

· Brain Cancer / Glioblastoma:
“Further engineered MSC pipeline developments in planning stage”
http://files.cynata.com/528/19.10.30.Cynata-Corporate-Presentation.pdf

· Industriallyscalable biomaterials that facilitate the expansion and delivery of MSCs, withfunding received under Victorian Medical Research Accelerator Fund:
http://files.cynata.com/467/19.03.11.Joint-Study-of-Cynata-MSCs-Receives-VMRAF-Funding.pdf

Possibleupdates:

· FDAinteraction:
“FDA Meeting Provides Clear Path for Cynata US Development Plans”
http://files.cynata.com/282/17.07.05.FDA-Meeting-Provides-Clear-Path-for-US-Development-Plans.pdf

· HealthCanada:
“Health Canada Meeting Advances Cynata’s Global Development Plans”
http://files.cynata.com/289/17.08.31.Health-Canada-Meeting-Advances-CYP-Global-Development-Plans.pdf

· Although reading it in almost every single announcement, it feels like we are closer than ever to our second and this time more lucrative deal, or even another takeover approach (just remember to offer a fair price this time )
“Cynata continues to focus on early commercialisation of Cynata’s Cymerus MSC products, and is in active commercial discussions for numerous therapeutic targets”
http://files.cynata.com/539/19.11.27.Cynata-AGM-Presentation.pdf