Announcement • May 08
Cynata Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 1.5 million. Cynata Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 1.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 6,000,000
Price\Range: AUD 0.25
Discount Per Security: AUD 0.015
Transaction Features: Subsequent Direct Listing Announcement • May 04
Cynata Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 1.5 million. Cynata Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 1.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 6,000,000
Price\Range: AUD 0.25
Transaction Features: Subsequent Direct Listing Board Change • Feb 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 1 highly experienced director. MD, CEO & Director Kilian Kelly was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Dec 15
Cynata Therapeutics Limited Completes Patient Enrolment in Phase 2 aGvHD Clinical Trial Cynata Therapeutics Limited announced that patient enrolment has been completed in its Phase 2 clinical trial of CYP-001 in adults with newly diagnosed, high risk acute graft versus host disease (aGvHD). A total of 65 participants have been enrolled in the trial across numerous clinical centres in the US, Europe and Australia. Each participant was randomised to receive either steroids plus CYP-001, or steroids plus placebo. The trial involves a 100-day primary evaluation period, which is expected to conclude in March 2026, with results anticipated around June 2026. The primary endpoint is Overall Response Rate at Day 28. In a successful Phase 1 trial in patients with SR-aGvHD, 87% of patients showed an Overall Response, 53% showed a Complete Response, and 60% survival for at least two years. Importantly, there were no serious adverse events or safety concerns related to CYP-001 treatment. This ground-breaking trial led to two publications in the prestigious journal Nature Medicine. CYP-001 has been granted Orphan Drug Designation by the US FDA for the treatment of aGvHD. New Risk • Nov 25
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$8.8m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$8.8m free cash flow). Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (31% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (AU$12m net loss in 3 years). Revenue is less than US$5m (AU$1.9m revenue, or US$1.2m). Market cap is less than US$100m (AU$66.5m market cap, or US$43.0m). Announcement • Sep 18
Cynata Therapeutics Limited, Annual General Meeting, Nov 13, 2025 Cynata Therapeutics Limited, Annual General Meeting, Nov 13, 2025. New Risk • Aug 31
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 32% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (32% increase in shares outstanding). Minor Risks Less than 1 year of cash runway based on current free cash flow (-AU$8.8m). Share price has been volatile over the past 3 months (14% average weekly change). Revenue is less than US$5m (AU$1.9m revenue, or US$1.2m). Market cap is less than US$100m (AU$49.9m market cap, or US$32.6m). New Risk • Aug 29
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -AU$8.8m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Minor Risks Less than 1 year of cash runway based on current free cash flow (-AU$8.8m). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Revenue is less than US$5m (AU$2.1m revenue, or US$1.4m). Market cap is less than US$100m (AU$45.2m market cap, or US$29.5m). New Risk • Jul 18
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$538k net loss in 2 years). Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (26% increase in shares outstanding). Revenue is less than US$5m (AU$1.7m revenue, or US$1.1m). Market cap is less than US$100m (AU$41.8m market cap, or US$27.3m). Announcement • Apr 07
Cynata Therapeutics Limited Announces Positive Efficacy Data Observed in Preclinical Studies Conducted with Cymerus Ipsc1-Derived Mscs in Models of Ischaemic Heart Disease Cynata Therapeutics Limited announced positive efficacy data observed in preclinical studies conducted with Cynata's Cymerus™? iPSC-derived MSCs in models of ischaemic heart disease. MSCs have the potential to treat ischaemic heart disease, the leading cause of death worldwide, by releasing proteins and other bioactive molecules. This project evaluated a new, minimally invasive method to deliver beneficial molecules from MSCs over an extended period, using a retrievable encapsulation device. The device, which can be implanted under the skin, protects the cells while still permitting the release of molecules into the circulation. Key Highlights. In a rat model of heart attack (known as an ischaemia-reperfusion model), treatment with encapsulated Cymerus™? MSCs resulted in the following: Significantly improved heart function and a reduction in harmful structural changes in the heart, compared to controls treated with encapsulated placebo. Less heart muscle thickening, smaller scar tissue, and fewer fibrous tissue buildups. Encapsulated Cymerus MSCs were still alive and functional twelve weeks after implantation. Cymerus™? M SCs produce proteins that support tissue health, aid in healing, help to protect cells from damage, play a role in regulating the immune system and reduce inflammation. In an in vitro model of human heart tissues created and grown in a laboratory (known as "cardiac spheroids"), tissues treated with proteins from Cymerus™? Mscs showed improved survival and function compared to controls treated with placebo. Chief Investigator of the study, Associate Professor Shiang (Max) Lim (Head, Cardiac Regeneration Laboratory, St Vincent's Institute of Medical Research, Melbourne) said: This study demonstrates the utility of a clinically viable, minimally invasive method for sustained delivery of active molecules released by Cymerus™? MScs, which has the potential to address a major gap in the treatment of ischaemic heart disease". New Risk • Feb 28
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: AU$8.9m Forecast net loss in 2 years: AU$538k This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$538k net loss in 2 years). Shareholders have been diluted in the past year (25% increase in shares outstanding). Revenue is less than US$5m (AU$1.7m revenue, or US$1.1m). Market cap is less than US$100m (AU$58.6m market cap, or US$36.5m). Buy Or Sell Opportunity • Feb 14
Now 20% undervalued Over the last 90 days, the stock has risen 2.0% to AU$0.25. The fair value is estimated to be AU$0.31, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has declined by 37% over the last 3 years. Earnings per share has declined by 23%. Revenue is forecast to grow by 172% in 2 years. Earnings are forecast to grow by 79% in the next 2 years. Announcement • Jan 23
Cynata Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 8.115 million. Cynata Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 8.115 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 44,444,445
Price\Range: AUD 0.18
Discount Per Security: AUD 0.0108
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 638,886
Price\Range: AUD 0.18
Discount Per Security: AUD 0.0108
Transaction Features: Subsequent Direct Listing New Risk • Jan 05
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 25% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Shareholders have been diluted in the past year (25% increase in shares outstanding). Revenue is less than US$5m (AU$2.3m revenue, or US$1.4m). Market cap is less than US$100m (AU$52.4m market cap, or US$32.6m). Price Target Changed • Dec 18
Price target decreased by 32% to AU$0.83 Down from AU$1.22, the current price target is provided by 1 analyst. New target price is 374% above last closing price of AU$0.17. Stock is up 59% over the past year. The company is forecast to post a net loss per share of AU$0.046 next year compared to a net loss per share of AU$0.054 last year. Breakeven Date Change • Dec 18
Forecast to breakeven in 2027 The analyst covering Cynata Therapeutics expects the company to break even for the first time. New forecast suggests the company will make a profit of AU$900.0k in 2027. Average annual earnings growth of 73% is required to achieve expected profit on schedule. Announcement • Dec 06
Cynata Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 8.115 million. Cynata Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 8.115 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 44,444,445
Price\Range: AUD 0.18
Discount Per Security: AUD 0.0108
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 638,886
Price\Range: AUD 0.18
Discount Per Security: AUD 0.0108
Transaction Features: Subsequent Direct Listing Announcement • Sep 24
Cynata Therapeutics Limited, Annual General Meeting, Nov 19, 2024 Cynata Therapeutics Limited, Annual General Meeting, Nov 19, 2024. New Risk • Aug 30
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$10.0m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-AU$10.0m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$4.6m net loss in 2 years). Share price has been volatile over the past 3 months (13% average weekly change). Revenue is less than US$5m (AU$2.7m revenue, or US$1.9m). Market cap is less than US$100m (AU$36.1m market cap, or US$24.6m). Announcement • Apr 09
Cynata Therapeutics Limited Completes Patient Enrolment in CYP-006TK Diabetic Foot Ulcer Clinical Trial Cynata Therapeutics Limited announced the completion of patient enrolment in its Phase 1 clinical trial of CYP-006TK in diabetic foot ulcers (DFU). CYP-006TK is Cynata's Cymerus iPSC-derived MSC topical wound dressing product candidate, which comprises MSCs seeded onto a novel silicon dressing. Due to reduced blood flow, patients with diabetes are at risk of developing non-healing wounds on the feet/lower limbs, which are also known as DFU. In addition to causing severe pain and discomfort, DFU pose a significant risk of infection, and if therapy is unsuccessful, amputation may be necessary. In this trial, CYP-006TK is being investigated as a potential treatment to promote wound healing in patients with DFU. The pre-specified sample size has now been reached, with a total of 30 patients with DFU randomised on a 1:1 basis to receive either: (i) CYP-006TK treatment for four weeks, followed by standard of care treatment for the rest of the study; or (ii) standard of care treatment throughout the study. In accordance with the study protocol, patients will be followed for 24 weeks following treatment initiation, which means that the last patient visit in this trial is expected to occur around September 2024. Announcement • Mar 06
Cynata Therapeutics Limited Announces Updates on Phase 2 Clinical Trial of CYP-001 Cynata Therapeutics Limited confirmed that the first patient has been enrolled and treated in its Phase 2 clinical trial of CYP-001 in high-risk acute graft versus host disease (aGvHD). CYP-001 is Cynata's Cymerus™ off-the-shelf iPSC[1]-derived MSC[2] product candidate for intravenous infusion, which previously generated very encouraging safety and efficacy results in a Phase 1 clinical trial in steroid-resistant aGvHD. The US FDA has cleared an Investigational New Drug (IND) application for CYP-001 and granted the product Orphan Drug Designation[4] for the treatment of aGvHD. aGvHD is a potentially life-threatening complication of bone marrow transplants or similar procedures. It arises when immune cells in the transplant (the graft) attack the recipient's tissues (the host) as "foreign". In this trial, CYP-001 is being investigated as a potential immune modulating treatment for aGvHD. This global Phase 2 trial aims to enrol approximately 60 patients with high-risk aGvHD, who will be randomised to receive either steroids plus CYP-001, or steroids plus placebo. Additional details on the trial may be found at clinicaltrials.gov using identifier NCT05643638. The trial has been approved to commence in Australia, the USA and Turkey, and numerous clinical centres across those jurisdictions are now open for recruitment. The first patient was enrolled in the USA. New Risk • Feb 24
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -AU$12m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Minor Risks Less than 1 year of cash runway based on current free cash flow (-AU$12m). Currently unprofitable and not forecast to become profitable over next 2 years (AU$6.4m net loss in 2 years). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Revenue is less than US$5m (AU$2.4m revenue, or US$1.6m). Market cap is less than US$100m (AU$35.9m market cap, or US$23.6m). Announcement • Oct 11
Cynata Therapeutics Limited Announces Resignation of David Atkins as Director Cynata Therapeutics Limited that Dr. David Atkins has informed the Board that he will not be standing for re-election as a Director at the Company's Annual General Meeting (AGM) to be held on 13 November 2023 and accordinglywill cease to be a Director from the conclusion of the AGM. New Risk • Aug 29
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$14m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$14m free cash flow). Earnings have declined by 11% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (25% increase in shares outstanding). Revenue is less than US$5m (AU$2.0m revenue, or US$1.3m). Market cap is less than US$100m (AU$24.3m market cap, or US$15.6m). Announcement • Jan 30
Cynata Therapeutics Limited Receives IRB Approval for Proposed aGvHD Phase 2 Clinical Trial Cynata Therapeutics Limited has announced that it has received approval to commence the proposed phase 2 clinical trial in acute graft-versus-host disease (aGvHD) from Advarra Inc., a central Institutional Research Board (IRB) service provider in the USA. IRB approval is an essential step in the process of opening clinical study sites and to commencing a clinical trial in humans in the United States. Cynata is now finalising contractual and logistic arrangements with individual sites (hospitals) to prepare for patient recruitment. This follows the landmark clearance of Cynata's Investigational New Drug (IND) application in 2022 and grant of Orphan Drug Status for CYP-001. The proposed clinical trial is titled "A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase 2 Study to Investigate the Efficacy and Safety of CYP-001 in Combination with Corticosteroids vsCorticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease" and is expected to be conducted in around 60 patients at sites in the United States, Europe and Australia. Announcement • Jan 09
Cynata Therapeutics Limited Receives Notice of Acceptance from IP Australia for Novel Application of Cymerus MSCs Cynata Therapeutics Limited has announced that a Notice of Acceptance has been received from IP Australia, the intellectual property office of the Australian Government, for a patent application covering its proprietary CymerusTM mesenchymal stem cell (MSC) platform technology. The patent application entitled "Method for Treating Allergic Airways Disease (AAD)/Asthma" is wholly owned by Cynata and describes a novel method of use of Cynata's proprietary Cymerus MSC products in treating diseases of the lungs and airways. The Notice of Acceptance is sent to the applicant when IP Australia intends to issue a patent. The patent adds to the existing broad and comprehensive IP protection of the Cymerus platform and its unique ability to yield highly consistent MSCs at scale, from a single donation, to create therapeutic stem cell products. Cynata anticipates that the patent will be granted around mid-March 2023, with an expiration date of 31 August 2038. Announcement • Nov 05
LUMC to Fund New Clinical Trial of Cynata's Cymerus™ MSCs in Kidney Transplantation Cynata Therapeutics Limited announced that the LUMC is funding an important clinical trial to investigate Cynata's Cymerus™ MSCs as a treatment for renal graft rejection and to potentially reduce the requirement for anti-rejection drugs. The clinical trial, entitled the "Safety and Efficacy of iPSC-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients - the Nereid Study", will be led by Prof. Ton Rabelink, Head of the Department of Internal Medicine of LUMC and will seek to recruit 10 patients who have undergone a renal transplant. The trial is expected to commence in 2023, pending receipt of customary and relevant regulatory, ethics and administrative approvals. The clinical trial, entitled "Safety and Efficacy of iPSC-derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients – the Nereid Study", is an open label, non-randomized, non-blinded, prospective, single centre clinical phase Ib study. It will be conducted in 10 renal allograft recipients, aged 18-75 years old. The principal investigator is Dr. HS Spijker, Department of Nephrology, LUMC. Following their transplant surgery, patients will receive a drug used to treat graft rejection and two doses of Cymerus MSCs 6 and 7 weeks after transplantation followed by withdrawal of anti-rejection medication. The primary end point is safety by assessing absence of acute rejection (absence of graft loss after 6 months) after withdrawal of anti-rejection medication. Other end points include assessment of renal function at 6 months and the incidence of opportunistic infections. Announcement • Oct 17
Cynata Therapeutics Limited Receives Notice of Allowance for Australia & Canada Cymerus Patents Cynata Therapeutics Limited announced that a Notice of Acceptance has been received from IP Australia for a patent application, entitled "Colony Forming Medium and Use Thereof" covering its proprietary Cymerus mesenchymal stem cell (MSC) technology. A Notice of Allowance has also been received from the Canadian Intellectual Property Office (CIPO) in respect of the same application and also for a further patent application entitled "Pluripotent Stem Cell Assay". The patent applications are all wholly-owned by Cynata and describe important aspects of the Company's unique cell therapy manufacturing processes. The Notice of Acceptance is sent to the applicant when IP Australia (i.e. the Australian Government's patent agency) intends to issue a patent. Cynata anticipates that the Australian patent will be granted by late January 2023, with an expiration date of 14 March 2037. Similarly, the CIPO Notice of Allowance is sent to the applicant when the CIPO intends to issue a patent. The Canadian patents are expected to be granted by mid-January 2023, with an expiration date of 14 March 2037, with respect to the first application described above, and by 15 November 2037, with respect to the second application. Announcement • Oct 12
Cynata Therapeutics Limited Announces Successful Completion of Planned DSMB Review of DFU Trial Cynata Therapeutics Limited announced that an independent DSMB has successful concluded a review of Cynata's DFU clinical trial. Following the routine review, the DSMB has recommended that the clinical trial continue as planned. Undertaking a review by an independent DSMB is consistent with good clinical practice. The primary responsibilities of the DSMB are to review and evaluate the available study data for participant safety, study conduct and progress, and to make recommendations concerning the continuation, modification, or termination of the trial. The study protocol for the DFU clinical trial includes oversight by a DSMB as well as provision for an interim review, which has now been successfully completed. Key highlights: A planned Data Safety Monitoring Board (DSMB) review of Cynata's diabetic foot ulcer (DFU) clinical trial has been successfully completed; The DSMB recommends the DFU clinical trial continue unchanged; The DFU clinical trial is investigating the safety and early efficacy of Cynata's unique topical CymerusTM mesenchymal stem cell (MSC) product, CYP-006TK, in patients with DFUs; DFUs are chronic wounds on the feet of patients with diabetes (also known as diabetic wounds), potentially leading to serious infection and amputation. They represent a very significant unmet medical need affecting up to 34% of diabetes patients. Announcement • Sep 27
Cynata Therapeutics Limited, Annual General Meeting, Nov 22, 2022 Cynata Therapeutics Limited, Annual General Meeting, Nov 22, 2022. Agenda: To consider re-election of directors. Announcement • Sep 26
Cynata Therapeutics Limited Receives Grant Award to Fund Study of Cynata Mscs in Heart Disease from Australian Government National Health and Medical Research Council Cynata Therapeutics Limited announced that the Australian Government National Health and Medical Research Council (NHMRC) has awarded a grant of approximately $1 million under the NHMRC 2021 MRFF Cardiovascular Health Mission, to fund a major preclinical research project to investigate Cynata's Cymerus MSCs as a treatment for IHD. The project will be led by Dr. Shiang (Max) Lim (Head, Cardiac Regeneration Laboratory, St Vincent's Institute of Medical Research, Melbourne). It will also involve a number of other leading institutions, including the University of Adelaide, Baker Heart and Diabetes Institute, the University of South Australia, Duke-National University of Singapore Medical School, the University of Arizona, Monash University, Westmead Institute for Medical Research, and hearts4heart. Cynata will supply Cymerus MSCs at its cost to facilitate the study. The project is expected to run for a period of two years. It will involve encapsulating Cymerus MSCs in a clinical grade device which can be implanted below the skin (subcutaneously) to allow sustained delivery of the bioactive molecules released by the MSCs. Aims of the project include optimisation of the encapsulation approach, and demonstration of long-term cardiac repair in rat and sheep models of acute myocardial infarction, i.e. heart attack. If successful, it is anticipated that these studies would support progression to human clinical trials. Announcement • Aug 30
Cynata Therapeutics Limited Appoints Janine Rolfe as Independent Non-Executive Director, Effective 1 September 2022 Cynata Therapeutics Limited announced the appointment of Ms. Janine Rolfe as an independent Non-Executive Director, effective 1 September 2022. Ms. Rolfe brings to the Cynata Board over two decades' legal, governance and management experience across multiple sectors, including highly regulated industries and complex global businesses. Before recently transitioning as a professional non-executive director, Ms. Rolfe's last executive position was General Counsel & Company Secretary of Link Administration Holdings Limited (Link Group). Prior to that, Ms. Rolfe founded Company Matters Pty Limited and worked both in-house (Qantas Airways Limited) and in private practice(Mallesons Stephen Jaques, now King & Wood Mallesons), across a diverse and distinguished career. Announcement • Aug 29
Cynata Therapeutics Limited Announces Preclinical Study Showing Optimisation of CymerusTM MSCs for Coronary Artery Disease Published in Leading Peer-Reviewed Journal Cynata Therapeutics Limited announced that a paper describing the optimisation of CymerusTM mesenchymal stem cells (MSCs) for the treatment of coronary artery disease (CAD) has been published in the highly respected peer-reviewed Journal of Tissue Engineering and Regenerative Medicine. The newly published results arise from Cynata's collaboration with UNSW Sydney (the University of New South Wales). The studies were led by A/Prof Kristopher Kilian, Scientia Associate Professor at the School of Chemistry and the School of Materials Science & Engineering in the UNSW Faculty of Science. The therapeutic effects of MSCs in CAD are believed to result from secretion of bioactive molecules that stimulate the formation of new blood vessels (angiogenesis) and modulation of the immune system. A/Prof Kilian's studies demonstrated that modification of the cell culture matrix (the material on whichthe cells are grown) "primes" Cymerus MSCs and enhances their pro-angiogenic and immunomodulatory properties. These effects are expected to improve the therapeutic potential of Cymerus MSCs in the treatment of CAD and related conditions, as demonstrated by the fact that the primed cells led to an increase in the formation of new blood vessels in vitro and in vivo. Importantly, it was shown that the priming effects were maintained after the cells were cryopreserved (frozen), which would make it possible to store large batches of primed cells for clinical use. Announcement • Jul 14
Cynata Therapeutics Limited Receives Notice of Allowance from US Patent Office for Use of the Cymerus MSCs in Asthma Cynata Therapeutics Limited has announced that a Notice of Allowance has been received from the United States Patent and Trademark Office (USPTO) for a patent application covering the use of its proprietary Cymerus mesenchymal stem cell technology in treating asthma and allergic airways disease (AAD). The patent application entitled "Method for Treating Allergic Airways Disease (AAD)/Asthma" is wholly owned by Cynata. The inventors are Professor Chrishan Samuel, a Monash Biomedicine Discovery Fellow and Head of the Fibrosis Laboratory, and Dr. Simon Royce, Research Fellow, Department of Pharmacology at Monash University. The Notice of Allowance is sent to the applicant when the USPTO intends to issue a patent. The patent adds to the existing broad and comprehensive IP protection of the Cymerus manufacturing platform and its unique ability to yield highly consistent mesenchymal stem cells (MSCs) at scale, from a single donation, to create therapeutic stem cell products. Cynata anticipates that the patent will be granted around October 2022, with an expiration date of 31 August 2038. Announcement • Jun 14
Cynata Therapeutics Limited Announces the Completion of A Pre-Clinical Study That Has Provided Further Evidence in Support of the Highly Potent Anti-Inflammatory Effects of Cynata's Proprietary Cymerus MSCs Cynata Therapeutics Limited announced the completion of a pre-clinical study that has provided further evidence in support of the highly potent anti-inflammatory effects of Cynata's proprietary Cymerus MSCs. The study, conducted by Professor Chrishan Samuel, a Monash Biomedicine Discovery Fellow and Head of the Fibrosis Laboratory, Department of Pharmacology at Monash University, was in mice subjected to bleomycin (BLM)-induced pulmonaryfibrosis, which mimics features of idiopathic pulmonary fibrosis (IPF) in humans. Professor Samuel intends to submit a report of the study for publication in an appropriate scientific journal. The key findings of the study, which involved Cymerus MSC dosing, either once or once-weekly over a 2-week treatment period and comparison with saline controls (n = 6-10 per group, p values from <0.05 to <0.001), were as follows: Significantly ameliorated the BLM-induced M2 macrophage, dendritic cell and T cell influx into the airways/lungs as well as pro-inflammatory TNF-, IL-6 and IL-1 levels within the airways/lung; Significantly promoted anti-inflammatory IL-10 and IFN- levels within the airways/lung; Significantly reduced the BLM-induced pSmad2 levels and restored the BLM-induced loss of Smad7 levels within the airways/lung (without affecting pSmad3 levels); Did not affect MAP kinase levels nor CTGF, PDGF or ET-1 levels within the airway/lungs; Significantly restored or promoted the BLM-induced loss of MMP-13 and MMP-2 levels as well as the MMP-13/TIMP-1 and MMP-2/TIMP-2 balance (without affecting MMP-9 levels or theMMP-9/TIMP-1 balance); and Significantly reduced the BLM-induced interstitial collagen area, interstitial collagen area to tissue area ratio, interstitial collagen fibre density, thickness and length (without affecting interstitial collagen fibre cross-linking). Announcement • May 30
Cynata Therapeutics Limited Adds New Site for MEMD Clinical Trial Cynata Therapeutics Limited announced that St George Hospital in Sydney is now a participating site and is seeking to recruit patients in the MEND clinical trial (a pilot, open-label, randomised controlled clinical trial to investigate early efficacy of CYP-001 in adults admitted to intensive care with respiratory failure), thereby accelerating the recruitment process. The St George Hospital and Health Services is part of the South Eastern Sydney Local Health District. It is an accredited, principal teaching hospital of the University of New South Wales and, with around 550 beds, is the hospital within the Local Health District and among the leading centres for trauma and emergency management in the State. As advised in an announcement dated 29 March 2021, the MEND trial aims to recruit 24 adult patients admitted to intensive care with respiratory failure who will be randomly assigned to receive standard care or Cynata's novel CymerusTM mesenchymal stem cell (MSC) product CYP-001 plus standard care. Announcement • May 27
United States Food and Drug Administration Clears IND for Cynata Therapeutics Limited's Phase 2 Clinical Trial of CYP-001 in GvHD Cynata Therapeutics Limited announced that the United States (US) Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Cynata's Phase 2 clinical trial of CYP-001 1, Cynata's lead product, in patients with acute graft versus host disease (aGvHD). The proposed Phase 2 clinical trial will seek to recruit approximately 60 patients with high risk aGvHD, at clinical centres in a number of countries, including the US and Australia. Participants will be randomised to receive either CYP-001 or placebo, in addition to corticosteroids. The primary objective of the trial is to assess efficacy of CYP-001 in subjects with high risk aGvHD by Overall Response Rate (ORR) at Day 28. The trial is expected to commence enrolment by later this year, with results of the primary evaluation expected in early 2024. Price Target Changed • Apr 27
Price target decreased to AU$2.00 Down from AU$2.25, the current price target is provided by 1 analyst. New target price is 426% above last closing price of AU$0.38. Stock is down 39% over the past year. The company posted a net loss per share of AU$0.059 last year. Announcement • Apr 21
Cynata Therapeutics Limited Advances Clinical Trial in Diabetic Foot Ulcers Cynata Therapeutics Limited announced enrolment of initial patients in a clinical trial of CYP-006TK as a potential treatment for diabetic foot ulcers (DFU). Subjects are now being followed as planned for the 4-week treatment period out to the conclusion of the study at 24 weeks. As advised in an announcement dated 22 December 2021, the Phase I trial (protocol number CYP-DFU- P1-01) aims to recruit 30 adult patients with DFU who will be randomly assigned to receive CYP-006TK or standard care of treatment. CYP-006TK is a novel polymer-coated silicon wound dressing seeded with Cymerus mesenchymal stem cells (MSCs) to facilitate topical application to the wound. Cynata has exclusively licensed the dressing technology from leading manufacturer of innovative biomedical coatings, TekCyte Limited. Announcement • Jan 28
Cynata Therapeutics Limited Receives Decision to Grant A Patent in Japan Cynata Therapeutics Limited announced that a Decision to Grant a Patent has been received from the Japanese Patent Office (JPO) for a patent application covering its proprietary CymerusTM mesenchymal stem cell technology.The patent application entitled "Pluripotent Stem Cell Assay" is wholly-owned by Cynata. The Decision to Grant a Patent is sent to the applicant (Cynata) when the JPO intends to issue a patent. This patent joins a rapidly growing estate of issued patents covering the Cymerus technology and builds on the broad IP protection of Cynata's CymerusTM manufacturing platform and its unique ability to yield highly consistent mesenchymal stem cells (MSCs) at scale, from a single donation, to create therapeutic stem cell products. Cynata anticipates that the patent will be granted around early-March 2022, with an expiration date of 15 November 2037. The inventors named on the patent are Professor Igor Slukvin, founder, advisor and shareholder of Cynata, Ms Diana Drier and Dr Derek Hei. Announcement • Dec 23
Cynata Therapeutics Limited Commences DFU Clinical Trial Cynata Therapeutics Limited announced its clinical trial of CYP-006TK in patients with diabetic foot ulcers has commenced and is now open for patient enrolment. The Phase I trial aims to recruit 30 adult patients with DFU who will be randomly assigned to receive CYP-006TK or standard care of treatment. CYP-006TK is a novel polymer-coated silicon wound dressing seeded with CymerusTM mesenchymal stem cells to facilitate topical application to the wound. Cynata has exclusively licensed the dressing technology from leading manufacturer of innovative biomedical coatings, TekCyte Limited. The trial will take place at Royal Adelaide Hospital and The Queen Elizabeth Hospital, Adelaide, under the leadership of Professor Robert Fitridge, who is Professor of Vascular Surgery at the University of Adelaide, and Consultant Vascular Surgeon with the Central Adelaide Local Health Network. Patients will receive study treatment for a period of 4 weeks, evaluation will continue for a total of 24 weeks. The primary outcome measure in the trial will be safety, while secondary outcome measures will include wound healing, pain and quality of life at 12 and 24 weeks after treatment initiation. Cynata currently expects to complete the trial during the 2022 calendar year. Announcement • Jul 01
Cynata Therapeutics Limited Receives Approval by the Central Adelaide Local Health Network Human Research Ethics Committee to Commence A Clinical Trial Cynata Therapeutics Limited announced that it has received approval by the Central Adelaide Local Health Network Human Research Ethics Committee to commence a clinical trial of Cynata's CymerusTM mesenchymal stem cell (MSC) product in patients with diabetic foot ulcers. The investigational treatment period is 4 weeks, and each patient will be evaluated for a total of 24 weeks. The primary endpoint of the trial is safety, while secondary efficacy endpoints include the following outcome measures after 12 and 24 weeks: Percentage ulcer area change; Days to complete ulcer healing; Days to 50% ulcer healing; Percentage change in ulcer volume; Ulcer pain. The trial will take place at Royal Adelaide Hospital and The Queen Elizabeth Hospital in Adelaide, under the leadership of Professor Robert Fitridge, who is Professor of Vascular Surgery at the University of Adelaide, Head of Vascular Surgery at The Queen Elizabeth Hospital, and Consultant Vascular Surgeon with the Central Adelaide Local Health Network. Patient recruitment is expected to commence in the second half of this year, subject to the completion of customary regulatory and administrative approvals, as well as other trial start up activities, which are currently underway. Announcement • Jun 30
Cynata Therapeutics Limited Progresses Toward Clinical Trial in Diabetic Foot Ulcers Cynata Therapeutics Limited announced the appointment of leading clinical research organisation (CRO) Datapharm Australia to assist in the conduct and management of the proposed clinical trial of Cynata's Cymerus mesenchymal stem cell (MSC) product in diabetic foot ulcers. Having now made substantial progress on clinical trial design and endpoint selection as presaged in the Company's 3 June 2021 announcement, the engagement of Datapharm represents an important milestone toward commencing the trial. Commencement of the trial is subject to regulatory and ethics clearance and completion of trial start up activities, all of which are presently underway. Patient enrolment for the trial is expected to be initiated in the second half of this year. Datapharm is an Australian full-service CRO providing clinical trial management, design, site set-up, clinical monitoring, statistical services, data management, medical writing, pharmacovigilance, GCP auditing and patient recruitment services. The value of the contract with Datapharm is not considered material from a quantitative perspective. Announcement • May 24
Cynata Therapeutics Limited Announces First Patient Enrolled in Cynata Mend Clinical Trial Cynata Therapeutics Limited announced that the first patient has been enrolled in its MEND (MEseNchymal coviD-19) clinical trial. Originally designed to recruit COVID-19 patients admitted to intensive care with respiratory distress the study was expanded in late March this year to include patients in intensive care with respiratory failure resulting from causes beyond COVID-19. Key highlights: First patient with respiratory failure enrolled in Cynata's MEND clinical trial; Trial to investigate early efficacy of Cynata's CymerusTM mesenchymal stem cells (MSCs) in patients with respiratory failure, who meet the well-established criteria for Acute Respiratory Distress Syndrome (ARDS);
Respiratory failure/distress (including ARDS) is a severe and life-threatening illness, representing a major unmet medical need; Trial cements Cynata's position in the development of next generation
commercially scalable stem cell products. Announcement • Mar 03
Cynata Therapeutics Limited to Investigate New Study of the High Potency of Cymerus MSCs Cynata Therapeutics Limited announced the initiation of a new study to investigate in a pre-clinical model of lung disease the potential molecular mechanisms involved in the observed high potency of Cynata's proprietary CymerusTM mesenchymal stem cells (MSCs). The data generated in this model, which mimics features of idiopathic pulmonary fibrosis (IPF), will add to Cynata's substantial body of knowledge. The observations are expected to provide very useful information relevant to the potential mechanisms of action of Cynata's MSC products and will be important in leveraging commercial and regulatory activities. Lung diseases such as IPF represent an enormous unmet medical need, as existing treatment options have only modest effects on disease progression and survival rates. The study will be led by Professor Chrishan Samuel of the Monash Biomedicine Discovery Institute and Department of Pharmacology at Monash University in Melbourne. Professor Samuel's study is expected to commence shortly and conclude within 6 months. Is New 90 Day High Low • Feb 26
New 90-day low: AU$0.64 The company is down 21% from its price of AU$0.80 on 27 November 2020. The Australian market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 11% over the same period. Is New 90 Day High Low • Feb 01
New 90-day low: AU$0.66 The company is down 15% from its price of AU$0.78 on 03 November 2020. The Australian market is up 13% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 4.0% over the same period. Is New 90 Day High Low • Dec 11
New 90-day low: AU$0.74 The company is down 15% from its price of AU$0.88 on 11 September 2020. The Australian market is up 14% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 6.0% over the same period. Announcement • Nov 11
Cynata Therapeutics Limited Announces Phase 3 Osteoarthritis Clinical Trial Commences Cynata Therapeutics Limited announced that the Phase 3 SCUlpTOR ("Stem Cells as a symptom- and strUcture-modifying Treatment for medial tibiofemoral OsteoaRthritis") Trial of CYP-004, Cynata's CymerusTM mesenchymal stem cell (MSC) product for osteoarthritis, has now commenced. This trial is sponsored by the University of Sydney and funded by an Australian Government National Health and Medical Research Council (NHMRC) competitive Project Grant. The trial will take place at study centres in Sydney and Tasmania and subject treatment will commence with an initial four patients from the University's volunteers' database, who will be assessed for four weeks, before the study opens for enrolment more widely. As no additional volunteers are being sought at this time, patients who are interested in participating in the trial should wait until wider enrolment commences before contacting study centres, which is expected to happen early in 2021. The aim of the trial is to assess the effect of Cymerus MSCs compared to placebo on clinical outcomes and knee joint structure over a two-year period, in 440 patients with osteoarthritis of the knee. Announcement • Sep 24
Cynata Therapeutics Limited Announces Positive Efficacy Data from A Study of Cymerustm Mesenchymal Stem Cells Cynata Therapeutics Limited announced further positive efficacy data from a study of its CymerusTM mesenchymal stem cells (MSCs) in a preclinical heart attack model. In particular, treatment with Cymerus MSCs was shown to enhance the recovery of the blood supply to the damaged heart through the generation of new blood vessels. New vessel formation is accepted as an essential element of repair after the damage caused by a myocardial infarction, i.e. heart attack. Additional efficacy data from preclinical disease model on recovery of cardiac function post heart attack help to explain the previously announced superior therapeutic effects demonstrated by Cymerus MSC treatment when compared to conventional bone marrow-derived MSC treatment and placebo. The new data show that Cynata's Cymerus MSCs enhance the recovery of the blood supply to the damaged heart by: Enhancing the development of new blood capillaries (around twice as many capillaries were shown in the Cymerus MSC group versus placebo controls); Enhancing arteriogenesis (growth of arterioles: small blood vessels) - whereas bone marrow- derived MSCs did not (nearly three times as many arterioles were shown in the Cymerus MSC group versus placebo controls); Releasing higher levels of molecules known to be involved in the stimulation of new blood vessel growth (provides a rationale for the increased growth of blood vessels seen following treatment with Cymerus MSCs). This builds on the significant dataset demonstrating the potential benefits of treatment with Cynata's Cymerus MSCs and Cynata will continue to work with relevant parties to determine the next steps for this program and broader clinical development. The data arise from further studies conducted by a team led by Associate Professor James Chong (Westmead Institute for Medical Research, Sydney). As previously announced, initial studies by Associate Professor Chong's team showed that Cymerus MSC treatment improved recovery of cardiac function post heart attack compared to either placebo or bone marrow-derived MSCs (BM-MSCs). The latest results help to explain the mechanism for the superior therapeutic effects of Cymerus MSCs compared to conventional BM-MSCs and placebo in this disease model. The data from this study will be submitted for publication to a peer-reviewed medical journal. 
