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 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. Announcement • Sep 18
Cynata Therapeutics Limited, Annual General Meeting, Nov 13, 2025 Cynata Therapeutics Limited, Annual General Meeting, Nov 13, 2025. 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". 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 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. 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. 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. 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.