Cynata Therapeutics’ (ASX:CYP) March quarterly report highlights progress on clinical trials, capital raising - Kalkine Media

Highlights

• Cynata Therapeutics added new sites for its ongoing diabetic foot ulcer trial during the March 2023 quarter
• IRB and ethics committee approval for the Phase 2 acute graft-versus-host disease clinical trial has been received
• Capital raising completed (subsequent to the quarter) to provide support for the company's clinical trial programs and working capital

Clinical-stage stem cell company Cynata Therapeutics Limited (ASX: CYP) recently released its quarterly activities report for the period ended 31 March 2023. Cynata continues to develop its proprietary Cymerus™ stem cell based therapies, and notably during the reported quarter, advanced on multiple fronts including the ongoing clinical trials in osteoarthritis and diabetic foot ulcers (DFU).

Cynata Therapeutics also completed a capital raising subsequent to the reported quarter, which strengthens its balance sheet and provides funds for a planned Phase 2 clinical trial in acute graft-versus-host disease (aGvHD). Below are the major takeaways from CYP's report.

Diabetic Foot Ulcer (DFU) clinical trial

The company recently announced positive preliminary data from the first six patients in the ongoing trial. Average ulcer size reduced at a faster rate in all the three patients who had received the mesenchymal stem cell (MSC) product code-named CYP-006TK as compared to those who were given standard of care (SoC). The initial data has been encouraging and demonstrates the safety and efficacy profile of the unique topical MSC product in chronic wounds. Read more.

Source: Company update

Notably, Cynata is seeking to enroll 30 patients for the DFU trial. Recruitment into the trial was enhanced during the March quarter with the addition of three new clinical sites, which will help drive patient enrolment and achieve the release of headline data by the end of this year. The new sites are Royal Perth Hospital (a manufacturing process has also been established here to produce CYP-006TK), Fiona Stanley Hospital, and Sir Charles Gairdner Hospital.

Acute graft-versus-host disease (aGvHD) Phase 2

The company received a green light from an Institutional Research Board service provider (based in the US) and from the Australian Human Research Ethics Committee. This development enables Cynata to move forward with its aGvHD clinical trial (Phase 2) plans in the relevant territories. The goal is to recruit 60 patients globally with reach spanning the US, Europe, and Australia. Notably, the Company’s earlier Phase 1 in aGvHD was very successful, achieving all safety and efficacy endpoints, and CYP is hopeful that Phase 2 clinical trial (expected to begin in H1 2023) will build on this solid foundation.

New renal transplantation trial

Cynata has partnered with Leiden University Medical Centre (LUMC), with the latter providing funds for the proposed renal transplantation clinical trial (Phase 1) and the former providing Cymerus™ MSCs. Cynata retains full commercial rights under the arrangement. The trial looks to recruit 10 patients and the expected start date is mid-2023, with Cynata and LUMC presently working towards getting the requisite customary regulatory, ethics and administrative approvals.

Osteoarthritis trial

Cynata has partnered with the University of Sydney for a Phase 3 clinical trial, called the SCUlpTOR trial (structure-modifying treatment for medial tibiofemoral osteoarthritis) -- centered on patients with knee osteoarthritis. The trial seeks to recruit around 440 patients and, during the March quarter, the focus was on continued patient recruitment and treatment. This would make the trial the biggest randomized, placebo controlled trials of MSCs in osteoarthritis patients in the world. More than half of this target has been achieved and full patient recruitment is expected by the end of 2023. Initial data readout is likely to occur in late 2025.

It is pertinent to note that the trial is funded through an Australian Government National Health and Medical Research Council project grant, representing outstanding leverage for shareholders. Cynata Therapeutics holds full commercial rights to the trial data .

Capital Raising

CYP raised, subsequent to the reported quarter, AU$5 million through a share placement, and closed a share purchase plan (SPP) deriving a further AU$2 million, which was oversubscribed (Read More). The funds raised by the company would be deployed in the aGvHD clinical trial (Phase 2) and working capital.

Cynata Therapeutics had a cash balance of AU$13.5 million as at 31 March 2023. CYP shares traded at AU$0.155 (market cap over AU$28 million) on 12 May 2023.