An Australian stem cell and regenerative medicine company

October 06, 2016

World first for allogeneic iPSC-derived cell therapy: Cynata gains clinical trial approval from UK regulatory authority

Melbourne, Australia; 19 September 2016: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP) has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with its Phase 1 clinical

September 05, 2016

Cynata and FUJIFILM Sign Non-binding Development and Commercialisation Term Sheet

Melbourne, Australia; 5 September 2016: Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX: CYP), announced the execution of a term sheet with FUJIFILM Corporation of Japan for the development and commercialisation of certain Cynata technology, including Cynata’s lead induced pluripotent stem cell (iPSC) derived therapeutic mesenchymal stem cell (MSC) product, CYP-001. Pursuant to the term sheet, the parties will work together to seek to finalise a definitive agreement. If the parties enter into a definitive agreement, Cynata expects it to be finalised in the fourth quarter of 2016.

July 14, 2016

Interview with non-executive Director Dr Paul Wotton

This is an exclusive interview with Dr. Paul Wotton, who joined Cynata Therapeutics Board of Directors in June, 2016.  He was previously President and CEO of Ocata Therapeutics, Inc. (NASDAQ: OCAT) joining the company in July 2014 and managing it through an all-cash take-over by Atellas Pharma valued at $379 million.

http://www.bioinformant.com

May 08, 2016

Sistemic Ltd. and Cynata Therapeutics Limited

Sistemic Ltd. and Cynata Therapeutics Limited (ASX:CYP) announced today that they have entered into an agreement which will see Sistemic use its novel SistemQC™ miRNA technology platforms, together with its extensive internal databases of cellular products to develop an in-process assessment assay for Cynata’s unique Cymerus™ Cell Therapy (CT) products.

This follows an extensive period of feasibility assessment where Cynata evaluated the Sistemic technology portfolio and approach.

The development of CT products represents a major breakthrough in the potential to treat a wide range of diseases which are currently untreatable. Nevertheless, the sector has many challenges, not least in terms of standardisation and scale-up. The combination of Sistemic’s predictive miRNA technology, with the standardised and highly scalable technology from Cynata, presents a potential winning combination and paves the way for rapid industrialisation of a wide range of CT products which could revolutionise the way a wide range of diseases are treated.

Full release available here 

February 01, 2016

MHRA Favorable Advice Received; Proceeding to Clinical Testing

Cynata Therapeutics Limited

CYP-AU: Price: A$0.30; Market Cap (MM): A$22

Rating: Buy; Price Target: A$1.00

Raghuram Selvaraju, Ph.D., Senior Biotechnology Analyst

MHRA Favorable Advice Received; Proceeding to Clinical Testing

Click here for complete report and disclosures

Regulatory path cleared for initiation of clinical testing. Yesterday, Cynata announced that it had received favorable advice from the Medicines and Healthcare Products Regulatory Agency (MHRA), the principal healthcare regulatory body in the United Kingdom (i.e., the U.K. equivalent of the U.S. FDA), to move ahead with clinical testing of a candidate based on the firm's proprietary Cymerus technology platform. Cynata aims to initiate a Phase 1 clinical study in graft-vs.-host disease (GvHD) in 2Q 2016. The firm expects to obtain additional regulatory clearances in other jurisdictions in the coming months, so as to broaden the number of territories in which patients can be enrolled. In the wake of the favorable notice from the MHRA, we reiterate our Buy rating and 12-month price target of A$1.00 per share on Cynata.

Potential groundbreaking clinical program in stem cell therapy. We note that the Cymerus(tm) platform constitutes the world's only allogeneic inducible pluripotent stem cell (iPSC)-derived therapeutic technology. This approach permits the generation of a potentially infinite number of mesenchymal stem cells (MSCs) for deployment in a wide array of therapeutic contexts. We note that the favorable data generated by other MSC-producing companies in GvHD and the approved status of at least one MSC-derived product, Prochymal(r), in Canada and New Zealand for this indication bode reasonably positively for Cynata's clinical development program in this area.

Capital-efficient business model. In our view, Cynata possesses a cost-effective approach to the development of its stem cell platform, choosing to position itself as a manufacturing portal rather than simply a drug developer. The company is planning to conduct relatively capital-efficient proof-of-concept clinical studies to establish the validity of its stem cell production platform, then partner with more established companies for therapeutics development.

Valuation methodology and risks. We have employed a discounted cash flow (DCF)-based approach that assigns a value of ~A$81M to Cynata's technology platform, based only on collaborations focusing on the cardiology, regenerative medicine and oncology domains. Our valuation translates into a price of A$1.00 per share, taking into account roughly A$12M in cash and 90M fully-diluted shares outstanding as of end-2016. Risks that could impede achievement of our price target include, but are not limited to: (i) delays in regulatory clearances for and enrollment in clinical trials; (ii) inability of Cynata to consummate partnerships validating the value of its technology platform; and (iii) adverse results from clinical studies with Cynata's candidates.

Raghuram Selvaraju, Ph.D., Senior Biotechnology Analyst

212-916-3966

rselvaraju@rodm.com