2009.08.25 – JAK2 inhibitor CYT387
Preliminary Final Report
Announced by: CYT
Announced on: 25/08/2009 14:55:00
25 August 2009
Cytopia Preliminary Final Report
Cytopia Limited (ASX:CYT) today announced its audited financial results for the year to 30
June 2009, reporting operating revenue of $4.2m and an operating loss of $6.5m.
Anti-cancer Vascular Disrupting Agent (VDA) CYT997
Cytopia’s development programme accelerated during the year with the conclusion of the
company’s second Phase I clinical trial investigating the safety and tolerability of the
compound dosed orally in advanced cancer patients. Data from this study confirmed that
the drug is well absorbed following oral administration, suggesting that CYT997 has a key
advantage over most other VDAs which can only be administered intravenously. The oral
Phase I clinical study was supported in part by the company’s now expired Commercial
Ready Grant from the Commonwealth Government.
The company’s Phase II clinical trial in relapsed brain tumours (GBM) has continued
throughout the year. Promising preliminary data has been obtained. The trial is now open
at three clinical centres in Australia with further sites in Australia and overseas to be
The company’s Phase II myeloma study remains open to enrolment.
JAK2 inhibitor CYT387
Cytopia concluded the formal preclinical development programme for CYT387 and filed an
Investigational New Drug Application (IND) with the United States Food and Drug
Administration (FDA) in June. Preparatory activities for the Phase I/II clinical trial in
myelofibrosis patients (a severe disorder of the bone marrow mediated by upregulation of
JAK2) are well advanced. Subject to final regulatory approval, the company intends to
commence enrolment into the study in late 2009.
Novartis JAK3 Collaboration
The company has completed the initial three year funded laboratory research term that
commenced in 2006. Novartis is now responsible for the subsequent development of drug
candidates that have arisen from the collaboration, with milestone and royalty payments
due to Cytopia as development ensues.
With a shift in internal activites to development of clinical stage programs, the company
continues to pursue collaborations and outsourced arrangements to progress early stage
and preclinical programs. The company will seek to expand collaborations such as that
with the Cancer Therapeutics CRC for the development of a FAK inhibitor to treat cancer
to deliver new value opportunity for shareholders.
The reported operating loss after tax for the year ended 30 June 2009 was $6.5m (2008:
Operating revenue totalled $4.2m (2008: $4.4m), while operating expenses totalled $11.5m
(2008: $12.7). R&D expenditure decreased to $7.9m (2008: $9.5m).
The year concluded with a cash position of $4.0m (2008: $11.0m), which is sufficient for
existing operations to continue into early calendar 2010.
Cytopia Ltd is an Australian biotechnology company focused on the development of new
drugs to treat cancer and other diseases. Cytopia conducts its drug development through
subsidiaries based in Australia and USA and specialises in developing new small molecule
compounds with an improved therapeutic profile for the treatment of cancer.
The lead program for the company is CYT997, a vascular disrupting agent (VDA) for the
treatment of various cancers, currently being trialed in Phase II clinical studies. This
compound is delivered orally as well as intravenously. Cytopia also has built on its range of
JAK and other kinase inhibitors with CYT387, a novel oral JAK2 inhibitor focused on the
treatment of myeloproliferative disorders and cancer, expected to enter Phase I clinical
studies in 2009.
Mr. Andrew Macdonald
Chief Executive Officer
T: +61 3 9208 4222