ZURICH, August 6, 2013 /PRNewswire/ --
- Global Phase 2b clinical trial with CYT003 progressing as planned
- Development team for CYT003 strengthened
- A*Star and Cytos bring Singapore's first influenza vaccine to clinical testing
- All agenda items approved at the Annual Shareholders' Meeting
Cytos Biotechnology Ltd. ("Cytos" or the "Company") announced today its financial results and business highlights for the quarter ended June 30, 2013.
The Phase 2b clinical trial with Cytos' lead product candidate CYT003 in allergic asthma is progressing as planned. The clinical trial is enrolling patients at more than ninety centers, in eight countries, in the United States and Europe. Approximately 360 adult patients with moderate to severe allergic asthma, not sufficiently controlled on current standard inhaled corticosteroid (ICS +/- LABA) therapy, will be treated in this study. Enrolment is expected to be completed by year-end 2013. Top-line data are planned for Q2 2014. Upon completion of enrolment, Cytos can call the second tranche of the convertible loan notes and will be receiving a payment of CHF 6.625 million.
The development team for CYT003 has been further strengthened with the hire of Dr. Dorothee Krumwieh, who joined Cytos in May 2013 as Vice President and Program Leader for CYT003. Prior to joining Cytos, Dr. Krumwieh was in charge of the neurological development programs at Merck Serono. Previously, Dr. Krumwieh held various positions in research and regulatory affairs and lead cross functional development programs in oncology and dermatology at Merck Serono, Serono and Behringwerke AG. Dorothee Krumwieh received a PhD in immunology from the University of Freiburg im Breisgau, Germany.
On May 17, 2013, Cytos announced that A*STAR and Cytos brought Singapore's first influenza vaccine to clinical testing. The first healthy subject was dosed in a Phase 1 clinical trial with the H1N1 influenza vaccine candidate based on Cytos' proprietary bacteriophage Qbeta virus-like particle (VLP) technology.
At the Annual Shareholders' Meeting, held on June 28, 2013, all agenda items were approved by the shareholders, including the extension of the authorized capital until June 27, 2015, as well as the re-election of Dr. Christian Itin and Kurt von Emster as members of the Board of Directors.
Three-month period from April 1 to June 30, 2013
On June 30, 2013, funds available for financing the operations (including cash, cash equivalents and trade and other receivables) amounted to CHF 18.1 million. The funds were CHF 5.5 million less than on March 31, 2013, primarily due to expenses incurred in on-going operating activities.
On June 30, 2013, the nominal value of convertible bonds not held by the Company amounted to CHF 13.17 million. Cytos did not buy back any convertible bonds on the market during the second quarter of 2013.
The nominal value of the secured convertible loan notes (first tranche) is CHF 6.625 million. Upon completion of enrolment in the ongoing Phase 2b clinical trial with CYT003 in allergic asthma, the Company can call the second tranche of CHF 6.625 million, which is expected to happen towards the end of this year.
Revenue comprising deferred income from license fees paid by Novartis of CHF 0.25 million has been recognized in the second quarter 2013, unchanged from the second quarter 2012.
Financial summary (IFRS, consolidated)
(in CHF million) Q2 2013 Q2 2012 Revenue 0.3 0.4 Net operating cost (6.5) (2.2) Operating loss (6.3) (1.8) Net loss (8.1) (2.6) Net loss per share (in CHF) (0.36) (0.27) (in CHF million) 30.6.2013 31.3.2013 Cash, cash equivalents & trade and other receivables 18.1 23.6 Full-time equivalents 24.5 22.5
The detailed Q2 Financial Report 2013 can be downloaded at:
About Cytos Biotechnology Ltd
Cytos is a public biopharmaceutical company focused on the development of targeted immuno-therapies. The Company's lead product candidate CYT003 is a novel, first-in-class, immune modulator in Phase 2 clinical development as a potential new treatment for asthma.
CYT003 has a novel mechanism of action that inhibits the immune response that causes asthma, and may therefore be beneficial for the control of asthma. In a successfully completed Phase 2a study, CYT003 was shown to maintain asthma control and lung function in patients with persistent allergic asthma despite withdrawal of standard therapy with inhaled corticosteroids. CYT003 has been shown to have a good safety and tolerability profile in more than 450 individuals receiving the active agent so far.
Cytos was founded in 1995 as a spinoff from the Swiss Federal Institute of Technology (ETH) in Zurich. It is located in Schlieren (Zurich), Switzerland. The Company is listed according to the Main Standard on the SIX Swiss Exchange Ltd under the symbol CYTN.
This foregoing press release may contain forward-looking statements that include words or phrases such as "would", "can", "expect", "are intended for", "are designed to", or other similar expressions. These forward-looking statements are subject to a variety of significant uncertainties, including scientific, business, economic and financial factors, and therefore actual results may differ significantly from those presented. There can be no assurance that any further therapeutic entities will enter clinical trials, that clinical trial results will be predictive for future results, that therapeutic entities will be the subject of filings for regulatory approval, that any drug candidates will receive marketing approval from the U.S. Food and Drug Administration or equivalent regulatory authorities, or that drugs will be marketed successfully. Against the background of these uncertainties readers should not rely on forward-looking statements. The Company assumes no responsibility to update forward-looking statements or adapt them to future events or developments.
SOURCE Cytos Biotechnology Ltd