DGAP-Adhoc: Cytos Biotechnology Ltd (SIX:CYTN) today published the topline results of the global Phase 2b clinical trial with CYT003.
Cytos Biotechnology AG / Key word(s): Research Update
14.04.2014 07:00
Release of an ad hoc announcement pursuant to Art. 53 KR
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Cytos Biotechnology Ltd announces negative topline results of clinical
trial with CYT003
Phase 2b Study of CYT003 in moderate to severe allergic asthma misses
endpoints
Company evaluates options of ordinary winding down of operations and
liquidation
Schlieren, Switzerland - April 14, 2014 - Cytos Biotechnology AG (SIX:
CYTN) today announced that the Phase 2b study of CYT003 in patients with
moderate to severe allergic asthma did not achieve a statistically
significant reduction of the Asthma Control Questionnaire (ACQ) score at
week 12 in the target patient population compared to placebo. Patients on
placebo and at all dose levels of CYT003 achieved a clinically relevant
improvement in their asthma control measured by ACQ. Additional endpoints,
including lung function also failed to show a statistically significant
difference to placebo. The clinical study was planned to continue with a
blinded observation period of 9 months. Considering the clear outcome,
Cytos has determined to unblind and terminate the clinical study.
As a result of the failure to achieve the primary endpoint, the previously
announced condition for the conversion of convertible loan notes has not
been achieved, and the company therefore considers the prospects of raising
new funding sufficient to continue as a going concern to be remote.
Consequently, the company's board of directors has instructed management to
evaluate the options for an ordinary winding down of operations and
liquidation of the company or a possible bankruptcy. In addition, the
company has initiated the consultation process for a mass dismissal of all
of the company's 36 employees.
Dr. Christian Itin, Chairman and CEO of Cytos, commented: "We are very
disappointed with the outcome of the Phase 2b study and would like to thank
our patients and investigators for their support of the study. We would
also like to thank our employees for their outstanding effort that was
required to rebuild the company after the restructuring and mass dismissals
in 2012. When developing the plans for winding down operations, we will
seek to minimize adverse consequences for our employees and other
stakeholders."
The cash balance of the company as of March 31st, 2014 was CHF31 million.
The company does not expect to be able to repay any convertible bonds which
are all subordinated to other creditors. Likewise, the company also does
not expect to be able to pay any liquidation dividend to shareholders.
Results of the Phase 2b study will be presented at the American Thoracic
Society meeting, May 16-21, 2014 in San Diego, USA.
For further information, please contact:
Cytos Biotechnology Ltd
Harry Welten
Chief Financial Officer
Tel: +41 44 733 46 46
harry.welten@cytos.com
US investor Enquiries:
Susan A. Noonan
Tel: +1 (212) 966 3650
susan@sanoonan.com
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.
www.cytos.com
Forward Looking Statements
This media release contains certain forward-looking statements that involve
risks and uncertainties that could cause actual results to be materially
different from historical results or from any future results expressed or
implied by such forward-looking statements. You are urged to consider
statements that include the words "will" or "expect" or the negative of
those words or other similar words to be uncertain and forward-looking.
Factors that may cause actual results to differ materially from any future
results expressed or implied by any forward-looking statements include
scientific, business, economic and financial factors, including that CYT003
may not demonstrate safety or efficacy in clinical trials, that there may
be delays in development or that CYT003 may not receive marketing approval,
and that the Company relies on outside financing to meet capital
requirements, which may not be available under acceptable terms or at all.
Against the background of these uncertainties, readers should not rely on
forward-looking statements. The Company assumes no responsibility for
updating forward-looking statements or adapting them to future events or
developments.
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Additional features:
Document: http://n.equitystory.com/c/fncls.ssp?u=PIRASLQHNC
Document title: CYT003 topline results_140414
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Language: English
Company: Cytos Biotechnology AG
Wagistr. 25
8952 Schlieren
Switzerland
Phone: +41 44 733 4747
Fax: +41 44 733 4740
E-mail: info@cytos.com
Internet: www.cytos.com
ISIN: CH0011025217, CH0029060735
Valor: -
Listed: Freiverkehr in Berlin, München, Stuttgart;
Frankfurt in Open Market ; SIX
End of Announcement EQS Group News-Service
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