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Cytos Biotechnology Announces Full Year 2008 Financial Results and Annual Highlights
Schlieren (Zurich), Switzerland, February 11, 2009 – Cytos Biotechnology Ltd (SIX:CYTN) today presented its full year 2008 financial results and annual highlights. A conference call to discuss the financial results will be held, Thursday, February 12, 2009 at 10am (CET).
Financial Results 2008 (consolidated):
- Cash, cash equivalents, financial assets and trade receivables from collaboration partners were
CHF 98.0 million at year end 2008, only CHF 11.0 million lower than end of 2007
(CHF 109.0 million).
- According to present financial plans, Cytos Biotechnology is thus well financed into
the year 2011.
- Revenues in 2008 were CHF 19.7 million; net loss was CHF 26.0 million.
- Cash used in operations was CHF 3.3 million/month in 2008, well below guidance.
Highlights 2008:
Signing of the Immunodrug™ agreement with Pfizer in human health
In August 2008, Cytos Biotechnology and Pfizer have signed an exclusive global research, option and license agreement for novel vaccines for a defined number of human diseases worth up to CHF 150 million plus royalties. End of 2008, Pfizer has exercised its options under this agreement and has taken commercial licenses for specified vaccines based on the Immunodrug™ technology.
Progress in clinical Immunodrug™ development
CYT006-AngQb for hypertension
– Two phase II dose and regimen optimization studies on track
The two phase II studies with a total of 140 hypertensive patients will investigate an optimized treatment regimen and higher doses of CYT006-AngQb. Initial study results are expected for the second quarter 2009.
– Excellent long-term safety profile confirmed
Up to three years after treatment of hypertensive patients in a phase IIa study, there were no safety-relevant observations reported for CYT006-AngQb, thus underscoring its potential for longterm chronic disease management.
– Publication of the first-in-patients phase IIa study results in the renowned medical journal The Lancet (The Lancet, 2008, 371:821).
CYT003-QbG10 for allergic diseases
– Clinical proof-of-concept for the allergen-independent monotherapy CYT003-QbG10
In a phase II study in 80 allergic patients, CYT003-QbG10 was shown to be safe, well tolerated and efficacious. CYT003-QbG10 significantly reduced rhinoconjunctivitis symptoms in daily life compared to placebo, and the average combined symptom and medication score was also significantly lower in CYT003-QbG10 treated patients than in patients on placebo. Positive data from a subgroup of patients with asthma suggest potential use of this product candidate also in this important indication.
– Start of phase IIb study with CYT003-QbG10 monotherapy
A phase IIb dose-finding study was initiated to evaluate the safety, tolerability and efficacy of two different doses of CYT003-QbG10. The study will include 300 patients with rhinoconjunctivitis due to house dust mite allergy. Initial study results are expected in the third quarter 2009.
NIC002 for smoking cessation
– Initiation of phase II study by Novartis
Novartis, the licensee of NIC002 for smoking cessation, has initiated a phase II clinical trial with 200 smokers. The study will evaluate the safety, tolerability and efficacy (i.e. abstinence from smoking) of a new NIC002 treatment regimen designed to yield high anti-nicotine antibody levels.
CAD106 for Alzheimer’s disease
– Phase I study in Alzheimer’s patients completed
This phase I study conducted by Novartis, the licensee of CAD106 for Alzheimer’s disease, investigated the safety, tolerability and beta-amyloid specific antibody response following treatment with CAD106 or placebo. Clinical data from the first group of 31 patients (of whom 24 were on CAD106) presented at the International Conference for Alzheimer’s Disease (ICAD) indicated that CAD106 was safe, well tolerated and induced a beta-amyloid-specific antibody response in two thirds of the CAD106-treated patients.
– Start of two phase IIa studies in Europe and in the US
Novartis has initiated two phase IIa studies in up to 60 Alzheimer’s disease patients in different European countries and the US triggering a compensation of CHF 5 million to Cytos Biotechnology. This also marks the first time that a vaccine candidate based on Cytos Biotechnology’s Immunodrug™ technology gained IND approval by the US regulatory authorities and thus represents an important milestone for this novel class of biopharmaceuticals.
CYT004-MelQbG10 for malignant melanoma
– Optimization of treatment regimen ongoing
A phase IIa study was initiated with 20 patients suffering from malignant melanoma at the disease stages III and IV. The study will investigate the safety, tolerability and T cell immunogenicity of different treatment regimens of CYT004-MelQbG10. First results of the study are expected for late 2009.
Wolfgang Renner, PhD, CEO of Cytos Biotechnology commented: “Careful use of our financial resources has always been of paramount importance to us, irrespective of the economic environment. At the same time, we always aimed at advancing a broad pipeline of therapeutic vaccine candidates in important chronic disease areas. We ended 2008 with CHF 98 million in financial funds, which is only CHF 11 million below the CHF 109 million at the end of 2007. Concurrently, we completed two phase II studies in allergic diseases and initiated a large phase IIb study in the same indication; and we are conducting two phase II studies in hypertension and a phase IIa study in malignant melanoma. On top of this, a novel vaccine candidate for the treatment of type 2 diabetes is now ready to enter clinical development and a further four programs have achieved preclinical proof-ofconcept. Also our partnered clinical programs with Novartis in smoking cessation and Alzheimer’s disease are progressing well.
The goal of our new partnership with Pfizer is to leverage the value of our ImmunodrugTM technology in programs that are outside the scope of our own. As already in 2007, our collaborations with big Pharma have again in 2008 significantly contributed to the financing of our company and our proprietary programs. Since these collaborations generate almost no costs to us, they financed approximately 75% of our operations in the past two years.
The strategy that we devised many years ago, namely to focus on the research intensive part of the pharmaceutical value chain and to selectively partner with leading pharmaceutical companies for the development of vaccines addressing mass markets, makes us less dependent from volatile financial markets, and allows us and our shareholders to retain most of the potential value that lies in our proprietary programs and in the patented ImmunodrugTM technology platform. Therapeutic vaccines for the treatment of common chronic diseases are a newly emerging therapeutic area, which has been pioneered to a significant degree by Cytos Biotechnology’s scientists. Beginning of 2009 we believe that we have the technological skills and the support of our top-tier partners in the industry to bring these novel kinds of medicine to the patients, which has always been the goal of all our efforts.”
Full year consolidated financial figures 2008:
Balance Sheet
Funds available for financing the operations amounted at December 31, 2008 to CHF 98.0 million and include cash, cash equivalents, financial assets and trade receivables from collaboration partners. They were thus only CHF 11.0 million lower than at the end of 2007. This net change is composed of payments from collaboration partners and financing of the ongoing operating activities.
Revenues
Revenues decreased from CHF 35.9 million in 2007 to CHF 19.7 million in 2008. The revenues in 2008 resulted mainly from payments made by Pfizer for the Immunodrug™ agreement in human health and a compensation of CHF 5.0 million by Novartis due to the progress made with the Alzheimer’s vaccine candidate CAD106. Revenues in 2007 were driven by the up-front payment of CHF 35.0 million received from the collaboration with Novartis for the vaccine NIC002 for smoking cessation.
Cash burn
The gross cash burn for operating activities decreased from CHF 3.4 million per month in 2007 to CHF 3.3 million per month in 2008.
Financial summary (consolidated)
(in CHF million) Results 2008 Results 2007
Research and collaboration revenues 19.7 35.9
Net operating costs (43.6) (44.2)
Operating loss (23.9) (8.3)
Net loss (26.0) (6.9)
Net loss per share (in CHF) (4.94) (1.31)
(in CHF million) December 31, 2008 December 31, 2007
Cash, cash equivalents, financial assets & trade receivables 98.0 109.0
Full-time employees (number) 132 130
The full financial statements can be found on www.cytos.com.
Full year statutory financial figures 2008:
Financial summary (statutory)
(in CHF million) Results 2008 Results 2007
Research and collaboration revenues 27.7 36.0
Total operating expenses (40.2) (46.1)
Operating loss (12.4) (10.1)
Other income 41.5 0.5
Net profit/(loss) 28.9 (9.5)
(in CHF million) December 31, 2008 December 31, 2007
Total assets 151.1 112.8
Total liabilities 88.3 79.3
Shareholder’s equity 62.8 33.5
The full financial statements can be found on www.cytos.com.
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