LAUSANNE, Switzerland, August 6, 2001 (PRIMEZONE) -- Modex Therapeutics Ltd. (SWX New Market:MDXN) today announced its financial results for the second quarter ended June 30, 2001.
Income
Income from operations for the quarter was CHF 362,000. This represented an increase of CHF 215,000 compared to the previous year due to an increase in income received from the funding of collaboration agreements relating to the BioDelivery technology, which amounted to CHF 86,000, together with income from sale of products of CHF 129,000 relating to the sales of EpiDex(tm) in Germany and Switzerland.
Operating Expenses
Total operating expenses for the quarter were CHF 5.3 million, which was an increase of CHF 1.3 million over the previous year. This rise relates to the increased development costs for EpiDex(tm) and the initial selling and marketing expenses related to EpiDex(tm) for Germany and Switzerland, together with the preparation for the launch of EpiDex(tm) in the European market.
Net Loss
Net loss for the quarter amounted to CHF 4.4 million and, year to date, this amounts to CHF 7.4 million, which is in line with the Company's forecast.
Strong Financial Position
At the end of June, cash and short-term investments amounted to CHF 63.5 million, which provides Modex with the financial resources for the future growth of the company.
"I am pleased to report strong progress at Modex during Q2," commented Dr. Jacques Essinger, CEO of Modex. "In particular the following achievements were made in our clinical and organizational development:
1. Positive preliminary results from EpiDex(tm) Phase II clinical
trial
In June, we announced preliminary results on the first 36 patients of the 80-patient Phase II clinical trial of EpiDex(tm), our skin replacement product.
This clinical trial is the first of its kind. It compares our tissue engineered autologous skin product, EpiDex(tm), to the surgical autograft, which is regarded as the gold standard for the treatment of recalcitrant chronic skin ulcers.
The preliminary results show that in terms of complete wound healing at 12 weeks, EpiDex(tm) is comparable to the surgical autograft for the very hard to heal recalcitrant chronic skin ulcers. In addition, for those wounds not closed after 12 weeks, patients who were treated with EpiDex(tm) had a significant reduction in the skin ulcer surface area, whereas patients treated with the surgical autograft showed no clear reduction in the skin ulcer surface area. EpiDex(tm) was also demonstrated to be well tolerated and safe.
We are excited by these positive preliminary results and look forward to publishing the final results from the 80 patients in October.
2. Switch to a larger device for the BioDelivery program
Following the positive results announced in March of the Phase I trial conducted for the delivery of the hormone Erythropoietin (EPO), using our proprietary encapsulated cell technology delivery system (BioDelivery program), and further tests conducted on the device in Q2, we decided to switch from the existing hollow fiber device to a larger device. The larger device, known as the flat sheet, can hold up to 10 times more cells than the hollow fiber device and provides Modex with a broader delivery range with respect to its chosen programs.
Although the decision to work with a larger device results in a 12-month delay in the EPO BioDelivery program, we are convinced that the change will enlarge the potential therapeutic range and applications of the BioDelivery platform.
3. Chief Operating Officer appointed
We continue to strengthen our management team and recently appointed Mr. Jim Hogan as Chief Operating Officer (COO). Jim has over 20 years of experience in the healthcare industry including 10 years in a multinational environment with Pfizer Europe and, more recently, as head of operations of three biotech start-up companies in Switzerland, Israel and US.
As COO, Jim is responsible for all operational matters, including overseeing all development programs as well as the commercialization and production of EpiDex(tm).
Jim's arrival at Modex allows me to focus on developing external opportunities to build our technology platform, as well as expanding the distribution capabilities for our existing products.
4. Board of Directors strengthened
At the Annual General Meeting, held on June 23, the shareholders approved the appointment of Mr. Jean-Pierre Boucher to the Board of Directors.
Mr. Boucher has over 30 years of experience in the pharmaceutical and medical device industry, including 15 years experience as President of Stryker Europe, where he was responsible for all European activities including research, manufacturing and distribution.
Mr. Boucher's contribution will be extremely valuable as Modex commercializes its products in the European and US markets and continues to grow its internal programs.
Outlook
In October we will announce the final results of the EpiDex(tm) clinical trial. Once these results are finalized we will be in a position to accelerate our marketing launch of EpiDex(tm).
In terms of Corporate Development, the recent strengthening of the management team will enable us to accelerate our growth of existing products, the expansion of our development programs and the process of evaluating opportunities to acquire new products or technologies.
I look forward to announcing the final clinical trial results of EpiDex(tm) in October."
A Leader in the Field of T3R
Modex Therapeutics Ltd. is a Swiss biotechnology company, based in Lausanne, with a focus on tissue repair, replacement and regeneration (T3R). T3R heralds a new era for healthcare, aiming at regenerating cells for the repair or replacement of deficient tissue. Modex currently focuses its development work on two cell-derived products and technologies:
EpiDex(tm) is a skin equivalent product in Phase II trials that is derived from stem and precursor cells found in the human hair follicle.
BioDelivery proprietary technology uses immortalized fibroblastic cells to continuously deliver therapeutic proteins and has several candidates in various stages of development.
The strategy of the company is to in-license advanced and promising T3R technologies, to drive them to a mature stage, and to realize the added value by licensing or selling the developed products to pharmaceutical, biotechnology or medical device companies. Modex Therapeutics (MDXN) has been listed on the SWX New Market since June 2000.
The full Q2 Report is available on the website www.mdxn.ch
Please click on the link to view the full press release. If you have any problems please contact Noonan/Russo on +44 20 7726 4452.