Endorex Announces Third Quarter Results (see bolds)
Wednesday November 10, 5:59 pm Eastern Time
Company Press Release
CHICAGO--(BW HealthWire)--Nov. 10, 1999--Endorex Corporation (AMEX:DOR - news) reported a net loss of $1.6 million, or $.18 per share, for the quarter ended September 30, 1999, compared to $1.5 million, or $0.16 per share, for the third quarter of 1998.
The third quarter of 1999 included a $0.5 million charge representing Endorex's share of equity losses for its oral vaccine delivery joint venture with Elan Corporation, plc. (``Elan'). Research and development expenses for the current quarter were down $0.5 million or 61% due to expenses being allocated to the joint venture. In the prior year, Endorex and Elan were sharing the joint venture's expenses equally and Endorex's expenses related to the joint venture were included in research and development.
For the nine months ended September 30, 1999, Endorex reported a net loss of $5.6 million, or $.63 per share, compared with a loss of $12.3 million, or $1.23 per share, for 1998. The prior year loss included a one-time charge of $8 million as Endorex's share of initial license fees paid by the joint venture to Elan. Elan also invested $8 million in Endorex convertible preferred stock, effectively offsetting the impact of the license fees on the balance sheet, as well as $2 million investment in common stock.
Research and development expenses year-to-date were down $0.6 million due to expenses being allocated to the joint venture as described above. As of September 30, 1999 the Company had $9 million in cash and securities in addition to $5.6 million of unused lines of credit and restricted cash.
The oral vaccine joint venture with Elan has made clear strides in developing improved technologies to allow for orally administered vaccines. To date, the joint venture has reported initial positive results with orally administered non-living subunit vaccines using the Orasome delivery system. The results to date are usually only seen with living virus or bacterial vaccines and are very rarely seen with non-living subunits. The joint venture has also reported that this delivery system is capable of inducing potent immune responses when administered intranasally, which is significant because the results show that small quantities of antigens can elicit responses at levels similar to injected vaccines. As a result of these positive outcomes, it is anticipated that the joint venture will begin to develop a prototype combination oral vaccine. Such new vaccines have been made possible by the joint venture's advances in delivery technology that include safe and effective adjuvants and site specific targeting. ``Targeting' vaccines to the correct sites in the gastrointestinal tract or the nasal passage gets the antigen to the right place; otherwise antigens are lost and are ineffective. Adjuvants boost the overall immune response to the antigen, creating a higher level of immunization. This element is critical in persons with diminished immune systems, such as the elderly, where vaccines are much less effective. During the third quarter, in vivo data on the joint venture's development of a tetanus vaccine was presented at the Annual Meeting of the International Conference on Antimicrobial Agents and Chemotherapy (ICAAC), in San Francisco, as well as at a British antiviral meeting.
In September, Endorex announced that its oncology subsidiary, Wisconsin Genetics, Inc., initiated a phase I (safety) trial in cancer patients to evaluate a new formulation of its cancer drug, Perillyl alcohol (``POH'), following the recent filing of its Investigational New Drug (``IND') application with the Food & Drug Administration.
To date, the National Cancer Institute (``NCI') has sponsored several Phase I trials and five Phase II trials for the treatment of cancer, using an initial formulation of POH developed by the NCI. Recently, two of the NCI-sponsored Phase II trials, for ovarian and colorectal cancer, were closed due to a lack of objective response. NCI-sponsored Phase II trials continue for breast, prostate and pancreatic cancer, as well as a chemoprevention trial. ``The data from the NCI trials, which use the initial formulation of POH, have and will continue to help us profile POH's activity in different types of cancer,' stated Michael S. Rosen, President/CEO of Endorex and Wisconsin Genetics. ``This data will also help us to plan our own Phase II trials with the new formulation, after completion of the Phase I trial.'
``We believe, the development of the new oral formulation of POH will significantly enhance overall patient compliance and enrollment and reduce the key side effects seen with the earlier formulation developed by the NCI,' continued Rosen.
Endorex also presented new data on the mechanism of action of its second cancer drug, ImmTher©, currently under evaluation in a randomized Phase II trial for the treatment of the bone cancer Ewing's sarcoma at M.D. Anderson Cancer Center at the University of Texas and Memorial Sloan Kettering Cancer Center. This new data was published in the cancer journal Cancer Immunology and Immunotherapy very recently, and demonstrates ImmTher's ability to stimulate key immune responses in the body to defend against cancer including the stimulation of key cytokines such Interleukin-12.
Endorex is a drug delivery company. The Company's drug delivery technologies focus on: 1) oral/mucosal delivery of drugs and vaccines, 2) a disposable microinfusion pump for delivery of selected drugs for life-threatening diseases, and 3) improved delivery of cancer therapy. The Company's oral delivery technology, the Orasome(TM) system was licensed from the Massachusetts Institute of Technology. In 1998, Endorex formed two joint ventures with Elan Corporation, plc. Endorex is also developing improved delivery of cancer therapy with two families of compounds: the monoterpenes and the muramyl dipeptides (biologicals).
The statements made in this press release contain certain forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, that involve a number of known and unknown risks and uncertainties. Such statements are only predictions and actual events or results in future periods may differ materially from what is currently anticipated. In particular, no assurance can be given that the company will become profitable, that the Orasome delivery system or POH drug candidate will lead to successful products or become profitable, that any of the company's cancer drug candidates will receive regulatory approval or become commercially successful. In addition to the matters described in this press release, risk factors as described from time to time in Endorex's filing with the Securities and Exchange Commission, including, but not limited to, its most recent reports on Form 10-QSB and Form 10-KSB, may affect the results achieved by Endorex. The Company assumes no obligation to update the information in this release.
Copies of Endorex's press releases can be obtained from the Company's web site at www.endorex.com. |
