Pharmos Reports 2001 Third Quarter and Nine Month Results; Progress Noted in Phase III Clinical Trial
ISELIN, N.J., Nov. 6 /PRNewswire/ -- Pharmos Corporation (Nasdaq: PARS and Nasdaq Europe: PHRM) today reported financial results for the third quarter and nine month period ended September 30, 2001. During the third quarter, increased enrollment in the Company's ongoing Phase III clinical trial and higher levels of research and development to advance the Company's core central nervous system and neuro-inflammatory programs contributed significantly to increased expenses. Sales of the ophthalmic products Lotemax® and Alrex® rose 3% in the third quarter and 13% in the nine month period ended September 30, 2001 compared to the respective periods in 2000. Proceeds from the Company's recent transaction in which it sold its ophthalmic business will be reflected in the fourth quarter of 2001.
Haim Aviv, Ph.D., Pharmos Chairman and CEO, said, ``During the third quarter we focused on achieving several important goals. We continued the roll-out of our Phase III trial of dexanabinol for traumatic brain injury in Europe, accelerating enrollment as we increased the number of centers involved in the study. We also implemented a plan to build our development team to ensure that the clinical development of dexanabinol achieves the best possible results and that we can properly support the expected start of clinical development of a new compound for stroke next year. Finally, realized the value of our ophthalmic business to support Pharmos' mission to be a leader in the area of neurological and inflammation-based disorders.''
For the 2001 third quarter, Pharmos reported a net loss of $1,997,046, or $.04 per share, on total revenues of $1,712,646, compared to a net loss of $1,531,159, or $.03 per share, on revenues of $1,761,735 for the comparable period in 2000. For the nine months ended September 30, 2001, Pharmos reported a net loss of $7,113,894, or $.13 per share, on revenues of $4,298,441, compared to a net loss of $4,276,235, or $.08 per share, on revenues of $3,840,152 for the comparable period in 2000. The increase in net loss per share is attributable primarily to increased R&D expenditures. R&D expenses rose as a result of increased clinical costs in connection with the international Phase III trial of dexanabinol for severe traumatic brain injury (TBI) and higher staffing levels to support related activity and to expand programs developing the Company's other non-psychotropic cannabinoid derivatives for a range of neurological and inflammation-based conditions. Cash and cash equivalents, including restricted cash, equaled $21,985,582 at September 30, 2001.
In October 2001, Pharmos completed the sale of its loteprednol etabonate ophthalmic business to Bausch & Lomb for up to $49 million in cash plus assumption of certain obligations. Proceeds from the sale will support the Company's efforts to strengthen its pipeline of therapeutics for neurological and inflammation-related indications. Under the terms of the transaction, Pharmos received from Bausch & Lomb approximately $25 million in cash for the sale of Lotemax and Alrex, and will receive an amount estimated at approximately $14 million for LE-T, a third product in advanced clinical development, upon its approval by the FDA, the exact amount of which will be determined based on the actual approval date. An additional milestone payment of up to $10 million will be paid to Pharmos to the extent sales of LE-T exceed an agreed-upon sales forecast in the first two years.
Pharmos' pivotal Phase III trial of dexanabinol for TBI progressed during the third quarter. The rate of patient enrollment increased, with 36 centers in Europe and Israel currently participating. Total enrollment of approximately 860 patients is expected to be completed in 2003. The Company's research and development programs also made important progress, some of the results of which will be presented later this month at the Society for Neuroscience meeting in San Diego, California. Pharmos hopes to complete its preclinical development of a treatment for stroke, the next indication after TBI targeted for clinical testing, and commence a human study for the indication in 2002. Preclinical studies are also underway testing various other compounds from the Company's synthetic cannabinoid library for neuropathic pain, multiple sclerosis and other neurological and inflammation-based indications.
Conference Call/Webcast
Pharmos will host a conference call to review the third quarter 2001 results at 12:00 p.m. Eastern Time on November 6, 2001. A live webcast of the conference call will be available by logging on to videonewswire.com. If you are unable to participate, the webcast will be archived at pharmoscorp.com (``Investors'' page) for 30 days. |
