>>Panacos Reports Third Quarter 2007 Financial Results
Thursday October 25, 4:03 pm ET
WATERTOWN, Mass.--(BUSINESS WIRE)--Panacos Pharmaceuticals, Inc. (NASDAQ:PANC - News), a biotechnology company dedicated to developing the next generation of antiviral therapeutic products, today announced its financial results for the quarter ended September 30, 2007 and reviewed progress in its development programs.
Recent Business Highlights:
The Company announced preliminary results today from the 300 mg cohort of a Phase 2b dose escalation study of bevirimat (PA-457) in patients failing HIV therapy due to drug resistance. The results from this cohort showed a mean viral reduction of 1.02 log10, with a continuation of predictable and linear pharmacokinetics. The results support further dose escalation to determine the dose or doses of bevirimat to take into pivotal clinical trials in 2008.
Panacos announced that it had completed a Phase 1 study with two distinct liquid formulations of bevirimat suitable for long-term dosing in HIV patients. Both formulations have similar bioavailability to the solution formulation currently being used in the Phase 2b dose escalation study. The Company intends to commercialize both a liquid and a solid version of bevirimat, and continues to evaluate a number of novel solid formulation options with the goal of selecting a formulation candidate to take into human trials in 2008. Preliminary market research indicates that a majority of the HIV-positive adult market would consider a liquid formulation of bevirimat to be an attractive option.
The Company drew down the remaining $10 million of the $20 million loan facility announced in June. The second $10 million tranche was received on October 1, 2007 and therefore is not reflected in the 3Q financials.
Third Quarter Financial Highlights:
For the third quarter of 2007, Panacos reported a net loss of $7.9 million, or $0.15 per share, versus a net loss of $7.9 million, or $0.16 per share, for the third quarter of 2006. Revenue from research funding in the third quarter of 2007 decreased to $30,000 from $33,000 for the third quarter of 2006.
Research and development expenses in the third quarter of 2007 decreased to $5.0 million from $5.7 million in the third quarter of 2006, primarily as a result of timing-related decreased expenses in the Company's pipeline research and development programs. General and administrative expenses in the third quarter of 2007 were $3.2 million, the same amount as reported in the third quarter of 2006.
Unrestricted cash, cash equivalents and marketable securities were $48.2 million at September 30, 2007. As of September 30, 2007 the Company had approximately 53.5 million common shares outstanding.
“With positive new data for bevirimat and a strong financial position, we look forward to the remainder of 2007 and beyond," commented Alan W. Dunton, M.D., Panacos’ President and Chief Executive Officer. ”Our search for a new Chief Financial Officer is underway, and in the meantime, Robert Pelletier continues to provide excellent financial leadership to the Company.”
Panacos will hold a conference call today to discuss the second quarter results and the Company's development programs at 4:30 p.m. (EDT). The conference call can be accessed via the web at www.panacos.com or by dialing 866.831.6234 (domestic) or 617.213.8854 (international), between 4:15 and 4:25 p.m. and entering the passcode 67813660. A replay of the conference call will be available from 6:30 p.m. on October 25, 2007 through November 26, 2007, and can be accessed via the web at www.panacos.com or by dialing toll-free 888.286.8010, and outside the U.S. 617.801.6888 with passcode 14818744.<<
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So the 300mg cohort results look solid, good (see below for the PR with all the numbers). But I haven't found many that think the liquid formulation is commercially viable, no matter what PANC's market research says. Might depend on the taste.
Anyhow, PANC enjoying a bit of an after hours bounce, presumably on the clinical news.
>>Panacos Announces Greater than 1 Log10 Mean Reduction in 300 mg Bevirimat Cohort
Thursday October 25, 4:02 pm ET
WATERTOWN, Mass.--(BUSINESS WIRE)--Panacos Pharmaceuticals, Inc. (NASDAQ:PANC - News), a biotechnology company dedicated to developing the next generation of antiviral therapeutic products, today announced preliminary results from the 300 mg cohort of a Phase 2b study of bevirimat (PA-457) in patients failing HIV therapy due to drug resistance. In this cohort, eight patients received 300 mg of bevirimat solution once daily and two patients received placebo for 14 days on top of their failing background regimen.
A mean viral load reduction of 1.02 log10 was seen in the eight bevirimat-treated patients on day 15, the primary endpoint of the study. Of these patients, six (75%) had greater than a 0.5 log10 reduction and five (63%) had greater than a 1.0 log10 reduction. Patients receiving placebo had a negligible change in viral load at this same time point. The 300 mg cohort had a greater viral load reduction than the previous cohort where patients were dosed with a 250 mg bevirimat solution and a mean viral load reduction of 0.68 log10 was observed.
Bevirimat continued to be well tolerated in this cohort, consistent with previous clinical experience. While Panacos continues to be blinded to patients’ treatment assignments, all adverse events were mild and observed in only two patients. Following final review of the safety data and FDA confirmation, Panacos intends to proceed to the next cohort, in which treatment-experienced patients will receive a 350 mg bevirimat solution or placebo on top of their failing background regimen daily for two weeks.
“We were very pleased with the results from the 300 mg cohort,” said Alan W. Dunton, M.D., Panacos’ President and Chief Executive Officer. “These data are consistent with the previously presented model that the clinically relevant dose range would likely be between 300-400 mg. We look forward to initiating the 350 mg cohort as we work to determine the optimal dose or doses of bevirimat to take into pivotal clinical trials in 2008.”
Following dosing with 300 mg of bevirimat solution administered on top of patients' failing background regimens, the mean trough plasma concentration of bevirimat at steady state was 48.4 micrograms/ml compared to 38.3 micrograms/ml at steady state in the 250 mg oral solution cohort. These plasma concentrations indicate that bevirimat continues to exhibit predictable and linear pharmacokinetics with the oral solution formulation that are consistent with expectations.
Panacos will be discussing these results on its regularly scheduled quarterly conference call at 4:30 p.m. today. The conference call can be accessed via the web at www.panacos.com or by dialing 866.831.6234 (domestic) or 617.213.8854 (international), between 4:15 and 4:25 p.m. and entering the passcode 67813660. A replay of the conference call will be available from 6:30 p.m. on October 25, 2007 through November 26, 2007, and can be accessed via the web at www.panacos.com or by dialing toll-free 888.286.8010, and outside the U.S. 617.801.6888 with passcode 14818744.<<
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Cheers, Tuck |
