>>Panacos Reports Second Quarter 2008 Financial Results
Wednesday July 30, 4:00 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 second quarter of 2008 and reviewed progress in its development programs.
“We continue to make significant progress in bevirimat’s development program. We have identified the target patient population, and we are moving forward with confidence,” said Alan W. Dunton, MD, President and Chief Executive Officer of Panacos. “Using a simple and rapid genotype assay, we are able to identify the HIV patients prior to initiating treatment who should respond well and are the best candidates for bevirimat. Based on our recently announced prospective clinical study in HIV patients, we believe we have identified the ideal patient profile that will be incorporated into future clinical studies of bevirimat, including Phase 3 studies, pending regulatory concurrence. Additionally, we have created tablet formulations that we believe will allow all patients to reach the optimal plasma concentration and will be moving the formulations into the clinic. We also are actively seeking a partner for bevirimat to assist us with conducting the Phase 3 studies and to commercialize the product worldwide. Our next-generation maturation program has achieved a significant milestone as our scientists have identified several compounds that retain activity against polymorphisms in the molecular target, Gag.”
“On the corporate front, we have announced we transferred our Nasdaq listing to Nasdaq Capital Market from Nasdaq Global Market and are deferring for now any action on a reverse split, which was approved by our stockholders at our recent annual meeting. Also, we will explore partnership opportunities for our pipeline products to maximize shareholder value,” concluded Dr. Dunton.
Financial Highlights:
For the second quarter of 2008, Panacos reported a net loss of $9.7 million, or $0.18 per share, versus a net loss of $10.1 million, or $0.19 per share, for the second quarter of 2007. Revenue from research funding in the second quarter of 2008 decreased to $18,000 from $106,000 in the second quarter of 2007.
Research and development expenses in the second quarter of 2008 increased to $6.7 million from $6.2 million in the second quarter of 2007, due primarily to increased external expenditures in the Company's research and development programs. General and administrative expenses in the second quarter of 2008 decreased to $2.6 million from $3.5 million in the second quarter of 2007.
Unrestricted cash, cash equivalents and marketable securities were $35.9 million at June 30, 2008. As of June 30, 2008, the Company had approximately 53.6 million common shares outstanding.
Recent Business Highlights:
- The Company announced it has identified factors that predict treatment response to bevirimat. Three codon positions, 369, 370 or 371 on the 500-amino acid HIV-A Gag protein, were recognized to be specific predictors of treatment response to bevirimat. Those patients whose virus has polymorphisms (variants) at these positions are less likely to respond to the drug. These findings were highlighted during multiple presentation sessions at the 17th International HIV Drug Resistance Workshop in Sitges, Spain.
- The Company announced it has completed a Phase 2b prospective study of bevirimat in treatment-experienced and treatment-naive patients, confirming the factors that predict response to bevirimat. With 14 days of bevirimat treatment, patients without the Gag changes recorded a statistically significant higher mean viral load reduction than patients with Gag polymorphisms. The frequency of Gag polymorphisms is variable, depending on the population tested. Based on a North American academic patient database and a 2007 publication from HIV clinics in France, the range of patients free of Gag polymorphisms (and hence expected to have an optimal treatment response) was approximately 60-68%.
- The Company announced it will present clinical data on bevirimat at the 48th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) to be held in Washington, D.C., from October 25 – October 28, 2008.
Conference Call Information
Panacos will hold a conference call today to discuss the second quarter results and corporate developments at 4:30 p.m. (EST). The conference call can be accessed via the web at www.panacos.com or by dialing 866.356.4281 (domestic) or 617.597.5395 (international) and entering the passcode 68347559. A replay of the conference call will be available from 6:30 p.m. on July 30, 2008 through August 29, 2008, 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 24473243.
Panacos’ Development Programs
Panacos’ lead compound, bevirimat (PA-457), is the first in the new class of HIV drugs under development called maturation inhibitors, discovered by Company scientists and their academic collaborators. Bevirimat is designed to have potent activity against a broad range of HIV strains, and studies have shown bevirimat is a potent inhibitor of HIV isolates that are resistant to currently approved drugs. Panacos has completed 12 clinical studies with bevirimat in over 500 patients and healthy volunteers, showing significant reductions in viral load in HIV-infected patients and a promising safety profile. It is currently in Phase 2b clinical trials. The Company has completed a Phase 2b dose escalation study of bevirimat (Study 203) and determined the optimal dose range. The retrospective clinical data from Study 203 resulted in the discovery of the patient response predictors to bevirimat, which now has been confirmed in multiple laboratory analyses and the prospective study.
In addition to bevirimat, the Company has a second-generation program in HIV maturation inhibition and has selected a lead compound for preclinical development in its oral HIV fusion inhibitor program. The new understanding of the role of Gag polymorphisms in maturation inhibitor activity is unique to Panacos, and the Company is building a strong intellectual property position around its important discovery.<<
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Cheers, Tuck |
