BioCryst Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2011 Financial Results
"We are pleased with the recent results of our 12-week Phase 2b gout
study, which showed that adding low doses of BCX4208
to allopurinol doubled the proportion of patients reaching therapeutic
goal compared to the standard of care of allopurinol alone," said
Third Quarter Financial Results
For the three months ended
Third quarter 2011 research and development (R&D) expenses decreased to
General and administrative (G&A) expenses for the third quarter of 2011
decreased to
During the third quarter 2011, the Company realized financing costs
associated with its non-dilutive peramivir royalty monetization
transaction completed in the first quarter of 2011. These costs relate
to a
The net loss for the third quarter 2011 was
As of
Year to Date Financial Results
For the nine months ended September 30, 2011, total revenues were
R&D expenses decreased to
G&A expenses of
The net loss for the nine months ended September 30, 2011 was
Clinical Development Update & Outlook
-
In October, BioCryst announced positive top-line results from its
279-patient Phase 2b randomized, double-blind, dose-response study of BCX4208
added to allopurinol 300 mg in gout patients who had failed to reach
the clinically important serum uric acid (sUA) goal of 6 mg/dL on
allopurinol alone. BCX4208 doses evaluated in the study showed
response rates ranging from 33% to 49%, approximately doubling the
proportion of patients reaching goal on placebo (18%). BCX4208 added
to allopurinol was generally safe and well-tolerated at all doses
studied. Over half of the patients originally randomized into this
study continued treatment into a 3-month extension phase, totaling
6-months of uninterrupted BCX4208 add-on treatment. The Company is
also conducting a Phase 1 study to evaluate the metabolic profile of
BCX4208. Results from both of these studies are expected in
January 2012 -
Additional results from the BCX4208
Phase 2b study have been accepted as a late-breaker oral presentation
at the 2011
American College of Rheumatology and the Association of Rheumatology Health Professionals (ACR/ARHP) AnnualScientific Meeting . The oral presentation of the study results is titled "BCX4208 Combined With Allopurinol Increases Response Rates in Patients With Gout Who Fail to Reach Goal Range Serum Urate on Allopurinol Alone: A Randomized, Double-Blind, Placebo-Controlled Trial" and is scheduled forNovember 8, 2011 at2:30-4:30 p.m. Central Time (Presentation Number L10) - BioCryst has opened enrollment of patients into its 12-week Phase 2 study of BCX4208 in patients with gout and moderately impaired renal function
-
BioCryst has activated approximately 50 additional clinical sites to
support enrollment in the ongoing Phase 3 efficacy study of the
influenza anti-viral i.v. peramivir. Sites in
Europe ,North America andIndia are prepared to enroll patients during the upcoming Northern Hemisphere flu season. A planned interim analysis to confirm or revise the study's current enrollment target of 160 patients for the primary efficacy analysis population is expected to be conducted no later than mid-2012 - The Company continues to advance both of its leading pre-clinical assets towards IND filings during the second half of 2012. These novel compounds include BCX4161, a potent inhibitor of kallikrein for potential development as an oral, prophylactic treatment for hereditary angioedema, and BCX5191, a potent and selective nucleoside analog targeting RNA polymerase for the potential treatment of hepatitis C
Conference Call and Webcast
BioCryst's leadership team will host a conference call and webcast on
About
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding future results, performance or achievements. These
statements involve known and unknown risks, uncertainties and other
factors which may cause our actual results, performance or achievements
to be materially different from any future results, performances or
achievements expressed or implied by the forward-looking statements.
These statements reflect our current views with respect to future events
and are based on assumptions and subject to risks and uncertainties.
Given these uncertainties, you should not place undue reliance on these
forward-looking statements. Some of the factors that could affect the
forward-looking statements contained herein include: that there can be
no assurance that our compounds will prove effective in clinical
studies; that development and commercialization of our compounds may not
be successful; that HHS may further condition, reduce or eliminate
future funding of the peramivir program; that we or our licensees may
not be able to enroll the required number of subjects in planned
clinical trials of our product candidates and that such clinical trials
may not be successfully completed; that BioCryst or its licensees may
not commence as expected additional human clinical trials with our
product candidates; that our product candidates may not receive required
regulatory clearances from the
BCRXW
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| FINANCIAL SUMMARY | |||||||||||||||
| Statements of Operations (Unaudited) | |||||||||||||||
| (in thousands, except per share) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
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September 30, | ||||||||||||||
| 2011 | 2010 | 2011 | 2010 | ||||||||||||
| Revenues: | |||||||||||||||
| Product sales | $ | - | $ | - | $ | - | $ | 325 | |||||||
| Royalties | - | - | - | 711 | |||||||||||
| Collaborative and other research and development | 5,249 | 12,000 | 14,419 | 44,651 | |||||||||||
| Total revenues | 5,249 | 12,000 | 14,419 | 45,687 | |||||||||||
| Expenses: | |||||||||||||||
| Cost of products sold | - | - | - | 86 | |||||||||||
| Research and development | 14,772 | 19,197 | 41,687 | 58,851 | |||||||||||
| General and administrative | 3,282 | 3,793 | 11,277 | 10,799 | |||||||||||
| Total expenses | 18,054 | 22,990 | 52,964 | 69,736 | |||||||||||
| Loss from operations | (12,805 | ) | (10,990 | ) | (38,545 | ) | (24,049 | ) | |||||||
| Interest and other income | 92 | 126 | 329 | 397 | |||||||||||
| Interest expense | (1,160 | ) | - | (2,614 | ) | - | |||||||||
| Loss on foreign currency derivative | (586 | ) | - | (2,926 | ) | - | |||||||||
| Net loss | $ | (14,459 | ) | $ | (10,864 | ) | $ | (43,756 | ) | $ | (23,652 | ) | |||
| Basic and diluted net loss per common share | $ | (0.32 | ) | $ | (0.24 | ) | $ | (0.97 | ) | $ | (0.53 | ) | |||
| Weighted average shares outstanding | 45,178 | 44,884 | 45,103 | 44,445 | |||||||||||
| Balance Sheet Data (in thousands) | |||||||||||||||
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| (Unaudited) | (Note 1) | ||||||||||||||
| Cash, cash equivalents and securities | $ | 61,040 | $ | 66,341 | |||||||||||
| Receivables from collaborations | 11,634 | 30,227 | |||||||||||||
| Total assets | 92,511 | 109,447 | |||||||||||||
| Non-recourse notes payable | 30,000 | - | |||||||||||||
| Accumulated deficit | (340,328 | ) | (296,572 | ) | |||||||||||
| Stockholders' equity | 26,042 | 65,503 | |||||||||||||
| Note 1: Derived from audited financial statements. | |||||||||||||||
or
WCG
Catherine
Kyroulis, 212-301-7174 (Media)
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