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BioCryst Reports First Quarter 2008 Financial Results and Clinical Update
BioCryst Reports First Quarter 2008 Financial Results and Clinical Update
BIRMINGHAM, Ala., May 8 /PRNewswire-FirstCall/ -- BioCryst
Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced financial results for the
quarter ended March 31, 2008. The Company reported revenues of $10.8M in the
first quarter of 2008, compared to $9.2M in the first quarter of 2007. The
net loss for the quarter ended March 31, 2008 was $13.1M, or $0.34 per share,
compared to a net loss for the quarter ended March 31, 2007 of $8.8M, or $0.30
per share.
Research and development (R&D) expenses were $21.9M in the first quarter
of 2008, compared to R&D expenses of $16.2M in the first quarter of 2007. The
increase is primarily attributable to costs associated with the advancement of
clinical programs, the costs related to manufacturing lead drug candidates and
the increase in personnel related costs, which included an increase in the
non-cash share-based compensation charge.
General and administrative (G&A) expenses for the first quarter of 2008
were $2.9M compared to G&A expenses of $2.4M for the same quarter in 2007.
The higher G&A expenses were primarily due to an increase in professional fees
and personnel related costs.
As of March 31, 2008, the Company had cash, cash equivalents and
investments of $81.2 million.
"Our financial flexibility and stability will allow us to pursue all of
the significant milestones we have set forth for our pipeline candidates,"
said Jon P. Stonehouse, Chief Executive Officer of BioCryst. "2008 will be a
very active year in the clinic for BioCryst, and we are fortunate to have the
financial basis to advance our drug candidates in order to deliver the
greatest value to both patients and our shareholders."
Recent Corporate Highlights
Forodesine HCl cutaneous T-cell lymphoma (CTCL) trial update and chronic
lymphocytic leukemia (CLL) trial initiation
The forodesine HCl CTCL pivotal trial is enrolling as planned. This trial
has been reviewed under a Special Protocol Assessment (SPA) from the United
States Food & Drug Administration (FDA) to support regulatory approval.
BioCryst has also initiated a second clinical trial for patients with CLL
based upon data presented at the December 2007 ASH meeting, which demonstrated
the potential of forodesine HCl as a treatment for CLL, both as a single agent
and in combination with bendamustine. This second CLL trial is a single-arm
study evaluating single agent forodesine HCl as a treatment for patients with
CLL; response rate is the primary endpoint. The first patient was dosed
during the first quarter 2008, and BioCryst will provide a trial update by
year end.
Intramuscular (i.m.) peramivir clinical development update
BioCryst initiated a Phase III i.m. peramivir trial early this year and
voluntarily discontinued it after 82 of the planned 600 patients had enrolled
because of a decision to pursue higher doses in a Phase II setting. Patients
with influenza A and B were treated with either placebo or 300mg of i.m.
peramivir. Although only 14% of the planned patients were enrolled in the
study, results supported the activity of 300mg peramivir. The study was
designed to show a difference within the influenza A subgroup, where
preliminary clinical data showed a 30 hour reduction in time to alleviation of
symptoms in patients that received peramivir compared to those who received
placebo. Preliminary results from the overall population showed a reduction
in time to alleviation of symptoms of approximately 14 hours. Because the
trial was not carried out to completion, the sample size was small; the
observed treatment effect was not statistically significant.
These results are consistent with data from previous clinical trials:
-- Reductions in time to alleviation of symptoms are consistent with prior
Phase II study results of the 300mg dose of i.m. peramivir.
-- Reductions in viral shedding and percentage of patients shedding virus
were consistent with the data seen in our previous phase II study.
-- Pharmacokinetic data in the treated population indicate that patients
achieved consistent drug levels, which were similar to those seen in
our previous well-controlled Phase I trial.
BioCryst is continuing development of a more concentrated formulation and
plans to test higher doses of i.m. peramivir in the next Phase II study. The
doses to be studied in Phase II will be selected based on a planned mid 2008
analysis of the ongoing Phase I study of the more concentrated formulation.
"We are encouraged by the signs of activity of i.m. peramivir and are
prepared to move forward and evaluate a higher dose. The consistency seen
between the results of our recent clinical trials gives us confidence that
i.m. peramivir has the potential to be an effective treatment for influenza,"
stated Dr. Thomas J. Simon, Interim Chief Medical Officer.
BCX-4208 development update
Following review of a planned interim analysis of the ongoing Phase IIa
trial of BCX-4208 in psoriasis, Roche has terminated its license agreement for
the development of BCX-4208 for autoimmune diseases and transplant. As a
result, BioCryst will regain worldwide rights to BCX-4208. Roche and BioCryst
have agreed to complete the ongoing Phase IIa trial. The planned interim
analysis showed that BCX-4208 was safe and well-tolerated; clinical efficacy
was not demonstrated.
The ongoing Phase IIa trial is a randomized, double blind, placebo
controlled, dose ranging study in 66 patients with moderate to severe plaque
psoriasis. BCX-4208 is administered once a day for 6 weeks at a dose of
either 20mg or 120mg. The primary objectives of this study are to assess the
safety, tolerability, and pharmacokinetic profile of BCX-4208. Secondary
objectives include assessment of pharmacodynamic measures and clinical
response. The planned interim analysis of the Phase IIa trial included 30
patients divided evenly across the three study arms. The safety analysis
includes follow-up on all 30 patients. Of the 30 patients evaluated for
efficacy, 18 patients completed all 6 weeks of dosing. The 12 patients who
discontinued prior to completing 6 weeks of dosing were equally distributed
across the three arms of the study.
In an ongoing Phase I multiple ascending dose study, BCX-4208 showed a
dose response effect on reducing lymphocyte counts at doses up to 1040mg
administered once daily for 7 days. Interim data from the ongoing Phase IIa
study at 20mg and 120mg showed similar dose-dependant effects on reduction of
peripheral blood lymphocyte counts. Affected lymphocyte subsets in the Phase
II study included CD4+, CD8+, CD56+, and CD20+ cells.
"While Roche's decision is disappointing, we are very encouraged by the
effects on lymphocyte counts that we are seeing with BCX-4208. Similar
activity with other experimental and marketed drugs has been associated with
clinical efficacy in the treatment of various autoimmune diseases. Together
with the good safety and tolerability profile of BCX-4208 observed to date,
these data provide a strong scientific rationale for continuing to explore the
activity of BCX-4208 in the treatment of autoimmune diseases," Mr. Stonehouse
commented. "We look forward to evaluating the final data from the full cohort
of 66 subjects later this year."
Conference Call and Webcast
The Company will sponsor a conference call at 8:30 a.m. Eastern Time on
May 8, 2008 to discuss the financial results and the status of each of our
programs in more detail. This call is open to the public and can be accessed
live either over the Internet from www.biocryst.com or by dialing
1-800-860-2442 (U.S.). No passcode is needed for the call.
About BioCryst
BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography
and structure-based drug design for the development of novel therapeutics to
treat cancer, cardiovascular diseases, autoimmune diseases, and viral
infections. The Company is advancing multiple internal programs toward
potential commercialization including forodesine HCl in oncology, BCX-4208 in
psoriasis and peramivir in seasonal and life-threatening influenza. BioCryst
is collaborating with Mundipharma for the development and commercialization of
forodesine HCl in markets acrossEurope,Asia,Australia and certain
neighboring countries. In January 2007, the U.S. Department of Health and
Human Services (HHS) awarded a $102.6 million, four-year contract to BioCryst
to advance development of peramivir to treat seasonal and life-threatening
influenza. In February 2007, BioCryst established a partnership with Shionogi
& Co. to develop and commercialize peramivir inJapan. For more information
about BioCryst, please visit the Company's web site at
http://www.biocryst.com.
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 our belief that many subjects in the
Phase II clinical trials of peramivir did not receive adequate dosing by
intramuscular injection may not be correct, that HHS and the Food & Drug
Administration (FDA) may not agree with our analysis, that HHS may further
condition, reduce or eliminate future funding of the peramivir program, that
the peramivir program may not be successful, that the pivotal trial with
forodesine HCl in cutaneous T-cell lymphoma (CTCL) may not meet its endpoint,
that the Phase II trial of BCX-4208 for psoriasis may not be successfully
completed, that development and commercialization of forodesine HCl in CTCL
may not be successful, 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 FDA, that ongoing and
future preclinical and clinical development may not have positive results,
that we or our licensees may not be able to continue future development of our
current and future development programs, that our development programs may
never result in future product, license or royalty payments being received by
BioCryst, that BioCryst may not be able to retain its current pharmaceutical
and biotechnology partners for further development of its product candidates
or it may not reach favorable agreements with potential pharmaceutical and
biotechnology partners for further development of its product candidates, that
our projected burn rate may not be consistent with our expectations, that
BioCryst may not have sufficient cash to continue funding the development,
manufacturing, marketing or distribution of its products and that additional
funding, if necessary, may not be available at all or on terms acceptable to
BioCryst. Please refer to the documents BioCryst files periodically with the
Securities and Exchange Commission, specifically BioCryst's most recent Annual
Report on Form 10-K, most recent Registration Statement on Form S-3 (File No.
333-145638), Quarterly Reports on Form 10-Q, current reports on Form 8-K which
identify important factors that could cause the actual results to differ
materially from those contained in the projections or forward-looking
statements.
BIOCRYST PHARMACEUTICALS, INC.
FINANCIAL SUMMARY
Statements of Operations (Unaudited)
(in thousands, except per share)
Three Months Ended
March 31,
2008 2007
Revenues:
Collaborative and other research and
development $10,768 $9,159
Expenses:
Research and development 21,898 16,195
General and administrative 2,886 2,372
Total expenses 24,784 18,567
Loss from operations (14,016) (9,408)
Interest and other income 918 583
Net loss $(13,098) $(8,825)
Basic and diluted net loss per
common share $(0.34) $(0.30)
Weighted average shares outstanding 38,059 29,274
Balance Sheet Data (in thousands)
March 31, 2008 December 31, 2007
(Unaudited) (Audited)
Cash, cash equivalents and securities $81,166 $85,009
Receivables from collaborations 28,579 39,128
Total assets 129,144 142,717
Accumulated deficit (237,634) (224,536)
Stockholders' equity 54,223 64,905
SOURCE BioCryst Pharmaceuticals, Inc.
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