Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to
Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest
event reported): May 8, 2008
BioCryst Pharmaceuticals,
Inc.
(Exact name of registrant as
specified in its charter)
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Delaware |
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000-23186 |
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62-1413174 |
(State or other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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2190 Parkway Lake Drive,
Birmingham, Alabama |
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35244 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s telephone number,
including area code: (205) 444-4600
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(Former name or former address if changed since last report.) |
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
1
Item 2.02. Results of
Operations and Financial Condition:
On May 8, 2008,
the Company issued a news release announcing its financial results for the
quarter ended March 31, 2008, which also referenced a conference call to
discuss these results and provide an update on the status of the
Company’s programs. A copy of the news release is furnished as exhibit
99.1 hereto and is incorporated by reference into Item 9.01 of Form 8-K.
Item 9.01. Financial Statements
and Exhibits:
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Exhibit No.
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Description
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99.1
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Press release dated May 8, 2008 entitled
“BioCryst Reports First Quarter 2008 Financial Results and Clinical
Update”. |
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SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
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Dated: May 8, 2008 |
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BioCryst Pharmaceuticals, Inc.
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By: |
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/s/ Michael A.
Darwin |
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Michael A. Darwin |
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Principal Accounting
Officer |
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EXHIBIT INDEX
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Item
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Description
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99.1
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Press release dated May 8, 2008 entitled
“BioCryst Reports First Quarter 2008 Financial Results and Clinical
Update”. |
4
Filed by Bowne Pure Compliance
Exhibit 99.1
BIOCRYST PHARMACEUTICALS, INC.
2190 PARKWAY LAKE DRIVE
BIRMINGHAM, AL 35244
205-444-4600 205-444-4640 FAX
www.biocryst.com
Contact: Stuart Grant, Senior Vice President, Chief Financial Officer of BioCryst Pharmaceuticals
(205) 444-4600
BioCryst Reports First Quarter 2008 Financial Results and Clinical Update
Birmingham, Alabama May 8, 2008 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:
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Reductions in time to alleviation of symptoms are consistent with prior Phase
II study results of the 300mg dose of i.m. peramivir. |
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Reductions in viral shedding and percentage of patients shedding virus were
consistent with the data seen in our previous phase II study. |
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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 Roches 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 across Europe, 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 in
Japan. For more information about BioCryst, please visit the Companys 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 BioCrysts 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.
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BIOCRYST PHARMACEUTICALS, INC.
FINANCIAL SUMMARY
Statements of Operations (Unaudited)
(in thousands, except per share)
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Three Months Ended |
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March 31, |
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2008 |
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2007 |
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Revenues: |
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Collaborative and other research and
development |
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$ |
10,768 |
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$ |
9,159 |
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Expenses: |
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Research and development |
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21,898 |
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16,195 |
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General and administrative |
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2,886 |
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2,372 |
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Total expenses |
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24,784 |
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18,567 |
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Loss from operations |
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(14,016 |
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(9,408 |
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Interest and other income |
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918 |
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583 |
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Net loss |
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$ |
(13,098 |
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$ |
(8,825 |
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Basic and diluted net loss per common share |
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$ |
(0.34 |
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$ |
(0.30 |
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Weighted average shares outstanding |
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38,059 |
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29,274 |
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Balance Sheet Data (in thousands)
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March 31, 2008 |
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December 31, 2007 |
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(Unaudited) |
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(Audited) |
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Cash, cash equivalents and securities |
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$ |
81,166 |
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$ |
85,009 |
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Receivables from collaborations |
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28,579 |
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39,128 |
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Total assets |
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129,144 |
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142,717 |
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Accumulated deficit |
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(237,634 |
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(224,536 |
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Stockholders equity |
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54,223 |
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64,905 |
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