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): February 21, 2014

 

 

BioCryst Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   000-23186   62-1413174

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

4505 Emperor Blvd., Suite 200

Durham, North Carolina 27703

(Address of Principal Executive Offices)

(919) 859-1302

(Registrant’s telephone number, including area code)

(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 (see General Instruction A.2 below):

 

  ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 210.14d-2(b))

 

  ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

Item 1.01. Entry into a Material Definitive Agreement.

On February 21, 2014, BioCryst Pharmaceuticals, Inc. (the “Company”) and the U.S. Department of Health and Human Services (“HHS”) mutually agreed to amend the Agreement dated January 3, 2007 between the Company and HHS (the “Agreement”) to extend the Agreement’s current expiration date of February 28, 2014 for 31 days. The new expiration date is changed to March 31, 2014. The extension of the Agreement will allow ongoing stability testing of peramivir to continue beyond the current contract expiration date. All other terms and conditions of the Agreement remain unchanged.

 

Item 2.02. Results of Operations and Financial Condition.

On February 26, 2014, BioCryst Pharmaceuticals, Inc. issued a news release announcing recent corporate developments and its financial results for the year ended December 31, 2013, which also referenced a conference call and webcast to discuss these recent corporate developments and financial results. A copy of the news release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

 

Item 7.01. Regulation FD Disclosure

The information furnished on Exhibit 99.1 is incorporated by reference under this Item 7.01 as if fully set forth herein.

The information furnished is not deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, is not subject to the liabilities of that section and is not deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

 

Item 8.01. Other Events.

On February 25, 2014, BioCryst Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review the New Drug Application (“NDA”) for intravenous (i.v.) peramivir that was submitted to the FDA in December 2013. The FDA assigned the NDA a standard review time, resulting in a PDUFA (Prescription Drug User Fee Act) action date of December 23, 2014. The FDA has informed BioCryst that at this time it does not plan to hold an Advisory Committee review of the NDA.

In June 2013, BioCryst completed a pre-NDA meeting with the FDA regarding peramivir. BioCryst reached agreement with FDA regarding all requirements for a complete NDA submission. The peramivir NDA submission included results in over 2,700 subjects treated with peramivir in 27 clinical trials. Peramivir has been approved in Japan and Korea. It is estimated that more than one million patients have received peramivir treatment to date.

On February 25, 2014, the Company issued a news release announcing the events described in this Item 8.01. A copy of the news release is filed as Exhibit 99.2 hereto and is incorporated herein by reference.

Forward-Looking Statements

This Current Report on Form 8-K 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 BioCryst’s 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 the FDA may not provide regulatory approval for any use of peramivir or that the approval may be limited; that BARDA/HHS may further condition, reduce or eliminate future funding of the peramivir program; that the Company may not be able to access adequate capital to move peramivir forward; the Company may not be able to successfully commercialize peramivir on its own; that the Company may not reach favorable agreements with potential pharmaceutical and biotechnology partners for the commercialization of peramivir; and that peramivir may never be purchased by any government entity for stockpiling. 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, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit
No.

  

Description

10.1    Amendment #17 to the Agreement between BioCryst Pharmaceuticals, Inc. and the U.S. Department of Health and Human Services, dated February 21, 2014
99.1    Press release dated February 26, 2014 entitled “BioCryst Provides Fourth Quarter and Full Year 2013 Financial Results”
99.2    Press Release dated February 25, 2014 entitled “BioCryst Announces Peramivir NDA Acceptance by the FDA”

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.

 

Dated: February 26, 2014     BioCryst Pharmaceuticals, Inc.
    By:  

/s/ Alane Barnes

      Alane Barnes
     

Vice President, General Counsel, and Corporate Secretary

EXHIBIT INDEX

 

Exhibit
No.

  

Description

10.1    Amendment #17 to the Agreement between BioCryst Pharmaceuticals, Inc. and the U.S. Department of Health and Human Services, dated February 21, 2014
99.1    Press release dated February 26, 2014 entitled “BioCryst Provides Fourth Quarter and Full Year 2013 Financial Results”
99.2    Press Release dated February 25, 2014 entitled “BioCryst Announces Peramivir NDA Acceptance by the FDA”

Exhibit 10.1

 

LOGO

1. CONTRACT ID CODE PAGE OF PAGES AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1 1 2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable) 0017 See Block 16C N/A 6. ISSUED BY CODE ASPR-BARDA 7. ADMINISTERED BY (If other than Item 6) CODE ASPR-BARDA01 ASPR-BARDA ASPR-BARDA 330 INDEPENDENCE AVE SW 330 INDEPENDENCE AVE SW RM G644 ROOM 640-G WASHINGTON DC 20201 WASHINGTON DC 20201 8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NO. BIOCRYST PHARMACEUTICALS, INC. 4505 EMPEROR BOULEVARD, SUITE 200 9B. DATED (SEE ITEM 11) DURHAM, NC 27703 10A. MODIFICATION OF CONTRACT/ORDER NO. HHSO100200700032C 10B. DATED (SEE ITEM 13) CODE FACILITY CODE 01/03/2007 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: (a) By completing items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. 12. ACCOUNTING AND APPROPRIATION DATA (If required) N/A 13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: BILATERAL MODIFICATION AT THE MUTUAL AGREEMENT OF THE PARTIES D. OTHER (Specify type of modification and authority) E. IMPORTANT: Contractor is not, is required to sign this document and return 1 copies to the issuing office. 14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) This Contract’s expiration date is extended by 31 days from 02/28/2014 to 03/31/2014. Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print) KEVIN NILLES 15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED (Signature of person authorized to sign) (Signature of Contracting Officer) NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83) Previous edition unusable Prescribed by GSA FAR (48 CFR) 53.243

Exhibit 99.1

 

LOGO

BIOCRYST REPORTS FOURTH QUARTER AND FULL YEAR 2013 FINANCIAL RESULTS

Research Triangle Park, North Carolina – February 26, 2014 – BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the fourth quarter and full year ended December 31, 2013.

“Since our last quarterly results update, we have initiated the OPuS-1 Phase 2 trial to evaluate orally-administered BCX4161 in patients with hereditary angioedema, advanced two optimized plasma kallikrein inhibitors into preclinical development for HAE and filed BioCryst’s first NDA seeking FDA approval of peramivir,” said Jon P. Stonehouse, President & Chief Executive Officer. “Our team is committed to sustaining the momentum and tight expense management we established last year. In 2014, you can expect us to advance all three of our HAE assets as well as both of our infectious disease programs. This includes making peramivir available in the U.S. for the 2014-15 influenza season, provided our NDA is approved.”

Fourth Quarter Financial Results

For the three months ended December 31, 2013, revenues increased to $10.6 million from $4.1 million in the fourth quarter of 2012, primarily as a result of an increase in collaborative revenue under our contract with the Biomedical Advanced Research and Development Authority/ Health and Human Services (BARDA/HHS) for the development of peramivir. The collaborative revenue from BARDA/HHS was predominantly associated with activities supporting the December 20, 2013 filing of a New Drug Application (NDA) seeking regulatory approval for intravenous (i.v.) peramivir in the U.S.

Research and Development (R&D) expenses for the fourth quarter of 2013 increased to $15.6 million from $11.1 million in the fourth quarter of 2012. The increase in R&D expense in 2013, as compared to the fourth quarter of 2012, resulted from higher development costs associated with the peramivir and hereditary angioedema (HAE) programs, which were partially offset by lower development costs associated with the ulodesine and BCX5191 programs.

General and administrative (G&A) expenses for the fourth quarter of 2013 decreased to $1.3 million compared to $1.9 million in the fourth quarter of 2012, largely due to lower administrative expenses during 2013 as a consequence of restructuring the Company’s operations and cost structure as announced in December 2012.

Interest expense, which is related to non-recourse notes, was $1.2 million in the fourth quarter of 2013 and 2012. Also, a $2.1 million mark-to-market gain on the Company’s foreign currency hedge was recognized in the fourth quarter of 2013, compared to a $782,000 mark-to-market

gain in the fourth quarter of 2012. These gains result from periodic changes in the U.S. dollar/Japanese yen exchange rate and the related mark-to-market valuation of our underlying hedge arrangement.

The net loss for the fourth quarter of 2013 was $5.4 million, or $0.09 per share, compared to a net loss of $11.1 million, or $0.22 per share, for the fourth quarter 2012.

2013 Financial Results

For the year ended December 31, 2013, total revenues decreased to $17.3 million from $26.3 million in 2012. The decrease was primarily due to the recognition of $7.8 million of previously deferred forodesine-related revenue in the first quarter of 2012.

R&D expenses decreased to $42.7 million for 2013 from $51.5 million in 2012. The decrease from 2012 resulted primarily from lower BCX5191 and ulodesine development costs, as well as reduced R&D infrastructure costs. This decrease was partially offset by higher BCX4161 and BCX4430 development costs incurred in 2013. Expenses for 2013 also included a one-time $5.0 million non-cash write-off of a “deferred collaboration costs” asset associated with ulodesine and our Purine Nucleoside Phosphorylase Inhibitor (PNP) licensing agreement. R&D expenses in 2012 included the recognition of $1.9 million of non-cash, previously deferred expenses associated with the transfer of forodesine development activity to Mundipharma International Holdings Ltd. in 2012 and an amendment of the underlying forodesine license agreement.

G&A expenses decreased to $5.2 million in 2013 from $6.8 million in 2012, due to realization of cost containment measures resulting from our 2012 restructuring. Total operating expenses decreased to $48.0 million in 2013 from $60.2 million in 2012. In addition to the decreases in R&D and G&A expenses discussed above, 2012 operating expenses included $1.8 million of restructuring expense, which contributed to the decrease in 2013 operating expenses as compared to 2012.

Interest expense, which is related to non-recourse notes, was $4.8 million in 2013 and $4.7 million in 2012. In addition, a $5.3 million mark-to-market gain on the Company’s foreign currency hedge was recognized in 2013, compared to a $749,000 mark-to-market loss in 2012. These gains/losses result from periodic changes in the U.S. dollar/Japanese yen exchange rate and the related mark-to-market valuation of our underlying hedge arrangement.

The net loss for 2013 decreased to $30.1 million or $0.55 per share, compared to a net loss of $39.1 million, or $0.79 per share for 2012.

Cash, cash equivalents and investments totaled $40.8 million at December 31, 2013 and represented a $3.7 million increase from the $37.1 million at December 31, 2012. Net operating cash use for the fourth quarter of 2013 was $4.4 million. Net operating cash use for 2013 was $22.8 million and decreased 38 percent from $36.8 million utilized in 2012.

Clinical Development Update & Outlook

 

  •   In November, BioCryst dosed the first subject in OPuS-1 ( O ral P rophylaxi S-1 ), a Phase 2a proof of concept clinical trial of orally-administered BCX4161 in patients with hereditary angioedema. The OPuS-1 clinical trial is testing 400 mg of BCX4161 administered three times daily for 28 days in up to 25 HAE patients who have a high frequency of attacks ( ³ 1 per week), in a randomized, placebo-controlled, two-period cross-over design. The ongoing trial has advanced to a point where we now expect to report results by the end of the second quarter 2014.

 

  •   BioCryst announced in December that it has selected two optimized plasma kallikrein inhibitors to advance into preclinical development as potential once-daily, oral treatments for the prevention of HAE attacks.

 

  •   In December, the National Institute of Allergy and Infectious Diseases (NIAID) exercised an additional option to conduct the investigational new drug (IND) enabling program and to submit an IND. This option represented an additional $2.5 million to BioCryst in order to advance the development of BCX4430 as a treatment for Marburg virus disease, and represents a total of $7.5 million of funding granted under a $22 million contract awarded in September 2013.

 

  •   In December, BioCryst submitted a NDA filing for i.v. peramivir to the U.S. Food & Drug Administration (FDA) seeking an indication as the first i.v. neuraminidase inhibitor approved in the U.S. for the treatment of acute uncomplicated influenza in adults. On February 24, 2014, the FDA notified BioCryst that its NDA filing was accepted for standard review with a PDUFA (Prescription Drug User Fee Act) action date of December 23, 2014. The FDA has informed BioCryst that it does not currently plan to hold an Advisory Committee review of the NDA.

 

  •   Peramivir has been developed by BioCryst under a $234.8 million contract from BARDA/HHS since 2007. With the completion of the NDA filing, this development contract is expected to expire on March 31, 2014.

 

  •   Two scientific posters describing BioCryst’s research related to the treatment of HAE are scheduled for presentation at the 2014 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting February 28 - March 4, 2014 in San Diego.

 

  •   BioCryst plans to initiate a new drug discovery program against at least one rare disease target during the first quarter of 2014.

Financial Outlook for 2014

Based upon current trends, assumptions, and development plans, BioCryst expects its 2014 net operating cash use to be in the range of $35 to $43 million, and its operating expenses to be in the range of $48 to $59 million. Our operating expense range excludes equity-based compensation expense due to the difficulty in projecting this expense, as it is impacted by the

volatility and price of the Company’s stock, as well as by the vesting of the Company’s outstanding performance-based stock options. In addition, based upon forecasted development activity and the related revenue under the Company’s U.S. Government contracts, the Company expects its 2014 revenue to decrease from 2013 levels.

Conference Call and Webcast

BioCryst’s leadership team will host a conference call and webcast today, February 26, 2014 at 11:00 a.m. Eastern Time to discuss these financial results and recent corporate developments. To participate in the conference call, please dial 1-877-303-8027 (United States) or 1-760-536-5165 (International). No passcode is needed for the call. The webcast can be accessed by logging onto www.BioCryst.com. Please connect to the website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and rare diseases, with the goal of addressing unmet medical needs of patients and physicians. BioCryst’s core development programs include BCX4161 and two next generation oral inhibitors of plasma kallikrein for hereditary angioedema; peramivir, a viral neuraminidase inhibitor for the treatment of influenza; and BCX4430, a broad spectrum antiviral for hemorrhagic fevers. For more information, please visit the Company’s website at 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 BioCryst’s 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 are 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 BioCryst may not be able to enroll the required number of subjects in its ongoing Phase 2a clinical trial for BCX4161; that the Phase 2a clinical trial for BCX4161 may not have a favorable outcome or be successfully completed; that the Phase 2a clinical trial for BCX4161 may take longer or cost more than expected; that BioCryst or its licensees may not be able to enroll the required number of subjects in planned clinical trials of other product candidates; that the Company or its licensees may not advance human clinical trials with product candidates as expected; that the FDA may require additional studies beyond the studies planned for product candidates, or may not provide regulatory clearances which may result in delay of planned clinical trials, or may impose a clinical hold with respect to such product candidate, or withhold market approval for product candidates; that BioCryst may not receive government funding to further support the development of BCX4430 or peramivir; that BARDA/HHS and

NIAID may further condition, reduce or eliminate future funding; that peramivir may never be approved for any use by the FDA; that ongoing and future preclinical and clinical development of HAE second generation candidates may not have positive results; that the Company or its licensees may not be able to continue development of ongoing and future development programs; that such development programs may never result in future product, license or royalty payments being received; that the Company may not be able to retain its current pharmaceutical and biotechnology partners for further development of its product candidates or may not reach favorable agreements with potential pharmaceutical and biotechnology partners for further development of product candidates, that its actual financial results may not be consistent with its expectations, including that 2013 operating expenses and cash usage may not be within management’s expected ranges. 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, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.

###

BCRXW

CONTACT: Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910

BIOCRYST PHARMACEUTICALS, INC.

FINANCIAL SUMMARY

(in thousands, except per share amounts)

Statements of Operations (Unaudited)

 

     Three Months Ended     Twelve Months Ended  
     December 31,     December 31,  
     2013     2012     2013     2012  

Revenues:

        

Royalty revenue

   $ 520      $ 469      $ 2,562      $ 3,317   

Collaborative and other research and development

     10,047        3,632        14,769        22,976   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     10,567        4,101        17,331        26,293   

Expenses:

        

Research and development

     15,614        11,090        42,730        51,464   

General and administrative

     1,270        1,929        5,220        6,826   

Royalty

     17        18        98        132   

Restructuring costs

     —          1,759        —          1,759   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total expenses

     16,901        14,796        48,048        60,181   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (6,334 )      (10,695 )      (30,717 )      (33,888 ) 

Interest and other income

     21        40        93        222   

Interest expense

     (1,242 )      (1,180 )      (4,778 )      (4,666 ) 

Gain (loss) on foreign currency derivative

     2,126        782        5,294        (749 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (5,429 )    $ (11,053 )    $ (30,108 )    $ (39,081 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per common share

   $ (0.09 )    $ (0.22 )    $ (0.55 )    $ (0.79 ) 
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares outstanding

     59,091        50,883        55,216        49,474   

 

 

Balance Sheet Data (in thousands)

 

     December 31, 2013     December 31, 2012  
     (Unaudited)     (Note 1)  

Cash, cash equivalents and investments

   $ 40,637      $ 36,750   

Restricted cash

     151        308   

Receivables from collaborations

     2,115        4,562   

Total assets

     48,866        57,439   

Non-recourse notes payable

     30,000        30,000   

Accumulated deficit

     (422,709 )      (392,601 ) 

Stockholders’ deficit

     (1,126 )      (454 ) 

Note 1: Derived from audited financial statements.

Exhibit 99.2

 

LOGO

BIOCRYST ANNOUNCES PERAMIVIR NDA ACCEPTANCE BY THE FDA

Research Triangle Park, North Carolina – February 25, 2014 – BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravenous (i.v.) peramivir that was submitted to the FDA in December 2013. The FDA assigned the NDA a standard review time, resulting in a PDUFA (Prescription Drug User Fee Act) action date of December 23, 2014. The FDA has informed BioCryst that at this time, it does not plan to hold an Advisory Committee review of the NDA.

“We are pleased that BioCryst’s first NDA filing has been accepted by the FDA. We believe the approval of peramivir and its mode of i.v. administration would benefit many influenza patients, including those who cannot tolerate treatment by oral or inhaled administration,” said Jon P. Stonehouse, President & Chief Executive Officer. “BioCryst is preparing to make peramivir available in the U.S. during the 2014-15 influenza season, provided approval is granted within that timeframe.”

In June 2013, BioCryst completed a pre-NDA meeting with the FDA regarding peramivir. BioCryst reached agreement with FDA regarding all requirements for a complete NDA submission. The peramivir NDA submission included results in over 2,700 subjects treated with peramivir in 27 clinical trials. Peramivir has been approved in Japan and Korea. It is estimated that more than one million patients have received peramivir treatment to date.

About Peramivir

Peramivir is a potent, intravenously administered investigational anti-viral agent that rapidly delivers high plasma concentrations to the sites of infection. Discovered by BioCryst, peramivir inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against multiple influenza strains, including H7N9 and pandemic H1N1 swine flu viral strains. Peramivir has been developed under a $234.8 million contract from BARDA/HHS. In January 2010, Shionogi & Co., Ltd. launched intravenous peramivir in Japan under the name RAPIACTA ® to treat patients with influenza and in August 2010, Green Cross Corporation announced that it had received marketing and manufacturing authorization for i.v. peramivir in Korea to treat patients with influenza A & B viruses, including H1N1 and avian influenza. For more information about peramivir, please visit BioCryst’s Web site at http://www.biocryst.com/peramivir.

About BioCryst Pharmaceuticals

BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and rare diseases, with the goal of addressing unmet medical needs of patients and physicians. BioCryst’s core development programs include BCX4161 and two next generation oral inhibitors of plasma kallikrein for hereditary angioedema; peramivir, a viral neuraminidase inhibitor for the treatment of influenza; and BCX4430, a broad spectrum antiviral for hemorrhagic fevers. For more information, please visit the Company’s website at 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 BioCryst’s 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 the FDA may not provide regulatory approval for any use of peramivir or that the approval may be limited; that BARDA/HHS may further condition, reduce or eliminate future funding of the peramivir program; that the Company may not be able to access adequate capital to move peramivir forward; the Company may not be able to successfully commercialize peramivir on its own; that the Company may not reach favorable agreements with potential pharmaceutical and biotechnology partners for the commercialization of peramivir; that peramivir may never be purchased by any government entity for stockpiling. 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, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, all of which identify important factors that could cause the actual results to differ materially from those contained in BioCryst’s projections and forward-looking statements.

###

BCRXW

CONTACT: Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910