1. —ORLADEYO (berotralstat) approvals expected in U.S. and Japan in Q4 2020, EU in early 2021—

    —200 mg/400mg BCX9930 data from treatment-naïve PNH patients expected in Q3 2020, 200 mg/400mg data from poor-responders to C5 inhibitors expected by year end 2020 —

    —Information from Part 1 of galidesivir trial in COVID-19 patients expected by end of Q3 2020—

                                                                         

    RESEARCH TRIANGLE PARK, N.C., Aug. 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the second quarter ended June 30, 2020, and provided a corporate update.

    "BioCryst is currently in an exciting transformation from a company primarily focused on R&D to one that is about to launch its first oral drug to patients with HAE (ORLADEYO) this year, generating meaningful revenue starting next year, with global peak sales potential of greater than half a billion dollars. In parallel, we plan to fill our pipeline with a single molecule, BCX9930, by investing to accelerate this program across multiple rare disease indications based on the proof of concept data we have," said Jon Stonehouse, president and chief executive officer of BioCryst.

    "We expect to end the year with ORLADEYO approved in the U.S. and Japan, additional data at 200 mg and 400 mg with BCX9930 in PNH patients, and clinical data from galidesivir in COVID-19 patients," Stonehouse added.

    Program Updates and Key Milestones

    Hereditary Angioedema (HAE) Program – ORLADEYO: Oral, once-daily treatment for prevention of HAE attacks

    • BioCryst expects three regulatory approvals for ORLADEYO in Q4 2020 and early 2021.

       
      • The U.S. Food and Drug Administration (FDA) is reviewing a new drug application for ORLADEYO and has set an action date of December 3, 2020, under the Prescription Drug User Fee Act (PDUFA).

         
      • In Japan, ORLADEYO is being reviewed under Sakigake designation. The Pharmaceutical and Medical Devices Agency (PMDA) has confirmed their regulatory review schedule and the company expects an approval decision in December 2020.

         
      • On March 30, 2020, the company announced that the European Medicines Agency (EMA) had validated its marketing authorization application (MAA) submission for ORLADEYO and begun its formal review of the MAA under the centralized procedure. The company expects an opinion from the Committee for Medicinal Products for Human Use (CHMP) within approximately 12 months from MAA validation.

         
    • BioCryst has completed significant preparations to support the launch of ORLADEYO in the U.S.

       
      • The company has attracted an accomplished U.S. rare disease sales team, which averages 20 years in pharmaceutical sales and nearly a decade of rare disease experience.

         
      • The company is well-positioned in terms of product supply and inventory on-hand to support the launch and anticipated global demand for ORLADEYO.

         
    • On June 9, 2020, the company announced that it had established an expanded access program with ORLADEYO for patients with HAE in the United States. Through this program, physicians may be able to request ORLADEYO for HAE patients who do not have access to the product through a clinical trial.

       
    • On June 6, at the European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress, the company presented new data highlighting the burden of therapy faced by HAE patients taking currently available injectable prophylactic medication. Patients taking oral, once daily ORLADEYO experienced sustained decreases in their attack frequency and improvements in quality of life scores over 48 weeks. ORLADEYO was also safe and generally well-tolerated over 48 weeks in both the APeX-2 and APeX-S clinical trials.

    "Our ongoing dialogue and research with HAE patients and physicians continue to reinforce their strong demand for an oral, once-daily medicine that is safe and provides the significant and sustained attack reduction we are seeing with ORLADEYO in our clinical program. Nearly half of patients in our APeX-2 and APeX-S trials have prior experience with injectable or infused therapies and most have chosen to remain on ORLADEYO," said Charlie Gayer, chief commercial officer of BioCryst.

    Complement Oral Factor D Inhibitor Program – BCX9930

    • On August 3, 2020, the company announced that the FDA has granted Fast Track designation for BCX9930 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). According to the FDA, the purpose of the Fast Track designation is to get important new drugs to the patient earlier by facilitating the development, and expediting the review of, drugs to treat serious conditions and fill an unmet medical need.

       
    • On May 6, 2020, the company reported proof of concept data for BCX9930 in three treatment-naïve PNH patients in the lowest dose cohort of 50 mg (14 days) and 100 mg (14 days) twice-daily. BCX9930 inhibited complement and was safe and generally well tolerated.

       
    • Based on the investigators' assessment, three patients receiving 50 mg and 100 mg twice daily experienced clinical benefit, continued on therapy and are now receiving BCX9930 therapy at higher doses. An additional treatment-naïve PNH cohort, which starts at 200 mg (14 days) followed by 400 mg (14 days) twice-daily, has also begun enrollment. The company expects to report data from treatment-naïve PNH patients receiving 200 mg / 400 mg twice daily in Q3 2020.

       
    • The company plans to report data from PNH patients who are poor responders to C5 inhibitors receiving 200 mg / 400 mg twice daily by the end of 2020.

       
    • Based on the safety and proof-of-concept data generated to date in PNH patients, the company is working closely with key opinion leaders in hematology and nephrology to map the development strategy across a broad set of indications.

    "We plan to meet with regulators later this year to confirm our advanced development plan for BCX9930 in PNH. Because the alternative pathway of complement is also directly related to several complement-mediated diseases, we plan to broaden and accelerate the BCX9930 program to patients in multiple disease areas as quickly as possible," said Dr. William Sheridan, chief medical officer of BioCryst.

     Coronavirus Antiviral Program – Galidesivir (BCX4430)

    • In response to the COVID-19 pandemic, the company is conducting a randomized, double-blind, placebo-controlled clinical trial (NCT03891420) in Brazil to assess the safety, clinical impact and antiviral effects of galidesivir in COVID-19 patients. The company expects to provide information from Part 1 of this ongoing clinical trial by the end of Q3 2020.

       
    • The galidesivir program is being substantially funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA). The goal of the galidesivir clinical program is to evaluate clinical activity that would support additional government investment and advanced development of galidesivir, including additional drug supply.

    Additional Updates

    • The company remains on track to report data in 2H 2020 from its ongoing Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva (FOP), in healthy subjects.

    Second Quarter 2020 Financial Results

    For the three months ended June 30, 2020, total revenues were $2.9 million, compared to $1.4 million in the second quarter of 2019. The increase was primarily due to an increase in collaboration revenue under U.S. government development contracts.

    Research and development (R&D) expenses for the second quarter of 2020 were $27.5 million, similar to $27.7 million in the second quarter of 2019. During the second quarter of 2020, R&D spending increased on the company's complement-mediated diseases and galidesivir programs, which was offset by a reduction in spend on the ORLADEYO program as the company approaches commercial launch.

    Selling, general and administrative (SG&A) expenses for the second quarter of 2020 increased to $13.9 million, compared to SG&A expenses of $8.7 million in the second quarter of 2019. The increase was primarily due to increased spending on commercial activities and medical affairs to support the U.S. commercial launch of ORLADEYO in 2020.

    Interest and other income were $2.8 million in the second quarter of 2020, compared to $0.5 million in the second quarter of 2019. The increase was primarily due to recognition of income from our arbitration proceedings.

    Interest expense was $2.9 million in the second quarter of 2020, compared to $3.0 million in the second quarter of 2019.

    Net loss for the second quarter of 2020 was $38.6 million, or $0.24 per share, compared to a net loss of $37.6 million, or $0.34 per share, for the second quarter of 2019. 

    Cash, cash equivalents and investments and restricted cash totaled $191.6 million at June 30, 2020, and reflect an increase from $137.8 million at December 31, 2019 and $114.6 million at March 31, 2020. Operating cash use for the second quarter of 2020 was $31.8 million.

    Financial Outlook for 2020

    With the additional capital raised in Q2 and the safety and proof-of concept data generated to-date with BCX9930 in PNH patients, the company is investing in accelerated development of BCX9930 and expects full year 2020 net operating cash use to be in the range of $150 to $165 million, and its operating expenses to be in the range of $180 to $195 million. The company's operating expense range excludes equity-based compensation expense due to the difficulty in reliably 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.

    Conference Call and Webcast

    BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 5142479. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 5142479.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO (berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 are identified by use of terms such as "expect," "plan," "anticipate," "will," "may," "project," and similar words, although some forward-looking statements may be expressed differently. 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: the ongoing COVID-19 pandemic, which could create challenges in all aspects of BioCryst's business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst's and its partners' development, regulatory processes and supply chains, could negatively impact BioCryst's ability to access the capital or credit markets to finance its operations, or could have the effect of heightening many of the risks described below or in the documents BioCryst files periodically with the Securities and Exchange Commission; developing and commercializing ORLADEYO or any HAE product candidate may take longer or may be more expensive than planned; ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates as expected; the FDA, EMA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose certain restrictions, warnings, or other requirements on product candidates, may impose a clinical hold with respect to such product candidates, or may withhold market approval for product candidates; product candidates, if approved, may not achieve market acceptance; BioCryst's ability to successfully commercialize its product candidates, manage its growth, and compete effectively; risks related to the international expansion of BioCryst's business; and actual financial results may not be consistent with expectations, including that 2020 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:

    John Bluth

    +1 919 859 7910

    BIOCRYST PHARMACEUTICALS, INC.
    CONSOLIDATED FINANCIAL SUMMARY
    (in thousands, except per share)
                
    Statements of Operations (Unaudited)           
                
      Three Months Ended  Six Months Ended
      June 30,  June 30,
      2020   2019   2020   2019 
    Revenues:           
    Product sales$-  $-  $218  $1,679 
    Royalty revenue 44   696   1,989   3,018 
    Collaborative and other research and development 2,827   752   5,487   2,638 
    Total revenues 2,871   1,448   7,694   7,335 
                  
    Expenses:            
    Cost of product sales -   -   -   1,399 
    Research and development 27,498   27,681   57,365   55,174 
    Selling, general and administrative 13,883   8,659   29,748   14,897 
    Royalty -   26   69   113 
    Total operating expenses 41,381   36,366   87,182   71,583 
                
    Loss from operations (38,510)  (34,918)  (79,488)  (64,248)
                
    Interest and other income 2,758   547   9,204   1,143 
    Interest expense (2,918)  (3,035)  (5,965)  (5,761)
    Gain (loss) on foreign currency derivative 63   (223)  43   183 
                
    Net loss$(38,607) $(37,629) $(76,206) $(68,683)
                
    Basic and diluted net loss per common share$(0.24) $(0.34) $(0.48) $(0.62)
                
    Weighted average shares outstanding 161,569   110,338   157,862   110,253 
                



           
           
    Balance Sheet Data (in thousands)      
     June 30, 2020 December 31, 2019
     (Unaudited) (Note 1)
    Cash, cash equivalents and investments $  189,403  $  136,226 
    Restricted cash    2,188     1,551 
    Receivables from collaborations    3,997     22,146 
    Total assets    214,706     175,282 
    Non-recourse notes payable    29,780     29,561 
    Senior credit facility    50,771     50,309 
    Accumulated deficit    (916,834)    (840,628)
    Stockholders' equity    76,507     38,252 
    Shares of common stock outstanding    176,429     154,082 
             
    Note 1:  Derived from audited financial statements.        

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  2. RESEARCH TRIANGLE PARK, N.C., Aug. 04, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted 20 newly-hired employees inducement options to purchase an aggregate of 290,000 shares of BioCryst common stock on July 31, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

    The options have an exercise price of $4.07 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant…

    RESEARCH TRIANGLE PARK, N.C., Aug. 04, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted 20 newly-hired employees inducement options to purchase an aggregate of 290,000 shares of BioCryst common stock on July 31, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

    The options have an exercise price of $4.07 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO (berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:

    John Bluth

    +1 919 859 7910

    Primary Logo

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  3. RESEARCH TRIANGLE PARK, N.C., Aug. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

    According to the FDA, the purpose of the Fast Track designation is to get important new drugs to the patient earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need.

    A drug that receives Fast Track designation is eligible for some or all of the following:

    • More frequent meetings with FDA to discuss the drug's development plan and ensure collection…

    RESEARCH TRIANGLE PARK, N.C., Aug. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its oral Factor D inhibitor, BCX9930, for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

    According to the FDA, the purpose of the Fast Track designation is to get important new drugs to the patient earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need.

    A drug that receives Fast Track designation is eligible for some or all of the following:

    • More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval.

       
    • More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers.

       
    • Eligibility for accelerated approval and priority review, if relevant criteria are met.

       
    • Rolling review, which means that a drug company can submit completed sections of its new drug application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

    "PNH patients have a tremendous need for therapy improvements and it is exciting for patients that the FDA has reviewed our proof of concept PNH data and granted Fast Track status. This designation can significantly accelerate the development timeline for BCX9930," said Dr. William Sheridan, chief medical officer of BioCryst.

    "We look forward to working closely with the FDA to fully utilize the opportunities presented by our Fast Track designation to advance this important medicine to patients as quickly as possible in PNH. In addition, we look forward to regulatory discussions later this year on clinical trials for BCX9930 in nephrology indications," Sheridan added.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including ORLADEYO™ (berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 potential benefits associated with an FDA Fast Track designation. These statements involve known and unknown risks, uncertainties and other factors which may cause the opportunities associated with the Fast Track designation for BCX9930 to be materially different from those expressed or implied by the forward-looking statements. These statements reflect our current views 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: Fast Track designation by the FDA may not lead to a faster development, regulatory review, or approval process with the FDA and does not increase the likelihood that BCX9930 will receive marketing approval; the ongoing COVID-19 pandemic could create challenges in all aspects of BioCryst's business, including without limitation delays, stoppages, difficulties and increased expenses with respect to BioCryst's and its partners' development, regulatory processes and supply chains, negatively impact BioCryst's ability to access the capital or credit markets to finance its operations, or have the effect of heightening many of the risks described below or in the documents BioCryst files periodically with the Securities and Exchange Commission; ongoing and future preclinical and clinical development of BCX9930 may not have positive results; BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; BioCryst may not advance human clinical trials with product candidates as expected; and the FDA may require additional studies beyond the studies planned for product candidates, may not provide regulatory clearances which may result in delay of planned clinical trials, may impose a clinical hold with respect to such product candidates, or may withhold market approval for product candidates.  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:

    John Bluth

    +1 919 859 7910

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  4. RESEARCH TRIANGLE PARK, N.C., July 23, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will report its second quarter 2020 financial results on Thursday, August 6, 2020.

    BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 5142479. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic…

    RESEARCH TRIANGLE PARK, N.C., July 23, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will report its second quarter 2020 financial results on Thursday, August 6, 2020.

    BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 5142479. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 5142479.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:

    John Bluth

    +1 919 859 7910

    Primary Logo

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  5. RESEARCH TRIANGLE PARK, N.C., July 02, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees inducement options to purchase an aggregate of 70,000 shares of BioCryst common stock on June 30, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

    The options have an exercise price of $4.77 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the…

    RESEARCH TRIANGLE PARK, N.C., July 02, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees inducement options to purchase an aggregate of 70,000 shares of BioCryst common stock on June 30, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with Nasdaq Listing Rule 5635(c)(4).

    The options have an exercise price of $4.77 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:

    John Bluth

    +1 919 859 7910

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  6. Data published in Science Translational Medicine

    —Broad-spectrum antiviral activity against multiple RNA viruses

    RESEARCH TRIANGLE PARK, N.C., June 10, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced new data published in Science Translational Medicine show, in a primate model, that galidesivir was safe, provided post-exposure prevention of Zika viral replication across a range of doses, and rapidly reduced viral loads to undetectable levels when dosed up to 72 hours after infection with Zika virus.

    "Galidesivir reduced Zika virus replication from the first dose administered without impairing the adaptive immune response that protects against subsequent infection. These data provide an encouraging…

    Data published in Science Translational Medicine

    —Broad-spectrum antiviral activity against multiple RNA viruses

    RESEARCH TRIANGLE PARK, N.C., June 10, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced new data published in Science Translational Medicine show, in a primate model, that galidesivir was safe, provided post-exposure prevention of Zika viral replication across a range of doses, and rapidly reduced viral loads to undetectable levels when dosed up to 72 hours after infection with Zika virus.

    "Galidesivir reduced Zika virus replication from the first dose administered without impairing the adaptive immune response that protects against subsequent infection. These data provide an encouraging foundation for studying SARS-CoV-2, another RNA-replicating virus, in this same animal species," said James B. Whitney, Ph.D., assistant professor of medicine at Harvard Medical School and lead author of the study.

    "The rapid reduction in Zika viral load we see in this robust animal model further demonstrates the broad antiviral potential of galidesivir against multiple pathogens. The current COVID-19 pandemic has reinforced the urgent global need for effective broad-spectrum antiviral therapies to combat these outbreaks," said Dr. William Sheridan, chief medical officer of BioCryst.

    Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well tolerated in previously reported Phase 1 trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS. A Phase 1 trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19 is currently enrolling patients across multiple sites in Brazil.

    Zika Study Details

    In the Zika virus study of galidesivir, 70 Rhesus macaques were studied with different routes of infection, different doses of galidesivir, and galidesivir treatment initiated at different time points after infection.  Endpoints included Zika virus RNA quantity in plasma, saliva, urine, and cerebrospinal fluid (CSF), and a variety of immunologic measurements, including antibody seroconversion to Zika virus.  Galidesivir was safe and showed robust antiviral activity at all stages of Zika infection and at multiple different doses.  Zika-infected animals that were treated with galidesivir developed an immune response to Zika that was protective against subsequent Zika re-challenge.

    About Galidesivir (BCX4430)

    Galidesivir, a broad-spectrum antiviral drug, is an adenosine nucleoside analog that acts to block viral RNA polymerase. It is in advanced development for the treatment of COVID-19, Marburg virus disease and Yellow Fever. Phase 1 clinical safety and pharmacokinetics trials of galidesivir by both intravenous and intramuscular routes of administration in healthy subjects have been completed. In animal studies, galidesivir has demonstrated activity against a variety of serious pathogens, including Ebola, Marburg, Yellow Fever and Zika viruses. Galidesivir has also demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including coronaviruses, filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, and flaviviruses. BioCryst is developing galidesivir in collaboration with U.S. government agencies and other institutions.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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, performance 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 developing and manufacturing any product candidate, including galidesivir, may take longer or may be more expensive than planned; that funding for the continued development and manufacture of galidesivir may not be available; that ongoing and future preclinical and clinical studies with galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates, including galidesivir; that BioCryst may not advance human clinical trials with product candidates, including galidesivir, as expected; that the FDA, EMA, PMDA, ANVISA, CONEP or other applicable regulatory or ethics agency decisions may be negatively impacted by the COVID-19 pandemic; that such agencies 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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:

    John Bluth

    +1 919 859 7910

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  7. RESEARCH TRIANGLE PARK, N.C., June 09, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company has established an expanded access program (EAP) with oral, once-daily berotralstat, an investigational drug, for patients with hereditary angioedema (HAE) in the United States.

    Through this program, physicians may be able to request berotralstat for HAE patients who do not have access to the product through a clinical trial.

    According to the U.S. Food and Drug Administration (FDA), expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical…

    RESEARCH TRIANGLE PARK, N.C., June 09, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company has established an expanded access program (EAP) with oral, once-daily berotralstat, an investigational drug, for patients with hereditary angioedema (HAE) in the United States.

    Through this program, physicians may be able to request berotralstat for HAE patients who do not have access to the product through a clinical trial.

    According to the U.S. Food and Drug Administration (FDA), expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

    Requests for expanded access to berotralstat must be made by a U.S. licensed physician. Physicians can request access for a patient by sending an email to or calling 1-888-225-8677.

    A new drug application for berotralstat is currently under review by the FDA with an action date of December 3, 2020 under the Prescription Drug User Fee Act (PDUFA).

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 the ongoing COVID-19 pandemic could create challenges in all aspects of our business, including without limitation delays, stoppages, difficulties and increased expenses with respect to our and our partners' development, regulatory processes and supply chains, could negatively impact our ability to access the capital or credit markets to finance our operations, or could have the effect of heightening many of the risks described below or in the documents we file periodically with the Securities and Exchange Commission; that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that BioCryst may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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:

    John Bluth

    +1 919 859 7910

    Primary Logo

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  8. RESEARCH TRIANGLE PARK, N.C., June 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today presented findings from two patient surveys conducted to gain insights into patients' current hereditary angioedema (HAE) treatment expectations, experience and satisfaction. Patient-reported attack history shows patients treated with current injectable or infused prophylactic medications (Takhzyro®, Haegarda®, Cinryze®) continue to experience breakthrough attacks with a mean ranging from 0.9 to 1.8 attacks over the three months prior to survey.

    In addition, the majority of patients surveyed did not expect to have zero attacks even when taking prophylaxis therapy.

    The data were presented at the European Academy of Allergy and…

    RESEARCH TRIANGLE PARK, N.C., June 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today presented findings from two patient surveys conducted to gain insights into patients' current hereditary angioedema (HAE) treatment expectations, experience and satisfaction. Patient-reported attack history shows patients treated with current injectable or infused prophylactic medications (Takhzyro®, Haegarda®, Cinryze®) continue to experience breakthrough attacks with a mean ranging from 0.9 to 1.8 attacks over the three months prior to survey.

    In addition, the majority of patients surveyed did not expect to have zero attacks even when taking prophylaxis therapy.

    The data were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress.

    "While the injectable and infused medications introduced over the past 12 years have provided added prophylactic attack control for HAE patients, most patients in the study continue to experience breakthrough attacks, and medication adherence continues to be a challenge. HAE patients have indicated an interest in new preventative treatment options, with the majority agreeing that they would prefer an oral medication, despite liking their current prophylactic medication," said Jinky Rosselli, vice president of global business analysis and operations at BioCryst, who conducted the research.  

    Study Methods and Results

    Study participants were U.S. adult patients with a diagnosis of Type I or Type II HAE.  Patients participated in surveys in 2018 (n=75) and 2019 (n=100). Two patients participated in both surveys. The patient surveys were conducted anonymously in compliance with the EphMRA code of conduct. 

    • In the 2019 survey, 85 percent of patients reported taking at least one medicine to prevent HAE attacks, compared to 64 percent in the 2018 survey.

       
    • The majority (89 percent) of patients using prophylaxis in the 2019 survey reported using at least one of the three most commonly prescribed injectable or infused prophylactic therapies.

       
    • Over the three months prior to the survey, these patients reported a mean of 0.9, 1.6 and 1.8 attacks while taking Haegarda®, Cinryze® and Takhzyro®, respectively.  Patients taking these injectable or infused therapies reported similar attack rates in the 2018 study.



    • In the 2019 survey, 21 percent of patients using prophylaxis reported the expectation to have zero attacks over the next 12 months.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 the ongoing COVID-19 pandemic could create challenges in all aspects of our business, including without limitation delays, stoppages, difficulties and increased expenses with respect to our and our partners' development, regulatory processes and supply chains, could negatively impact our ability to access the capital or credit markets to finance our operations, or could have the effect of heightening many of the risks described below or in the documents we file periodically with the Securities and Exchange Commission; that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that BioCryst may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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:

    John Bluth

    +1 919 859 7910

     

    Primary Logo

    View Full Article Hide Full Article
  9. RESEARCH TRIANGLE PARK, N.C., June 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced new data from the APeX-2 and APeX-S clinical trials, which showed that hereditary angioedema (HAE) patients taking oral, once-daily berotralstat experienced sustained decreases in their attack frequency and improvements in quality of life (QoL) scores over 48 weeks. Berotralstat was also safe and generally well-tolerated over 48 weeks in both APeX-2 and APeX-S.

    The data were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress.

    "As HAE patients continue in our long‑term clinical trials, we are seeing reductions in attack rate and increases in QoL scores which highlight the impact…

    RESEARCH TRIANGLE PARK, N.C., June 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced new data from the APeX-2 and APeX-S clinical trials, which showed that hereditary angioedema (HAE) patients taking oral, once-daily berotralstat experienced sustained decreases in their attack frequency and improvements in quality of life (QoL) scores over 48 weeks. Berotralstat was also safe and generally well-tolerated over 48 weeks in both APeX-2 and APeX-S.

    The data were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress.

    "As HAE patients continue in our long‑term clinical trials, we are seeing reductions in attack rate and increases in QoL scores which highlight the impact oral, once-daily berotralstat could have in reducing the burden of disease for patients currently dependent on injectable or infused prophylaxis options," said Dr. William Sheridan, chief medical officer of BioCryst. 

    • In APeX-2, 31 patients who were randomized to 150 mg of oral, once-daily berotralstat at the beginning of the study and completed 48 weeks of therapy had a mean baseline attack rate of 2.9 attacks per month, which declined to 1.5 attacks per month after one month and to 1.0 attack per month at 12 months.

       
    • In APeX-S, patients completing 48 weeks of treatment on 150 mg of berotralstat (n=73) had a median attack rate of zero attacks per month in six of the 12 months, including month 12 (week 48).

       
    • The low attack rate experienced by HAE patients on 150 mg of oral, once-daily berotralstat reduced the burden of disease and translated into clinically meaningful improvements in mean angioedema quality of life (AE-QoL) total score, as measured by the disease-specific AE-QoL questionnaire.  This persisted through month 12 (week 48) in the APeX-S trial.

       
      • Improvements in mean change from baseline AE-QoL total score exceeding the minimum clinically important difference (MCID) of six points were observed by week four and at week 48 the mean AE-QoL total score for the berotralstat 150-mg treatment group had decreased by 14.7 points compared with baseline.

    An integrated 48-week analysis across both APeX-2 and APeX-S showed no new safety findings. Berotralstat was safe and generally well tolerated in a total of 342 patients with a total of 232 patient-years of daily oral dosing. The most common adverse event was the common cold, which occurred with similar frequency in berotralstat and placebo patients. Gastrointestinal events led to discontinuation of berotralstat in 3.2 percent of patients. Drug-related serious adverse events occurred in three of 342 subjects (0.9 percent) and resolved after stopping or interrupting berotralstat dosing.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 the ongoing COVID-19 pandemic could create challenges in all aspects of our business, including without limitation delays, stoppages, difficulties and increased expenses with respect to our and our partners' development, regulatory processes and supply chains, could negatively impact our ability to access the capital or credit markets to finance our operations, or could have the effect of heightening many of the risks described below or in the documents we file periodically with the Securities and Exchange Commission; that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that BioCryst may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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:

    John Bluth

    +1 919 859 7910

     

    Primary Logo

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  10. RESEARCH TRIANGLE PARK, N.C., June 02, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees inducement options to purchase an aggregate of 147,500 shares of BioCryst common stock on May 29, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $4.50 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant…

    RESEARCH TRIANGLE PARK, N.C., June 02, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees inducement options to purchase an aggregate of 147,500 shares of BioCryst common stock on May 29, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $4.50 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  11. RESEARCH TRIANGLE PARK, N.C., June 01, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today the completion of an underwritten public offering of 22,044,447 shares of its common stock, including 3,333,334 shares sold pursuant to the exercise in full of the underwriters' option to purchase additional shares, and of pre-funded warrants to purchase up to an aggregate of 3,511,111 shares of common stock.  The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters' option to purchase additional shares, were approximately $115 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst. 

    BioCryst expects…

    RESEARCH TRIANGLE PARK, N.C., June 01, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today the completion of an underwritten public offering of 22,044,447 shares of its common stock, including 3,333,334 shares sold pursuant to the exercise in full of the underwriters' option to purchase additional shares, and of pre-funded warrants to purchase up to an aggregate of 3,511,111 shares of common stock.  The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters' option to purchase additional shares, were approximately $115 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst. 

    BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory, pre-launch and commercial activities for the prophylactic berotralstat (BCX7353) program in the United States and European Union; advancement of the worldwide development, manufacturing, regulatory and clinical activities for BCX9930 for complement-mediated diseases; post-approval commitments for RAPIVAB™/ALPIVAB™; and capital expenditures and other general working capital needs.

    J.P. Morgan and Piper Sandler acted as joint book-running managers for the offering. H.C. Wainwright & Co. and JMP Securities acted as lead managers for the offering.

    A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

    This offering was made by means of a prospectus supplement and related prospectus.  A prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov.  Copies of the final prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-866-803-9204 or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at .

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding future results and achievements and use of proceeds. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, achievements, or outcomes to be materially different from any future results, performances, achievements, or outcomes expressed or implied by the forward-looking statements, including risks and uncertainties associated with market conditions and other risks and uncertainties inherent in BioCryst's business. Please refer to the documents that BioCryst files periodically with the SEC, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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:
    John Bluth
    +1 919 859 7910

    Primary Logo

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  12. RESEARCH TRIANGLE PARK, N.C., May 28, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 10:30 a.m. ET.

    Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals
    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment…

    RESEARCH TRIANGLE PARK, N.C., May 28, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 10:30 a.m. ET.

    Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals
    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
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  13. RESEARCH TRIANGLE PARK, N.C., May 27, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today the pricing of an underwritten public offering of 18,711,113 shares of its common stock, offered at a price to the public of $4.50 per share. In addition, and in lieu of common stock, BioCryst is offering to certain investors pre-funded warrants to purchase up to an aggregate of 3,511,111 shares of common stock at a purchase price of $4.49 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds from this offering to BioCryst are expected to be $100 million, before deducting underwriting…

    RESEARCH TRIANGLE PARK, N.C., May 27, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today the pricing of an underwritten public offering of 18,711,113 shares of its common stock, offered at a price to the public of $4.50 per share. In addition, and in lieu of common stock, BioCryst is offering to certain investors pre-funded warrants to purchase up to an aggregate of 3,511,111 shares of common stock at a purchase price of $4.49 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds from this offering to BioCryst are expected to be $100 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by BioCryst. 

    BioCryst has granted the underwriters a 30-day option to purchase up to an additional 3,333,334 shares of its common stock. The offering is expected to close on or about June 1, 2020, subject to customary closing conditions. BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory, pre-launch and commercial activities for the prophylactic berotralstat (BCX7353) program in the United States and European Union; advancement of the worldwide development, manufacturing, regulatory and clinical activities for BCX9930 for complement-mediated diseases; post-approval commitments for RAPIVABTM/ALPIVABTM; and capital expenditures and other general working capital needs.

    J.P. Morgan and Piper Sandler are acting as joint book-running managers for the offering. H.C. Wainwright & Co. and JMP Securities are acting as lead managers for the offering.

    A shelf registration statement on Form S-3 relating to the securities being offered by BioCryst has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

    This offering is being made by means of a prospectus supplement and related prospectus. A preliminary prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement, when available, and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-866-803-9204 or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at .

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding future results and achievements, use of proceeds and the completion of this offering. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, achievements, or outcomes to be materially different from any future results, performances, achievements, or outcomes expressed or implied by the forward-looking statements, including risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to this offering and other risks and uncertainties inherent in BioCryst's business. Please refer to the documents that BioCryst files periodically with the SEC, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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

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    +1 919 859 7910

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  14. RESEARCH TRIANGLE PARK, N.C., May 27, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that it is offering to sell $100 million of its common stock and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock in an underwritten public offering. As part of this offering, BioCryst intends to grant the underwriters a 30-day option to purchase additional shares of common stock in an amount equal to up to 15% of the securities offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    J.P. Morgan and…

    RESEARCH TRIANGLE PARK, N.C., May 27, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that it is offering to sell $100 million of its common stock and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock in an underwritten public offering. As part of this offering, BioCryst intends to grant the underwriters a 30-day option to purchase additional shares of common stock in an amount equal to up to 15% of the securities offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    J.P. Morgan and Piper Sandler are acting as joint book-running managers for the offering.

    All of the securities to be sold in the offering are being sold by BioCryst, with the proceeds to be used for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory, pre-launch and commercial activities for the prophylactic berotralstat (BCX7353) program in the United States and European Union; advancement of the worldwide development, manufacturing, regulatory and clinical activities for BCX9930 for complement-mediated diseases; post-approval commitments for RAPIVABTM/ALPIVABTM; and capital expenditures and other general working capital needs.

    A shelf registration statement on Form S-3 relating to the securities being offered by BioCryst has been previously filed with and declared effective by the U.S. Securities and Exchange Commission (SEC). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

    This offering is being made by means of a prospectus supplement and related prospectus. A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-866-803-9204, or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at .

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding future results and achievements, use of proceeds, granting the underwriters an option to purchase additional shares and the completion of this offering. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, achievements, or outcomes to be materially different from any future results, performances, achievements, or outcomes expressed or implied by the forward-looking statements, including risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to this offering and other risks and uncertainties inherent in BioCryst's business. Please refer to the documents that BioCryst files periodically with the SEC, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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

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    John Bluth
    +1 919 859 7910
     

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  15. RESEARCH TRIANGLE PARK, N.C., May 26, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present new data on berotralstat (BCX7353), an oral, once-daily therapy under regulatory review in the United States, Japan and the European Union for the prevention of hereditary angioedema (HAE) attacks, at the upcoming digital congress of the European Academy of Allergy and Clinical Immunology (EAACI) June 6-8.  EAACI plans to make content from the congress available at 9:00a CET on June 6.

    • Long-Term Safety and Tolerability of Berotralstat (BCX7353) for Hereditary Angioedema (HAE) Prophylaxis: APeX-S Study Results; oral abstract session 21 (#484)
       
    • Berotralstat (BCX7353) Treatment Demonstrates

    RESEARCH TRIANGLE PARK, N.C., May 26, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present new data on berotralstat (BCX7353), an oral, once-daily therapy under regulatory review in the United States, Japan and the European Union for the prevention of hereditary angioedema (HAE) attacks, at the upcoming digital congress of the European Academy of Allergy and Clinical Immunology (EAACI) June 6-8.  EAACI plans to make content from the congress available at 9:00a CET on June 6.

    • Long-Term Safety and Tolerability of Berotralstat (BCX7353) for Hereditary Angioedema (HAE) Prophylaxis: APeX-S Study Results; oral abstract session 21 (#484)
       
    • Berotralstat (BCX7353) Treatment Demonstrates Robust and Durable Reduction in the Rate of Hereditary Angioedema (HAE) Attacks Over 48 Weeks of the Phase 3 APeX-2 Study; poster discussion session 06 (#1406)
       
    • Berotralstat (BCX7353) Treatment Following 24-Weeks of Placebo Results in Rapid and Sustained Reduction in the Rate of Hereditary Angioedema (HAE) Attacks: APeX-2 Study Results; thematic poster session 07 (#1219)
       
    • Berotralstat (BCX7353) Treatment Demonstrates Robust and Durable Reduction in the Rate of Hereditary Angioedema (HAE) Attacks Over 48 Weeks of the Phase 3 APeX-2 Study; thematic poster session 07 (#1241)
       
    • Hereditary Angioedema Patients in the United States Report Expanded Use of Prophylaxis, but Continue to Experience Attacks; thematic poster session 07 (#196)

    "As berotralstat gets closer to potential approval in Japan and the U.S. later this year, and the EU early next year, it is exciting to share additional data highlighting the meaningful impact an oral, once-daily medicine is having for HAE patients in our clinical program," said Dr. William Sheridan, chief medical officer of BioCryst.  

    About BioCryst Pharmaceuticals
    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 the ongoing COVID-19 pandemic could create challenges in all aspects of our business, including without limitation delays, stoppages, difficulties and increased expenses with respect to our and our partners' development, regulatory processes and supply chains, could negatively impact our ability to access the capital or credit markets to finance our operations, or could have the effect of heightening many of the risks described below or in the documents we file periodically with the Securities and Exchange Commission; that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that BioCryst may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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

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    John Bluth
    +1 919 859 7910

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  16. RESEARCH TRIANGLE PARK, N.C., May 15, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced companywide activities in support of hae day :-) 2020, a global awareness day for hereditary angioedema (HAE).

    BioCryst stands in solidarity with the HAE community by participating in the annual HAE Global Walk. Since actual community walks cannot currently be organized, BioCryst employees around the world are joining virtually with others supporting hae day :-) by logging their steps and photographing their activities to raise awareness of HAE.

    "HAE is a rare genetic disorder that causes swelling to various parts of the body, and can be fatal when the swelling affects the throat due to the risk of suffocation," said…

    RESEARCH TRIANGLE PARK, N.C., May 15, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced companywide activities in support of hae day :-) 2020, a global awareness day for hereditary angioedema (HAE).

    BioCryst stands in solidarity with the HAE community by participating in the annual HAE Global Walk. Since actual community walks cannot currently be organized, BioCryst employees around the world are joining virtually with others supporting hae day :-) by logging their steps and photographing their activities to raise awareness of HAE.

    "HAE is a rare genetic disorder that causes swelling to various parts of the body, and can be fatal when the swelling affects the throat due to the risk of suffocation," said Henrik Balle Boysen, executive vice president and chief operating officer of HAE International, the international patient organization leading hae day :-).

    "hae day :-) is an important part of HAE International's comprehensive global awareness raising initiative to facilitate faster diagnosis and access to life saving HAE therapies," he added.

    "We have heard consistently from HAE patients and their physicians that an oral prophylactic therapy would be life-changing. With potential approvals of oral, once-daily berotralstat beginning around the world later this year, and the exceptional commercial team we are building, BioCryst is excited to deliver our innovative new therapy to them," said Charlie Gayer, chief commercial officer of BioCryst.

    About BioCryst Pharmaceuticals
    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 the ongoing COVID-19 pandemic could create challenges in all aspects of our business, including without limitation delays, stoppages, difficulties and increased expenses with respect to our and our partners' development, regulatory processes and supply chains, could negatively impact our ability to access the capital or credit markets to finance our operations, or could have the effect of heightening many of the risks described below or in the documents we file periodically with the Securities and Exchange Commission; that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that BioCryst may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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

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    John Bluth
    +1 919 859 7910

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  17. RESEARCH TRIANGLE PARK, N.C., May 07, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the Bank of America 2020 Healthcare Conference on Thursday, May 14, 2020 at 9:00 a.m. ET and the 2020 RBC Capital Markets Global Healthcare Conference on Wednesday, May 20, 2020 at 3:40 p.m. ET. Both are being conducted as virtual conferences.

    About BioCryst Pharmaceuticals 
    Links to a live audio webcast and replay of these presentations may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays…

    RESEARCH TRIANGLE PARK, N.C., May 07, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the Bank of America 2020 Healthcare Conference on Thursday, May 14, 2020 at 9:00 a.m. ET and the 2020 RBC Capital Markets Global Healthcare Conference on Wednesday, May 20, 2020 at 3:40 p.m. ET. Both are being conducted as virtual conferences.

    About BioCryst Pharmaceuticals 
    Links to a live audio webcast and replay of these presentations may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

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    John Bluth
    +1 919 859 7910
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  18. —Berotralstat approval/launch timelines in U.S., Japan, EU remain on track—

    —Early clinical data supports BCX9930 as oral monotherapy for complement-mediated diseases—

    —Patient dosing underway in galidesivir trial in COVID-19 patients in Brazil—

    RESEARCH TRIANGLE PARK, N.C., May 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the first quarter ended March 31, 2020, and provided a corporate update.

    "This is a transformational year for BioCryst as we prepare to launch berotralstat in multiple territories to bring our oral, once-daily prophylactic medicine to HAE patients, and begin generating significant revenue," said Jon Stonehouse, president and chief executive officer of BioCryst…

    —Berotralstat approval/launch timelines in U.S., Japan, EU remain on track—

    —Early clinical data supports BCX9930 as oral monotherapy for complement-mediated diseases—

    —Patient dosing underway in galidesivir trial in COVID-19 patients in Brazil—

    RESEARCH TRIANGLE PARK, N.C., May 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the first quarter ended March 31, 2020, and provided a corporate update.

    "This is a transformational year for BioCryst as we prepare to launch berotralstat in multiple territories to bring our oral, once-daily prophylactic medicine to HAE patients, and begin generating significant revenue," said Jon Stonehouse, president and chief executive officer of BioCryst.

    "We are excited to see the clinical response in treatment-naïve PNH patents at the 50 mg and 100 mg twice-daily dose levels, and more than 98 percent suppression of complement in both alternative pathway assays at the 200 mg and 400 mg twice-daily levels in healthy volunteers," said Dr. William Sheridan, chief medical officer of BioCryst. 

    "This profile provides strong support for BCX9930 as an oral monotherapy. We look forward to studying 200 mg and 400 mg twice-daily in PNH patients and advancing this program to treat multiple complement-mediated diseases," Sheridan added.

    Program Updates and Key Milestones

    Hereditary Angioedema (HAE) Program – Berotralstat (BCX7353): Oral, once-daily treatment for prevention of HAE attacks

    • BioCryst expects three regulatory approvals for berotralstat in 2020 and early 2021. These timelines remain on track.
       
      • The U.S. Food and Drug Administration (FDA) is currently reviewing a new drug application for berotralstat and has set an action date of December 3, 2020, under the Prescription Drug User Fee Act (PDUFA).
         
      • In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing a new drug application (JNDA) for berotralstat under the Sakigake timeline, and the company expects approval in Japan in the second half of 2020.
         
      • On March 30, 2020, the company announced that the European Medicines Agency (EMA) had validated its marketing authorization application (MAA) submission for berotralstat and begun their formal review of the MAA under the centralized procedure. An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected within approximately 12 months from MAA validation.
         
    • Ongoing commercial launch preparations are on track in the U.S., EU and Japan. The company does not expect delays due to COVID-19.  
       
    • On May 5, 2020, the company announced that the United States Patent and Trademark Office issued a notice of allowance for a new composition of matter patent which extends patent protection for berotralstat in the U.S. market by four years through October 2039. 

    Complement Oral Factor D Inhibitor Program – BCX9930

    • Low dose cohort (50 mg and 100 mg twice-daily) data in three treatment-naïve paroxysmal nocturnal hemoglobinuria (PNH) patients who completed 28 days of therapy shows BCX9930 inhibited complement and was safe and generally well tolerated.
       
      • Patients were severely ill with pre-treatment LDH from 3.7 to 11× the upper limit of normal (ULN) and low hemoglobin of 6.0 to 8.2 g/dL.
         
      • All patients had dose-dependent reductions in LDH and increases in hemoglobin.
         
      • No drug-related serious adverse events were observed.
         
      • No PNH patients experienced rash.
         
      • Based on the investigators' assessment of clinical benefit, all three patients continued on therapy with BCX9930 (100 mg twice-daily) following the 28-day study window.
         
    • With the recent enrollment of a fourth patient with PNH, enrollment is now complete in treatment-naïve cohort 1 (50 mg and 100 mg twice-daily). Treatment-naïve cohort 2 (200 mg and 400 mg twice-daily) is expected to begin enrollment upon completion of cohort 1, with data expected in Q3 2020.
       
    • The company plans to begin enrolling PNH patients resistant to C5 inhibitors in Q3 2020 and expects to report data from these treatment-resistant patients by the end of 2020.
       
    • Data from the 200 mg and 400 mg twice-daily multiple ascending dose (MAD) cohorts in healthy volunteers shows >98 percent suppression of the alternative pathway beyond 12 hours and no dose-limiting adverse events. 

    Given these data, the company expects to achieve its goal of monotherapy for PNH patients in cohort 2 (200 mg and 400 mg twice-daily).
                 
    Additional details can be found on slides, which can be accessed at the Investors' section of BioCryst's website at http://www.biocryst.com.

    Coronavirus Antiviral Program – Galidesivir (BCX4430)

    • Patient dosing is underway in Brazil in a randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19. The trial (NCT03891420) is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
       
      • Part 1 of the trial is enrolling 24 hospitalized adults diagnosed with moderate to severe COVID-19 confirmed by PCR. Three cohorts of eight patients will be randomized to receive intravenous (IV) galidesivir (n=6) or placebo (n=2) every 12 hours for seven days. Upon completion of part 1 of the trial, an optimized dosing regimen of galidesivir will be selected for part 2 of the trial, based on part 1 results. In part 2 of the trial, up to 42 hospitalized patients with COVID-19 will be randomized 2:1 to receive IV galidesivir or placebo.
         
    • In vitro testing of galidesivir against SARS-CoV-2, the virus that causes COVID-19, is underway. Galidesivir has been shown to be active against more than 20 RNA viruses in nine different families, including coronaviruses.
       
    • The company also is working closely with the government to increase the supply of galidesivir.

    Additional Updates

    • On April 2, 2020, the company announced the appointment of Anthony Doyle as senior vice president and chief financial officer.
       
    • The company remains on track to report data in 2H 2020 from its ongoing Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva (FOP), in healthy subjects.

    First Quarter 2020 Financial Results

    For the three months ended March 31, 2020, total revenues were $4.8 million, compared to $5.9 million in the first quarter of 2019. The decrease was primarily due to reduced peramivir product sales and lower royalty revenues, partially offset by amortization of deferred revenue from the Torii Pharmaceutical, Co. commercialization agreement.

    Research and development (R&D) expenses for the first quarter of 2020 increased to $29.9 million from $27.5 million in the first quarter of 2019, primarily due to due to increased spending on the company's complement-mediated diseases program and other preclinical development initiatives.

    Selling, general and administrative (SG&A) expenses for the first quarter of 2020 increased to $15.9 million, compared to $6.2 million in the first quarter of 2019. The increase was primarily due to increased spending on commercial activities and medical affairs to support the U.S. commercial launch of berotralstat in 2020 and contingent legal costs associated with our Seqirus UK Limited (Seqirus) dispute.

    Interest and other income were $6.4 million in the first quarter of 2020, compared to $0.6 million in the first quarter of 2019. The increase was primarily due to the partial arbitration award related to our Seqirus dispute.

    Interest expense was $3.0 million in the first quarter of 2020, compared to $2.7 million in the first quarter of 2019 and was associated with an increase in the outstanding balance of the company's secured credit facility in February 2019 and increased interest expense associated with the company's non-recourse notes payable.

    Net loss for the first quarter of 2020 was $37.6 million, or $0.24 per share, compared to a net loss of $31.1 million, or $0.28 per share, for the first quarter of 2019. 

    Cash, cash equivalents and investments totaled $114.6 million at March 31, 2020, and reflect a decrease from $137.8 million at December 31, 2019. Operating cash use for the first quarter of 2020 was $23.1 million.

    Financial Outlook for 2020

    BioCryst expects full year 2020 net operating cash use to be in the range of $125 to $150 million, and its operating expenses to be in the range of $135 to $160 million. The company's operating expense range excludes equity-based compensation expense due to the difficulty in reliably 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.

    Conference Call and Webcast

    BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 4679821. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 4679821.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 the ongoing COVID-19 pandemic could create challenges in all aspects of our business, including without limitation delays, stoppages, difficulties and increased expenses with respect to our and our partners' development, regulatory processes and supply chains, could negatively impact our ability to access the capital or credit markets to finance our operations, or could have the effect of heightening many of the risks described below or in the documents we file periodically with the Securities and Exchange Commission; that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that BioCryst may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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:
    John Bluth
    +1 919 859 7910

    BIOCRYST PHARMACEUTICALS, INC.
    CONSOLIDATED FINANCIAL SUMMARY
    (in thousands, except per share)
             
    Statements of Operations (Unaudited)        
             
      Three Months Ended
      March 31,
        2020       2019  
    Revenues:        
    Product sales $ 218     $ 1,679  
    Royalty revenue   1,945       2,322  
    Collaborative and other research and development   2,660       1,886  
    Total revenues   4,823       5,887  
             
    Expenses:    
    Cost of product sales   -       1,399  
    Research and development   29,867       27,493  
    Selling, general and administrative   15,865       6,238  
    Royalty   69       87  
    Total operating expenses   45,801       35,217  
             
    Loss from operations   (40,978 )     (29,330 )
             
    Interest and other income   6,446       596  
    Interest expense   (3,047 )     (2,726 )
    (Loss) gain on foreign currency derivative   (20 )     406  
             
    Net loss $ (37,599 )   $ (31,054 )
             
    Basic and diluted net loss per common share $ (0.24 )   $ (0.28 )
             
    Weighted average shares outstanding   154,156       110,167  
             


               
    Balance Sheet Data (in thousands)          
      March 31, 2020   December 31, 2019
      (Unaudited)   (Note 1)
    Cash, cash equivalents and investments $ 113,058     $ 136,226  
    Restricted cash   1,559       1,551  
    Receivables from collaborations   5,642       22,146  
    Total assets   136,589       175,282  
    Non-recourse notes payable   29,671       29,561  
    Senior credit facility   50,539       50,309  
    Accumulated deficit   (878,227 )     (840,628 )
    Stockholders' equity   3,648       38,252  
    Shares of common stock outstanding   154,192       154,082  
                 

    Note 1: Derived from audited financial statements.

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  19. RESEARCH TRIANGLE PARK, N.C., May 05, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for patent application 16/671,649. The resulting U.S. patent, once issued, will extend the patent protection for berotralstat (BCX7353) in the United States by four years through October 2039.

    The allowed patent application covers crystalline salt forms of berotralstat active pharmaceutical ingredient (API).

    "The extension of U.S. patent protection for berotralstat, through 2039, adds significant value to BioCryst. We look forward to the U.S. approval and launch of oral, once-daily berotralstat later this year," said Jon Stonehouse…

    RESEARCH TRIANGLE PARK, N.C., May 05, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance for patent application 16/671,649. The resulting U.S. patent, once issued, will extend the patent protection for berotralstat (BCX7353) in the United States by four years through October 2039.

    The allowed patent application covers crystalline salt forms of berotralstat active pharmaceutical ingredient (API).

    "The extension of U.S. patent protection for berotralstat, through 2039, adds significant value to BioCryst. We look forward to the U.S. approval and launch of oral, once-daily berotralstat later this year," said Jon Stonehouse, chief executive officer of BioCryst.

    The U.S. Food and Drug Administration is reviewing a new drug application (NDA) for approval of oral, once-daily berotralstat for the prevention of hereditary angioedema attacks. The Prescription Drug User Fee Act (PDUFA) date for the NDA is December 3, 2020.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 the ongoing COVID-19 pandemic could create challenges in all aspects of our business, including without limitation delays, stoppages, difficulties and increased expenses with respect to our and our partners' development, regulatory processes and supply chains, could negatively impact our ability to access the capital or credit markets to finance our operations, or could have the effect of heightening many of the risks described below or in the documents we file periodically with the Securities and Exchange Commission; that developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that BioCryst may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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:
    John Bluth
    +1 919 859 7910

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  20. RESEARCH TRIANGLE PARK, N.C., May 04, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted two newly-hired employees inducement options to purchase an aggregate of 525,000 shares of BioCryst common stock on April 30, 2020 as inducements material to each employee entering into employment with BioCryst. This includes a grant of 500,000 shares to the company's new chief financial officer, Anthony Doyle. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $3.91 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date…

    RESEARCH TRIANGLE PARK, N.C., May 04, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted two newly-hired employees inducement options to purchase an aggregate of 525,000 shares of BioCryst common stock on April 30, 2020 as inducements material to each employee entering into employment with BioCryst. This includes a grant of 500,000 shares to the company's new chief financial officer, Anthony Doyle. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $3.91 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. For Mr. Doyle's grant, 100,000 options will vest on the first anniversary of the grant or upon termination if, within the first year of his employment, Mr. Doyle is impacted by a reduction in force at the company, and the remainder of which will vest in three equal annual installments, beginning on the second anniversary of his start date. The options for the other employee vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  21. RESEARCH TRIANGLE PARK, N.C., April 22, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will report its first quarter 2020 financial results on Wednesday, May 6, 2020.

    BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 4679821. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers…

    RESEARCH TRIANGLE PARK, N.C., April 22, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will report its first quarter 2020 financial results on Wednesday, May 6, 2020.

    BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 4679821. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 4679821.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  22. RESEARCH TRIANGLE PARK, N.C., April 09, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company has opened enrollment into a randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19. The trial (NCT03891420) is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

    Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well tolerated in previously reported Phase 1 trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different…

    RESEARCH TRIANGLE PARK, N.C., April 09, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company has opened enrollment into a randomized, double-blind, placebo-controlled clinical trial to assess the safety, clinical impact and antiviral effects of galidesivir in patients with COVID-19. The trial (NCT03891420) is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

    Galidesivir is an investigational broad-spectrum antiviral drug that was safe and well tolerated in previously reported Phase 1 trials in healthy subjects. Galidesivir has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including the coronaviruses that cause MERS and SARS.

    In the COVID-19 trial, efficacy measures include time to clinical improvement, time to hospital discharge, time to undetectable levels (as measured by polymerase chain reaction (PCR) in respiratory specimens) of SARS-CoV-2, the virus that causes COVID-19, and all-cause mortality.

    The trial will be conducted in Brazil under a U.S. investigational new drug application, and the protocol also has been approved by the Agência Nacional de Vigilância Sanitária (ANVISA) and the Brazilian National Ethics Committee (CONEP).

    "Galidesivir has been safe and well-tolerated in Phase 1 studies, and, as a potent broad-spectrum antiviral medicine, we are hopeful that we will see a benefit in patients with COVID-19. This trial is part of the scientific community's effort to urgently find effective treatments for patients in this global health emergency," said Dr. William Sheridan, chief medical officer of BioCryst.

    "We have begun to see COVID-19 cases in Brazil, and we have a good opportunity to enroll and treat patients earlier in their disease course to determine if galidesivir can benefit patients with COVID-19," said Dr. Esper Kallas, infectious diseases specialist and professor of medicine at the School of Medicine, University of São Paulo, and principal investigator of the COVID-19 clinical trial with galidesivir.

    Galidesivir COVID-19 Trial Design
    Part 1 of the trial will enroll 24 hospitalized adults diagnosed with moderate to severe COVID-19 confirmed by PCR. Three cohorts of eight patients will be randomized to receive intravenous (IV) galidesivir (n=6) or placebo (n=2) every 12 hours for 7 days. Upon completion of part 1 of the trial, an optimized dosing regimen of galidesivir will be selected for part 2 of the trial, based on part 1 results including safety, viral load reduction in respiratory tract secretions, improvement in COVID-19 signs and symptoms and clinical manifestations, and mortality. In part 2 of the trial, up to 42 hospitalized patients with COVID-19 will be randomized 2:1 to receive IV galidesivir or placebo. After treatment, the patients will remain hospitalized until resolution of COVID-19 symptoms allows release. All patients will be followed for mortality through Day 56.

    The galidesivir development program is substantially funded with federal funds from NIAID and by the Biomedical Advanced Research and Development Authority (BARDA).  Since September 2013, NIAID has supported BioCryst in developing galidesivir as a therapeutic for Ebola and Marburg viruses under contract HHSN272201300017C. Since March 2015, BARDA has supported the galidesivir development program under contract HHSO100201500007C for the continued development of galidesivir as a potential treatment for filoviruses.

    About Galidesivir (BCX4430)
    Galidesivir, a broad-spectrum antiviral drug, is an adenosine nucleoside analog that acts to block viral RNA polymerase. It is in advanced development for the treatment of COVID-19, Marburg virus disease and Yellow Fever. Phase 1 clinical safety and pharmacokinetics trials of galidesivir by both intravenous and intramuscular routes of administration in healthy subjects have been completed. In animal studies, galidesivir has demonstrated activity against a variety of serious pathogens, including Ebola, Marburg, Yellow Fever and Zika viruses. Galidesivir has also demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including coronaviruses, filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, and flaviviruses. BioCryst is developing galidesivir in collaboration with U.S. government agencies and other institutions.

    About BioCryst Pharmaceuticals
    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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, performance 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 developing and manufacturing any product candidate, including galidesivir, may take longer or may be more expensive than planned; that funding for the continued development and manufacture of galidesivir may not be available; that ongoing and future preclinical and clinical studies with galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates, including galidesivir; that BioCryst may not advance human clinical trials with product candidates, including galidesivir, as expected; that the FDA, EMA, PMDA, ANVISA, CONEP or other applicable regulatory or ethics agency decisions may be negatively impacted by the COVID-19 pandemic; that such agencies 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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:
    John Bluth
    +1 919 859 7910

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  23. RESEARCH TRIANGLE PARK, N.C., April 08, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the 19th Annual Needham Healthcare Conference on Wednesday, April 15, 2020 at 10:00 a.m. ET. The conference is being conducted as a virtual conference.

    Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals
    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing…

    RESEARCH TRIANGLE PARK, N.C., April 08, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the 19th Annual Needham Healthcare Conference on Wednesday, April 15, 2020 at 10:00 a.m. ET. The conference is being conducted as a virtual conference.

    Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company's website at www.BioCryst.com.

    Contact:

    John Bluth

    +1 919 859 7910

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  24. RESEARCH TRIANGLE PARK, N.C., April 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted 10 newly-hired employees options to purchase an aggregate of 286,000 shares of BioCryst common stock on March 31, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.00 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date…

    RESEARCH TRIANGLE PARK, N.C., April 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted 10 newly-hired employees options to purchase an aggregate of 286,000 shares of BioCryst common stock on March 31, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.00 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

    Primary Logo

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  25. RESEARCH TRIANGLE PARK, N.C., April 02, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the appointment of Anthony Doyle as senior vice president and chief financial officer (CFO).

    Mr. Doyle joins BioCryst from Worldwide Clinical Trials, a full-service global contract research organization, where he has served as CFO since 2014.

    From 2004 to 2012, Mr. Doyle held a series of increasingly responsible roles at General Electric (GE), moving through FP&A, controller, audit, tax and commercial finance rotations in the GE Financial Management and Corporate Audit Staff finance and leadership training programs. He then led risk and pricing for GE Healthcare's $1.2 billion U.S. diagnostic imaging business and served…

    RESEARCH TRIANGLE PARK, N.C., April 02, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the appointment of Anthony Doyle as senior vice president and chief financial officer (CFO).

    Mr. Doyle joins BioCryst from Worldwide Clinical Trials, a full-service global contract research organization, where he has served as CFO since 2014.

    From 2004 to 2012, Mr. Doyle held a series of increasingly responsible roles at General Electric (GE), moving through FP&A, controller, audit, tax and commercial finance rotations in the GE Financial Management and Corporate Audit Staff finance and leadership training programs. He then led risk and pricing for GE Healthcare's $1.2 billion U.S. diagnostic imaging business and served as global program manager for GE Healthcare Solutions, a hospital and healthcare outcomes-based consulting company. From 2012 to 2014, he was CFO of World Book, a Berkshire Hathaway company.

    "Anthony is a seasoned, global, life science leader who brings a track record of accomplishment helping build and grow businesses. This is exactly what we need as we prepare for our first launch with berotralstat and advance our very exciting pipeline," said Jon Stonehouse, chief executive officer of BioCryst.

    "BioCryst is a uniquely positioned biotech company with significant potential near-term revenues and a dynamic pipeline right behind it. I am excited to add my experience to the team as the company accelerates through its commercial transition and delivers important new oral medicines to patients with rare diseases," Doyle said.

    Mr. Doyle received his B.A. from Dublin City University (Ireland) and his DESEM from Reims Management School (France).

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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, performance 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 developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical studies may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that BioCryst may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency decisions or processes may be negatively impacted by the COVID-19 pandemic; that such agencies 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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:
    John Bluth
    +1 919 859 7910

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  26. RESEARCH TRIANGLE PARK, N.C., March 30, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) submission for approval of oral, once-daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks.

    With this validation, the EMA has begun their formal review of the MAA under the centralized procedure for all member states of the European Union, and Norway, Iceland and Liechtenstein.

    An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected within approximately 12 months.

    "Berotralstat would represent the first targeted oral therapy approved for HAE prophylaxis in Europe…

    RESEARCH TRIANGLE PARK, N.C., March 30, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) submission for approval of oral, once-daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks.

    With this validation, the EMA has begun their formal review of the MAA under the centralized procedure for all member states of the European Union, and Norway, Iceland and Liechtenstein.

    An opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected within approximately 12 months.

    "Berotralstat would represent the first targeted oral therapy approved for HAE prophylaxis in Europe and would deliver a major advance in therapy to HAE patients," said Jon Stonehouse, chief executive officer of BioCryst.

    "HAE treatment in Europe tends to be consolidated and we have developed excellent relationships with HAE-treating physicians through our clinical trials. This is allowing us to build an efficient and experienced European commercial team to bring our innovative medicine to patients," Stonehouse added.

    BioCryst expects three regulatory approvals for berotralstat in 2020 and early 2021. The U.S. Food and Drug Administration (FDA) is currently reviewing a new drug application for berotralstat and has set an action date of December 3, 2020 under the Prescription Drug User Fee Act (PDUFA). In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing a new drug application (JNDA) for berotralstat under the Sakigake timeline, and the company expects Japanese approval in the second half of 2020.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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, performance 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 developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical studies may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that BioCryst may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency decisions or processes may be negatively impacted by the COVID-19 pandemic; that such agencies 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 candidates, or withhold market approval for product candidates; that actual financial results may not be consistent with expectations, including that 2020 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:
    John Bluth
    +1 919 859 7910

    Primary Logo

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  27. Additional new data show that the percentage of HAE attacks requiring re-treatment with multiple doses of on-demand therapy was lower for patients receiving berotralstat (150 mg) than placebo.

    The posters are available on the BioCryst website…

    RESEARCH TRIANGLE PARK, N.C., March 16, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced new data from the APeX-2 trial showing 150 mg of oral, once-daily berotralstat (BCX7353) for prophylaxis of hereditary angioedema (HAE) attacks reduced patients' monthly use of standard of care (SoC) on-demand medicine by 53.6 percent (p<0.001) compared to placebo, and reduced the number of HAE attacks requiring acute SoC treatment by 49.2 percent (p<0.001) compared to placebo.

    Additional new data show that the percentage of HAE attacks requiring re-treatment with multiple doses of on-demand therapy was lower for patients receiving berotralstat (150 mg) than placebo.

    The posters are available on the BioCryst website at https://www.biocryst.com/our-focus/scientific-publications, and are expected to be shared online by the American Academy of Allergy, Asthma & Immunology (AAAAI), which recently cancelled its planned annual meeting.  

    "Patients receiving berotralstat had fewer attacks, treated fewer attacks, experienced less severe attacks and used less on-demand medication compared to placebo. These data from APeX-2 provide further evidence that HAE patients are seeing significant benefits from oral, once-daily berotralstat," said Dr. William Sheridan, chief medical officer of BioCryst.

    In APeX-2, patients experienced a rapid and sustained decrease in their attack frequency over 48 weeks. Thirty patients who were randomized to 150 mg of berotralstat at the beginning of the trial and completed 48 weeks of therapy had a baseline mean attack rate of 2.9 attacks per month, which declined to 1.4 attacks per month after one month and to 1.0 attacks per month at month 12.

    APeX-2 patients who switched from placebo to 150 mg of berotralstat after week 24 saw dramatic and sustained reductions in their HAE attack rate.  Their mean attack rate dropped to 0.5 attacks per 28 days at month seven and to 0.4 attacks per 28 days at month 12.

    An integrated 48-week analysis across both the APeX-2 and APeX-S trials showed berotralstat was safe and generally well tolerated in a total of 342 patients with a total of 232 patient-years of daily oral dosing. The most frequent adverse drug reactions were mild-to-moderate gastrointestinal events that were brief in duration and self-limited.

    APeX-2 is a randomized, double-blind, placebo-controlled, three-arm trial testing two dose levels of orally administered once-daily berotralstat (110 mg and 150 mg) for prevention of angioedema attacks. The trial enrolled 121 patients with Type I and II HAE in the United States, Canada and Europe. Following completion of the 24-week analysis period, patients continued on study drug in an ongoing extension phase of APeX-2 through 48 weeks. Patients randomized to placebo for 24 weeks were re-randomized to receive one of the two doses of study drug in the extension phase of the trial. Patients who complete 48 weeks may continue in the trial on open-label berotralstat.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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, performance 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 the FDA, PMDA, EMA or other applicable regulatory agency may not approve berotralstat, within the timeframe expected, or at all, may ultimately determine that there are deficiencies in the development program or execution thereof, may require additional information or studies, may disagree with our analyses regarding the safety and efficacy conclusions; in the future they could determine that an advisory committee is necessary; we may learn of previously unknown issues; ongoing studies may take longer or may be more expensive than planned; in the event that berotralstat is approved in any territory, we or our partners may be unable to successfully commercialize as expected; that actual financial results may not be consistent with expectations, including that 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:
    John Bluth
    +1 919 859 7910

    Primary Logo

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  28. —Berotralstat NDA accepted by FDA; PDUFA date December 3, 2020—

    —JNDA accepted by PMDA under Sakigake timeline; approval expected 2H 2020—

    —PNH proof of concept data with oral Factor D inhibitor, BCX9930, expected 2Q 2020—

    RESEARCH TRIANGLE PARK, N.C., March 05, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the fourth quarter and full year ended December 31, 2019, and provided a corporate update.

    "2020 is off to a strong start, with NDAs accepted and approvals lined up later this year in the U.S. and Japan, and continued progress with our oral Factor D program as we approach proof of concept data in PNH patients in the second quarter of the year," said Jon Stonehouse, president…

    —Berotralstat NDA accepted by FDA; PDUFA date December 3, 2020—

    —JNDA accepted by PMDA under Sakigake timeline; approval expected 2H 2020—

    —PNH proof of concept data with oral Factor D inhibitor, BCX9930, expected 2Q 2020—

    RESEARCH TRIANGLE PARK, N.C., March 05, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the fourth quarter and full year ended December 31, 2019, and provided a corporate update.

    "2020 is off to a strong start, with NDAs accepted and approvals lined up later this year in the U.S. and Japan, and continued progress with our oral Factor D program as we approach proof of concept data in PNH patients in the second quarter of the year," said Jon Stonehouse, president and chief executive officer of BioCryst.

    "We are hearing increasing excitement from both HAE patients and physicians about the availability of an oral option to manage their disease, and we are attracting outstanding commercial talent to bring this new medicine to patients," Stonehouse added.

    Upcoming Key Milestones

    HAE Program – Berotralstat (BCX7353)

    • Submit Marketing Authorization Application (MAA) for oral, once-daily berotralstat for the prevention of hereditary angioedema (HAE) attacks with the European Medicines Administration (EMA) (Q1 2020)
       
    • Approval and launch of oral, once-daily berotralstat in Japan (2H 2020)
       
    • Approval and launch of oral, once-daily berotralstat in U.S. (December 3, 2020 PDUFA date)

    Complement Oral Factor D Inhibitor Program – BCX9930

    • Report data from a proof of concept study in paroxysmal nocturnal hemoglobinuria (PNH) patients receiving oral BCX9930 (2Q 2020)  

    ALK-2 Inhibitor Program – BCX9250

    • Report data from Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva (FOP), in healthy subjects (2H 2020)

    Coronavirus Antiviral Update – Galidesivir (BCX4430)
    Galidesivir is a broad-spectrum antiviral currently being developed in a Phase 2 clinical trial (Yellow Fever) under contracts with the National Institute of Allergy and Infectious Diseases (NIAID) and U.S. Department of Health and Human Services (HHS).

    Galidesivir has been shown to be active against more than 20 RNA viruses in nine different families, including coronaviruses. In Phase 1 trials in healthy volunteers, galidesivir was generally safe and well tolerated.

    The company is in active dialogue with relevant U.S. public health authorities as they assess potential approaches to treat and prevent COVID-19, and whether galidesivir could be useful.

    Recent Corporate Developments

    • On March 5, 2020, the company announced it had dosed its first PNH patients in a proof of concept study with its oral Factor D inhibitor, BCX9930.
       
    • On March 3, 2020, the company announced it will present at the Barclays Global Healthcare Conference in Miami Beach, Florida on Tuesday, March 10, 2020. The company's presentation time has been changed to 8:30 a.m. ET that day.
       
    • On February 27, 2020, the company announced it will present abstracts with new data on oral, once-daily berotralstat (BCX7353) at the upcoming annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) March 13-16 in Philadelphia. 
       
    • On February 25, 2020 the company announced the appointment of former Pfizer CFO, Alan G. Levin, to its Board of Directors.
       
    • On February 18, 2020, the company announced that the U.S. Food and Drug Administration (FDA) had accepted and filed its new drug application (NDA) for the approval of oral, once-daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks. The Prescription Drug User Fee Act (PDUFA) date for the NDA is December 3, 2020. In the NDA filing acceptance letter, the FDA stated that they are not currently planning to hold an advisory committee meeting to discuss the NDA.
       
    • On February 3, 2020, the company announced that it had submitted a new drug application (JNDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for approval of oral, once-daily berotralstat for the prophylactic treatment of HAE.
       
    • On January 15, 2020 the company announced the appointments of Charles Gayer as chief commercial officer and Allen Hodge as vice president and general manager for the United States.
       
    • On January 12, 2020, the company announced that the APeX-J trial in Japan met its primary endpoint (p=0.003) for prevention of HAE attacks, and berotralstat was safe and generally well-tolerated.
       
    • On December 11, 2019, the company announced it had submitted a new drug application to the FDA for approval of oral, once-daily berotralstat (BCX7353) for the prevention of HAE attacks.
       
    • On November 18, 2019, the company announced it had completed a public offering of common stock and received gross proceeds of approximately $63.3 million.  In addition, the company completed a pre-funded warrants transaction on November 21, 2019 that provided gross proceeds of $19.9 million.

    Fourth Quarter 2019 Financial Results

    For the three months ended December 31, 2019, total revenues were $39.7 million, compared to $2.7 million in the fourth quarter of 2018. The increase was primarily due to the recognition of $20.1 million of the $22.0 million upfront payment from Torii for commercialization rights in Japan for berotralstat for the prevention of HAE attacks, and $13.9 million of RAPIVAB® (peramivir injection) product sales under our procurement contract with the Centers for Disease Control.

    Research and development (R&D) expenses for the fourth quarter of 2019 increased to $26.8 million from $23.4 million in the fourth quarter of 2018, primarily due to increased spending on the company's complement-mediated diseases program and other preclinical development initiatives.

    Selling, general and administrative (SG&A) expenses for the fourth quarter of 2019 increased to $10.5 million, compared to $4.5 million in the fourth quarter of 2018. The increase was primarily due to increased spending on commercial activities and medical affairs to support the U.S. commercial launch of berotralstat in 2020 and, to a lesser extent, legal expenses associated with our ongoing arbitration.

    Interest expense was $3.1 million in the fourth quarter of 2019, compared to $2.4 million in the fourth quarter of 2018 and was associated with an increase in the outstanding balance of the company's secured credit facility in February 2019 and increased interest expense associated with the company's non-recourse notes payable.

    Net loss for the fourth quarter of 2019 was $2.6 million, or $0.02 per share, compared to a net loss of $27.4 million, or $0.25 per share, for the fourth quarter of 2018. 

    Cash, cash equivalents and investments totaled $137.8 million at December 31, 2019, and reflect an increase from $128.4 million at December 31, 2018. Cash and investments reflect the proceeds from a November 2019 equity offering and a prefunded warrants transaction, as well as a $22.0 million upfront payment from Torii, offset by normal operating expenses. Net proceeds from these transactions yielded just over $100 million in capital in the fourth quarter and provide the company sufficient capital to fund the launch of berotralstat in the United States as well as its other planned operations through 2020. Operating cash use for the fourth quarter of 2019 was $33.5 million, and for the full year of 2019 was $111.4 million.

    Full Year 2019 Financial Results

    For the full year ended December 31, 2019, total revenues were $48.8 million, compared to $20.7 million in the full year ended December 31, 2018. The increase was primarily due to the recognition of $20.1 million of the $22.0 million upfront payment from Torii, $13.9 of RAPIVAB product sales under our procurement contract and $3.7 million of peramivir product sales to our licensing partners. The increase in revenues was partially offset by the recognition of $12.0 million of peramivir milestones recognized in 2018 that did not recur in 2019.

    R&D expenses in 2019 increased to $107.1 million from $84.9 million in 2018, primarily due to increased spending on the company's complement-mediated diseases program and other preclinical development initiatives.

    SG&A expenses in 2019 increased to $37.1 million, compared to $29.5 million in 2018. The increase was primarily due to increased spending on commercial activities and medical affairs to support the U.S. commercial launch of berotralstat in 2020. The increased commercial and medical affairs costs were partially offset by the non-recurring merger-related costs associated with the company's terminated merger with Idera and a $4.9 million reserve for collectability of the EMA approval milestone of peramivir.

    Interest expense was $11.9 million in 2019, compared to $9.2 million in 2018. The increase was associated with an increase in the outstanding balance of the company's secured credit facility in February 2019 and increased interest expense associated with the company's non-recourse notes payable.

    Net loss for 2019 was $108.9 million, or $0.94 per share, compared to a net loss of $101.3 million, or $0.98 per share, for 2018. 

    Financial Outlook for 2020

    BioCryst expects full year 2020 net operating cash use to be in the range of $125 to $150 million, and its operating expenses to be in the range of $135 to $160 million. The company's operating expense range excludes equity-based compensation expense due to the difficulty in reliably 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.

    Conference Call and Webcast

    BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 7351587. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 7351587.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and galidesivir may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the company may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 actual financial results may not be consistent with expectations, including that 2020 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:
    John Bluth
    +1 919 859 7910



    BIOCRYST PHARMACEUTICALS, INC.
    CONSOLIDATED FINANCIAL SUMMARY
      (in thousands, except per share)
                           
    Statements of Operations (Unaudited)                      
                           
        Three Months Ended     Twelve Months Ended
        December 31,     December 31,
        2019       2018       2019       2018  
    Revenues:                      
    Product sales $ 15,519     $ -     $ 17,533     $ -  
    Royalty revenue   2,777       1,775       6,303       6,101  
      Collaborative and other research and development   21,429       954       24,999       14,552  
    Total revenues   39,725       2,729       48,835       20,653  
                           
    Expenses:        
      Cost of product sales   2,327       -       3,726       -  
      Research and development   26,774       23,431       107,068       84,888  
      Selling, general and administrative   10,489       4,490       37,121       29,514  
    Royalty   244       70       375       471  
    Total operating expenses   39,834       27,991       148,290       114,873  
                           
    Loss from operations   (109 )     (25,262 )     (99,455 )     (94,220 )
                           
    Interest and other income   388       686       1,933       2,252  
    Interest expense   (3,087 )     (2,414 )     (11,892 )     (9,176 )
    Gain (loss) on foreign currency derivative   186       (442 )     517       (108 )
                           
    Net loss $ (2,622 )   $ (27,432 )   $ (108,897 )   $ (101,252 )
                           
    Basic and diluted net loss per common share $ (0.02 )   $ (0.25 )   $ (0.94 )   $ (0.98 )
                           
    Weighted average shares outstanding   131,303       109,802       115,600       103,185  
                           
                           
                           
    Balance Sheet Data (in thousands)                      
      December 31, 2019   December 31, 2018
      (Unaudited)   (Note 1)
    Cash, cash equivalents and investments $ 136,226   $ 126,843
    Restricted cash   1,551     1,544
    Receivables from collaborations   22,146     4,293
    Total assets   175,282     146,841
    Non-recourse notes payable   29,561     29,121
    Senior credit facility   50,309     29,952
    Accumulated deficit   (840,628)     (731,969)
    Stockholders' equity   38,252     49,235
    Shares of common stock outstanding   154,082     110,063
                           
    Note 1: Derived from audited financial statements.                      
                           

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  29. RESEARCH TRIANGLE PARK, N.C., March 05, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the first patients have been dosed with BCX9930 in a proof of concept trial in paroxysmal nocturnal hemoglobinuria (PNH). These patients were naïve to eculizumab and ravulizumab.

    BCX9930 is an oral Factor D inhibitor discovered and developed by BioCryst for the treatment of complement-mediated diseases. The company expects to report data from the proof of concept study in PNH patients in the second quarter of 2020.

    "In PNH, our goal for BCX9930 is to develop a safe, well-tolerated, oral monotherapy with excellent efficacy, whether or not patients have ever been treated with a C5 inhibitor," said Dr. William Sheridan…

    RESEARCH TRIANGLE PARK, N.C., March 05, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the first patients have been dosed with BCX9930 in a proof of concept trial in paroxysmal nocturnal hemoglobinuria (PNH). These patients were naïve to eculizumab and ravulizumab.

    BCX9930 is an oral Factor D inhibitor discovered and developed by BioCryst for the treatment of complement-mediated diseases. The company expects to report data from the proof of concept study in PNH patients in the second quarter of 2020.

    "In PNH, our goal for BCX9930 is to develop a safe, well-tolerated, oral monotherapy with excellent efficacy, whether or not patients have ever been treated with a C5 inhibitor," said Dr. William Sheridan, chief medical officer of BioCryst.

    "Based on the outstanding safety and PK/PD profile we have seen with BCX9930 in healthy subjects, and the historically excellent translation of complement markers into clinical results in PNH patients, we are confident that we will demonstrate proof of concept in PNH, and other alternative pathway complement-mediated diseases," Sheridan added.

    Because Factor D is essential for alternative pathway overactivity in PNH, and all other complement diseases of the alternative pathway, successful proof of concept data with BCX9930 would enable BioCryst to advance the program across other target indications.

    Study Design

    In this proof of concept study of the safety and effectiveness of oral BCX9930, up to 16 PNH patients will receive BCX9930 twice daily (BID) for 28 days. Patients in the first cohort will receive 50 mg BID for 14 days, then 100 mg BID for 14 days, for a total of 28 days. For patients in the second cohort, the planned dosing regimen is 200 mg BID for 14 days, followed by 400 mg BID for 14 days. Each cohort of up to eight patients can enroll up to four treatment-naïve patients and up to four poor responders to eculizumab or ravulizumab. Key markers of effectiveness to be evaluated include levels of LDH, hemoglobin and reticulocytes. BID treatment will continue for subjects who show benefit, such as improvement in LDH levels or hemoglobin.  Safety will be monitored clinically and with laboratory tests.

    About Complement-Mediated Diseases

    The complement system is part of the body's natural immune system and is responsible for helping the body eliminate microbes (including viral and bacterial infections) and damaged cells. It is comprised of proteins which are primarily produced in the liver and circulate in the blood. Once activated, the complement system stimulates inflammation, phagocytosis and cell lysis.

    Excessive or uncontrolled activation of the complement system can cause severe, and potentially fatal, immune and inflammatory disorders.

    The complement system comprises biological cascades of amplifying enzyme cleavages involving more than 30 proteins and protein fragments, and may be activated through three pathways: the classical pathway (initiated by antibody-antigen complexes), the lectin pathway (initiated by lectin binding) and the alternative pathway (initiated by microbial surfaces).

    The alternative pathway also provides a critical amplification loop for all three pathways, regardless of the initiating mechanism. Factor D is an essential enzyme in the alternative pathway, thus making Factor D an attractive target to address complement-mediated diseases.

    Complement-mediated diseases can cause death or severe morbidity. Patients with these diseases currently have no approved treatments, or are limited to treatment with repeated intravenous infusions.

    About BCX9930

    Discovered by BioCryst, BCX9930 is a novel, oral, potent and selective small molecule inhibitor of Factor D currently in Phase 1 clinical development for the treatment of complement-mediated diseases. In parts 1 and 2 of a Phase 1 SAD/MAD assessment, BCX9930 was safe and generally well tolerated, with no serious adverse events, and no safety signals in routine laboratory monitoring. A benign rash that resolved within a median of five days of onset was observed in the majority of MAD subjects. At 100 mg BID, BCX9930 showed rapid, sustained and >95% suppression of the alternative pathway of the complement system. Preclinical data showed that BCX9930 was a potent and specific inhibitor of Factor D. 

    About BioCryst Pharmaceuticals
    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva (FOP). RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 the development of BCX9930 may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930 may not advance as expected, enroll the required number of subjects or have positive results; that further analysis of the current data or from additional data from the study may yield results which are different from our current view, that the FDA, EMA or other applicable regulatory agency may not agree with our interpretation, may require additional studies beyond the studies planned, may not provide regulatory clearances, may impose a clinical hold or may withhold market approval with respect to BCX9930.  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

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    John Bluth
    +1 919 859 7910

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  30. RESEARCH TRIANGLE PARK, N.C., March 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the Barclays Global Healthcare Conference in Miami Beach, Florida on Tuesday, March 10, 2020 at 8:00 a.m. ET.

    Links to a live audio webcast and replay of the presentation may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353…

    RESEARCH TRIANGLE PARK, N.C., March 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the Barclays Global Healthcare Conference in Miami Beach, Florida on Tuesday, March 10, 2020 at 8:00 a.m. ET.

    Links to a live audio webcast and replay of the presentation may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  31. RESEARCH TRIANGLE PARK, N.C., March 02, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted 10 newly-hired employees options to purchase an aggregate of 333,000 shares of BioCryst common stock on February 28, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $3.00 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date…

    RESEARCH TRIANGLE PARK, N.C., March 02, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted 10 newly-hired employees options to purchase an aggregate of 333,000 shares of BioCryst common stock on February 28, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $3.00 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  32. RESEARCH TRIANGLE PARK, N.C., Feb. 27, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present abstracts with new data on berotralstat (BCX7353), an oral, once daily therapy under regulatory review in the United States and Japan for the prevention of hereditary angioedema (HAE) attacks, at the upcoming annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) March 13-16 in Philadelphia. 

    • Oral Prophylaxis with Berotralstat (BCX7353) Reduces Use of Standard of Care (SOC) On-demand Medication in Patients with Hereditary Angioedema (HAE): APeX-2 Study Results; Poster #328, Sunday, March 15, 9:45 a.m. ET
       
    • Patterns of Treatment and Retreatment of Acute Attacks of Hereditary

    RESEARCH TRIANGLE PARK, N.C., Feb. 27, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present abstracts with new data on berotralstat (BCX7353), an oral, once daily therapy under regulatory review in the United States and Japan for the prevention of hereditary angioedema (HAE) attacks, at the upcoming annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) March 13-16 in Philadelphia. 

    • Oral Prophylaxis with Berotralstat (BCX7353) Reduces Use of Standard of Care (SOC) On-demand Medication in Patients with Hereditary Angioedema (HAE): APeX-2 Study Results; Poster #328, Sunday, March 15, 9:45 a.m. ET
       
    • Patterns of Treatment and Retreatment of Acute Attacks of Hereditary Angioedema (HAE) with Standard of Care (SOC) On-Demand Medication: Results from the APeX-2 Study; Poster #331, Sunday, March 15, 9:45 a.m. ET
       
    • Relative Reductions in Attack Rate with Prophylactic Berotralstat (BCX7353) in Subjects with Hereditary Angioedema (HAE): Responder Analysis from the APeX-2 Study; Poster #326, Sunday, March 15, 9:45 a.m. ET
       
    • Gastrointestinal (GI) Adverse Events (AEs) Observed with Berotralstat (BCX7353) Treatment for Hereditary Angioedema (HAE) are Primarily Mild, Self-limited, and Diminish with Time on Treatment; Poster #315, Sunday, March 15, 9:45 a.m. ET

    "There is tremendous enthusiasm from both patients and physicians for the potential of oral, once daily berotralstat, and we look forward to sharing the latest new analyses that highlight the excellent outcomes patients had in our APeX-2 trial," said Dr. William Sheridan, chief medical officer of BioCryst.  

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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, performance 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 the FDA, PMDA, EMA or other applicable regulatory agency may not approve berotralstat, within the timeframe expected, or at all, may ultimately determine that there are deficiencies in the development program or execution thereof, may require additional information or studies, may disagree with our analyses regarding the safety and efficacy conclusions; in the future they could determine that an advisory committee is necessary; we may learn of previously unknown issues; ongoing studies may take longer or may be more expensive than planned; in the event that berotralstat is approved in any territory, we or our partners may be unable to successfully commercialize as expected; that actual financial results may not be consistent with expectations, including that 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:
    John Bluth
    +1 919 859 7910

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  33. RESEARCH TRIANGLE PARK, N.C., Feb. 25, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company has appointed former Pfizer chief financial officer (CFO), Alan G. Levin, to its board of directors (BOD).

    In addition to his 20-year career at Pfizer, Mr. Levin served as CFO of Endo Pharmaceuticals, Inc. over a five-year period where the company experienced a nearly 400 percent increase in its market capitalization.

    He currently serves on the BOD of Diffusion Pharmaceuticals, Inc., a development stage company focused on therapeutics to enhance the effectiveness of treatments for stroke and cancer, and on the advisory board of Auven Therapeutics, a global private equity fund that acquires and pursues…

    RESEARCH TRIANGLE PARK, N.C., Feb. 25, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company has appointed former Pfizer chief financial officer (CFO), Alan G. Levin, to its board of directors (BOD).

    In addition to his 20-year career at Pfizer, Mr. Levin served as CFO of Endo Pharmaceuticals, Inc. over a five-year period where the company experienced a nearly 400 percent increase in its market capitalization.

    He currently serves on the BOD of Diffusion Pharmaceuticals, Inc., a development stage company focused on therapeutics to enhance the effectiveness of treatments for stroke and cancer, and on the advisory board of Auven Therapeutics, a global private equity fund that acquires and pursues accelerated development of breakthrough therapeutic drugs, prior to licensing them to commercial partners.

    From 2014 through 2019, Mr. Levin served on the BOD of Aceto Corporation, a multinational company involved in the sale and distribution of generic drugs, pharmaceutical intermediates and performance chemicals. He also serves on the BOD of the Critical Path Institute, a nonprofit collaboration between the U.S. Food and Drug Administration and the pharmaceutical industry, focused on streamlining and accelerating the development and regulatory pathways for innovative medicines.

    "With a significant therapy nearing approval this year, and a pipeline of home-grown oral medicines for rare diseases right behind it, BioCryst is transitioning into a commercial company positioned for long-term success delivering innovative medicines to patients. I look forward to adding my contribution to the outstanding board and management team," said Mr. Levin.

    "We welcome Alan and the exceptional experience he brings from 20 years in leadership at one of the world's most successful pharmaceutical companies, combined with his deep understanding of biotech and finance," said Robert Ingram, chairman of BioCryst.

    Mr. Levin is an audit committee financial expert, as defined by the Securities and Exchange Commission, and is a certified public accountant.  He holds a bachelor's degree from Princeton University and a master's degree from New York University's Stern School of Business.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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, performance 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 we may not receive regulatory approval of berotralstat within the timeframe expected, or at all; we may learn of previously unknown issues; ongoing or future studies, including any related to berotralstat, may take longer or be more expensive than planned; and in the event that berotralstat is approved in any territory, we or our partners may be unable to successfully commercialize as expected.  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:
    John Bluth
    +1 919 859 7910

     

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  34. RESEARCH TRIANGLE PARK, N.C., Feb. 20, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will report its fourth quarter and full year 2019 financial results on Thursday, March 5, 2020.

    BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 7351587. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056…

    RESEARCH TRIANGLE PARK, N.C., Feb. 20, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will report its fourth quarter and full year 2019 financial results on Thursday, March 5, 2020.

    BioCryst management will host a conference call and webcast at 8:30 a.m. ET that day to discuss the financial results and provide a corporate update.

    The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 7351587. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 7351587.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  35. RESEARCH TRIANGLE PARK, N.C., Feb. 18, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced that the U.S. Food and Drug Administration (FDA) has accepted and filed its new drug application (NDA) for the approval of oral, once daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks.

    The Prescription Drug User Fee Act (PDUFA) date for the NDA is December 3, 2020.

    In the NDA filing acceptance letter, the FDA stated that they are not currently planning to hold an advisory committee meeting to discuss the NDA.

    "HAE patients and their physicians tell us they have been waiting for a once daily oral therapy to prevent attacks, and the acceptance of our submission, with a PDUFA date this year…

    RESEARCH TRIANGLE PARK, N.C., Feb. 18, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced that the U.S. Food and Drug Administration (FDA) has accepted and filed its new drug application (NDA) for the approval of oral, once daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks.

    The Prescription Drug User Fee Act (PDUFA) date for the NDA is December 3, 2020.

    In the NDA filing acceptance letter, the FDA stated that they are not currently planning to hold an advisory committee meeting to discuss the NDA.

    "HAE patients and their physicians tell us they have been waiting for a once daily oral therapy to prevent attacks, and the acceptance of our submission, with a PDUFA date this year, means their wait is nearly over," said Jon Stonehouse, chief executive officer of BioCryst. "We are sharply focused on building out a very experienced commercial team and executing our commercial plan, so we are ready to go fast when we get approval." 

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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, performance 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 the FDA, PMDA, EMA or other applicable regulatory agency may not approve berotralstat, within the timeframe expected, or at all, may ultimately determine that there are deficiencies in the development program or execution thereof, may require additional information or studies, may disagree with our analyses regarding the safety and efficacy conclusions; in the future they could determine that an advisory committee is necessary; we may learn of previously unknown issues; ongoing studies may take longer or may be more expensive than planned; in the event that berotralstat is approved in any territory, we or our partners may be unable to successfully commercialize as expected; that actual financial results may not be consistent with expectations, including that 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:
    John Bluth
    +1 919 859 7910

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  36. RESEARCH TRIANGLE PARK, N.C., Feb. 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees options to purchase an aggregate of 140,000 shares of BioCryst common stock on January 31, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.85 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date…

    RESEARCH TRIANGLE PARK, N.C., Feb. 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees options to purchase an aggregate of 140,000 shares of BioCryst common stock on January 31, 2020 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.85 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  37. RESEARCH TRIANGLE PARK, N.C., Feb. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that it has submitted a new drug application (JNDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for approval of oral, once daily berotralstat for the prophylactic treatment of hereditary angioedema (HAE).

    "The data from APeX-J and the berotralstat clinical program are very exciting for HAE patients in Japan," said Dr. Isao Ohsawa, president of Saiyu Soka hospital and principal investigator of the APeX-J trial. 

    "Based on the clinical benefit observed in patients in APeX-J, I expect many patients in Japan will want to use this new treatment, once it becomes available," he added.

    BioCryst received…

    RESEARCH TRIANGLE PARK, N.C., Feb. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that it has submitted a new drug application (JNDA) to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for approval of oral, once daily berotralstat for the prophylactic treatment of hereditary angioedema (HAE).

    "The data from APeX-J and the berotralstat clinical program are very exciting for HAE patients in Japan," said Dr. Isao Ohsawa, president of Saiyu Soka hospital and principal investigator of the APeX-J trial. 

    "Based on the clinical benefit observed in patients in APeX-J, I expect many patients in Japan will want to use this new treatment, once it becomes available," he added.

    BioCryst received Orphan Drug and Sakigake designations for berotralstat. Under the Sakigake timeline, the company expects potential approval in the second half of 2020.

    "Berotralstat would be the first approved chronic therapy for HAE patients in Japan and would address a significant unmet medical need," said Jon Stonehouse, president and chief executive officer of BioCryst.

    Torii Pharmaceutical, Co. is BioCryst's commercial partner in Japan for berotralstat. Under the terms of its commercial agreement with Torii, BioCryst received a $22 million upfront payment and is eligible to receive an additional milestone payment of up to $20 million based on the timing of PMDA approval and upon receipt of a reimbursement price approval from Japan's National Health Insurance system in excess of the threshold specified in the agreement.  In addition, BioCryst will receive tiered royalties of up to 40 percent of Japanese net sales of berotralstat.

    The JNDA contains data from both the APeX-J and APeX-2 clinical trials. The company recently announced that the APeX-J trial in Japan met its primary endpoint (p=0.003) of a reduction in HAE attacks from baseline for berotralstat 150 mg compared to placebo, and berotralstat was safe and generally well-tolerated in the trial. In APeX-2, berotralstat also met its primary endpoint (p<0.001) for berotralstat 150 mg compared to placebo, and was safe and generally well-tolerated.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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. Factors that could cause actual results to differ materially from the forward-looking statements contained herein include, without limitation, the following:  the results of our partnership with Torii may not meet our current expectations (including with respect to the receipt or amounts of potential milestone or royalty payments); competitor products may limit the commercial potential of berotralstat in Japan and the amount of any related royalties we would be entitled to receive; there are risks related to our relying on the performance of our partner, particularly with respect to the conduct of commercialization activities in line with our current expectations; there are risks related to government actions, including that decisions and other actions relating to approval, pricing, and exclusivity of berotralstat in Japan may not be taken when expected or at all, or that the outcomes of such decisions and other actions may not be in line with our current expectations; we rely on third-party contract manufacturing organizations to manufacture berotralstat and any failure of such parties to meet their obligations may impair our ability to supply the required amounts of berotralstat to our partner; there are inherent risks related to commercializing drugs, including regulatory, manufacturing and supply risks; development activities for any indication may take longer or may be more expensive than planned; ongoing and future preclinical and clinical development of our HAE drug candidates (including for APeX-S) may not have positive results; we may not be able to enroll the required number of subjects in planned clinical trials; we may not advance human clinical trials as expected (including those for berotralstat); the FDA, EMA, PMDA or other applicable regulatory agency may refuse to review our applications, require additional studies beyond the studies planned for product candidates (including berotralstat), or may not provide regulatory clearances for studies, which could result in delays of planned clinical trials; and applicable regulatory bodies may impose a clinical hold with respect to, or withhold market approval for, product candidates (including berotralstat). Please refer to the documents the Company files periodically with the Securities and Exchange Commission, specifically our 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 our projections and forward-looking statements.

    BCRXW

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    John Bluth
    +1 919 859 7910

     

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  38. RESEARCH TRIANGLE PARK, N.C., Jan. 15, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the appointments of Charles Gayer as chief commercial officer and Allen Hodge as vice president and general manager for the United States.

    Mr. Gayer joined BioCryst in 2015 as vice president of global strategic marketing. Since July 2019 he has served as interim chief commercial officer, playing a key role in defining the strategy, and building the commercial operations, to support the launch of berotralstat, BioCryst's oral kallikrein inhibitor for hereditary angioedema (HAE).

    Prior to joining BioCryst, Mr. Gayer held several U.S. and global commercial leadership roles in highly competitive rare disease categories at…

    RESEARCH TRIANGLE PARK, N.C., Jan. 15, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced the appointments of Charles Gayer as chief commercial officer and Allen Hodge as vice president and general manager for the United States.

    Mr. Gayer joined BioCryst in 2015 as vice president of global strategic marketing. Since July 2019 he has served as interim chief commercial officer, playing a key role in defining the strategy, and building the commercial operations, to support the launch of berotralstat, BioCryst's oral kallikrein inhibitor for hereditary angioedema (HAE).

    Prior to joining BioCryst, Mr. Gayer held several U.S. and global commercial leadership roles in highly competitive rare disease categories at Grifols and Talecris Biotherapeutics from 2007 through 2015. Prior to joining Talecris, he spent six years at GlaxoSmithKline in a range of marketing and sales roles. He received his B.A. from Princeton University and his M.B.A. from the Fuqua School of Business of Duke University.

    "With Charlie's leadership and experience, BioCryst is well-positioned to deliver berotralstat to patients around the world, as we transform into a fully-integrated commercial organization. He has a record of success in rare disease markets and has added valuable strategic insight and creativity to BioCryst over the past four years," said Jon Stonehouse, chief executive officer of BioCryst.

    Mr. Hodge joins BioCryst from Array Biopharma, where he helped to build the commercial organization that successfully launched Braftovi® and Mektovi®, an oral combination used for the treatment of patients with a rare form of melanoma. From 2012 through 2015 he was a sales director at ViroPharma (later Shire), where his teams had responsibility for Cinryze® and Firazyr®, two pioneering injectable treatments for HAE. He began his career at Pfizer, where he spent nine years in increasingly responsible sales roles. He received his B.S. from Arkansas Tech University and his master's from Boston University.

    "In addition to his proven sales success in HAE, Allen has the recent experience of leading highly successful rare disease launches that built tremendous value for patients and shareholders. Charlie and Allen are attracting exceptional talent to the commercial team as we prepare for an exciting 2020 with multiple regulatory submissions, approvals and launches of berotralstat," Stonehouse added.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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, performance 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 developing any HAE product candidate may take longer or may be more expensive than planned; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the company may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 actual financial results may not be consistent with expectations, including that 2019 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:
    John Bluth
    +1 919 859 7910

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  39. RESEARCH TRIANGLE PARK, N.C., Jan. 12, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will provide updates on berotralstat, an oral kallikrein inhibitor for hereditary angioedema (HAE), and BCX9930, an oral Factor D inhibitor for complement-mediated diseases, this week at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco.   

    "BioCryst is positioned for transformation in 2020 with multiple global approvals and launches of berotralstat, and PNH proof of concept data with BCX9930. The $100 million in additional capital we brought into the company in Q4 2019 provides a foundation for progress and value creation in 2020," said Jon Stonehouse, president and chief executive…

    RESEARCH TRIANGLE PARK, N.C., Jan. 12, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will provide updates on berotralstat, an oral kallikrein inhibitor for hereditary angioedema (HAE), and BCX9930, an oral Factor D inhibitor for complement-mediated diseases, this week at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco.   

    "BioCryst is positioned for transformation in 2020 with multiple global approvals and launches of berotralstat, and PNH proof of concept data with BCX9930. The $100 million in additional capital we brought into the company in Q4 2019 provides a foundation for progress and value creation in 2020," said Jon Stonehouse, president and chief executive officer of BioCryst.

    Berotralstat Program Updates:

    • New drug application (NDA) submitted to U.S Food and Drug Administration in December 2019
       
    • APeX-J trial in Japan met its primary endpoint (p=0.003) for prevention of HAE attacks, and berotralstat was safe and generally well-tolerated
       
    • JNDA submission to Japanese Pharmaceuticals and Medical Devices Agency (PMDA) on-track for Q1 2020
       
    • Marketing authorization application to European Medicines Agency (EMA) on-track for Q1 2020

    BCX9930 Program Updates:

    As previously announced, results from an ongoing three part Phase 1 trial of BCX9930 showed rapid, sustained and >95% suppression of the alternative pathway (AP) of the complement system at 100 mg every 12 hours, as measured by the AP Wieslab® assay.

    In two initial multiple ascending dose (MAD) assessment cohorts, healthy volunteers received 50 mg or 100 mg of oral BCX9930 or placebo (each MAD cohort randomized 10:2) administered every 12 hours for seven days. Healthy volunteers in the MAD cohorts were prophylactically dosed with the broad-spectrum antibiotic, amoxicillin/clavulanate.  BCX9930 was safe and generally well tolerated at all doses studied in single ascending dose and MAD cohorts. There were no serious adverse events. A clinically benign rash was observed in some healthy volunteers in the MAD (two in the 50 mg cohort, seven in the 100 mg cohort), which was self-limited and resolved in 4-8 days after onset.

    The company has now completed an additional MAD cohort with 50 mg of oral BCX9930 or placebo administered every 12 hours for 14 days, with vaccination instead of an antibiotic. Key observations from the additional MAD cohort include:

    • Benign rash (similar to prior MAD cohorts) that was self-limited and resolved in 4 to 8 days post-onset seen in seven healthy volunteers
       
    • Successfully dosed-through benign rash, with rash resolving on-drug, in both patients who continued dosing, per protocol
       
    • Biopsies of rashes from multiple subjects confirm benign assessment

    The company is on-track to report proof of concept data in paroxysmal nocturnal hemoglobinuria (PNH) patients in 1H 2020.

    Additional details can be found on slides, which can be accessed at may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva (FOP). RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930 or BCX9250 may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the company may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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. 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:
    John Bluth
    +1 919 859 7910

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  40. RESEARCH TRIANGLE PARK, N.C., Jan. 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted two newly-hired employees options to purchase an aggregate of 20,000 shares of BioCryst common stock on December 31, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $3.45 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date…

    RESEARCH TRIANGLE PARK, N.C., Jan. 06, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted two newly-hired employees options to purchase an aggregate of 20,000 shares of BioCryst common stock on December 31, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $3.45 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

    Primary Logo

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  41. RESEARCH TRIANGLE PARK, N.C., Jan. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 15, 2020 at 5:00 p.m. ET.

    Links to a live audio webcast and replay of these presentations may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat…

    RESEARCH TRIANGLE PARK, N.C., Jan. 03, 2020 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 15, 2020 at 5:00 p.m. ET.

    Links to a live audio webcast and replay of these presentations may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  42. RESEARCH TRIANGLE PARK, N.C., Dec. 11, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of oral, once daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks.

    "HAE patients are waiting for a safe, effective oral therapy to manage their disease and this NDA submission brings berotralstat an important step closer to meeting this need for patients and their physicians," said Jon Stonehouse, chief executive officer of BioCryst.

    "Thank you to all of the HAE patients who have participated in our clinical trials, to the clinical investigators and their teams around the world who conducted…

    RESEARCH TRIANGLE PARK, N.C., Dec. 11, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of oral, once daily berotralstat (BCX7353) for the prevention of hereditary angioedema (HAE) attacks.

    "HAE patients are waiting for a safe, effective oral therapy to manage their disease and this NDA submission brings berotralstat an important step closer to meeting this need for patients and their physicians," said Jon Stonehouse, chief executive officer of BioCryst.

    "Thank you to all of the HAE patients who have participated in our clinical trials, to the clinical investigators and their teams around the world who conducted our clinical trials, and to the BioCryst team for always remembering that patients are waiting for our oral, once daily medicine. Our commercial team is hard at work preparing to commercialize berotralstat in 2020," Stonehouse added.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including berotralstat (BCX7353), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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, performance 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 developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the company may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 actual financial results may not be consistent with expectations, including that 2019 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:
    John Bluth
    +1 919 859 7910

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  43. RESEARCH TRIANGLE PARK, N.C., Dec. 04, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees options to purchase an aggregate of 142,500 shares of BioCryst common stock on November 29, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.85 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date…

    RESEARCH TRIANGLE PARK, N.C., Dec. 04, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees options to purchase an aggregate of 142,500 shares of BioCryst common stock on November 29, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.85 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  44. RESEARCH TRIANGLE PARK, N.C., Nov. 18, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today the completion of an underwritten public offering of 43,620,690 shares of its common stock, including 5,689,655 shares sold pursuant to the exercise in full of the underwriters' option to purchase additional shares.  The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters' option to purchase additional shares, were approximately $63.3 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst. 

    BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include…

    RESEARCH TRIANGLE PARK, N.C., Nov. 18, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today the completion of an underwritten public offering of 43,620,690 shares of its common stock, including 5,689,655 shares sold pursuant to the exercise in full of the underwriters' option to purchase additional shares.  The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters' option to purchase additional shares, were approximately $63.3 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst. 

    BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for the prophylactic BCX7353 program, primarily focusing on the U.S., EU and Japan; development of the BCX9930 program; development of the BCX9250 program; post-approval commitments for RAPIVAB®/ALPIVABTM; funding clinical development of pipeline assets; and capital expenditures and other general corporate expenses.

    J.P. Morgan acted as sole book-running manager for the offering. JMP Securities and H.C. Wainwright & Co. acted as lead managers for the offering.

    A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

    This offering was made by means of a prospectus supplement and related prospectus.  A prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov.  Copies of the final prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding future results and achievements and use of proceeds. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, achievements, or outcomes to be materially different from any future results, performances, achievements, or outcomes expressed or implied by the forward-looking statements, including risks and uncertainties associated with market conditions and other risks and uncertainties inherent in BioCryst's business. Please refer to the documents that BioCryst files periodically with the SEC, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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:   John Bluth, BioCryst Pharmaceuticals, +1-919-859-7910

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  45. RESEARCH TRIANGLE PARK, N.C., Nov. 14, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the Jefferies London Healthcare Conference on Thursday, November 21, 2019 at 3:40 a.m. ET and the Piper Jaffray 31st Annual Healthcare Conference in New York on Tuesday, December 3, 2019 at 4:30 p.m. ET.

    Links to a live audio webcast and replay of these presentations may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway…

    RESEARCH TRIANGLE PARK, N.C., Nov. 14, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the Jefferies London Healthcare Conference on Thursday, November 21, 2019 at 3:40 a.m. ET and the Piper Jaffray 31st Annual Healthcare Conference in New York on Tuesday, December 3, 2019 at 4:30 p.m. ET.

    Links to a live audio webcast and replay of these presentations may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  46. RESEARCH TRIANGLE PARK, N.C., Nov. 13, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today the pricing of an underwritten public offering of 37,931,035 shares of its common stock, offered at a price to the public of $1.45 per share.  The gross proceeds from this offering to BioCryst are expected to be $55 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by BioCryst. 

    BioCryst has granted the underwriters a 30-day option to purchase up to an additional 5,689,655 shares of its common stock.  The offering is expected to close on or about November 18, 2019, subject to customary closing conditions. BioCryst expects to use the net proceeds of this offering…

    RESEARCH TRIANGLE PARK, N.C., Nov. 13, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today the pricing of an underwritten public offering of 37,931,035 shares of its common stock, offered at a price to the public of $1.45 per share.  The gross proceeds from this offering to BioCryst are expected to be $55 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by BioCryst. 

    BioCryst has granted the underwriters a 30-day option to purchase up to an additional 5,689,655 shares of its common stock.  The offering is expected to close on or about November 18, 2019, subject to customary closing conditions. BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for the prophylactic BCX7353 program, primarily focusing on the U.S., EU and Japan; development of the BCX9930 program; development of the BCX9250 program; post-approval commitments for RAPIVAB®/ALPIVAB; funding clinical development of pipeline assets; and capital expenditures and other general corporate expenses.

    J.P. Morgan is acting as sole book-running manager for the offering. JMP Securities and H.C. Wainwright & Co. are acting as lead managers for the offering.

    A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

    This offering is being made by means of a prospectus supplement and related prospectus.  A preliminary prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov.  Copies of the final prospectus supplement, when available, and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding future results and achievements, use of proceeds and the completion of this offering. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, achievements, or outcomes to be materially different from any future results, performances, achievements, or outcomes expressed or implied by the forward-looking statements, including risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to this offering and other risks and uncertainties inherent in BioCryst's business. Please refer to the documents that BioCryst files periodically with the SEC, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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: John Bluth, BioCryst Pharmaceuticals, +1-919-859-7910

     

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  47. RESEARCH TRIANGLE PARK, N.C., Nov. 12, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that it is offering to sell $55 million of its common stock in an underwritten public offering. As part of this offering, BioCryst intends to grant the underwriters a 30-day option to purchase up to an additional $8.25 million of its common stock. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    J.P. Morgan is acting as sole book-running manager for the offering. JMP Securities and H.C. Wainwright & Co. are acting as lead managers for the offering.

    All of the shares to be sold in the offering are…

    RESEARCH TRIANGLE PARK, N.C., Nov. 12, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that it is offering to sell $55 million of its common stock in an underwritten public offering. As part of this offering, BioCryst intends to grant the underwriters a 30-day option to purchase up to an additional $8.25 million of its common stock. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    J.P. Morgan is acting as sole book-running manager for the offering. JMP Securities and H.C. Wainwright & Co. are acting as lead managers for the offering.

    All of the shares to be sold in the offering are being sold by BioCryst, with the proceeds to be used for general corporate purposes, which may include, but are not limited to, worldwide development, manufacturing, regulatory and commercial activities for the prophylactic BCX7353 program, primarily focusing on the U.S., EU and Japan; development of the BCX9930 program; development of the BCX9250 program; post-approval commitments for RAPIVABTM/ALPIVABTM; funding clinical development of pipeline assets; and capital expenditures and other general corporate expenses.

    A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

    This offering is being made by means of a prospectus supplement and related prospectus. A preliminary prospectus supplement relating to the offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements regarding future results and achievements, use of proceeds, granting the underwriters an option to purchase additional shares and the completion of this offering. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance, achievements, or outcomes to be materially different from any future results, performances, achievements, or outcomes expressed or implied by the forward-looking statements, including risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to this offering and other risks and uncertainties inherent in BioCryst's business. Please refer to the documents that BioCryst files periodically with the SEC, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, 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: John Bluth, BioCryst Pharmaceuticals, +1-919-859-7910

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  48. RESEARCH TRIANGLE PARK, N.C., Nov. 07, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present two abstracts at the upcoming Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) November 7-11 in Houston.  

    • Oral Prophylaxis with BCX7353 Reduces HAE Attack Rates and is Well-Tolerated: APeX-2 Study Results; Poster P150, Friday, November 8, 3:00 p.m. CT
       
    • Safety and Tolerability of Once-Daily Oral Kallikrein Inhibitor BCX7353 in Phase 3 APeX-2 HAE Study; Poster P154, Friday, November 8, 4:00 p.m. CT

    About BioCryst Pharmaceuticals

    BioCryst discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs…

    RESEARCH TRIANGLE PARK, N.C., Nov. 07, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present two abstracts at the upcoming Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) November 7-11 in Houston.  

    • Oral Prophylaxis with BCX7353 Reduces HAE Attack Rates and is Well-Tolerated: APeX-2 Study Results; Poster P150, Friday, November 8, 3:00 p.m. CT
       
    • Safety and Tolerability of Once-Daily Oral Kallikrein Inhibitor BCX7353 in Phase 3 APeX-2 HAE Study; Poster P154, Friday, November 8, 4:00 p.m. CT

    About BioCryst Pharmaceuticals

    BioCryst discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema; BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases; galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 ongoing and future preclinical and clinical development of HAE second generation drug candidates (including APeX-2, APeX-S and APeX-J) may not have positive results, may be more expensive or may not move as quickly as planned; that the FDA, EMA or other applicable regulatory agency may not provide regulatory clearances which may result in delay of planned clinical trials or failure to achieve market approval for product candidates. 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:
    John Bluth
    +1 919 859 7910

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  49. —New drug application for oral, once-daily BCX7353 for prevention of hereditary angioedema attacks
    on-track for submission to FDA in Q4 2019—

    —Data from proof of concept study in PNH patients with oral Factor D inhibitor, BCX9930, expected in 1H 2020—

    RESEARCH TRIANGLE PARK, N.C., Nov. 06, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the third quarter ended September 30, 2019 and provided a corporate update.

    "BioCryst is positioned for a transformational 2020, with the potential approval and launch of BCX7353 in the U.S., regulatory filings for BCX7353 in Japan and Europe, and data from our PNH proof of concept study with BCX9930 reading out in the first half of the year," said…

    —New drug application for oral, once-daily BCX7353 for prevention of hereditary angioedema attacks
    on-track for submission to FDA in Q4 2019—

    —Data from proof of concept study in PNH patients with oral Factor D inhibitor, BCX9930, expected in 1H 2020—

    RESEARCH TRIANGLE PARK, N.C., Nov. 06, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the third quarter ended September 30, 2019 and provided a corporate update.

    "BioCryst is positioned for a transformational 2020, with the potential approval and launch of BCX7353 in the U.S., regulatory filings for BCX7353 in Japan and Europe, and data from our PNH proof of concept study with BCX9930 reading out in the first half of the year," said Jon Stonehouse, president and chief executive officer of BioCryst.

    "We are also actively evaluating multiple approaches to add capital to the balance sheet by the end of 2019, as we did with the Japanese licensing agreement for BCX7353, which we announced earlier this week," Stonehouse added.

    Upcoming Key Milestones
                 
    HAE Program – BCX7353

    • Submit a new drug application (NDA) for oral, once-daily BCX7353 for the prevention of hereditary angioedema (HAE) attacks with the U.S. Food and Drug Administration (FDA) (Q4 2019)
       
    • Submit a marketing authorization application for oral, once-daily BCX7353 for the prevention of HAE attacks with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA) (Q1 2020)
       
    • Commence ZENITH-2, a Phase 3 clinical trial of oral BCX7353 (750 mg) for the treatment of acute HAE attacks, in 2020, pending the completion of interactions with regulators on the Phase 3 program and additional work on the acute oral formulation (2020)

    Complement Oral Factor D Inhibitor Program – BCX9930

    • Report data from a proof of concept study in paroxysmal nocturnal hemoglobinuria (PNH) patients receiving oral BCX9930 (1H 2020)  

    ALK-2 Inhibitor Program – BCX9250

    • Continue ongoing Phase 1 clinical trial of BCX9250, an oral ALK-2 kinase inhibitor for treatment of fibrodysplasia ossificans progressiva (FOP), in healthy subjects

    Recent Corporate Developments

    • On November 6, 2019, the company provided a commercial update based on new 48-week clinical data from the APeX-2 and APeX-S trials, and detailed market research conducted with HAE patients, physicians who treat HAE and payors.

    • On November 5, 2019, the company announced it had licensed commercialization rights in Japan to Torii Pharmaceutical, Co. for BCX7353 for up to $42 million of upfront and potential milestone payments, including a $22 million upfront payment.
    • On November 1, 2019, the company announced it had begun enrollment of a Phase 1 trial of BCX9250, an oral ALK-2 inhibitor discovered and developed by BioCryst, for the treatment of FOP. The trial will evaluate the safety and tolerability and characterize the pharmacokinetic and pharmacodynamic profiles of BCX9250 in single and multiple ascending doses in healthy volunteers. 
    • On November 1, 2019, the company announced results from a Phase 1 trial of BCX9930, an oral Factor D inhibitor discovered and developed by BioCryst, showing that BCX9930 was safe and generally well tolerated, and demonstrated rapid, sustained and >95% suppression of the alternative pathway of the complement system at 100 mg every 12 hours. Based on these results, the company is advancing the program into a proof of concept (PoC) study in PNH patients and plans to report data from the PoC study in the first half of 2020.
    • On September 26, 2019, the company announced the U.S. Department of Health and Human Services (HHS) had exercised its option to purchase an additional 10,000 doses of BioCryst's approved antiviral influenza therapy, RAPIVAB® (peramivir injection).
    • On September 23, 2019, the company announced it had appointed clinical rare disease expert, Helen Thackray, M.D., FAAP, to its board of directors.

    Third Quarter 2019 Financial Results

    For the three months ended September 30, 2019, total revenues were $1.8 million, compared to $1.5 million in the third quarter of 2018. The increase was primarily due to the recognition of $0.3 million of peramivir product sales to Shionogi & Co., Ltd., the company's commercial partner in Japan.

    Research and development (R&D) expenses for the third quarter of 2019 increased to $25.1 million from $22.0 million in the third quarter of 2018, primarily due to increased spending on our complement-mediated diseases programs, which entered Phase 1 clinical testing in June 2019.

    Selling, general and administrative (SG&A) expenses for the third quarter of 2019 increased to $11.7 million, compared to $7.9 million in the third quarter of 2018. The increase was primarily due to increased spending on commercial activities and medical affairs to support the U.S. commercial launch of BCX7353 in 2020.

    Interest expense was $3.0 million in the third quarter of 2019, compared to $2.3 million in the third quarter of 2018, and was primarily due to an increase in the outstanding balance of the company's secured credit facility in February 2019.

    Net loss for the third quarter of 2019 was $37.6 million, or $0.34 per share, compared to a net loss of $29.6 million, or $0.28 per share, for the third quarter of 2018. 

    Cash, cash equivalents and investments totaled $70.0 million at September 30, 2019, and reflect a decrease from $128.4 million at December 31, 2018.  Operating cash use for the third quarter of 2019 was $24.5 million. Net operating cash use for the first nine months of 2019 was $77.9 million, as compared to $70.7 million for the first nine months of 2018.

    Financial Outlook

    BioCryst continues to expect full year 2019 net operating cash use to be in the range of $105 to $130 million, and its operating expenses to be in the range of $120 to $145 million. The company's operating expense range excludes equity-based compensation expense due to the difficulty in reliably 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.

    Conference Call and Webcast

    BioCryst management will host a conference call and webcast at 8:00 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 4891026. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 4891026.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the company may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 actual financial results may not be consistent with expectations, including that 2019 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:
    John Bluth
    +1 919 859 7910

    BIOCRYST PHARMACEUTICALS, INC.
    CONSOLIDATED FINANCIAL SUMMARY
    (in thousands, except per share)
                           
    Statements of Operations (Unaudited)                      
                           
        Three Months Ended     Nine Months Ended
        September 30,     September 30,
        2019   2018     2019   2018
    Revenues:                      
    Product sales $   335     $ -     $   2,014     $ -  
    Royalty revenue     508       523         3,526       4,326  
    Collaborative and other research and development     932       931         3,570       13,598  
    Total revenues     1,775       1,454         9,110       17,924  
                           
    Expenses:        
    Cost of product sales     -       -         1,399       -  
    Research and development     25,120       22,006         80,294       61,457  
    Selling, general and administrative     11,735       7,923         26,632       25,024  
    Royalty     18       18         131       401  
    Total operating expenses     36,873       29,947         108,456       86,882  
                           
    Loss from operations     (35,098 )     (28,493 )       (99,346 )     (68,958 )
                           
    Interest and other income     402       611         1,545       1,566  
    Interest expense     (3,044 )     (2,346 )       (8,805 )     (6,762 )
    Gain on foreign currency derivative     148       631         331       334  
                           
    Net loss $   (37,592 )   $ (29,597 )   $   (106,275 )   $ (73,820 )
                           
    Basic and diluted net loss per common share $   (0.34 )   $ (0.28 )   $   (0.96 )   $ (0.73 )
                           
    Weighted average shares outstanding     110,416       105,410         110,308       100,955  
                           
                           
                           
                           
    Balance Sheet Data (in thousands)                      
      September 30, 2019   December 31, 2018
      (Unaudited)   (Note 1)
    Cash, cash equivalents and investments   $ 68,435         $ 126,843    
    Restricted cash     1,547           1,544    
    Receivables from collaborations     3,598           4,293    
    Total assets     90,500           146,841    
    Non-recourse notes payable     29,451           29,121    
    Senior credit facility     50,077           29,952    
    Accumulated deficit     (838,006 )         (731,969 )  
    Stockholders' (deficit) equity     (41,253 )         49,235    
    Shares of common stock outstanding     110,438           110,063    
                           
    Note 1: Derived from audited financial statements.                      

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  50. —Results of the APeX-S and APeX-2 trials show patients taking 150 mg of oral, once daily BCX7353 achieved a stable average attack rate of ≤ 1 attack per month at 48 weeks—

    —75 percent of patients taking 150 mg BCX7353 completed 48 weeks of dosing in the Phase 3 APeX‑2 trial—

    —Comprehensive market research from 100 HAE patients and 175 treating physicians shows strong demand for oral, once daily BCX7353—

    RESEARCH TRIANGLE PARK, N.C., Nov. 06, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced 48-week results from its APeX-S and APeX-2 trials and comprehensive market research which support the significant commercial opportunity for oral, once daily BCX7353 in HAE.

    "The 48-week clinical trial data we now have…

    —Results of the APeX-S and APeX-2 trials show patients taking 150 mg of oral, once daily BCX7353 achieved a stable average attack rate of ≤ 1 attack per month at 48 weeks—

    —75 percent of patients taking 150 mg BCX7353 completed 48 weeks of dosing in the Phase 3 APeX‑2 trial—

    —Comprehensive market research from 100 HAE patients and 175 treating physicians shows strong demand for oral, once daily BCX7353—

    RESEARCH TRIANGLE PARK, N.C., Nov. 06, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced 48-week results from its APeX-S and APeX-2 trials and comprehensive market research which support the significant commercial opportunity for oral, once daily BCX7353 in HAE.

    "The 48-week clinical trial data we now have from APeX-S and APeX-2 highlight the control patients are having over their attacks with oral, once daily BCX7353, and consequently why 75 percent of patients stayed on-study through 48 weeks when they had other choices," said Jon Stonehouse, chief executive officer of BioCryst.

    "Since receiving the 24-week data from APeX-2 in May, we have conducted detailed and comprehensive market research to update our understanding of the commercial potential and value of BCX7353 with patients, treating physicians and payors. It is clear from this work that, regardless of their current treatment, HAE patients are eager to use, physicians are expecting to prescribe and payors are willing to reimburse oral once a day BCX7353," Stonehouse added. 

    Key Findings from 48-week APeX-S and APeX-2 Data:

    • In APeX-2, patients experienced a rapid and sustained decrease in their attack frequency over 48 weeks. Thirty patients who were randomized to 150 mg of BCX7353 at the beginning of the study and completed 48 weeks of therapy had a baseline attack rate of 2.9 attacks per month, which declined to 1.4 attacks per month after one month and to 1.0 attacks per month at month 12.
       
    • APeX-2 patients who switched from placebo to 150 mg of BCX7353 at the week 24 visit saw dramatic and sustained reductions in their HAE attack rate. Their mean attack rate dropped to 0.5 attacks per month at month seven and to 0.4 attacks per month at month 12.
       
    • APeX-S patients taking 150 mg of BCX7353 had similar attack control as those in APeX-2. Patients completing 48 weeks of treatment on 150 mg of BCX7353 (n=73) had a median attack rate of zero attacks per month in six of the 12 months, including month 12 (week 48).
       
    • 75 percent of HAE patients who were on 150 mg of oral BCX7353 in the APeX-2 trial completed 48 weeks of treatment.
       
    • The integrated 48-week analysis across both APeX-2 and APeX-S showed no new safety findings. BCX7353 was safe and generally well tolerated in a total of 342 patients with a total of 232 patient-years of daily oral dosing. The most common adverse event was the common cold, which occurred with similar frequency in BCX7353 and placebo patients. Gastrointestinal events led to discontinuation of BCX7353 in three percent of patients. Drug-related serious adverse events occurred in three of 342 subjects (0.9%) and resolved after stopping or interrupting BCX7353 dosing.
       
    • In APeX-S, alanine aminotransferase levels >3xULN were seen in 14 of 49 patients who discontinued androgens within 28 days prior to study entry, compared to one of 104 patients who discontinued androgens more than 28 days prior to study entry and zero of 74 patients who had never used androgens. These observations support a proposed four-week washout period for current androgen patients before beginning therapy with BCX7353.

    Key Findings from Market Research

    • The prevalence of HAE in the U.S. is higher than previously estimated. A comprehensive study of U.S. administrative claims data from 274 million covered lives establishes a prevalence of approximately 10,000 total HAE patients and 7,500 diagnosed and treated HAE patients in U.S.
       
    • More than 80 percent of the 100 HAE patients in the market research self-reported being on prophylactic therapy.
       
    • The 175 physicians in the market research, who in total treat more than 1,300 HAE patients, report they currently treat 58 percent of HAE patients with prophylactic therapy and anticipate they will treat 80 percent of HAE patients with prophylactic therapy in the future. 
       
    • Patient demand for BCX7353 is strong, regardless of their current therapy. When 100 patients were shown the APeX-2 24-week product profile, 60 percent of HAE patients said they would be very willing to use BCX7353.
       
    • HAE-treating physicians expect to prescribe BCX7353 to 41 percent of their HAE patients.
       
    • Payors expressed a broad willingness to reimburse oral BCX7353 in pricing research with insurance plans and pharmacy benefit managers representing more than 100 million covered lives.

    Conference Call and Webcast

    BioCryst management will host a conference call and webcast at 8:00 a.m. ET today. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 4891026. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 4891026.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the company may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 actual financial results may not be consistent with expectations, including that 2019 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:
    John Bluth
    +1 919 859 7910

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  51. —Agreement includes up to $42 million of upfront and potential milestone payments plus royalties on net sales—

    —JNDA submission to PMDA on track for Q1 2020—

    —Deal leverages Torii's proven track record to deliver innovative therapies to Japanese patients—

    RESEARCH TRIANGLE PARK, N.C., Nov. 05, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that it has licensed commercialization rights in Japan to Torii Pharmaceutical, Co. for BCX7353, an oral, once-daily treatment for the prevention of hereditary angioedema  (HAE) attacks.

    BioCryst will receive a $22 million upfront payment and is eligible to receive up to an additional $20 million upon achievement of certain milestones.  In addition, BioCryst will receive…

    —Agreement includes up to $42 million of upfront and potential milestone payments plus royalties on net sales—

    —JNDA submission to PMDA on track for Q1 2020—

    —Deal leverages Torii's proven track record to deliver innovative therapies to Japanese patients—

    RESEARCH TRIANGLE PARK, N.C., Nov. 05, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that it has licensed commercialization rights in Japan to Torii Pharmaceutical, Co. for BCX7353, an oral, once-daily treatment for the prevention of hereditary angioedema  (HAE) attacks.

    BioCryst will receive a $22 million upfront payment and is eligible to receive up to an additional $20 million upon achievement of certain milestones.  In addition, BioCryst will receive tiered royalties ranging from the mid-teens to potentially 40 percent of Japanese net sales of BCX7353.

    "We are excited to partner with Torii to accelerate access for Japanese patients to BCX7353," said Jon Stonehouse, president and chief executive officer of BioCryst. "Torii has a strong and recent history of significant commercial success as a Japanese partner, and the breadth of experience and infrastructure to build the prophylactic HAE market with BCX7353."   

    BioCryst received Orphan Drug and Sakigake designation for BCX7353 and plans to submit a Japanese New Drug application (JNDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) in the first quarter of 2020.

    "Given its clinical profile and the tremendous unmet need of HAE patients here in Japan, we are honored to add BCX7353 to our portfolio," said Goichi Matsuda, president of Torii. "We are well positioned to use our experience in building disease awareness, in driving patient identification, and our broad reach across the base of treaters, including dermatologists, allergists, and other specialists, to bring this important treatment to HAE patients."

    "With no approved treatments in Japan for the prevention of HAE attacks, there is a significant unmet need today," said professor Beverley Yamamoto, president of the Japanese Hereditary Angioedema Patient Association. "A safe, effective oral prophylactic therapy would offer tremendous benefit to Japanese HAE patients and their families."

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    About Torii Pharmaceutical Co., Ltd.

    The corporate mission of Torii Pharmaceutical Co., Ltd. is to contribute to the improvement of human health and to fulfill its responsibilities to customers, shareholders, society and employees, by supplying world-class pharmaceutical products.  Torii Pharma focuses on Renal diseases, Hemodialysis, Allergy and Skin diseases as its therapeutic areas of importance. Torii is a member of Japan Tobacco Inc. (JT) group. Collaboration with JT takes the form of functional focus, with JT undertaking R&D on new compounds and Torii integrating manufacture and marketing.  In addition to Torii's independent activities, Torii‘s partnership with JT includes in-licensing of high-quality pharmaceuticals. More details can be found on the corporate website https://www.torii.co.jp/ en/

    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. Factors that could cause actual results to differ materially from the forward-looking statements contained herein include, without limitation, the following:  the results of our partnership with Torii may not meet our current expectations (including with respect to the receipt or amounts of potential milestone or royalty payments); competitor products may limit the commercial potential of BCX7353 in Japan and the amount of any related royalties we would be entitled to receive; there are risks related to our relying on the performance of our partner, particularly with respect to the conduct of commercialization activities in line with our current expectations; there are risks related to government actions, including that decisions and other actions relating to approval, pricing, and exclusivity of BCX7353 in Japan may not be taken when expected or at all, or that the outcomes of such decisions and other actions may not be in line with our current expectations; we rely on third-party contract manufacturing organizations to manufacture BCX7353 and any failure of such parties to meet their obligations may impair our ability to supply the required amounts of BCX7353 to our partner; there are inherent risks related to commercializing drugs, including regulatory, manufacturing and supply risks; development activities for any indication may take longer or may be more expensive than planned; ongoing and future preclinical and clinical development of our HAE drug candidates (including for APeX-2, APeX-S and APeX-J) may not have positive results; we may not be able to enroll the required number of subjects in planned clinical trials; we may not advance human clinical trials as expected (including those for BCX7353); the FDA, EMA, PMDA or other applicable regulatory agency may require additional studies beyond the studies planned for product candidates (including BCX7353), or may not provide regulatory clearances, which could result in delays of planned clinical trials; and applicable regulatory bodies may impose a clinical hold with respect to, or withhold market approval for, product candidates (including BCX7353). Please refer to the documents the Company files periodically with the Securities and Exchange Commission, specifically our 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 our projections and forward-looking statements.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  52. RESEARCH TRIANGLE PARK, N.C., Nov. 04, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees options to purchase an aggregate of 217,500 shares of BioCryst common stock on October 31, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.00 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date…

    RESEARCH TRIANGLE PARK, N.C., Nov. 04, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees options to purchase an aggregate of 217,500 shares of BioCryst common stock on October 31, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.00 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10-year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  53. —BCX9250 significantly suppressed heterotrophic ossification in preclinical studies—

    —Urgent medical need with no approved treatments for FOP —

    —Phase 1 data expected in 2H 2020—

    RESEARCH TRIANGLE PARK, N.C., Nov. 01, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company has begun a Phase 1 clinical trial with BCX9250, an oral activin receptor-like kinase-2 (ALK-2) inhibitor discovered and developed by BioCryst for the treatment of fibrodysplasia ossificans progressiva (FOP).

    The Phase 1 trial will evaluate single and multiple ascending doses of oral BCX9250 in healthy volunteers. The company expects to report the results from the trial in the second half of 2020.

    "BCX9250 for FOP represents…

    —BCX9250 significantly suppressed heterotrophic ossification in preclinical studies—

    —Urgent medical need with no approved treatments for FOP —

    —Phase 1 data expected in 2H 2020—

    RESEARCH TRIANGLE PARK, N.C., Nov. 01, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company has begun a Phase 1 clinical trial with BCX9250, an oral activin receptor-like kinase-2 (ALK-2) inhibitor discovered and developed by BioCryst for the treatment of fibrodysplasia ossificans progressiva (FOP).

    The Phase 1 trial will evaluate single and multiple ascending doses of oral BCX9250 in healthy volunteers. The company expects to report the results from the trial in the second half of 2020.

    "BCX9250 for FOP represents the third program for potent and selective oral compounds for rare diseases invented and developed by BioCryst to enter the clinic, joining our plasma kallikrein inhibitors for hereditary angioedema and Factor D inhibitor for complement-mediated diseases," said Dr. William Sheridan, chief medical officer of BioCryst.

    "FOP is a devastating disease with no approved therapies, and we look forward to seeing clinical data with BCX9250 from this initial study in healthy volunteers to inform how we proceed strategically with the program," Sheridan added.

    In preclinical studies, BCX9250 demonstrated potency for the target kinase, selectivity, safety and strong suppression of heterotopic ossification (HO) in animal models.

    About Fibrodysplasia Ossificans Progressiva

    Fibrodysplasia Ossificans Progressiva is a rare, severely disabling condition characterized by the irregular formation of bone outside the normal skeleton, also known as heterotopic ossification (HO). HO can occur in muscles, tendons and soft tissue. Patients with FOP become bound by this irregular ossification over time, with restricted movement and fused joints, resulting in deformities and premature mortality. There are currently no approved treatments for FOP.

    About BCX9250

    Discovered by BioCryst, BCX9250 is a novel, oral, inhibitor of the ALK-2 enzyme. The ALK-2 enzyme is a part of the normal signaling pathway for bone formation and responds to binding its specific ligands (bone morphogenic proteins, BMPs) by stimulating normal bone growth and renewal in healthy children and adults. Specific activating mutations of the ALK-2 gene are seen in all cases of FOP. An activating mutation in ALK-2 is necessary for the disease to occur, making the ALK-2 kinase an ideal drug target for treatment of FOP. The goal of the ALK-2 inhibitor project at BioCryst is to discover and develop orally administered kinase inhibitor drug candidates that are able to slow or prevent the progressive formation of HO.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema; BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases; galidesivir, a potential treatment for Marburg virus disease and Yellow Fever;  and  BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 developing BCX9250 may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9250 may not advance as expected, enroll the required number of subjects or have positive results; that the FDA, EMA or other applicable regulatory agency may require additional studies beyond the studies planned, may not provide regulatory clearances, may impose a clinical hold or may withhold market approval with respect to BCX9250.  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:
    John Bluth
    +1 919 859 7910

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  54. —Phase 1 data showed rapid, sustained and &gt;95% inhibition of alternative pathway of complement system with 100 mg of oral BCX9930 BID—

    —BCX9930 safe and generally well tolerated—

    —Part 1 SAD and part 2 MAD data support advancement of program into part 3 proof of concept (PoC) study in PNH patients; data from PNH PoC study expected in 1H 2020—

    —Company to host conference call at 8:30 a.m. ET—

    RESEARCH TRIANGLE PARK, N.C., Oct. 28, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced results from an ongoing three part Phase 1 trial of BCX9930, an oral Factor D inhibitor discovered and developed by BioCryst for the treatment of complement-mediated diseases, in 72 healthy volunteers. BCX9930 was safe and generally…

    —Phase 1 data showed rapid, sustained and >95% inhibition of alternative pathway of complement system with 100 mg of oral BCX9930 BID—

    —BCX9930 safe and generally well tolerated—

    —Part 1 SAD and part 2 MAD data support advancement of program into part 3 proof of concept (PoC) study in PNH patients; data from PNH PoC study expected in 1H 2020—

    —Company to host conference call at 8:30 a.m. ET—

    RESEARCH TRIANGLE PARK, N.C., Oct. 28, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced results from an ongoing three part Phase 1 trial of BCX9930, an oral Factor D inhibitor discovered and developed by BioCryst for the treatment of complement-mediated diseases, in 72 healthy volunteers. BCX9930 was safe and generally well tolerated, and showed rapid, sustained and >95% suppression of the alternative pathway (AP) of the complement system at 100 mg every 12 hours, as measured by the AP Wieslab® assay.

    In part 1 of the trial, a single ascending dose (SAD) assessment, six cohorts of healthy volunteers received a single dose of 10 mg, 30 mg, 100 mg, 300 mg, 600 mg or 1200 mg of oral BCX9930 or placebo (each SAD cohort randomized 6:2). In part 2 of the trial, the multiple ascending dose (MAD) assessment, two cohorts of healthy volunteers received 50 mg or 100 mg of oral BCX9930 or placebo (each MAD cohort randomized 10:2) administered every 12 hours for seven days. Healthy volunteers in the MAD cohorts were prophylactically dosed with the broad-spectrum antibiotic, amoxicillin/clavulanate.

    BCX9930 was safe and generally well tolerated at all doses studied. There were no serious adverse events. A clinically benign rash was observed in some healthy volunteers in the MAD (two in the 50 mg cohort, seven in the 100 mg cohort), which was self-limited and resolved in 4-8 days after onset. There were no discontinuations from the trial.  

    Based on the safety, tolerability, PK and PD dose-response results from parts 1 and 2 of the Phase 1 trial, the company plans to complete additional MAD dosing cohorts and advance to part 3 of the trial, a proof of concept (PoC) study of BCX9930 in paroxysmal nocturnal hemoglobinuria (PNH) patients who are poor responders to eculizumab or ravulizumab, and treatment-naïve patients.  The company expects to report data from the PoC study in PNH patients in the first half of 2020.

    Additional data from the Phase 1 trial of BCX9930 can be found in slides at the investors section of the company website at www.biocryst.com.

    "We are excited that BioCryst's oral Factor-D inhibitor, BCX9930, was safe, generally well-tolerated and demonstrated rapid, strong, and sustained suppression of the alternative pathway. Based on these excellent data from the SAD/MAD cohorts, we look forward to advancing to part 3 of the trial, a proof of concept study in PNH patients, and reporting data in the first half of 2020," said Dr. William Sheridan, chief medical officer of BioCryst.

    About Complement-Mediated Diseases

    The complement system is part of the body's natural immune system and is responsible for helping the body eliminate microbes (including viral and bacterial infections) and damaged cells. It is comprised of proteins which are primarily produced in the liver and circulate in the blood. Once activated, the complement system stimulates inflammation, phagocytosis and cell lysis.

    Excessive or uncontrolled activation of the complement system can cause severe, and potentially fatal, immune and inflammatory disorders.

    The complement system comprises biological cascades of amplifying enzyme cleavages involving more than 30 proteins and protein fragments, and may be activated through three pathways: the classical pathway (initiated by antibody-antigen complexes), the lectin pathway (initiated by lectin binding) and the alternative pathway (initiated by microbial surfaces).

    The alternative pathway also provides a critical amplification loop for all three pathways, regardless of the initiating mechanism. Factor D is an essential enzyme in the alternative pathway, thus making Factor D an attractive target to address complement-mediated diseases.

    About BCX9930

    Discovered by BioCryst, BCX9930 is a novel, oral, potent and selective small molecule inhibitor of Factor D currently in Phase 1 clinical development for the treatment of complement-mediated diseases. Patients with complement-mediated diseases, many of which can cause death or severe morbidity, currently either have no treatments available, or are limited to repeated intravenous infusion treatments. In parts 1 and 2 of a Phase 1 SAD/MAD assessment, BCX9930 was safe and generally well tolerated and, at 100 mg BID, showed rapid, sustained and >95% suppression of the alternative pathway of the complement system. Preclinical data showed that BCX9930 was a potent and specific inhibitor of Factor D.  Based on results from parts 1 and 2 of the Phase 1 trial in healthy volunteers, the company plans to complete additional multiple ascending dose cohorts while advancing to part 3 of the trial, a proof of concept study in PNH patients, which the company plans to report data from in the first half of 2020.

    Conference Call and Webcast

    BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the Phase 1 trial of BCX9930, and next steps for the program. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 1691557. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 1691557.

    About BioCryst Pharmaceuticals

    BioCryst discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema; BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases; galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and a preclinical program to develop oral ALK-2 inhibitors for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 the development of BCX9930 may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930 may not advance as expected, enroll the required number of subjects or have positive results; that further analysis of the current data or from additional data from the study may yield results which are different from our current view, that the FDA, EMA or other applicable regulatory agency may not agree with our interpretation, may require additional studies beyond the studies planned, may not provide regulatory clearances, may impose a clinical hold or may withhold market approval with respect to BCX9930.  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:
    John Bluth
    +1 919 859 7910
     

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  55. RESEARCH TRIANGLE PARK, N.C., Oct. 03, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted three newly-hired employees options to purchase an aggregate of 103,000 shares of BioCryst common stock on September 30, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.87 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant…

    RESEARCH TRIANGLE PARK, N.C., Oct. 03, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted three newly-hired employees options to purchase an aggregate of 103,000 shares of BioCryst common stock on September 30, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.87 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10 year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and a preclinical program to develop oral ALK-2 inhibitors for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  56. RESEARCH TRIANGLE PARK, N.C., Sept. 26, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the U.S. Department of Health and Human Services (HHS) has exercised its option to purchase an additional 10,000 doses of BioCryst's approved antiviral influenza therapy, RAPIVAB® (peramivir injection).  

    With the exercise of the second option, BioCryst plans to deliver a total of 20,000 doses of RAPIVAB, which will add approximately $14 million of non-dilutive capital to the company, by the end of 2019.

    The RAPIVAB purchase by the HHS Office of the Assistant Secretary for Preparedness and Response will supply the Strategic National Stockpile, the nation's largest supply of life-saving pharmaceuticals and medical…

    RESEARCH TRIANGLE PARK, N.C., Sept. 26, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the U.S. Department of Health and Human Services (HHS) has exercised its option to purchase an additional 10,000 doses of BioCryst's approved antiviral influenza therapy, RAPIVAB® (peramivir injection).  

    With the exercise of the second option, BioCryst plans to deliver a total of 20,000 doses of RAPIVAB, which will add approximately $14 million of non-dilutive capital to the company, by the end of 2019.

    The RAPIVAB purchase by the HHS Office of the Assistant Secretary for Preparedness and Response will supply the Strategic National Stockpile, the nation's largest supply of life-saving pharmaceuticals and medical supplies for use in a public health emergency.

    "RAPIVAB is an important antiviral with proven benefits for influenza patients, and we appreciate the opportunity to fulfill these orders for HHS as they support patients and our national security," said Jon Stonehouse, chief executive officer of BioCryst.

    "This $14 million in non-dilutive capital from the U.S. government is important to BioCryst as we continue to actively evaluate several additional opportunities to bolster our balance sheet by the end of 2019 to support our exciting progress across multiple programs," Stonehouse added.

    These orders are part of a $34.7 million contract (Contract No. 75D301-18-C-02984) the Centers for Disease Control and Prevention has awarded for the procurement of up to 50,000 doses of RAPIVAB® (peramivir injection) over a five-year period.

    About RAPIVAB (peramivir injection)
    RAPIVAB (peramivir injection) is approved in the United States for the treatment of acute uncomplicated influenza in patients 2 years and older who have been symptomatic for no more than two days. It is administered via an intravenous infusion for a minimum of 15 minutes at recommended doses of 600 mg/kg for adults and adolescents and 12 mg/kg for pediatric patients ages 2 to 12 years. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. Visit http://www.rapivab.com to learn more.

    About BioCryst Pharmaceuticals
    BioCryst discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema; BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases; galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and a preclinical program to develop oral ALK-2 inhibitors for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 the U.S. government may purchase smaller quantities of RAPIVAB® than currently anticipated, or none at all; that the company relies on third-party manufacturers to manufacture RAPIVAB in a timely manner and in accordance with applicable governmental regulations, and any failure of such third-party manufacturers to perform their obligations could impact the company's ability to supply RAPIVAB pursuant to the government contract; and that government contracts contain certain terms and conditions, including termination provisions, that subject the company to additional risks. 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:
    John Bluth
    +1 919 859 7910

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  57. RESEARCH TRIANGLE PARK, N.C., Sept. 24, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the Cantor Global Healthcare Conference in New York on Friday, October 4, 2019 at 12:35 p.m. ET.

    Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for…

    RESEARCH TRIANGLE PARK, N.C., Sept. 24, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the Cantor Global Healthcare Conference in New York on Friday, October 4, 2019 at 12:35 p.m. ET.

    Links to a live audio webcast and replay of this presentation may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and a preclinical program to develop oral ALK-2 inhibitors for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  58. RESEARCH TRIANGLE PARK, N.C., Sept. 23, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company has appointed clinical rare disease expert, Helen Thackray, M.D., FAAP, to its board of directors.

    Dr. Thackray currently serves as chief medical officer and senior vice president of clinical development at GlycoMimetics, Inc., a clinical-stage biotechnology company advancing a novel pipeline of orphan drug candidates to address unmet needs for patients. 

    She joined GlycoMimetics in 2006, and leads their orphan product, fast track, and breakthrough therapy programs at all stages of development in rare diseases.  Prior to joining GlycoMimetics, Dr. Thackray was vice president of clinical development…

    RESEARCH TRIANGLE PARK, N.C., Sept. 23, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company has appointed clinical rare disease expert, Helen Thackray, M.D., FAAP, to its board of directors.

    Dr. Thackray currently serves as chief medical officer and senior vice president of clinical development at GlycoMimetics, Inc., a clinical-stage biotechnology company advancing a novel pipeline of orphan drug candidates to address unmet needs for patients. 

    She joined GlycoMimetics in 2006, and leads their orphan product, fast track, and breakthrough therapy programs at all stages of development in rare diseases.  Prior to joining GlycoMimetics, Dr. Thackray was vice president of clinical development at Biosynexus, and served for over a decade on the research ethics review board of the National Center for Healthcare Statistics, part of the Centers for Disease Control and Prevention (CDC).

    She is a board-certified pediatrician, practicing and serving on the faculty of the Children's National Medical Center and George Washington University School of Medicine and Health Sciences from 2000-2019.  Dr. Thackray has authored more than 60 peer-reviewed articles and presentations.

    "Advocacy for patients, and for better therapeutic options for those with rare diseases, has been my central focus throughout my career.  With a deep pipeline of home-grown oral medicines for rare diseases, BioCryst is positioned to deliver dramatic improvements for patient care.  I am excited to join BioCryst as the company makes the transition from clinical to commercial with its first rare disease program," Dr. Thackray said.

    "As a physician and chief medical officer, Helen adds important, complementary and contemporary clinical rare disease experience to our board as BioCryst prepares to launch oral BCX7353 to patients next year, and advances our multiple clinical rare disease programs," said Robert Ingram, chairman of BioCryst.

    Dr. Thackray holds a Bachelor of Science degree in biological sciences from Stanford University, and an M.D. from the George Washington University School of Medicine and Health Sciences.  She completed her pediatric residency and chief residency at Children's National Medical Center, trained in medical genetics at the National Human Genome Research Institute at the National Institutes of Health, and is a Fellow of the American Academy of Pediatrics (FAAP).

    About BioCryst Pharmaceuticals

    BioCryst discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema; BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases; galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and a preclinical program to develop oral ALK-2 inhibitors for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. 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 developing any HAE product candidate may take longer or may be more expensive than planned; that ongoing and future preclinical and clinical development of BCX9930, BCX9250 and our HAE drug candidates (including APeX-S,  APeX-J, and the BCX9930 Phase 1) may not have positive results; that BioCryst may not be able to enroll the required number of subjects in planned clinical trials of product candidates; that the company may not advance human clinical trials with product candidates as expected; that the FDA, EMA, PMDA or other applicable regulatory agency 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 actual financial results may not be consistent with expectations, including that 2019 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:
    John Bluth
    +1 919 859 7910

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  59. RESEARCH TRIANGLE PARK, N.C., Sept. 04, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees options to purchase an aggregate of 112,500 shares of BioCryst common stock on August 30, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.99 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date…

    RESEARCH TRIANGLE PARK, N.C., Sept. 04, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the compensation committee of BioCryst's board of directors granted five newly-hired employees options to purchase an aggregate of 112,500 shares of BioCryst common stock on August 30, 2019 as inducements material to each employee entering into employment with BioCryst. The options were granted in accordance with NASDAQ Listing Rule 5635(c)(4).

    The options have an exercise price of $2.99 per share, which is equal to the closing price of BioCryst common stock on the last business day prior to the grant date. The options vest in four equal annual installments beginning on the one-year anniversary of the grant date, in each case subject to the new employee's continued service with the company. Each stock option has a 10 year term and is subject to the terms and conditions of BioCryst's Inducement Equity Incentive Plan and a stock option agreement covering the grant.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and a preclinical program to develop oral ALK-2 inhibitors for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

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  60. RESEARCH TRIANGLE PARK, N.C., Sept. 03, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the H.C. Wainwright Global Investment Conference in New York on Monday, September 9, 2019 at 9:10 a.m. ET.

    Links to a live audio webcast and replay of the presentation may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment…

    RESEARCH TRIANGLE PARK, N.C., Sept. 03, 2019 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the company will present at the H.C. Wainwright Global Investment Conference in New York on Monday, September 9, 2019 at 9:10 a.m. ET.

    Links to a live audio webcast and replay of the presentation may be accessed in the Investors section of BioCryst's website at http://www.biocryst.com.

    About BioCryst Pharmaceuticals

    BioCryst Pharmaceuticals discovers novel, oral small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including BCX7353, an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for Marburg virus disease and Yellow Fever, and a preclinical program to develop oral ALK-2 inhibitors for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst's first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the Company's website at www.BioCryst.com.

    BCRXW

    Contact:
    John Bluth
    +1 919 859 7910

    Primary Logo

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