UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________
FORM
_________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
_______________________________
(Exact name of registrant as specified in its charter)
_______________________________
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
(Address of Principal Executive Offices) (Zip Code)
(
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report)
_______________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On August 25, 2022, the Company issued a press release announcing the events described in Item 8.01 of this Current Report on Form 8-K. A copy of the news release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.
The information contained in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
On August 25, 2022, BioCryst Pharmaceuticals, Inc. (the “Company”) announced that it has entered into an amendment (the “Amendment”) to its contract dated September 1, 2018 with the Department of Health and Human Services (“HHS”) for the procurement of the Company’s approved antiviral influenza therapy, RAPIVAB® (peramivir injection). Pursuant to the Amendment, HHS exercised Option Period 4 under the contract to purchase an additional 10,000 doses of RAPIVAB during the period of September 1, 2022 through August 31, 2023 for a total price of approximately $6.9 million. The order is the final of five purchase options under the Company’s procurement contract for RAPIVAB. This description of the Amendment is qualified in its entirety by reference to the full text of the Amendment furnished as Exhibit 10.1 to this Current Report on Form 8-K.
The Company has previously disclosed that it is commencing the close out of its September 2013 galidesivir contract with the National Institute of Allergy and Infectious Diseases within the HHS. In addition, the Company’s other government funding for galidesivir is expected to expire later in 2022. The Company has no plans to continue the galidesivir program without government funding.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements, including statements regarding sales of RAPIVAB and expectations regarding the Company’s galidesivir program. These statements involve known and unknown risks, uncertainties, and other factors which may cause actual results to be materially different from those 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 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 its government procurement contract; the availability of government funding; government contracts contain certain terms and conditions that subject the Company to additional risks; and the ongoing COVID-19 pandemic, which could create challenges in all aspects of the Company’s business, including without limitation delays, stoppages, difficulties, and increased expenses with respect to the Company’s and its partners’ supply chains, negatively impact the Company’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening the other risks described herein or in the documents the Company files periodically with the Securities and Exchange Commission. Please refer to the documents the Company files periodically with the Securities and Exchange Commission, specifically the Company’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 actual results to differ materially from those contained in the Company’s forward-looking statements.
(d) Exhibits
| Exhibit No. | Description | |||
| 10.1 | Amendment, dated August 10, 2022, to the Contract dated September 1, 2018 between BioCryst Pharmaceuticals, Inc. and the Department of Health and Human Services | |||
| 99.1 | Press release dated August 25, 2022 entitled "U.S. Government Exercises Option to Purchase Additional RAPIVAB® (peramivir injection) from BioCryst for Pandemic Influenza Preparedness" | |||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BioCryst Pharmaceuticals, Inc. | ||
| Date: August 25, 2022 | By: | /s/ Alane Barnes |
| Alane Barnes | ||
| Chief Legal Officer | ||
EXHIBIT 10.1
EXHIBIT 99.1
U.S. Government Exercises Option to Purchase Additional RAPIVAB® (peramivir injection) from BioCryst for Pandemic Influenza Preparedness
RESEARCH TRIANGLE PARK, N.C., Aug. 25, 2022 (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 antiviral influenza therapy, RAPIVAB® (peramivir injection), for approximately $7 million.
The RAPIVAB purchase by the HHS Administration for Strategic Preparedness and Response will strengthen the nation’s preparedness to respond to a potential pandemic influenza event.
The order is the final of five purchase options from a $34.7 million contract (Contract No. 75D301-18-C-02984) the Centers for Disease Control and Prevention awarded in 2018 for the procurement of up to 50,000 doses of RAPIVAB over a five-year period. With the fulfillment of this new order, BioCryst will have delivered all 50,000 doses to HHS under the contract.
About RAPIVAB® (peramivir injection)
RAPIVAB® (peramivir injection) is approved in the United States for the treatment of acute uncomplicated influenza in patients six months 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 six months 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.
U.S. Indication and Important Safety Information
Indication
RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 6 months and older who have been symptomatic for no more than 2 days.
Limitations of Use
- Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus; a limited number of subjects infected with influenza B virus were enrolled.
- Influenza viruses change over time. Emergence of resistance substitutions could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use RAPIVAB.
- The efficacy of RAPIVAB could not be established in patients with serious influenza requiring hospitalization.
Contraindications
RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis to peramivir or any component of the product. Severe allergic reactions have included anaphylaxis, erythema multiforme and Stevens-Johnson Syndrome.
Warnings and Precautions
- Cases of anaphylaxis and serious skin/hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme have occurred with RAPIVAB. Discontinue RAPIVAB and initiate appropriate treatment if anaphylaxis or serious skin reaction occurs or is suspected.
- Neuropsychiatric events: Patients with influenza may be at an increased risk of hallucinations, delirium and abnormal behavior early in their illness. Monitor for signs of abnormal behavior.
- Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. RAPIVAB has not been shown to prevent such complications.
Adverse Reactions
The most common adverse reaction in adults (18 years of age and older) was diarrhea (8% RAPIVAB vs 7% placebo). Lab abnormalities (incidence ≥2%) occurring more commonly with RAPIVAB than placebo were elevated ALT > 2.5 times the upper limit of normal (3% vs 2%), elevated serum glucose >160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit of normal (4% vs 2%), and neutrophils <1.0 x 109/L (8% vs 6%). In a subset of subjects with serious influenza requiring hospitalization treated with RAPIVAB 600 mg as monotherapy (N=101), the following adverse reactions were also reported more frequently with RAPIVAB as compared to placebo: constipation (4% versus 2%), insomnia (3% versus 0%), AST increased (3% versus 2%), and hypertension (2% versus 0%).
The safety profile of RAPIVAB in subjects 6 months to 17 years of age was generally similar to that observed in adults. The only adverse reaction reported in pediatric subjects treated with RAPIVAB (occurring in ≥2% of subjects) and not reported in adults was vomiting (3% versus 9% for oseltamivir). The only clinically significant laboratory abnormality (DAIDS Grade 2) occurring in ≥2% of pediatric subjects treated with RAPIVAB (and not previously reported in adults) was proteinuria by dipstick analysis (3% versus 0% for oseltamivir).
Concurrent Use With Live Attenuated Influenza Vaccine
Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV) and thus may reduce vaccine efficacy. The concurrent use of RAPIVAB with LAIV intranasal has not been evaluated. Avoid use of LAIV within 2 weeks before or 48 hours after administration of RAPIVAB, unless medically indicated.
Please see full prescribing information for RAPIVAB.
You are encouraged to report negative side effects of prescription drugs to the FDA. To report suspected adverse reactions, contact BioCryst Pharmaceuticals at 1-833-633-2279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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. Oral, once-daily ORLADEYO® (berotralstat) is approved in the United States and multiple global markets. BioCryst has several ongoing development programs including BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva, and galidesivir, a potential treatment for Marburg virus disease and yellow fever. RAPIVAB® (peramivir injection) is approved in the U.S. and multiple global markets, with post-marketing commitments 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 sales of RAPIVAB. These statements involve known and unknown risks, uncertainties and other factors which may cause BioCryst’s actual results to be materially different from those 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: BioCryst 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 BioCryst’s ability to supply RAPIVAB pursuant to its government procurement contract; government contracts contain certain terms and conditions that subject BioCryst to additional risks; and 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’ supply chains, negatively impact BioCryst’s ability to access the capital or credit markets to finance its operations, or have the effect of heightening the other risks described herein or in the documents BioCryst files periodically with the Securities and Exchange Commission. 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 forward-looking statements.
BCRXW
Investors:
John Bluth
+1 919 859 7910
jbluth@biocryst.com
Media:
Catherine Collier Kyroulis
+1 917 886 5586
ckyroulis@biocryst.com