SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 20, 2019
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
910 Clopper Road Suite 201S
|(Address of principal executive offices)||(Zip Code)|
Registrants telephone number, including area code: (240) 654-1450
(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:
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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
Name of each exchange
on which registered
|Common stock, par value $0.0001 per share||ALT||The NASDAQ Global Market|
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. ☐
|Item 1.01.|| |
Entry into a Material Definitive Agreement.
On August 21, 2019, Altimmune, Inc. (the Company) announced that the Biomedical Advanced Research and Development Authority (BARDA) modified its existing contract with the Company with respect to the Companys NasoShield program by increasing the base contract of $24.1 million by $3.7 million to a total of $27.8 million and extending the performance period through December 2020. The modification was executed effective August 20, 2019. The increase in funding is primarily intended to fund a Phase 1b clinical study to evaluate the safety and immunogenicity associated with different dosing positions of NasoShield versus placebo in healthy adults. In addition, the funding supports nonclinical studies designed to inform and support the Phase 1b study.
The NasoShield program is funded through a contract with BARDA (HHSO100201600008C), with a total potential value of $133.7 million if all options in the contract are exercised, which would advance the candidate through the end of Phase 2 development.
A copy of the Companys press release issued in connection with this announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
|Item 9.01|| |
Financial Statements and Exhibits.
|99.1||Press release of Altimmune, Inc. dated August 21, 2019.|
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.
|Date: August 21, 2019||ALTIMMUNE, INC.|
|Chief Financial Officer|
Altimmune Announces $3.7 Million in Additional BARDA Funding to Advance NasoShield Clinical Development
Phase 1b clinical trial will study effect of dosing methodology on immune response to intranasal anthrax vaccine
GAITHERSBURG, MD, August 21, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the Biomedical Advanced Research and Development Authority (BARDA) is modifying its existing anthrax vaccine development contract with Altimmune by awarding an additional $3.7 million. The increase in funding is primarily directed toward a Phase 1b clinical trial of NasoShield to evaluate alternative methods of intranasal dosing in humans.
In 2018, BARDA awarded Altimmune $2.5 million for further NasoShield development including a comparison of different methods of administration of the vaccine in preclinical models. The data from this study demonstrated that a simple modification to the method of intranasal dose administration had a dramatic impact on the resulting immunogenicity. These results suggest that the 2018 Phase 1 study of NasoShield in healthy adults might have shown a more robust immunogenic effect had a modified administration method been employed. The planned Phase 1b clinical trial will evaluate modified methods of intranasal dosing on NasoShield safety and immunogenicity and is expected to start in 2019.
We are extremely pleased that BARDA has made this additional funding available for a clinical study to advance this potentially transformative anthrax vaccine, said Dr. Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. BARDA has been an outstanding partner for NasoShield and we are excited to continue its development with their support.
In contrast to the currently licensed vaccine that requires three injected doses of vaccine over one month for protection, NasoShield is being developed as a single-dose, intranasal anthrax vaccine. The NasoShield product characteristics may also provide for greatly improved logistics in distribution and administration allowing it to be used more effectively than the currently approved vaccine in the event of an anthrax incident. The NasoShield program is funded through a contract with BARDA (HHSO100201600008C), with a total potential value of $133.7 million if all options in the contact are exercised.
Altimmune is a clinical stage biopharmaceutical company focused on developing treatments for liver disease and immune modulating therapies. The Companys diverse pipeline includes next generation peptide therapeutics for NASH (ALT-801) and chronic Hepatitis B (HepTcellTM), conjugated immunostimulants for the treatment of cancer (ALT-702) and intranasal vaccines (NasoVAXTM and NasoShieldTM). For more information on Altimmune, please visit www.altimmune.com.
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, the initiation of a Phase 1b NasoShield clinical study in 2019, the prospects for commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words may, could, should, anticipate, believe, estimate, expect, intend, plan, predict and similar expressions and their variants, as they relate to Altimmune, Inc. (the Company) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: the reliability of the results of the studies relating to human safety and possible adverse effects resulting from the administration of the Companys product candidates; the impact of the Tax Cuts and Jobs Act; delays caused by third parties challenging government contracts awarded to the Company; the receipt of future potential payments under government contracts or grants; the Companys ability to identify potential future government contracts or grant awards; the Companys ability to obtain potential regulatory approvals on the timelines anticipated, or at all; the Companys ability to obtain additional patents or extend existing patents on the timelines anticipated, or at all; the Companys ability to identify and consummate potential future strategic partnerships or business combinations; the Companys ability to expand its pipeline of products and the success of future product advancements, including the success of future clinical trials, and the Companys ability to commercialize its products; the Companys anticipated financial or operational results; the Companys ability to obtain additional capital resources; unforeseen safety and efficacy issues; breaches of data privacy, or disruptions in the Companys information technology systems; and the Companys ability to continue to satisfy the listing requirements of the NASDAQ Global Market. Further information on the factors and risks that could affect the Companys business, financial conditions and results of operations are contained in the Companys filings with the U.S. Securities and Exchange Commission, including under the heading Risk Factors in the Companys annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, which are available at www.sec.gov.
|Will Brown||Ashley R. Robinson|
|Chief Financial Officer||Managing Director LifeSci Advisors|
|Phone: 240-654-1450||Phone: 617-535-7742|
|Email: firstname.lastname@example.org||Email: email@example.com|