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): April 1, 2021
(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:
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
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 8.01. Other Events.
On April 1, 2021, Altimmune, Inc. (the Company) issued a press release announcing the results from the Phase 1b trial for the Companys intranasal anthrax vaccine candidate, NasoShield. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
|Item 9.01|| |
Financial Statements and Exhibits.
|99.1||Press release of Altimmune, Inc. dated April 1, 2021|
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: April 1, 2021||ALTIMMUNE, INC.|
|Chief Financial Officer|
Altimmune Reports Data from its Phase 1b Clinical Trial of NasoShield
GAITHERSBURG, MD, April 1, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported clinical data today on its NasoShield intranasal anthrax vaccine candidate. The Phase 1b trial evaluated the safety and immunogenicity of one and two-dose regimens of NasoShield in healthy volunteers. The clinical trial was conducted with support from the Biomedical Advanced Research and Development Authority (BARDA).
The trial enrolled 42 healthy subjects who received intranasally administered NasoShield or saline placebo and were then monitored for 6 months post-dosing. The primary endpoint was the safety and tolerability of NasoShield. The primary immunogenicity readouts included the serum binding antibody to protective antigen and anthrax toxin blocking antibody responses at 28- and 56-days post-dose administration. Stimulation of the mucosal IgA immune response in the nasal cavity was also assessed.
The clinical data from the Phase 1b trial showed that:
Serum binding antibody responses to the protective antigen of Bacillus anthracis, the bacterium and causative agent of anthrax, were significantly greater than in the placebo arm.
Antibody responses blocking anthrax toxin were blunted compared to protective antigen antibody responses and were low compared to prior studies conducted with BioThrax®, the only approved anthrax vaccine.
Notably, as with Altimmunes other intranasally administered replication-deficient adenovirus vaccines, nasal mucosal IgA responses specific for protective antigen were observed in up to 80% of subjects post-vaccination.
The safety and tolerability of NasoShield was excellent and comparable to intranasal saline placebo in both the number and characteristics of adverse or reactogenicity events, consistent with other clinical trials of Altimmunes intranasal vaccine candidates.
The NasoShield program is funded through a contract (HHSO100201600008C) with BARDA which, if all options are exercised, is expected to provide funding through the end of Phase 2 development. The Company plans to conduct a comprehensive review of the data with BARDA to determine the path for continued development of the program.
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.
Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID), anthrax (NasoShield) and influenza (NasoVAX); an intranasal immune modulating therapeutic for COVID-19 (T-COVID); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell). For more information on Altimmune, please visit www.altimmune.com.
Follow @Altimmune, Inc. on LinkedIn
Follow @AltimmuneInc on Twitter
Forward-Looking Statement for Altimmune
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 potential for additional funding from BARDA, the potential immunization effects of NasoShield, and the prospects for regulatory approval, 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: potential impacts due to the COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Companys product candidates; funding delays, reductions in or elimination of U.S. government funding and/or non-renewal of expiring funding under the Companys agreement with BARDA; and the Companys ability to satisfy certain technical milestones under the Companys contracts with BARDA that would entitle the Company to receive additional funding over the period of the agreement. 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 report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC, which is available at www.sec.gov.
Altimmune Investor & Media Contacts:
|Chief Financial Officer||
Sr. Dir, Investor Relations
Phone : 410-474-8200