Heat Biologics, Inc. (NASDAQ:HTBX) Files An 8-K Regulation FD Disclosure

Heat Biologics, Inc. (NASDAQ:HTBX) Files An 8-K Regulation FD Disclosure
Item 7.01.   Regulation FD Disclosure.

On July 29, 2020, Heat Biologics, Inc. (the “Company”) issued a press release announcing successful pre-clinical testing of the Company’s COVID-19 vaccine, which demonstrated in-vivo confirmation of vaccine immunogenicity in animal models, including expansion of human-HLA-restricted T-cells against immunodominant epitopes of SARS-CoV-2 Spike protein.  Testing demonstrated expansion of antibody-supporting CD4+, and virus killing CD8+ T-cells in the lungs of the animals, a major site for COVID-19 infection. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

The press release attached as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.

The Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although it may do so from time to time if its management believes it is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosures.

Item 8.01   Other Information

On July 29, 2020, the Company issued a press release announcing successful pre-clinical testing of the Company’s COVID-19 vaccine, which demonstrated in-vivo confirmation of vaccine immunogenicity in animal models, including expansion of human-HLA-restricted T-cells against immunodominant epitopes of SARS-CoV-2 Spike protein. Testing demonstrated expansion of antibody-supporting CD4+, and virus killing CD8+ T cells in the  lungs of the animals, a major site for COVID-19 infection.

Item 9.01   Financial Statements and Exhibits.

(d) Exhibits.

The following exhibit is furnished with this Current Report on Form 8-K.

  


HEAT BIOLOGICS, INC. Exhibit
EX-99.1 2 htbx_ex99z1.htm PRESS RELEASE Press Release   EXHIBIT 99.1 Heat Biologics COVID-19 Vaccine Demonstrates Immunogenicity Proof-of-Concept in Pre-Clinical Studies Confirms stimulation of human-HLA-restricted transgenic mouse T-cells against immunodominant epitopes of SARS-CoV-2 Spike protein Durham,…
To view the full exhibit click here

Story continues below

About Heat Biologics, Inc. (NASDAQ:HTBX)

Heat Biologics, Inc. is a development-stage company focused on developing allogeneic, off-the-shelf cellular therapeutic vaccines to combat a range of cancers. The Company is an immuno-oncology company, which focuses on T cell-stimulating platform technologies, such as Immune Pan-Antigen Cytotoxic Therapy (ImPACT) and Combination Pan-Antigen Cytotoxic Therapy (ComPACT). Using its ImPACT platform technology, the Company has developed HS-410 (vesigenurtacel-L) as a product candidate to treat non-muscle invasive bladder cancer (NMIBC), and HS-110 (viagenpumatucel-L), which is intended for use in combination with an anti-PD-1 checkpoint inhibitor, as a potential treatment for patients with non-small cell lung cancer (NSCLC). Using its ComPACT platform technology, it has developed HS-120 as a potential treatment for NSCLC. It is conducting a Phase II trial of HS-410 in patients with NMIBC, and a Phase Ib trial of HS-110, in combination with nivolumab (Opdivo) to treat patients with NSCLC.

An ad to help with our costs