Item 7.01. Regulation FD Disclosure.

On January 12, 2022, Heat Biologics, Inc. (the "Company") issued a press release announcing that promising new preclinical data regarding PTX-35 has been accepted for publication in the American Journal of Transplantation. The Company's subsidiary, Pelican Therapeutics, Inc. "Pelican Therapeutics"), is developing PTX-35, a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells and can be manipulated to expand regulatory T-cell subsets. PTX-35 is the Company's first antibody-based product, currently in a Phase 1 clinical trial for the treatment of patients with solid tumors. The following are the PTX-35 key findings:



   º A single dose of the preclinical version of PTX-35 (mPTX-35), was able to
     expand regulatory T cells (Tregs) and significantly improve disease and
     graft survival outcomes.
   º Chemically induced pancreatic failure (a model for type-1 diabetes) could
     be partially reversed when mice were transplanted with beta-cell islet
     allografts and treated with mPTX-35.
   º Disease protection in preclinical models was correlated with a significant
     expansion of Tregs and protection of the allograft, resulting in euglycemia
     and a graft survival benefit.
   º Long-term surviving grafts showed a marked increase in Treg infiltration
     which directly correlated with mPTX-35 agonist activity.

The Company also announced that it expected to file for an End of Phase 2 meeting with the FDA this quarter with the goal of discussing potential Phase 3 registration pathways for HS-110.

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 pursuant 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 Events.

On January 12, 2022, the Company issued a press release announcing that promising new preclinical data regarding PTX-35 has been accepted for publication in the American Journal of Transplantation. Pelican Therapeutics is developing PTX-35, a novel, potential first-in-class antibody immunomodulator of TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T cells and can be manipulated to expand regulatory T-cell subsets. PTX-35 is the Company's first antibody-based product, currently in a Phase 1 clinical trial for the treatment of patients with solid tumors. The following are the PTX-35 key findings:



   º A single dose of the preclinical version of PTX-35 (mPTX-35), was able to
     expand regulatory T cells (Tregs) and significantly improve disease and
     graft survival outcomes.
   º Chemically induced pancreatic failure (a model for type-1 diabetes) could
     be partially reversed when mice were transplanted with beta-cell islet
     allografts and treated with mPTX-35.
   º Disease protection in preclinical models was correlated with a significant
     expansion of Tregs and protection of the allograft, resulting in euglycemia
     and a graft survival benefit.
   º Long-term surviving grafts showed a marked increase in Treg infiltration
     which directly correlated with mPTX-35 agonist activity.

The Company also announced that it expected to file for an End of Phase 2 meeting with the FDA this quarter with the goal of discussing potential Phase 3 registration pathways for HS-110.




Item 9.01.  Financial Statements and Exhibits.



(d) Exhibits.

The following Exhibit 99.1 is furnished with this Current Report on Form 8-K:





Exhibit
 Number    Description

  99.1       Press release, dated January 12, 2022
  104      Cover Page Interactive Data File (the cover page XBRL tags are
           embedded within the inline XBRL document)

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