UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): May 20, 2021

Heat Biologics, Inc.

(Exact name of registrant as specified in charter)

Delaware

(State or other jurisdiction of incorporation)

627 Davis Drive, Suite 400

Morrisville, North Carolina 27560

(Address of principal executive offices and zip code)

(919) 240-7133

(Registrant’s telephone number including area code)

N/A

(Former Name and 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 registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

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).

If an emerging growth company, indicate by checkmark 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 7.01.   Regulation FD Disclosure.

On May 20, 2021, Heat Biologics, Inc. (the “Company”) issued a press release announcing that an abstract with interim data from the Company’s Phase 2 study of HS-110 in combination with nivolumab for the treatment of advanced non-small cell lung cancer has been accepted for poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held virtually from June 4-8, 2021. At the 2021 ASCO Annual Meeting, the Company will be presenting a poster entitled “Interim results of viagenpumatucel-L (HS-110) plus nivolumab in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) in two treatment settings” (the “Abstract”).

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. A copy of the Abstract is attached hereto as Exhibit 99.2 and is incorporated herein by reference. 

The furnishing of the attached Abstract is not an admission as to the materiality of any information therein. The information contained in the Abstract is summary information that is intended to be considered in the context of more complete information included in the Company’s filings with the SEC and other public announcements that the Company has made and may make from time to time by press release or otherwise.

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 May 20, 2021, the Company announced that an abstract entitled “Interim results of viagenpumatucel-L (HS-110) plus nivolumab in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC) in two treatment settings” (the “Abstract”) has been accepted for poster presentation at the 2021 ASCO Annual Meeting. In a cohort of previously treated, checkpoint inhibitor naïve patients with advanced NSCLC (cohort A, N = 47), the Company observed longer progression free survival (PFS) and overall survival (OS) in patients with injection site reactions (ISR) (hazard ratio [HR]=0.43, p=0.01; HR=0.23, p<0.001) and longer OS in patients with PD-L1 expression level ≥ 1% (HR 0.25, p=0.02). In patients who progressed after checkpoint inhibitor treatment (cohort B, N = 68), the Company observed longer OS in ISR+ patients (HR=0.48, p=0.03) and a trend toward extended OS in patients with baseline blood tumor mutational burden <10 mutations/ megabase (HR=0.58, p=0.20). HS-110 treatment emergent adverse events (TEAEs) were reported in 21 (44.7%) patients in cohort A and 18 (26.5%) patients in cohort B. TEAEs reported in >5% of patients included fatigue, maculopapular rash, nausea, diarrhea, and pruritus. Few HS-110–related TEAEs led to discontinuation of treatment [cohort A, 5 (10.6%); cohort B, 3 (4.4%)], and no serious adverse events were considered related to HS-110 in this study. A copy of the Abstract is attached as Exhibit 99.2 to this Current Report on Form 8-K.

In addition, the Company also updated its corporate presentation, to among other things, include the updated data from the Abstract that was presented at the 2021 ASCO Annual Meeting. A copy of the corporate presentation is attached hereto as Exhibit 99.3 and is incorporated herein by reference.

Item 9.01.   Financial Statements and Exhibits.

(d) Exhibits.

The following exhibits are furnished with this Current Report on Form 8-K.

SIGNATURES

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.