8-K

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): November 5, 2019

Heat Biologics, Inc.

(Exact name of registrant as specified in charter)

Delaware

(State or other jurisdiction of incorporation)

001-35994	26-2844103
(Commission File Number)	(IRS Employer Identification No.)

627 Davis Drive

Morrisville, NC  27560

 (Address of principal executive offices and zip code)

(919) 240-7133

(Registrant’s telephone number including area code)

801 Capitola Drive, Durham, NC 27713

(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:

¨ 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	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.0002 par value per share	HTBX	The Nasdaq Capital 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 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 November 5, 2019, an abstract (the “Abstract”) titled “Treating Advanced Non-Small Lung Cancer Patients after Checkpoint Inhibitor Treatment Failure with a Novel Combination of Viagenpumatucel-L (HS-110) plus Nivolumab” which had been submitted by Heat Biologics, Inc. (the “Company”) to The Society for Immunotherapy of Cancer’s (SITC) in connection with its 34^th Annual Meeting was published by SITC. The data presented was obtained from the Company’s ongoing phase 2 study of previously-treated non-small lung cancer patients (NSCLC) of HS-110 in combination with nivolumab (Cohort B). Patients in this cohort have progressed after ≥ 4 months of prior treatment with a checkpoint inhibitor. The study evaluates whether the addition of HS-110 to nivolumab may restore responsiveness to treatment after tumor progression on prior checkpoint inhibitor therapy. Cohort B data presented below is based on 56 patients in the intent-to-treat (ITT) population at the time of data cut-off:

·

Response rate by RECIST 1.1

o

Partial response (PR) in 7 patients (13%)

o

Stable disease (SD) in 26 patients (46%)

o

Disease control rate (DCR) was (59%)

·

Median overall survival (OS) was estimated at 11.8 months (95% CI; 6.6 - not reached months) with 39 of the 56 patients censored (70% of patients still alive).

·

Median progression free survival (mPFS) was estimated at 3.2 months (95% CI; 1.9 - 4.0 months) with 17 patients censored.

·

Subset analysis based on Injection Site Reaction (ISR):

o

Patients who experienced an ISR versus those who did not experience ISR:

§

Improved PFS (3.7 vs 1.8 months; HR 0.40, p =0.0068)

§

Improved OS (12 vs 5 months; HR 0.16, p=0.0005)

·

Combination of HS-110 and nivolumab was well tolerated by patients.

o

92% of adverse events (AEs) were mild (Grade 1 or 2).

o

There were only four grade 4 events, and no grade 5 AEs.

A copy of the Abstract is attached to this Current Report on Form 8-K as Exhibit 99.1 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 Securities and Exchange Commission (the “SEC”) and other public announcements that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures.

Item 8.01   Other Events.

On November 5, 2019, the Company issued a press release announcing that on November 5, 2019 an abstract titled “Treating Advanced Non-Small Lung Cancer Patients after Checkpoint Inhibitor Treatment Failure with a Novel Combination of Viagenpumatucel-L (HS-110) plus Nivolumab” which had been submitted by the Company to The Society for Immunotherapy of Cancer’s (SITC) in connection with its 34^th Annual Meeting was published by SITC. A copy of the press release regarding the Abstract is attached as Exhibit 99.2 and incorporated herein by reference.

A copy of the Company’s new corporate slide presentation that includes information from the Abstract and data from the Company’s ongoing phase 2 study is also attached to this Current Report on Form 8-K as Exhibit 99.3 and is incorporated herein by reference.

The Company undertakes no duty or obligation to update or revise information included in this Current Report or the Exhibits.

Item 9.01.   Financial Statements and Exhibits.

(d) Exhibits.

The following exhibits are filed with this Current Report on Form 8-K:

Exhibit Number	Description
99.1	Abstract titled “Treating Advanced Non-Small Lung Cancer Patients after Checkpoint Inhibitor Treatment Failure with a Novel Combination of Viagenpumatucel-L (HS-110) plus Nivolumab”
99.2	Press Release of Heat Biologics, Inc. dated November 5, 2018
99.3	Corporate Presentation dated November 2019

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.

Dated:  November 5, 2019	HEAT BIOLOGICS, INC.
	By:	/s/ Jeffrey Wolf
	Name:	Jeffrey Wolf
	Title:	Chairman, President and Chief Executive Officer

EX-99.1

EXHIBIT 99.1

Treating advanced non-small lung cancer (NSCLC) patients after checkpoint inhibitor treatment failurewith a novel combination of Viagenpumatucel-L (HS-110) plus nivolumab

Daniel Morgensztern¹, Saiama N. Waqar¹, Lyudmila Bazhenova², Rachel E. Sanborn³, Lori McDermott⁴, Jeff Hutchins⁴, Luis E. Raez⁵, Corey J. Langer⁶,  Roger B. Cohen⁶

¹Washington University School of Medicine, St. Louis, MO; ²UC San Diego, Moores Cancer Center, La Jolla, CA; ³Earle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR; ⁴Heat Biologics, Inc, Durham, NC; ⁵Memorial Cancer Institute, Pembroke Pines, FL; ⁶University of PennsylvaniaPerelman School of Medicine, Philadelphia, PA

Background:

Viagenpumatucel-L (HS-110) is an allogeneic cellular vaccine derived from a human lung adenocarcinoma cell line transfected with the gp96-Ig fusion protein that functions as an antigen chaperone for cross presentation and dendritic cell activation. DURGA is a multi-cohort study evaluating the combination of HS-110 and anti-PD-1 monoclonal antibodies in patients with advanced NSCLC. We report on Cohort B, which enrolled patients with progressive disease (PD) after receiving a minimum of 4 months of treatment with a checkpoint inhibitor (CPI) at any time prior to study entry.

Methods:

Patients with previously treated NSCLC received weekly HS-110 (1 X 10⁷ cells) intradermally for 18 consecutive weeks and nivolumab IV 240 mg every 2 weeks, followed by nivolumab maintenance until tumor progression or intolerable toxicity. Tissue was tested at baseline for PD-L1 expression (≥ 1% or < 1%) and tumor infiltrating lymphocytes (TILs). TIL high was defined as >10% CD8+ lymphocytes in the tumor stroma. The primary endpoint was objective response rate (ORR) by RECIST 1.1. Secondary endpoints included ORR and clinical benefit rate using iRECIST, progression-free survival (PFS), overall survival (OS) and adverse events (AEs).

Results:

As of March 2019, 56 patients were enrolled and evaluated for efficacy. The median number of prior treatment lines was 2 [range 1 to 6]. Seven patients (13%) achieved partial response and 26 patients (46%) had stable disease. Median PFS and median OS were 3.2 months and 11.8 months, respectively. Immune ORR and clinical benefit rate by iRECIST were 14% and 61%, respectively. Patients experiencing injection site reactions (ISR) had improved PFS (3.7 vs 1.8 months; HR 0.21, p =0.0021) and improved OS (12 vs 5 months; HR 0.16, p=0.0005) compared to those without ISR.  96% of patients experienced at least one adverse event, and 92% of all AEs were grade 1 or 2. The most common AEs were fatigue (34%), hypocalcemia (18%), cough (16%) and diarrhea and dyspnea (14% each). There were four grade 4 events: QTc prolongation, stroke, pericardial tamponade, and hyponatremia, none of which were deemed related to treatment. There were no grade 5 AEs.  

Conclusions:

The combination of HS-110 and nivolumab is well tolerated, and does not appear to increase the incidence of immune-related AEs as compared to CPI monotherapy. Patients continue to be enrolled into this cohort. Data suggest that re-challenging the immune system with nivolumab and HS-110 after CPI treatment failure restores responsiveness and clinical benefit for some patients.

EX-99.2

EXHIBIT 99.2

Heat Biologics Reports Positive Phase 2 Interim Data in NSCLC Patients

Who Previously Failed Checkpoint Inhibitor Treatment

Announces Abstract Summarizing Favorable
Interim Phase 2 Data of HS-110 Plus Nivolumab

Additional Data to be Reported in Poster Presentation
at the SITC 34^th Annual Meeting on November 8, 2019

DURHAM, NC – November 5, 2019 – Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, today announced that an abstract has been posted on The Society for Immunotherapy of Cancer's (SITC) website in connection with the Company’s planned poster presentation at SITC’s 34th Annual Meeting on November 8, 2019.

The abstract summarizes the latest interim top line data from Cohort B of the Company’s Phase 2 trial of the Company’s “off-the-shelf” cell-based therapy, HS-110, in combination with Opdivo® (Nivolumab) in advanced non-small cell lung cancer (NSCLC), which completed enrollment in July 2019. This cohort enrolled patients who had previously received a checkpoint inhibitor (CPI) and whose disease had subsequently progressed. The data suggests that re-challenging the immune system with nivolumab and HS-110 after checkpoint inhibitor treatment failure may restore responsiveness and clinical benefit. Additionally, the combination of HS-110 and nivolumab is well-tolerated, and no increase in the incidence of immune-related adverse events was observed to date, as compared to CPI monotherapy. The full abstract is available at: https://www.heatbio.com/technology/scientific-publications

Jeff Wolf, Heat Biologics' CEO, commented, “NSCLC patients who progressed after checkpoint inhibitor treatment have limited therapeutic options. The latest results are encouraging and suggest that HS-110 in combination with nivolumab may address this key unmet medical need. As of this data cut, the median overall survival (OS) is estimated to be 11.8 months, with 70% of the patients still alive. I am unaware of any published checkpoint combination studies that offered superior OS in patients that had experienced previous checkpoint inhibitor treatment failure in NSCLC. This data also compares favorably to reported studies using chemotherapy following checkpoint inhibitor progression ^{1, 2} ”.

Signals of clinical efficacy were observed in the reported objective response rate (ORR), disease control rate (DCR) and progression free survival (PFS). Importantly, patients experiencing dermal injection site reactions (ISR) had statistically significant improvement in PFS and OS compared to those without ISR (Hazard Ratio = 0.40, p=0.0068 and Hazard Ratio = 0.16, p=0.0005, respectively). Additional data will be presented at SITC on November 8 ,2019.

Details of Heat Biologics’ poster presentation:

Abstract Title: Treating advanced non-small lung cancer (NSCLC) patients after checkpoint inhibitor treatment failure with a novel combination of Viagenpumatucel-L (HS-110) plus nivolumab

Poster #: P411

Date: Friday, November 8, 2019, 7am – 8pm (Eastern Time)

Location: Gaylord National Hotel & Convention Center, Washington DC

References:

¹ Costantini A, Corny J, Fallet V et al. Efficacy of next treatment received after nivolumab progression in patients with advanced nonsmall cell lung cancer. ERJ Open Res. 2018 Apr 20;4(2).

² Schvartsman G, Peng SA, Bis G, et al. Response rates to single-agent chemotherapy after exposure to immune checkpoint inhibitors in advanced non-small cell lung cancer. Lung Cancer. 2017 Oct;112:90-95.

About Heat Biologics, Inc.

Heat Biologics is a biopharmaceutical company developing immunotherapies designed to activate a patient's immune system against cancer using CD8+ "Killer" T-cells. HS-110 is the Company’s first biologic product candidate in a series of proprietary immunotherapies designed to stimulate a patient's own T-cells to attack cancer. Heat has completed enrollment in its Phase 2 clinical trial for advanced non-small cell lung cancer, in combination with Bristol-Myers Squibb's nivolumab (Opdivo®) or with Merck's pembrolizumab (Keytruda®). Pelican Therapeutics, a subsidiary of Heat, is focused on the development of co-stimulatory monoclonal antibody and fusion protein-based therapies designed to activate the immune system. Heat also has numerous pre-clinical programs at various stages of development. For more information, please visit www.heatbio.com.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 on our current expectations and projections about future events. In some cases, forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and include statements such as: the data suggests that re-challenging the immune system with nivolumab and HS-110 after checkpoint inhibitor treatment failure may restore responsiveness and clinical benefit and these latest results suggests that HS-110 in combination with nivolumab may address a key unmet medical need for NSCLC patients . These statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements, including the ability of Heat’s therapies to perform as designed, to demonstrate safety and efficacy, as well as results that are consistent with prior results, the ability to enroll patients and complete the clinical trials on time and achieve desired results and benefits, Heat’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Heat’s ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, Heat’s ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to retain its key scientists or management personnel, and the other factors described in Heat’s Annual Report on Form 10-K and 10-K/A for the year ended December 31, 2018 and other subsequent filings with the SEC. The information in this release is provided only as of the date of this release and the company undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law

Media and Investor Relations Contact

David Waldman

+1 919 289 4017

investorrelations@heatbio.com

EX-99.3

EXHIBIT 99.3