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): May 29, 2015

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.)

801 Capitola Drive

Durham, NC 27713

(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)

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(b) 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))

Item 7.01 – Regulation FD Disclosure

Heat Biologics, Inc. (the “Company”) will be making several investor presentations over the next few weeks.  In connection with the presentations, the Company intends to discuss the slide presentation furnished as Exhibit 99.1 hereto, which is incorporated herein by reference.

The slide presentation attached as Exhibit 99.1 to this Report includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained in the slide presentation or in the press release are “forward-looking” rather than historical.

The information included in this Item 7.01 and in Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. The Company undertakes no duty or obligation to update or revise information included in this Report or any of the Exhibits.

Item 9.01 – Financial Statements and Exhibits.

(d)	Exhibits.
	The following exhibit is being filed as part of this Report.

Exhibit Number	Description
99.1	Presentation  materials to be provided at Heat Biologics, Inc.’s presentations

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:  May 29, 2015	HEAT BIOLOGICS, INC.
	By:	/s/ Jeff Wolf
	Name:	Jeff Wolf
	Title:	Chairman, President and Chief Executive Officer

EX-99.1

 Corporate Presentation  May 29, 2015  NASDAQ:HTBX 

 Forward Looking Statements  This presentation includes statements that are, or may be deemed, ‘‘forward-looking statements.’’ In some cases, these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or, in each case, their negative or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. They appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned discovery and development of drugs targeting cancer stem cells, the strength and breadth of our intellectual property, our ongoing and planned preclinical studies and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our ability to partner our product development, the degree of clinical utility of our products, particularly in specific patient populations, expectations regarding clinical trial data, our results of operations, financial condition, liquidity, prospects, growth and strategies, the length of time that we will be able to continue to fund our operating expenses and capital expenditures, our expected financing needs and sources of financing, the industry in which we operate and the trends that may affect the industry or us.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare, regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this presentation, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation as a result of, among other factors, the factors referenced in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2014 and our quarterly report on Form 10-Q for the subsequent quarters (collectively, our “SEC Filings”). In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this presentation, they may not be predictive of results or developments in future periods. Any forward-looking statements that we make in this presentation speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this presentation, except as required by law.You should read carefully the factors described in the “Risk Factors” sections of our SEC Filings to better understand the risks and uncertainties inherent in our business.   * 

 Overview  Heat’s ImPACT allogeneic immunotherapy platform specifically designed to activate patient’s CD8+ cytotoxic T cells against multiple tumor antigensTwo lead programs are actively enrolling patients in randomized, controlled Phase II trials in lung and bladder cancerPositive safety profile with >80 patients dosed in 5 clinical studies with no treatment-related SAE’s, AE’s primarily Gr.1 injection site reactionsClinical evidence validating mechanism of action in two ongoing randomized controlled Phase 2 programs in NSCLC and bladder cancerMultiple near-term value-driving milestones with clinical and pre-clinical milestones expected to be reported at least quarterly for the next two years  Allogeneic Immune Pan-Antigen Cytotoxic Therapy “ImPACT” Platform  * 

 ImPACT Immunotherapy PlatformSpecifically Designed to Activate Pan-Antigen CD8+ T-Cells to Kill Tumor Cells  *  Intradermal InjectedImPACT Cells   ①  ImPACT cells secrete Gp96-Ig chaperone + tumor antigens (TAA)  ②  Dual antigen carrier & adjuvant activates Dendritic Cells  ③  Selectively activate CD8+ T-Cells  ④  CD8+ T-cellscirculate & eliminate tumor cells  ⑤ 

 ImPACT® Modified Cell  Vaccine Injection into Patient  ImPACT Drug Development and Manufacturing   ImPACT® Cell  Killer T-Cell  *  Choose cancer of interest  Proprietary screening assay to identify representative cancer cell lines  Transform clonal cancer cells into ImPACT cells that secrete own antigens  Mass produce ImPACT cells to treat all patients  Inject ImPACT cells into patients  ImPACT cells secrete antigens to activate killer T-cells to destroy patient’s tumor  ImPACT® cells secrete antigens to specifically activate patient’s killer T-Cells  Killer T-Cells destroy patient’s tumor 

 HS-110 NSCLC (Lung Cancer) Program  *    T-cell activation for non-immunogenic tumorsCombination with low-dose cyclophosphamide, known modulator of tumor-induced immunosuppressionSuccess of checkpoint inhibitors demonstrates NSCLC responsive to immunotherapy  Opportunity in NSCLC  Product Candidate  Cancer  Preclinical  Mfg  Phase 1  Phase 2  Phase 3  HS-110 Viagenpumatucel-L  Lung(NSCLC)            HS-410Vesigenurtacel-L  Bladder(NMIBC)            HS-110 Viagenpumatucel-L  Lung(NSCLC)            Multiple Programs  Undisclosed            100 patient randomized control NMIBC  Multi-arm combination  123 patient randomized control 3rd line NSCLC   123 patient randomized control 3rd line NSCLC  

 HS-110 Phase 1 Late-Stage Advanced NSCLC  *  HS-110 ≥ 2nd line Phase 1  HS-110 well-tolerated with no overt toxicity Single agent clinical activity in heavily pre-treated patients with advanced NSCLC7 of 15 patients stable disease after single course of therapy Median 1 year overall survival rate of patients in the study was 44% (95% CI: 21.6-65.1) comparing favorably to 42% rate in patients treated with Nivolumab in 2nd line  1 year OS Rate 42%  Nivolumab (BMS PD-1 MAb)2nd Line Phase 1  Comparable Efficacy of HS-110 and Checkpoint Blockade  Scott Gettinger, Yale Cancer Center, 2014 ASCO annual Meeting 

 Immune Response Predictive of Survival  Responders saw a threefold increase in median overall survival compared to non-responders in the trial, from 4.5 months to 16.9 months  Non-Responders  Responders  >3x Extension of Median OS for Responders  6  12  18  24  30  36  0.25  0.50  1.00  0.75  Proportion Surviving  Months From Treatment Start  0  (N=4)  (N=11)  Hazard Ratio: 0.02195% CI: 0.002 - 0.204  *  Peripheral blood immune response observed in 73% (11 out of 15) of patients who completed their first course of therapyImmune response predictive of survival Immune responders median overall survival = 16.9 monthsImmune non-responders median overall survival = 4.5 monthsLong-term survivalThree patients survived >3 yrs.One patient survived > 4 yrs.    

 Phase 2 HS-110/CY Combo NSCLC Design  *  RegimenLow-dose cyclophosphamide (CY) 50 mg daily for 7 days every 2 weeks for 12 weeks or until progressionHS-110 107 cells weekly for 12 weeks then every 9 weeks until irPD or 12 months, whichever comes firstMulti-center trial of ~25 sites in US and AustraliaLead centers: University of Pennsylvania in USA; Peter MacCallum Cancer Center in AUSSample Size123 patients randomized 2:1 80% power with alpha = 0.1 to detect a 50% reduction in the risk of death Interim analysis for immune response after 14 and 40 patients randomized to experimental group  3rd or 4th line 

 HS-410 Bladder Cancer Program  *    Treat patients with minimal residual disease at a high-risk of recurrence within 2 yearsLeverage potential mechanistic synergy with BCGThere has not been a new approved drug in non-muscle invasive bladder cancer in over 25 years  Product Candidate  Cancer  Preclinical  Mfg  Phase 1  Phase 2  Phase 3  HS-110 Viagenpumatucel-L  Lung(NSCLC)            HS-410Vesigenurtacel-L  Bladder(NMIBC)            HS-110 Viagenpumatucel-L  Lung(NSCLC)            Multiple Programs  Undisclosed            100 patient randomized control NMIBC  Multi-arm combination  123 patient randomized control 3rd line NSCLC   Opportunity in Bladder Cancer  100 patient randomized control NMIBC 

 Evidence of CD8+ Tumor Infiltration in HS-410 Phase 1 Study  *  Patient 1 Patient 2  Total T CellsHelper T CellsCytotoxic T Cells  Human data consistent with mechanism of action from preclinical modelsTumor-infiltrating lymphocytes associated with clinical outcome  T1 disease at diagnosisDownstaged to Ta at week 7Non-specific, low-level immune infiltrateRecurred at week 13  T1 disease at diagnosisDownstaged to Ta at week 7Highly polarized, high-level immune infiltrateDisease free at week 21 

 Evidence of CD8+ Tumor Infiltration in HS-410 Phase 1 Study  * 

 Evidence of CD8+ Tumor Infiltration in HS-410 Phase 1 Study  *  Non-Responder Phenotype:High Baseline TIL, PD-L1 Positive at Baseline  Responder Phenotype:Low Baseline TIL, PD-L1 Negative at Baseline 

 Injection Site Reactions – Delayed-Type Hypersensitivity  *    Week 1 Injection (L Thigh)  Week 2 Injection (R Thigh)  Week 3 Injection (R Buttocks)  ISR Start Date  4 Days Post Injection  1 Day Post Injection  Immediately Post Injection  Post Injection  No Reaction  No Reaction    One WeekPost Injection        Two Weeks Post Injection        Confidential  The kinetics of the appearance of the injection site reactions are consistent with a delayed-type hypersensitivity reaction and cell-mediated immune responses. 

 Phase 2 HS-410 Bladder Trial Design  *  Randomized Controlled Phase 2   HS-410 Low Dose + BCG N = 25  Placebo + BCGN = 25  HS-410 High Dose + BCG N = 25  HS-410 High Dose N = 25  Phase 2 Patient receive BCG?  No  Yes  1  1  1  DesignFast Track designation receivedEndpoints1-yr and 2-yr recurrence-free survivalImmune response in PBMC and tissueDosing regimen 12 week induction followed by maintenance according to BCG scheduleOperationsMulti-center trial of ~16 sites in USLead center: University of Chicago School of MedicinePositive safety profile with no SAEs to-date 

 *  2015 Milestones  2nd half of 2015  USA FDA  Fast Track Designation  Phase 2  Enrollment complete  Phase 1  One-year safety and immune response data  1st half of 2015  BladderHS-410  Phase 2  Immune response, first interim analysis  Phase 2  - Immune response, second interim analysis- Phase 2 enrollment complete  LungHS-110  Multi-Arm Combination Phase 1b  Initiate a master multi-arm trial evaluating HS-110 combination with other immunotherapies  Phase 1  Preliminary Immune response    Additional milestones may include partnership/collaboration opportunities, research developments and new data publications    Heat Biologics (Nasdaq: HTBX)    gp-96+costimulatory data 

 ImPACT Clinical Findings  Heat’s ImPACT platform is mechanistically differentiated from all other vaccine platforms, providing specific CD8+ T cells activation to multiple tumor antigensPatient tumor biopsies demonstrate specific CD8+ T cell infiltration following treatment, and survival benefit in NSCLC consistent with reported data for PD-1 antibodiesFrequent quarterly reporting of clinical milestones through 2016  * 

 Heat Biologics (NASDAQ: HTBX): Company Snapshot  *  *As of May 21, 2015**Does not include $7.5 million milestone-based debt facility   Shares Outstanding  8.39M  Share Price*  ~$6.63  Market Capitalization*  ~$51M  Cash as of 3/31/15**  ~$21M  Enterprise Value*  ~$30M  Heat’s ImPACT allogeneic “off-the-shelf” platform generates robust pan-antigen T cell activation for highly-differentiated mechanism of actionPositive safety profile with >80 patients dosed in 5 clinical studies Clinical evidence validating mechanism of action in two ongoing randomized controlled Phase 2 programs in NSCLC and bladder cancerMultiple near-term value-driving inflection pointsFounded in 2008, completed IPO 2013 

 Management and Advisors  *  Jeff WolfFounder & CEO  Founded several biomedical companies including Avigen, TyRx Pharma (sold to Medtronic), EluSys Therapeutics, GenerationOne  Anil Goyal, Ph.D.VP Business Development  20+ years biotech business development experience: Serenex (acquired by Pfizer), Millennium Pharmaceuticals, Genome Therapeutics, Qualiber, Ascletis Pharmaceuticals, Merck  Taylor Schreiber, M.D., Ph.D.VP Research & Development  Co-developer ImPACT and TNFRSF25 technologies; 10+ years laboratory experience; Author numerous immunology and immunotherapy abstracts and publications  Melissa Price, Ph.D.VP Clinical & Regulatory Affairs  14+ years in oncology clinical development in biotech and CRO space: INC Research, Novaquest, Attenuon  Scientific And Clinical Advisors 

 Living Drug Factories to Treat Cancer   Thank youfor more information visit www.heatbio.com 

 Appendix 

 60% O2 down-regulates Adenosine,CD73 and CD39 in the TME in mice models  Hatfield et al J.Mol.Med. 2014  * 

 No treatment  60% O2  Gp96-Ig vaccine  Gp96-Ig vaccine + 60% O2  Day 25 - Analysis  Vaccine  *  Tumor remission by combination treatment with gp96-Ig vaccine + 60% O2 in mice models  Eckhard R Podack, Phacilitate Immunotherapy, 2015 

 NoTx  60%O2  Gvax +60%O2  Gp96-Ig +60%O2  Day 25 - Analysis  Vaccine  Gp96-Ig versus GVAX  *  Eckhard R Podack, Phacilitate Immunotherapy, 2015 

 Gp96-Ig + 60% O2 restores normal lung weight in mice models  *  Eckhard R Podack, Phacilitate Immunotherapy, 2015 

 Inhibition of CTL by Hypoxia induced Adenosine  Tumor  Hypoxia  HIF1a   Oxydative PhosphorylationGycolysisVEGFCD39, CD73  TME: CD39 CD73ATP  ADP + P  Adenosine + P-P CD73  Adenosine + A2aR-CTL  cAMP  CTL  60% O2  60% O2  60% O2  *  Eckhard R Podack, Phacilitate Immunotherapy, 2015