PART I [Business](index=8&type=section&id=Item%201.%20Business) A biopharmaceutical company developing immune therapies for cancer and infectious diseases via its proprietary gp96 and DR3/TNFRSF25 platforms - The company is a fully integrated biopharmaceutical firm specializing in therapies that arm the immune system against diseases like cancer and infectious disease[28](index=28&type=chunk) - The company's strategy includes becoming fully integrated, maximizing commercial opportunities, developing its CDMO subsidiary Scorpion, obtaining regulatory approvals, and expanding its patent portfolio[90](index=90&type=chunk)[93](index=93&type=chunk) Key Product Platforms and Clinical Assets | Platform | Key Asset | Indication | Development Stage | | :--- | :--- | :--- | :--- | | **gp96 Platform** | HS-110 (viagenpumatucel-L) | Non-Small Cell Lung Cancer (NSCLC) | Phase 2 (Enrollment Complete) | | | HS-130 (ComPACT®) | Advanced Solid Tumors | Phase 1 (Enrollment Complete) | | **RapidVax® Platform** | RapidVax® Base Cell | Infectious/Emerging Diseases | Preclinical | | **DR3/TNFRSF25 Platform** | PTX-35 | Advanced Solid Tumors | Phase 1 | - On December 20, 2021, the company entered into an agreement to acquire Elusys Therapeutics, Inc, which commercializes **ANTHIM®** (obiltoxaximab), an FDA-approved monoclonal antibody for the biodefense threat anthrax[35](index=35&type=chunk) - The company is establishing in-house manufacturing capabilities through its subsidiary Scorpion Biological Services, Inc, with a new **20,144 sq. ft. facility** in San Antonio, TX, expected to be operational in **Q2 2022**[77](index=77&type=chunk)[80](index=80&type=chunk) - The development of PTX-35 is supported by a **$15.2 million grant** from the Cancer Prevention and Research Institute of Texas (CPRIT), which requires **$7.6 million** in matching funds from the company's subsidiary, Pelican[100](index=100&type=chunk)[103](index=103&type=chunk) [Risk Factors](index=62&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial financial, clinical development, and operational risks, including a history of net losses and reliance on key product candidates Financial Performance and Position Risks | Risk Factor | 2021 Figure | 2020 Figure | | :--- | :--- | :--- | | **Net Loss** | $35.4 million | $26.4 million | | **Accumulated Deficit (at YE)** | $165.7 million | $130.6 million | | **Net Cash Used in Operations** | $38.1 million | $22.0 million | - The company has a limited operating history, has not generated any product revenue, and anticipates incurring **substantial losses** for the foreseeable future with uncertain profitability[210](index=210&type=chunk)[215](index=215&type=chunk) - The business is substantially dependent on the success of its product candidates, with only three currently in clinical trials, and **no guarantee any will be commercialized**[235](index=235&type=chunk) - Risks related to the pending Elusys merger include potential failure to complete the transaction, difficulties in integrating the business, and **substantial dependence on U.S. Government contracts** for Anthim revenue[334](index=334&type=chunk)[336](index=336&type=chunk)[339](index=339&type=chunk) - The company relies on third parties for manufacturing, conducting clinical trials (CROs), and supplying materials, which exposes it to risks of delays, quality issues, and lack of control[266](index=266&type=chunk)[273](index=273&type=chunk)[280](index=280&type=chunk) - The company's stock price has been volatile, with a closing price of **$3.04 per share** on December 31, 2021, compared to a high of **$17.00 per share** on February 9, 2021[236](index=236&type=chunk) - During 2021, the company recorded a non-cash goodwill impairment charge and an indefinite-lived intangible assets impairment charge totaling **$3.8 million** related to the Pelican acquisition[240](index=240&type=chunk) [Properties](index=122&type=section&id=Item%202.%20Properties) The company leases office and laboratory facilities in North Carolina, Texas, and New Jersey, including a new biomanufacturing site in San Antonio - The company's executive offices are located in Morrisville, NC, and it also leases office and lab space in San Antonio, TX, and North Brunswick, NJ[387](index=387&type=chunk)[388](index=388&type=chunk)[389](index=389&type=chunk) - In October 2021, its subsidiary Scorpion entered into a lease for a **20,144 sq. ft.** office and lab space in San Antonio, TX, for biomanufacturing purposes, with monthly base rent starting at **$50,360**[391](index=391&type=chunk) [Legal Proceedings](index=124&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that would be expected to have a material adverse effect on its business or financial condition - The company is not presently a party to any material legal proceedings[393](index=393&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=124&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the NYSE American under 'HTBX', a reverse stock split was effected in 2020, and no dividends are anticipated - The company's common stock trades on the NYSE American under the symbol **'HTBX'**[396](index=396&type=chunk) - A **one-for-seven reverse stock split** of the common stock was effected on December 11, 2020[398](index=398&type=chunk) - The company has **never paid cash dividends** and does not plan to in the foreseeable future[399](index=399&type=chunk) Equity Compensation Plan Information (as of Dec 31, 2021) | Plan Category | Securities to be issued upon exercise of outstanding options | Weighted-average exercise price of outstanding options | Securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 2,909,972 | $7.55 | 358,897 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=126&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's net loss widened to $35.4 million in 2021 due to increased R&D expenses and impairment charges, while maintaining sufficient cash to fund operations into 2024 Financial Highlights (Years Ended December 31) | Metric | 2021 | 2020 | | :--- | :--- | :--- | | Grant Revenue | $2.1 million | $2.8 million | | Research & Development Expense | $18.8 million | $12.9 million | | General & Administrative Expense | $16.8 million | $14.9 million | | Goodwill Impairment Loss | $1.5 million | $0 | | In-process R&D Impairment Loss | $2.4 million | $0 | | **Net Loss** | **$35.4 million** | **$26.4 million** | | Net Loss Per Share | ($1.41) | ($1.63) | | Cash & Short-term Investments (at YE) | $96.4 million | $111.8 million | - The increase in R&D expense was primarily due to a **$2.4 million impairment loss** on in-process R&D, a **$1.3 million increase** in COVID-19 program costs, and a **$0.9 million increase** in PTX-35 expenses[451](index=451&type=chunk)[453](index=453&type=chunk) - The company recorded a full goodwill impairment loss of **$1.5 million** in 2021 due to a sustained decline in its stock price[454](index=454&type=chunk) - As of December 31, 2021, the company had **$96.4 million** in cash, cash equivalents, and short-term investments, which management believes is sufficient to fund operations into 2024[424](index=424&type=chunk)[483](index=483&type=chunk) - Net cash used in operating activities increased to **$38.1 million** in 2021 from **$22.0 million** in 2020, primarily due to a higher net loss and an increase in other assets related to equipment purchases for the new facility[484](index=484&type=chunk) [Financial Statements and Supplementary Data](index=149&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements, with the auditor's report highlighting critical audit matters related to valuation and impairment - The report includes the consolidated balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity, and statements of cash flows for the years ended December 31, 2021 and 2020[615](index=615&type=chunk)[640](index=640&type=chunk) - The independent auditor's report identified two Critical Audit Matters: the **valuation of contingent consideration** from the Pelican acquisition and the **impairment of goodwill and in-process R&D**, both of which involved complex and subjective management judgments[645](index=645&type=chunk)[646](index=646&type=chunk)[651](index=651&type=chunk) [Controls and Procedures](index=149&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls, procedures, and internal control over financial reporting were effective as of year-end 2021 - Management concluded that the company's disclosure controls and procedures were **effective** as of December 31, 2021[494](index=494&type=chunk) - Management's assessment concluded that the company's internal controls over financial reporting were **effective** as of December 31, 2021, based on the COSO framework[495](index=495&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=152&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details the company's leadership team, board composition, director independence, and committee structure - The executive officers are **Jeffrey Wolf** (Chairman, CEO, President) and **William L. Ostrander** (CFO, Secretary)[505](index=505&type=chunk) - The Board of Directors has determined that **three of its four members are independent**[520](index=520&type=chunk) - The Board maintains an Audit Committee, Compensation Committee, and Nominating and Governance Committee, each composed entirely of **independent directors**[516](index=516&type=chunk)[517](index=517&type=chunk) - The company has a combined Chairman and CEO role (held by Jeffrey Wolf) but has appointed an **independent Lead Director** (Dr. Prendergast) to preside over executive sessions and liaise between management and independent directors[534](index=534&type=chunk)[537](index=537&type=chunk) [Executive Compensation](index=163&type=section&id=Item%2011.%20Executive%20Compensation) CEO Jeffrey Wolf's total 2021 compensation was approximately $5.9 million, driven by significant equity awards, as part of a program designed to align pay with performance 2021 Summary Compensation Table | Name and Principal Position | Year | Salary | Bonus | Stock Awards | Option Awards | Other | Total | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Jeffrey Wolf** (CEO) | 2021 | $539,623 | $270,000 | $2,633,525 | $1,964,424 | $500,000 | **$5,907,572** | | **William L. Ostrander** (CFO) | 2021 | $274,817 | $96,250 | $0 | $451,602 | $0 | **$822,669** | - The company's executive compensation philosophy is based on aligning with stockholders' interests, being competitive to attract and retain talent, and rewarding the achievement of goals[552](index=552&type=chunk) - In 2021, CEO Jeffrey Wolf's base salary was increased to **$540,000** and CFO William L. Ostrander's was increased to **$275,000**[569](index=569&type=chunk) - The Compensation Committee retained **Meridian Compensation Partners, LLC** as its independent compensation consultant in 2020 and 2021[556](index=556&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=181&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 2022, CEO Jeffrey Wolf held 6.6% beneficial ownership, with all executive officers and directors as a group holding 8.7% Security Ownership of Management (as of March 9, 2022) | Name of Beneficial Owner | Shares Beneficially Owned | Percentage Ownership | | :--- | :--- | :--- | | Jeffrey Wolf (CEO & Chairman) | 1,739,660 | 6.6% | | William L. Ostrander (CFO) | 59,440 | * | | John K. A. Prendergast, Ph.D. (Director) | 287,409 | 1.1% | | John Monahan, Ph.D. (Director) | 119,980 | * | | Edward B. Smith, III (Director) | 120,050 | * | | **All Executive Officers and Directors as a group (5 persons)** | **2,326,539** | **8.7%** | [Certain Relationships and Related Transactions, and Director Independence](index=183&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The pending merger with Elusys Therapeutics, founded by CEO Jeffrey Wolf, is the primary related party transaction, and all directors except the CEO are independent - The pending acquisition of Elusys Therapeutics is a related party transaction, as Elusys was founded by CEO Jeff Wolf, who owns approximately **1.2%** of Elusys's outstanding stock[607](index=607&type=chunk) - The Board of Directors has determined that all current directors are independent under NYSE American rules, with the exception of Mr. Wolf due to his role as President and CEO[611](index=611&type=chunk) [Principal Accountant Fees and Services](index=185&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) BDO USA, LLP served as the independent auditor, with total audit fees of $376,123 for fiscal year 2021 Accountant Fees (BDO USA, LLP) | Fee Category | 2021 | 2020 | | :--- | :--- | :--- | | Audit Fees and Expenses | $376,123 | $329,213 | - All audit and non-audit services provided by the independent registered public accounting firm were **pre-approved** by the Audit Committee[613](index=613&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=187&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements and indexes all exhibits filed with the Form 10-K, including material contracts and governance documents - This item lists the financial statements, financial statement schedules, and exhibits filed with the Form 10-K[615](index=615&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number: 001-35994 Heat Biologics, Inc. (Exact Name of Registrant as Specified in Its ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number: 001-35994 Heat Biologics, Inc. (Exact Name of Registrant as Specified in Its Chart ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ◻ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number: 001-35994 Heat Biologics, Inc. (Exact Name of Registrant as Specified in Its Char ...

PART I [Business](index=8&type=section&id=Item%201.%20Business) Heat Biologics develops immune therapies and vaccines using its gp96 platform, with a diverse clinical pipeline [Overview and Technology Platforms](index=8&type=section&id=Overview%20and%20Technology%20Platforms) The gp96 platform (ImPACT®, ComPACT™) activates T-cells for cancer and infectious diseases, featuring HS-110, HS-130, PTX-35, and a COVID-19 vaccine - The company's core technology is the gp96 platform, designed to activate the immune system for applications in oncology and infectious diseases[25](index=25&type=chunk) - The platform includes two main technologies: ImPACT®, which functions as an immune activator, and ComPACT™, which combines T-cell activation with co-stimulation in a single product[32](index=32&type=chunk)[34](index=34&type=chunk) - A COVID-19 vaccine program was initiated in March 2020 in collaboration with the University of Miami, utilizing the gp96 platform to express SARS-CoV-2 antigens[35](index=35&type=chunk) - Subsidiary Pelican Therapeutics is developing PTX-35, an agonist antibody targeting TNFRSF25, a T-cell costimulatory receptor, to stimulate 'memory' CD8+ cytotoxic T-cells[40](index=40&type=chunk) [Clinical and Preclinical Pipeline](index=12&type=section&id=Clinical%20and%20Preclinical%20Pipeline) The clinical pipeline includes HS-110 for NSCLC and HS-130 for solid tumors, with PTX-35 and a COVID-19 vaccine in preclinical or early clinical stages HS-110 Phase 2 NSCLC Trial Interim Data (as of Feb 9, 2021) | Cohort | Description | N | Median OS | 1-Year Survival Rate | | :--- | :--- | :-: | :--- | :--- | | Cohort A | Checkpoint inhibitor naïve | 47 | 24.6 months | 61.7% | | Cohort B | Previously treated with checkpoint inhibitor | 68 | 11.9 months | N/A | - The COVID-19 vaccine cell line (ZVX-60) was completed and transferred to Waisman Biomanufacturing in January 2021 to initiate the manufacturing process[52](index=52&type=chunk)[53](index=53&type=chunk) - The FDA cleared the Investigational New Drug (IND) application for PTX-35 in June 2020, and the first patient was treated in a Phase 1 trial for advanced solid tumors the same month[58](index=58&type=chunk) [Strategy, Acquisitions, and Grants](index=20&type=section&id=Strategy%2C%20Acquisitions%2C%20and%20Grants) The strategy focuses on regulatory approval, commercialization, partnerships, IP expansion, and non-dilutive funding, notably through the Pelican Therapeutics acquisition and CPRIT grant - Key strategic elements include obtaining regulatory approval, maximizing commercial opportunities, enhancing partnerships, expanding the patent portfolio, and securing non-dilutive grant funding[77](index=77&type=chunk)[79](index=79&type=chunk) - In April 2017, the company acquired an **80%** controlling interest in Pelican Therapeutics, which was later increased to **85%**, involving cash, stock, and future milestone-based payments[78](index=78&type=chunk)[81](index=81&type=chunk)[85](index=85&type=chunk) - Pelican was awarded a **$15.2 million** grant from CPRIT for the development of PTX-35, with **$13.7 million** provided as of December 31, 2020, requiring **$7.6 million** in matching funds[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) [Intellectual Property and Licensing](index=26&type=section&id=Intellectual%20Property%20and%20Licensing) The company protects its technology via patents, trade secrets, and exclusive licenses from the University of Miami for its core programs - Heat holds approximately **30** granted U.S. and foreign patents and has **40** pending applications, while Pelican holds approximately **50** granted patents and has **20** pending applications[93](index=93&type=chunk) - The company's core ImPACT®, ComPACT™, PTX-35, and COVID-19 vaccine technologies are based on intellectual property exclusively licensed from the University of Miami (UM)[94](index=94&type=chunk)[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) - License agreements with UM obligate the company and its subsidiaries to pay various fees, including upfront, annual, milestone, and royalty payments on net sales of products covered by the licensed patents[98](index=98&type=chunk)[101](index=101&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk) [Manufacturing, Competition, and Regulation](index=34&type=section&id=Manufacturing%2C%20Competition%2C%20and%20Regulation) The company relies on third-party manufacturers, faces intense competition, and operates under extensive FDA and other healthcare regulations - The company does not own or operate manufacturing facilities and relies on third-party manufacturers like GenCure Biomanufacturing and Waisman Biomanufacturing for its product candidates[114](index=114&type=chunk)[116](index=116&type=chunk) - The company faces intense competition from major pharmaceutical and biotechnology companies such as Bristol-Myers Squibb, Merck, Genentech, and Amgen, which have greater resources and more established products[120](index=120&type=chunk) - Products are subject to extensive regulation by the FDA, requiring a multi-phase clinical trial process to demonstrate safety and efficacy before a Biologics License Application (BLA) can be submitted for marketing approval[127](index=127&type=chunk)[128](index=128&type=chunk)[135](index=135&type=chunk) - Beyond the FDA, the company's activities are subject to other healthcare laws, including the federal anti-kickback statute, False Claims Act, and HIPAA, which govern sales, marketing, and data privacy[153](index=153&type=chunk)[154](index=154&type=chunk)[157](index=157&type=chunk) [Corporate and Human Capital](index=54&type=section&id=Corporate%20and%20Human%20Capital) Heat Biologics, incorporated in Delaware, has 39 employees across its subsidiaries, with research teams in San Antonio and Morrisville, implementing COVID-19 safety measures - As of December 31, 2020, the company had **39** full-time employees, with research teams located in San Antonio, Texas (**10**) and Morrisville, North Carolina (**21**)[188](index=188&type=chunk) - The company operates through multiple wholly-owned or majority-owned subsidiaries, including Heat Biologics I, Zolovax, Pelican Therapeutics, Skunkworx Bio, and Scorpion Biological Services[184](index=184&type=chunk) - In response to COVID-19, the company implemented health and safety measures including work-from-home flexibility, increased cleaning protocols, and adjusted attendance policies[195](index=195&type=chunk) [Risk Factors](index=57&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its financial position, clinical development, intellectual property, and general business operations [Risks Relating to our Company, Financial Position and Capital Requirements](index=57&type=section&id=Risks%20Relating%20to%20our%20Company%2C%20Financial%20Position%20and%20Capital%20Requirements) The company has a limited operating history, consistent net losses, no product revenue, and requires additional capital, with COVID-19 posing further risks - The company has incurred net losses every year since inception, with a net loss of **$26.4 million** in 2020 and an accumulated deficit of **$130.6 million** as of December 31, 2020[199](index=199&type=chunk) - The company may need to raise additional capital to fund long-term operations, and failure to do so could force delays or elimination of development programs[201](index=201&type=chunk)[202](index=202&type=chunk) - The COVID-19 pandemic could adversely impact business and clinical trials through delays in patient enrollment, supply chain interruptions, and diversion of healthcare resources[207](index=207&type=chunk)[208](index=208&type=chunk) - The company's stock price has been volatile, with a high of **$17.00** and a low of **$11.51** on a single day (February 9, 2021), which could lead to substantial investor losses[218](index=218&type=chunk) [Risks Related to Our Clinical Development, Regulatory Approval and Commercialization](index=67&type=section&id=Risks%20Related%20to%20Our%20Clinical%20Development%2C%20Regulatory%20Approval%20and%20Commercialization) Success depends on navigating expensive, uncertain clinical trials, obtaining regulatory approvals, and managing third-party dependencies and intense competition - Clinical trials are very expensive, time-consuming, and difficult to design, with a high risk of failure at any stage[235](index=235&type=chunk) - The company relies on third-party CROs to conduct clinical trials and third-party manufacturers for product supply, making it vulnerable to their performance and potential disruptions[252](index=252&type=chunk)[256](index=256&type=chunk) - The COVID-19 vaccine program faces significant competition from companies like Pfizer-BioNTech, Moderna, and Johnson & Johnson, which have already received emergency use authorization for their vaccines[245](index=245&type=chunk) - The company has no experience in selling, marketing, or distributing products and will need to establish these capabilities or rely on strategic partnerships, which may not be successful[270](index=270&type=chunk) [Risks Related to Intellectual Property](index=97&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's competitive position relies on limited IP protection, licensed technologies, and faces potential infringement claims and government "march-in rights" - The company has limited protection for its intellectual property and relies on licenses for various technologies material to its business; termination of these licenses would have a material adverse effect[310](index=310&type=chunk)[316](index=316&type=chunk) - The company's technology or products may be found to infringe upon third-party intellectual property rights, which could lead to costly litigation and potentially halt development[313](index=313&type=chunk) - The U.S. government may have "march-in rights" to certain intellectual property developed with federal grant money, allowing it to grant licenses to third parties under specific circumstances[318](index=318&type=chunk)[320](index=320&type=chunk) [General Risk Factors](index=101&type=section&id=General%20Risk%20Factors) General risks include high dependence on key personnel, potential Nasdaq delisting, stockholder dilution from future financings, and stock price volatility - The company is highly dependent on its key executive officers and scientific advisors, whose knowledge would be difficult to replace[322](index=322&type=chunk) - Failure to meet The Nasdaq Capital Market's continued listing requirements, such as the minimum bid price, could result in the delisting of the company's common stock[326](index=326&type=chunk) - Future financing needs may result in the issuance of additional securities, causing dilution to existing stockholders[345](index=345&type=chunk) [Unresolved Staff Comments](index=109&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reported no unresolved staff comments from the SEC - There are no unresolved staff comments[346](index=346&type=chunk) [Properties](index=109&type=section&id=Item%202.%20Properties) The company leases executive offices and laboratory spaces in Morrisville, NC, San Antonio, TX, and other locations for its subsidiaries - The company's executive offices and lab are located in Morrisville, NC, with a lease expiring in October 2027[347](index=347&type=chunk) - Subsidiary Pelican Therapeutics leases office and lab space in San Antonio, TX, and subsidiary Skunkworx leases lab space[348](index=348&type=chunk) [Legal Proceedings](index=109&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not presently a party to any material legal proceedings[349](index=349&type=chunk) [Mine Safety Disclosures](index=109&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[350](index=350&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=111&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The common stock trades on Nasdaq under "HTBX", underwent a reverse stock split, and the company has no plans for cash dividends - The company's common stock trades on the Nasdaq Capital Market under the symbol "HTBX"[353](index=353&type=chunk) - A one-for-seven reverse stock split was effected on December 11, 2020, reducing the number of outstanding shares from approximately **159.8 million** to **22.8 million**[355](index=355&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future[356](index=356&type=chunk) Equity Compensation Plan Information (as of Dec 31, 2020) | Plan Category | Securities to be issued upon exercise | Weighted-average exercise price | Securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 1,480,139 | $11.05 | 1,788,730 | [Selected Financial Data](index=112&type=section&id=Item%206.%20Selected%20Financial%20Data) This section is not applicable as the company qualifies as a smaller reporting company - Not applicable because the company is a smaller reporting company[363](index=363&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=112&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported an increased net loss in 2020, stable R&D, higher G&A, and significantly improved liquidity from stock offerings, sufficient into 2024 [Results of Operations](index=126&type=section&id=Results%20of%20Operations) Grant revenue slightly decreased, total operating expenses rose due to G&A, and the net loss attributable to Heat Biologics widened in 2020 compared to 2019 Financial Performance Comparison (in millions) | Metric | FY 2020 | FY 2019 | | :--- | :--- | :--- | | Grant Revenue | $2.8 | $3.0 | | R&D Expense | $12.9 | $13.0 | | G&A Expense | $14.9 | $9.4 | | Total Operating Expenses | $29.1 | $23.8 | | Net Loss Attributable to Heat Biologics | $26.0 | $20.0 | R&D Expense by Program (in millions) | Program | 2020 | 2019 | | :--- | :--- | :--- | | HS-110 | $1.3 | $0.1 | | HS-130 | $0.8 | $0.4 | | PTX 35/other biologics | $2.0 | $3.0 | | COVID-19 | $0.5 | $— | | Other programs | $0.5 | $3.3 | | Unallocated R&D expenses | $7.8 | $6.2 | | **Total** | **$12.9** | **$13.0** | [Liquidity and Capital Resources](index=131&type=section&id=Liquidity%20and%20Capital%20Resources) The company significantly strengthened its financial position in 2020, ending with **$111.8 million** in cash, primarily from **$114.4 million** in stock offerings, sufficient into 2024 - The company raised an aggregate of **$114.4 million** through at-the-market offerings during the year ended December 31, 2020[383](index=383&type=chunk)[432](index=432&type=chunk) Key Liquidity and Cash Flow Data (in millions) | Metric | Dec 31, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | Cash, Cash Equivalents & Short-term Investments | $111.8 | $14.8 | | Net Cash Used in Operating Activities | ($22.0) | ($12.8) | | Net Cash Provided by Financing Activities | $119.3 | $0.02 | - Management expects current funds to be sufficient to fund operations into 2024[384](index=384&type=chunk)[433](index=433&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=135&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - Not applicable because the company is a smaller reporting company[448](index=448&type=chunk) [Financial Statements and Supplementary Data](index=135&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section refers to the consolidated financial statements and related notes, included from page F-1 to F-32 of the report - This section directs the reader to the full financial statements beginning on page F-1[449](index=449&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=135&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reported no changes in or disagreements with its accountants on accounting and financial disclosure - None[450](index=450&type=chunk) [Controls and Procedures](index=137&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal controls over financial reporting were effective as of December 31, 2020, with no material changes in Q4 2020 - Management concluded that disclosure controls and procedures were effective as of December 31, 2020[452](index=452&type=chunk) - Management concluded that internal controls over financial reporting were effective as of December 31, 2020, based on the COSO framework[453](index=453&type=chunk) - There were no changes in internal control over financial reporting during the fourth quarter of 2020 that materially affected, or are reasonably likely to materially affect, the company's internal control[456](index=456&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=139&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) This section details the company's directors and executive officers, board structure, and committee composition, including an independent Lead Director - The executive team includes Jeffrey Wolf (Chairman & CEO) and William L. Ostrander (CFO)[461](index=461&type=chunk) - The Board has three independent directors: John Monahan, Ph.D., Edward B. Smith, III, and John K.A. Prendergast, Ph.D[480](index=480&type=chunk) - The Board has standing Audit, Compensation, and Nominating and Governance Committees, all composed of independent directors[476](index=476&type=chunk) - The company has a separate independent Lead Director, Dr. Prendergast, who presides over executive sessions of independent directors and liaises with management[496](index=496&type=chunk) [Executive Compensation](index=148&type=section&id=Item%2011.%20Executive%20Compensation) The executive compensation program aligns pay with stockholder interests, using independent consultants to benchmark base salary, performance bonuses, and equity incentives 2020 Summary Compensation Table | Name and Principal Position | Year | Salary | Bonus | Stock Awards | Option Awards | Other | Total | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Jeffrey Wolf (CEO) | 2020 | $440,406 | $220,203 | $910,800 | $4,348,528 | $500,000 | $6,419,937 | | William L. Ostrander (CFO) | 2020 | $226,600 | $45,321 | $— | $66,427 | $— | $338,348 | | Jeff T. Hutchins (Former CSO/COO) | 2020 | $331,667 | $— | $— | $218,733 | $129,987 | $680,387 | - The compensation philosophy is to align executive pay with stockholder interests, be competitive to attract talent, and reward the achievement of goals[505](index=505&type=chunk)[510](index=510&type=chunk) - CEO Jeffrey Wolf's 2020 compensation included a **$500,000** special bonus to cover estimated taxes from a restricted share award[503](index=503&type=chunk)[506](index=506&type=chunk) - Non-employee directors receive annual cash fees for board and committee service, as well as equity awards, with the lead independent director receiving a monthly fee of **$14,000**[565](index=565&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=168&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 22, 2021, directors and executive officers as a group beneficially owned **7.7%** of common stock, with Jeffrey Wolf holding **5.6%** Security Ownership of Management (as of March 22, 2021) | Name of Beneficial Owner | Total Number of Shares Beneficially Owned | Percentage Ownership | | :--- | :--- | :--- | | Jeffrey Wolf (CEO) | 1,450,930 | 5.6% | | All Executive Officers and Directors, as a group (6 persons) | 2,014,226 | 7.7% | [Certain Relationships and Related Transactions, and Director Independence](index=170&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) This section discloses related party transactions, including executive compensation and future milestone payments, and confirms three directors are independent under Nasdaq rules - The Audit Committee is responsible for reviewing and approving all related party transactions[573](index=573&type=chunk) - The Board has determined that directors John Monahan, John K.A. Prendergast, and Edward B. Smith, III are independent as defined by Nasdaq rules[579](index=579&type=chunk) [Principal Accountant Fees and Services](index=172&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) BDO USA, LLP served as the independent auditor, with fees primarily for audit services in 2020 and 2019, all pre-approved by the Audit Committee Accountant Fees | Fee Type | 2020 | 2019 | | :--- | :--- | :--- | | Audit Fees and Expenses | $329,213 | $321,175 | - All audit and non-audit services provided by the independent registered public accounting firm were pre-approved by the Audit Committee[582](index=582&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=174&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed as part of the Annual Report on Form 10-K, covering fiscal years 2020 and 2019 - This item lists the consolidated financial statements for the years ended December 31, 2020 and 2019, and all exhibits filed with the report[587](index=587&type=chunk) [Form 10-K Summary](index=188&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable to the company - Not applicable[602](index=602&type=chunk)

1 Heat Biologics NASDAQ: HTBX CORPORATE PRESENTATION November 5, 2019 Forward Looking Statements This presentation includes statements that are, or may be deemed, ''forward-looking statements'' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. 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 ...