Product Development and Manufacturing - ANTHIM® (obiltoxaximab) received FDA approval in 2016 and has generated $6.0 million in procurement contracts for the Canadian government since the acquisition of Elusys[41] - The company plans to develop a 500,000+ square foot biomanufacturing facility in Manhattan, Kansas, with over $300 million in funding and incentives applied for[37] - Scorpius Biomanufacturing, Inc. aims to reduce reliance on third-party manufacturers and has commenced operations in San Antonio, Texas, since September 2022[35] - The total funding received for the development of ANTHIM® is approximately $151 million from various government agencies, with an additional $6 million in procurement contracts[44] - The anticipated commercial manufacturing facility in Kansas is expected to enhance competitiveness for U.S. government contracts and biodefense assets[34] - The company has three customers for Scorpius but has not yet recognized any revenue from these contracts[38] - The company has enhanced in-house manufacturing capabilities and leased a 20,144 square foot facility in San Antonio, TX, with operations commencing in October 2022[77] - The company plans to offer excess biomanufacturing capacity to third parties as a fee-for-service CDMO model through its subsidiary Scorpius[84] - The manufacturing of ANTHIM® is currently reliant on a single manufacturer, Lonza, which has transitioned to a 6,000 liter scale, requiring new regulatory approvals from the FDA[190] - The manufacturing of ANTHIM® will not occur at the previously used facility, requiring new regulatory approval[193] - The company operates a single manufacturing facility in San Antonio, Texas, increasing exposure to disruptions from unforeseen events[194] - The company relies on third-party suppliers for raw materials, and any delays in supply could adversely impact manufacturing and financial results[196] - The company has no long-term supply contracts with single-source suppliers, increasing risk of supply chain disruptions[197] Financial Performance and Projections - As of December 31, 2022, the company reported an accumulated deficit of $209.2 million and a net loss of approximately $43.9 million for the year[159] - The company has not generated significant revenue from product sales, with only $6.0 million generated from new sales of ANTHIM® since acquiring Elusys[162] - The company anticipates incurring additional expenses associated with ANTHIM® before generating significant revenue from sales, which is not expected for several years[158] - The company expects to continue experiencing negative cash flows and significant operating losses for the foreseeable future[168] - The accumulated deficit increased from $165.7 million as of December 31, 2021, to $209.2 million as of December 31, 2022, reflecting a rise of approximately 26%[169] - The company expects to incur additional operating losses in the future, with cumulative losses anticipated to increase as it engages in full-scale manufacturing of ANTHIM®[169] - The agreement with Lonza obligates the company to pay approximately $34 million over a two-year period for manufacturing services and an additional $19 million for raw materials[169] - For the year ended December 31, 2022, all revenue was derived from a single ANTHIM® purchase order and one customer for CDMO services, highlighting significant revenue concentration risk[186] - The company plans to expand its customer base outside of the United States, but remains dependent on a limited number of customers for a substantial majority of its revenues[187] - The ability to generate product revenues from ANTHIM® is heavily dependent on U.S. government spending, particularly in biodefense, which poses a risk to revenue stability[188] - The company has identified material weaknesses in its internal control over financial reporting, which may affect the accuracy and reliability of its financial statements[177] - The company is considering multiple financing alternatives, including equity and debt financings, to support its long-term operations, which may lead to dilution for existing shareholders[170] - The company is substantially dependent on the success of its product ANTHIM®, which is currently its only revenue-generating product[192] Regulatory Compliance and Risks - Compliance with various local, state, national, and international regulations is essential, and failure to do so can adversely affect financial conditions and operations[115] - The costs associated with regulatory compliance can be significant, impacting the company's financial results[115] - The company must adhere to environmental and safety regulations, which could lead to substantial costs and liabilities[116] - The anti-kickback statute imposes strict regulations on remuneration practices, with potential penalties for violations[120] - Changes to manufacturing processes require FDA approval, and significant issues can lead to product recalls or market withdrawal[112] - The FDA may require post-marketing Phase 4 testing to monitor the effects of approved products, which can lead to changes in labeling or additional risk management measures[106] - Regulatory compliance is critical, as failure to meet requirements could lead to delays or denials of product approvals, impacting revenue[205] - The company faces risks related to the use of hazardous materials, which could lead to liability or operational interruptions[201] - The company’s ability to manufacture products is contingent on its customers receiving and maintaining regulatory approvals for their product candidates[200] - The company requires FDA approval to commercialize its product candidates, including ANTHIM®, which is contingent on regulatory approvals for the new manufacturing facility[211] - The approval process for marketing products outside the U.S. varies by country, and satisfactory pricing may not be guaranteed even after regulatory approval[143] - The FDA has substantial post-market authority, which could lead to increased costs and delays in product development and regulatory review[213] - The company may need to conduct additional preclinical and clinical testing as a condition for marketing approval, particularly for oncology products[212] - Regulatory approval processes in foreign jurisdictions carry similar risks as those in the U.S., with no assurance of receiving necessary approvals[214] Strategic Focus and Partnerships - The company is focused on biodefense and biomanufacturing, shifting resources away from clinical-stage oncology assets[33] - The company formed a Biothreat Advisory Board in August 2021 to guide the development of biosecurity initiatives, including experts from defense and biodefense sectors[51] - The RapidVax® platform is being developed as a flexible vaccine solution, leveraging gp96-based vaccines to enhance T-cell activation and memory cell generation[55] - The company is focused on maximizing commercial opportunities for ANTHIM® and is actively seeking strategic partnerships to enhance its economic potential[66] - The company plans to expand its patent portfolio, particularly for new pre-clinical biodefense technologies developed by its subsidiaries[70] - The company is exploring partnerships for licensing and collaborative relationships to enhance its market position in innovative medical countermeasures[70] - The company intends to seek additional non-dilutive grant funding to support the development of its technologies and assets[70] - NightHawk and Skunkworx hold 5 non-provisional international applications and approximately 10 U.S. provisional applications related to biodefense technologies[75] - Shattuck Labs paid an initial license fee of $50,000 and an additional $100,000 in milestone payments in February 2023[76] Market Competition and Challenges - The company faces intense competition in the market, particularly for ANTHIM®, which competes against a larger manufacturer with more resources[223] - Market acceptance of ANTHIM® and other product candidates is uncertain, and failure to achieve acceptance could severely impact revenue generation[222] - The competitive landscape includes fully integrated pharmaceutical companies and established CDMOs, posing challenges for market share acquisition[224] - The company faces uncertainty regarding coverage and reimbursement for its product candidates, which may impact sales and pricing strategies[134] - Legislative changes in the U.S. healthcare system may increase pressure on drug pricing, potentially affecting anticipated revenues from product candidates[141] - The company anticipates ongoing healthcare reforms that may result in downward pressure on product pricing and reimbursement rates[142]

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, 2022 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 NightHawk Biosciences, Inc. (Exact Name of Registrant as Specified in It ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Qs (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 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 NightHawk Biosciences, Inc. (Exact Name of Registrant as Specified in ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES 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 Charter) Delaware 26-2844103 (State o ...

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 Heat Biologics, Inc. 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 Delaware (State or Other Jurisdiction of Incorporat ...

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 ...

Table of Contents (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K þ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ◻ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number: 0 ...

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 September 30, 2020 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) þ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 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 ...