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, 2023 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 627 Davis Drive, Suite 300 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from ____________ to ____________ Commission ...

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): March 7, 2024 Scorpius Holdings, 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, Suite 400 Morrisville, North Carolina 27560 (Address ...

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, 2023 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 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☐ 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. ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Delaware (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, 2023 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 speci ...

Business Focus and Strategy - The company specializes in the end-to-end development, manufacturing, and commercialization of innovative medical countermeasures, particularly focusing on biodefense and biomanufacturing capabilities[29]. - The company is focused on identifying novel assets to combat emerging biological threats as part of its biodefense strategy[41]. - 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 company is focused on maximizing commercial opportunities for ANTHIM® and is actively seeking strategic partnerships to enhance its economic potential[66]. - The company is exploring partnerships for licensing and collaborative relationships to enhance its market position in innovative medical countermeasures[70]. - The company aims to streamline the commercialization of medical countermeasures by prioritizing American-made equipment and in-house biomanufacturing[62]. Product Development and Regulatory Compliance - 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[30][41]. - ANTHIM® is the only licensed anthrax antitoxin treatment in the EU and Canada, approved for both treatment and prophylaxis of inhalational anthrax[30][45]. - The FDA review process for NDAs and BLAs typically takes 10 to 12 months for standard reviews and 6 to 8 months for priority reviews[95]. - The FDA may extend the review process for drug applications by up to three additional months for late-submitted information[98]. - An approval letter from the FDA allows for commercial marketing of a drug, but may require a risk evaluation and mitigation strategy (REMS) to ensure safety[100]. - Post-approval requirements include ongoing compliance with FDA regulations, which can affect product marketability and profitability[102]. - Manufacturers must maintain compliance with current good manufacturing practices (cGMP) to ensure product stability and safety[103]. - The FDA may require post-marketing Phase 4 testing to monitor the effects of approved products, which can lead to additional regulatory scrutiny[106]. - Changes to approved applications, such as new indications or manufacturing processes, require FDA approval and may involve significant clinical data[101]. - Noncompliance with regulatory requirements can result in severe consequences, including product recalls or withdrawal from the market[115]. - The company must comply with various local, state, national, and international regulations, which can affect manufacturing and distribution processes[112]. - The company requires FDA approval to commercialize its product candidates, including ANTHIM®, which is contingent on regulatory approvals for the new manufacturing facility[211]. Financial Performance and Challenges - 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 to $209.2 million as of December 31, 2022, compared to $165.7 million as of December 31, 2021, reflecting ongoing financial challenges[169]. - The company expects to incur additional operating losses in the future, with cumulative losses anticipated to increase as it continues to develop its product candidates[169]. - The company has entered a new line of business providing contract development and manufacturing services, but it has not yet proven its ability to operate a CDMO facility successfully[162]. - For the year ended December 31, 2022, all revenue was derived from a single purchase order for ANTHIM® and one customer for CDMO services, highlighting a lack of revenue diversification[186]. - The company is considering multiple financing alternatives, including equity financings and debt financings, to meet its capital needs, which may lead to dilution for existing shareholders[170]. Operational and Market Risks - The company faces uncertainty regarding coverage and reimbursement for product candidates, which may affect sales and pricing strategies[134]. - The company anticipates ongoing legislative healthcare reforms may result in downward pressure on product pricing and reimbursement rates[142]. - The company is substantially dependent on the success of its product ANTHIM®, which is currently the only source of revenue following the termination of licenses for other product candidates[192]. - The ability to generate product revenues from ANTHIM® is heavily dependent on U.S. government spending, particularly in biodefense, which poses a risk to future revenue generation[188]. - The company does not have long-term contracts with CDMO customers, making its revenue stream vulnerable to market fluctuations and customer decisions[189]. - The company faces intense competition in the market, particularly for ANTHIM®, which competes against a larger manufacturer with more resources[223]. - There is uncertainty regarding market acceptance of ANTHIM® and other product candidates, which could adversely affect revenue if they fail to gain traction[222]. - The company may face challenges in competing for market share against established pharmaceutical companies and other CDMOs with greater financial resources[224]. Manufacturing and Development Capabilities - The company plans to develop a 500,000+ square foot biodefense-focused 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, in September 2022[32][35]. - The company has enhanced in-house development capabilities and leased a 20,144 square foot facility in San Antonio, TX, which commenced operations in October 2022[77]. - 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 or non-compliance could adversely affect manufacturing and financial results[196][198]. Research and Development - Research and development expenses were $23.5 million and $16.5 million during the years ended December 31, 2022 and 2021, respectively[146]. - The company has formed several subsidiaries to focus on various aspects of its business, including biodefense and contract manufacturing[148]. - All product candidates are currently in the preclinical stage, necessitating extensive preclinical and clinical testing before any BLA submission can be made[215]. - Clinical trials are expected to take several years to complete, with significant costs and potential delays due to various factors such as safety issues and patient recruitment challenges[217]. - The success of clinical trials is uncertain, and failure at any stage could lead to abandonment of product candidates and delays in future development[216].

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) ☐ 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 Its Charter) Delaware (State or Other Jurisdiction of Incorporation or Organization) 627 Davis Drive, Suite 400 ☒ QUARTERLY REPORT PURSUANT ...

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 ...