Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 20, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2023 | |
Entity File Number | 001-35994 | |
Entity Registrant Name | NightHawk Biosciences, Inc. | |
Entity Incorporation | DE | |
Entity Tax Identification Number | 26-2844103 | |
Entity Address, Address Line One | 627 Davis Drive, Suite 300 | |
Entity Address, City or Town | Morrisville | |
Entity Address, State or Province | NC | |
Entity Address, Postal Zip Code | 27560 | |
City Area Code | 919 | |
Local Phone Number | 240-7133 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | NHWK | |
Security Exchange Name | NYSEAMER | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,081,890 | |
Entity Central Index Key | 0001476963 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current Assets | ||
Cash and cash equivalents | $ 2,042,741 | $ 3,191,714 |
Short-term investments | 4,167,755 | 35,837,309 |
Accounts receivable | 313,906 | 81,456 |
Grant receivable | 1,524,522 | |
Prepaid expenses and other current assets | 1,261,228 | 1,491,123 |
Current assets held for sale | 16,394,533 | 7,928,136 |
Total Current Assets | 24,180,163 | 50,054,260 |
Property and Equipment, net | 18,683,898 | 20,438,521 |
Operating lease right-of-use asset | 5,346,910 | 5,866,261 |
Finance lease right-of-use asset | 20,979,923 | 15,329,075 |
Other assets | 453,135 | 260,011 |
Deposits | 271,115 | 270,461 |
Non-current assets held for sale | 12,178,323 | |
Total Assets | 69,915,144 | 104,396,912 |
Current Liabilities | ||
Accounts payable | 2,873,696 | 4,213,732 |
Deferred revenue, current portion | 4,056,646 | 1,585,808 |
Operating lease liability, current portion | 404,566 | 397,855 |
Finance lease liability, current portion | 895,625 | 301,048 |
Accrued expenses and other liabilities | 2,031,618 | 1,916,601 |
Current liabilities held for sale | 14,225,696 | 9,622,279 |
Total Current Liabilities | 24,487,847 | 18,037,323 |
Long Term Liabilities | ||
Deferred revenue, net of current portion | 32,500 | 32,500 |
Operating lease liability, net of current portion | 2,825,536 | 3,079,887 |
Financing lease liability, net of current portion | 9,122,617 | 5,520,034 |
Non-current liabilities held for sale | 5,290,500 | |
Total Liabilities | 36,468,500 | 31,960,244 |
Commitments and Contingencies (Note 13 and Note 14) | ||
Stockholders' Equity | ||
Common stock, $0.0002 par value; 250,000,000 shares authorized, 26,081,890 and 25,661,488 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 5,217 | 5,126 |
Additional paid-in capital | 285,090,202 | 283,019,456 |
Accumulated deficit | (248,962,791) | (209,153,659) |
Accumulated other comprehensive income | 159,929 | 51,924 |
Total Stockholders' Equity - NightHawk Biosciences, Inc. | 36,292,557 | 73,922,847 |
Non-Controlling Interest | (2,845,913) | (1,486,179) |
Total Stockholders' Equity | 33,446,644 | 72,436,668 |
Total Liabilities and Stockholders' Equity | $ 69,915,144 | $ 104,396,912 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Consolidated Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.0002 | $ 0.0002 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 26,081,890 | 25,661,488 |
Common stock, shares outstanding | 26,081,890 | 25,661,488 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue: | ||||
Revenue | $ 723,126 | $ 58,861 | $ 2,146,804 | $ 290,259 |
Operating expenses: | ||||
Cost of revenues | 545,023 | 1,540,454 | ||
Research and development | 5,155,359 | 5,379,780 | 16,600,186 | 13,334,021 |
Selling, general and administrative | 6,082,539 | 4,838,169 | 19,603,075 | 13,299,474 |
In-process research and development impairment | 3,500,000 | 3,500,000 | ||
Change in fair value of contingent consideration | (3,118,515) | (3,342,515) | ||
Total operating expenses | 11,782,921 | 10,599,434 | 37,743,715 | 26,790,980 |
Operating loss | (11,059,795) | (10,540,573) | (35,596,911) | (26,500,721) |
Change in fair value of warrant liability | 1,456 | 10,746 | ||
Other expense (income), net | (110,352) | 74,913 | (329,103) | 234,517 |
Unrealized (loss) gain on available-for-sale securities | (36,116) | (145,558) | 99,437 | (1,577,174) |
Total non-operating loss | (146,468) | (69,189) | (229,666) | (1,331,911) |
Net loss before income taxes from continuing operations | (11,206,263) | (10,609,762) | (35,826,577) | (27,832,632) |
Income tax (expense) benefit | (37,063) | 571,120 | 3,288,937 | |
Net loss from continuing operations before income taxes | (11,206,263) | (10,646,825) | (35,255,457) | (24,543,695) |
Net loss from discontinued operations before income taxes | (3,040,577) | (2,700,946) | (5,848,220) | (3,931,784) |
Income tax (expense) benefit from discontinued operations | (65,189) | (65,189) | ||
Net loss | (14,312,029) | (13,347,771) | (41,168,866) | (28,475,479) |
Net loss - non-controlling interest | (1,179,559) | (89,421) | (1,359,734) | (265,256) |
Net loss attributable to NightHawk Biosciences, Inc. | $ (13,132,470) | $ (13,258,350) | $ (39,809,132) | $ (28,210,223) |
Net loss per share, basic - continuing operations (in dollars per share) | $ (0.38) | $ (0.41) | $ (1.30) | $ (0.95) |
Net loss per share, diluted - continuing operations (in dollars per share) | (0.38) | (0.41) | (1.30) | (0.95) |
Net loss per share, basic - discontinued operations (in dollars per share) | (0.12) | (0.11) | (0.23) | (0.15) |
Net loss per share, diluted - discontinued operations (in dollars per share) | (0.12) | (0.11) | (0.23) | (0.15) |
Net loss per share common share attributable to NightHawk Biosciences, Inc., basic | (0.50) | (0.52) | (1.53) | (1.10) |
Net loss per share common share attributable to NightHawk Biosciences, Inc., diluted | $ (0.50) | $ (0.52) | $ (1.53) | $ (1.10) |
Weighted-average common shares outstanding, basic (in shares) | 26,050,562 | 25,613,316 | 26,022,244 | 25,603,481 |
Weighted-average common shares outstanding, diluted (in shares) | 26,050,562 | 25,613,316 | 26,022,244 | 25,603,481 |
Comprehensive loss: | ||||
Net loss | $ (14,312,029) | $ (13,347,771) | $ (41,168,866) | $ (28,475,479) |
Unrealized gain on foreign currency translation | 54,967 | 115,659 | 108,005 | 210,245 |
Total comprehensive loss | (14,257,062) | (13,232,112) | (41,060,861) | (28,265,234) |
Comprehensive loss attributable to non-controlling interest | (1,179,559) | (89,421) | (1,359,734) | (265,256) |
Comprehensive loss - NightHawk Biosciences, Inc. | $ (13,077,503) | $ (13,142,691) | $ (39,701,127) | $ (27,999,978) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Common Stock | APIC | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income | Non-Controlling Interest | Total |
Beginning Balance at Dec. 31, 2021 | $ 5,055 | $ 278,890,153 | $ (165,718,953) | $ (67,941) | $ (1,074,743) | $ 112,033,571 |
Issuance of common stock from vesting of restricted stock awards | 65 | (65) | ||||
Issuance of common stock - ESPP | 2 | (2) | ||||
Stock based compensation | 2,430,389 | 2,430,389 | ||||
Other comprehensive income | 210,245 | 210,245 | ||||
Net loss | (28,210,223) | (265,256) | (28,475,479) | |||
Ending Balance at Sep. 30, 2022 | 5,122 | 281,320,475 | (193,929,176) | 142,304 | (1,339,999) | 86,198,726 |
Beginning Balance at Jun. 30, 2022 | 5,120 | 280,603,302 | (180,670,826) | 26,645 | (1,250,578) | 98,713,663 |
Issuance of common stock - ESPP | 2 | (2) | ||||
Stock based compensation | 717,175 | 717,175 | ||||
Other comprehensive income | 115,659 | 115,659 | ||||
Net loss | (13,258,350) | (89,421) | (13,347,771) | |||
Ending Balance at Sep. 30, 2022 | 5,122 | 281,320,475 | (193,929,176) | 142,304 | (1,339,999) | 86,198,726 |
Beginning Balance at Dec. 31, 2022 | 5,126 | 283,019,456 | (209,153,659) | 51,924 | (1,486,179) | 72,436,668 |
Issuance of common stock from vesting of restricted stock awards | 79 | (79) | ||||
Issuance of common stock - ESPP | 12 | (12) | ||||
Stock based compensation | 2,070,837 | 2,070,837 | ||||
Other comprehensive income | 108,005 | 108,005 | ||||
Net loss | (39,809,132) | (1,359,734) | (41,168,866) | |||
Ending Balance at Sep. 30, 2023 | 5,217 | 285,090,202 | (248,962,791) | 159,929 | (2,845,913) | 33,446,644 |
Beginning Balance at Jun. 30, 2023 | 5,210 | 284,453,899 | (235,830,321) | 104,962 | (1,666,354) | 47,067,396 |
Issuance of common stock - ESPP | 7 | (7) | ||||
Stock based compensation | 636,310 | 636,310 | ||||
Other comprehensive income | 54,967 | 54,967 | ||||
Net loss | (13,132,470) | (1,179,559) | (14,312,029) | |||
Ending Balance at Sep. 30, 2023 | $ 5,217 | $ 285,090,202 | $ (248,962,791) | $ 159,929 | $ (2,845,913) | $ 33,446,644 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Cash Flows from Operating Activities | |||||
Net loss | $ (14,312,029) | $ (13,347,771) | $ (41,168,866) | $ (28,475,479) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Goodwill impairment loss | 3,873,079 | ||||
Intangible asset impairment loss | 2,277,921 | ||||
Intangible asset impairment loss | 3,500,000 | 3,500,000 | |||
Depreciation and amortization | 4,668,589 | 988,715 | |||
Amortization of intangible asset | 1,091,250 | 666,875 | |||
Noncash lease expense | 318,073 | 127,681 | |||
Stock-based compensation | 600,000 | 700,000 | 2,070,837 | 2,430,389 | |
Change in fair value of common stock warrants | (1,456) | (10,746) | |||
Change in fair value of contingent consideration | (3,118,515) | (3,342,515) | |||
Change in fair value of contingent consideration | (300,000) | (177,354) | |||
Unrealized (gain) loss on investments | (99,437) | 1,577,174 | |||
Deferred tax liability | (571,120) | (3,073,000) | |||
Payment of contingent consideration | (100,344) | ||||
Increase (decrease) in cash arising from changes in assets and liabilities, net of acquisitions: | |||||
Accounts receivable | (7,022,657) | (5,843,564) | |||
Other assets | (193,124) | 12,493,539 | |||
Prepaid expenses and other current assets | 2,330,808 | 1,210,730 | |||
Grant receivable | 1,524,522 | (206,163) | |||
Contract receivables | 24,526,231 | ||||
Inventory | 5,844,000 | ||||
Income tax receivable | 600,877 | 443,968 | |||
Right-of-use assets | 57,103 | (9,974,366) | |||
Deferred tax liability | (215,937) | ||||
Deposits | 25,596 | (33,064) | |||
Accounts payable | (749,600) | 2,354,279 | |||
Deferred revenue | 2,470,838 | 718,850 | |||
Accrued expenses and other liabilities | (1,681,915) | (3,512,090) | |||
Other long-term liabilities | (53,530) | ||||
Net Cash (Used In) Provided by Operating Activities | (30,454,924) | 2,141,977 | |||
Cash Flows from Investing Activities | |||||
Purchase of short-term investments | (439,779) | (1,989,767) | |||
Sale of short-term investments | 32,208,771 | 44,947,779 | |||
Purchases of property and equipment | (1,852,665) | (19,271,087) | |||
Disposal of property and equipment | 220,802 | ||||
Acquisition of Elusys Therapeutics, net of cash paid | 2,719,898 | ||||
Payment of contingent consideration | (22,784,571) | ||||
Net Cash Provided By Investing Activities | 30,137,129 | 3,622,252 | |||
Cash Flows from Financing Activities | |||||
Repayments of principal under finance lease | (2,751,037) | (145,672) | |||
Net Cash Used In Financing Activities | (2,751,037) | (145,672) | |||
Effect of exchange rate changes on cash and cash equivalents | (3,188) | (14,194) | |||
Net (Decrease) Increase in Cash and Cash Equivalents | (3,072,020) | 5,604,363 | |||
Cash and Cash Equivalents - Beginning of the Period | 8,434,554 | 8,053,879 | $ 8,053,879 | ||
Cash and Cash Equivalents - End of the Period | 5,362,534 | 13,658,242 | 5,362,534 | 13,658,242 | $ 8,434,554 |
Supplemental Disclosure for Cash Flow Information: | |||||
Right-of-use assets obtained upon operating lease commencements | 351,098 | ||||
Right-of-use assets obtained upon financing lease commencements | 9,983,504 | 16,470,969 | |||
Right-of-use assets surrendered upon financing lease modifications | (3,092,408) | ||||
Right-of-use assets obtained upon operating lease modifications | 87,839 | ||||
Supplemental disclosure of non-cash investing and financing activities: | |||||
Purchases of property and equipment included in accounts payable | 1,233,232 | ||||
Contingent and deferred cash consideration related to Elusys acquisition | 42,853,685 | ||||
Reconciliation of cash and cash equivalents at September 30, 2023 and 2022 | |||||
Cash and cash equivalents included in current assets held for sale | $ 3,319,793 | $ 5,242,840 | $ 3,319,793 | $ 5,242,840 |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Basis of Presentation and Significant Accounting Policies | |
Basis of Presentation and Significant Accounting Policies | 1. Basis of Presentation and Significant Accounting Policies Basis of Presentation and Principles of Consolidation Effective May 3, 2022, Heat Biologics, Inc. changed its name to NightHawk Biosciences, Inc. (the “Company” or “NightHawk”) by filing a Certificate of Amendment (the “Certificate of Amendment”) to its Third Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware. The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial reporting. Certain information or footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed, or omitted, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). In the opinion of the Company’s management, these financial statements include all normal and recurring adjustments necessary for the fair statement of the results for the interim periods presented. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2023. The consolidated financial statements as of and for the three and nine months ended September 30, 2023 and 2022 are unaudited. The balance sheet as of December 31, 2022 is derived from the audited consolidated financial statements as of that date. These financial statements should be read in conjunction with the audited consolidated financial statements and related notes contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 31, 2023 (the “2022 Annual Report”). The accompanying unaudited consolidated financial statements as of and for the three and nine months ended September 30, 2023 and 2022 include the accounts of NightHawk Biosciences, Inc., and its subsidiaries (“the Company”), Pelican Therapeutics, Inc. (“Pelican”), Heat Biologics I, Inc. (“Heat I”), Heat Biologics III, Inc. (“Heat III”), Heat Biologics IV, Inc. (“Heat IV”), Heat Biologics GmbH, Heat Biologics Australia Pty Ltd., Zolovax, Inc., Skunkworx Bio, Inc. (formerly known as Delphi Therapeutics, Inc.), Scorpius BioManufacturing, Inc. (“Scorpius”) (formerly Scorpion Biological Services, Inc), Blackhawk Bio, Inc., Abacus Biotech, Inc., and Elusys Therapeutics, Inc. (“Elusys”). The functional currency of the entities located outside the United States of America (the foreign entities) is the applicable local currency of the foreign entities. Assets and liabilities of the foreign entities are translated at period-end exchange rates. Statement of operations accounts are translated at the average exchange rate during the period. The effects of foreign currency translation adjustments are included in other comprehensive loss, which is a component of accumulated other comprehensive income in stockholders’ equity. All significant intercompany accounts and transactions have been eliminated in consolidation. At September 30, 2023 and December 31, 2022, NightHawk held an 85% controlling interest in Pelican and a 94% controlling interest in Scorpius. NightHawk accounts for its less than 100% interest in accordance with U.S. GAAP. Accordingly, the Company presents non-controlling interest as a component of stockholders’ equity on its consolidated balance sheets and reports non-controlling interest net loss under the heading “net loss – non-controlling interest” on its consolidated statements of operations and comprehensive loss. In September 2023, the Company commenced the active marketing for the sale of Elusys Therapeutics, Inc. The divestiture has not been consummated as of September 30, 2023 however, the Company has reflected Elusys Therapeutics, Inc. as a discontinued operation in the consolidated financial statements for all periods presented. See Note 2 for further discussion. Unless otherwise noted, amounts and disclosure throughout the Notes to the consolidated financial statements are related to the Company’s continuing operations. Going Concern Uncertainty The Company has an accumulated deficit of approximately $249.0 million as of September 30, 2023 and a net loss before income taxes from continuing operations of approximately $35.3 million for the nine months ended September 30, 2023 and has not generated significant revenue or positive cash flows from operations. The Company expects to incur significant expenses and continued losses from operations for the foreseeable future. The Company expects its expenses to increase in connection with its ongoing activities, particularly as the Company ramps up operations in its in-house bioanalytic, process development and manufacturing facility in San Antonio, TX, which is now its main focus. In addition, any new business ventures that the Company may engage in are likely to require commitments of capital. Accordingly, the Company will need to obtain substantial additional funding in connection with its planned operations. Adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital when needed or on attractive terms, it would be forced to delay, reduce or eliminate its programs, any future commercialization efforts or the manufacturing services it plans to provide. To meet its capital needs, the Company intends to continue to consider multiple alternatives, including, but not limited to, additional equity financings such as sales of its common stock under at-the-market offerings, debt financings, partnerships, grants, funding collaborations and other funding transactions, if any are available. As of September 30, 2023, the Company had approximately $6.2 million in cash and cash equivalents and short-term investments, which it believes is sufficient to fund its operations into the first quarter of 2024. The Company will need to generate significant revenues to achieve profitability, and it may never do so. As a result of these circumstances, management has determined that there is substantial doubt about the Company's ability to continue as a going concern within one year after the consolidated interim financial statements are issued. Risk and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of regulatory approval of the Company’s drug candidates or its manufacturing facility, the timing of completion of construction of the planned manufacturing facility in Kansas, uncertainty of market acceptance of the Company’s products or manufacturing capability or success of new business ventures, competition from substitute products and larger companies, government budget and spending on biological threat programs, securing and protecting proprietary technology, strategic relationships and dependence on key individuals and sole source suppliers. New risks and uncertainties may develop and it is not possible for us to predict all such risk factors, nor can we assess the effect of all such risk factors on our business. The Company depends on third-party suppliers for key materials and services used in its manufacturing processes, and is subject to certain risks related to the loss of these third-party suppliers or their inability to supply adequate materials and services. Cash and Cash Equivalents The Company considers all cash and other highly liquid investments with initial maturities from the date of purchase of three months or less to be cash and cash equivalents. Derivative Financial Instruments The Company has issued common stock warrants in connection with the execution of certain equity financings. The fair value of the warrants, which were deemed to be derivative instruments, was recorded as a derivative liability under the provisions of Accounting Standards Codification (“ASC”) Topic 815, Derivatives and Hedging (“ASC 815”) The fair value of the warrants, including the warrants issued in connection with the January 2020 common stock offering and recorded as a liability, was determined using the Monte Carlo simulation model, which is deemed to be an appropriate model due to the terms of the warrants issued. The fair value of warrants was affected by changes in inputs to the Monte Carlo simulation model including the Company’s stock price, expected stock price volatility, the remaining term, and the risk-free interest rate. This model uses Level 3 inputs, including stock price volatility, in the fair value hierarchy established by ASC 820 Fair Value Measurement Short-term Investments The Company’s short-term investments are equity securities and are carried at their fair value based on quoted market prices. Realized and unrealized gains and losses on equity securities are included in net earnings in the period earned or incurred. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Estimates are used for, but not limited to, useful lives of fixed assets, contingent consideration, income taxes, revenue, and stock-based compensation. Actual results may differ from those estimates. Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed the operations and managed the business as one segment. Business Combinations The accounting for the Company’s business combinations consists of allocating the purchase price to tangible and intangible assets acquired and liabilities assumed based on their estimated fair values, with the excess recorded as goodwill. The Company has up to one year from the acquisition date to use information as of each acquisition date to adjust the fair value of the acquired assets and liabilities, which may result in material changes to their recorded values with an offsetting adjustment to goodwill. Determining the fair value of assets acquired and liabilities assumed requires significant judgment, which includes, among other factors, analysis of historical performance and estimates of future performance. The Company has used discounted cash flow analyses, which were based on its best estimate of future revenue, earnings and cash flows as well as its discount rate, adjusted for risk, and estimated attrition rates. Goodwill and Intangible Assets The Company classifies intangible assets into three categories: (1) intangible assets with definite lives subject to amortization, (2) intangible assets with indefinite lives not subject to amortization and (3) goodwill. The Company determines the useful lives of definite-lived intangible assets after considering specific facts and circumstances related to each intangible asset. Factors the Company considers when determining useful lives include the contractual term of any agreement related to the asset, the historical performance of the asset, and other economic facts; including competition and specific market conditions. Intangible assets that are deemed to have definite lives are amortized, primarily on a straight-line basis, over their estimated useful lives. Intangible assets that are deemed to have indefinite lives, including goodwill, are reviewed for impairment annually, or more frequently if events or changes in circumstances indicate that the asset might be impaired. The impairment test for indefinite-lived intangibles, other than goodwill, consists of a comparison of the fair value of the intangible asset with its carrying amount. If the carrying amount exceeds the fair value, an impairment charge is recognized in an amount equal to that excess. Indefinite-lived intangible assets, such as goodwill, are not amortized. The Company tests the carrying amounts of goodwill for recoverability on an annual basis or when events or changes in circumstances indicate a potential impairment exists, using a fair value-based test. The Company records a goodwill impairment charge if a reporting unit’s carrying value exceeds its fair value. In-process research and development (“IPR&D”) assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development projects. IPR&D assets represent the fair value assigned to technologies that the Company acquires, which at the time of acquisition have not reached technological feasibility and have no alternative future use. During the period that the assets are considered indefinite-lived, they are tested for impairment on an annual basis, or more frequently if the Company becomes aware of any events occurring or changes in circumstances that indicate that the fair value of the IPR&D assets are less than their carrying amounts. If and when development is complete, which generally occurs upon regulatory approval and the ability to commercialize products associated with the IPR&D assets, these assets are then deemed definite-lived and are amortized based on their estimated useful lives at that point in time. If development is terminated or abandoned, the Company may have a full or partial impairment charge related to the IPR&D assets, calculated as the excess of the carrying value of the IPR&D assets over fair value. Contingent Consideration Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations. The Company estimates the fair value of the contingent consideration as of the acquisition date using the estimated future cash outflows based on the probability of meeting future milestones. The milestone payments will be made upon the achievement of clinical and commercialization milestones as well as single low digit royalty payments and payments upon receipt of sublicensing income. Subsequent to the date of acquisition, the Company reassesses the actual consideration earned and the probability-weighted future earn-out payments at each balance sheet date. Any adjustment to the contingent consideration liability will be recorded in the consolidated statements of operations and comprehensive loss, for the change that occurred during the fiscal year. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded under long term liabilities in the consolidated balance sheets. Contingent consideration is included in discontinued operations on the consolidated balance sheet. Cost of revenues and selling, general and administrative expenses Cost of revenues consists of production wages, material costs and overhead, and other costs related to the recognition of revenue. Selling, general and administrative expenses consist of salaries and related costs for administrators, public company costs, business development personnel as well as legal, patent-related expenses and consulting fees. Public company costs include compliance, auditing services, tax services, insurance and investor relations. Research and Development Research and development includes costs associated with developmental products not yet approved by the FDA as well as costs associated with bringing developmental products into advanced phase clinical trials as incurred. These costs consist primarily of pre-manufacturing and manufacturing drug costs, clinical trial execution, investigator payments, license fees, salaries, stock-based compensation and related personnel costs. Other costs include fees paid to consultants and outside service providers related to the development of the Company’s product candidates and other expenses relating to the design, development, testing and enhancement of its product candidates. Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely method based on historical experience as well as applicable information currently available. Product Sales The Company recognizes revenue from product sales when its performance obligation with its customers has been satisfied. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of the product, which is typically upon acceptance of the product at the delivery site. The Company invoices its customers after acceptance of the product and invoice payments are generally due within 30 days of the invoice date. The Company records product sales net of any variable consideration, including refund rights. The Company uses the most likely amount method when estimating its variable consideration, unless terms are specified within contracts. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates to reflect known changes. Grant Revenue The Company recognized revenue from a grant related to the Cancer Prevention and Research Institute of Texas (“CPRIT”) contract, which was accounted for under ASU No. 2018-08, Not-For-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made, The CPRIT grant covered the period from June 1, 2017 through May 31, 2023, for a total grant award of up to $15.2 million. CPRIT advanced grant funds upon request by the Company consistent with the agreed upon amounts and schedules as provided in the contract. The first tranche of funding of $1.8 million was received in May 2017, a second tranche of funding of $6.5 million was received in October 2017, and the third tranche of funding of $5.4 million was received in December 2019. The remaining $1.5 million was received in April 2023. Funds received were reflected in deferred revenue as a liability until revenue was earned. Grant revenue was recognized when qualifying costs are incurred. When grant funds were received after costs had been incurred, the Company recorded revenue and a corresponding grants receivable until grant funds were received. As of September 30, 2023, all $15.2 million has been recognized and received. License revenue The Company has licensed certain provisional patent applications and know-how related to fusion proteins to treat cancer and other diseases that were not being developed by the Company. Shattuck Labs, Inc. (“Shattuck”) paid the Company an initial license fee of $50,000 in June 2016 and is obligated to pay the Company fees upon its receipt of sublicensing income, achievement of certain milestones, and royalties upon sales of commercial products. In March 2023, the Company received a milestone payment of $100,000 from Shattuck due to completion of a Phase 1A monotherapy dose escalation clinical trial of SL-172154. However, the technology that the Company out-licensed remains in the early stages of development since there is a low likelihood of success for any technology at such stage, there can be no assurance that any products will be developed by Shattuck or that the Company will derive any additional future revenue from Shattuck. Process development revenue Process development revenue generally represents revenue from services associated with the custom development of a manufacturing process and analytical methods for a customer’s product. Process development revenue is recognized over time utilizing an input method by tracking the progress toward completion by measuring inputs to date relative to total estimated inputs needed to satisfy the performance obligation. Under a process development contract, the customer owns the product details and process, which has no alternative use. These process development projects are customized to each customer to meet its specifications and typically include only one performance obligation. Each process represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of its product as the product is being created or enhanced by our services and can make changes to its process or specifications upon request. Under these agreements, the Company is entitled to consideration for progress to date that includes an element of profit margin. The transaction price for services provided under the Company’s contracts reflects its best estimate of the amount of consideration to which it is entitled in exchange for providing goods and services to our customers. For contracts with multiple performance obligations, the Company allocates transaction price to each performance obligation identified in a contract on a relative standalone selling price basis. If observable standalone selling prices are not available, the Company estimates the applicable standalone selling price based on the pricing of other comparable services or on a price that the Company believes the market is willing to pay for the applicable service. In determining the transaction price, the Company also considered the different sources of variable consideration including, but not limited to, discounts, credits, refunds, price concessions or other similar items. The Company has included in the transaction price some or all of an amount of variable consideration, utilizing the most likely method, only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The actual amount of consideration ultimately received may differ. Deferred Revenue Deferred revenue is comprised of an exclusive license agreement with Shattuck and process development customer deposits received in advance of our fulfillment of performance obligations. License Agreements The Company has licensed certain provisional patent applications and know-how related to fusion proteins to treat cancer and other diseases that were not being developed by the Company. Shattuck paid the Company an initial license fee of $50,000 in June 2016 and is obligated to pay the Company fees upon its receipt of sublicensing income, achievement of certain milestones, and royalties upon sales of commercial products. In-as-much as the technology that the Company out-licensed remains in the early stages of development since there is a low likelihood of success for any technology at such stage, there can be no assurance that any products will be developed by Shattuck or that the Company will derive any additional future revenue from Shattuck. Process Development Process development deferred revenue generally represents customer payments received in advance of the Company’s fulfillment of performance obligations associated with the custom development of a manufacturing process and analytical methods for a customer’s product. As of September 30, 2023, there was $4.1 million of deferred revenue related to process development. Accounts Receivable Accounts receivable are primarily comprised of amounts owed to us for services and sales provided under our customer contracts and are recorded at the invoiced amount net of an allowance for doubtful accounts, if necessary. The Company applies judgment in assessing the ultimate realization of our receivables and we estimate an allowance for doubtful accounts based on various factors, such as the aging of our receivables, historical experience, and the financial condition of our customers. Prepaid Expenses and Other Current Assets The Company’s prepaid expenses and other current assets consist primarily of amounts paid in advance for manufacturing activities, clinical trial support, contract assets and insurance. Contract assets consist of unbilled receivables. Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance to the extent that utilization is not presently more likely than not. Other Assets The balance consists of $0.5 million of land option agreements for the Kansas facility. Other Liabilities In conjunction with the acquisition of Elusys, the Company recorded an uncertain tax position reserve for the research and development credits utilized on the Elusys pre-acquisition short period 2022 return. The Company is not able to assert that the credit amounts utilized are more likely than not to be sustained by the IRS upon audit and thus a liability of $1.0 million was recorded and is included in discontinued operations on the consolidated balance sheet. Discontinued Operations In accordance with ASC Subtopic 205-20, Presentation of Financial Statements Assets classified as held for sale that are not sold after the initial one-year period are assessed to determine if they meet the exception to the one-year requirement to continue being classified as held for sale. The disposal group that is held for sale is the Elusys Therapeutics, Inc. subsidiary. Significant Accounting Policies The significant accounting policies used in preparation of these interim financial statements are disclosed in the audited consolidated financial statements and related notes included in the Company’s 2022 Annual Report. Impact of Recently Adopted Accounting Standards In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments (ASU 2016-13), which amends the impairment model by requiring entities to use a forward looking approach based on expected losses to estimate credit losses on certain types of financial instruments, including trade receivables. For trade receivables and other instruments, entities will be required to use a new forward-looking expected loss model that generally will result in the earlier recognition of allowances for losses. The Company adopted ASU 2016-13 as of January 1, 2023. The cumulative effect of applying the new credit loss standard was not material and, therefore, did not result in an adjustment to retained earnings. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements or related financial statement disclosures. |
Discontinued Operations
Discontinued Operations | 9 Months Ended |
Sep. 30, 2023 | |
Discontinued Operations | |
Discontinued Operations | 2. Discontinued Operations The Company considers assets to be held for sale when management approves and commits to a plan to actively market the assets for sale at a reasonable price in relation to its fair value, the assets are available for immediate sale in their present condition, an active program to locate a buyer and other actions required to complete the sale have been initiated, the sale of the assets is expected to be completed within one year and it is unlikely that significant changes will be made to the plan. Upon designation as held for sale, the Company ceases to record depreciation and amortization expenses and measures the assets at the lower of their carrying value or estimated fair value less costs to sell. Assets held for sale are included in the Company’s consolidated balance sheets. Gains and losses are not recognized until the date of sale and will be recognized in income (loss) from operating activities. As of September 30, 2023, the Company’s activities with regard to the divesture of the Elusys Therapeutics business met the criteria to report within discontinued operations. The Company has reclassified its previously issued financial statements to segregate the discontinued operations as of the earliest period presented. The Company evaluated its intangible asset and goodwill for impairment under ASC 360-10, Impairment or disposal of long-lived assets Intangibles—Goodwill and Other. Assets and liabilities classified as held for sale in the Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022 relate to the planned divestiture of the Elusys Therapeutics business and consist of the following: Assets of discontinued operations: September 30, 2023 December 31, 2022 Current assets: Cash and cash equivalents $ 3,319,793 $ 5,242,840 Accounts receivable 6,699,200 — Income tax refund receivable — 600,877 Prepaid expenses and other current assets 72,432 2,084,419 Intangible assets, net 5,300,204 — Other assets 1,002,904 — Total Current Assets 16,394,533 7,928,136 Long term assets: Property and equipment, net — 41,853 Intangible assets, net — 8,669,375 Goodwill — 3,301,959 Operating lease right-of-use asset — 138,885 Deposits — 26,251 Total long term assets — 12,178,323 Total assets held for sale $ 16,394,533 20,106,459 Liabilities held for sale: Current liabilities: Accounts payable $ 800,258 $ 210,321 Accrued expenses and other liabilities 475,618 2,385,319 Contingent consideration, current portion 11,946,916 6,934,115 Operating lease liability, current portion — 92,524 Other liabilities 1,002,904 — Total current liabilities $ 14,225,696 $ 9,622,279 Long term liabilities: Contingent consideration, net of current portion — 5,290,500 Total long term liabilities — 5,290,500 Total liabilities held for sale $ 14,225,696 $ 14,912,779 The Company determined that the disposal group represents a strategic shift that will have a major effect on the Company's operations and financial results, and has therefore reflected the Elusys Therapeutics business as a discontinued operation for all periods presented. Details of the loss from discontinued operations included in our consolidated statement of operations are as follows: Three Months Ended Nine Months Ended, September 30, September 30, 2023 2022 2023 2022 Revenue $ 6,699,200 $ 5,980,994 $ 6,699,200 6,012,993 Operating expenses: Cost of revenues 2,161,601 6,319,723 2,161,601 6,319,723 Research and development 1,026,483 1,524,748 2,191,796 2,230,373 Selling, general and administrative 335,851 276,018 1,147,730 481,877 Amortization of intangible asset 363,750 316,875 1,091,250 666,875 Goodwill impairment loss 3,873,079 — 3,873,079 — Intangible asset impairment loss 2,277,921 — 2,277,921 — Change in fair value of contingent consideration (286,855) — (177,354) — Total operating expenses 9,751,830 8,437,364 12,566,023 9,698,848 Loss from operations (3,052,630) (2,456,370) (5,866,823) (3,685,855) Other expense, net 12,053 (244,576) 18,603 (245,929) Total non-operating income (loss) 12,053 (244,576) 18,603 (245,929) Net loss from discontinued operations before income taxes (3,040,577) (2,700,946) (5,848,220) (3,931,784) Income tax expense from discontinued operations (65,189) — (65,189) — Net loss from discontinued operations $ (3,105,766) $ (2,700,946) $ (5,913,409) $ (3,931,784) |
Acquisitions
Acquisitions | 9 Months Ended |
Sep. 30, 2023 | |
Acquisitions | |
Acquisitions | 3 Pelican Therapeutics In 2017, the Company consummated the acquisition of 80% of the outstanding equity of Pelican, a related party, and Pelican became a majority owned subsidiary of the Company. During the quarter ended March 31, 2018, cash consideration of approximately $300,000 was distributed to the participating Pelican stockholders and the remainder of approximately $200,000 for certain Pelican liabilities not satisfied was recognized as other income in the statements of operations and comprehensive loss for the period. In October 2018, the Company entered into an agreement with the University of Miami (“UM”) whereby UM exchanged its shares of stock in the Company’s subsidiaries, Heat I, Inc. and Pelican. The stock exchange resulted in the Company increasing its controlling ownership in Pelican from 80% to 85%. Under the agreement, the Company was also obligated to make future payments based on the achievement of certain clinical and commercialization milestones, as well as low single digit royalty payments and payments upon receipt of sublicensing income. However, due to the discontinuation of PTX-35 no future milestone payments are expected to be made. The goodwill and in-process R&D resulting from the acquisition were fully impaired as of December 31, 2022. Elusys Therapeutics On April 18, 2022 (“Closing Date”), the Company closed on the acquisition of Elusys. The Company paid at the closing a cash upfront payment of $3,000,000 to the former owners (“Sellers”) of Elusys. The Company was obligated to pay the Sellers $2,000,000 of deferred cash consideration (“Merger Consideration”) at the same time that the payment of the receivable consideration was to be distributed to the Sellers as described below, which was paid in the second quarter of 2022. Earn out payments will be paid to the Sellers for a period of 12 years from the date of the closing equal to 10% of the gross dollar amount of payments received during each one year period during such twelve year period with respect to any sale, license or commercialization anywhere in the world of ANTHIM® that either: (a) occurs during the first nine years after the Closing Date in any respect; or (b) occurs thereafter pursuant to any contract, agreement, commitment or order that is placed, granted, awarded, or entered into during the first nine years after the Closing Date. Per the merger agreement that was executed in connection with the acquisition of Elusys (the “Merger Agreement”), upon collection of the Elusys contract receivables of $24.5 million, The Company is obligated to remit payment of $22.3 million (the “Receivable Consideration”) to the Sellers. In April 2022, $20.8 million was remitted to the Sellers less a hold back of $1.5 million related to future fulfillment cost. Elusys is expected to receive additional revenue from the future fulfillment of an existing U.S. Government contract, and the Company agreed to fulfill the future obligations of Elusys under such contract and pass through and distribute to the Sellers the payments received under such contract minus the costs associated with such fulfillment obligations, subject to certain adjustments to the Merger Consideration specified in the Merger Agreement, including income taxes payable with respect to such payments (the “Contract Deferred Consideration”). The Merger Agreement further provides that 80% of any amounts paid to and received by Elusys (the “Additional Earn Out”) after the Closing Date and prior to June 30, 2023, shall be paid to the Sellers, subject to certain adjustments specified in the Merger Agreement. The Company acquired Elusys to expand its role in the biodefense space, complementing its focus to target emerging biological threats. The Company initially expected to leverage the capabilities of its Scorpius biomanufacturing facility in Manhattan, Kansas, to manufacture Elusys’s therapies internally and therefore benefit from significant operating synergies, cost savings, as well as enhanced oversight, quality control, and speed to market. However, the Company is unable to manufacture the Elusys’ therapies internally. In addition, the Company has been unable to generate sufficient revenue from its current manufacturing facility or raise sufficient capital to enable it to build the biomanufacturing facility in Manhattan, Kansas and instead has been required to place contract with third parties for the manufacture of the Elusys’ therapies. See Note 15-Commitments and Contingencies. The fair value of the purchase consideration was approximately $42.9 million. The purchase consideration consists of $3.0 million in cash and $2.0 million in deferred cash consideration, and the estimated fair value of the contingent and deferred consideration liabilities related to the receivable consideration, contract deferred consideration, earn out and additional earn out totaling $37.9 million. The valuation of the contract deferred consideration and earn out liabilities were valued using a discounted cash flow analysis that utilized discount rates of 24% and 14%, respectively. The value of the additional earn out liability was calculated as 80% of the estimated gross sales price of 1,500 pre-filled vials of ANTHIM®, less estimated fulfillment costs to be incurred. The value of the receivable consideration was equal to the value of the contract receivables acquired, less holdback expenses, as this liability was settled within 30 days of the Closing Date . The acquisition of Elusys was accounted for as a business combination and reflects the application of acquisition accounting in accordance with ASC 805, Business Combinations. The acquired Elusys’ assets, including identifiable intangible assets and liabilities assumed, have been recorded at their fair values with the excess purchase price assigned to goodwill. The recognition of goodwill is largely attributed to the value paid for Elusys’ capabilities, which will broaden NightHawk’s role in the biodefense space. The goodwill recorded for this transaction is valued at $3.9 million and will be deductible for tax purposes over 15 years . The purchase price of $42.9 million has been allocated to the underlying assets and liabilities based on their fair value at the date of acquisition. The excess of the purchase price over the fair value of assets acquired and liabilities assumed was recorded as goodwill: Aggregate consideration: Cash consideration $ 3,000,000 Deferred cash consideration 2,000,000 Earn out 5,900,000 Additional earn out 4,735,000 Receivable consideration 22,318,685 Contract deferred consideration 4,900,000 Total purchase consideration $ 42,853,685 The purchase price allocation resulted in the following amounts being allocated to the assets acquired and liabilities assumed as of the closing date based on their respective fair values summarized below: Purchase price allocation: Cash and cash equivalents $ 5,719,899 Contract receivables 24,526,232 Prepaid expenses and other current assets 1,818,278 Inventory 5,844,000 Intangible asset – definite-lived (Note 7) 9,700,000 Property and equipment 50,224 Operating lease right of use assets 352,906 Other assets 1,329,153 Total assets acquired 49,340,692 Accounts payable (204,794) Accrued expenses and other current liabilities (5,155,363) Operating lease obligations (352,906) Deferred income tax liability (3,644,120) Other liabilities (1,002,904) Total liabilities assumed (10,360,087) Net assets acquired and liabilities assumed 38,980,605 Goodwill 3,873,080 Total purchase consideration $ 42,853,685 From the Elusys acquisition date through September 30, 2022, $6.0 million of total revenue and a net loss before income taxes of $2.7 million associated with Elusys operations are included discontinued operations in the condensed consolidated statements of operations and comprehensive loss for the three months ended September 30, 2022. $6.0 million of total revenue and a net loss before income taxes of $3.9 million associated with Elusys operations are included discontinued operations in the condensed consolidated statements of operations and comprehensive loss for the nine months ended September 30, 2022. The following unaudited pro forma financial information assumes the companies were combined as of January 1, 2021. The unaudited pro forma financial information as presented below is for informational purposes only and is based on estimates and assumptions that have been made solely for purposes of developing such pro forma information. This is not necessarily indicative of the results of operations that would have been achieved if the acquisition had taken place on January 1, 2021, nor is it necessarily indicative of future results. Consequently, actual results could differ materially from the unaudited pro forma financial information presented below. The following table presents the pro forma operating results as if Elusys had been included in the Company’s Consolidated Statements of Operations and Comprehensive Loss as of January 1, 2021 (unaudited): Three months ended Nine months ended September 30, September 30, 2022 2022 (unaudited) (unaudited) Revenue $ 29,347,513 $ 29,892,585 Net loss $ (1,296,510) $ (21,282,125) Net income (loss) per share, basic and diluted $ (0.05) $ (0.83) |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 4. Fair Value of Financial Instruments The carrying amount of certain of the Company’s financial instruments, including cash and cash equivalents, accounts payable and accrued expenses and other payables approximate fair value due to their short maturities. As a basis for determining the fair value of certain of the Company’s financial instruments, the Company utilizes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level I – Observable inputs such as quoted prices in active markets for identical assets or liabilities. Level II – Observable inputs, other than Level I prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level III – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This hierarchy requires the Company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the entire fair value measurement requires management to make judgments and consider factors specific to the asset or liability. The Company’s cash equivalents are classified within Level I of the fair value hierarchy. The Company’s short-term investments consist of Level I securities which are comprised of highly liquid money market funds. The estimated fair value of the short-term investments was based on quoted market prices. There were no transfers between fair value hierarchy levels during the quarters ended September 30, 2023 or 2022. In January 2020, the Company issued warrants in connection with the public offering of common stock (the “January 2020 Warrants”). Pursuant to the terms of these warrants, the warrants were not considered indexed to the Company’s own stock and therefore are required to be measured at fair value and reported as a liability in the consolidated balance sheets. Additionally, upon the closing of the January 2020 offering, 479,595 outstanding warrants were evaluated for whether they were modified for accounting purposes, and it was determined that they were required to be classified as a liability. The fair value of the warrant liability is based on the Monte Carlo methodology. The Company is required to revalue the warrants at each reporting date with any changes in fair value recorded in our consolidated statements of operations and comprehensive loss. The valuation of the warrants is classified under Level 3 of the fair value hierarchy due to the need to use assumptions in the valuation that are both significant to the fair value measurement and unobservable. In order to calculate the fair value of the warrants, certain assumptions were made, including the selling price or fair market value of the underlying common stock, risk-free interest rate, volatility, and remaining life. Changes to the assumptions could cause significant adjustments to valuation. The Company estimated a volatility factor utilizing its own data. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for treasury securities of similar maturity. The following table presents quantitative information about the inputs used in the valuation for the Company’s fair value measurement of the warrant liability classified as Level 3: September 30, 2023 December 31, 2022 Current stock price $ 0.53 $ 0.81 Estimated volatility of future stock price 59.02 % 80.94 % Risk free interest rate 5.55 % 4.75 % Contractual term 0.16 years 0.90 years As of September 30, 2023, there were a total of 9,357 warrants outstanding that are subject to quarterly revaluation with a fair value of $0. The fair value of financial instruments measured on a recurring basis is as follows: As of September 30, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 4,167,755 $ 4,167,755 $ — $ — As of December 31, 2022 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 35,837,309 $ 35,837,309 $ — $ — The following tables summarize the change in fair value, as determined by Level 3 inputs, for all assets and liabilities using unobservable Level 3 inputs for the three and nine months ended September 30, 2023 and 2022: Elusys Contingent Elusys Contingent Consideration: Consideration Balance at June 30, 2023 $ 12,334,115 Payment of contingent consideration (100,344) Change in fair value (286,855) Reclassification to held for sale (11,946,916) Balance at September 30, 2023 $ — Elusys Contingent Elusys Contingent Consideration: Consideration Balance at December 31, 2022 $ 12,224,614 Payment of contingent consideration (100,344) Change in fair value (177,354) Reclassification to held for sale (11,946,916) Balance at September 30, 2023 $ — Pelican Contingent Warrant Consideration Liability Balance at June 30, 2022 $ 3,118,515 $ 1,730 Change in fair value (3,118,515) (1,456) Balance at September 30, 2022 $ — $ 274 Pelican Contingent Warrant Consideration Liability Balance at December 31, 2021 $ 3,342,515 $ 11,020 Change in fair value (3,342,515) (10,746) Balance at September 30, 2022 $ — $ 274 The change in the fair value of the contingent consideration of $(0.3) million and $(3.1) million for the three months ended September 30, 2023 and 2022, respectively, was primarily due to the change in timing and amount of the contract deferred consideration. The change in the fair value of the contingent consideration of $(0.2) million and $(3.3) million for the nine months ended September 30, 2023 and 2022, respectively, was primarily due to the change in timing and amount of the contract deferred consideration. Adjustments associated with the change in fair value of contingent consideration are included in the Company’s consolidated statements of operations and comprehensive loss. The following table presents quantitative information about the inputs and valuation methodologies used for the Company’s fair value measurements of contingent consideration classified as Level 3 (which have now been reclassified to liabilities held for sale in our consolidated balance sheets) as of September 30, 2023 and December 31, 2022: As of September 30, 2023 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Elusys revenue earn-out Discounted cash flow analysis Timing of expected payments 2026-2029 Discount rate 14.0% Future revenue projections $ 141.4 million As of December 31, 2022 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Elusys revenue earn-out Discounted cash flow analysis Timing of expected payments 2025-2036 Discount rate 24.5% Future revenue projections $ 325.9 million Elusys deferred contract consideration Discounted cash flow analysis Timing of expected payments 2023 Discount rate 15.5% Future revenue projections $ 7.6 million The Company records certain non-financial assets on a non-recurring basis, including goodwill and in-process R&D. This analysis requires significant judgments, including primarily the estimation of future development costs, the probability of success in various phases of its development programs, potential post-launch cash flows and a risk-adjusted weighted average cost of capital. The September 30, 2023 deferred contract consideration was valued using the estimated actual expected payout. The triggering event for payment to prior Elusys shareholders is the receipt of funds from the US Government. This amount is in accounts receivable, discontinued operations, at September 30, 2023. |
Short-Term Investments
Short-Term Investments | 9 Months Ended |
Sep. 30, 2023 | |
Short-Term Investments. | |
Short-Term Investments | 5. Short-Term Investments Short-term investments consist of equity securities. The Company holds its securities at fair value as of September 30, 2023 and December 31, 2022. Unrealized gains and losses on securities are reported in the other expense line item in the statements of operations and comprehensive loss. Short-term investments at September 30, 2023 and December 31, 2022 consisted of mutual funds with fair values of $4.2 million and $35.8 million, respectively. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expenses And Other Current Assets. | |
Prepaid Expenses and Other Current Assets | 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following at: September 30, December 31, 2023 2022 Prepaid manufacturing expense $ 475,536 $ 91,477 Contract assets 363,918 — Other prepaid expenses and current assets 280,787 1,132,502 Prepaid insurance 104,126 201,252 Prepaid preclinical and clinical expenses 36,861 65,892 $ 1,261,228 $ 1,491,123 |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2023 | |
Property and Equipment | |
Property and Equipment | 7. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the shorter of their estimated useful lives or remaining lease term, ranging generally from three Property and equipment consist of the following: September 30, December 31, 2023 2022 Lab equipment $ 21,080,029 $ 18,060,058 Leasehold improvements 2,827,289 2,486,329 Construction-in-process — 2,053,335 Computers 850,211 502,084 Furniture and fixtures 277,882 245,770 Vehicles — 44,562 Total 25,035,411 23,392,138 Accumulated depreciation (6,351,513) (2,953,617) Property and equipment, net $ 18,683,898 $ 20,438,521 Depreciation expense was $1.2 million and $3.4 million for the three and nine months ended September 30, 2023, respectively, and $0.4 million and $0.7 million for the three and nine months ended September 30, 2022, respectively. |
Goodwill and Other Intangible A
Goodwill and Other Intangible Assets | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Other Intangible Assets | |
Goodwill and Other Intangible Assets | 8. The Company performs an annual impairment test at the reporting unit level as of April 1st of each fiscal year or more frequently when an event occurs or circumstances change that indicate the carrying value may not be recoverable. Pelican Goodwill and In-Process R&D Goodwill of $2.2 million and in-process R&D of $5.9 million were recorded in connection with the acquisition of Pelican, as described in Note 3 and have been allocated to the Pelican reporting unit. During the fourth quarter of 2021, due to a sustained decline in the quoted market price of its common stock, the Company performed an interim impairment analysis using the income approach and in-process R&D with a total carrying value of $5.9 million was written down to its estimated fair value of $3.5 million and an impairment charge of $2.4 million during the fourth quarter of 2021 was recorded and goodwill in the amount of $1.5 million was fully impaired. During the third quarter of 2022, the Company elected to terminate any further development of PTX-35. As a result of the termination, the in-process R&D affiliated with PTX-35, in the amount of $3.5 million, was fully impaired. Elusys Goodwill and Intangible Assets Goodwill of $3.9 million and an intangible asset of $9.7 million were recorded in connection with the acquisition of Elusys which has been allocated to the Elusys reporting unit. During the fourth quarter of 2022, due to a sustained decline in the quoted market price of its common stock, the Company performed an interim goodwill impairment analysis using the income approach. However, through its quantitative analysis, the Company determined the carrying value was not in excess of its estimated fair value and therefore no impairment charge was recorded at December 31, 2022. The Company’s annual impairment analysis was performed on April 1, 2023 using the income approach that determined the carrying value remained not in excess of its estimated fair value and, therefore, no impairment charge was necessary. The Company evaluated its intangible asset and goodwill for impairment under ASC 360-10, Impairment or disposal of long-lived assets and ASC 350, Intangibles—Goodwill and Other . As a result, goodwill was fully impaired by $3.9 million and intangible assets were partially impaired by $2.3 million. Elusys’ intangible asset relates to the ANTHIM® formulation and was amortized over its remaining patent life of approximately 80 months . The intangible asset is no longer being amortized now that is included in discontinued operations. The change in the carrying amount of goodwill and intangible assets during the nine months ended September 30, 2023 is as follows: Intangible Goodwill Assets Balance at December 31, 2022 $ 3,301,959 $ 8,669,375 Impairment (3,873,079) (2,277,921) Acquisition fair value adjustments 571,120 — Amortization of intangible asset — (1,091,250) Reclassified to discontinued operations — (5,300,204) Balance at September 30, 2023 $ — $ — The Company finalized the purchase price allocation for the Elusys acquisition in April 2023 and recorded a measurement period adjustment that increased goodwill by approximately $0.6 million, increased other assets by $1.0 million, increased the liability for uncertain tax positions by $1.0 million and increased the deferred tax liability by the $0.6 million (see Note 13). |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses and Other Liabilities | |
Accrued Expenses and Other Liabilities | 9. Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consist of the following: September 30, December 31, 2023 2022 Accrued marketing expenses $ 749,998 $ — Accrued preclinical and clinical trial expenses 252,618 953,252 Compensation and related benefits 373,211 491,191 Accrued manufacturing expenses 345,646 6,133 Other expenses 240,145 426,025 Accrued franchise tax 70,000 40,000 $ 2,031,618 $ 1,916,601 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | 10. Stockholders’ Equity Common Stock Warrants As of September 30, 2023, the Company had outstanding warrants to purchase 313,358 shares of common stock issuable at a weighted-average exercise price of $11.55 per share. As of December 31, 2022, the Company had outstanding warrants to purchase 747,383 shares of common stock issuable at a weighted-average exercise price of $11.06 per share. The following table summarizes the activity of the Company’s common stock warrants for the nine months ended September 30, 2023. The Company had no common stock warrant activity during the nine months ended September 30, 2022. Common Stock Warrants Outstanding, December 31, 2022 747,383 Expired (434,025) Outstanding, September 30, 2023 313,358 Equity Compensation Plans The Company maintains various equity compensation plans (“Plans”) with substantially similar provisions under which it may award employees, directors and consultants incentive and non-qualified stock options, restricted stock, stock appreciation rights and other stock-based awards with terms established by the Compensation Committee of the Board of Directors which has been appointed by the Board of Directors to administer the plans. Accounting for Stock-Based Compensation: Stock Compensation Expense Stock Options Fair Value Determination The following weighted-average assumptions were used for option grants during the three and nine months ended September 30, 2023 and 2022: ● Volatility – The Company used an average historical stock price volatility from its own data. ● Expected life of options – The expected term represents the period that the Company’s stock option grants are expected to be outstanding. The Company elected to utilize the “simplified” method to estimate the expected term. Under this approach, the weighted-average expected life is presumed to be the average of the vesting term and the contractual term of the option. ● Risk-free interest rate – The rate is based on U.S. Treasury interest rates at the time of the grant whose term is consistent with the expected life of the stock options. ● Dividend yield – The expected dividend yield was considered to be 0% since the Company has not paid any dividends and has no plan to do so in the future. ● Forfeitures – As required by ASC 718, Compensation—Stock Compensation, the Company reviews recent forfeitures and stock compensation expense. The Company accounts for forfeitures as they occur. The following table summarizes weighted-average assumptions used in our calculations of fair value for the nine months ended September 30, 2023 and 2022: 2023 2022 Dividend yield — % — % Expected volatility 101.92 % 102.75 % Risk-free interest rate 2.47 % 2.51 % Expected lives (years) 5.6 years 6.0 years Stock Option Activity – The following is a summary of the stock option activity for the nine months ended September 30, 2023: Weighted Weighted Average Aggregate Average Exercise Intrinsic Remaining Shares Price Value Contractual Life Stock options outstanding at December 31, 2022 7,036,874 $ 3.67 $ 16,842 Expired (102,847) 8.59 Forfeited (214,084) 3.42 Stock options outstanding at September 30, 2023 6,719,943 $ 3.61 $ 10,947 8.3 Years Stock options exercisable at September 30, 2023 3,949,543 $ 4.85 $ 10,947 7.9 Years Unrecognized compensation expense related to unvested stock options was $3.2 million as of September 30, 2023, which is expected to be recognized over a weighted-average period of 1.1 years and will be adjusted for forfeitures as they occur. Restricted Stock The following is a summary of restricted stock award activity for the nine months ended September 30, 2023: Weighted Average Shares Fair Value Restricted stock at December 31, 2022 34,001 $ 3.22 Released (34,001) 3.22 Restricted stock at September 30, 2023 — $ — Restricted Stock Units - Under the Plans, the Company may issue time-based Restricted Stock Units (“RSUs”). RSUs are not actual shares, but rather a right to receive shares in the future. The shares are not issued and the employee cannot sell or transfer shares prior to vesting and has no voting rights until the RSUs vest. The employees' time-based RSUs vest pro-rata over 36 months . The grant date fair value of the RSUs is equal to the closing market price of our common stock on the grant date. The Company recognizes the grant date fair value of RSUs the Company expects to issue as compensation expense ratably over the requisite service period. The following is a summary of restricted stock unit activity for the nine months ended September 30, 2023: Weighted Average Shares Fair Value RSUs at December 31, 2022 — $ — Granted 360,000 1.18 Released (80,000) 1.18 RSUs at September 30, 2023 280,000 $ 1.18 |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2023 | |
Revenue | |
Revenue | 11. Revenue Product sales On April 19, 2022, Elusys entered into a contract with Public Works and Government Services of Canada to deliver 3,000 vials of ANTHIM® (FDA-approved anthrax antitoxin) for treatment of inhalational anthrax due to Bacillus anthrax. The total contract award was $5.9 million with a delivery date on or before September 30, 2022. This order was fulfilled on September 13, 2022 for the total contract amount of $5.9 million, of which after deducting fulfillment expenses, $1.1 million was retained by Elusys and $4.6 million was paid to Seller. This is included in discontinued operations on the consolidated statements of operations and comprehensive loss. On September 13, 2023, Elusys completed the manufacturing conversion of 23,732 vials of ANTHIM® with its contract with the US Department of Health and Human Services for the contract amount of $6.7 million which is included in discontinued operations on the consolidated statements of operations and comprehensive loss. Grant revenue In June 2016, Pelican entered into a cancer research grant contract (or “Grant Contract”) with CPRIT, under which CPRIT awarded a grant not to exceed $15.2 million for use in developing cancer treatments by targeting a novel T-cell costimulatory receptor (namely, TNFRSF25). The grant contract covers a period from June 1, 2016 through November 30, 2020, as amended through May 31, 2023. The first tranche of funding of $1.8 million was received in May 2017, a second tranche of funding of $6.5 million was received in October 2017 and a third tranche of funding of $5.4 million was received in December 2019. The remaining $1.5 million was received in April 2023 after the Company had fulfilled every requirement of the grant and the grant had been approved to be finalized. As of September 30, 2023, all $15.2 million has been recognized and received. There was no grant revenue during the three and nine months ended September 30, 2023 and $0.1 million and $0.3 million of grant revenue during the three and nine months ended September 30, 2022. The grant is subject to customary CPRIT funding conditions including a matching funds requirement where Pelican will match $0.50 for every $1.00 from CPRIT. Consequently, Pelican was required to provide $7.6 million in matching funds over the life of the project. Upon commercialization of the product, the terms of the grant require Pelican to pay tiered royalties in the low to mid-single digit percentages. Such royalties reduce to less than one percent after a mid-single-digit multiple of the grant funds have been paid to CPRIT in royalties. Through September 30, 2023, $15.2 million of grant funding has been recognized as revenue and received. As of December 31, 2022, the Company had a grant receivable balance of $1.5 million for CPRIT proceeds not yet received but for which the costs had been incurred or the conditions of the award have been met. In April, 2023, the final $1.5 million of funding was received. License revenue In June 2016, NightHawk licensed certain provisional patent applications and know-how related to fusion proteins to treat cancer and other diseases with Shattuck. Shattuck paid the Company an initial license fee of $50,000 in June 2016 and is obligated to pay the Company fees upon its receipt of sublicensing income, achievement of certain milestones, and royalties upon sales of commercial products. In March 2023, the Company received a milestone payment of $100,000 from Shattuck due to completion of a Phase 1A monotherapy dose escalation clinical trial of SL-172154. Process development revenue During the three and nine months ended September 30, 2023, the Company recognized $0.6 million and $2.0 million in process development revenue. All process development revenue was primarily derived from two customers who each represented over 10% of the total recognized revenue. These revenues were derived from the contract liability which was recorded in the prior period as deferred revenue. The following table presents changes in contract liabilities for the three months ended September 30, 2023 and 2022: Contract liabilities Balance at June 30, 2023 $ (2,734,524) Changes to the beginning balance arising from: Reclassification to revenue as the result of performance obligations satisfied 638,625 Net change to contract balance recognized since beginning of period due to amounts collected (1,993,247) Balance at September 30, 2023 $ (4,089,146) Contract liabilities Balance at June 30, 2022 $ (35,000) Changes to the beginning balance arising from: Net change to contract balance recognized since beginning of period due to amounts collected (716,350) Balance at September 30, 2022 $ (751,350) The following table presents changes in contract liabilities for the nine months ended September 30, 2023 and 2022: Contract liabilities Balance at December 31, 2021 $ (35,000) Changes to the beginning balance arising from: Net change to contract balance recognized since beginning of period due to amounts collected (1,583,308) Balance at December 31, 2022 (1,618,308) Changes to the beginning balance arising from: Reclassification to revenue as the result of performance obligations satisfied 1,962,303 Net change to contract balance recognized since beginning of period due to amounts collected (4,433,141) Balance at September 30, 2023 $ (4,089,146) The timing of revenue recognition, billings and cash collections results in billed accounts receivable and contract liabilities (customer deposits and deferred revenue). Contract liabilities represent customer deposits and deferred revenue billed and/or received in advance of our fulfillment of performance obligations. Contract liabilities convert to revenue as we perform our obligations under the contract. The opening and closing balances of the Company’s accounts receivables are as follows: Opening on January 1, 2022 $ 66,049 Closing on December 31, 2022 $ 81,456 Closing on September 30, 2023 $ 313,906 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss Per Share | |
Net Loss Per Share | 12. Net Loss Per Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the periods. Fully diluted net loss per common share is computed using the weighted average number of common and dilutive common equivalent shares outstanding during the periods. Common equivalent shares consist of stock options, warrants, and unvested restricted stock that are computed using the treasury stock method. For the three and nine months ended September 30, 2023 and 2022, all of the Company’s common stock options, unvested restricted stock units and warrants are anti-dilutive and therefore have been excluded from the diluted calculation. The following table reconciles net loss to net loss attributable to NightHawk Biosciences, Inc.: For the Three Months Ended For the Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Net loss $ (14,312,029) $ (13,347,771) $ (41,168,866) $ (28,475,479) Net loss - Non-controlling interest (1,179,559) (89,421) (1,359,734) (265,256) Net loss attributable to NightHawk $ (13,132,470) $ (13,258,350) $ (39,809,132) $ (28,210,223) Weighted-average common shares outstanding, basic and diluted 26,050,562 25,613,316 26,022,244 25,603,481 Net loss per share, basic and diluted - continuing operations $ (0.38) $ (0.41) $ (1.30) $ (0.95) Net loss per share, basic and diluted - discontinued operations (0.12) (0.11) (0.23) (0.15) Net loss per common share attributable to NightHawk Biosciences, Inc., basic and diluted $ (0.50) $ (0.52) $ (1.53) $ (1.10) The following potentially dilutive securities were excluded from the calculation of diluted net loss per share during the three and nine months ended September 30, 2023 and 2022 due to their anti-dilutive effect: 2023 2022 Outstanding stock options 6,719,943 3,006,968 Restricted stock subject to forfeiture and restricted stock units 280,000 46,859 Outstanding common stock warrants 313,358 747,383 |
Income Tax
Income Tax | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax | |
Income Tax | 13. Income Tax Income taxes have been computed using the asset and liability method in accordance with ASC 740 “Income Taxes”. The Company computes its interim provision for income taxes by applying the estimated annual effective tax rate method. The Company estimates an annual effective tax rate of 0% for the year ending December 31, 2023. This rate does not include the impact of income tax expense or benefit recognized as discrete items. The total tax expense or (benefit) during the three months ended September 30, 2023 and 2022, was approximately $0.1 million and $(0.04) million, respectively. The total tax expense or (benefit) during the nine months ended September 30, 2023 and 2022, was approximately $(0.5) million and $(3.3) million, respectively. In general, the variation between the Company's quarterly or YTD effective income tax rate and the U.S. statutory rate of 21% is primarily due to: (i) changes in the Company’s valuation allowances against deferred tax assets, and (ii) income tax benefits of $(0.6) million and $(3.0) million recognized as discrete items during the quarters ended June 30, 2023 and June 30, 2022, respectively, related to the purchase accounting for the Elusys Therapeutics, Inc. acquisition. The Company incurred losses for the nine month period ended September 30, 2023 and is forecasting additional losses through the year, resulting in an estimated net loss for both financial statement and tax purposes for the year ending December 31, 2023. Due to the Company’s history of losses, there is not sufficient evidence to record a net deferred tax asset associated with the U.S., Australian, and German operations. Accordingly, a full valuation allowance has been recorded related to the net deferred tax assets in those jurisdictions. U.S. GAAP requires a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is cumulatively more than 50% likely to be realized upon ultimate settlement. As of September 30, 2023, the Company's liability for unrecognized tax benefits was $1.5 million. Of this balance, $1.0 million would affect the Company's effective tax rate if recognized and is included in discontinued operations. The Company’s policy for recording interest and penalties is to record them as a component of income tax expense. For the nine months ended September 30, 2023, the Company accrued interest and penalty related to uncertain tax positions in the total amount of $0.1 million. This amount is included in the total income tax expense or (benefit) from discontinued operations presented in the Consolidated Statements of Operations and Comprehensive Loss. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Leases | 14. Leases The Company accounts for its leases under ASC 842, Leases The Company conducts its operations from leased facilities in Morrisville, North Carolina; San Antonio, Texas; Parsippany, New Jersey and North Brunswick, New Jersey. The North Carolina lease will expire in 2030, the Texas lease will expire in 2037, the Parsippany lease will expire in July 2024 and the New Brunswick leases will expire in July 2025. The leases are for general office space, manufacturing space, and lab space and require the Company to pay property taxes, insurance, common area expenses and maintenance costs. In June 2021, the Company entered into a lease agreement with Durham KTP Tech 7, LLC, to lease a 15,996 square foot facility in Morrisville, North Carolina to expand its research and development activities. The lease has a term of eight years following the commencement date and provides the Company the option to extend the lease term for one five year term; however the option to extend was not included in the ROU asset and liability. It is subject to fixed rate escalation increases and also provides up to $2.4 million for tenant improvements. NightHawk recorded an operating lease right-of-use asset of $5.6 million and lease liability of $3.2 million for this lease in the accompanying consolidated balance sheets. In October 2021, Scorpius entered into a lease agreement with Merchants Ice II, LLC to lease a 20,144 square foot facility in San Antonio, TX for general office, laboratory, research, analytical, and/or biomanufacturing purposes. Merchants Ice II, LLC is a nonprofit entity investing in the building with the intention to encourage development of emerging technologies. As a result, investments made by both Merchants Ice II, LLC and Scorpius into the building may qualify and share tax credits under the New Market Tax Credit (“NMTC”) program. Scorpius agreed that all investments and expenditures qualifying under the NMTC (i.e., certain equipment and building improvements) would be purchased by Merchants Ice II, LLC to generate the largest possible tax incentive and Scorpius would reimburse Merchants Ice II, LLC for these payments. The lease officially commenced on September 15, 2022. As of December 31, 2022, Scorpius has reimbursed Merchants Ice II, LLC $24.3 million. There were no additional reimbursements during the nine months ended September 30, 2023. Based on ASC 842, the Company has capitalized $13.2 million of the reimbursements as lab equipment, expensed $0.9 million as supplies and facilities, and $10.2 million has been included in the finance lease right-of-use asset. The lease has a term of fifteen years following the commencement date and provides Scorpius the option to extend the lease term for one fifteen-year term, and one subsequent ten year term upon expiration of the first extended term. These options to extend were not included in the ROU asset and lease liability. It is subject to fixed rate escalation increases and also provides up to $2.4 million for tenant improvements. Scorpius recorded a finance lease right-of-use asset of $15.1 million and lease liability of $5.1 million for this lease in the accompanying consolidated balance sheets. In December 2022, Scorpius entered into a lease agreement with TPB Merchants Ice, LLC to lease an 8,042 square foot facility in San Antonio, TX for additional general office, laboratory, research, analytical, and/or biomanufacturing purposes. The lease has a term of fifteen years following the commencement date and provides Scorpius the option to extend the lease term for one fifteen-year term, and one subsequent ten-year term upon expiration of the first extended term. It is subject to fixed rate escalation increases and provides up to $6.5 million for tenant improvements. Scorpius paid the lessor $5.4 million in prepaid rent which rolled-up into the right-of-use asset upon lease commencement. The lease commenced on May 2, 2023. Scorpius recorded a right-of-use asset of $7.8 million and a lease liability of $2.3 million for this lease in the accompanying consolidated balance sheets. Total cash paid for operating leases during the three and nine months ended September 30, 2023 was $0.2 million and $0.6 million and is included within cash flows from operating activities within the consolidated statement of cash flows. The Company’s lease cost is reflected in the accompanying statements of operations and comprehensive loss within general and administrative and research and development as follows: For the Three Months Ended September 30, 2023 For the Nine Months Ended September 30, 2023 Operating lease cost $ 287,590 956,673 Finance lease cost Amortization of lease assets 526,709 1,240,249 Interest on lease liabilities 235,566 525,791 Total finance lease cost $ 762,275 $ 1,766,040 The weighted average remaining lease term and incremental borrowing rate as of September 30, 2023 and 2022 were as follows: For the Nine Months Ended September 30, 2023 For the Nine Months Ended September 30, 2022 Weighted average remaining lease term Operating leases 6.7 years 4.2 years Finance leases 11.3 years 9.5 years Weighted average incremental borrowing rate Operating leases 9.45 % 5.25 % Finance leases 10.12 % 6.65 % Maturities of operating and finance lease liabilities as of September 30, 2023 were as follows: Operating Leases Finance Leases Total 2023 (excluding the nine months ended September 30, 2023) $ 175,322 411,365 $ 586,687 2024 667,825 1,825,556 2,493,381 2025 635,180 1,736,837 2,372,017 2026 575,350 1,664,975 2,240,325 2027 592,572 902,127 1,494,699 2028 610,407 931,290 1,541,697 2029 628,723 961,311 1,590,034 Thereafter 536,933 9,340,354 9,877,287 Total minimum lease payments 4,422,312 17,773,815 22,196,127 Less: imputed interest (1,192,210) (7,755,573) (8,947,783) Present value of lease liabilities $ 3,230,102 $ 10,018,242 $ 13,248,344 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | 15. Commitments and Contingencies Elusys relies on Lonza, a third-party manufacturer, to produce commercial quantities of its ANTHIM® bulk drug product requirements. Elusys has firm orders with Lonza for future purchases of bulk drug substance, with remaining total non-cancellable future commitments of approximately $53.0 million through 2025. If Elusys were to terminate certain firm orders with Lonza without cause, it will be required to pay for bulk drug substance scheduled for manufacture under its arrangement. |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Basis of Presentation and Significant Accounting Policies | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation Effective May 3, 2022, Heat Biologics, Inc. changed its name to NightHawk Biosciences, Inc. (the “Company” or “NightHawk”) by filing a Certificate of Amendment (the “Certificate of Amendment”) to its Third Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware. The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial reporting. Certain information or footnote disclosures normally included in the annual financial statements prepared in accordance with U.S. GAAP have been condensed, or omitted, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). In the opinion of the Company’s management, these financial statements include all normal and recurring adjustments necessary for the fair statement of the results for the interim periods presented. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2023. The consolidated financial statements as of and for the three and nine months ended September 30, 2023 and 2022 are unaudited. The balance sheet as of December 31, 2022 is derived from the audited consolidated financial statements as of that date. These financial statements should be read in conjunction with the audited consolidated financial statements and related notes contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on March 31, 2023 (the “2022 Annual Report”). The accompanying unaudited consolidated financial statements as of and for the three and nine months ended September 30, 2023 and 2022 include the accounts of NightHawk Biosciences, Inc., and its subsidiaries (“the Company”), Pelican Therapeutics, Inc. (“Pelican”), Heat Biologics I, Inc. (“Heat I”), Heat Biologics III, Inc. (“Heat III”), Heat Biologics IV, Inc. (“Heat IV”), Heat Biologics GmbH, Heat Biologics Australia Pty Ltd., Zolovax, Inc., Skunkworx Bio, Inc. (formerly known as Delphi Therapeutics, Inc.), Scorpius BioManufacturing, Inc. (“Scorpius”) (formerly Scorpion Biological Services, Inc), Blackhawk Bio, Inc., Abacus Biotech, Inc., and Elusys Therapeutics, Inc. (“Elusys”). The functional currency of the entities located outside the United States of America (the foreign entities) is the applicable local currency of the foreign entities. Assets and liabilities of the foreign entities are translated at period-end exchange rates. Statement of operations accounts are translated at the average exchange rate during the period. The effects of foreign currency translation adjustments are included in other comprehensive loss, which is a component of accumulated other comprehensive income in stockholders’ equity. All significant intercompany accounts and transactions have been eliminated in consolidation. At September 30, 2023 and December 31, 2022, NightHawk held an 85% controlling interest in Pelican and a 94% controlling interest in Scorpius. NightHawk accounts for its less than 100% interest in accordance with U.S. GAAP. Accordingly, the Company presents non-controlling interest as a component of stockholders’ equity on its consolidated balance sheets and reports non-controlling interest net loss under the heading “net loss – non-controlling interest” on its consolidated statements of operations and comprehensive loss. In September 2023, the Company commenced the active marketing for the sale of Elusys Therapeutics, Inc. The divestiture has not been consummated as of September 30, 2023 however, the Company has reflected Elusys Therapeutics, Inc. as a discontinued operation in the consolidated financial statements for all periods presented. See Note 2 for further discussion. Unless otherwise noted, amounts and disclosure throughout the Notes to the consolidated financial statements are related to the Company’s continuing operations. |
Going Concern Uncertainty | Going Concern Uncertainty The Company has an accumulated deficit of approximately $249.0 million as of September 30, 2023 and a net loss before income taxes from continuing operations of approximately $35.3 million for the nine months ended September 30, 2023 and has not generated significant revenue or positive cash flows from operations. The Company expects to incur significant expenses and continued losses from operations for the foreseeable future. The Company expects its expenses to increase in connection with its ongoing activities, particularly as the Company ramps up operations in its in-house bioanalytic, process development and manufacturing facility in San Antonio, TX, which is now its main focus. In addition, any new business ventures that the Company may engage in are likely to require commitments of capital. Accordingly, the Company will need to obtain substantial additional funding in connection with its planned operations. Adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital when needed or on attractive terms, it would be forced to delay, reduce or eliminate its programs, any future commercialization efforts or the manufacturing services it plans to provide. To meet its capital needs, the Company intends to continue to consider multiple alternatives, including, but not limited to, additional equity financings such as sales of its common stock under at-the-market offerings, debt financings, partnerships, grants, funding collaborations and other funding transactions, if any are available. As of September 30, 2023, the Company had approximately $6.2 million in cash and cash equivalents and short-term investments, which it believes is sufficient to fund its operations into the first quarter of 2024. The Company will need to generate significant revenues to achieve profitability, and it may never do so. As a result of these circumstances, management has determined that there is substantial doubt about the Company's ability to continue as a going concern within one year after the consolidated interim financial statements are issued. |
Risk and Uncertainties | Risk and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, uncertainty of regulatory approval of the Company’s drug candidates or its manufacturing facility, the timing of completion of construction of the planned manufacturing facility in Kansas, uncertainty of market acceptance of the Company’s products or manufacturing capability or success of new business ventures, competition from substitute products and larger companies, government budget and spending on biological threat programs, securing and protecting proprietary technology, strategic relationships and dependence on key individuals and sole source suppliers. New risks and uncertainties may develop and it is not possible for us to predict all such risk factors, nor can we assess the effect of all such risk factors on our business. The Company depends on third-party suppliers for key materials and services used in its manufacturing processes, and is subject to certain risks related to the loss of these third-party suppliers or their inability to supply adequate materials and services. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all cash and other highly liquid investments with initial maturities from the date of purchase of three months or less to be cash and cash equivalents. |
Derivative Financial Instruments | Derivative Financial Instruments The Company has issued common stock warrants in connection with the execution of certain equity financings. The fair value of the warrants, which were deemed to be derivative instruments, was recorded as a derivative liability under the provisions of Accounting Standards Codification (“ASC”) Topic 815, Derivatives and Hedging (“ASC 815”) The fair value of the warrants, including the warrants issued in connection with the January 2020 common stock offering and recorded as a liability, was determined using the Monte Carlo simulation model, which is deemed to be an appropriate model due to the terms of the warrants issued. The fair value of warrants was affected by changes in inputs to the Monte Carlo simulation model including the Company’s stock price, expected stock price volatility, the remaining term, and the risk-free interest rate. This model uses Level 3 inputs, including stock price volatility, in the fair value hierarchy established by ASC 820 Fair Value Measurement |
Short-term Investments | Short-term Investments The Company’s short-term investments are equity securities and are carried at their fair value based on quoted market prices. Realized and unrealized gains and losses on equity securities are included in net earnings in the period earned or incurred. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Estimates are used for, but not limited to, useful lives of fixed assets, contingent consideration, income taxes, revenue, and stock-based compensation. Actual results may differ from those estimates. |
Segments | Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed the operations and managed the business as one segment. |
Business Combinations | Business Combinations The accounting for the Company’s business combinations consists of allocating the purchase price to tangible and intangible assets acquired and liabilities assumed based on their estimated fair values, with the excess recorded as goodwill. The Company has up to one year from the acquisition date to use information as of each acquisition date to adjust the fair value of the acquired assets and liabilities, which may result in material changes to their recorded values with an offsetting adjustment to goodwill. Determining the fair value of assets acquired and liabilities assumed requires significant judgment, which includes, among other factors, analysis of historical performance and estimates of future performance. The Company has used discounted cash flow analyses, which were based on its best estimate of future revenue, earnings and cash flows as well as its discount rate, adjusted for risk, and estimated attrition rates. |
Goodwill and Intangible Assets | Goodwill and Intangible Assets The Company classifies intangible assets into three categories: (1) intangible assets with definite lives subject to amortization, (2) intangible assets with indefinite lives not subject to amortization and (3) goodwill. The Company determines the useful lives of definite-lived intangible assets after considering specific facts and circumstances related to each intangible asset. Factors the Company considers when determining useful lives include the contractual term of any agreement related to the asset, the historical performance of the asset, and other economic facts; including competition and specific market conditions. Intangible assets that are deemed to have definite lives are amortized, primarily on a straight-line basis, over their estimated useful lives. Intangible assets that are deemed to have indefinite lives, including goodwill, are reviewed for impairment annually, or more frequently if events or changes in circumstances indicate that the asset might be impaired. The impairment test for indefinite-lived intangibles, other than goodwill, consists of a comparison of the fair value of the intangible asset with its carrying amount. If the carrying amount exceeds the fair value, an impairment charge is recognized in an amount equal to that excess. Indefinite-lived intangible assets, such as goodwill, are not amortized. The Company tests the carrying amounts of goodwill for recoverability on an annual basis or when events or changes in circumstances indicate a potential impairment exists, using a fair value-based test. The Company records a goodwill impairment charge if a reporting unit’s carrying value exceeds its fair value. In-process research and development (“IPR&D”) assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development projects. IPR&D assets represent the fair value assigned to technologies that the Company acquires, which at the time of acquisition have not reached technological feasibility and have no alternative future use. During the period that the assets are considered indefinite-lived, they are tested for impairment on an annual basis, or more frequently if the Company becomes aware of any events occurring or changes in circumstances that indicate that the fair value of the IPR&D assets are less than their carrying amounts. If and when development is complete, which generally occurs upon regulatory approval and the ability to commercialize products associated with the IPR&D assets, these assets are then deemed definite-lived and are amortized based on their estimated useful lives at that point in time. If development is terminated or abandoned, the Company may have a full or partial impairment charge related to the IPR&D assets, calculated as the excess of the carrying value of the IPR&D assets over fair value. |
Contingent Consideration | Contingent Consideration Consideration paid in a business combination may include potential future payments that are contingent upon the acquired business achieving certain milestones in the future (“contingent consideration”). Contingent consideration liabilities are measured at their estimated fair value as of the date of acquisition, with subsequent changes in fair value recorded in the consolidated statements of operations. The Company estimates the fair value of the contingent consideration as of the acquisition date using the estimated future cash outflows based on the probability of meeting future milestones. The milestone payments will be made upon the achievement of clinical and commercialization milestones as well as single low digit royalty payments and payments upon receipt of sublicensing income. Subsequent to the date of acquisition, the Company reassesses the actual consideration earned and the probability-weighted future earn-out payments at each balance sheet date. Any adjustment to the contingent consideration liability will be recorded in the consolidated statements of operations and comprehensive loss, for the change that occurred during the fiscal year. Contingent consideration liabilities expected to be settled within 12 months after the balance sheet date are presented in current liabilities, with the non-current portion recorded under long term liabilities in the consolidated balance sheets. Contingent consideration is included in discontinued operations on the consolidated balance sheet. |
Cost of revenues and selling, general and administrative expense | Cost of revenues and selling, general and administrative expenses Cost of revenues consists of production wages, material costs and overhead, and other costs related to the recognition of revenue. Selling, general and administrative expenses consist of salaries and related costs for administrators, public company costs, business development personnel as well as legal, patent-related expenses and consulting fees. Public company costs include compliance, auditing services, tax services, insurance and investor relations. |
Research and Development | Research and Development Research and development includes costs associated with developmental products not yet approved by the FDA as well as costs associated with bringing developmental products into advanced phase clinical trials as incurred. These costs consist primarily of pre-manufacturing and manufacturing drug costs, clinical trial execution, investigator payments, license fees, salaries, stock-based compensation and related personnel costs. Other costs include fees paid to consultants and outside service providers related to the development of the Company’s product candidates and other expenses relating to the design, development, testing and enhancement of its product candidates. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely method based on historical experience as well as applicable information currently available. Product Sales The Company recognizes revenue from product sales when its performance obligation with its customers has been satisfied. The performance obligation is satisfied at a point in time when the Company’s customers obtain control of the product, which is typically upon acceptance of the product at the delivery site. The Company invoices its customers after acceptance of the product and invoice payments are generally due within 30 days of the invoice date. The Company records product sales net of any variable consideration, including refund rights. The Company uses the most likely amount method when estimating its variable consideration, unless terms are specified within contracts. The Company recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period. These estimates may differ from actual consideration received. The Company evaluates these estimates to reflect known changes. Grant Revenue The Company recognized revenue from a grant related to the Cancer Prevention and Research Institute of Texas (“CPRIT”) contract, which was accounted for under ASU No. 2018-08, Not-For-Profit Entities (Topic 958): Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made, The CPRIT grant covered the period from June 1, 2017 through May 31, 2023, for a total grant award of up to $15.2 million. CPRIT advanced grant funds upon request by the Company consistent with the agreed upon amounts and schedules as provided in the contract. The first tranche of funding of $1.8 million was received in May 2017, a second tranche of funding of $6.5 million was received in October 2017, and the third tranche of funding of $5.4 million was received in December 2019. The remaining $1.5 million was received in April 2023. Funds received were reflected in deferred revenue as a liability until revenue was earned. Grant revenue was recognized when qualifying costs are incurred. When grant funds were received after costs had been incurred, the Company recorded revenue and a corresponding grants receivable until grant funds were received. As of September 30, 2023, all $15.2 million has been recognized and received. License revenue The Company has licensed certain provisional patent applications and know-how related to fusion proteins to treat cancer and other diseases that were not being developed by the Company. Shattuck Labs, Inc. (“Shattuck”) paid the Company an initial license fee of $50,000 in June 2016 and is obligated to pay the Company fees upon its receipt of sublicensing income, achievement of certain milestones, and royalties upon sales of commercial products. In March 2023, the Company received a milestone payment of $100,000 from Shattuck due to completion of a Phase 1A monotherapy dose escalation clinical trial of SL-172154. However, the technology that the Company out-licensed remains in the early stages of development since there is a low likelihood of success for any technology at such stage, there can be no assurance that any products will be developed by Shattuck or that the Company will derive any additional future revenue from Shattuck. Process development revenue Process development revenue generally represents revenue from services associated with the custom development of a manufacturing process and analytical methods for a customer’s product. Process development revenue is recognized over time utilizing an input method by tracking the progress toward completion by measuring inputs to date relative to total estimated inputs needed to satisfy the performance obligation. Under a process development contract, the customer owns the product details and process, which has no alternative use. These process development projects are customized to each customer to meet its specifications and typically include only one performance obligation. Each process represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of its product as the product is being created or enhanced by our services and can make changes to its process or specifications upon request. Under these agreements, the Company is entitled to consideration for progress to date that includes an element of profit margin. The transaction price for services provided under the Company’s contracts reflects its best estimate of the amount of consideration to which it is entitled in exchange for providing goods and services to our customers. For contracts with multiple performance obligations, the Company allocates transaction price to each performance obligation identified in a contract on a relative standalone selling price basis. If observable standalone selling prices are not available, the Company estimates the applicable standalone selling price based on the pricing of other comparable services or on a price that the Company believes the market is willing to pay for the applicable service. In determining the transaction price, the Company also considered the different sources of variable consideration including, but not limited to, discounts, credits, refunds, price concessions or other similar items. The Company has included in the transaction price some or all of an amount of variable consideration, utilizing the most likely method, only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The actual amount of consideration ultimately received may differ. |
Deferred Revenue | Deferred Revenue Deferred revenue is comprised of an exclusive license agreement with Shattuck and process development customer deposits received in advance of our fulfillment of performance obligations. License Agreements The Company has licensed certain provisional patent applications and know-how related to fusion proteins to treat cancer and other diseases that were not being developed by the Company. Shattuck paid the Company an initial license fee of $50,000 in June 2016 and is obligated to pay the Company fees upon its receipt of sublicensing income, achievement of certain milestones, and royalties upon sales of commercial products. In-as-much as the technology that the Company out-licensed remains in the early stages of development since there is a low likelihood of success for any technology at such stage, there can be no assurance that any products will be developed by Shattuck or that the Company will derive any additional future revenue from Shattuck. Process Development Process development deferred revenue generally represents customer payments received in advance of the Company’s fulfillment of performance obligations associated with the custom development of a manufacturing process and analytical methods for a customer’s product. As of September 30, 2023, there was $4.1 million of deferred revenue related to process development. |
Accounts Receivable | Accounts Receivable Accounts receivable are primarily comprised of amounts owed to us for services and sales provided under our customer contracts and are recorded at the invoiced amount net of an allowance for doubtful accounts, if necessary. The Company applies judgment in assessing the ultimate realization of our receivables and we estimate an allowance for doubtful accounts based on various factors, such as the aging of our receivables, historical experience, and the financial condition of our customers. |
Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets The Company’s prepaid expenses and other current assets consist primarily of amounts paid in advance for manufacturing activities, clinical trial support, contract assets and insurance. Contract assets consist of unbilled receivables. |
Income Tax | Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance to the extent that utilization is not presently more likely than not. |
Other Assets | Other Assets The balance consists of $0.5 million of land option agreements for the Kansas facility. |
Other Liabilities | Other Liabilities In conjunction with the acquisition of Elusys, the Company recorded an uncertain tax position reserve for the research and development credits utilized on the Elusys pre-acquisition short period 2022 return. The Company is not able to assert that the credit amounts utilized are more likely than not to be sustained by the IRS upon audit and thus a liability of $1.0 million was recorded and is included in discontinued operations on the consolidated balance sheet. |
Discontinued Operations | Discontinued Operations In accordance with ASC Subtopic 205-20, Presentation of Financial Statements Assets classified as held for sale that are not sold after the initial one-year period are assessed to determine if they meet the exception to the one-year requirement to continue being classified as held for sale. The disposal group that is held for sale is the Elusys Therapeutics, Inc. subsidiary. |
Significant Accounting Policies | Significant Accounting Policies The significant accounting policies used in preparation of these interim financial statements are disclosed in the audited consolidated financial statements and related notes included in the Company’s 2022 Annual Report. |
Impact of Recently Adopted Accounting Standards | Impact of Recently Adopted Accounting Standards In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments (ASU 2016-13), which amends the impairment model by requiring entities to use a forward looking approach based on expected losses to estimate credit losses on certain types of financial instruments, including trade receivables. For trade receivables and other instruments, entities will be required to use a new forward-looking expected loss model that generally will result in the earlier recognition of allowances for losses. The Company adopted ASU 2016-13 as of January 1, 2023. The cumulative effect of applying the new credit loss standard was not material and, therefore, did not result in an adjustment to retained earnings. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements or related financial statement disclosures. |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Discontinued Operations | |
Schedule of Assets, liabilities and operations classified as held for sale | Assets of discontinued operations: September 30, 2023 December 31, 2022 Current assets: Cash and cash equivalents $ 3,319,793 $ 5,242,840 Accounts receivable 6,699,200 — Income tax refund receivable — 600,877 Prepaid expenses and other current assets 72,432 2,084,419 Intangible assets, net 5,300,204 — Other assets 1,002,904 — Total Current Assets 16,394,533 7,928,136 Long term assets: Property and equipment, net — 41,853 Intangible assets, net — 8,669,375 Goodwill — 3,301,959 Operating lease right-of-use asset — 138,885 Deposits — 26,251 Total long term assets — 12,178,323 Total assets held for sale $ 16,394,533 20,106,459 Liabilities held for sale: Current liabilities: Accounts payable $ 800,258 $ 210,321 Accrued expenses and other liabilities 475,618 2,385,319 Contingent consideration, current portion 11,946,916 6,934,115 Operating lease liability, current portion — 92,524 Other liabilities 1,002,904 — Total current liabilities $ 14,225,696 $ 9,622,279 Long term liabilities: Contingent consideration, net of current portion — 5,290,500 Total long term liabilities — 5,290,500 Total liabilities held for sale $ 14,225,696 $ 14,912,779 Three Months Ended Nine Months Ended, September 30, September 30, 2023 2022 2023 2022 Revenue $ 6,699,200 $ 5,980,994 $ 6,699,200 6,012,993 Operating expenses: Cost of revenues 2,161,601 6,319,723 2,161,601 6,319,723 Research and development 1,026,483 1,524,748 2,191,796 2,230,373 Selling, general and administrative 335,851 276,018 1,147,730 481,877 Amortization of intangible asset 363,750 316,875 1,091,250 666,875 Goodwill impairment loss 3,873,079 — 3,873,079 — Intangible asset impairment loss 2,277,921 — 2,277,921 — Change in fair value of contingent consideration (286,855) — (177,354) — Total operating expenses 9,751,830 8,437,364 12,566,023 9,698,848 Loss from operations (3,052,630) (2,456,370) (5,866,823) (3,685,855) Other expense, net 12,053 (244,576) 18,603 (245,929) Total non-operating income (loss) 12,053 (244,576) 18,603 (245,929) Net loss from discontinued operations before income taxes (3,040,577) (2,700,946) (5,848,220) (3,931,784) Income tax expense from discontinued operations (65,189) — (65,189) — Net loss from discontinued operations $ (3,105,766) $ (2,700,946) $ (5,913,409) $ (3,931,784) |
Acquisitions (Tables)
Acquisitions (Tables) - Elusys Therapeutics | 9 Months Ended |
Sep. 30, 2023 | |
Acquisitions | |
Schedule of purchase price allocation | Aggregate consideration: Cash consideration $ 3,000,000 Deferred cash consideration 2,000,000 Earn out 5,900,000 Additional earn out 4,735,000 Receivable consideration 22,318,685 Contract deferred consideration 4,900,000 Total purchase consideration $ 42,853,685 The purchase price allocation resulted in the following amounts being allocated to the assets acquired and liabilities assumed as of the closing date based on their respective fair values summarized below: Purchase price allocation: Cash and cash equivalents $ 5,719,899 Contract receivables 24,526,232 Prepaid expenses and other current assets 1,818,278 Inventory 5,844,000 Intangible asset – definite-lived (Note 7) 9,700,000 Property and equipment 50,224 Operating lease right of use assets 352,906 Other assets 1,329,153 Total assets acquired 49,340,692 Accounts payable (204,794) Accrued expenses and other current liabilities (5,155,363) Operating lease obligations (352,906) Deferred income tax liability (3,644,120) Other liabilities (1,002,904) Total liabilities assumed (10,360,087) Net assets acquired and liabilities assumed 38,980,605 Goodwill 3,873,080 Total purchase consideration $ 42,853,685 |
Schedule of proforma operating results | Three months ended Nine months ended September 30, September 30, 2022 2022 (unaudited) (unaudited) Revenue $ 29,347,513 $ 29,892,585 Net loss $ (1,296,510) $ (21,282,125) Net income (loss) per share, basic and diluted $ (0.05) $ (0.83) |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value of Financial Instruments | |
Schedule of fair value of financial instruments measured on a recurring basis | As of September 30, 2023 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 4,167,755 $ 4,167,755 $ — $ — As of December 31, 2022 Description Total Level 1 Level 2 Level 3 Assets: Short-term investments $ 35,837,309 $ 35,837,309 $ — $ — |
Schedule of change in fair value, as determined by Level 3 inputs, for all assets and liabilities using unobservable Level 3 inputs | Elusys Contingent Elusys Contingent Consideration: Consideration Balance at June 30, 2023 $ 12,334,115 Payment of contingent consideration (100,344) Change in fair value (286,855) Reclassification to held for sale (11,946,916) Balance at September 30, 2023 $ — Elusys Contingent Elusys Contingent Consideration: Consideration Balance at December 31, 2022 $ 12,224,614 Payment of contingent consideration (100,344) Change in fair value (177,354) Reclassification to held for sale (11,946,916) Balance at September 30, 2023 $ — Pelican Contingent Warrant Consideration Liability Balance at June 30, 2022 $ 3,118,515 $ 1,730 Change in fair value (3,118,515) (1,456) Balance at September 30, 2022 $ — $ 274 Pelican Contingent Warrant Consideration Liability Balance at December 31, 2021 $ 3,342,515 $ 11,020 Change in fair value (3,342,515) (10,746) Balance at September 30, 2022 $ — $ 274 |
Schedule of fair value inputs | September 30, 2023 December 31, 2022 Current stock price $ 0.53 $ 0.81 Estimated volatility of future stock price 59.02 % 80.94 % Risk free interest rate 5.55 % 4.75 % Contractual term 0.16 years 0.90 years As of September 30, 2023 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Elusys revenue earn-out Discounted cash flow analysis Timing of expected payments 2026-2029 Discount rate 14.0% Future revenue projections $ 141.4 million As of December 31, 2022 Valuation Significant Weighted Average Methodology Unobservable Input (range, if applicable) Elusys revenue earn-out Discounted cash flow analysis Timing of expected payments 2025-2036 Discount rate 24.5% Future revenue projections $ 325.9 million Elusys deferred contract consideration Discounted cash flow analysis Timing of expected payments 2023 Discount rate 15.5% Future revenue projections $ 7.6 million |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expenses And Other Current Assets. | |
Schedule of prepaid expenses and other current assets | September 30, December 31, 2023 2022 Prepaid manufacturing expense $ 475,536 $ 91,477 Contract assets 363,918 — Other prepaid expenses and current assets 280,787 1,132,502 Prepaid insurance 104,126 201,252 Prepaid preclinical and clinical expenses 36,861 65,892 $ 1,261,228 $ 1,491,123 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property and Equipment | |
Schedule of property and equipment | September 30, December 31, 2023 2022 Lab equipment $ 21,080,029 $ 18,060,058 Leasehold improvements 2,827,289 2,486,329 Construction-in-process — 2,053,335 Computers 850,211 502,084 Furniture and fixtures 277,882 245,770 Vehicles — 44,562 Total 25,035,411 23,392,138 Accumulated depreciation (6,351,513) (2,953,617) Property and equipment, net $ 18,683,898 $ 20,438,521 |
Goodwill and Other Intangible_2
Goodwill and Other Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Other Intangible Assets | |
Schedule of carrying amount of goodwill and intangible assets | Intangible Goodwill Assets Balance at December 31, 2022 $ 3,301,959 $ 8,669,375 Impairment (3,873,079) (2,277,921) Acquisition fair value adjustments 571,120 — Amortization of intangible asset — (1,091,250) Reclassified to discontinued operations — (5,300,204) Balance at September 30, 2023 $ — $ — |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Expenses and Other Liabilities | |
Schedule of accrued expenses and other liabilities | September 30, December 31, 2023 2022 Accrued marketing expenses $ 749,998 $ — Accrued preclinical and clinical trial expenses 252,618 953,252 Compensation and related benefits 373,211 491,191 Accrued manufacturing expenses 345,646 6,133 Other expenses 240,145 426,025 Accrued franchise tax 70,000 40,000 $ 2,031,618 $ 1,916,601 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity | |
Schedule of common stock warrants outstanding | Common Stock Warrants Outstanding, December 31, 2022 747,383 Expired (434,025) Outstanding, September 30, 2023 313,358 |
Schedule of stock option valuation assumptions | 2023 2022 Dividend yield — % — % Expected volatility 101.92 % 102.75 % Risk-free interest rate 2.47 % 2.51 % Expected lives (years) 5.6 years 6.0 years |
Schedule of stock option activity | Weighted Weighted Average Aggregate Average Exercise Intrinsic Remaining Shares Price Value Contractual Life Stock options outstanding at December 31, 2022 7,036,874 $ 3.67 $ 16,842 Expired (102,847) 8.59 Forfeited (214,084) 3.42 Stock options outstanding at September 30, 2023 6,719,943 $ 3.61 $ 10,947 8.3 Years Stock options exercisable at September 30, 2023 3,949,543 $ 4.85 $ 10,947 7.9 Years |
Schedule of restricted stock activity | Weighted Average Shares Fair Value Restricted stock at December 31, 2022 34,001 $ 3.22 Released (34,001) 3.22 Restricted stock at September 30, 2023 — $ — |
Schedule of RSU activity | Weighted Average Shares Fair Value RSUs at December 31, 2022 — $ — Granted 360,000 1.18 Released (80,000) 1.18 RSUs at September 30, 2023 280,000 $ 1.18 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue | |
Schedule of changes in contract liabilities | Contract liabilities Balance at June 30, 2023 $ (2,734,524) Changes to the beginning balance arising from: Reclassification to revenue as the result of performance obligations satisfied 638,625 Net change to contract balance recognized since beginning of period due to amounts collected (1,993,247) Balance at September 30, 2023 $ (4,089,146) Contract liabilities Balance at June 30, 2022 $ (35,000) Changes to the beginning balance arising from: Net change to contract balance recognized since beginning of period due to amounts collected (716,350) Balance at September 30, 2022 $ (751,350) Contract liabilities Balance at December 31, 2021 $ (35,000) Changes to the beginning balance arising from: Net change to contract balance recognized since beginning of period due to amounts collected (1,583,308) Balance at December 31, 2022 (1,618,308) Changes to the beginning balance arising from: Reclassification to revenue as the result of performance obligations satisfied 1,962,303 Net change to contract balance recognized since beginning of period due to amounts collected (4,433,141) Balance at September 30, 2023 $ (4,089,146) |
Schedule of opening and closing balances of the Company's accounts receivables | Opening on January 1, 2022 $ 66,049 Closing on December 31, 2022 $ 81,456 Closing on September 30, 2023 $ 313,906 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Net Loss Per Share | |
Schedule of reconciliation of net loss | For the Three Months Ended For the Nine Months Ended September 30, September 30, 2023 2022 2023 2022 Net loss $ (14,312,029) $ (13,347,771) $ (41,168,866) $ (28,475,479) Net loss - Non-controlling interest (1,179,559) (89,421) (1,359,734) (265,256) Net loss attributable to NightHawk $ (13,132,470) $ (13,258,350) $ (39,809,132) $ (28,210,223) Weighted-average common shares outstanding, basic and diluted 26,050,562 25,613,316 26,022,244 25,603,481 Net loss per share, basic and diluted - continuing operations $ (0.38) $ (0.41) $ (1.30) $ (0.95) Net loss per share, basic and diluted - discontinued operations (0.12) (0.11) (0.23) (0.15) Net loss per common share attributable to NightHawk Biosciences, Inc., basic and diluted $ (0.50) $ (0.52) $ (1.53) $ (1.10) |
Schedule of potentially dilutive securities | 2023 2022 Outstanding stock options 6,719,943 3,006,968 Restricted stock subject to forfeiture and restricted stock units 280,000 46,859 Outstanding common stock warrants 313,358 747,383 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases | |
Schedule of lease cost | For the Three Months Ended September 30, 2023 For the Nine Months Ended September 30, 2023 Operating lease cost $ 287,590 956,673 Finance lease cost Amortization of lease assets 526,709 1,240,249 Interest on lease liabilities 235,566 525,791 Total finance lease cost $ 762,275 $ 1,766,040 |
Schedule of weighted average remaining lease term and incremental borrowing rate | For the Nine Months Ended September 30, 2023 For the Nine Months Ended September 30, 2022 Weighted average remaining lease term Operating leases 6.7 years 4.2 years Finance leases 11.3 years 9.5 years Weighted average incremental borrowing rate Operating leases 9.45 % 5.25 % Finance leases 10.12 % 6.65 % |
Schedule of maturities of operating and finance lease liabilities | Operating Leases Finance Leases Total 2023 (excluding the nine months ended September 30, 2023) $ 175,322 411,365 $ 586,687 2024 667,825 1,825,556 2,493,381 2025 635,180 1,736,837 2,372,017 2026 575,350 1,664,975 2,240,325 2027 592,572 902,127 1,494,699 2028 610,407 931,290 1,541,697 2029 628,723 961,311 1,590,034 Thereafter 536,933 9,340,354 9,877,287 Total minimum lease payments 4,422,312 17,773,815 22,196,127 Less: imputed interest (1,192,210) (7,755,573) (8,947,783) Present value of lease liabilities $ 3,230,102 $ 10,018,242 $ 13,248,344 |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies - Narrative (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 88 Months Ended | ||||||||||
Apr. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2019 USD ($) | Oct. 31, 2017 USD ($) | May 31, 2017 USD ($) | Jun. 30, 2016 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) segment | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Oct. 31, 2018 | Sep. 30, 2018 | |
Accumulated deficit | $ 248,962,791 | $ 248,962,791 | $ 248,962,791 | $ 209,153,659 | ||||||||||
Net loss from continuing operations | 11,206,263 | $ 10,646,825 | 35,255,457 | $ 24,543,695 | ||||||||||
Cash, cash equivalents and short term investments | 6,200,000 | 6,200,000 | 6,200,000 | |||||||||||
Derivative warrant liability | 0 | $ 0 | 0 | |||||||||||
Number of operating segments | segment | 1 | |||||||||||||
Unrecognized tax benefit | 1,500,000 | $ 1,500,000 | 1,500,000 | |||||||||||
Revenue | 723,126 | 58,861 | 2,146,804 | 290,259 | ||||||||||
Customer deposits | 4,100,000 | 4,100,000 | 4,100,000 | |||||||||||
Land option agreements | 500,000 | 500,000 | 500,000 | |||||||||||
Other liabilities | $ 1,000,000 | $ 1,000,000 | $ 1,000,000 | |||||||||||
Held for sale | ||||||||||||||
Discontinued operation, period of continuing involvement after disposal | 1 year | |||||||||||||
Elusys Therapeutics business | ||||||||||||||
Discontinued operation, period of continuing involvement after disposal | 1 year | |||||||||||||
Shattuck | ||||||||||||||
License fee received | $ 50,000 | |||||||||||||
Initial license fees received | 50,000 | |||||||||||||
Proceeds from milestone payment | $ 100,000 | |||||||||||||
Pelican Therapeutics, Inc. | ||||||||||||||
Ownership interest in subsidiary | 85% | 85% | 85% | 85% | 85% | 80% | ||||||||
Scorpius Therapeutics, Inc. | ||||||||||||||
Ownership interest in subsidiary | 94% | 94% | 94% | 94% | ||||||||||
Pelican Therapeutics, Inc. | Grant and contract revenue | ||||||||||||||
Amount awarded from CPRIT grant | $ 15,200,000 | |||||||||||||
Revenue | $ 1,500,000 | $ 0 | $ 100,000 | $ 0 | $ 300,000 | $ 15,200,000 | ||||||||
Remaining grant amount receivable | $ 1,500,000 | |||||||||||||
Pelican Therapeutics, Inc. | Grant and contract revenue | Tranche 1 | ||||||||||||||
Revenue | $ 1,800,000 | |||||||||||||
Pelican Therapeutics, Inc. | Grant and contract revenue | Tranche 2 | ||||||||||||||
Revenue | $ 6,500,000 | |||||||||||||
Pelican Therapeutics, Inc. | Grant and contract revenue | Tranche 3 | ||||||||||||||
Revenue | $ 5,400,000 | |||||||||||||
Pelican Therapeutics, Inc. | Grant and contract revenue | Maximum | ||||||||||||||
Amount awarded from CPRIT grant | $ 15,200,000 |
Discontinued Operations - Sched
Discontinued Operations - Schedule of Assets and liabilities classified as held for sale in Consolidated Balance Sheets (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 |
Current assets: | |||
Cash and cash equivalents | $ 3,319,793 | $ 5,242,840 | |
Total Current Assets | 16,394,533 | $ 7,928,136 | |
Long term assets: | |||
Total long term assets | 12,178,323 | ||
Current liabilities: | |||
Total current liabilities | 14,225,696 | 9,622,279 | |
Long term liabilities: | |||
Total long term liabilities | 5,290,500 | ||
Held for sale | Elusys Therapeutics business | |||
Current assets: | |||
Cash and cash equivalents | 3,319,793 | 5,242,840 | |
Accounts receivable | 6,699,200 | ||
Income tax refund receivable | 600,877 | ||
Prepaid expenses and other current assets | 72,432 | 2,084,419 | |
Intangible assets, net | 5,300,204 | 8,669,375 | |
Other assets | 1,002,904 | ||
Total Current Assets | 16,394,533 | 7,928,136 | |
Long term assets: | |||
Property and equipment, net | 41,853 | ||
Intangible assets, net | 5,300,204 | 8,669,375 | |
Goodwill | 3,301,959 | ||
Operating lease right-of-use asset | 138,885 | ||
Deposits | 26,251 | ||
Total long term assets | 12,178,323 | ||
Total assets held for sale | 16,394,533 | 20,106,459 | |
Current liabilities: | |||
Accounts payable | 800,258 | 210,321 | |
Accrued expenses and other liabilities | 475,618 | 2,385,319 | |
Contingent consideration, current portion | 11,946,916 | 6,934,115 | |
Operating lease liability, current portion | 92,524 | ||
Other liabilities | 1,002,904 | ||
Total current liabilities | 14,225,696 | 9,622,279 | |
Long term liabilities: | |||
Contingent consideration, net of current portion | 5,290,500 | ||
Total long term liabilities | 5,290,500 | ||
Total liabilities held for sale | $ 14,225,696 | $ 14,912,779 |
Discontinued Operations - Sch_2
Discontinued Operations - Schedule of discontinued operation in operations statement (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Discontinued operation operating expense | ||||
Intangible asset impairment loss | $ 2,277,921 | |||
Net loss from discontinued operations before income taxes | $ (3,040,577) | $ (2,700,946) | (5,848,220) | $ (3,931,784) |
Income tax expense from discontinued operations | (65,189) | (65,189) | ||
Elusys Therapeutics business | ||||
Discontinued operation operating expense | ||||
Goodwill impairment loss | 3,900,000 | |||
Intangible asset impairment loss | 2,300,000 | |||
Held for sale | Elusys Therapeutics business | ||||
Discontinued Operations | ||||
Revenue | 6,699,200 | 5,980,994 | 6,699,200 | 6,012,993 |
Discontinued operation operating expense | ||||
Cost of revenues | 2,161,601 | 6,319,723 | 2,161,601 | 6,319,723 |
Research and development | 1,026,483 | 1,524,748 | 2,191,796 | 2,230,373 |
Selling, general and administrative | 335,851 | 276,018 | 1,147,730 | 481,877 |
Amortization of intangible asset | 363,750 | 316,875 | 1,091,250 | 666,875 |
Goodwill impairment loss | 3,873,079 | 3,873,079 | ||
Intangible asset impairment loss | 2,277,921 | 2,277,921 | ||
Change in fair value of contingent consideration | (286,855) | (177,354) | ||
Total operating expenses | 9,751,830 | 8,437,364 | 12,566,023 | 9,698,848 |
Loss from operations | (3,052,630) | (2,456,370) | (5,866,823) | (3,685,855) |
Other expense, net | 12,053 | (244,576) | 18,603 | (245,929) |
Total non-operating income (loss) | 12,053 | (244,576) | 18,603 | (245,929) |
Net loss from discontinued operations before income taxes | (3,040,577) | (2,700,946) | (5,848,220) | (3,931,784) |
Income tax expense from discontinued operations | (65,189) | (65,189) | ||
Net loss from discontinued operations | $ (3,105,766) | $ (2,700,946) | $ (5,913,409) | $ (3,931,784) |
Acquisitions - Narrative (Detai
Acquisitions - Narrative (Details) | 1 Months Ended | 3 Months Ended | ||||||
Apr. 18, 2022 USD ($) | Apr. 30, 2022 USD ($) | Mar. 31, 2018 USD ($) | Sep. 30, 2023 item | Dec. 31, 2022 USD ($) | Oct. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2017 | |
Acquisitions | ||||||||
Business combination additional earn out liabilities of gross sale price for number of pre-filled Vials | item | 1,500 | |||||||
Pelican Therapeutics, Inc. | ||||||||
Acquisitions | ||||||||
Ownership interest in subsidiary | 85% | 85% | 85% | 80% | ||||
Pelican Therapeutics, Inc. | ||||||||
Acquisitions | ||||||||
Percentage of voting interests acquired in acquisition | 80% | |||||||
Cash consideration | $ 200,000 | |||||||
Milestone payment | $ 0 | |||||||
Pelican Therapeutics, Inc. | Stockholders | ||||||||
Acquisitions | ||||||||
Cash consideration | $ 300,000 | |||||||
Elusys Therapeutics | ||||||||
Acquisitions | ||||||||
Earn out payments period | 12 years | |||||||
Percentage of earn out payments | 10% | |||||||
Frequency of periodic earn out payment | 1 year | |||||||
Period of occurrence of earn payment | 9 years | |||||||
Receivable consideration | $ 22,318,685 | |||||||
Consideration paid | $ 20,800,000 | |||||||
Holding back related to future fulfillment cost | $ 1,500,000 | |||||||
Contract receivables | 24,526,232 | |||||||
Fair value of the purchase consideration | 42,900,000 | |||||||
Cash consideration | 3,000,000 | |||||||
Deferred cash consideration | 2,000,000 | |||||||
Fair value of contingent and deferred consideration liabilities | $ 37,900,000 | |||||||
Discount rate for deferred consideration | 24% | |||||||
Discount rate for earn out liabilities | 14% | |||||||
Preliminary value of Additional Earn Out liability as percentage | 80% | |||||||
Goodwill | $ 3,873,080 | $ 3,301,959 | ||||||
Goodwill deductible for tax purposes | 15 years |
Acquisitions - Components of Pu
Acquisitions - Components of Purchase Consideration (Details) - USD ($) | 9 Months Ended | |
Apr. 18, 2022 | Sep. 30, 2022 | |
Acquisitions | ||
Total purchase consideration | $ 42,853,685 | |
Elusys Therapeutics | ||
Acquisitions | ||
Cash consideration | $ 3,000,000 | |
Deferred cash consideration | 2,000,000 | |
Earn out | 5,900,000 | |
Additional earn out | 4,735,000 | |
Receivable consideration | 22,318,685 | |
Contract deferred consideration | 4,900,000 | |
Total purchase consideration | $ 42,853,685 |
Acquisitions - Purchase Price A
Acquisitions - Purchase Price Allocation (Details) - Elusys Therapeutics - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2022 | Apr. 18, 2022 | |
Purchase price allocation: | ||||
Cash and cash equivalents | $ 5,719,899 | |||
Contract receivables | 24,526,232 | |||
Prepaid expenses and other current assets | 1,818,278 | |||
Inventory | 5,844,000 | |||
Intangible asset - definite-lived (Note 7) | 9,700,000 | |||
Property and equipment | 50,224 | |||
Operating lease right of use assets | 352,906 | |||
Other assets | 1,329,153 | |||
Total assets acquired | 49,340,692 | |||
Accounts payable | (204,794) | |||
Accrued expenses and other current liabilities | (5,155,363) | |||
Operating lease obligations | (352,906) | |||
Deferred income tax liability | (3,644,120) | |||
Other liabilities | (1,002,904) | |||
Total liabilities assumed | (10,360,087) | |||
Net assets acquired and liabilities assumed | 38,980,605 | |||
Goodwill | $ 3,301,959 | 3,873,080 | ||
Total purchase consideration | $ 42,853,685 | |||
Total revenue of acquiree from acquisition date | $ 6,000,000 | $ 6,000,000 | ||
Net loss before income taxes of acquiree from acquisition date | $ 2,700,000 | $ 3,900,000 |
Acquisitions - Supplemental Pro
Acquisitions - Supplemental Pro Forma Financial Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2022 | Sep. 30, 2022 | |
Acquisitions | ||
Revenue | $ 29,347,513 | $ 29,892,585 |
Net loss | $ (1,296,510) | $ (21,282,125) |
Net loss per share, basic | $ (0.05) | $ (0.83) |
Net loss per share, diluted | $ (0.05) | $ (0.83) |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Schedule of Warrant Weighted Average Assumptions (Details) | 1 Months Ended | 9 Months Ended | ||
Jan. 31, 2020 shares | Sep. 30, 2023 USD ($) item $ / shares shares | Dec. 31, 2022 $ / shares item | Sep. 30, 2022 USD ($) | |
Fair Value of Financial Instruments | ||||
Assets transfer from level 1 to level 2 | $ 0 | $ 0 | ||
Level 3 Asset transferred, net | 0 | |||
Level 3 liabilities transferred, net | $ 0 | |||
Warrants outstanding | shares | 9,357 | |||
Warrants and rights outstanding, Value | $ 0 | |||
Current stock price | ||||
Fair Value of Financial Instruments | ||||
Fair value measurement input | $ / shares | 0.53 | 0.81 | ||
Estimated volatility of future stock price | ||||
Fair Value of Financial Instruments | ||||
Fair value measurement input | 0.5902 | 0.8094 | ||
Risk free interest rate | ||||
Fair Value of Financial Instruments | ||||
Fair value measurement input | 0.0555 | 0.0475 | ||
Contractual term | ||||
Fair Value of Financial Instruments | ||||
Fair value measurement input | item | 0.16 | 0.90 | ||
Warrant | ||||
Fair Value of Financial Instruments | ||||
Number of warrants reclassified to liability | shares | 479,595 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Schedule of Fair Value Financial Instruments (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Liabilities: | ||
Derivative warrant liability | $ 0 | |
Recurring | ||
Assets: | ||
Short-term investments | 4,167,755 | $ 35,837,309 |
Recurring | Level 1 | ||
Assets: | ||
Short-term investments | $ 4,167,755 | $ 35,837,309 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments - Change in Fair Value (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Contingent Consideration | Pelican Therapeutics, Inc. | ||||
Change in fair value | ||||
Balance at the beginning | $ 3,118,515 | $ 3,342,515 | ||
Change in fair value | (3,118,515) | (3,342,515) | ||
Contingent Consideration | Elusys Therapeutics | ||||
Change in fair value | ||||
Balance at the beginning | $ 12,334,115 | $ 12,224,614 | ||
Payment of contingent consideration | (100,344) | (100,344) | ||
Change in fair value | (286,855) | (177,354) | ||
Reclassification to held for sale | $ (11,946,916) | $ (11,946,916) | ||
Warrant Liability | ||||
Change in fair value | ||||
Balance at the beginning | 1,730 | 11,020 | ||
Change in fair value | (1,456) | (10,746) | ||
Balance at end | $ 274 | $ 274 |
Fair Value of Financial Instr_6
Fair Value of Financial Instruments - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Fair Value of Financial Instruments | ||||
Change in fair value of contingent consideration | $ (3,118,515) | $ (3,342,515) | ||
Change in fair value of contingent consideration | $ (300,000) | $ (177,354) |
Fair Value of Financial Instr_7
Fair Value of Financial Instruments - Schedule of Inputs and Valuation Methodologies Used (Details) - Level 3 - Elusys Therapeutics $ in Millions | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Revenue earn-out | Discount rate | Discounted cash flow analysis | ||
Fair Value of Financial Instruments | ||
Contingent Consideration | 0.140 | 0.245 |
Revenue earn-out | Future revenue projections | ||
Fair Value of Financial Instruments | ||
Contingent Consideration | 141.4 | |
Revenue earn-out | Future revenue projections | Discounted cash flow analysis | ||
Fair Value of Financial Instruments | ||
Contingent Consideration | 325.9 | |
Deferred contract consideration | Discount rate | Discounted cash flow analysis | ||
Fair Value of Financial Instruments | ||
Contingent Consideration | 0.155 | |
Deferred contract consideration | Future revenue projections | Discounted cash flow analysis | ||
Fair Value of Financial Instruments | ||
Contingent Consideration | 7.6 |
Short-Term Investments (Details
Short-Term Investments (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Mutual funds | ||
Estimated fair value | $ 4.2 | $ 35.8 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid Expenses And Other Current Assets | ||
Prepaid manufacturing expense | $ 475,536 | $ 91,477 |
Contract assets | 363,918 | |
Other prepaid expenses and current assets | 280,787 | 1,132,502 |
Prepaid insurance | 104,126 | 201,252 |
Prepaid preclinical and clinical expenses | 36,861 | 65,892 |
Prepaid expenses and other current assets | $ 1,261,228 | $ 1,491,123 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Property and Equipment | |||||
Total | $ 25,035,411 | $ 25,035,411 | $ 23,392,138 | ||
Accumulated depreciation | (6,351,513) | (6,351,513) | (2,953,617) | ||
Property and equipment, net | 18,683,898 | 18,683,898 | 20,438,521 | ||
Depreciation expense | 1,200,000 | $ 400,000 | $ 3,400,000 | $ 700,000 | |
Minimum | |||||
Property and Equipment | |||||
Estimated useful lives | 3 years | ||||
Maximum | |||||
Property and Equipment | |||||
Estimated useful lives | 8 years | ||||
Lab equipment | |||||
Property and Equipment | |||||
Total | 21,080,029 | $ 21,080,029 | 18,060,058 | ||
Leasehold improvements | |||||
Property and Equipment | |||||
Total | 2,827,289 | 2,827,289 | 2,486,329 | ||
Construction-in-process | |||||
Property and Equipment | |||||
Total | 2,053,335 | ||||
Computers | |||||
Property and Equipment | |||||
Total | 850,211 | 850,211 | 502,084 | ||
Furniture and fixtures | |||||
Property and Equipment | |||||
Total | $ 277,882 | $ 277,882 | 245,770 | ||
Vehicles | |||||
Property and Equipment | |||||
Total | $ 44,562 |
Goodwill and Other Intangible_3
Goodwill and Other Intangible Assets (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Apr. 01, 2023 | Apr. 18, 2022 | Apr. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2017 | |
Goodwill and other intangible assets | |||||||||
In-process research and development impairment | $ 3,500,000 | $ 3,500,000 | |||||||
Goodwill impairment loss | $ 3,873,079 | ||||||||
Pelican Therapeutics, Inc. | |||||||||
Goodwill and other intangible assets | |||||||||
Goodwill acquired | $ 2,200,000 | ||||||||
In-process research and development impairment | $ 3,500,000 | ||||||||
Goodwill impairment loss | $ 1,500,000 | ||||||||
Pelican Therapeutics, Inc. | In-process R&D. | |||||||||
Goodwill and other intangible assets | |||||||||
Finite-lived intangible assets acquired | $ 5,900,000 | ||||||||
Carrying value written down | 5,900,000 | ||||||||
Intangible assets fair value | 3,500,000 | ||||||||
In-process research and development impairment | $ 2,400,000 | ||||||||
Elusys Therapeutics | |||||||||
Goodwill and other intangible assets | |||||||||
Goodwill acquired | $ 3,900,000 | ||||||||
Finite-lived intangible assets acquired | $ 9,700,000 | ||||||||
Balance of finite-lived intangible assets | $ 8,669,375 | ||||||||
In-process research and development impairment | $ 0 | $ 0 | |||||||
Goodwill impairment loss | $ 3,873,079 | ||||||||
Remaining amortization period | 80 months | ||||||||
Increase in goodwill | $ 600,000 | ||||||||
Increase in other assets | 1,000,000 | ||||||||
Increase in liability for uncertain tax positions | 1,000,000 | ||||||||
Increase in deferred tax liability | $ 600,000 |
Goodwill and Other Intangible_4
Goodwill and Other Intangible Assets - Carrying amount of goodwill and intangible assets (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Goodwill | ||
Impairment | $ (3,873,079) | |
Intangible Assets | ||
Impairment | (2,277,921) | |
Amortization of intangible asset | (1,091,250) | $ (666,875) |
Elusys Therapeutics | ||
Goodwill | ||
Goodwill beginning balance | 3,301,959 | |
Impairment | (3,873,079) | |
Acquisition fair value adjustments | 571,120 | |
Intangible Assets | ||
Intangible assets beginning balance | 8,669,375 | |
Impairment | (2,277,921) | |
Amortization of intangible asset | (1,091,250) | |
Reclassified to discontinued operations | $ (5,300,204) |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Expenses and Other Liabilities | ||
Accrued marketing expenses | $ 749,998 | |
Accrued preclinical and clinical trial expenses | 252,618 | $ 953,252 |
Compensation and related benefits | 373,211 | 491,191 |
Accrued manufacturing expenses | 345,646 | 6,133 |
Other expenses | 240,145 | 426,025 |
Accrued franchise tax | 70,000 | 40,000 |
Accrued expenses and other current liabilities | $ 2,031,618 | $ 1,916,601 |
Stockholders' Equity - Changes
Stockholders' Equity - Changes in Outstanding Warrants (Details) - Common stock warrants - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Stockholders' Equity | ||
Warrants to purchase common stock | 313,358 | 747,383 |
Weighted-average exercise price | $ 11.55 | $ 11.06 |
Outstanding, beginning balance | 747,383 | |
Expired | (434,025) | |
Outstanding, ending balance | 313,358 |
Stockholders' Equity - Accounti
Stockholders' Equity - Accounting for Stock-Based Compensation (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stockholders' Equity | ||||
Stock-based compensation | $ 600,000 | $ 700,000 | $ 2,070,837 | $ 2,430,389 |
Compensation expenses capitalized | $ 0 | $ 0 | $ 0 | $ 0 |
Employee stock options | ||||
Stockholders' Equity | ||||
Vesting period | 4 years | |||
Expiration term | 10 years | 10 years | ||
Employee stock options | Maximum | ||||
Stockholders' Equity | ||||
Expiration term | 10 years |
Stockholders' Equity - Stock Op
Stockholders' Equity - Stock Option Valuation Assumptions (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Stockholders' Equity | ||||
Dividend yield | 0% | 0% | 0% | 0% |
Expected volatility | 101.92% | 102.75% | ||
Risk-free interest rate | 2.47% | 2.51% | ||
Expected lives (years) | 5 years 7 months 6 days | 6 years | ||
Weighted average grant date fair value (in dollars per share) | $ 2.25 |
Stockholders' Equity - Stock _2
Stockholders' Equity - Stock Option Activity (Details) | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
Shares | |
Stock options outstanding at beginning of period | 7,036,874 |
Granted | 0 |
Expired | (102,847) |
Forfeited | (214,084) |
Stock options outstanding at end of period | 6,719,943 |
Stock options exercisable at end of period | 3,949,543 |
Weighted Average Exercise Price | |
Stock options outstanding at beginning of period (in dollars per share) | $ / shares | $ 3.67 |
Expired (in dollars per share) | $ / shares | 8.59 |
Forfeited | $ / shares | 3.42 |
Stock options outstanding at end of period (in dollars per share) | $ / shares | 3.61 |
Stock options exercisable at end of period | $ / shares | $ 4.85 |
Aggregate Intrinsic Value | |
Stock options outstanding at beginning of period | $ | $ 16,842 |
Stock options outstanding at end of period | $ | 10,947 |
Stock options exercisable at end of period | $ | $ 10,947 |
Weighted Average Remaining Contractual Life | |
Stock options outstanding at end of period | 8 years 3 months 18 days |
Stock options exercisable at end of period | 7 years 10 months 24 days |
Unrecognized stock-based compensation expense | $ | $ 3,200,000 |
Unrecognized stock-based compensation expense, recognition period | 1 year 1 month 6 days |
Stockholders' Equity - Restrict
Stockholders' Equity - Restricted Stock (Details) | 9 Months Ended |
Sep. 30, 2023 $ / shares shares | |
Restricted stock | |
Shares | |
Restricted stock at beginning of period | shares | 34,001 |
Released | shares | (34,001) |
Weighted Average Fair Value | |
Restricted stock at beginning of period | $ / shares | $ 3.22 |
Released | $ / shares | $ 3.22 |
RSU's | |
Shares | |
Granted | shares | 360,000 |
Released | shares | (80,000) |
Restricted stock at end of period | shares | 280,000 |
Weighted Average Fair Value | |
Granted | $ / shares | $ 1.18 |
Released | $ / shares | 1.18 |
Restricted stock at end of period | $ / shares | $ 1.18 |
Vesting period | 36 months |
Revenue (Details)
Revenue (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 88 Months Ended | |||||||||||
Sep. 13, 2023 USD ($) item | Sep. 13, 2022 USD ($) | Apr. 19, 2022 USD ($) item | Apr. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2019 USD ($) | Oct. 31, 2017 USD ($) | May 31, 2017 USD ($) | Jun. 30, 2016 USD ($) | Sep. 30, 2023 USD ($) customer | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) customer | Sep. 30, 2022 USD ($) | Dec. 31, 2022 USD ($) | Sep. 30, 2023 USD ($) customer | Dec. 31, 2021 USD ($) | |
Grant Revenue | ||||||||||||||||
Revenue | $ 723,126 | $ 58,861 | $ 2,146,804 | $ 290,259 | ||||||||||||
Grant receivable | $ 1,524,522 | |||||||||||||||
Process Development Revenue | ||||||||||||||||
Process development revenue recognized | $ 600,000 | $ 2,000,000 | ||||||||||||||
Number of customers process development revenue was derived from | customer | 2 | 2 | 2 | |||||||||||||
Process development contract liabilities, beginning of period | $ (2,734,524) | (35,000) | $ (1,618,308) | (35,000) | (35,000) | |||||||||||
Reclassification to revenue as the result of performance obligations satisfied | 638,625 | 1,962,303 | ||||||||||||||
Net change to contract balance recognized since beginning of period due to amounts collected | (1,993,247) | (716,350) | (4,433,141) | (1,583,308) | ||||||||||||
Process development contract liabilities, end of period | (4,089,146) | (751,350) | (4,089,146) | (751,350) | (1,618,308) | $ (4,089,146) | ||||||||||
Accounts receivable | 313,906 | 313,906 | 81,456 | 313,906 | $ 66,049 | |||||||||||
Shattuck | ||||||||||||||||
License Revenue | ||||||||||||||||
License fee received | $ 50,000 | |||||||||||||||
Proceeds from milestone payment | $ 100,000 | |||||||||||||||
ANTHIM Vials | ||||||||||||||||
Grant Revenue | ||||||||||||||||
Number of vials to be delivered | item | 3,000 | |||||||||||||||
Contract award | $ 5,900,000 | |||||||||||||||
Number of vials, manufacturing conversion | item | 23,732 | |||||||||||||||
Revenue | $ 6,700,000 | |||||||||||||||
ANTHIM Vials | Elusys Therapeutics business | ||||||||||||||||
Grant Revenue | ||||||||||||||||
Contract amount retained | $ 1,100,000 | |||||||||||||||
Disposal group including discontinued operation Amount paid to seller | 4,600,000 | |||||||||||||||
ANTHIM Vials | Accounts receivable | ||||||||||||||||
Grant Revenue | ||||||||||||||||
Contract with customer, receivable, after allowance for credit loss, current | $ 5,900,000 | |||||||||||||||
Pelican Therapeutics, Inc. | Grant and contract revenue | ||||||||||||||||
Grant Revenue | ||||||||||||||||
Amount awarded from CPRIT grant | 15,200,000 | |||||||||||||||
Revenue | $ 1,500,000 | 0 | $ 100,000 | 0 | $ 300,000 | 15,200,000 | ||||||||||
Remaining grant amount receivable | $ 1,500,000 | |||||||||||||||
Amount the company is required to match of each dollar of grant | 0.50 | 0.50 | 0.50 | |||||||||||||
Threshold amount for match of grant | 1 | 1 | 1 | |||||||||||||
Contribution to be made by Pelican | $ 7,600,000 | $ 7,600,000 | $ 7,600,000 | |||||||||||||
Grant receivable | $ 1,500,000 | |||||||||||||||
Pelican Therapeutics, Inc. | Grant and contract revenue | Maximum | ||||||||||||||||
Grant Revenue | ||||||||||||||||
Amount awarded from CPRIT grant | $ 15,200,000 | |||||||||||||||
Royalty percentage after threshold is met | 1% | |||||||||||||||
Pelican Therapeutics, Inc. | Grant and contract revenue | Tranche 1 | ||||||||||||||||
Grant Revenue | ||||||||||||||||
Revenue | $ 1,800,000 | |||||||||||||||
Pelican Therapeutics, Inc. | Grant and contract revenue | Tranche 2 | ||||||||||||||||
Grant Revenue | ||||||||||||||||
Revenue | $ 6,500,000 | |||||||||||||||
Pelican Therapeutics, Inc. | Grant and contract revenue | Tranche 3 | ||||||||||||||||
Grant Revenue | ||||||||||||||||
Revenue | $ 5,400,000 |
Net Loss Per Share - Reconcilia
Net Loss Per Share - Reconciliation of Net Loss (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Net Loss Per Share | ||||
Net loss | $ (14,312,029) | $ (13,347,771) | $ (41,168,866) | $ (28,475,479) |
Net loss - Non-controlling interest | (1,179,559) | (89,421) | (1,359,734) | (265,256) |
Net loss attributable to NightHawk | $ (13,132,470) | $ (13,258,350) | $ (39,809,132) | $ (28,210,223) |
Weighted-average common shares outstanding, basic (in shares) | 26,050,562 | 25,613,316 | 26,022,244 | 25,603,481 |
Weighted-average common shares outstanding, diluted (in shares) | 26,050,562 | 25,613,316 | 26,022,244 | 25,603,481 |
Net loss per share, basic - continuing operations (in dollars per share) | $ (0.38) | $ (0.41) | $ (1.30) | $ (0.95) |
Net loss per share, diluted - continuing operations (in dollars per share) | (0.38) | (0.41) | (1.30) | (0.95) |
Net loss per share, basic - discontinued operations (in dollars per share) | (0.12) | (0.11) | (0.23) | (0.15) |
Net loss per share, diluted - discontinued operations (in dollars per share) | (0.12) | (0.11) | (0.23) | (0.15) |
Net loss per share common share attributable to NightHawk Biosciences, Inc., basic | (0.50) | (0.52) | (1.53) | (1.10) |
Net loss per share common share attributable to NightHawk Biosciences, Inc., diluted | $ (0.50) | $ (0.52) | $ (1.53) | $ (1.10) |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Employee stock options | ||
Net Loss Per Share | ||
Potentially dilutive securities | 6,719,943 | 3,006,968 |
Restricted stock subject to forfeiture and restricted stock units | ||
Net Loss Per Share | ||
Potentially dilutive securities | 280,000 | 46,859 |
Common stock warrants | ||
Net Loss Per Share | ||
Potentially dilutive securities | 313,358 | 747,383 |
Income Tax (Details)
Income Tax (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2023 | Jun. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2023 | |
Income Tax | |||||||
Income tax expense (benefit) | $ 100 | $ (40) | $ (500) | $ (3,300) | |||
Statutory federal tax rate | 21% | ||||||
Accrued interest and penalty related to uncertain tax positions | 100 | $ 100 | |||||
Unrecognized tax benefit | 1,500 | 1,500 | |||||
Unrecognized income tax benefits impact on effective income tax rate | $ 1,000 | $ 1,000 | |||||
Forecast | |||||||
Income Tax | |||||||
Effective tax rate | 0% | ||||||
Elusys Therapeutics | |||||||
Income Tax | |||||||
Income tax benefit recognized as discrete item | $ (600) | $ (3,000) |
Leases - Facility Lease (Detail
Leases - Facility Lease (Details) | 1 Months Ended | |||||
Sep. 15, 2022 USD ($) lease | Dec. 31, 2022 USD ($) ft² lease | Oct. 31, 2021 ft² | Jun. 30, 2021 USD ($) ft² lease | Sep. 30, 2023 USD ($) | May 02, 2023 USD ($) | |
Leases | ||||||
Operating lease right-of-use asset | $ 5,866,261 | $ 5,346,910 | ||||
Operating lease liability | 3,230,102 | |||||
Finance lease right-of-use asset | 15,329,075 | 20,979,923 | ||||
Finance lease liability | $ 10,018,242 | |||||
Merchants Ice II, LLC | Lab equipment | ||||||
Leases | ||||||
Reimbursement of expenses, capitalized | $ 13,200,000 | |||||
Morrisville, NC | ||||||
Leases | ||||||
Area of facility to be leased | ft² | 15,996 | |||||
Lease term | 8 years | |||||
Number of lease renewal terms | lease | 1 | |||||
Lease renewal term | 5 years | |||||
Maximum amount of tenant improvements provided for under lease | $ 2,400,000 | |||||
Operating lease right-of-use asset | 5,600,000 | |||||
Operating lease liability | $ 3,200,000 | |||||
San Antonio, TX | Merchants Ice II, LLC | ||||||
Leases | ||||||
Area of facility to be leased | ft² | 20,144 | |||||
Reimbursement of expenses to lessor | $ 24,300,000 | |||||
Lease term | 15 years | |||||
Number of lease renewal terms | lease | 1 | |||||
Lease renewal term | 15 years | |||||
Number of lease subsequent renewal terms | lease | 1 | |||||
Lease subsequent renewal term | 10 years | |||||
Maximum amount of tenant improvements provided for under lease | $ 2,400,000 | |||||
Reimbursements, expensed | 900,000 | |||||
Reimbursement included in finance lease right of use asset | 10,200,000 | |||||
Finance lease right-of-use asset | 15,100,000 | |||||
Finance lease liability | $ 5,100,000 | |||||
San Antonio, TX | TPB Merchants Ice, LLC | ||||||
Leases | ||||||
Area of facility to be leased | ft² | 8,042 | |||||
Lease term | 15 years | |||||
Number of lease renewal terms | lease | 1 | |||||
Lease renewal term | 15 years | |||||
Number of lease subsequent renewal terms | lease | 1 | |||||
Lease subsequent renewal term | 10 years | |||||
Maximum amount of tenant improvements provided for under lease | $ 6,500,000 | |||||
Finance lease right-of-use asset | $ 7,800,000 | |||||
Finance lease liability | $ 2,300,000 | |||||
Prepaid rent to lessor | $ 5,400,000 |
Leases - Lease Cost (Details)
Leases - Lease Cost (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases | |||
Operating lease payments | $ 200,000 | $ 600,000 | |
Operating lease cost | 287,590 | 956,673 | |
Finance lease cost | |||
Amortization of lease assets | 526,709 | 1,240,249 | |
Interest on lease liabilities | 235,566 | 525,791 | |
Total finance lease cost | $ 762,275 | $ 1,766,040 | |
Weighted average remaining lease term (years), Operating leases | 6 years 8 months 12 days | 6 years 8 months 12 days | 4 years 2 months 12 days |
Weighted average remaining lease term (years), Finance leases | 11 years 3 months 18 days | 11 years 3 months 18 days | 9 years 6 months |
Weighted average incremental borrowing rate, Operating leases | 9.45% | 9.45% | 5.25% |
Weighted average incremental borrowing rate, Finance leases | 10.12% | 10.12% | 6.65% |
Leases - Maturities of Operatin
Leases - Maturities of Operating and Finance Lease Liabilities (Details) | Sep. 30, 2023 USD ($) |
Maturities of operating lease liabilities | |
2023 (excluding the nine months ended September 30, 2023) | $ 175,322 |
2024 | 667,825 |
2025 | 635,180 |
2026 | 575,350 |
2027 | 592,572 |
2028 | 610,407 |
2029 | 628,723 |
Thereafter | 536,933 |
Total minimum lease payments | 4,422,312 |
Less: imputed interest | (1,192,210) |
Present value of operating lease liabilities | 3,230,102 |
Maturities of finance lease liabilities | |
2023 (excluding the nine months ended September 30, 2023) | 411,365 |
2024 | 1,825,556 |
2025 | 1,736,837 |
2026 | 1,664,975 |
2027 | 902,127 |
2028 | 931,290 |
2029 | 961,311 |
Thereafter | 9,340,354 |
Total minimum lease payments | 17,773,815 |
Less: imputed interest | (7,755,573) |
Present value of lease liabilities | 10,018,242 |
Maturities of lease liabilities | |
2023 (excluding the nine months ended September 30, 2023) | 586,687 |
2024 | 2,493,381 |
2025 | 2,372,017 |
2026 | 2,240,325 |
2027 | 1,494,699 |
2028 | 1,541,697 |
2029 | 1,590,034 |
Thereafter | 9,877,287 |
Total minimum lease payments | 22,196,127 |
Less: imputed interest | (8,947,783) |
Present value of lease liabilities | $ 13,248,344 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
ANTHIM | |
Future commitments | $ 53 |