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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2022

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______________ to _______________

Commission file number: 001-35994

NightHawk Biosciences, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

(State or Other Jurisdiction of

Incorporation or Organization)

26-2844103

(I.R.S. Employer

Identification No.)

627 Davis Drive, Suite 400

Morrisville, NC

(Address of Principal Executive Offices)

27560

(Zip Code)

(919240-7133

(Registrant’s Telephone Number, including Area Code)

Heat Biologics, Inc.

(Former name, address, and fiscal year, if changed since the last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

NHWK

NYSE American LLC

Common Stock Purchase Rights

NYSE American LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes   No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes   No 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  No 

As of August 10, 2022, there were 25,661,488 shares of Common Stock, $0.0002 par value per share, outstanding.

Table of Contents

NIGHTHAWK BIOSCIENCES, INC.

TABLE OF CONTENTS

Page No.

PART I—FINANCIAL INFORMATION

Item 1.

Financial Statements

2

Consolidated Balance Sheets as of June 30, 2022 (unaudited) and December 31, 2021

2

Consolidated Statements of Operations and Comprehensive Loss (unaudited) for the three and six months ended June 30, 2022 and June 30, 2021

3

Consolidated Statements of Stockholders’ Equity (unaudited) for the three and six months ended June 30, 2022 and June 30, 2021

4

Consolidated Statements of Cash Flows (unaudited) for the six months ended June 30, 2022 and June 30, 2021

6

Notes to the Consolidated Financial Statements (unaudited)

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

26

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

Item 4.

Controls and Procedures

34

PART II—OTHER INFORMATION

Item 1.

Legal Proceedings

35

Item 1A.

Risk Factors

35

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

38

Item 3.

Defaults Upon Senior Securities

39

Item 4.

Mine Safety Disclosures

39

Item 5.

Other Information

39

Item 6.

Exhibits

40

SIGNATURES

42

Table of Contents

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Forward-looking statements are not guarantees of future performance and our actual results could differ materially from the results discussed in the forward-looking statements. Factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, our ability to raise additional capital to support our clinical development program, our manufacturing operations and other operations, our ability to develop products of commercial value and to identify, discover and obtain rights to additional potential product candidates, our ability to protect and maintain our intellectual property and the ability of our licensors to obtain and maintain patent protection for the technology or products that we license from them, the outcome of research and development activities, our reliance on third-parties, the timing of completion of construction of the planned manufacturing facilities in Texas and Kansas, our ability to successfully operate a manufacturing facility, competitive developments, the effect of current and future legislation and regulation and regulatory actions, as well as other risks described more fully in this Quarterly Report on Form 10-Q and our other filings with the Securities and Exchange Commission (the “SEC”). Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those identified below, under Part II, Item 1A. “Risk Factors” and elsewhere herein and those identified under Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 11, 2022 (the “2021 Annual Report”). Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason.

As a result of these and other factors, we may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

NOTE REGARDING COMPANY REFERENCES

Throughout this Quarterly Report on Form 10-Q, “NightHawk,” “NightHawk Biosciences,” “the Company,” “we” and “our” refer to NightHawk Biosciences, Inc.

1

Table of Contents

PART I—FINANCIAL INFORMATION

ITEM 1.       FINANCIAL STATEMENTS

NIGHTHAWK BIOSCIENCES, INC.

Consolidated Balance Sheets

    

June 30, 

December 31, 

2022

    

2021

(unaudited)

Current Assets

Cash and cash equivalents

$

10,242,659

$

8,053,879

Short-term investments

 

59,707,339

 

88,324,922

Accounts receivable

 

148,160

 

66,049

Income tax refund receivable

1,132,057

Prepaid expenses and other current assets

 

2,314,503

 

2,886,520

Inventory

5,844,000

Total Current Assets

 

79,388,718

 

99,331,370

Property and Equipment, net

 

5,252,596

 

2,158,479

Intangible assets, net

 

14,350,000

 

3,500,000

Goodwill

5,067,747

Grant receivable

 

1,524,522

 

1,318,359

Operating lease right-of-use asset

2,197,339

1,782,884

Finance lease right-of-use asset

344,979

470,700

Other assets

 

23,507,333

 

12,193,540

Deposits

 

221,559

 

205,901

Total Assets

$

131,854,793

$

120,961,233

Liabilities and Stockholders' Equity

 

  

 

  

Current Liabilities

 

  

 

  

Accounts payable

$

4,516,845

$

922,782

Operating lease liability, current portion

599,930

350,343

Finance lease liability, current portion

217,088

260,574

Accrued expenses and other liabilities

 

2,743,709

 

2,419,676

Contingent consideration, current portion

6,875,777

593,037

Contingent consideration, related party - current portion

178,338

174,333

Total Current Liabilities

 

15,131,687

 

4,720,745

Long Term Liabilities

 

  

 

  

Other long-term liabilities

 

56,454

 

53,530

Derivative warrant liability

1,730

11,020

Deferred tax liability

 

3,541,937

 

215,937

Deferred revenue, net of current portion

 

35,000

 

35,000

Operating lease liability, net of current portion

 

1,279,037

 

1,060,856

Financing lease liability, net of current portion

 

187,770

 

255,429

Contingent consideration

15,703,382

1,990,118

Contingent consideration, related party

530,133

585,027

Total Liabilities

 

36,467,130

 

8,927,662

Stockholders' Equity

 

  

 

  

Common stock, $0.0002 par value; 250,000,000 shares authorized, 25,649,824 shares issued and outstanding at June 30, 2022 and December 31, 2021

 

5,120

 

5,055

Additional paid-in capital

 

280,603,302

 

278,890,153

Accumulated deficit

 

(183,996,826)

 

(165,718,953)

Accumulated other comprehensive income (loss)

 

26,645

 

(67,941)

Total Stockholders' Equity - NightHawk Biosciences, Inc.

 

96,638,241

 

113,108,314

Non-Controlling Interest

 

(1,250,578)

 

(1,074,743)

Total Stockholders' Equity

 

95,387,663

 

112,033,571

Total Liabilities and Stockholders' Equity

$

131,854,793

$

120,961,233

See Notes to Consolidated Financial Statements

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NIGHTHAWK BIOSCIENCES, INC.

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2022

    

2021

    

2022

    

2021

Revenue:

Grant and contract revenue

$

50,981

$

459,494

$

263,399

$

998,139

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

 

4,726,517

 

4,216,294

 

8,659,864

 

7,622,542

General and administrative

 

4,890,544

 

2,853,265

 

8,667,167

 

7,620,910

Amortization of intangible asset

350,000

350,000

Change in fair value of contingent consideration

 

(203,000)

 

105,000

 

(224,000)

 

111,000

Total operating expenses

 

9,764,061

 

7,174,559

 

17,453,031

 

15,354,452

Loss from operations

 

(9,713,080)

 

(6,715,065)

 

(17,189,632)

 

(14,356,313)

Change in fair value of warrant liability

1,511

4,679

9,290

(4,023)

Interest income

 

175,173

 

176,798

 

295,875

 

371,963

Unrealized loss on available-for-sale securities

(595,038)

(56,071)

(1,431,631)

(202,384)

Other expense, net

 

(132,476)

 

(30,917)

 

(137,610)

 

(52,959)

Total non-operating (loss) income

 

(550,830)

 

94,489

 

(1,264,076)

 

112,597

Net loss before income taxes

 

(10,263,910)

 

(6,620,576)

 

(18,453,708)

 

(14,243,716)

Income tax benefit (expense)

 

 

 

 

Net loss

 

(10,263,910)

 

(6,620,576)

 

(18,453,708)

 

(14,243,716)

Net loss - non-controlling interest

 

(106,624)

 

(77,379)

 

(175,835)

 

(168,341)

Net loss attributable to NightHawk Biosciences, Inc.

$

(10,157,286)

$

(6,543,197)

$

(18,277,873)

$

(14,075,375)

Net loss per share, basic and diluted

$

(0.40)

$

(0.26)

$

(0.71)

$

(0.57)

Weighted-average common shares outstanding, basic and diluted

 

25,602,965

 

25,137,466

 

25,598,481

 

24,671,281

Comprehensive loss:

 

  

 

  

 

  

 

  

Net loss

$

(10,263,910)

$

(6,620,576)

$

(18,453,708)

$

(14,243,716)

Unrealized gain on foreign currency translation

 

149,855

 

26,661

 

94,586

 

44,929

Total comprehensive loss

 

(10,114,055)

 

(6,593,915)

 

(18,359,122)

 

(14,198,787)

Comprehensive loss attributable to non-controlling interest

 

(106,624)

 

(77,379)

 

(175,835)

 

(168,341)

Comprehensive loss - NightHawk Biosciences, Inc.

$

(10,007,431)

$

(6,516,536)

$

(18,183,287)

$

(14,030,446)

See Notes to Consolidated Financial Statements

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NIGHTHAWK BIOSCIENCES, INC.

Consolidated Statements of Stockholders’ Equity

(Unaudited)

Three Months Ended June 30, 2022

Accumulated

Other

Total

Common

Accumulated

Comprehensive

Non-Controlling

Stockholders'

    

Stock

    

APIC

    

Deficit

    

(Loss) Income

    

Interest

    

Equity

Balance at March 31, 2022

$

5,120

$

279,800,072

$

(173,839,540)

$

(123,210)

$

(1,143,954)

$

104,698,488

Stock-based compensation

803,230

803,230

Other comprehensive income

 

 

 

149,855

 

 

149,855

Net loss

 

 

 

(10,157,286)

 

 

(106,624)

 

(10,263,910)

Balance at June 30, 2022

 

$

5,120

 

$

280,603,302

 

$

(183,996,826)

 

$

26,645

 

$

(1,250,578)

 

$

95,387,663

Six Months Ended June 30, 2022

    

Accumulated

Other

Total

Common

Accumulated

Comprehensive

Non-Controlling

Stockholders'

    

Stock

    

APIC

    

Deficit

    

(Loss) Income

    

Interest

    

Equity

Balance at December 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)

Stock-based compensation

1,713,214

1,713,214

Other comprehensive income

 

 

 

 

94,586

 

 

94,586

Net loss

 

 

 

(18,277,873)

 

 

(175,835)

 

(18,453,708)

Balance at June 30, 2022

 

$

5,120

 

$

280,603,302

 

$

(183,996,826)

 

$

26,645

 

$

(1,250,578)

 

$

95,387,663

See Notes to Consolidated Financial Statements

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NIGHTHAWK BIOSCIENCES, INC.

Consolidated Statements of Stockholders’ Equity

(Unaudited)

Three Months Ended June 30, 2021

    

Accumulated

Other

Total

Common

Accumulated

Comprehensive

Non-Controlling

Stockholders'

    

Stock

    

APIC

    

Deficit

    

Income (Loss)

    

Interest

    

Equity

Balance at March 31, 2021

$

5,027

$

275,618,780

$

(138,179,663)

$

(147,788)

$

(836,366)

$

136,459,990

Stock-based compensation

 

 

606,268

 

 

 

 

606,268

Other comprehensive income

26,661

26,661

Net loss

 

 

 

(6,543,197)

 

 

(77,379)

 

(6,620,576)

Balance at June 30, 2021

 

$

5,027

 

$

276,225,048

 

$

(144,722,860)

 

$

(121,127)

 

$

(913,745)

 

$

130,472,343

Six Months Ended June 30, 2021

    

Accumulated

Other

Total

Common

Accumulated

Comprehensive

Non-Controlling

Stockholders'

    

Stock

    

APIC

    

Deficit

    

Loss

    

Interest

    

Equity

Balance at December 31, 2020

$

4,519

$

247,048,349

$

(130,647,485)

$

(166,056)

$

(745,404)

$

115,493,923

Issuance of common stock under ATM, net of issuance costs

 

420

 

26,303,862

 

 

 

 

26,304,282

Issuance of common stock from vesting of restricted stock awards

 

82

 

(82)

 

 

 

 

Stock issuance costs

 

 

(658,184)

 

 

 

 

(658,184)

Stock-based compensation

 

 

3,503,848

 

 

 

 

3,503,848

Issuance of restricted stock

3

(3)

Exercise of options

 

6

 

27,255

 

 

 

 

27,261

Cancellation and payout of fractional shares

 

(3)

 

3

 

 

 

 

Other comprehensive income

 

 

 

 

44,929

 

 

44,929

Net loss

 

 

 

(14,075,375)

 

 

(168,341)

 

(14,243,716)

Balance at June 30, 2021

 

$

5,027

 

$

276,225,048

 

$

(144,722,860)

 

$

(121,127)

 

$

(913,745)

 

$

130,472,343

See Notes to Consolidated Financial Statements

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NIGHTHAWK BIOSCIENCES, INC.

Consolidated Statements of Cash Flows

(Unaudited)

For the Six Months Ended

June 30, 

    

2022

    

2021

Cash Flows from Operating Activities

Net loss

$

(18,453,708)

$

(14,243,716)

Adjustments to reconcile net loss to net cash used in operating activities:

 

  

 

  

Depreciation and amortization

 

420,630

 

237,160

Amortization of intangible asset

350,000

Noncash lease expense

53,313

43,295

Noncash interest expense

11,870

7,087

Stock-based compensation

 

1,713,214

 

3,503,848

Change in fair value of common stock warrants

(9,290)

4,023

Change in fair value of contingent consideration

 

(224,000)

 

111,000

Unrealized loss on investments

 

1,431,631

 

202,384

Increase (decrease) in cash arising from changes in assets and liabilities:

 

 

Accounts receivable

 

(82,992)

 

74,159

Prepaid expenses and other current assets

 

1,336,620

 

(282,654)

Contract receivables

24,526,231

Grant receivable

 

(206,163)

 

(368,465)

Other assets

(11,013,793)

Deposits

 

10,592

 

(29,487)

Accounts payable

 

3,421,220

 

129,493

Accrued expenses and other liabilities

 

(4,719,416)

 

200,883

Other long-term liabilities

 

2,925

 

12,706

Deferred revenue

 

2,500

 

(603,717)

Net Cash Used In Operating Activities

 

(1,428,616)

 

(11,002,001)

Cash Flows from Investing Activities

 

  

 

  

Purchase of short-term investments

 

(1,762,833)

 

(61,202,605)

Sale of short-term investments

28,948,785

60,877,673

Purchase of property and equipment

(3,350,670)

(3,647,559)

Acquisition of Elusys Therapeutics, net of cash paid

2,719,898

Payment of contingent consideration

(22,784,571)

Net Cash Provided By (Used In) Investing Activities

 

3,770,609

 

(3,972,491)

Cash Flows from Financing Activities

 

  

 

  

Proceeds from the issuance of common stock

 

 

26,304,282

Proceeds from exercise of stock options

27,261

Stock issuance costs

 

 

(658,184)

Repayments on principal of finance lease

(111,146)

(60,342)

Net Cash (Used In) Provided by Financing Activities

 

(111,146)

 

25,613,017

Effect of exchange rate changes on cash and cash equivalents

 

(42,067)

 

(3,128)

Net Increase in Cash and Cash Equivalents

 

2,188,780

 

10,635,397

Cash and Cash Equivalents – Beginning of Period

 

8,053,879

 

10,931,890

Cash and Cash Equivalents – End of Period

$

10,242,659

$

21,567,287

Supplemental Disclosure for Cash Flow Information:

 

  

 

  

Cash paid for receivable consideration included in contract receivables

$

20,784,571

$

Supplemental disclosure of non-cash investing and financing activities:

Purchases of other assets included in accounts payable

$

2,345,624

$

Right-of-use assets obtained on operating lease commencements

$

704,004

$

Contingent and deferred cash consideration related to Elusys acquisition

$

45,953,685

$

See Notes to Consolidated Financial Statements

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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”) 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 six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2022.

The consolidated financial statements as of and for the three and six months ended June 30, 2022 and 2021 are unaudited. The balance sheet as of December 31, 2021 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, 2021 filed with the SEC on March 11, 2022 (the “2021 Annual Report”).

The accompanying unaudited consolidated financial statements as of and for the three and six months ended June 30, 2022 and 2021 include the accounts of the Company, and its subsidiaries, 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.), Scorpion Biological Services, Inc. (“Scorpion”) (formerly Scorpion Biosciences, Inc), Elusys Therapeutics, Inc. (“Elusys”), Blackhawk Bio, Inc, and Abacus Biotech, Inc. 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 loss in stockholders’ equity. All significant intercompany accounts and transactions have been eliminated in consolidation. At June 30, 2022 and December 31, 2021, NightHawk held 85% controlling interest in Pelican. 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.

Liquidity and Capital Resources

The Company has an accumulated deficit of approximately $184.0 million as of June 30, 2022 and a net loss of approximately $10.3 million and $18.5 million for the three and six months ended June 30, 2022 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 continues its research and development and advances its clinical trials of, and seeks marketing approval for, its product candidates, builds its in-house bioanalytic, process development and manufacturing facility and expands its infectious disease/biological threat program, including its support of the development of, and commencement of operations at, a new biodefense-focused large molecule and biologics biomanufacturing facility in Manhattan, Kansas. As of June 30, 2022, a lease has not been executed for this facility. In addition, if the Company obtains marketing approval for any of its product candidates, the Company expects to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Furthermore, any new business ventures that the Company may engage in are likely to require commitments of capital. Accordingly, the Company will in the future need to obtain substantial additional funding in connection with its planned operations.

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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 research and development 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 June 30, 2022, the Company had approximately $69.9 million in cash and cash equivalents and short-term investments, which it believes is sufficient to fund its operations for at least one year from the date these consolidated financial statements were issued. This is based on the Company’s current estimates, and the Company could use its available capital resources sooner than it currently expects. The Company will need to generate significant revenues to achieve profitability, and it may never do so.

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 results of clinical trials and reaching milestones, uncertainty of regulatory approval of the Company’s potential drug candidates or its manufacturing facility, the timing of completion of construction of the planned manufacturing facilities, 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, securing and protecting proprietary technology, strategic relationships and dependence on key individuals and sole source suppliers.

The Company relies on third-party manufacturers to purchase from their third-party vendors the materials necessary to produce product candidates and manufacture product candidates for clinical studies. The Company also depends on third-party suppliers for key materials and services used in research and development, as well as 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. The Company does not control the manufacturing processes of the contract development and manufacturing organizations, or CDMOs, with whom it contracts and is dependent on these third parties for the production of its therapeutic candidates in accordance with relevant regulations (such as current Good Manufacturing Practices, or cGMP), which include, among other things, quality control, quality assurance and the maintenance of records and documentation.

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 ASC Topic 815 Derivatives and Hedging (“ASC 815”) because they are not considered indexed to the Company’s own stock. Subsequently, the liability is adjusted to fair value as of the end of each reporting period and the changes in fair value of derivative liabilities are recorded in the consolidated statements of operations and comprehensive loss under the caption “Change in fair value of warrant liability.” See Note 3 for additional information.

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. At June 30, 2022, the fair value of such warrants was $1,730, which is classified as a long-term derivative warrant liability on the Company’s consolidated balance sheets.

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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, in process research and development (“IPR&D”), income taxes, valuation of warrant liabilities, 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 our 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. We have 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. In some cases, we have used discounted cash flow analyses, which were based on our best estimate of future revenue, earnings and cash flows as well as our 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 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 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 are not amortized.

In-process research and development, or 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

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impairment charge related to the IPR&D assets, calculated as the excess of the carrying value of the IPR&D assets over their 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. 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.

Deferred Revenue

Deferred revenue is comprised of an exclusive license agreement with Shattuck Labs, Inc. (“Shattuck”) pursuant to which the Company 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 is in the early stages of development and 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 revenue from Shattuck.

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.

Inventory

The Company maintains inventory consisting of bulk drug substance (“BDS”) used in the manufacturing process. The Company values inventory at net realizable value. Net realizable value represents the estimated selling price for inventories less all estimated costs to sell.

The Company performs an analysis and records a provision for potentially obsolete inventory. The reserve for obsolescence is generally an estimate of the amount of inventory held at period end that is expected to expire in the future based on projected sales volume and expected product expiration or sell-by dates. These assumptions require the Company to analyze the aging of and forecasted demand for its inventory and make estimates regarding future product sales.

Grants Receivable and Revenue Recognition

The Company’s primary source of revenue is grant revenue related to the Cancer Prevention and Research Institute of Texas (“CPRIT”) contract, which is being accounted for under ASU No. 2018-08, Not-For-Profit Entities (Topic 958):

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Clarifying the Scope and the Accounting Guidance for Contributions Received and Contributions Made, as a conditional non-exchange contribution.

The CPRIT grant covers the periods from June 1, 2017 through May 31, 2023, for a total grant award of up to $15.2 million. CPRIT advances 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 will be paid, on a reimbursement basis, after the Company has fulfilled every objective of the final goals of the grant. Funds received are reflected in deferred revenue as a liability until revenue is earned. Grant revenue is recognized when qualifying costs are incurred. When grant funds are received after costs have been incurred, the Company records revenue and a corresponding grants receivable until grant funds are received. As of the June 30, 2022, all $15.2 million has been recognized.

On January 7, 2020, the Company was awarded a grant of up to $224,713 from the National Institute of Allergy and Infectious Diseases which is under the umbrella of the National Institutes of Health (“NIH”). The NIH grant provides funding for continued development of the Company’s technologies for PTX-35. The grant funds will be made available by the NIH to the Company as allowable expenses are incurred. For the three and six months ended June 30, 2022 and 2021, the Company incurred no allowable expenses under the NIH grant and did not recognize any corresponding grant revenue for those periods.

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, and insurance.

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 likely.

Other Assets

In conjunction with a lease agreement further discussed in Note 13, Scorpion has made reimbursement payments to the lessor for costs incurred in conjunction with the leased site.  These payments are included in other assets on the consolidated balance sheets and will be classified as a right-of-use asset upon commencement.

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 2021 Annual Report. Due to the acquisition of Elusys, there have been significant changes in the critical accounting policies and estimates during the first six months of fiscal year 2022 which are reflected above.

Recently Issued Accounting Standards

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses which requires financial assets measured at amortizedcost basis to be presented at the net amount expected to be collected. This standard is effective for

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fiscal years beginning after December 15, 2022 and the Company is currently evaluating the expected impact of this standard but does not expect it to have a material impact onits consolidated financial statements upon adoption.

In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivativesand Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This ASU simplifies the accounting for convertible instruments. This ASU also requires entities to use the if-convertedmethod for all convertible instruments in calculating diluted earnings-per-share. The ASU is effective for annual periods beginning afterDecember 15, 2021 with early adoption permitted. This standard was adopted in the first quarter of 2022 and resulted in no material impact.

2. Acquisitions

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. 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 Pelican stock acquisition agreement, the Company is 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. The fair value of these future milestone payments is reflected in the contingent consideration account under current liabilities with the non-current portion under long term liabilities on the balance sheet. The estimated fair value of the contingent consideration was determined using a probability-weighted income approach. The Company estimates the fair value of the contingent consideration on a quarterly basis. At the time of the Pelican acquisition, the Company’s CEO and certain affiliated entities as well as two of the Company’s other directors and certain affiliated entities directly or indirectly owned shares of Pelican common stock purchased by the Company. As a result, approximately 22.7% of any such milestone payments will be paid to the Companys CEO and certain affiliated entities as well as certain two other directors of the Company which is presented separately on the balance sheet as contingent consideration, related party. On June 22, 2020, the Company achieved the first milestone when it dosed the first patient in the first Phase 1 clinical trial of PTX-35 in solid tumors.

As discussed in Note 10, in May 2016, Pelican was awarded a $15.2 million CPRIT Grant from CPRIT for development of Pelican’s lead product candidate, PTX-35. The CPRIT Grant supports Pelican in developing PTX-35 through its current Phase 1 clinical trial designed to evaluate PTX-35 in combination with other immunotherapies.

Elusys Therapeutics

On April 18, 2022 (“Closing Date”), the Company closed on the acquisition of Elusys. NightHawk paid at the closing a cash upfront payment of $3,000,000 to the former owners (“Sellers”) of Elusys. NightHawk will also pay the Sellers $2,000,000 of deferred cash consideration (“Merger Consideration”) at the same time that the payment of the receivable consideration is to be distributed to the Sellers as described below. 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, upon collection of the Elusys contract receivables of $24.5 million, NightHawk will remit payment of $22.3 million (the “Receivable Consideration”) to the Sellers. During the second quarter $20.8 million was remitted to the sellers less a hold back related to future fulfillment cost. Elusys is expected to receive additional revenue from the future fulfillment of an existing U.S. Government contract, and NightHawk has agreed to fulfill the future

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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, with respect to the sale of 1,500 pre-filled vials of ANTHIM® 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 NightHawk’s RapidVax® platform, which is designed to target emerging biological threats.  NightHawk plans to leverage Elusys’ existing relationships and distribution channels. In addition, NightHawk expects to leverage the capabilities of its planned Scorpion biomanufacturing facility in Manhattan, Kansas, which will enable the Company to manufacture these therapies internally and therefore benefit from significant operating synergies, as well as enhanced oversight, quality control, and speed to market.  The Company is also exploring opportunities to expand ANTHIM® distribution abroad. The acquisition is aligned with NightHawk’s vision to establish a fully-integrated ecosystem to deliver medical innovations faster, better, and more efficiently.

The fair value of the purchase consideration was approximately $46.0 million. The purchase consideration consists of $3.0 million in cash and $2.0 million in deferred cash consideration, and the preliminary 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 $41.0 million. The preliminary valuation of the contract deferred consideration and earn out liabilities were valued using a discounted cash flow analysis that utilized discount rates of 26% and 14%, respectively. The preliminary 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 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 preliminary estimated 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 $5.1 million and will be deductible for tax purposes over 15 years. A preliminary purchase price allocation has been performed and the recorded amounts for intangible assets, inventory, other assets, contingent and deferred consideration liabilities, deferred income tax liability and other liabilities are subject to change pending finalization of valuation efforts and review of tax matters. The amounts recognized will be finalized as the information necessary to complete the analysis is obtained, but no later than one year after the closing date.

The preliminary fair value of the purchase consideration, or the purchase price, is estimated to be $46.0 million. The following table highlights the components of the preliminary purchase consideration:

Aggregate consideration:

    

Cash consideration

$

3,000,000

Deferred cash consideration

2,000,000

Earn out

7,400,000

Additional earn out

4,735,000

Receivable consideration

22,318,685

Contract deferred consideration

6,500,000

Total estimated purchase consideration

$

45,953,685

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The preliminary 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 preliminary 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

1,905,490

Inventory

5,844,000

Intangible asset – definite-lived (Note 7)

11,200,000

Property and equipment

50,224

Operating lease right of use assets

352,906

Other assets

326,249

Total assets acquired

49,925,000

Accounts payable

(204,794)

Accrued expenses and other current liabilities

(5,155,363)

Operating lease obligations

(352,906)

Deferred income tax liability

(3,326,000)

Total liabilities assumed

(9,039,063)

Net assets acquired and liabilities assumed

40,885,937

Goodwill

5,067,748

Total estimated purchase consideration

$

45,953,685

In connection with the acquisition, the Company incurred one-time expenses consisting primarily of legal fees, accounting fees and consultant fees. For the three and six months ended June 30, 2022, we incurred approximately $0.1 million and $0.6 million of acquisition costs related to the Elusys transaction, which are included in general and administrative expenses in the consolidated statements of operations.

From the Elusys acquisition date through June 30, 2022, $0.03 million of total revenue and a net loss of $1.2 million associated with Elusys operations are included in the condensed consolidated statements of operations and comprehensive loss for the three months ended June 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

Six months ended

June 30,

June 30,

2022

2021

2022

 

2021

 

(unaudited)

(unaudited)

(unaudited)

(unaudited)

Revenue

$

23,358,641

$

490,294

$

23,852,732

$

2,596,706

Net loss

 

1,551,554

 

(6,999,444)

 

(8,276,775)

 

(16,469,898)

Net loss per share, basic and diluted

0.06

(0.28)

(0.32)

(0.67)

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3. 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 June 30, 2022 or 2021.

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 statement 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:

June 30, 2022

December 31, 2021

Current stock price

$

2.55

$

3.04

Estimated volatility of future stock price

83.76

%

133.13

%

Risk free interest rate

2.83

%

0.55

%

Contractual term

1.41

years

1.90

years

As of June 30, 2022, there were a total of 9,357 warrants outstanding that were reported as a liability on the consolidated balance sheet.

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The fair value of financial instruments measured on a recurring basis is as follows:

As of June 30, 2022

Description

    

Total

    

Level 1

    

Level 2

    

Level 3

Assets:

Short-term investments

$

59,707,339

$

59,707,339

 

 

Liabilities:

 

  

 

  

 

  

 

  

Contingent consideration

$

23,287,630

 

$

23,287,630

Warrant liability

$

1,730

 

 

$

1,730

As of December 31, 2021

Description

    

Total

    

Level 1

    

Level 2