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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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, 2023

OR

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

For the transition period from to

Commission File Number: 001-39676

 

INHIBIKASE THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

26-3407249

( State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

3350 Riverwood Parkway SE, Suite 1900
Atlanta, GA

30339

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (678) 392-3419

 

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, $0.001 par value

 

IKT

 

The Nasdaq Stock Market 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, 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 1, 2023, the registrant had 5,348,326 shares of common stock, $0.001 par value per share, outstanding.

 

 


Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets as of June 30, 2023 (Unaudited) and December 31, 2022

1

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2023 and 2022 (Unaudited)

2

Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2023 and 2022 (Unaudited)

3

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2023 and 2022 (Unaudited)

4

Notes to Unaudited Condensed Consolidated Financial Statements

5

Item 2.

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

14

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

25

Item 4.

Controls and Procedures

25

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

26

Item 1A.

Risk Factors

26

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

26

Item 3.

Defaults Upon Senior Securities

26

Item 4.

Mine Safety Disclosures

26

Item 5.

Other Information

26

Item 6.

Exhibits

27

Signatures

29

 

 

i


 

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements (Unaudited).

Inhibikase Therapeutics, Inc.

Condensed Consolidated Balance Sheets

 

 

June 30,
2023

 

 

December 31,
2022

 

 

 

(unaudited)

 

 

(Note 3)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

   Cash and cash equivalents

 

$

1,905,108

 

 

$

7,188,553

 

   Marketable securities

 

 

19,029,908

 

 

 

15,861,620

 

   Accounts receivable

 

 

79,604

 

 

 

39,881

 

   Prepaid research and development

 

 

425,229

 

 

 

1,117,616

 

   Prepaid expenses and other current assets

 

 

543,923

 

 

 

163,452

 

      Total current assets

 

 

21,983,772

 

 

 

24,371,122

 

   Equipment and improvements, net

 

 

86,523

 

 

 

236,532

 

   Right-of-use asset

 

 

277,092

 

 

 

328,643

 

         Total assets

 

$

22,347,387

 

 

$

24,936,297

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

   Accounts payable

 

$

754,146

 

 

$

1,151,173

 

   Lease obligation, current

 

 

147,966

 

 

 

145,836

 

   Accrued expenses and other current liabilities

 

 

1,830,924

 

 

 

2,398,436

 

      Total current liabilities

 

 

2,733,036

 

 

 

3,695,445

 

   Lease obligation, net of current portion

 

 

149,971

 

 

 

205,451

 

         Total liabilities

 

 

2,883,007

 

 

 

3,900,896

 

Commitments and contingencies (see Note 13)

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding at June 30, 2023 and December 31, 2022

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized; 5,290,826 and 4,224,294 shares issued and outstanding at June 30, 2023 and December 31, 2022

 

 

5,291

 

 

 

4,224

 

Additional paid-in capital

 

 

77,588,389

 

 

 

68,798,301

 

Accumulated other comprehensive income (loss)

 

 

(1,714

)

 

 

104,718

 

Accumulated deficit

 

 

(58,127,586

)

 

 

(47,871,842

)

      Total stockholders' equity

 

 

19,464,380

 

 

 

21,035,401

 

         Total liabilities and stockholders’ equity

 

$

22,347,387

 

 

$

24,936,297

 

 

 

 

 

 

 

 

 

See accompanying notes to condensed consolidated financial statements.

1


 

Inhibikase Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Grant revenue

 

$

116,410

 

 

$

6,552

 

 

$

180,931

 

 

$

52,583

 

Total revenue

 

 

116,410

 

 

 

6,552

 

 

 

180,931

 

 

 

52,583

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,535,698

 

 

 

2,982,183

 

 

 

7,389,817

 

 

 

5,999,174

 

Selling, general and administrative

 

 

1,783,113

 

 

 

1,664,308

 

 

 

3,708,464

 

 

 

3,333,944

 

Total costs and expenses

 

 

6,318,811

 

 

 

4,646,491

 

 

 

11,098,281

 

 

 

9,333,118

 

Loss from operations

 

 

(6,202,401

)

 

 

(4,639,939

)

 

 

(10,917,350

)

 

 

(9,280,535

)

Interest income (expense)

 

 

424,435

 

 

 

 

 

 

661,606

 

 

 

(5

)

Net loss

 

 

(5,777,966

)

 

 

(4,639,939

)

 

 

(10,255,744

)

 

 

(9,280,540

)

Other comprehensive income, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

  Unrealized loss on marketable securities

 

 

(167,536

)

 

 

 

 

 

(106,432

)

 

 

 

Comprehensive Loss

 

$

(5,945,502

)

 

$

(4,639,939

)

 

$

(10,362,176

)

 

$

(9,280,540

)

Net loss per share – basic and diluted

 

$

(1.11

)

 

$

(1.10

)

 

$

(2.09

)

 

$

(2.20

)

Weighted-average number of common shares – basic and diluted

 

 

5,226,101

 

 

 

4,224,294

 

 

 

4,918,206

 

 

 

4,222,496

 

See accompanying notes to condensed consolidated financial statements.

2


 

Inhibikase Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders' Equity

(Unaudited)

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional
Paid-In
Capital

 

 

Accumulated Other Comprehensive Income (loss)

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
Equity

 

Balance at December 31, 2022

 

 

4,224,294

 

 

$

4,224

 

 

$

68,798,301

 

 

$

104,718

 

 

$

(47,871,842

)

 

$

21,035,401

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

123,273

 

 

 

 

 

 

 

 

 

123,273

 

Issuance of common stock, pre-funded warrants and warrants, net of issuance costs

 

 

971,532

 

 

 

972

 

 

 

8,541,970

 

 

 

 

 

 

 

 

 

8,542,942

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

61,104

 

 

 

 

 

 

61,104

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,477,778

)

 

 

(4,477,778

)

Balance at March 31, 2023

 

 

5,195,826

 

 

$

5,196

 

 

$

77,463,544

 

 

$

165,822

 

 

$

(52,349,620

)

 

$

25,284,942

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

124,845

 

 

 

 

 

 

 

 

 

124,845

 

Issuance of common stock, pre-funded warrants and warrants, net of issuance costs

 

 

95,000

 

 

 

95

 

 

 

 

 

 

 

 

 

 

 

 

95

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(167,536

)

 

 

 

 

 

(167,536

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,777,966

)

 

 

(5,777,966

)

Balance at June 30, 2023

 

 

5,290,826

 

 

$

5,291

 

 

$

77,588,389

 

 

$

(1,714

)

 

$

(58,127,586

)

 

$

19,464,380

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional
Paid-In
Capital

 

 

Accumulated Other Comprehensive Income

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
Equity

 

Balance at December 31, 2021

 

 

4,212,317

 

 

$

4,212

 

 

$

68,229,024

 

 

$

 

 

$

(29,817,687

)

 

$

38,415,549

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

123,229

 

 

 

 

 

 

 

 

 

123,229

 

Issuance of common stock for services

 

 

8,334

 

 

 

8

 

 

 

66,992

 

 

 

 

 

 

 

 

 

67,000

 

Issuance of common stock, stock options exercised

 

 

3,643

 

 

 

4

 

 

 

44,138

 

 

 

 

 

 

 

 

 

44,142

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,640,601

)

 

 

(4,640,601

)

Balance at March 31, 2022

 

 

4,224,294

 

 

$

4,224

 

 

$

68,463,383

 

 

$

 

 

$

(34,458,288

)

 

$

34,009,319

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

132,767

 

 

 

 

 

 

 

 

 

132,767

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,639,939

)

 

 

(4,639,939

)

Balance at June 30, 2022

 

 

4,224,294

 

 

$

4,224

 

 

$

68,596,150

 

 

$

 

 

$

(39,098,227

)

 

$

29,502,147

 

See accompanying notes to condensed consolidated financial statements.

3


 

Inhibikase Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(10,255,744

)

 

$

(9,280,540

)

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

 

 

 

 

 

 

   Depreciation

 

 

164,247

 

 

 

 

   Stock-based compensation expense

 

 

248,118

 

 

 

255,996

 

   Non-cash consulting fees

 

 

 

 

 

67,000

 

   Changes in operating assets and liabilities:

 

 

 

 

 

 

   Accounts receivable

 

 

(39,721

)

 

 

103,589

 

   Operating lease right‑of‑use assets

 

 

51,551

 

 

 

 

   Prepaid expenses and other assets

 

 

(380,471

)

 

 

691,243

 

   Prepaid research and development

 

 

692,387

 

 

 

(812,053

)

   Accounts payable

 

 

(397,027

)

 

 

(229,334

)

   Operating lease liabilities

 

 

(53,350

)

 

 

 

   Accrued expenses and other current liabilities

 

 

(567,509

)

 

 

890,416

 

   Deferred revenue

 

 

 

 

 

23,684

 

Net cash used in operating activities

 

 

(10,537,519

)

 

 

(8,289,999

)

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

Purchases of equipment and improvements

 

 

(14,238

)

 

 

(43,089

)

Purchases of investments - marketable securities

 

 

(18,681,260

)

 

 

 

Maturities of investments - marketable securities

 

 

15,406,535

 

 

 

 

Net cash used in investing activities

 

 

(3,288,963

)

 

 

(43,089

)

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

Issuance of common stock from exercise of stock options

 

 

 

 

 

44,142

 

Proceeds from issuance of common stock, pre-funded warrants and warrants, net of issuance costs

 

 

8,543,037

 

 

 

 

Repayments of note payable

 

 

 

 

 

(248,911

)

Net cash provided by/(used in) financing activities

 

 

8,543,037

 

 

 

(204,769

)

Net decrease in cash and cash equivalents

 

 

(5,283,445

)

 

 

(8,537,857

)

Cash and cash equivalents at beginning of period

 

 

7,188,553

 

 

 

40,750,133

 

Cash and cash equivalents at end of period

 

$

1,905,108

 

 

$

32,212,276

 

Supplemental disclosures of cash flow information

 

 

 

 

 

 

Cash paid for interest

 

$

 

 

$

973

 

Issuance costs

 

$

1,456,479

 

 

$

 

See accompanying notes to condensed consolidated financial statements.

4


 

Inhibikase Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

1.
Nature of Business

Inhibikase Therapeutics, Inc. (the “Company,” “we” or “our”) is a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases. The Company’s multi-therapeutic pipeline has a primary focus on neurodegeneration and its lead program utilizing IkT-148009, a selective inhibitor of the non-receptor Abelson Tyrosine Kinases, targets the treatment of Parkinson’s disease inside and outside the brain as well as other diseases that arise from Abelson Tyrosine Kinases. In 2021, we commenced clinical development of IkT-148009, which we believe can modify the course of Parkinson’s disease including its manifestation in the gastrointestinal tract, or GI. In January, 2023, the Company initiated its Phase 2 program for IkT-148009 as a treatment for Parkinson’s disease. As of the date of this Report, 22 of 35 planned sites are currently screening and enrolling patients and the first patient has completed the 12 week treatment regimen.

In March, 2023 the Company opened its IND for IkT-148009 as a treatment for the orphan disease Multiple System Atrophy or MSA.

The Company is also developing platform technologies for alternate ways to deliver protein kinase inhibitors in patients. Our first example of this technology is IkT-001Pro, a prodrug of the anticancer agent imatinib mesylate, to treat Stable Phase Chronic Myelogenous Leukemia (SP-CML). Pursuant to its IND, which was cleared by the FDA in August 2022, IkT-001Pro is being evaluated in a two-part dose finding/dose equivalence study in up to 59 healthy volunteers (the 501 trial). The study is designed to evaluate the 96-hour pharmacokinetics of imatinib delivered as IkT-001Pro and determine the dose of IkT-001Pro that can deliver imatinib equivalent to 400 mg imatinib mesylate, the standard-of-care dose for SP-CML. Following completion of the 501 study, Inhibikase will confer with the FDA and seek agreement on the requirements for the New Drug Application (“NDA”) process following the proposed approval path for IkT-001Pro under the 505(b)(2) approval pathway.

2.
Liquidity

The Company has recognized recurring losses. At June 30, 2023, the Company had working capital of $19,250,736 and accumulated deficit of $58,127,586, cash of $1,905,108 marketable securities of $19,029,908 and accounts payable, accrued expenses and other current liabilities of $2,733,036.

The future success of the Company is dependent on its ability to successfully obtain additional working capital, obtain regulatory approval for and successfully launch and commercialize its product candidates and to ultimately attain profitable operations. Historically, the Company has funded its operations primarily through cash received in connection with revenue from its various grant programs. In addition, in December 2020, June 2021 and January 2023, the Company raised approximately $14.6 million, $41.1 million and $8.6 million in net proceeds for working capital from its initial public offering (“IPO”), June 2021 Offering and January 2023 Offering, respectively.

The Company is subject to a variety of risks similar to other early-stage life science companies including, but not limited to, the successful development, regulatory approval, and market acceptance of the Company’s product candidates, development by its competitors of new technological innovations, protection of proprietary technology, and raising additional working capital. The Company has incurred significant research and development expenses and general and administrative expenses related to its product candidate programs. The Company anticipates costs and expenses to increase in the future as the Company continues to develop its product candidates.

The Company may seek to fund its operations through additional public equity, private equity, or debt financings, as well as other sources. However, the Company may be unable to raise additional working capital, or if it is able to raise additional capital, it may be unable to do so on commercially favorable terms. The Company’s failure to raise capital or enter into such other arrangements if and when needed would have a negative impact on the Company’s business, results of operations and financial condition and the Company’s ability to continue to develop its product candidates.

5


 

The Company estimates that its working capital at June 30, 2023 is sufficient to fund its normal operations into the fourth quarter of 2024.

On June 23, 2023, at the Company’s annual meeting of stockholders, the Company’s stockholders approved an amendment to the Company’s restated certificate of incorporation to grant discretionary authority to the board of directors to effect a reverse stock split of the Company’s common stock. Following the receipt of the stockholders’ approval, the Company’s board of directors approved the reverse stock split at the ratio of 1 post-split share for every 6 pre-split shares, which was effective as of June 30, 2023. On July 17, 2023, the Company received a letter from Nasdaq informing the Company that it has regained compliance with the Minimum Bid Price Rule.

The accompanying unaudited condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.

3.
Basis of Presentation and Significant Accounting Policies

Basis of Presentation of Interim Financial Statements

The accompanying unaudited condensed consolidated financial statements were prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for interim financial statements and, in the opinion of management, include all normal and recurring adjustments necessary to present fairly the results of the interim periods shown. The December 31, 2022 balance sheet was derived from December 31, 2022 audited financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“US GAAP”) have been condensed or omitted pursuant to such SEC rules and regulations. Management believes that the disclosures made are adequate to make the information presented not misleading. The results for the interim periods are not necessarily indicative of results to be expected for the fiscal year ending December 31, 2023. The condensed unaudited consolidated financial statements contained herein should be read in conjunction with the Company’s annual audited financial statements and notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC.

 

On June 30, 2023, we effected a reverse stock split at the ratio of 1 post-split share for every 6 pre-split shares. All common stock, options and warrant amounts and references have been retroactively adjusted for all figures presented to reflect this split unless specifically stated otherwise.

The unaudited condensed consolidated financial statements have been prepared in conformity with US GAAP, which prescribes elimination of all significant intercompany accounts and transactions in the accounts of the Company and its wholly-owned subsidiary, IKT Securities Corporation, Inc., which was incorporated in the Commonwealth of Massachusetts in December 2021. Any reference in these notes to applicable guidance is meant to refer to the authoritative US GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and are generally adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

The Company qualifies as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, as amended, or the JOBS Act. The JOBS Act permits an emerging growth company such as the Company to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. The Company has elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that it either (i) irrevocably elects to “opt out” of such extended transition period or (ii) no longer qualifies as an emerging growth company.

Use of Estimates

The preparation of the Company’s financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company utilizes certain estimates in the determination of our liquidity and working capital adequacy, the fair value of its stock options and warrants, deferred tax valuation allowances and revenue recognition, to record expenses relating to research and development contracts and accrued

6


 

expenses. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates.


New Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on its condensed consolidated financial statements and disclosures.

In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 will change how companies account for credit losses for most financial assets and certain other instruments. For trade receivables, loans and held-to-maturity debt securities, companies will be required to recognize an allowance for credit losses rather than reducing the carrying value of the asset. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments — Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates to amend the effective date of ASU 2016-13, for entities eligible to be “smaller reporting companies,” as defined by the SEC, to be effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company adopted ASU 2016-13 as of January 1, 2023, on a prospective basis. The adoption did not have a material impact on the Company’s condensed consolidated financial statements.

In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). ASU 2020-06 simplifies the accounting for convertible debt instruments by reducing the number of accounting models and the number of embedded features that could be recognized separately from the host contract. Consequently, more convertible debt instruments will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. ASU 2020-06 also requires use of the if-converted method in the diluted earnings per share calculation for convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years for smaller reporting companies, with early adoption permitted. The Company adopted ASU 2020-06 as of January 1, 2023, on a prospective basis. The adoption did not have a material impact on the Company’s condensed consolidated financial statements.

Concentrations of Credit Risk

For the three and six months ended June 30, 2023 and 2022, the Company derived 100% of its total revenue from a single source, the United States Government, in the form of federal research grants.

Revenue Recognition

The Company generates revenue from research and development grants under contracts with third parties that do not create customer-vendor relationships. The Company’s research and development grants are non-exchange transactions and are not within the scope of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). Contribution revenue earned from activities performed pursuant to research and development grants is reported as grant revenue in the Company’s unaudited condensed consolidated statements of operations and comprehensive loss. Revenue from these grants is recognized as the Company incurs qualifying expenses as stipulated by the terms of the respective grant. Cash received from grants in advance of incurring qualifying expenses is recorded as deferred revenue. The Company records revenue and a corresponding receivable when qualifying costs are incurred before the grants are received.

Leases

The Company accounts for its leases under ASU 2021-09, ASU 2018-10, and ASC Topic 842, Leases (“ASC 842”). ASC 842 requires a lessee to record a right-of-use asset and a corresponding lease liability for most lease arrangements on the Company's balance sheet. Under the standard, disclosure of key information about leasing arrangements to assist users of the financial statements with assessing the amount, timing and uncertainty of cash flows arising from leases is required.

Leases are classified as either finance leases or operating leases. A lease is classified as a finance lease if any one of the following criteria are met: the lease transfers ownership of the asset by the end of the lease term, the lease contains an option to purchase the asset that is reasonably certain to be exercised, the lease term is for a major part of the remaining useful life of the asset or the present value of the lease payments equals or exceeds substantially all of the fair value of the asset. A lease is classified as an operating lease if it does not meet any of these criteria.

7


 

For all leases at the lease commencement date, a right-of-use asset and a lease liability are recognized. The right-of-use asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease.

The right-of-use asset is initially measured at cost, which primarily comprises the initial amount of the lease liability, plus any initial direct costs incurred if any, less any lease incentives received. All right-of-use assets are reviewed for impairment. The lease liability is initially measured at the present value of the lease payments, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, the secured incremental borrowing rate for the same term as the underlying lease.

Lease payments included in the measurement of the lease liability comprise the following: the fixed noncancelable lease payments, payments for optional renewal periods where it is reasonably certain the renewal period will be exercised, and payments for early termination options unless it is reasonably certain the lease will not be terminated early.

Lease cost for operating leases consists of the lease payments plus any initial direct costs, primarily brokerage commissions, and is recognized on a straight-line basis over the lease term. Included in lease cost are any variable lease payments incurred in the period that are not included in the initial lease liability and lease payments incurred in the period for any leases with an initial term of 12 months or less. Lease cost for finance leases consists of the amortization of the right-of-use asset on a straight-line basis over the lease term and interest expense determined on an amortized cost basis. The lease payments are allocated between a reduction of the lease liability and interest expense.

The Company has made an accounting policy election to not recognize leases with an initial term of 12 months or less within our condensed consolidated balance sheets and to recognize those lease payments on a straight-line basis in our condensed consolidated statements of operations and comprehensive loss over the lease term.

Equipment and Improvements

Equipment and improvements are stated at cost, less accumulated depreciation. For financial reporting purposes, depreciation is recognized using the straight-line method, allocating the cost of the assets over their estimated usefulness from three to five years for network equipment, office equipment, and furniture classified as fixed assets.

 

 

 

Estimated Useful Economic Life

Leasehold property improvements, right of use assets

 

Lesser of lease term or useful life

Furniture and office equipment

 

5 years

Lab equipment

 

3 Years

IT equipment

 

3 years

Fair Value Measurement

The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements.

· Level 1 — Fair values are determined utilizing quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access;

· Level 2 — Fair values are determined by utilizing quoted prices for identical or similar assets and liabilities in active markets or other market observable inputs such as interest rates, yield curves and foreign currency spot rates; and

· Level 3 — inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability.

 

Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.

 

The Company’s financial assets, which include cash equivalents and marketable securities, have been initially valued at the transaction price, and subsequently revalued at the end of each reporting period, utilizing third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market based approaches, to determine value and improvements are stated at cost, less accumulated depreciation.

 

Marketable Securities

8


 

The Company's marketable securities consist of U.S. Treasury securities with maturities of less than one year which are classified as available-for-sale and included in current assets on the condensed consolidated balance sheets. Available-for-sale debt securities are carried at fair value with unrealized gains and losses reported as a component of stockholders’ equity in accumulated other comprehensive income. Realized gains and losses, if any, are included in other income, net in the condensed consolidated statements of operations and comprehensive loss.

Available-for-sale securities are reviewed for possible impairment at least quarterly, or more frequently if circumstances arise that may indicate impairment. When the fair value of the securities declines below the amortized cost basis, impairment is indicated and it must be determined whether it is other than temporary. Impairment is considered to be other than temporary if the Company: (i) intends to sell the security, (ii) will more likely than not be forced to sell the security before recovering its cost, or (iii) does not expect to recover the security’s amortized cost basis. If the decline in fair value is considered other than temporary, the cost basis of the security is adjusted to its fair market value and the realized loss is reported.

 

4.
Fair Value of Financial Instruments

 

The following table summarizes cash equivalents and marketable securities measured at their fair value on a recurring basis as of June 30, 2023:

 

 

 

Fair Value Measurements as of June 30, 2023 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

   Money market funds

 

$

1,075,859

 

 

$

 

 

$

 

 

$

1,075,859

 

Total

 

$

1,075,859

 

 

$

 

 

$

 

 

$

1,075,859

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Marketable securities, available-for-sale:

 

 

 

 

 

 

 

 

 

 

 

 

   U.S. treasury obligations

 

$

19,029,908

 

 

$

 

 

$

 

 

$

19,029,908

 

Total

 

$

19,029,908

 

 

$

 

 

$

 

 

$

19,029,908

 

 

 

 

Fair Value Measurements as of December 31, 2022 Using:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

   Money market funds

 

$

5,304,405

 

 

$

 

 

$

 

 

$

5,304,405

 

Total

 

$

5,304,405

 

 

$

 

 

$

 

 

$

5,304,405

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Marketable securities, available-for-sale:

 

 

 

 

 

 

 

 

 

 

 

 

   U.S. treasury obligations

 

$

15,861,620

 

 

$

 

 

$