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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 September 30, 2024

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 November 1, 2024, the registrant had 67,192,570 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 September 30, 2024 (Unaudited) and December 31, 2023

1

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023 (Unaudited)

2

Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the Three and Nine Months Ended September 30, 2024 and 2023 (Unaudited)

3

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023 (Unaudited)

5

Notes to Unaudited Condensed Consolidated Financial Statements

6

Item 2.

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

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

27

Item 4.

Controls and Procedures

27

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

28

Item 1A.

Risk Factors

28

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

28

Item 3.

Defaults Upon Senior Securities

28

Item 4.

Mine Safety Disclosures

28

Item 5.

Other Information

28

Item 6.

Exhibits

29

Signatures

30

 

 

i


 

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements (Unaudited).

Inhibikase Therapeutics, Inc.

Condensed Consolidated Balance Sheets

 

 

 

 

September 30,
2024

 

 

December 31,
2023

 

 

 

(unaudited)

 

 

(Note 3)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

   Cash and cash equivalents

 

$

913,420

 

 

$

9,165,179

 

   Marketable securities

 

 

2,330,226

 

 

 

4,086,873

 

   Prepaid research and development

 

 

112,225

 

 

 

219,817

 

   Deferred offering costs

 

 

553,318

 

 

 

147,445

 

   Prepaid expenses and other current assets

 

 

280,914

 

 

 

591,734

 

      Total current assets

 

 

4,190,103

 

 

 

14,211,048

 

   Equipment and improvements, net

 

 

53,667

 

 

 

73,372

 

   Right-of-use asset

 

 

133,105

 

 

 

222,227

 

         Total assets

 

$

4,376,875

 

 

$

14,506,647

 

Liabilities and stockholders’ (deficit) equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

   Accounts payable

 

$

2,529,220

 

 

$

646,767

 

   Lease obligation, current

 

 

145,210

 

 

 

150,095

 

   Accrued expenses and other current liabilities

 

 

2,161,374

 

 

 

2,259,955

 

   Insurance premium financing payable

 

 

71,662

 

 

 

381,784

 

      Total current liabilities

 

 

4,907,466

 

 

 

3,438,601

 

   Lease obligation, net of current portion

 

 

 

 

 

90,124

 

         Total liabilities

 

 

4,907,466

 

 

 

3,528,725

 

Commitments and contingencies (see Note 13)

 

 

 

 

 

Stockholders’ (deficit) equity:

 

 

 

 

Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding at September 30, 2024 and December 31, 2023

 

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized; 7,464,070 and 6,186,280 shares issued and outstanding at September 30, 2024 and December 31, 2023

 

 

7,464

 

 

 

6,186

 

Additional paid-in capital

 

 

81,748,225

 

 

 

77,871,584

 

Accumulated other comprehensive income

 

 

1,754

 

 

 

877

 

Accumulated deficit

 

 

(82,288,034

)

 

 

(66,900,725

)

      Total stockholders' (deficit) equity

 

 

(530,591

)

 

 

10,977,922

 

         Total liabilities and stockholders’ (deficit) equity

 

$

4,376,875

 

 

$

14,506,647

 

 

 

 

 

 

 

 

 

See accompanying notes to condensed consolidated financial statements.

1


 

Inhibikase Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Grant revenue

 

$

 

 

$

79,569

 

 

$

 

 

$

260,500

 

Total revenue

 

 

 

 

 

79,569

 

 

 

 

 

 

260,500

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,189,873

 

 

 

3,225,551

 

 

 

10,016,982

 

 

 

10,615,368

 

Selling, general and administrative

 

 

1,637,603

 

 

 

1,622,894

 

 

 

5,643,386

 

 

 

5,331,358

 

Total costs and expenses

 

 

5,827,476

 

 

 

4,848,445

 

 

 

15,660,368

 

 

 

15,946,726

 

Loss from operations

 

 

(5,827,476

)

 

 

(4,768,876

)

 

 

(15,660,368

)

 

 

(15,686,226

)

Interest income

 

 

49,410

 

 

 

173,677

 

 

 

273,059

 

 

 

835,283

 

Net loss

 

 

(5,778,066

)

 

 

(4,595,199

)

 

 

(15,387,309

)

 

 

(14,850,943

)

Other comprehensive income (loss), net of tax

 

 

 

 

 

 

 

 

 

 

 

 

  Unrealized gains (loss) on marketable securities

 

 

2,778

 

 

 

1,571

 

 

 

877

 

 

 

(104,861

)

Comprehensive loss

 

$

(5,775,288

)

 

$

(4,593,628

)

 

$

(15,386,432

)

 

$

(14,955,804

)

Net loss per share – basic and diluted

 

$

(0.65

)

 

$

(0.75

)

 

$

(2.03

)

 

$

(2.48

)

Weighted-average number of common shares – basic and diluted

 

 

8,882,570

 

 

 

6,162,671

 

 

 

7,592,103

 

 

 

5,977,841

 

 

See accompanying notes to condensed consolidated financial statements.

2


 

Inhibikase Therapeutics, Inc.

Condensed Consolidated Statements of Stockholders' Equity (Deficit)

(Unaudited)

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional
Paid-In
Capital

 

 

Accumulated Other Comprehensive Income (Loss)

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
Equity (Deficit)

 

Balance at December 31, 2023

 

 

6,186,280

 

 

$

6,186

 

 

$

77,871,584

 

 

$

877

 

 

$

(66,900,725

)

 

$

10,977,922

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

53,434

 

 

 

 

 

 

 

 

 

53,434

 

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

 

 

290,564

 

 

 

291

 

 

 

397,316

 

 

 

 

 

 

 

 

 

397,607

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(2,677

)

 

 

 

 

 

(2,677

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,649,635

)

 

 

(4,649,635

)

Balance at March 31, 2024

 

 

6,476,844

 

 

 

6,477

 

 

 

78,322,334

 

 

 

(1,800

)

 

 

(71,550,360

)

 

 

6,776,651

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

30,697

 

 

 

 

 

 

 

 

 

30,697

 

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

 

 

739,301

 

 

 

739

 

 

 

3,247,394

 

 

 

 

 

 

 

 

 

3,248,133

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

776

 

 

 

 

 

 

776

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,959,608

)

 

 

(4,959,608

)

Balance at June 30, 2024

 

 

7,216,145

 

 

 

7,216

 

 

 

81,600,425

 

 

 

(1,024

)

 

 

(76,509,968

)

 

 

5,096,649

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

148,024

 

 

 

 

 

 

 

 

 

148,024

 

Issuance of common stock, stock options exercised

 

 

247,925

 

 

 

248

 

 

 

(224

)

 

 

 

 

 

 

 

 

24

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

2,778

 

 

 

 

 

 

2,778

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,778,066

)

 

 

(5,778,066

)

Balance at September 30, 2024

 

 

7,464,070

 

 

$

7,464

 

 

$

81,748,225

 

 

$

1,754

 

 

$

(82,288,034

)

 

$

(530,591

)

 

3


 

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

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

129,781

 

 

 

 

 

 

 

 

 

129,781

 

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

 

 

69,500

 

 

 

70

 

 

 

17,280

 

 

 

 

 

 

 

 

 

17,350

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

1,571

 

 

 

 

 

 

1,571

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(4,595,199

)

 

 

(4,595,199

)

Balance at September 30, 2023

 

 

5,360,326

 

 

$

5,361

 

 

$

77,735,450

 

 

$

(143

)

 

$

(62,722,785

)

 

$

15,017,883

 

 

See accompanying notes to condensed consolidated financial statements.

4


 

Inhibikase Therapeutics, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(15,387,309

)

 

$

(14,850,943

)

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

 

 

 

 

 

 

   Depreciation

 

 

19,705

 

 

 

170,830

 

   Stock-based compensation expense

 

 

232,155

 

 

 

377,899

 

   Non-cash consulting and marketing fees

 

 

 

 

 

17,280

 

   Changes in operating assets and liabilities:

 

 

 

 

 

 

   Accounts receivable

 

 

 

 

 

39,881

 

   Operating lease right‑of‑use assets

 

 

89,122

 

 

 

78,553

 

   Prepaid expenses and other assets

 

 

698

 

 

 

(208,086

)

   Prepaid research and development

 

 

107,592

 

 

 

770,051

 

   Accounts payable

 

 

1,329,135

 

 

 

(416,612

)

   Operating lease liabilities

 

 

(95,009

)

 

 

(81,244

)

   Accrued expenses and other current liabilities

 

 

(98,581

)

 

 

(540,221

)

Net cash used in operating activities

 

 

(13,802,492

)

 

 

(14,642,612

)

 

 

 

 

 

 

 

Cash flows from investing activities

 

 

 

 

 

 

Purchases of equipment and improvements

 

 

 

 

 

(14,238

)

Purchases of investments - marketable securities

 

 

(10,343,939

)

 

 

(20,629,391

)

Maturities of investments - marketable securities

 

 

12,101,463

 

 

 

34,415,890

 

Net cash provided by investing activities

 

 

1,757,524

 

 

 

13,772,261

 

 

 

 

 

 

 

 

Cash flows from financing activities

 

 

 

 

 

 

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

 

 

3,793,209

 

 

 

8,543,107

 

Net cash provided by financing activities

 

 

3,793,209

 

 

 

8,543,107

 

Net (decrease) increase in cash and cash equivalents

 

 

(8,251,759

)

 

 

7,672,756

 

Cash and cash equivalents at beginning of period

 

 

9,165,179

 

 

 

7,188,553

 

Cash and cash equivalents at end of period

 

$

913,420

 

 

$

14,861,309

 

Supplement disclosure of non-cash financing activities

 

 

 

 

 

 

Non-cash financing costs included in accounts payable

 

$

553,318

 

 

$

 

Supplemental disclosures of cash flow information

 

 

 

 

 

 

Issuance costs

 

$

1,203,350

 

 

$

1,456,479

 

See accompanying notes to condensed consolidated financial statements.

5


 

Inhibikase Therapeutics, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

1.
Nature of Business

We are a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of cardiopulmonary and neurodegenerative diseases and other diseases that arise from aberrant signaling through the Abelson Tyrosine Kinases. The Company’s multi-therapeutic pipeline includes IkT-001Pro, a prodrug of the anticancer agent imatinib, for the treatment of Pulmonary Arterial Hypertension and risvodetinib (also known as IkT-148009), a selective inhibitor of the non-receptor Abelson Tyrosine Kinases which could be disease-modifying for Parkinson’s disease. Risvodetinib has completed a Phase 2, double-blind placebo-controlled trial evaluating three doses of risvodetinib 1:1:1:1 randomized against placebo. IkT-001Pro has completed bioequivalence dose calibration studies to determine the dose of IkT-001Pro that is equivalent to either 400 mg or 600 mg imatinib mesylate in preparation for a future late-stage trial in Pulmonary Arterial Hypertension (PAH).

2. Liquidity

As at September 30, 2024, the Company had cash and cash equivalents of $913,420 and marketable securities of $2,330,226, which does not include the gross proceeds of approximately $110 million from the October 2024 Offering. See Note 14, Subsequent Event.

The Company has incurred recurring losses and at September 30, 2024, had an accumulated deficit of $82,288,034.

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.

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, general and administrative expenses related to its product candidate programs and negative cash flows from operations. 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, particularly with respect to its neurodegenerative disease programs, 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.

The Company estimates that its cash and cash equivalents and marketable securities at September 30, 2024, including the $110 million of gross proceeds from the October 2024 Offering, is sufficient to fund its normal operations for at least the next twelve months.

The accompanying 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, 2023 balance sheet was derived from the December 31, 2023 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, 2024. The unaudited condensed consolidated

6


 

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, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC.

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 U.S. 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 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 November 2023, the FASB issued Accounting Standards Update No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures which is intended to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The new guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, and early adoption is permitted. The guidance is to be applied retrospectively to all prior periods presented in the financial statements. Upon transition, the segment expense categories and amounts disclosed in the prior periods should be based on the significant segment expense categories identified and disclosed in the period of adoption. The Company is currently evaluating the potential impact of adopting this new guidance on our consolidated financial statements and related disclosures.

Concentrations of Credit Risk

For the three and nine months ended September 30, 2024, the Company did not report any revenues. For the three and nine months ended September 30, 2023, 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

7


 

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.

Research and Development Costs

Costs incurred in the research and development of the Company’s product candidates are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including activities associated with performing services under grant revenue contracts and include salaries and benefits, stock compensation, research-related subcontractors and consultants, supplies and overhead costs. Advance payments made to suppliers and contract research organizations are classified as prepaid research and development and are expensed as research and development as the supplies are consumed and the contract services are provided. During the three and nine months ended September 30, 2024, the Company incurred expenses of approximately $149 thousand and $446 thousand, respectively, with a related party vendor which were included in research and development expenses. During the three and nine months ended September 30, 2023, the Company incurred expenses of approximately $19 thousand and $30 thousand, respectively, with a related party vendor, which were included in research and development expenses. As of the periods ended September 30, 2024 and December 31, 2023, the Company had a payable or accrued expense balance with a related party vendor of approximately $74 thousand and $57 thousand, respectively, included in accounts payable and accrued expenses.

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 condensed and consolidated balance sheet. Under the standard, disclosure of key information about leasing arrangements to assist users of the condensed and consolidated 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.

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.

8


 

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

 

3-5 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 and financial liabilities, which include cash equivalents and marketable securities and accounts payable, 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.

 

Marketable Securities

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’ (deficit) 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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9


 

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 September 30, 2024 and December 31, 2023:

 

 

 

Fair Value Measurements as of September 30, 2024:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

   Money market funds

 

$

86,054

 

 

$

 

 

$

 

 

$

86,054

 

Total

 

$

86,054

 

 

$

 

 

$

 

 

$

86,054

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Marketable securities, available-for-sale:

 

 

 

 

 

 

 

 

 

 

 

 

   U.S. Treasury obligations

 

$

2,330,226

 

 

$

 

 

$

 

 

$

2,330,226

 

Total

 

$

2,330,226

 

 

$

 

 

$

 

 

$

2,330,226

 

 

 

 

 

Fair Value Measurements as of December 31, 2023:

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

   Money market funds

 

$

8,039,024

 

 

$

 

 

$

 

 

$

8,039,024

 

Total

 

$

8,039,024

 

 

$

 

 

$

 

 

$

8,039,024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Marketable securities, available-for-sale:

 

 

 

 

 

 

 

 

 

 

 

 

   U.S. Treasury obligations

 

$

4,086,873

 

 

$

 

 

$

 

 

$

4,086,873

 

Total

 

$

4,086,873

 

 

$

 

 

$

 

 

$

4,086,873

 

 

5.
Marketable Securities

 

Marketable securities consisted of the following as of:

 

September 30, 2024

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized Loss

 

 

Fair Value

 

Marketable securities, available-for-sale:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury obligations

 

$

2,328,472

 

 

$

1,754

 

 

$

 

 

$

2,330,226

 

Total

 

$

2,328,472

 

 

$

1,754

 

 

$

 

 

$

2,330,226

 

 

December 31, 2023

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized Loss

 

 

Fair Value

 

Marketable securities, available-for-sale:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Treasury obligations

 

$

4,085,996

 

 

$

877

 

 

$

 

 

$

4,086,873

 

Total

 

$

4,085,996

 

 

$

877

 

 

$

 

 

$

4,086,873

 

 

As of September 30, 2024, the Company held 11 U.S. Treasury debt securities that were in an unrealized gain position totaling $1,754. As of December 31, 2023, the Company held three U.S. Treasury debt securities that were in an unrealized gain position totaling $877. All U.S. Treasury obligations were due to mature in less than one year for the period and year ended September 30, 2024 and December 31, 2023, respectively.

 

The Company received proceeds of $12.1 million from maturities of marketable securities for the nine months ended September 30, 2024. The Company received proceeds of $41.1 million from maturities of marketable securities for the year ended December 31, 2023. The Company did not realize any gains or losses from maturities of marketable securities for the period ended September 30, 2024 or the year ended December 31, 2023.

 

 

 

 

 

10


 

6.
Equipment and Improvements

 

Equipment and Improvements, net

 

 

 

September 30,
2024

 

 

December 31,
2023

 

Furniture and office equipment

 

$

86,930

 

 

$

86,930

 

IT equipment

 

 

16,895

 

 

 

16,895

 

 

 

 

103,825

 

 

 

103,825

 

    Less: Accumulated depreciation

 

 

50,158

 

 

 

30,453

 

Total

 

$

53,667

 

 

$

73,372

 

 

Depreciation expense for the three and nine months ended September 30, 2024 was $6,568 and $19,705, respectively. Depreciation expense for the three and nine months ended September 30, 2023 was $6,568 and $170,830, respectively.

 

7.
Supplemental Condensed Consolidated Balance Sheet Information

Accrued expenses and other current liabilities consist of the following:

 

 

 

September 30,
2024

 

 

December 31,
2023

 

Accrued consulting

 

$

78,447

 

 

$

49,395

 

Accrued compensation

 

 

653,230

 

 

 

635,451

 

Accrued research and development

 

 

1,416,647

 

 

 

1,472,292

 

Accrued other

 

 

13,050

 

 

 

102,817

 

Total accrued expenses and other current liabilities

 

$

2,161,374

 

 

$

2,259,955

 

 

 

8. ATM Program

On February 1, 2024, the Company entered into an At The Market Offering (the “ATM”) with H.C. Wainwright & Co., LLC as sales agent (the “Agent”), pursuant to which the Company may, from time to time, issue and sell shares of its common stock, at an aggregate offering price of up to approximately $5.7 million (the “Shares”) through the Agent. Under the terms of the ATM Agreement with the Agent (the "ATM Agreement"), the Agent may sell the Shares at market prices by any method that is deemed to be an “ATM” as defined in Rule 415 under the Securities Act, as amended. On May 20, 2024, the Company reduced the aggregate offering price to $50,000, not including the shares of common stock previously sold.

 

9. Stockholders’ Equity (Deficit)

Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors, subject to the prior rights of holders of all classes of stock outstanding. As of September 30, 2024, a total of 3,337,435 shares of common stock were reserved for issuance upon the exercise of outstanding stock options and warrants under the 2020 Equity Incentive Plan (the "2020 Plan").

Share Issuances

Subject to the terms and conditions of the ATM Agreement, the Agent will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions. The Company has no obligation to sell any of the Shares and may at any time suspend sales under the ATM Agreement or terminate the ATM Agreement in accordance with its terms. The Company has provided the Agent with customary indemnification rights, and the Agent will be entitled to a fixed commission of 3.0% of the aggregate gross proceeds from the Shares sold. The ATM Agreement contains customary representations and warranties, and the Company is required to deliver customary closing documents and certificates in connection with sales of the Shares. As of September 30, 2024, 315,338 ATM Shares have been sold under the ATM Agreement with net proceeds of $820,509 to the Company.

11


 

On May 20, 2024, the Company entered into a securities purchase agreement with a single institutional investor in connection with a registered direct offering and concurrent private placement with the same institutional investor (collectively the "May 2024 Offering"). The May 2024 Offering consisted of (i) 714,527 shares of the Company's common stock sold at $1.68 per share, (ii) Pre-Funded Common Warrants to purchase up to 957,925 shares of common stock with an exercise price of $0.0001 which are immediately exercisable after the issuance until exercised in full, (iii) Series A Common Warrants to purchase 1,672,452 shares of common stock with an exercise price of $1.68 per share which expire on the one-year anniversary from the date of stockholder approval, and (iv) Series B Common Warrants to purchase 1,672,452 shares of common stock with an exercise price of $1.68 per share which expire on the five-year anniversary from the date of stockholder approval. All of the warrants in the May 2024 Offering were issued to a single investor. During the third quarter 2024, the investor exercised 247,925 Pre-Funded Common Warrants and exercised the remaining 710,000 Pre-Funded Common Warrants as of the date of this report. The Company received net proceeds from the May 2024 Offering of approximately $2.2 million.

On May 20, 2024, the Company also entered into a warrant inducement agreement with the same investor to exercise certain outstanding warrants that the Company issued in January 2023 ("January 2023 Existing Warrants"). Pursuant to the warrant inducement agreement, the investor agreed to exercise outstanding warrants to purchase an aggregate of 708,500 shares of the Company's common stock at an amended exercise price of $1.68 per share. These shares are held in abeyance and not considered outstanding. The shares held in abeyance will be held in abeyance until notice from the investor that the balance, or portion thereof, may be issued in compliance with a beneficial ownership limitation provision in the warrants. The Company also agreed to reduce the exercise price of the remaining unexercised portion of such warrants to purchase 1,229,484 shares of common stock to $1.68 per share and to issue the investor Series C Common Warrants to purchase 708,500 shares of the Company's common stock and Series D Common Warrants to purchase 708,500 shares of the Company's common stock ("January 2023 New Warrants"). Each will have an exercise price of $1.68 per share and will be exercisable beginning on the effective date of stockholder approval. The Series C Common Warrants will expire on the one-year anniversary from the date of stockholder approval and the Series D Common Warrants will expire on the five-year anniversary from the date of stockholder approval. The shares held in abeyance were issued to the investor on October 9, 2024.

The repricing of the January 2023 Existing Warrants and issuance of the Series C Common Warrants and the Series D Common Warrants is considered a modification of the January 2023 Existing Warrants under the guidance of ASU 2021-04. The modification is consistent with the "Equity Issuance" classification under that guidance as the reason for the modification was to induce the holder to cash exercise their warrants, resulting in the imminent exercise of the January 2023 Existing Warrants, which raised equity capital and generated net proceeds for the Company of approximately $1.0 million. The total fair value of the consideration of the modification includes the incremental fair value of the January 2023 Existing Warrants (determined by comparing the fair values immediately prior to and immediately after the modification) and the initial fair value of the January 2023 New Warrants. The fair values were calculated using the Black-Scholes model and the Company determined that the total fair value of the consideration related to the modification of the January 2023 Existing Warrants, including the initial fair value of the January 2023 New Warrants was $1.8 million.

 

10. Stock-Based Compensation

2020 Equity Incentive Plan

The Company’s 2020 Plan was established for granting stock incentive awards to directors, officers, employees and consultants to the Company.

 

Stock Options

During the nine months ended September 30, 2024, the Company granted 308,039 options with a weighted average strike price of $1.89 to purchase common stock to certain employees that either (i) vest annually in three equal parts over three years (ii) vest on the first anniversary of the grant of such option in the amount of one-third of such grant, and the remaining portion will vest in 24 equal monthly installments thereafter or (iii) vest on the first anniversary of the grant of such option. The Company granted 45,000 performance-based options with a weighted average strike price of $2.16 to purchase common stock to certain employees. These options are subject to performance vesting and will vest and become exercisable once the performance conditions are probable of being met. There is no assurance that the performance conditions will be met and therefore some or all of these options may never vest or become exercisable. The total aggregate grant date fair value of all options granted was $489,108. During the nine months ended September 30, 2024, certain performance conditions were met.

During the nine months ended September 30, 2023, the Company granted 86,669 options with a weighted average strike price of $2.81 to purchase common stock to certain employees that will either (i) vest annually in three equal parts over three years or (ii) vest

12


 

on the first anniversary of the grant of such option in the amount of one-third of such grant, and the remaining portion will vest in 24 equal monthly installments thereafter. The Company granted 25,000 performance-based options with a weighted average strike price of $1.33 to purchase common stock to certain employees. These options are subject to performance vesting and will vest and become exercisable once the performance conditions have been met. There is no assurance that the performance conditions will be met and therefore some or all of these options may never vest or become exercisable. The total aggregate grant date fair value of all options granted was $338,741. During the nine months ended September 30, 2023, no performance conditions were met.

For awards with performance conditions in which the award does not vest unless the performance condition is met, we recognize expense if, and to the extent that, we estimate that achievement of the performance condition is probable. If we conclude that vesting is probable, we recognize expense from the date we reach this conclusion through the estimated vesting date.

 

Stock-Based Compensation Expense

The following table summarizes the stock-based compensation expense for stock options granted to employees and non-employees:

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Research and development

 

$

84,370

 

 

$

41,842

 

 

$

94,594

 

 

$

120,718

 

Selling, general and administrative

 

 

63,654

 

 

 

87,939

 

 

 

137,561

 

 

 

257,181

 

Total stock-based compensation expense

 

$

148,024

 

 

$

129,781

 

 

$

232,155

 

 

$

377,899

 

 

11.
Net Loss Per Share

The following table presents the calculation of basic and diluted net loss per share applicable to common stockholders. Basic net loss per share is calculated by dividing net loss attributable to common shareholders by the weighted-average number of shares outstanding during the period which includes Pre-Funded Warrants and shares held in abeyance from date of issuance.

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(5,778,066

)

 

$

(4,595,199

)

 

$

(15,387,309

)

 

$

(14,850,943

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average number of common shares outstanding – basic and diluted

 

 

8,882,570

 

 

 

6,162,671

 

 

 

7,592,103

 

 

 

5,977,841

 

Net loss per share applicable to common stockholders – basic and diluted

 

$

(0.65

)

 

$

(0.75

)

 

$

(2.03

)

 

$

(2.48

)

 

The following shares were excluded from the calculation of diluted net loss per share applicable to common stockholders, prior to the application of the treasury stock method, because their effect would have been anti-dilutive for the periods presented:

 

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

Options to purchase shares of stock

 

 

1,140,280

 

 

 

835,913

 

Warrants to purchase shares of stock

 

 

7,738,040

 

 

 

3,080,090

 

Total

 

 

8,878,320

 

 

 

3,916,003

 

 

12.
Income Taxes

During the three and nine months ended September 30, 2024 and 2023, there was no provision for income taxes as the Company incurred losses during those periods. Deferred tax assets and liabilities reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company

13


 

recorded a full valuation allowance against its deferred tax assets as the Company believes it is more likely than not the deferred tax assets will not be realized.

 

13.
Commitments and Contingencies

Litigation

As previously disclosed, on April 26, 2024, the Company received a notice of a demand for arbitration with the American Arbitration Association from Pivot Holding LLC (“Pivot”), a successor in interest to Sphaera Pharma Pte. Ltd. (“Sphaera”), in connection with the Collaborative Research and Development Agreement dated February 29, 2012, as amended, between the Company and Sphaera (the “Collaboration Agreement”), alleging breach of contract by the Company for failure to pay certain milestone payments under the Collaboration Agreement and seeking damages. Also as previously disclosed, on June 17, 2024, the Company filed an answering statement and counterclaim denying that it had breached the Collaboration Agreement and counterclaiming. On September 30, 2024, following a non-binding confidential mediation, the Company and Pivot entered into a settlement agreement (the “Settlement Agreement”) pursuant to which the Company agreed to pay to Pivot a total sum of $500,000, which Pivot agreed shall constitute full and complete payment for, and shall fully satisfy, any and all amounts for any and all project milestone payments owed or that may be owed to Sphaera and/or Pivot by the Company under the Collaboration Agreement for: (i) “First dosing of patient in US phase 1 trial”; (ii) “US Phase 1 trial completion with endpoints met”; and (iii) “US Phase 2 trial completion with endpoints met” (each as described in the Collaboration Agreement) which payments would have totaled $1.625 million in the event Pivot were to be successful in claiming that the Company conducted Phase 1 and Phase 2 trials or that would be due upon successful milestones in the future. The Company also agreed to pay to Pivot a one-time payment of $4.4 million, increased from $4.0 million, upon FDA Approval (as described in the Collaboration Agreement) and the parties agreed that no further FDA Approval milestone payment(s) shall be due to Pivot in the event that the Company receives additional FDA Approval(s). The Settlement Agreement contains customary mutual releases and covenants not to sue. Except as otherwise provided in the Settlement Agreement, all terms in the Collaboration Agreement shall remain in full force and effect.

Lease

On April 18, 2022, the Company entered into an operating lease agreement for office space at its new location in Lexington, Massachusetts (the "Office Lease"). On August 8, 2022, the Company commenced occupancy of the leased space. The lease runs through September 30, 2025. We have an option to extend the lease term for an additional three (3) years thereafter.

The Company accounts for the Office Lease under the provisions of ASC 842. We recorded a right-of-use asset and a corresponding operating lease liability on the Company's condensed consolidated balance sheets upon the accounting commencement date in August 2022. The lease liability was measured at the accounting commencement date utilizing a 12% discount rate. The right-of-use asset had a balance of $133,105 at September 30, 2024. The operating lease obligations totaled $145,210 at September 30, 2024, all of which is included under current liabilities. The Company recorded lease expense of $35,296 and $105,887 and other short-term payments of $5,521 and $16,827 for the three and nine months ended September 30, 2024, respectively, in selling, general and administrative expenses and lease expense relating to the Office Lease of $35,296 and $105,887 and other short-term payments of $5,788 and $17,364 for the three and nine months ended September 30, 2023, respectively, in selling, general and administrative expenses.

The Office Lease contains escalating payments during the lease period. Upon execution of the Office Lease, the Company prepaid one month of rent and a security deposit, one of which will be held in escrow and credited at the termination of the lease and the other of which will be applied to the first month’s rent.

As of September 30, 2024, a security deposit of approximately $25,000 was included in prepaid expenses and other current assets on the Company’s condensed consolidated balance sheet related to the Office Lease.

Future minimum lease payments under this lease at September 30, 2024, are presented by calendar year as follows:

 

Year

 

 

 

2024

 

$

38,322

 

2025

 

 

114,966

 

Total lease payments

 

 

153,288