Quarterly report [Sections 13 or 15(d)]

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

v3.26.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
 9 Months Ended
Sep. 30, 2026
Accounting Policies [Abstract]  
BASIS OF PRESENTATION

BASIS OF PRESENTATION

The accompanying condensed unaudited financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("US GAAP") and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”) and have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. The accompanying condensed unaudited financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s Form 10-K filed with the SEC on March 12, 2026 (“2025 Annual Report”).

CASH, CASH EQUIVALENTS AND RESTRICTED CASH

CASH, CASH EQUIVALENTS AND RESTRICTED CASH

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash deposits. As of September 30, 2026, the Company had $6.1 million held as cash and cash equivalents, of which $5.7 million was held as cash equivalents. As of December 31, 2025, the Company had $4.4 million held as cash and cash equivalents, of which $0.1 million was held as cash equivalents. The Company maintains its cash in institutions insured by the Federal Deposit Insurance Corporation (“FDIC”) and has cash balances in accounts which exceed the federally insured limits as of September 30, 2026 and December 31, 2025. The Company has made a deposit to the bank for its credit cards in the amount of $57,000 and $56,000 as of September 30, 2026, and December 31, 2025, respectively, which is classified as restricted cash included in other assets.
USE OF ESTIMATES

USE OF ESTIMATES

The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based on amounts that differ from those estimates.
NET LOSS PER COMMON SHARE

NET LOSS PER COMMON SHARE

Basic net loss per share excludes the effect of dilution and is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding.

Diluted net loss per share is computed by giving effect to all potential shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three and nine months ended September 30, 2026 and 2025 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect.

In accordance with ASC 260-10-45-13, exercisable penny options are included in the calculation of weighted average basic and diluted earnings per share. Penny options of 102,900 and 115,627 have been included in the calculation of weighted average basic and diluted earnings per share for the three and nine months ended September 30, 2026 and September 30, 2025, respectively.

The following is a summary of awards outstanding as of September 30, 2026 and 2025, which are not included in the computation of basic and diluted weighted average shares:

 

 

Three and nine months ended
September 30,

 

 

2026

 

 

2025

 

Stock options (excluding exercisable penny stock options)

 

 

9,639,598

 

 

 

8,912,143

 

Restricted stock units

 

 

—

 

 

 

519,947

 

Warrants

 

 

6,545,785

 

 

 

5,827,035

 

Performance-based restricted stock units

 

 

2,800,000

 

 

 

—

 

Total

 

 

18,985,383

 

 

 

15,259,125

 

 
SEGMENT REPORTING

SEGMENT REPORTING

The Company operates in one reporting segment. The Company’s Chief Operating Decision Maker (“CODM”) is the Chief Executive Officer. The CODM uses operating expenses to measure performance against progress in its clinical trials and its product development. The determination of a single business segment is consistent with the financial information regularly provided to the Company’s CODM. The Company’s CODM reviews and evaluates the total net loss for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods. In addition to the significant expense categories included within the total net loss presented on the Company's Statements of Operations, the following table sets forth significant segment expenses:

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

(in thousands)

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Employee expenses

 

$

2,046

 

 

$

2,949

 

 

$

8,293

 

 

$

8,821

 

Research and Development (excluding employee expenses):

 

 

 

 

 

 

 

 

 

 

 

 

Consulting and professional fees

 

 

319

 

 

 

546

 

 

 

1,192

 

 

 

1,220

 

Clinical study expenses

 

 

19

 

 

 

92

 

 

 

278

 

 

 

297

 

Product development

 

 

4

 

 

 

677

 

 

 

207

 

 

 

2,032

 

Other*

 

 

315

 

 

 

313

 

 

 

903

 

 

 

951

 

Total Research and development expense

 

$

657

 

 

$

1,628

 

 

$

2,580

 

 

$

4,500

 

Selling, general and administrative expense (excluding employee expenses):

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative expenses

 

 

513

 

 

 

477

 

 

 

1,570

 

 

 

1,804

 

Commercialization readiness expenses

 

 

241

 

 

 

236

 

 

 

822

 

 

 

704

 

Total Selling, general and administrative expense

 

 

754

 

 

 

713

 

 

 

2,392

 

 

 

2,508

 

Total operating expenses

 

$

3,457

 

 

$

5,290

 

 

$

13,265

 

 

$

15,829

 

 

* Other primarily includes depreciation, patent, software, product testing and other miscellaneous expenses for the three and nine months ended September 30, 2026 and 2025.