What changed in this filing

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Item 9A. Controls and Procedures

2026-03-04 compared with 2025-03-13 · 40 added, 88 removed, 326 unchanged (28% of the section changed)

2 unchanged sentences

Under the supervision, and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), in connection with the period ending December 31, 2025.

Based on that evaluation, management has concluded that as of the respective period, our disclosure controls and procedures were not effective due to the material weaknesses in internal control over financial reporting described below.

Based on that evaluation, management has concluded that as of the respective period, our disclosure controls and procedures were not effective to the material weaknesses in internal control over financial reporting described below.

Notwithstanding the material weaknesses in our internal control over financial reporting, management has concluded that the audited consolidated financial statements included in this Form 10-K fairly present, in all material respects, our financial position, results of operations and cash flows for the periods presented in conformity with accounting principles generally accepted in the United States of America.

26 unchanged sentences

Management did not appropriately select, develop, and perform ongoing evaluations to ascertain whether the components of internal controls are present and functioning

These material weaknesses resulted in errors that required the restatement of the Company’s consolidated financial statements as of and for the fiscal years ended December 31, 2023 and December 31, 2022, as well as the restatement of the Company’s condensed consolidated financial statements as of and for the interim periods ended September 30, 2023, June 30, 2023, March 31, 2023, September 30, 2022, June 30, 2022, and March 31, 2022.

These material weaknesses resulted in errors that required the restatement of the Company’s consolidated financial statements as of and for the fiscal years ended December 31, 2023 and December 31, 2022, as well as the restatement of the Company’s condensed consolidated financial statements as of and for the interim periods ended March 31, 2024, September 30, 2023, June 30, 2023, March 31, 2023, September 30, 2022, June 30, 2022, and March 31, 2022.

Additionally, these material weaknesses could result in a misstatement of the account balances or disclosures that would result in a material misstatement to the annual or interim consolidated financial statements that would not be prevented or timely detected.

35 unchanged sentences

(1) The reported amounts represent the aggregate grant date fair value computed in accordance with Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation-Stock Compensation (“ASC 718”).

In the case of stock awards, the grant date fair value was determined based on the stock price on the grant date.

All assumptions made regarding the valuation of option awards can be referenced in Note 7 in the Notes to Restated Consolidated Financial Statements included in this prospectus.

The amounts reported for 2024 include stock option awards to Messrs.

Caruso, Longcor and Kolean with respect to 900,000 shares, 500,000 shares, and 290,000 shares, respectively, which awards were approved by the Compensation

Committee on November 30, 2023, subject to stockholder approval of an amendment to the Company’s 2021 Stock Incentive Plan (the “2021 Plan”) at the 2024 annual meeting of stockholders.

Because stockholder approval was received in 2024, these stock option awards are considered granted in 2024 under ASC 718 and are reflected as 2024 compensation in the 2024 Summary Compensation Table.

All assumptions made regarding the valuation of option awards can be referenced in Note 7 in the Notes to Restated Consolidated Financial Statements included in this Annual Report on Form 10-K.

The amounts reported for 2025 represent stock option awards to Messrs.

Caruso, Longcor and Kolean with respect to 30,000 shares, 16,666 shares, and 9,666 shares, respectively, which awards were approved by the Compensation Committee on February 14, 2025.

(2) Amounts in this column represent bonuses approved by the Compensation Committee based on its annual review of the performance of the executive officers against predetermined financial and strategic objectives established for the year.

NEOs are paid the same percentage upon the achievement of financial objectives and may be paid varied percentages upon the achievement of strategic objectives depending on the subject matter.

(3) The methodology used to compute the aggregate incremental cost of perquisites and other personal benefits for each individual NEO is based on the total cost to the Company, and such costs are required to be reported under SEC rules when the total costs are equal to or greater than $10,000 in the aggregate for a NEO.

The amounts presented are exclusively cash bonuses paid to the NEOs to satisfy the tax withholding obligations associated with fully vested stock awards received by the NEOs on December 8, 2023 following the release of positive top-line data.

paid the same percentage upon the achievement of financial objectives and may be paid varied percentages upon the achievement of strategic objectives depending on the subject matter.

Equity Awards

As described in Note (1) to the 2024 Summary Compensation Table above, on November 30, 2023 the Compensation Committee approved stock option awards to Messrs.

As described in Note (1) to the 2025 Summary Compensation Table above, on February 14, 2025 the Compensation Committee approved stock option awards to Messrs.

Caruso, Longcor and Kolean with respect to 30,000 shares, 16,666 shares, and 9,666 shares, respectively, subject to stockholder approval of an amendment to the 2021 Plan at the 2024 annual meeting of stockholders.

2 unchanged sentences

We entered into an employment agreement with Mr.

Caruso as of June 15, 2015, as amended and restated on April 15, 2019, pursuant to which Mr.

Caruso as of June 15, 2015, as amended and restated on April 15, 2019, and amended on March 12, 2025, pursuant to which Mr.

Caruso serves as President and Chief Executive Officer of the Company.

12 unchanged sentences

We entered into an employment agreement with Mr.

Longcor as of July 15, 2016, as amended and restated on April 15, 2019, and amended on November 10, 2019.

Longcor as of July 15, 2016, as amended and restated on April 15, 2019, and amended on November 10, 2019, and March 12, 2025.

Under the agreement, Mr.

13 unchanged sentences

In the event of a dismissal without cause or resignation by Mr.

Kolean for good reason, Mr.

Kolean will be entitled to nine months of severance.

In the event of dismissal without cause or

resignation by Mr.

Kolean for good reason, within the eighteen months following a change in control, Mr.

Kolean will be entitled to eighteen months of severance.

Kolean for good reason, contingent upon the execution of a release agreement in favor of the Company, Mr.

Kolean is entitled to (i) severance in an amount equal to nine months of Mr.

Kolean’s annual base salary, provided that if such termination occurs within 12 months after a change in control (i.e.

double trigger), such severance is increased to 18 months of Mr.

Kolean’s full base salary, each payable in monthly installments, (ii) payment or reimbursement of health insurance (for nine or 18 months, as applicable), each payable in monthly installments, and (iii) outplacement services not to exceed $7,500.

2025 Outstanding Equity Awards at Fiscal Year-End

The following table sets forth certain information with respect to outstanding equity awards as of December 31, 2024, with respect to our NEOs.

The following table sets forth certain information with respect to outstanding equity awards as of December 31, 2025, with respect to our NEOs, and reflects the reverse stock split of our common stock that occurred on June 24, 2025.

Option Awards

6 unchanged sentences

(1) These options are scheduled to vest one-third on the first anniversary of the grant date and in 24 equal monthly installments thereafter, subject to continuous employment with the Company through each vesting date.

(2) These options are scheduled to vest annually in increments of one-third over three years from the date of grant.

Pursuant to the terms of the option award agreements, options granted pursuant to the Amended and Restated 2015 Stock Incentive Plan and the 2021 Plan become fully vested upon a termination event within one year following a change in control, as defined in such plans.

Pursuant to the terms of the option award agreements, options granted pursuant to the 2021 Stock Incentive Plan become fully vested upon a termination event within one year following a change in control, as defined in such plan.

A termination event is defined as either termination of employment other than for cause or constructive termination resulting from a significant reduction in either the nature or scope of duties and responsibilities, a reduction in compensation or a required relocation.

2 unchanged sentences

We believe that the mix and design of our executive compensation plans and policies do not encourage management to assume excessive risks and are not reasonably likely to have a material adverse effect on us.

Pay Versus Performance

Initial Fixed

Actually Paid

Total for PEO

Shareholder Return

Caruso, served as the Company’s principal executive officer (“PEO”) for the entirety of 2024, 2023 and 2023 and the Company’s other NEOs for the entirety of 2024, 2023 and 2022 were Jarrod Longcor and Chad J.

Amounts reported in this column represent (i) the total compensation reported in the Summary Compensation Table for the applicable year in the case of Mr.

Caruso and (ii) the average of the total compensation reported in the Summary Compensation Table for the applicable year for the Company’s NEOs reported for the applicable year other than the principal executive officer for such years.

Amounts reported in this column represent the compensation actually paid to Mr.

Caruso as the Company’s President and Chief Executive Officer in the indicated fiscal years, based on his total compensation reported in the Summary Compensation Table for the indicated fiscal years and adjusted as shown in the table below:

Summary Compensation Table - Total Compensation(a)

- Grant Date Fair Value of Stock Awards and Option Awards Granted in Fiscal Year(b)

+Fair Value at Fiscal Year-End of Outstanding and Unvested Option Awards Granted in Fiscal Year(c)

+Change in Fair Value of Outstanding and Unvested Option Awards Granted in Prior Fiscal Years(d)

+Fair Value at Vesting of Stock Awards and Option Awards Granted in Fiscal Year That Vested During Fiscal Year(e)

+Change in Fair Value as of Vesting Date of Option Awards Granted in Prior Fiscal Years For Which Applicable Vesting Conditions Were Satisfied During Fiscal Year(f)

- Fair Value as of Prior Fiscal Year-End of Option Awards Granted in Prior Fiscal Years That Failed to Meet Applicable Vesting Conditions During Fiscal Year(g)

= Compensation Actually Paid

Represents Total Compensation as reported in the Summary Compensation Table for the indicated fiscal year.

Represents the aggregate grant date fair value of the stock awards and option awards granted to Mr.

Caruso during the indicated fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Represents the aggregate fair value as of the indicated fiscal year-end of Mr.

Caruso’s outstanding and unvested option awards granted during such fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Represents the aggregate change in fair value during the indicated fiscal year of the outstanding and unvested option awards held by Mr.

Caruso as of the last day of the indicated fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Represents the aggregate fair value at vesting of the stock awards and option awards that were granted to Mr.

Caruso and vested during the indicated fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Represents the aggregate change in fair value, measured from the prior fiscal year-end to the vesting date, of each option award held by Mr.

Caruso that was granted in a prior fiscal year and which vested during the indicated fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Represents the aggregate fair value as of the last day of the prior fiscal year of Mr.

Caruso’s option awards that were granted in a prior fiscal year and which failed to meet the applicable vesting conditions in the indicated fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Amounts reported in this column represent the compensation actually paid to the Company’s NEOs other than Mr.

Caruso in the indicated fiscal year, based on the average total compensation for such NEOs reported in the Summary Compensation Table for the indicated fiscal year and adjusted as shown in the table below:

Other NEOs Average(a)

Summary Compensation Table - Total Compensation(b)

- Grant Date Fair Value of Stock Awards and Option Awards Granted in Fiscal Year(c)

+Fair Value at Fiscal Year-End of Outstanding and Unvested Option Awards Granted in Fiscal Year(d)

+Change in Fair Value of Outstanding and Unvested Option Awards Granted in Prior Fiscal Years(e)

+Fair Value at Vesting of Stock Awards and Option Awards Granted in Fiscal Year That Vested During Fiscal Year(f)

+Change in Fair Value as of Vesting Date of Option Awards Granted in Prior Fiscal Years For Which Applicable Vesting Conditions Were Satisfied During Fiscal Year(g)

- Fair Value as of Prior Fiscal Year-End of Option Awards Granted in Prior Fiscal Years That Failed to Meet Applicable Vesting Conditions During Fiscal Year(h)

= Compensation Actually Paid

See footnote 1 for the NEOs included in the average for each indicated fiscal year.

Represents the average Total Compensation as reported in the Summary Compensation Table for the reported NEOs in the indicated fiscal year.

Represents the average aggregate grant date fair value of the stock awards and option awards granted to the reported NEOs during the indicated fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Represents the average aggregate fair value as of the indicated fiscal year-end of the reported NEOs’ outstanding and unvested option awards granted during such fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Represents the average aggregate change in fair value during the indicated fiscal year of the outstanding and unvested option awards held by the reported NEOs as of the last day of the indicated fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Represents the average aggregate fair value at vesting of the stock awards and option awards that were granted to the reported NEOs and vested during the indicated fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Represents the average aggregate change in fair value, measured from the prior fiscal year-end to the vesting date, of each option award held by the reported NEOs that was granted in a prior fiscal year and which vested during the indicated fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Represents the average aggregate fair value as of the last day of the prior fiscal year of the reported NEOs’ option awards that were granted in a prior fiscal year and which failed to meet the applicable vesting conditions in the indicated fiscal year, calculated using the same methodology as used in the Company’s financial statements under generally accepted accounting principles.

Pursuant to rules of the SEC, the comparison assumes $100 was invested on December 31, 2021, in our common stock.

Historic stock price performance is not necessarily indicative of future stock price performance.

2025 Director Compensation

2 unchanged sentences

Director fees consist of annual cash fees for service.

Granted on December 15, 2023, subject to stockholder approval of an amendment to the 2021 Plan at the 2024 annual meeting of stockholders.

Because stockholder approval was received in 2024, these stock option awards are considered granted in 2024 under ASC 718 and are reflected as 2024 compensation in the 2024 Director Compensation Table.

These stock options have an exercise price of $2.58 per share and fully vest on the first anniversary of the grant date, subject to continued service through applicable vesting date.

Granted on February 14, 2025.

These stock options have an exercise price of $8.70 per share and fully vested on the first anniversary of the grant date, subject to continued service through applicable vesting date.

The reported amounts represent the aggregate grant date fair value computed in accordance with ASC 718.

All assumptions made regarding the valuation of equity awards can be referenced in Note 7 in the Notes to Restated Consolidated Financial Statements included in this prospectus.

All assumptions made regarding the valuation of equity awards can be referenced in Note 7 in the Notes to Restated Consolidated Financial Statements included in this Annual Report on Form 10-K.

During 2025, we paid each of our non-employee directors a quarterly cash fee of $15,000 ($22,500 for Mr.

In addition, in December 2023, we granted to each non-employee director stock options to purchase 60,000 shares (90,000 shares for Mr.

Swirsky), which were subject to the approval of an amendment to the 2021 Plan at the 2024 annual meeting of stockholders.

Swirsky receives additional cash remuneration and option awards for his service as Chairman of the Board of the Company.

In addition, in February 2025, we granted to each non-employee director stock options to purchase 2,000 shares (3,000 shares for Mr.

Swirsky) (in each case, adjusted to reflect the reverse stock split of our common stock that occurred on June 24, 2025).

Swirsky receives additional cash remuneration and option awards for his service as Chairman of the Board.

We reimbursed directors for reasonable out-of-pocket expenses incurred in attending Board and committee meetings and undertaking certain matters on our behalf.

4 unchanged sentences

Under the Sarbanes-Oxley Act, in the event of misconduct that results in a financial restatement that would have reduced a previously paid incentive amount, we can recoup those improper payments from our executive officers.

The SEC also recently adopted rules which direct national stock exchanges to require listed companies to implement policies intended to recoup bonuses paid to executives if we are found to have misstated its financial results.

We have adopted our Executive Compensation Clawback Policy (the “Clawback Policy”) in order to comply with the final clawback rules adopted by the SEC under the Rule, and the listing standards, as set forth in the Nasdaq Listing Rule 5608 (the “Final Clawback Rules”).

The Clawback Policy provides for the mandatory recovery of erroneously awarded incentive-based compensation from our current and former executive officers as defined in the Rule (“Covered Officers”) in the event that we are required to prepare an accounting restatement, in accordance with the Final Clawback Rules.

We have adopted our Policy on Recoupment of Incentive Compensation (the “Clawback Policy”) in order to comply with the final clawback rules adopted by the SEC under the Rule, and the listing standards, as set forth in the Nasdaq Listing Rule 5608 (the “Final Clawback Rules”).

The Clawback Policy provides for the mandatory recovery of erroneously awarded incentive-based compensation from our current and former executive officers as defined in the Final Clawback Rule (“Covered Officers”) in the event that we are required to prepare an accounting restatement, in accordance with the Final Clawback Rules.

The recovery of such compensation applies regardless of whether a Covered Officer engaged in misconduct or otherwise caused or contributed to the requirement of an accounting restatement.

Under the Clawback Policy, our board of directors may recoup from the Covered Officers erroneously awarded incentive compensation received within a lookback period of the three completed fiscal years preceding the date on which we are required to prepare an accounting restatement.

Under the Clawback Policy, our Board may recoup from the Covered Officers erroneously awarded incentive compensation received within a lookback period of the three completed fiscal years preceding the date on which we are required to prepare an accounting restatement.

The foregoing description of the Clawback Policy does not purport to be complete and is qualified in its entirety by the terms and conditions of the Clawback Policy, a copy of which is attached hereto as Exhibit 97 and is incorporated herein by reference.

71 unchanged sentences

September 8, 2023

Certificate of Amendment to Second Amended and Restated Certificate of Incorporation

June 25, 2025

Form of common stock certificate

14 unchanged sentences

April 1, 2024

Form of Common Warrant

June 30, 2025

Form of Pre-Funded Warrant

June 30, 2025

Representative Warrant

June 30, 2025

Form of Series I Warrant

October 10, 2025

Form of Series II Warrant

October 10, 2025

Form of Restricted Common Stock Agreement**

71 unchanged sentences

Insider Trading Policy

March 13, 2025

List of Subsidiaries

March 13, 2025

Consent of Independent Registered Public Accounting Firm

4 unchanged sentences

Clawback Policy

April 1, 2024

Interactive Data Files (formatted in Inline XBRL)

27 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures