3 unchanged sentences
(in thousands, except share and per share amounts)
−Removed: June 30, 2025 December 31, 2024
+Added: September 30, 2025 December 31, 2024
Assets (unaudited)
17 unchanged sentences
Common stock, 0.0001 par value;
−Removed: 250,000,000 shares authorized as of June 30, 2025 and December 31, 2024;
−Removed: 2,496,800 and 525,485 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively
+Added: 250,000,000 shares authorized as of September 30, 2025 and December 31, 2024;
+Added: 3,268,727 and 525,485 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively
Additional paid-in capital
7 unchanged sentences
(in thousands, except share and per share amounts)
−Removed: Three Months Ended June 30, Six Months Ended June 30,
+Added: Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
9 unchanged sentences
$ ( 1.28 ) $ ( 11.42 ) $ ( 5.19 ) $ ( 77.55 )
−Removed: Weighted-average common shares outstanding, basic and diluted 2,205,139 36,379 1,369,933 27,522
+Added: Weighted-average of common stock outstanding, basic and diluted 2,621,498 185,924 1,791,706 80,714
See accompanying notes to unaudited interim consolidated financial statements.
2 unchanged sentences
(in thousands, except shares)
−Removed: Six Months Ended June 30, 2025
+Added: Nine Months Ended September 30, 2025
Common Stock Additional
7 unchanged sentences
Stock-based compensation — — 41 — 41
−Removed: Issuance of common stock and prefunded warrants in financing 1,388,888 — 4,143 — 4,143
+Added: Issuance of common stock and prefunded warrants, net of issuance costs 1,388,888 — 4,143 — 4,143
Issuance of common stock 582,554 — 825 — 825
1 unchanged sentence
Balance, June 30, 2025 (unaudited) 2,496,800 $ — $ 49,000 $ ( 45,678 ) $ 3,322
−Removed: Six Months Ended June 30, 2024
+Added: Stock-based compensation — — 465 — 465
+Added: Issuance of common stock 771,927 — 1,565 — 1,565
+Added: Net loss — — — ( 3,359 ) ( 3,359 )
+Added: Balance, September 30, 2025 (unaudited) 3,268,727 $ — $ 51,030 $ ( 49,037 ) $ 1,993
+Added: Nine Months Ended September 30, 2024
Common Stock Additional
4 unchanged sentences
Fractional share adjustment ( 1 ) — — — —
−Removed: Issuance of common stock and prefunded warrants in financing 1,495 — 4,389 — 4,389
+Added: Issuance of common stock and prefunded warrants, net of issuance costs 1,495 — 4,389 — 4,389
Prefunded warrant exercise 10,047 — — — —
7 unchanged sentences
Balance, June 30, 2024 (unaudited) 47,160 $ — $ 40,389 $ ( 35,670 ) $ 4,719
+Added: Stock-based compensation — — 37 — 37
+Added: Issuance of common stock 123,141 — 1,027 — 1,027
+Added: Warrant exercise 125,152 — — — —
+Added: Net loss — — — ( 2,123 ) ( 2,123 )
+Added: Balance, September 30, 2024 (unaudited) 295,453 $ — $ 41,453 $ ( 37,793 ) $ 3,660
See accompanying notes to unaudited interim consolidated financial statements.
2 unchanged sentences
(in thousands)
−Removed: Six Months Ended June 30,
+Added: Nine Months Ended September 30,
Operating activities:
14 unchanged sentences
Proceeds from issuance of common stock under ATM facility 2,560 1,988
+Added: Proceeds from warrant exercise — 1
Payment for fractional shares in connection with reverse stock split ( 1 ) ( 1 )
2 unchanged sentences
Cash provided by financing activities 6,242 9,550
−Removed: Net increase in cash and cash equivalents 94 4,545
+Added: Net (decrease) increase in cash and cash equivalents ( 973 ) 2,938
Cash and cash equivalents at beginning of period 5,028 1,808
12 unchanged sentences
The Company’s goal is to be an industry leader in developing therapies to treat these diseases and to improve the lives of patients suffering from such diseases.
−Removed: The Company’s lead product candidate, GRI-0621, is an oral inhibitor of type 1 invariant Natural Killer T (iNKT) cells and is being developed for the treatment of severe fibrotic lung diseases such as idiopathic pulmonary fibrosis (IPF).
+Added: The Company’s lead product candidate, GRI-0621, is an oral inhibitor of type 1 invariant Natural Killer T cells and is being developed for the treatment of severe fibrotic lung diseases such as idiopathic pulmonary fibrosis (IPF).
The Company’s product candidate portfolio also includes GRI-0803 and a proprietary library of 500+ compounds.
−Removed: GRI-0803, the lead molecule selected from the library, is a novel oral agonist of type 2 diverse Natural Killer T (dNKT) cells and is being developed for the treatment of autoimmune disorders, with much of its preclinical work in Systemic Lupus Erythematosus Disease (SLE) or lupus and multiple sclerosis (MS).
+Added: GRI-0803, the lead molecule selected from the library, is a novel oral agonist of type 2 diverse Natural Killer T cells and is being developed for the treatment of autoimmune disorders, with much of its preclinical work in Systemic Lupus Erythematosus Disease or lupus and multiple sclerosis (MS).
Recapitalization
5 unchanged sentences
The Company has not generated any significant revenues from operations since inception and does not expect to do so in the foreseeable future.
−Removed: The Company has incurred operating losses since its inception in 2009 and as a result has incurred $ 45,678 in accumulated deficit through June 30, 2025.
+Added: The Company has incurred operating losses since its inception in 2009 and as a result has incurred $ 49,037 in accumulated deficit through September 30, 2025.
The Company has financed its working capital requirements to date through the issuance of equity and debt securities.
−Removed: As of June 30, 2025, the Company had cash of approximately $ 5,122 .
+Added: As of September 30, 2025, the Company had cash and cash equivalents of approximately $ 4,055 .
On February 1, 2024, the Company entered into a securities purchase agreement (the February 2024 Purchase Agreement), pursuant to which the Company issued and sold Common Stock, pre-funded warrants and common warrants in a public offering (the February 2024 Offering) for net proceeds of $ 4,389 , after deducting offering expenses of $ 1,110 .
2 unchanged sentences
Under the Sales Agreement, Wainwright is entitled to compensation of 3.0 % of the gross offering proceeds of all shares of Common Stock sold through it pursuant to the Sales Agreement.
−Removed: As of June 30, 2025, the Company has sold 908,172 shares of Common Stock in the ATM Offering at a weighted-average price of $ 5.01 per share, for net proceeds of $ 4,292 , after deducting commissions to the sales agent and other ATM Offering related expenses of $ 254 .
+Added: As of September 30, 2025, the Company has sold 1,680,099 shares of Common Stock in the ATM Offering at a weighted-average price of $ 3.67 per share, for net proceeds of $ 5,858 , after deducting commissions to the sales agent and other ATM Offering related expenses of $ 308 .
On June 26, 2024, the Company entered into a securities purchase agreement (the June 2024 Purchase Agreement), pursuant to which the Company issued and sold Common Stock, pre-funded warrants and common warrants, in a public offering (the June 2024 Offering), for net proceeds of $ 3,172 , after deducting offering expenses of $ 1,057 .
3 unchanged sentences
On April 1, 2025, the Company entered into a securities purchase agreement (the April 2025 Purchase Agreement), pursuant to which the Company issued and sold Common Stock, pre-funded warrants and common warrants, in a public offering (the April 2025 Offering), for net proceeds of $ 4,020 , after deducting offering expenses of $ 979 .
−Removed: Based on the Company’s current operating plan, the Company believes that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2025.
+Added: Based on the Company’s current operating plan, the Company believes that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2026.
The Company’s ability to continue as a going concern is dependent on its ability to raise additional capital to fund its business activities, including its research and development program.
8 unchanged sentences
The December 31, 2024 balance sheet was derived from the Company’s audited consolidated financial statements.
−Removed: In the opinion of management, the unaudited interim consolidated financial statements furnished herein include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of June 30, 2025, and the consolidated results of operations and consolidated stockholders’ equity for the three and six months ended June 30, 2025 and 2024 and consolidated cash flows for the six months ended June 30, 2025 and 2024.
−Removed: Consolidated results of operations for the three and six months ended June 30, 2025, are not necessarily indicative of the operating results that may be expected for the year ending December 31, 2025.
+Added: In the opinion of management, the unaudited interim consolidated financial statements furnished herein include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of September 30, 2025, and the consolidated results of operations and consolidated stockholders’ equity for the three and nine months ended September 30, 2025 and 2024 and consolidated cash flows for the nine months ended September 30, 2025 and 2024.
+Added: Consolidated results of operations for the three and nine months ended September 30, 2025, are not necessarily indicative of the operating results that may be expected for the year ending December 31, 2025.
The unaudited interim consolidated financial statements, presented herein, do not contain the required disclosures under GAAP for annual consolidated financial statements.
16 unchanged sentences
Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
−Removed: As of June 30, 2025, the Company’s financial instruments included cash, cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses and certain liability classified warrants.
+Added: As of September 30, 2025, the Company’s financial instruments included cash, cash equivalents, prepaid expenses and other current assets, accounts payable, accrued expenses and certain liability classified warrants.
The carrying amounts reported in the consolidated balance sheets for cash, cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair value based on the short-term maturity of these instruments.
The Company recognizes transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer.
−Removed: At June 30, 2025, there were no financial assets or liabilities measured at fair value on a recurring basis other than the liability classified warrants.
+Added: At September 30, 2025, there were no financial assets or liabilities measured at fair value on a recurring basis other than the liability classified warrants.
In May 2022, Vallon Pharmaceuticals, Inc.
5 unchanged sentences
The valuation of the May 2022 Warrants is considered under Level 3 of the fair value hierarchy due to the need to use assumptions in the valuation that are both significant to the fair value measurement and unobservable.
−Removed: The change in the fair value of the Level 3 warrant liability is reflected in the consolidated statements of operations for the three and six months ended June 30, 2025.
−Removed: As of June 30, 2025 and December 31, 2024, the fair value of the warrant liability was immaterial.
+Added: The change in the fair value of the Level 3 warrant liability is reflected in the consolidated statements of operations for the three and nine months ended September 30, 2025.
+Added: As of September 30, 2025 and December 31, 2024, the fair value of the warrant liability was immaterial.
Deferred Stock Issuance Costs
3 unchanged sentences
Basic net loss per common share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during each period.
−Removed: For the six-month period ended June 30, 2024, basic net loss per common share includes the weighted average of the June 2024 Pre-Funded Warrants (as defined below).
Diluted net loss per common share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding during each period, plus the dilutive effect of common stock equivalents outstanding during each period, in accordance with ASC 260, Earnings Per Share .
−Removed: As the Company had a net loss in each of the three and six months ended June 30, 2025 and 2024, diluted net loss per common share is the same as basic net loss per common share for the period because the effects of potentially dilutive securities are antidilutive .
+Added: As the Company had a net loss in each of the three and nine months ended September 30, 2025 and 2024, diluted net loss per common share is the same as basic net loss per common share for the period because the effects of potentially dilutive securities are antidilutive .
Common stock equivalents excluded from the diluted net loss per common share calculations are as follows:
+Added: September 30,
Stock options 421,274 142
2 unchanged sentences
Recent Accounting Pronouncements
−Removed: The Company considered the applicability and impact of all ASUs issued during the quarter ended June 30, 2025.
+Added: The Company considered the applicability and impact of all ASUs issued during the quarter ended September 30, 2025.
ASUs not discussed below were assessed and determined to be either not applicable or expected to have minimal impact on these unaudited interim consolidated financial statements
4 unchanged sentences
This guidance is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024.
−Removed: The Company has adopted the provisions of ASU 2023-07 and has included the required disclosures in this Quarterly Report on Form 10-Q.
+Added: The Company has adopted the provisions of ASU 2023-07 and has included the required disclosures in this Quarterly Report on Form 10-Q (the Quarterly Report).
See Note 8 for additional disclosures.
PROPERTY AND EQUIPMENT
−Removed: June 30, 2025 December 31, 2024
+Added: September 30, 2025 December 31, 2024
Computer equipment $ 21 $ 21
1 unchanged sentence
Accumulated depreciation ( 33 ) ( 30 )
−Removed: Depreciation expense related to property and equipment was $ 1 in each of the three-month periods ended June 30, 2025 and 2024 and $ 2 in each of the six-month periods ended June 30, 2025 and 2024.
+Added: Depreciation expense related to property and equipment was $ 1 in each of the three-month periods ended September 30, 2025 and 2024 and $ 3 in each of the nine-month periods ended September 30, 2025 and 2024.
ACCRUED EXPENSES
Accrued expenses consist of the following:
−Removed: June 30, 2025 December 31, 2024
+Added: September 30, 2025 December 31, 2024
Research and development $ 755 $ 342
5 unchanged sentences
On February 1, 2024, the Company entered into the February 2024 Purchase Agreement, pursuant to which the Company sold, in the February 2024 Offering, (i) 1,495 shares (the February 2024 Shares) of Common Stock, (ii) 21,131 pre-funded warrants (the February 2024 Pre-Funded Warrants) exercisable for an aggregate of 21,131 shares of Common Stock, (iii) 22,631 Series B-1 common warrants (the Series B-1 Common Warrants) exercisable for an aggregate of 22,631 shares of Common Stock and (iv) 22,631 Series B-2 common warrants (the Series B-2 Common Warrants, and together with the Series B-1 Common Warrants, the Series B Common Warrants) exercisable for an aggregate of 22,631 shares of Common Stock for net proceeds of $ 4,389 , after deducting offering expenses of $ 1,110 .
−Removed: The Series B Common Warrants together with the February 2024 Pre-Funded Warrants are referred to in this Quarterly Report on Form 10-Q (the Quarterly Report) as the “February 2024 Warrants.” The securities were offered in combinations of (a) one February 2024 Share or one February 2024 Pre-Funded Warrant, together with (b) one Series B-1 Common Warrant and one Series B-2 Common Warrant, for a combined purchase price of $ 243.10 (less $ 0.0221 for each February 2024 Pre-Funded Warrant).
+Added: The Series B Common Warrants together with the February 2024 Pre-Funded Warrants are referred to in this Quarterly Report as the “February 2024 Warrants.” The securities were offered in combinations of (a) one February 2024 Share or one February 2024 Pre-Funded Warrant, together with (b) one Series B-1 Common Warrant and one Series B-2 Common Warrant, for a combined purchase price of $ 243.10 (less $ 0.0221 for each February 2024 Pre-Funded Warrant).
Subject to certain ownership limitations, the February 2024 Warrants were exercisable upon issuance.
3 unchanged sentences
The February 2024 Warrants were classified as equity and the allocated fair value of $ 4,279 is included in additional paid-in capital.
−Removed: As of June 30, 2025, all of the February 2024 Pre-Funded Warrants have been exercised.
−Removed: In connection with the issuance of the securities pursuant to the February 2024 Purchase Agreement, the exercise price of the Company’s previously outstanding Series A-1 Warrants was reduced to par, or $ 0.0001 , per share pursuant to the terms of the Series A-1 Warrants.
−Removed: As of June 30, 2025, all of the Series A-1 Warrants have been exercised.
+Added: As of September 30, 2025, all of the February 2024 Pre-Funded Warrants have been exercised.
+Added: In connection with the issuance of the securities pursuant to the February 2024 Purchase Agreement, the exercise price of the Company’s previously outstanding Series A-1 common warrants (the Series A-1 Warrants) was reduced to par, or $ 0.0001 , per share pursuant to the terms of the Series A-1 Warrants.
+Added: As of September 30, 2025, all of the Series A-1 Warrants have been exercised.
May 2024 At The Market Offering
1 unchanged sentence
Under the Sales Agreement, Wainwright is entitled to compensation of 3.0 % of the gross offering proceeds of all shares of Common Stock sold through it pursuant to the Sales Agreement.
−Removed: As of June 30, 2025, the Company has sold 908,172 shares of Common Stock in the ATM Offering at a weighted-average price of $ 5.01 per share, for net proceeds of $ 4,292 , after deducting commissions to the sales agent and other ATM Offering related expenses of $ 254 , of which 582,554 shares of Common Stock were sold during the quarter ended June 30, 2025, for gross proceeds of $ 941 and net proceeds of $ 825 .
+Added: As of September 30, 2025, the Company has sold 1,680,099 shares of Common Stock in the ATM Offering at a weighted-average price of $ 3.67 per share, for net proceeds of $ 5,858 , after deducting commissions to the sales agent and other ATM Offering related expenses of $ 308 .
+Added: During the three months ended September 30, 2025, the Company sold 771,927 shares of Common Stock in the ATM Offering at a weighted average price of $ 2.10 per share for gross proceeds of $ 1,619 and net proceeds of $ 1,565 .
+Added: During the nine months ended September 30, 2025, the Company sold 1,354,481 shares of Common Stock in the ATM Offering at a weighted-average price of $ 1.89 per share for gross proceeds of $ 2,560 and net proceeds of $ 2,475 .
On May 23, 2025, the Company filed a prospectus supplement to its registration statement on Form S-3 (File No.
3 unchanged sentences
The Series C Common Warrants together with the June 2024 Pre-Funded Warrants are referred to in this Quarterly Report as the “June 2024 Warrants.” The securities were offered in combinations of (a) one June 2024 Share or one June 2024 Pre-Funded Warrant, together with (b) one Series C-1 Common Warrant and one Series C-2 Common Warrant, for a combined purchase price of $ 31.11 (less $ 0.0017 for each June 2024 Pre-Funded Warrant).
−Removed: The June 2024 Pre-Funded Warrants were exercisable for one share of Common Stock at a price per share of $ 0.0017 , were exercisable immediately and have been exercised in full as of June 30, 2025.
+Added: The June 2024 Pre-Funded Warrants were exercisable for one share of Common Stock at a price per share of $ 0.0017 , were exercisable immediately and have been exercised in full as of September 30, 2025.
Each Series C-1 Common Warrant is exercisable into one share of Common Stock at a price per share of $ 31.11 for a five-year period beginning after September 6, 2024.
12 unchanged sentences
As compensation for such placement agent services, the Company agreed to pay Wainwright an aggregate cash fee equal to 7.0 % of the gross proceeds received by the Company from the Warrant Repricing Transaction, plus a management fee equal to 1.0 % of the gross proceeds received by the Company from the Warrant Repricing Transaction, and reimbursement for accountable expenses of $ 25,000 and non-accountable expenses of $ 10,000 .
−Removed: The Company has also issued to Wainwright or its designees the October 2024 PA Warrants to purchase up to an aggregate of 3,140 shares of Common Stock (the October 2024 PA Warrant).
+Added: The Company has also issued to Wainwright or its designees the warrants to purchase up to an aggregate of 3,140 shares of Common Stock (the October 2024 PA Warrants).
The October 2024 PA Warrants are immediately exercisable, expire on October 22, 2029, and have an exercise price of $ 21.25 per share.
2 unchanged sentences
April 2025 Securities Purchase Agreement
−Removed: On April 1, 2025, the Company entered into the April 2025 Purchase Agreement, pursuant to which the Company issued and sold, in the April 2025 Offering, (i) 202,000 shares (the April 2025 Shares) of Common Stock, (ii) 1,186,888 pre-funded warrants (the April 2025 Pre-Funded Warrants) exercisable for an aggregate of 1,186,888 shares of Common Stock, (iii) 1,388,888 Series E-1 common stock warrants (the Series E-1 Common Warrants) to purchase up to 1,388,888 shares of Common Stock, (iv) 1,388,888 Series E-2 common stock warrants (the Series E-2 Common Warrants) to purchase up to 1,388,888 shares of Common Stock, and (v) 1,388,888 Series E-3 common stock warrants (the Series E-3 Common Warrants, and collectively with the Series E-1 Warrants and the Series E-2 Warrants, the Series E Common Warrants) to purchase up to 1,388,888 shares of Common Stock, for net proceeds of $ 4,020 , after deducting offering expenses of $ 979 .
+Added: On April 1, 2025, the Company entered into the April 2025 Purchase Agreement, pursuant to which the Company issued and sold, in the April 2025 Offering, (i) 202,000 shares (the April 2025 Shares) of Common Stock, (ii) 1,186,888 pre-funded warrants (the April 2025 Pre-Funded Warrants) exercisable for an aggregate of 1,186,888 shares of Common Stock, (iii) 1,388,888 Series E-1 common stock warrants (the Series E-1 Common Warrants) to purchase up to 1,388,888 shares of Common Stock, (iv) 1,388,888 Series E-2 common stock warrants (the Series E-2 Common Warrants) to purchase up to 1,388,888 shares of Common Stock, and (v) 1,388,888 Series E-3 common stock warrants (the Series E-3 Common Warrants, and collectively with the Series E-1 Common Warrants and the Series E-2 Common Warrants, the Series E Common Warrants) to purchase up to 1,388,888 shares of Common Stock, for net proceeds of $ 4,020 , after deducting offering expenses of $ 979 .
The April 2025 Offering closed on April 2, 2025.
5 unchanged sentences
The Series E-3 Common Warrants expire on January 2, 2026.
−Removed: As of June 30, 2025, the April 2025 Pre-Funded Warrants have been exercised in full.
+Added: As of September 30, 2025, the April 2025 Pre-Funded Warrants have been exercised in full.
Wainwright acted as the exclusive placement agent for the April 2025 Offering pursuant to an engagement agreement between the Company and Wainwright dated as of March 7, 2025.
8 unchanged sentences
Risk-free interest rate
−Removed: As of June 30, 2025, the Company had the following warrants outstanding to purchase Common Stock:
+Added: As of September 30, 2025, the Company had the following warrants outstanding to purchase Common Stock:
Number of Shares Exercise Price per Share Expiration Date
−Removed: 210 $ 243.10 August 2025
1,388,888 $ 3.20 January 2026
14 unchanged sentences
STOCK-BASED COMPENSATION
−Removed: Amended and Restated 2018 Equity Incentive Plan
+Added: Amended and Restated 2018 Equity Incentive Plan, as Amended
On April 21, 2023, the stockholders of the Company approved the Amended and Restated GRI Bio, Inc.
−Removed: 2018 Equity Incentive Plan (the A&R 2018 Plan).
+Added: 2018 Equity Incentive Plan (the A&R 2018 Plan) and on August 13, 2025, the stockholders of the Company approved an amendment to the A&R 2018 Plan to increase the aggregate number of shares of the Company’s Common Stock thereunder by 400,000 .
The A&R 2018 Plan provides the Company with the ability to grant stock options, restricted stock and other equity-based awards to employees, directors and consultants.
Stock options granted by the Company under the A&R 2018 Plan generally have a contractual life of up to 10 years.
−Removed: As of June 30, 2025, awards granted under the A&R 2018 Plan representing the right to purchase or contingent right to receive up to an aggregate of 21,270 shares of the Company's Common Stock were outstanding and 21,275 shares of the Company’s Common Stock were reserved for issuance under the A&R 2018 Plan.
+Added: As of September 30, 2025, awards granted under the A&R 2018 Plan representing the right to purchase or contingent right to receive up to an aggregate of 421,274 shares of the Company's Common Stock were outstanding and 421,275 shares of the Company’s Common Stock were reserved for issuance under the A&R 2018 Plan.
The number of shares reserved for issuance under the A&R 2018 Plan may be increased pursuant to the A&R 2018 Plan’s “evergreen” provision on the first day of each calendar year beginning January 1, 2024 and ending on and including January 1, 2033, by a number of shares not to exceed 4 % of the aggregate number of shares of the Company’s Common Stock outstanding on the final day of the immediately preceding calendar year.
−Removed: The Company recorded stock-based compensation related to equity-based awards issued under the A&R 2018 Plan in the following expense categories of its accompanying consolidated statements of operations for the three and six months ended June 30, 2025 and 2024:
−Removed: For the Three Months Ended
−Removed: June 30, For the Six Months Ended
+Added: The Company recorded stock-based compensation related to equity-based awards issued under the A&R 2018 Plan in the following expense categories of its accompanying consolidated statements of operations for the three and nine months ended September 30, 2025 and 2024:
+Added: Three Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
2025 2024 2025 2024
3 unchanged sentences
The Company measures equity-based awards granted to employees and non-employees based on their fair value on the date of the grant and recognizes compensation expense for those awards over the requisite service period or performance-based period, which is generally the vesting period of the respective award.
−Removed: The measurement date for service-based equity awards is the date of grant, and
−Removed: equity-based compensation costs are recognized as expense over the requisite service period.
+Added: The measurement date for service-based equity awards is the date of grant, and equity-based compensation costs are recognized as expense over the requisite service period.
The Company records expense for performance-based awards if the Company concludes that it is probable that the performance condition will be achieved.
−Removed: The table below represents the activity of stock options granted to employees and non-employees for the six months ended June 30, 2025:
−Removed: Number of options Weighted-average exercise price Weighted-average remaining contractual term (years)
+Added: The table below represents the activity of stock options granted to employees and non-employees for the nine months ended September 30, 2025:
+Added: Number of options Weighted-average exercise price Weighted-average remaining contractual term (years) Aggregate Intrinsic Value ($)
Outstanding at December 31, 2024 142 $ 4,376.92 8.63 —
2 unchanged sentences
Forfeited/cancelled — — —
−Removed: Outstanding at June 30, 2025 21,270 $ 40.80 9.56
−Removed: Exercisable at June 30, 2025 21,208 $ 30.83 9.56
−Removed: Vested and expected to vest at June 30, 2025 21,270 $ 40.80 9.56
−Removed: As of June 30, 2025, all of the outstanding and exercisable stock options were out of the money and therefore had no intrinsic value.
−Removed: As of June 30, 2025, the unrecognized compensation cost related to unvested stock options expected to vest was $ 174 .
+Added: Outstanding at September 30, 2025 421,274 $ 3.76 9.92 106
+Added: Exercisable at September 30, 2025 291,431 $ 4.09 9.91 44
+Added: Vested and expected to vest at September 30, 2025 421,274 $ 3.76 9.92 106
+Added: As of September 30, 2025, the unrecognized compensation cost related to unvested stock options expected to vest was $ 317 .
This unrecognized compensation is expected to be recognized over a weighted-average amortization period of 0.97 years.
−Removed: The Company granted 21,128 stock options to its employees and non-employee directors during the six months ended June 30, 2025.
+Added: The Company granted an aggregate of 421,132 stock options to its employees and non-employee directors during the nine months ended September 30, 2025.
The Black-Scholes option-pricing model was used to estimate the grant date fair value of each stock option grant at the time of grant using the following weighted-average assumptions:
−Removed: For the Six Months Ended June 30, 2025
+Added: Nine Months Ended September 30, 2025
Volatility 120.89 %
3 unchanged sentences
Fair value of option on grant date $ 1.92
−Removed: No equity-based awards were granted during the six-month period ended June 30, 2024.
+Added: No equity-based awards were granted during the nine-month period ended September 30, 2024.
SEGMENT REPORTING
8 unchanged sentences
The Company has incurred significant losses since its inception and anticipates incurring continued losses in the future.
−Removed: As such, the CODM uses cash forecast models in deciding how to allocate resources based on the Company’s available cash resources, as well as its forecasted expenditures.
+Added: As such, the CODM uses cash forecast models in deciding how to allocate resources based on the Company’s available cash resources, as well as
+Added: its forecasted expenditures.
This information, in conjunction with the assessment of the probability of the success of the Company’s research and development activities, is used to plan the timing and size of future capital raises.
9 unchanged sentences
Baker also received a lump sum payment equal to 150 % of his target bonus and agreed to reduce amounts payable with respect to certain future milestone payments.
−Removed: SUBSEQUENT EVENTS
−Removed: The One Big Beautiful Bill Act (“OBBBA”) was enacted on July 4, 2025.
−Removed: The Company is in the process of assessing the impact of this legislation on its financial statements.
−Removed: The OBBBA is not currently expected to materially impact the Company’s effective tax rate or cash flows in the current fiscal year.
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.