What changed in this filing

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Item 1. Financial Statements

2025-11-04 compared with 2025-08-07 · 115 added, 93 removed, 483 unchanged (30% of the section changed)

19 unchanged sentences

(in thousands, except share and per share data)

September 30,

Current assets:

20 unchanged sentences

$ 0.0001 par value;

10,000,000 shares authorized at June 30, 2025 and December 31, 2024;

0 shares issued and outstanding at each of June 30, 2025 and December 31, 2024

10,000,000 shares authorized at September 30, 2025 and December 31, 2024;

0 shares issued and outstanding at each of September 30, 2025 and December 31, 2024

Common stock:

$ 0.0001 par value;

290,000,000 shares authorized at June 30, 2025 and December 31, 2024;

74,514,039 and 67,899,779 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively

290,000,000 shares authorized at September 30, 2025 and December 31, 2024;

74,681,872 and 67,899,779 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively

Additional paid-in capital

8 unchanged sentences

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Operating expenses:

5 unchanged sentences

Change in fair value of warrant liability

Income (loss) before equity method investment

Loss before equity method investment

Loss from equity method investment

Net income (loss)

Net income (loss) per share, basic

Net loss per share, basic

Net loss per share, diluted

Shares used to compute net income (loss) per share, basic

Shares used to compute net loss per share, basic

Shares used to compute net loss per share, diluted

Other comprehensive income (loss):

Other comprehensive loss:

Unrealized gain (loss) on marketable securities

Cumulative foreign currency translation adjustment

Comprehensive income (loss)

Comprehensive loss

The accompanying notes are an integral part of these condensed consolidated financial statements.

2 unchanged sentences

(in thousands, except share data)

Six Months Ended June 30, 2025

Nine Months Ended September 30, 2025

Comprehensive

13 unchanged sentences

Balance at June 30, 2025

Six Months Ended June 30, 2024

Common stock issued on exercise of stock options

Stock-based compensation expense

Unrealized gain on marketable securities

Foreign currency translation adjustment

Balance at September 30, 2025

Nine Months Ended September 30, 2024

Comprehensive

11 unchanged sentences

Balance at June 30, 2024

Common stock issued on exercise of stock options

Stock-based compensation expense

Unrealized gain on marketable securities

Foreign currency translation adjustment

Balance at September 30, 2024

The accompanying notes are an integral part of these condensed consolidated financial statements.

2 unchanged sentences

(in thousands)

Six Months Ended

Nine Months Ended

September 30,

Cash flows from operating activities

Net income (loss)

Adjustments to reconcile net income (loss) to net cash used in operating activities:

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

Depreciation and amortization

23 unchanged sentences

Net cash provided by financing activities

Net increase in cash and cash equivalents

Net decrease in cash and cash equivalents

Cash and cash equivalents at beginning of the period

29 unchanged sentences

certain ownership limitations.

As of June 30, 2025, all of the common warrants have been exercised, resulting in proceeds of $ 54.3 million.

As of September 30, 2025, all of the common warrants have been exercised, resulting in proceeds of $ 54.3 million.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, protection of proprietary technology, dependence on key personnel, contract manufacturer and contract research organizations, compliance with government regulations and the need to obtain additional financing to fund operations.

4 unchanged sentences

Because the outcome of any clinical trial and/or regulatory approval process is highly uncertain, the Company may not be able to accurately estimate the actual amounts necessary to successfully complete the development, regulatory approval process and commercialization of soquelitinib, ciforadenant and mupadolimab or any other product candidates.

The Company has incurred significant losses and negative cash flows from operations in all periods since inception and had an accumulated deficit of $ 389.8 million as of June 30, 2025.

The Company has incurred significant losses and negative cash flows from operations in all periods since inception and had an accumulated deficit of $ 400.0 million as of September 30, 2025.

To date, none of the Company’s product candidates have been approved for sale and therefore the Company has not generated any revenue from sales of commercial products.

1 unchanged sentence

The Company has funded its operations to date primarily through the sale of redeemable convertible preferred stock and common stock.

As of June 30, 2025, the Company had cash, cash equivalents and marketable securities of $ 74.4 million.

Management believes that the Company’s cash, cash equivalents and marketable securities as of June 30, 2025 will be sufficient to fund the Company’s planned operations for a period of at least 12 months from the date these condensed consolidated financial statements are issued.

As of September 30, 2025, the Company had cash, cash equivalents and marketable securities of $ 65.7 million.

The Company’s cash, cash equivalents and marketable securities are not sufficient to fund the Company’s planned operations for a period of at least 12 months from the date these condensed consolidated financial statements are issued.

To fund the Company’s planned operations, the Company will need to raise additional capital.

1 unchanged sentence

However, there can be no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its operations or on terms acceptable to the Company or at all.

If the Company is unsuccessful in its efforts to raise additional capital or if sufficient funds on acceptable terms are not available when needed, the Company could be required to significantly reduce operating expenses and delay, reduce the scope of or eliminate one or more of its development programs, out-license intellectual property rights to its product candidates and sell unsecured assets, or a combination of the above, any of which may have a material adverse effect on the Company’s business, results of operations, financial condition and/or its ability to fund its obligations on a timely basis or at all.

If the Company is unsuccessful in its efforts to raise additional capital or if sufficient funds on acceptable terms are not available when needed, the Company could be required to significantly reduce operating expenses and delay, reduce the scope of or eliminate one or more of its development programs, out-license intellectual property rights to its product candidates and sell assets, or a combination of the above, any of which may have a material adverse effect on the Company’s business, results of operations, financial condition and/or its ability to fund its obligations on a timely basis or at all.

Failure to manage discretionary spending or raise additional capital, as needed, may adversely impact the Company’s ability to achieve its intended business objectives.

These conditions raise substantial doubt about the Company’s ability to continue as a going concern for a period of one year from the date of the issuance of these condensed consolidated financial statements.

The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business.

The condensed consolidated financial statements do not reflect any adjustments relating to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary if the Company is unable to continue as a going concern.

Summary of Significant Accounting Policies

1 unchanged sentence

The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S.

The Company’s functional and reporting currency is the U.S.

The Company’s functional

and reporting currency is the U.S.

dollar, except for its investment in its equity method investee which is the Chinese renminbi (RMB).

3 unchanged sentences

The condensed consolidated balance sheet as of December 31, 2024 was derived from audited financial statements, but does not include all disclosures required by GAAP.

The condensed consolidated results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period.

The condensed consolidated results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period.

The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements and the related notes for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2025.

14 unchanged sentences

Substantially all of the Company’s cash and cash equivalents are deposited in accounts with two financial institutions that management believes are of high credit quality.

Such deposits may, at times, exceed federally insured limits.

Such deposits may, at times, exceed federally insured

The Company maintains its cash with an accredited financial institution and accordingly, such funds are subject to minimal credit risk.

2 unchanged sentences

government agency securities, which can be subject to certain credit risks.

However, the Company mitigates the risks by investing in high-grade instruments, limiting its exposure to any one issuer, and monitoring the ongoing creditworthiness

of the financial institutions and issuers.

However, the Company mitigates the risks by investing in high-grade instruments, limiting its exposure to any one issuer, and monitoring the ongoing creditworthiness of the financial institutions and issuers.

The Company has not experienced any losses on its deposits of cash, cash equivalents or marketable securities.

9 unchanged sentences

Significant Accounting Policies

There have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2025 from those discussed in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2025.

There have been no material changes to the Company’s significant accounting policies during the nine months ended September 30, 2025 from those discussed in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2025.

Recent Accounting Pronouncements

7 unchanged sentences

It also includes certain other amendments to improve the effectiveness of income tax disclosures.

The ASU’s amendments are effective for public business entities for annual periods beginning after December 15, 2024.

The ASU’s amendments are effective for public business entities for annual periods beginning

after December 15, 2024.

Entities are permitted to early adopt the standard “for annual financial statements that have not yet been issued or made available for issuance.” As adoption is either prospectively or retrospectively, the Company has adopted this ASU on a prospective basis.

5 unchanged sentences

The Company is currently evaluating the impact of ASU 2024-03 on its financial statement presentation and disclosures.

Net Income (Loss) per Share

The following table shows the calculation of net income (loss) per share (in thousands, except share and per share data):

Net Loss per Share

The following table shows the calculation of net loss per share (in thousands, except share and per share data):

Three Months Ended

Six Months Ended

Net income (loss) attributable to common stockholders, basic

Nine Months Ended

September 30,

Net loss attributable to common stockholders, basic

Gain from change in fair value of warrant liability

Net loss attributable to common stockholders, diluted

Weighted average common shares and pre-funded warrants outstanding used to compute basic net income (loss) per share

Shares issuable upon the exercise of the common warrants

Net loss - basic and diluted

Weighted average common shares and pre-funded warrants outstanding used to compute basic and diluted net loss per share

Weighted average shares issuable upon the exercise of common warrants

Weighted average common shares and prefunded warrants outstanding used to compute diluted net loss per share

Net income (loss) per share, basic

Net loss per share, basic

Net loss per share, diluted

Weighted average common shares outstanding used in the calculation of basic and diluted net income (loss) per share for the three and six months ended June 30, 2025 includes 8,275,913 shares of common stock issuable upon conversion of pre-funded warrants.

Weighted average common shares outstanding used in the calculation of basic and diluted net loss per share for the three and nine months ended September 30, 2025 and 2024 includes 8,275,913 and 4,144,085 shares of common stock issuable upon conversion of pre-funded warrants, respectively.

Refer to Note 9, “Warrants” for further details.

Shares issuable upon exercise of common warrants used in the computation of diluted net loss per share were calculated using the treasury stock method.

Shares issuable upon exercise of common warrants used in the calculation of diluted net loss per share were calculated using the treasury stock method.

The amounts in the table below were excluded from the calculation of diluted net loss per share, due to their anti-dilutive effect:

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Common warrants (1)

1 unchanged sentence

(1) Based on the treasury stock method, such common warrants that are in-the-money should be included in the calculation of diluted earnings per share (“EPS”) if the impact is not anti-dilutive.

Therefore, as the Company was in a net loss position for the three and six months ended June 30, 2024 and other income from the revaluation of the common warrants was $ 1.8 million for the three and six months ended June 30, 2024, the impact of including the

common warrants in calculating diluted EPS would be antidilutive and the Company has excluded the common warrants from the calculation of diluted net loss per share.

Therefore, as the Company was in a net loss position for the three and nine months ended September 30, 2024 and other loss from the revaluation of the common warrants was $32.8 million and $31.0 million for the three and nine months ended September 30, 2024, respectively, the impact of including the common warrants in calculating diluted EPS would be antidilutive and the Company has excluded the common warrants from the calculation of diluted net loss per share.

The Company views its operations and manages its business in one operating segment, that of the development and commercialization of drugs and antibodies that target critical elements of the immune system.

The Company’s CODM is made up of the Chief Executive Officer and Chief Financial Officer.

The Company’s Chief Operating Decision Maker (“CODM”) is made up of the Chief Executive Officer and Chief Financial Officer.

The CODM assesses performance for the segment and decides how to allocate resources based on consolidated net loss that is reported on the consolidated statement of operations and comprehensive loss.

1 unchanged sentence

Managing and allocating resources on a consolidated basis enables the CODM to assess the overall level of resources available and how to best deploy these resources across functions and programs that are in line with the Company’s long-term company-wide strategic goals.

The following table presents reportable segment net loss (income), including significant expense categories, attributable to the Company’s reportable segment for the three and six months ended June 30, 2025 and 2024 (in thousands):

The following table presents reportable segment net loss, including significant expense categories, attributable to the Company’s reportable segment for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Compensation and benefits, excluding stock-based compensation

7 unchanged sentences

Non-operating (income) and expense, net

Net loss (income)

(1) Includes consulting, non-clinical research and laboratory supplies.

2 unchanged sentences

The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values.

The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs.

The fair value hierarchy prioritizes valuation inputs based on the observable nature of those

The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality.

8 unchanged sentences

Financial Assets

The following tables present information as of June 30, 2025 and December 31, 2024 about the Company’s assets that are measured at fair value on a recurring basis and indicate the level of the fair value hierarchy the Company utilized to determine such fair values (in thousands):

June 30, 2025

The following tables present information as of September 30, 2025 and December 31, 2024 about the Company’s assets that are measured at fair value on a recurring basis and indicate the level of the fair value hierarchy the Company utilized to determine such fair values (in thousands):

September 30, 2025

Fair Value Measured Using

5 unchanged sentences

Marketable securities

As of June 30, 2025, all marketable securities had a maximum remaining maturity of less than sixteen months and are considered available for current operations.

As of June 30, 2025 and December 31, 2024, the fair value of available for sale marketable securities by type of security were as follows (in thousands):

June 30, 2025

As of September 30, 2025, all marketable securities had a maximum remaining maturity of less than thirteen months and are considered available for current operations.

As of September 30, 2025 and December 31, 2024, the fair value of available for sale marketable securities by type of security were as follows (in thousands):

September 30, 2025

Treasury securities

8 unchanged sentences

Warrant liability

During the six months ended June 30, 2025, the Company’s remaining outstanding common warrants were exercised and the changes in the Company’s warrant liability were as follows (in thousands):

During the nine months ended September 30, 2025, the Company’s remaining outstanding common warrants were exercised and the changes in the Company’s warrant liability were as follows (in thousands):

Warrant liability balance as of December 31, 2024

2 unchanged sentences

Exercise of warrants

Warrant liability balance as of June 30, 2025

Warrant liability balance as of September 30, 2025

The Company uses the Black-Scholes pricing model to determine the fair value of its warrant liabilities using Level 3 inputs.

8 unchanged sentences

(“Angel Pharmaceuticals”) is a corporate venture in the People’s Republic of China designed to develop, manufacture, and commercialize soquelitinib, ciforadenant and mupadolimab compounds for distribution within the countries of China, Taiwan, Macao, and Hong Kong based on intellectual property licenses contributed to Angel Pharmaceuticals by the Company.

As of June 30, 2025 and December 31, 2024, the Company’s ownership interest in Angel Pharmaceuticals was approximately 49.7 %, excluding 7 % of Angel Pharmaceuticals’ equity reserved for issuance under the Angel Pharmaceuticals Employee Stock Ownership Plan, and is accounted for as an equity method investment.

The Company recognized its share of loss in Angel Pharmaceuticals for the total amount of $ 0.4 million and $ 0.9 million as loss from equity method investment in the condensed consolidated statement of operations for the three and six months ended June 30, 2025, respectively.

As of September 30, 2025 and December 31, 2024, the Company’s ownership interest in Angel Pharmaceuticals was approximately 49.7 %, excluding 7 % of Angel Pharmaceuticals’ equity reserved for issuance under the Angel Pharmaceuticals Employee Stock Ownership Plan, and is accounted for as an equity method investment.

The Company recognized its share of loss in Angel Pharmaceuticals for the total amount of $ 0.3 million and $ 1.3 million as loss from equity method investment in the condensed consolidated statement of operations for the three and nine months ended September 30, 2025, respectively.

Summary Financial Information

1 unchanged sentence

Balance Sheet Data

June 30, 2025

September 30, 2025

December 31, 2024

6 unchanged sentences

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Statement of Operations Data

(in thousands)

Net income (loss)

Share of loss from investments accounted for using the equity method

1 unchanged sentence

Scripps Licensing Agreement

In December 2014, the Company entered into a license agreement with The Scripps Research Institute (“Scripps”), pursuant to which it was granted a non-exclusive, world-wide license for all fields of use under Scripps’ rights in certain know-how and technology related to a mouse hybridoma clone expressing an anti-human CD73 antibody, and to progeny, mutants or unmodified derivatives of such hybridoma and any antibodies expressed by such hybridoma, from which the Company developed mupadolimab.

rights in certain know-how and technology related to a mouse hybridoma clone expressing an anti-human CD73 antibody, and to progeny, mutants or unmodified derivatives of such hybridoma and any antibodies expressed by such hybridoma, from which the Company developed mupadolimab.

Scripps also granted the Company the right to grant sublicenses in conjunction with other proprietary rights the Company holds, or to others collaborating with or performing services for the Company.

15 unchanged sentences

In February 2017, the Company made a milestone payment of $ 3.0 million to Vernalis following the expansion of a cohort of patients with renal cell cancer treated with single agent ciforadenant in the Company’s Phase 1/1b clinical trial.

During the six months ended June 30, 2025 and 2024, no clinical or regulatory milestones were completed or paid to Vernalis, and the aggregate potential milestone payments were approximately $ 220 million for all indications as of June 30, 2025.

The Company has also agreed to pay Vernalis tiered incremental royalties based on the annual net sales of licensed products containing ciforadenant on a product by product and country by country basis, subject to certain offsets and reductions.

The tiered royalty rates for products containing ciforadenant range from the mid single digits up to the low double digits on a country by country net sales basis.

The royalties on other licensed products that do not include ciforadenant also increase with the amount of net sales on a product-by-product and country by country basis and range from the low single digits up to the mid single digits on a country by country net sales basis.

The Company is also obligated to pay to Vernalis certain sales milestones as indicated above when worldwide net sales reach specified levels over an agreed upon time period.

During the nine months ended September 30, 2025 and 2024, no clinical or regulatory milestones were completed or paid to Vernalis, and the aggregate potential milestone payments were approximately $ 220 million for all indications as of September 30, 2025.

4 unchanged sentences

Both parties have the right to terminate the agreement for an uncured material breach by the other party.

The Company may also terminate the agreement at its convenience by providing 90 days written notice, provided that the Company has not received notice of its own default under the agreement at the time the Company exercises such termination right.

The Company may also terminate the agreement at its convenience by providing 90 days written notice, provided that the Company has not received notice of

its own default under the agreement at the time the Company exercises such termination right.

Vernalis may also terminate the agreement if the Company challenges a licensed patent or undergoes a bankruptcy event.

5 unchanged sentences

The Company is also required to make development and sales milestone payments to Monash with respect to the licensed products.

During the six months ended June 30, 2025 and 2024, no development or sales milestones were completed or paid to Monash, and

the aggregate potential milestones were $ 45.1 million as of June 30, 2025.

During the nine months ended September 30, 2025 and 2024, no development or sales milestones were completed or paid to Monash, and the aggregate potential milestones were $ 45.1 million as of September 30, 2025.

The Company is also required to pay to Monash tiered royalties on net sales of licensed products sold by it, its affiliates and its sublicensees at a rate ranging in the low single digits.

4 unchanged sentences

Balance Sheet Components (in thousands)

September 30,

Prepaid and Other Current Assets

13 unchanged sentences

Accrued legal and accounting

During the three months ended June 30, 2025 and 2024, the Company recorded approximately $ 29,000 and $ 21,000 in depreciation expense, respectively, and during the six months ended June 30, 2025 and 2024, the Company recorded approximately $ 51,000 and $ 44,000 in depreciation expense, respectively.

During the three months ended September 30, 2025 and 2024, the Company recorded approximately $ 28,000 and $ 20,000 in depreciation expense, respectively, and during the nine months ended September 30, 2025 and 2024, the Company recorded approximately $ 79,000 and $ 65,000 in depreciation expense, respectively.

On May 6, 2024, the company completed a registered direct offering in which the Company sold an aggregate of 13,512,699 shares of common stock and common warrants to purchase up to 13,078,509 shares of common stock (or pre-funded warrants in lieu thereof) at a combined offering price of $ 1.7312 per share and common warrant, and pre-funded warrants to purchase up to 4,144,085 shares of common stock and common warrants to purchase up to 4,010,927 shares of common stock (or pre-funded warrants in lieu thereof), at a combined offering price of $ 1.7311 per share underlying each pre-funded warrant and common warrant, which equals the offering price per share and common warrant less the $ 0.0001 exercise price per share of the pre-funded warrants.

3 unchanged sentences

In accordance with accounting guidance discussed in Note 2, the Company recorded $ 5.0 million to additional paid-in capital upon issuance of the pre-funded warrants on May 6, 2024.

During the three months ended June 30, 2025, an additional 4,131,828 pre-funded warrants were issued in connection with the exercise of common warrants.

As of June 30, 2025, none of the pre-funded warrants have been exercised and 8,275,913 pre-funded warrants remain outstanding.

During the nine months ended September 30, 2025, an additional 4,131,828 pre-funded warrants were issued in connection with the exercise of common warrants.

As of September 30, 2025, none of the pre-funded warrants have been exercised and 8,275,913 pre-funded warrants remain outstanding.

The common warrants had an exercise price per share of common stock equal to $ 3.50 per share (or $ 3.4999 per pre-funded warrant).

The exercise price and the number of shares of common stock (or pre-funded warrants in lieu thereof) issuable upon exercise of the common warrants were subject to appropriate adjustments in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock.

stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock.

The common warrants were exercisable at any time after the date of issuance and had an expiration date of June 30, 2025.

In accordance with accounting guidance discussed in Note 2, “Summary of Significant Accounting Policies,” the Company recorded a decrease in fair value of warrant liability of $ 2.0 million and $ 27.1 million to other income in its condensed consolidated statement of operations and comprehensive loss for the three and six months ended June 30, 2025, respectively.

As of June 30, 2025, all of the common warrants have been exercised, resulting in proceeds of $ 54.3 million.

As of June 30, 2025, the amended and restated certificate of incorporation authorizes the Company to issue 290 million shares of common stock and 10 million shares of preferred stock.

In accordance with accounting guidance discussed in Note 2, “Summary of Significant Accounting Policies,” the Company recorded a decrease in fair value of warrant liability of $ 2.0 million and $ 27.1 million to other income in its condensed consolidated statement of operations and comprehensive loss for the nine months ended September 30, 2025, respectively.

As of September 30, 2025, all of the common warrants have been exercised, resulting in proceeds of $ 54.3 million.

As of September 30, 2025, the amended and restated certificate of incorporation authorizes the Company to issue 290 million shares of common stock and 10 million shares of preferred stock.

Each share of common stock is entitled to one vote.

Common stockholders are entitled to dividends if and when declared by the board of directors.

As of June 30, 2025, no dividends on common stock had been declared.

As of September 30, 2025, no dividends on common stock had been declared.

On August 6, 2024, the Company entered into an open market sale agreement (the “2024 Sales Agreement”) with Jefferies LLC (“Jefferies”) to sell shares of the Company’s common stock, from time-to-time, with aggregate gross sales proceeds of up to $ 100.0 million, through an at-the-market equity offering program under which Jefferies will act as its sales agent.

1 unchanged sentence

Jefferies is entitled to compensation for its services up to 3.0 % of the gross proceeds of any shares of common stock sold through Jefferies under the 2024 Sales Agreement.

During the six months ended June 30, 2025, the Company did not sell any shares of common stock under its at-the-market offering program.

As of June 30, 2025, $ 100.0 million remained available for sale under the 2024 Sales Agreement.

During the nine months ended September 30, 2025, the Company did not sell any shares of common stock under its at-the-market offering program.

As of September 30, 2025, $ 100.0 million remained available for sale under the 2024 Sales Agreement.

The Company has reserved shares of common stock for issuance as follows:

September 30,

Pre-funded warrants

12 unchanged sentences

In general, awards granted by the Company vest over four years and have a maximum exercise term of 10 years .

The 2016 Plan provides that grants must be at an exercise price of 100 % of fair market value of the Company’s common stock as determined by the board of directors on the date of the grant.

The 2016 Plan provides that grants must be at an exercise price of 100 % of fair market value of the Company’s common stock as determined by the board

of directors on the date of the grant.

In conjunction with adopting the 2016 Plan, the 2014 Plan was terminated and no further awards will be granted under the 2014 Plan.

7 unchanged sentences

Options forfeited

Balance at June 30, 2025

Balance at September 30, 2025

Stock-Based Compensation

1 unchanged sentence

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Research and development

General and administrative

During the six months ended June 30, 2025, the Company recorded no income tax expense due to the continued losses.

During the six months ended June 30, 2024, the Company recorded no income tax benefits for the net operating losses (NOLs) incurred due to the uncertainty of realizing a benefit from those items.

During the nine months ended September 30, 2025 and 2024, the Company recorded no income tax benefits for the net operating losses (NOLs) incurred due to the uncertainty of realizing a benefit from those items.

The Company continues to maintain a full valuation allowance against its net deferred tax assets.

2 unchanged sentences

tax code, including restoration of immediate recognition of domestic research and development expenditures and reinstatement of 100 % bonus depreciation for qualifying property.

As the Act was enacted after the Company’s reporting period ended June 30, 2025, no adjustments have been made to the condensed consolidated financial statements as of and for the three and six months ended June 30, 2025.

The impact of the Act, if applicable, will be reflected in the Company’s financial statements as of and for the three and nine months ending September 30, 2025, the period in which the legislation was enacted.

The Company is currently evaluating the impact of the Act on its condensed consolidated financial statements, including the effects on its deferred tax assets and liabilities.

The Company does not expect the Act to have a material impact on its consolidated financial statements for the year ending December 31, 2025 and management is currently evaluating the potential impact of the Act on the Company’s future periods.

Facility Lease

9 unchanged sentences

Therefore, the non-lease components were not included in the right-of-use asset and liability and are reflected as an expense in the period incurred.

As of June 30, 2025 and December 31, 2024, the right-of-use asset under the operating lease was $ 1.0 million and $ 1.2 million, respectively.

The elements of lease expense under the operating lease for the three and six months ended June 30, 2025 were as follows (in thousands):

As of September 30, 2025 and December 31, 2024, the right-of-use asset under the operating lease was $ 0.9 million and $ 1.2 million, respectively.

The elements of lease expense under the operating lease for the three and nine months ended September 30, 2025 were as follows (in thousands):

Three Months Ended

Six Months Ended

Nine Months Ended

Statements of operations and

September 30,

comprehensive loss location

11 unchanged sentences

Discount rate

As of June 30, 2025, minimum rental commitments under this lease were as follows (in thousands):

As of September 30, 2025, minimum rental commitments under this lease were as follows (in thousands):

Year Ended December 31 (in thousands)

23 unchanged sentences

On May 6, 2024, the Company closed a registered direct offering which resulted in gross proceeds of approximately $ 30.6 million.

The financing consisted of the sale of 13,512,699 shares of common stock and accompanying common stock warrants to purchase 13,078,509 shares of common stock (or pre-funded warrants in lieu thereof) at a combined offering price of $ 1.7312 per share, and the sale of pre-funded warrants to purchase 4,144,085 shares of common stock and accompanying common warrants to purchase 4,010,927 shares of common stock (or pre-

funded warrants in lieu thereof) at a combined offering price of $ 1.7311 per share.

The common warrants had an exercise price of $ 3.50 per share of common stock (or $ 3.4999 per pre-funded warrant in lieu thereof), are exercisable at any time after the date of issuance, subject to certain ownership limitations, and expired on June 30, 2025.

22 unchanged sentences

ICON is a clinical research organization and provides services to support the Company’s clinical trials.

During the three months ended June 30, 2025 and 2024, the Company recorded approximately $ 137,000 and $ 128,000 , respectively, in clinical trial expenses under its agreements with ICON.

During the three months ended September 30, 2025 and 2024, the Company recorded approximately $ 117,000 and $ 118,000 , respectively, in clinical trial expenses under its agreements with ICON.

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-Q

Item 1. Financial Statements