What changed in this filing

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Item 1. Financial Statements

2025-11-06 compared with 2025-08-07 · 109 added, 97 removed, 648 unchanged (24% of the section changed)

4 unchanged sentences

(In thousands, except share data)

September 30,

2025 December 31,

19 unchanged sentences

issued 8,756,686

and 8,409,582 shares at June 30, 2025 and December 31, 2024, respectively;

outstanding, 8,626,464 and 8,408,844 shares at June 30, 2025 and December 31, 2024,

and 8,409,582 shares at September 30, 2025 and December 31, 2024, respectively;

outstanding, 8,755,948 and 8,408,844 shares at September 30, 2025 and December 31, 2024,

Additional paid-in capital 579,812 578,418

Treasury stock, at cost;

738 shares at June 30, 2025 and December 31, 2024

738 shares at September 30, 2025 and December 31, 2024

( 708 ) ( 708 )

11 unchanged sentences

(In thousands, except per share data)

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

26 unchanged sentences

(In thousands)

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

1 unchanged sentence

Other comprehensive gain (loss):

Available for sale securities - net unrealized gain (loss) 4 4 3 ( 9 )

Available for sale securities - net unrealized gain 1 12 4 3

Cumulative translation adjustment arising during the period 7 33 35 7

Total other comprehensive gain (loss) 28 27 31 ( 35 )

Total other comprehensive gain 8 45 39 10

Comprehensive loss attributable to Lisata Therapeutics, Inc.

15 unchanged sentences

Shares Amount

Balance at March 31, 2024 8,308 $ 8 $ 577,283 $ ( 104 ) $ ( 533,482 ) $ ( 708 ) $ 42,997 $ ( 254 ) $ 42,743

Balance at June 30, 2024 8,322 $ 8 $ 577,552 $ ( 77 ) $ ( 538,526 ) $ ( 708 ) $ 38,249 $ ( 254 ) $ 37,995

Net loss — — — — ( 4,930 ) — ( 4,930 ) — ( 4,930 )

Share-based compensation ( 2 ) — 326 — — — 326 — 326

Net proceeds from issuances of common stock 14 — 32 — — — 32 — 32

Unrealized gain on marketable securities — — — 12 — — 12 — 12

Foreign currency translation adjustment — — — 33 — — 33 — 33

Balance at June 30, 2024 8,322 $ 8 $ 577,552 $ ( 77 ) $ ( 538,526 ) $ ( 708 ) $ 38,249 $ ( 254 ) $ 37,995

Balance at September 30, 2024 8,320 $ 8 $ 577,878 $ ( 32 ) $ ( 543,456 ) $ ( 708 ) $ 33,690 $ ( 254 ) $ 33,436

Common Stock Additional

11 unchanged sentences

Net proceeds from issuances of common stock 14 — 32 — — — 32 — 32

Unrealized loss on marketable securities — — — ( 9 ) — — ( 9 ) — ( 9 )

Unrealized gain on marketable securities — — — 3 — — 3 — 3

Foreign currency translation adjustment — — — 7 — — 7 — 7

Balance at June 30, 2024 8,322 $ 8 $ 577,552 $ ( 77 ) $ ( 538,526 ) $ ( 708 ) $ 38,249 $ ( 254 ) $ 37,995

Balance at September 30, 2024 8,320 $ 8 $ 577,878 $ ( 32 ) $ ( 543,456 ) $ ( 708 ) $ 33,690 $ ( 254 ) $ 33,436

Common Stock Additional

7 unchanged sentences

Shares Amount

Balance at March 31, 2025 8,621 $ 9 $ 578,923 $ ( 78 ) $ ( 552,790 ) $ ( 708 ) $ 25,356 $ ( 254 ) $ 25,102

Balance at June 30, 2025 8,627 $ 9 $ 579,227 $ ( 50 ) $ ( 557,449 ) $ ( 708 ) $ 21,029 $ ( 254 ) $ 20,775

Net loss — — — — ( 4,249 ) — ( 4,249 ) — ( 4,249 )

3 unchanged sentences

Foreign currency translation adjustment — — — 7 — — 7 — 7

Balance at June 30, 2025 8,627 $ 9 $ 579,227 $ ( 50 ) $ ( 557,449 ) $ ( 708 ) $ 21,029 $ ( 254 ) $ 20,775

Balance at September 30, 2025 8,757 $ 9 $ 579,812 $ ( 42 ) $ ( 561,698 ) $ ( 708 ) $ 17,373 $ ( 254 ) $ 17,119

Common Stock Additional

13 unchanged sentences

Foreign currency translation adjustment — — — 35 — — 35 — 35

Balance at June 30, 2025 8,627 $ 9 $ 579,227 $ ( 50 ) $ ( 557,449 ) $ ( 708 ) $ 21,029 $ ( 254 ) $ 20,775

Balance at September 30, 2025 8,757 $ 9 $ 579,812 $ ( 42 ) $ ( 561,698 ) $ ( 708 ) $ 17,373 $ ( 254 ) $ 17,119

LISATA THERAPEUTICS, INC.

2 unchanged sentences

(In thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities:

23 unchanged sentences

Effect of exchange rate changes on cash 9 10

Net increase in cash and cash equivalents 626 5,700

Net increase (decrease) in cash and cash equivalents 2,789 ( 3,084 )

Cash and cash equivalents at beginning of period 16,209 22,593

7 unchanged sentences

(together with its subsidiaries, the “Company”) is a clinical-stage pharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of solid tumors and other major diseases.

The Company's investigational product, certepetide (formerly known as LSTA1 or CEND-1), is designed to activate a novel uptake pathway that allows co-administered or tethered (i.e., molecularly bound) anti-cancer drugs to target and penetrate solid tumors more effectively.

The Company's investigational product, certepetide (formerly known as LSTA1 or CEND-1), is designed to activate a novel uptake pathway (the C-end rule active transport mechanism) that allows co-administered or tethered (i.e., molecularly bound) anti-cancer drugs to target and penetrate solid tumors more effectively.

Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor, while normal tissues are expected to remain unaffected.

1 unchanged sentence

The Company, its collaborators and other researchers have amassed and continue to amass significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies, and RNA-based therapeutics.

To date, certepetide has also demonstrated favorable safety, tolerability and activity in completed and ongoing clinical trials designed to enhance delivery of standard-of-care chemotherapy for pancreatic cancer.

In addition, certain preclinical data using certepetide in combination with antibody drug conjugates (ADCs) has been generated as part of the Company’s research collaboration with Catalent.

These data were presented recently at the 16 th Annual World ADC San Diego Conference on November 4, 2025.

The Company is exploring certepetide as a means to enable a variety of therapeutic modalities to treat a range of solid tumors more effectively.

Currently, certepetide is the subject of several Phase 2 clinical studies being conducted globally in a variety of solid tumor types, including metastatic pancreatic ductal adenocarcinoma (mPDAC), cholangiocarcinoma, appendiceal cancer, colon cancer and glioblastoma multiforme in combination with a variety of anti-cancer regimens.

The Company's leadership team has amassed several decades of collective biopharmaceutical and pharmaceutical product development experience across a variety of therapeutic categories and at all stages of development, ranging from preclinical through to product registration and launch.

Currently, certepetide is the subject of several Phase 2 clinical studies globally in a variety of solid tumor types, including metastatic pancreatic ductal adenocarcinoma (mPDAC), cholangiocarcinoma, appendiceal cancer, colon cancer and glioblastoma multiforme in combination with a variety of anti-cancer regimens.

The Company's leadership team has amassed many decades of collective biopharmaceutical and pharmaceutical product development experience across a variety of therapeutic categories and at all stages of development, ranging from preclinical through to product registration and launch.

The Company's goal is to develop and commercialize products that address important unmet medical needs.

The Company has a history of net operating losses and negative cash flows from its operating activities, and has cash, cash equivalents and marketable securities of approximately $ 22.0 million as of June 30, 2025.

The Company anticipates incurring additional losses until such time, if ever, that it can generate significant revenues from its products currently in development.

To manage capital for operating needs in the short-term, as previously disclosed, initiation of the FORTIFIDE study remains on hold and the Company has delayed commencement of certain Phase 3 readiness activities as it relates to chemistry, manufacturing and controls (“CMC”).

To manage capital for operating needs in the short-term, as previously disclosed, the Company has delayed commencement of certain readiness activities for its planned Phase 3 study in metastatic pancreatic ductal adenocarcinoma (mPDAC), particularly those related to chemistry, manufacturing and controls (“CMC”).

The Company’s ongoing trials continue to progress as planned.

The Company also identified certain operating efficiencies which had a positive impact on the cash flow forecast.

The Company believes that, as a result, it currently has sufficient cash to meet its funding requirements over the next year.

To meet our long-term liquidity needs, the Company expects that it will need additional financing by the fourth quarter of 2026, which could result in additional potential issuances of debt or equity securities in public or private financings, partnerships and/or collaborations and/or sale of assets.

The Company also continued to identify certain operating efficiencies which had a positive impact on the cash flow forecast.

The Company believes that, as a result, it currently has sufficient cash to meet its funding requirements over the next 12 months.

To meet our long-term liquidity needs, the Company expects that it will need additional financing by the end of 2026, which could result in additional potential issuances of debt or equity securities in public or private financings, partnerships and/or collaborations and/or sale of assets.

Basis of Presentation

2 unchanged sentences

Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries, which are unaudited, include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of June 30, 2025, and the results of its operations and its cash flows for the periods presented.

In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries, which are unaudited, include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of September 30, 2025, and the results of its operations and its cash flows for the periods presented.

The unaudited consolidated financial statements herein should be read together with the historical consolidated financial statements of the Company for the years ended December 31, 2024 and 2023 included in our 2024 Form 10-K.

Operating results for the three and six months ended June 30, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025.

Operating results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025.

Use of Estimates

The preparation of financial statements in conformity with U.S.

GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the

date of the consolidated financial statements.

GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements.

Estimates also affect the reported amounts of expenses during the reporting period.

28 unchanged sentences

safety and preservation of principal and diversification of risk, liquidity of investments sufficient to meet cash flow requirements, and a competitive after-tax rate of return.

The Company’s accounts receivable balance as of June 30, 2025 and December 31, 2024 is primarily derived from its license agreement dated November 30, 2024, more fully described in Note 17.

The Company’s accounts receivable balance as of September 30, 2025 and December 31, 2024 is primarily derived from its license agreement dated November 30, 2024, more fully described in Note 17.

The Company has no significant off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts, or other hedging arrangements.

7 unchanged sentences

Account balances are written off against the allowance when it is determined that the receivable will not be recovered.

As of June 30, 2025 and December 31, 2024, there was no allowance for credit losses.

As of September 30, 2025 and December 31, 2024, there was no allowance for credit losses.

Marketable Securities

48 unchanged sentences

The Company’s intangible asset consists of a single asset, a license agreement with Qilu Pharmaceutical, Co., Ltd.

(“Qilu”) acquired in the Company's acquisition of Cend Therapeutics, Inc (the “Cend Merger”), with a value of $ 0.4 million.

(“Qilu”) acquired in the Company's acquisition of Cend Therapeutics, Inc.

(the “Cend Merger”), with a value of $ 0.4 million.

The intangible asset is stated at fair value and is amortized using the straight-line method over its estimated useful life of 5.00 years.

Amortization expense was $ 18 thousand and $ 35 thousand for the three and six months ended June 30, 2025, respectively, and $ 18 thousand and $ 35 thousand for the three and six months ended June 30, 2024, respectively.

Amortization expense was $ 18 thousand and $ 53 thousand for the three and nine months ended September 30, 2025, respectively, and $ 18 thousand and $ 53 thousand for the three and nine months ended September 30, 2024, respectively.

The intangible asset is reviewed for potential impairment when events or circumstances indicate that carrying amounts may not be recoverable.

15 unchanged sentences

If licenses are bundled with other performance obligations, the Company would utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue.

The Company recognized $ 70 thousand and $ 0 revenue for the six months ended June 30, 2025 and 2024, respectively.

The Company recognized $ 70 thousand and $ 0 revenue for the nine months ended September 30, 2025 and 2024, respectively.

At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method.

4 unchanged sentences

Any such adjustments are allocated on a cumulative catch-up basis to satisfied and partially satisfied performance obligations, with the consideration allocated to an ongoing performance obligation being recognized over the period of performance.

For the three and six months ended June 30, 2025 and June 30, 2024, the Company has not recognized revenue related to milestones.

For the three and nine months ended September 30, 2025 and September 30, 2024, the Company has not recognized revenue related to milestones.

For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

2 unchanged sentences

The following table is a summary of available-for-sale securities recorded in cash and cash equivalents or marketable securities in the Company's Consolidated Balance Sheets (in thousands):

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value

7 unchanged sentences

The following table summarizes the classification of the available-for-sale securities in the Company's Consolidated Balance Sheets (in thousands):

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

Cash equivalents $ 14,492 $ 10,613

2 unchanged sentences

The following table summarizes the Company's portfolio of available-for-sale securities by contractual maturity (in thousands):

June 30, 2025

September 30, 2025

Amortized Cost Estimated Fair Value

4 unchanged sentences

Property and equipment consisted of the following (in thousands):

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

Computer equipment 494 589

3 unchanged sentences

Property and equipment, net $ 22 $ 72

The Company’s results included depreciation expense of approximately $ 52 thousand and $ 56 thousand for the six months ended June 30, 2025 and 2024, respectively.

The Company’s results included depreciation expense of approximately $ 78 thousand and $ 79 thousand for the nine months ended September 30, 2025 and 2024, respectively.

Note 5 – Income (Loss) Per Share

For the six months ended June 30, 2025 and 2024, the Company incurred net losses and therefore no common stock equivalents were utilized in the calculation of diluted loss per share as they are anti-dilutive in the periods presented.

At June 30, 2025 and 2024, the Company excluded the following potentially dilutive securities (in thousands):

For the nine months ended September 30, 2025 and 2024, the Company incurred net losses and therefore no common stock equivalents were utilized in the calculation of diluted loss per share as they are anti-dilutive in the periods presented.

At September 30, 2025 and 2024, the Company excluded the following potentially dilutive securities (in thousands):

September 30,

Stock options 1,503 1,454

9 unchanged sentences

The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities and their placement within the fair value hierarchy levels.

The Company's financial assets and liabilities that were accounted for at fair value on a recurring basis as of June 30, 2025 and December 31, 2024 were as follows (in thousands):

June 30, 2025 December 31, 2024

The Company's financial assets and liabilities that were accounted for at fair value on a recurring basis as of September 30, 2025 and December 31, 2024 were as follows (in thousands):

September 30, 2025 December 31, 2024

Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total

2 unchanged sentences

$ 14,492 $ — $ — $ 14,492 $ 10,613 $ 15,036 $ — $ 25,649

The carrying values of cash, cash equivalents, accounts receivable, accounts payable and accrued expenses approximate fair value as of June 30, 2025 and December 31, 2024, due to the short maturity nature of these items.

The carrying values of cash, cash equivalents, accounts receivable, accounts payable and accrued expenses approximate fair value as of September 30, 2025 and December 31, 2024, due to the short maturity nature of these items.

Note 7 – Accrued Liabilities

Accrued liabilities as of June 30, 2025 and December 31, 2024 were as follows (in thousands):

June 30, 2025 December 31, 2024

Accrued liabilities as of September 30, 2025 and December 31, 2024 were as follows (in thousands):

September 30, 2025 December 31, 2024

Salaries, employee benefits and related taxes $ 2,116 $ 2,640

5 unchanged sentences

Note 8 – Operating Leases

The Company has an operating lease for one office which expires on September 30, 2025.

The Company had an operating lease for one office which expired on September 30, 2025.

The Company estimates its incremental borrowing rate at lease commencement to determine the present value of lease payments as the Company's lease does not provide an implicit rate of return.

2 unchanged sentences

2016-02, Leases (Topic 842), the Company elected to account for non-lease components associated with its leases and lease components as a single lease component.

The Company's lease includes an option for the Company to extend the lease term and/or sub-lease space in whole or in part.

The Company's lease included an option for the Company to extend the lease term and/or sub-lease space in whole or in part for which the Company has not exercised.

Operating lease liabilities and right-of-use assets were recorded in the following captions of the Company's balance sheet as follows (in thousands):

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

Right-of-Use Assets:

4 unchanged sentences

Total Operating Lease Liabilities $ — $ 137

As of June 30, 2025, the weighted average remaining lease term for the Company's operating lease was 0.25 years, and the weighted average discount rate for the Company's operating lease was 9.625 %.

As of September 30, 2025, the weighted average remaining lease term for the Company's operating lease was 0.00 years, and the weighted average discount rate for the Company's operating lease was 0.0 %.

As of December 31, 2024, the weighted average remaining lease term for the Company's operating lease was 0.75 years, and the weighted average discount rate for the Company's operating lease was 9.625 %.

Future minimum lease payments under the lease agreement as of June 30, 2025 were as follows (in thousands):

Future minimum lease payments under the lease agreement as of September 30, 2025 were as follows (in thousands):

Years ended Operating Leases

12 unchanged sentences

If the Company’s public float exceeds $75.0 million on a future measurement date, it will no longer be subject to the Baby Shelf Limitation.

During the six months ended June 30, 2025, the Company issued 68,496 shares of common stock under the ATM Agreement for net proceeds of $ 247,496 .

Since inception through June 30, 2025, the Company has issued 136,669 shares of common stock under the ATM Agreement for net proceeds of $ 528,343 .

During the nine months ended September 30, 2025, the Company issued 197,980 shares of common stock under the ATM Agreement for net proceeds of $ 600,663 .

Since inception through September 30, 2025, the Company has issued 266,153 shares of common stock under the ATM Agreement for net proceeds of $ 881,510 .

Stock Options and Warrants

The following table summarizes the activity for stock options and warrants for the six months ended June 30, 2025:

The following table summarizes the activity for stock options and warrants for the nine months ended September 30, 2025:

Stock Options Warrants

6 unchanged sentences

Expired ( 26,795 ) 141.14 — —

Outstanding at June 30, 2025 1,511,070 $ 6.16 5.25 $ 142.7 1,496,744 $ 40.52 0.80 $ 1.5

Vested at June 30, 2025

Outstanding at September 30, 2025 1,502,881 $ 6.17 5.02 $ 110.3 1,496,744 $ 40.52 0.55 $ —

Vested at September 30, 2025

or expected to vest in the future 1,495,374 $ 6.18 5.00 $ 110.3 1,496,744 $ 40.52 0.55 $ —

Vested at June 30, 2025 1,344,062 $ 6.50 4.80 $ 140.3 1,496,744 $ 40.52 0.80 $ 1.5

Vested at September 30, 2025 1,337,823 $ 6.51 4.58 $ 109.5 1,496,744 $ 40.52 0.55 $ —

Restricted Stock

During the six months ended June 30, 2025 and 2024, the Company issued restricted stock for services as follows (in thousands, except share data):

Six Months Ended June 30,

During the nine months ended September 30, 2025 and 2024, the Company issued restricted stock for services as follows (in thousands, except share data):

Nine Months Ended September 30,

Number of shares of restricted stock issued 215,550 203,800

Value of restricted stock issued $ 819 $ 628

The weighted average estimated fair value of restricted stock issued for services in the six months ended June 30, 2025 and 2024 was $ 3.80 and $ 3.08 per share, respectively.

The weighted average estimated fair value of restricted stock issued for services in the nine months ended September 30, 2025 and 2024 was $ 3.80 and $ 3.08 per share, respectively.

The fair value of the restricted stock was determined using the Company’s closing stock price on the date of issuance.

The vesting terms of restricted stock issuances are generally between one year and four years .

The following is a summary of the changes in non-vested restricted stock for the six months ended June 30, 2025:

The following is a summary of the changes in non-vested restricted stock for the nine months ended September 30, 2025:

Restricted Stock Shares Weighted Average Grant-Date Fair Value

4 unchanged sentences

Forfeited ( 17,450 ) $ 3.50

Non-vested at June 30, 2025 265,036 $ 3.46

Non-vested at September 30, 2025 265,036 $ 3.46

Restricted Stock Units

During the six months ended June 30, 2025 and 2024, the Company issued restricted stock units for services as follows (in thousands, except share data):

Six Months Ended June 30,

During the nine months ended September 30, 2025 and 2024, the Company issued restricted stock units for services as follows (in thousands, except share data):

Nine Months Ended September 30,

Number of restricted stock units issued 78,945 205,300

Value of restricted stock units issued $ 300 $ 632

The weighted average estimated fair value of restricted stock units issued for services in the six months ended June 30, 2025 and 2024 was $ 3.80 and $ 3.08 per share, respectively.

The weighted average estimated fair value of restricted stock units issued for services in the nine months ended September 30, 2025 and 2024 was $ 3.80 and $ 3.08 per share, respectively.

The fair value of the restricted stock units was determined using the Company’s closing stock price on the date of issuance.

The vesting terms of restricted stock unit issuances are generally one year , or upon the achievement of performance-based milestones.

The following is a summary of the changes in non-vested restricted stock units for the six months ended June 30, 2025:

The following is a summary of the changes in non-vested restricted stock units for the nine months ended September 30, 2025:

Restricted Stock Units Weighted Average Grant-Date Fair Value

4 unchanged sentences

Forfeited — $ —

Non-vested at June 30, 2025 85,345 $ 3.98

Non-vested at September 30, 2025 78,945 $ 3.80

Note 10 – Share-Based Compensation

1 unchanged sentence

The Company utilizes share-based compensation in the form of stock options, restricted stock, restricted stock units and warrants.

The following table summarizes the components of share-based compensation expense for the three and six months ended June 30, 2025 and 2024 (in thousands):

Three Months Ended June 30, Six Months Ended June 30,

The following table summarizes the components of share-based compensation expense for the three and nine months ended September 30, 2025 and 2024 (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

2 unchanged sentences

Total share-based compensation expense $ 232 $ 327 $ 1,001 $ 1,018

Total compensation cost related to unvested awards not yet recognized and the weighted-average periods over which the awards were expected to be recognized at June 30, 2025 were as follows (in thousands):

Total compensation cost related to unvested awards not yet recognized and the weighted-average periods over which the awards were expected to be recognized at September 30, 2025 were as follows (in thousands):

Stock Options Restricted Stock Units Restricted Stock

1 unchanged sentence

Expected weighted-average period in years of compensation cost to be recognized 1.81 0.28 1.91

Total fair value of shares vested and the weighted average estimated fair values of shares granted for the six months ended June 30, 2025 and 2024 were as follows (in thousands):

Total fair value of shares vested and the weighted average estimated fair values of shares granted for the nine months ended September 30, 2025 and 2024 were as follows (in thousands):

Stock Options Warrants

Six Months Ended June 30, Six Months Ended June 30,

Nine Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

33 unchanged sentences

As of December 31, 2024 and 2023, the Company’s uncertain tax positions were $ 344 thousand and $ 344 thousand, respectively.

The uncertain tax positions are due to the acquisition of Cend related to Federal and state credits and certain state NOLs.

The uncertain tax positions are due to the acquisition of Cend related to Federal and state credits and certain state

The Company will continue to evaluate its uncertain tax positions in future periods.

7 unchanged sentences

The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act, including 100% bonus depreciation, domestic research cost expensing, and the business interest expense limitation.

ASC 740, "Income Taxes", requires the effects of changes in tax rates and laws on deferred tax balances to be recognized in the period in which the legislation is enacted.

Consequently, as of the date of enactment, the Company will evaluate all deferred tax balances under the newly enacted tax law and identify any other changes required to its financial statements as a result of the OBBBA.

The Company is still evaluating the impact of the OBBBA and will continue to monitor the possible future impact of changes in tax legislation.

The Company does not expect this to have a material impact to the financial statements.

ASC 740, “Income Taxes”, requires the tax effects of changes in tax rates and tax law be recognized in the period in which the legislation is enacted.

The Company completed its initial assessment of OBBBA for the quarter ended September 30, 2025.

For the provisions effective in 2025, there was no material impact to the Company’s effective tax rate for the quarter ended September 30, 2025.

The Company will continue to evaluate the impact of the new legislation on its consolidated financial statements as additional guidance is issued.

Note 12 – Segment Information

6 unchanged sentences

The CODM uses cash and marketable securities as a measure of segment assets in managing the enterprise.

The Company had revenue of $ 70 thousand and $ 70 thousand for the three and six months ended June 30, 2025, respectively, and $ 0 and $ 0 for the three and six months ended June 30, 2024, respectively.

Depreciation and amortization expense was $ 44 thousand and $ 87 thousand for the three and six months ended June 30, 2025, respectively and $ 45 thousand and $ 91 thousand for the three and six months ended June 30, 2024, respectively.

Equity method investment expense was $ 0 and $ 0 for the three and six months ended June 30, 2025, respectively, and $ 0 and $ 100 thousand for the three and six months ended June 30, 2024, respectively.

The following table illustrates our segment information for significant operating expenses and includes a reconciliation to net loss for the three and six months ended June 30, 2025 and 2024:

Three Months Ended June 30, Six Months Ended June 30,

The Company had revenue of $ 0 and $ 70 thousand for the three and nine months ended September 30, 2025, respectively, and $ 0 and $ 0 for the three and nine months ended September 30, 2024, respectively.

Depreciation and amortization expense was $ 44 thousand and $ 131 thousand for the three and nine months ended September 30, 2025, respectively and $ 42 thousand and $ 133 thousand for the three and nine months ended September 30, 2024, respectively.

Equity method investment expense was $ 0 and $ 0 for the three and nine months ended September 30, 2025, respectively, and $ 30 thousand and $ 130 thousand for the three and nine months ended September 30, 2024, respectively.

The following table illustrates our segment information for significant operating expenses and includes a reconciliation to net loss for the three and nine months ended September 30, 2025 and 2024:

Three Months Ended September 30, Nine Months Ended September 30,

2025 2024 2025 2024

21 unchanged sentences

Net loss $ ( 4,249 ) $ ( 4,930 ) $ ( 13,632 ) $ ( 15,375 )

Cash and marketable securities $ 21,970 $ 38,262

Cash, cash equivalents, and marketable securities $ 18,998 $ 35,856

(1) Included in Other are the GBM study,

4 unchanged sentences

The Company’s Australian subsidiary, which conducts core research and development activities, is eligible to receive a refundable tax incentive between 43.5 % to 48.5 % (depending upon the income tax rate) for qualified research and development activities.

As of June 30, 2025 and December 31, 2024, the Company had $ 0.7 million and $ 0.6 million, respectively, recorded as an income tax incentive receivable in prepaid and other current assets in the consolidated balance sheets, as the Company determined that the expenses met the eligibility criteria and the amounts claimed are expected to be received shortly after the related tax returns are filed.

As of September 30, 2025 and December 31, 2024, the Company had $ 0.7 million and $ 0.6 million, respectively, recorded as an income tax incentive receivable in prepaid and other current assets in the consolidated balance sheets, as the Company determined that the expenses met the eligibility criteria and the amounts claimed are expected to be received shortly after the related tax returns are filed.

Note 14 – Commitments and Contingencies

2 unchanged sentences

Mazzo, Ph.D., the Company’s Chief Executive Officer (the “Mazzo Second Amended and Restated Employment Agreement”).

The Mazzo Second Amended and Restated Employment Agreement supplements and amends the Amended and Restated Employment Agreement, dated and effective as of March 19, 2021, between Dr.

Second Amended and Restated Employment Agreement supplements and amends the Amended and Restated Employment Agreement, dated and effective as of March 19, 2021, between Dr.

Mazzo and the Company.

33 unchanged sentences

On June 10, 2025, the Company entered into an amended and restated separation benefits agreement with James Nisco, Senior Vice President Finance and Treasury and Chief Accounting Officer of the Company (the “Nisco Amendment”).

The Nisco Amendment supplements and amends the separation benefits provided in the Non-Change in Control Separation Pay Agreement between the Company and Mr.

The Nisco Amendment supplements and amends the separation benefits provided in the Non-Change in Control Separation Pay

Agreement between the Company and Mr.

Nisco, dated as of December 24, 2024, and the severance agreement between Mr.

36 unchanged sentences

Imam is also entitled to payment of accrued but unpaid paid time off and wages up to the date of termination and monthly COBRA coverage reimbursements for 12 months from the date of termination.

The Imam Non-Change in Control Separation Pay Agreement also provides an extension of the time period for exercising any fully vested option awards to the earlier of the one-year anniversary of the date the termination becomes effective and the original expiration date of the options.

The Imam Non-Change in Control Separation

Pay Agreement also provides an extension of the time period for exercising any fully vested option awards to the earlier of the one-year anniversary of the date the termination becomes effective and the original expiration date of the options.

The Imam Amendment:

29 unchanged sentences

On July 12, 2024, the Company purchased an additional SAFE from Impilo for $ 30 thousand.

As of June 30, 2025 and December 31, 2024, the Company owned 38.6 % of Impilo.

As of September 30, 2025 and December 31, 2024, the Company owned 38.6 % of Impilo.

These investments were expensed under the equity method of accounting in the prior year in other expense, net in the accompanying statement of operations.

16 unchanged sentences

Upon termination of the agreement for any reason, all rights and obligations of the Company with respect to the patents and patent applications shall terminate and revert to SBP.

SBP did no t own shares of the Company’s common stock as of June 30, 2025.

SBP did no t own shares of the Company’s common stock as of September 30, 2025.

Note 17 – Research Collaboration and License Agreements

8 unchanged sentences

Unless terminated early, the Qilu Agreement will continue in effect until the expiration of all Qilu payment obligations.

Either party may terminate the Qilu Agreement if an undisputed material breach by the other party is not cured within a defined

period of time, or upon notice for insolvency-related events of the other party that are not discharged within a defined time period.

Either party may terminate the Qilu Agreement if an undisputed material breach by the other party is not cured within a defined period of time, or upon notice for insolvency-related events of the other party that are not discharged within a defined time period.

Qilu may terminate the Qilu Agreement in its entirety, at any time with at least sixty days written notice.

3 unchanged sentences

(Kuva) to explore the synergistic potential of the Company's certepetide as a targeting and delivery agent for Kuva’s NanoMark™ imaging technology in solid tumors.

Under the Agreement, Kuva will assume full responsibility for research, development, and commercialization costs, while the Company will be responsible for supplying certepetide for additional consideration pursuant to a Clinical Supply Agreement.

Under the Agreement, Kuva will assume full responsibility for research, development, and commercialization costs, while the Company will be responsible for

supplying certepetide for additional consideration pursuant to a Clinical Supply Agreement.

In consideration for the license, the Company recognized $ 1.0 million as revenue upon delivery of the license in November 2024.

1 unchanged sentence

Note 18 – Subsequent Events

On July 15, 2025, the Company announced that it has been issued a patent from the United States Patent and Trademark Office covering the composition of matter of certepetide, more specifically, around its chemical structure and pharmacokinetic properties.

The granted patent, U.S.

12,351,653, further expands the Company’s intellectual property estate around certepetide and will expire in March 2040.

Non-Exclusive License Agreement

On October 8, 2025, the Company entered into a worldwide Non-Exclusive License Agreement (the “Non-Exclusive License Agreement” or the “Agreement”) with Catalent, Inc.

(“Catalent”), pursuant to which the Company granted to Catalent, on a non-exclusive basis, certain of its intellectual property to exploit use of the Company’s novel iRGD cyclic peptide, certepetide, as an antibody drug conjugate (ADC) payload as part of Catalent’s SMARTag ® ADC platform.

Under the Agreement, Catalent will assume full responsibility for research, development, and commercialization costs.

In connection with entering into the Non-Exclusive License Agreement, the Company is eligible to receive pre-determined development milestone payments of up to $ 10.5 million in the aggregate.

The Company is also eligible to receive tiered revenue sharing on future sales and/or partnerships, subject to specified royalty reductions as set forth in the Agreement, as well as a portion of any sublicense consideration received from the grant of any sublicense or similar rights under any of the rights or licenses granted to Catalent under the Agreement.

The Agreement will remain in effect until it expires on a product-by-product and country-by-country basis at the end of the royalty term.

Either party may terminate the Agreement upon the other party’s material breach, subject to specified notice and cure provisions, as well as resulting from the bankruptcy or insolvency of the other party.

Catalent may also terminate the Agreement in its entirety at any time by giving the Company at least thirty (30) days prior written notice.

In connection with the Agreement, Catalent has agreed to grant the Company a right of first negotiation for a license, in the event Catalent initiates a specific, organized out-licensing process of an asset resulting from the Agreement.

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