What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2025-08-07 compared with 2025-05-08 · 232 added, 88 removed, 513 unchanged (38% of the section changed)

25 unchanged sentences

issued 8,627,202

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

outstanding, 8,620,162 and 8,408,844 shares at March 31, 2025 and December 31, 2024,

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,

Additional paid-in capital 579,227 578,418

Treasury stock, at cost;

738 shares at March 31, 2025 and December 31, 2024

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

( 708 ) ( 708 )

11 unchanged sentences

(In thousands, except per share data)

Three Months Ended March 31,

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

2025 2024 2025 2024

Revenue $ 70 $ — $ 70 $ —

Operating Expenses:

18 unchanged sentences

Basic and diluted shares

8,605 8,308 8,604 8,301

See accompanying notes to consolidated financial statements.

3 unchanged sentences

(In thousands)

Three Months Ended March 31,

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

2025 2024 2025 2024

Net loss $ ( 4,659 ) $ ( 5,044 ) $ ( 9,383 ) $ ( 10,445 )

Other comprehensive gain (loss):

Available for sale securities - net unrealized loss ( 2 ) ( 13 )

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

Cumulative translation adjustment arising during the period 24 23 28 ( 26 )

17 unchanged sentences

Shares Amount

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

Net loss — — — — ( 5,044 ) — ( 5,044 ) — ( 5,044 )

Share-based compensation — — 237 — — — 237 — 237

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

Unrealized gain on marketable securities — — — 4 — — 4 — 4

Foreign currency translation adjustment — — — 23 — — 23 — 23

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

Common Stock Additional

Capital Accumulated

Comprehensive

Loss Accumulated

Deficit Treasury

Lisata Therapeutics,

Stockholders'

Subsidiary Total

Shares Amount

Balance at December 31, 2023 8,151 $ 8 $ 576,971 $ ( 42 ) $ ( 528,081 ) $ ( 708 ) $ 48,148 $ ( 254 ) $ 47,894

1 unchanged sentence

Share-based compensation 157 — 549 — — — 549 — 549

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

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

Foreign currency translation adjustment — — — ( 26 ) — — ( 26 ) — ( 26 )

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

Common Stock Additional

Capital Accumulated

Comprehensive

Loss Accumulated

Deficit Treasury

Lisata Therapeutics,

Stockholders'

Subsidiary Total

Shares Amount

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

Net loss — — — — ( 4,659 ) — ( 4,659 ) — ( 4,659 )

Share-based compensation ( 22 ) — 230 — — — 230 — 230

Net proceeds from issuances of common stock 28 — 74 — — — 74 — 74

Unrealized gain on marketable securities — — — 4 — — 4 — 4

Foreign currency translation adjustment — — — 24 — — 24 — 24

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

Common Stock Additional

11 unchanged sentences

Proceeds from option exercise 4 — 8 — — — 8 — 8

Unrealized loss on marketable securities — — — ( 2 ) — — ( 2 ) — ( 2 )

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

Foreign currency translation adjustment — — — 28 — — 28 — 28

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

LISATA THERAPEUTICS, INC.

2 unchanged sentences

(In thousands)

Three Months Ended March 31,

Six Months Ended June 30,

Cash flows from operating activities:

21 unchanged sentences

Net proceeds from issuance of common stock 286 32

Net cash used in financing activities ( 23 ) ( 142 )

Net cash provided by (used in) financing activities 41 ( 110 )

Effect of exchange rate changes on cash 7 ( 29 )

Net increase (decrease) in cash and cash equivalents 4,008 ( 788 )

Net increase in cash and cash equivalents 626 5,700

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

14 unchanged sentences

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 decades of collective biopharmaceutical and pharmaceutical product development experience across a variety of therapeutic categories and at all stages of development from preclinical through to product registration and launch.

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.

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 operating activities, and has cash, cash equivalents and marketable securities of approximately $ 25.8 million as of March 31, 2025.

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, initiation of the FORTIFIDE study remains on hold as the Company is investigating a potentially faster and more cost-effective approach to achieving the study objective.

The Company has similarly decided to delay commencement of certain phase 3 readiness activities for chemistry, manufacturing and controls (“CMC”).

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”).

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, 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.

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.

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 March 31, 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 June 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 months ended March 31, 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 six months ended June 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.

Estimates also affect the reported amounts of expenses during the reporting

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.

The Company bases its estimates on historical experience and other assumptions believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

27 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 March 31, 2025 and December 31, 2024 is derived from its license agreement dated November 30, 2024, more fully described in Note 17.

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

1 unchanged sentence

Accounts receivable is stated at historical cost, less allowance for credit losses.

The Company records an expense based on a forward-looking current expected credit loss model to maintain its allowance for credit losses, which replaced the

allowance for doubtful accounts.

The Company records an expense based on a forward-looking current expected credit loss model to maintain its allowance for credit losses.

When determining its allowance for trade accounts receivable, the Company considers the probability of recoverability of accounts receivable based on experience, taking into account current collection trends and general economic factors, including bankruptcy rates.

The Company also considers future economic trends to estimate expected

credit losses over the lifetime of the asset.

The Company also considers future economic trends to estimate expected credit losses over the lifetime of the asset.

Credit risks are assessed based on historical write-offs, net of recoveries, as well as an analysis of the aged accounts receivable balances with allowances generally increasing as the receivable ages.

1 unchanged sentence

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

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

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

Marketable Securities

The Company determines the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation at each balance sheet date.

All of the Company's marketable securities are considered as available-for-sale and

carried at estimated fair values and reported in cash equivalents and marketable securities.

All of the Company's marketable securities are considered as available-for-sale and carried at estimated fair values and reported in cash equivalents and marketable securities.

Unrealized gains and losses on available-for-sale securities, that are not the result of credit losses, are excluded from net income and reported in accumulated other comprehensive income (loss) as a separate component of stockholders' equity.

47 unchanged sentences

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 $ 17 thousand for the three months ended March 31, 2025, and $ 17 thousand for the three months ended March 31, 2024, respectively.

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.

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 no revenue for the three months ended March 31, 2025 and 2024.

The Company recognized $ 70 thousand and $ 0 revenue for the six months ended June 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 months ended March 31, 2025 and March 31, 2024, the Company has not recognized revenue related to milestones.

For the three and six months ended June 30, 2025 and June 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):

March 31, 2025 December 31, 2024

June 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):

March 31, 2025 December 31, 2024

June 30, 2025 December 31, 2024

Cash equivalents $ 12,117 $ 10,613

2 unchanged sentences

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

March 31, 2025

June 30, 2025

Amortized Cost Estimated Fair Value

4 unchanged sentences

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

March 31, 2025 December 31, 2024

June 30, 2025 December 31, 2024

Computer equipment 494 589

3 unchanged sentences

Property and equipment, net $ 48 $ 72

The Company’s results included depreciation expense of approximately $ 26 thousand and $ 29 thousand for the three months ended March 31, 2025 and 2024, respectively.

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.

Note 5 – Income (Loss) Per Share

For the three months ended March 31, 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 March 31, 2025 and 2024, the Company excluded the following potentially dilutive securities (in thousands):

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):

Stock options 1,511 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 March 31, 2025 and December 31, 2024 were as follows (in thousands):

March 31, 2025 December 31, 2024

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

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

2 unchanged sentences

$ 12,117 $ 5,135 $ — $ 17,252 $ 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 March 31, 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 June 30, 2025 and December 31, 2024, due to the short maturity nature of these items.

Note 7 – Accrued Liabilities

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

March 31, 2025 December 31, 2024

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

June 30, 2025 December 31, 2024

Salaries, employee benefits and related taxes $ 1,895 $ 2,640

12 unchanged sentences

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

March 31, 2025 December 31, 2024

June 30, 2025 December 31, 2024

Right-of-Use Assets:

Other assets $ 47 $ 138

Total Right-of-Use Asset $ 93 $ 138

Total Right-of-Use Assets $ 47 $ 138

Operating Lease Liabilities:

1 unchanged sentence

Total Operating Lease Liabilities $ 47 $ 137

As of March 31, 2025, the weighted average remaining lease term for the Company's operating lease was 0.50 years, and the weighted average discount rate for the Company's operating lease was 9.625 %.

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 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 March 31, 2025 were as follows (in thousands):

Future minimum lease payments under the lease agreement as of June 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 three months ended March 31, 2025, the Company issued 55,578 shares of common stock under the ATM Agreement for net proceeds of $ 211,369 .

Since inception, the Company has issued 123,751 shares of common stock under the ATM Agreement for net proceeds of $ 492,216 .

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 .

Stock Options and Warrants

The following table summarizes the activity for stock options and warrants for the three months ended March 31, 2025:

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

Stock Options Warrants

6 unchanged sentences

Expired ( 18,606 ) 201.38 — —

Outstanding at March 31, 2025 1,529,391 $ 6.22 5.62 $ 79.0 1,496,744 $ 40.52 1.05 $ —

Vested at March 31, 2025

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

or expected to vest in the future 1,501,693 $ 6.18 5.22 $ 142.7 1,496,744 $ 40.52 0.80 $ 1.5

Vested at March 31, 2025 1,344,298 $ 6.60 5.14 $ 78.0 1,496,744 $ 40.52 1.05 $ —

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

Restricted Stock

During the three months ended March 31, 2025 and 2024, the Company issued restricted stock for services as follows (in thousands, except share data):

Three Months Ended March 31,

Number of restricted stock issued 215,550 203,800

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,

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 three months ended March 31, 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 six months ended June 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 and four years .

The following is a summary of the changes in non-vested restricted stock for the three months ended March 31, 2025:

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:

Restricted Stock Shares Weighted Average Grant-Date Fair Value

4 unchanged sentences

Forfeited ( 17,450 ) $ 3.50

Non-vested at March 31, 2025 294,611 $ 3.47

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

Restricted Stock Units

During the three months ended March 31, 2025 and 2024, the Company issued restricted stock units for services as follows (in thousands, except share data):

Three Months Ended March 31,

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,

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 three months ended March 31, 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 six months ended June 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 three months ended March 31, 2025:

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

Restricted Stock Units Weighted Average Grant-Date Fair Value

4 unchanged sentences

Forfeited — $ —

Non-vested at March 31, 2025 85,345 $ 3.98

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

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 months ended March 31, 2025 and 2024 (in thousands):

Three Months Ended March 31,

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,

2025 2024 2025 2024

Research and development $ 27 $ 37 $ 153 $ 123

1 unchanged sentence

Total share-based compensation expense $ 239 $ 237 $ 769 $ 691

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 March 31, 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 June 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 2.00 0.51 2.11

Total fair value of shares vested and the weighted average estimated fair values of shares granted for the three months ended March 31, 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 six months ended June 30, 2025 and 2024 were as follows (in thousands):

Stock Options Warrants

Three Months Ended March 31, Three Months Ended March 31,

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

2025 2024 2025 2024

41 unchanged sentences

The sale of NJ NOLs resulted in a $ 962 thousand deferred income tax benefit and a loss on sale of $ 91 thousand recorded in other income (expense) in the consolidated financial statements.

On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act ("OBBBA").

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.

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 no revenue during the three months ended March 31, 2025 and 2024.

Depreciation and amortization expense was $ 43 thousand and $ 46 thousand for the three months ended March 31, 2025 and 2024, respectively.

Equity method investment expense was $ 0 and $ 100 thousand for the three months ended March 31, 2025 and 2024, respectively.

The following table illustrates our segment information for significant operating expenses and includes a reconciliation to net loss for the three months ended March 31, 2025 and 2024:

Three Months Ended March 31

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,

2025 2024 2025 2024

Revenue $ 70 $ — $ 70 $ —

Operating Expenses:

4 unchanged sentences

Clinical department 991 1,056 2,148 2,190

458 92 875 230

Research and development 2,253 2,601 4,856 5,842

6 unchanged sentences

Share based compensation expense 212 200 616 568

2 134 387 287

General and administrative 2,685 2,922 5,930 6,282

4 unchanged sentences

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

(1) Included in Other are the GBM study, FORTIFIDE study and research

oncology expenses

(2) Included in Other are facilities expense, human resource

and information technology expenses

(1) Included in Other are the GBM study,

FORTIFIDE study and research oncology

(2) Included in Other are facilities expense, human

resource and information technology expenses

Note 13 – Australia Research and Development Tax Incentive

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 March 31, 2025 and December 31, 2024, the Company had $ 0.6 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 – Contingencies

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.

Note 14 – Commitments and Contingencies

Second Amended and Restated Employment Agreement

On June 10, 2025, the Company entered into an amended and restated employment agreement with David J.

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.

Mazzo and the Company.

The Mazzo Second Amended and Restated Employment Agreement:

(i) amends Dr.

Mazzo’s base salary to $ 717,229 from $ 633,032 and removed the non-accountable expense allowance of $ 12,000 per year, (ii) clarifies that a material reduction in Dr.

Mazzo’s base salary is included in the definition of “Good Reason”, (iii) amends that in the event of Dr.

Mazzo’s termination from the Company within two years following a Change in Control (as defined therein), any determination on (a) whether Dr.

Mazzo’s termination constitutes a termination with or without Cause (as defined therein) or with or without Good Reason (as defined therein) and (b) Dr.

Mazzo’s entitlement to the separation benefits and payments described therein, will be determined by the board of directors of the Company as constituted immediately prior to such Change in Control, which board may delegate its authority to a qualified independent third party, (iv) amends Dr.

Mazzo’s COBRA benefit coverage after the date of termination to monthly reimbursement payments for the cost of Dr.

Mazzo’s group health plan coverage, except in the event that such payment would incur tax penalties to the Company, violate applicable nondiscrimination requirements or in the event that the Company terminates the group health plan, in which case the Company will pay Dr.

Mazzo a lump-sum cash payment equal to the aggregate cost of the remaining reimbursement payments less required withholdings, (v) amends the form of payment of Dr.

Mazzo’s bonus payments in the event of a termination not in connection to a Change in Control to a lump-sum payment, (vi) amends the definition of “Change in Control” therein to include the approval by the shareholders of the Company of any plan of complete liquidation of the Company, provided that the Change in Control meets all of the requirements of a “change in control” within the meaning of Treasury Regulation §1.409A-3(i)(5), (vii) clarifies that the base salary severance payments, to the extent that the payments are in the aggregate less than or equal to twice the compensation limit under Section 401(a)(17) of the Internal Revenue Code of 1986, as amended (the “Code”), comply with the involuntary separation pay plan exception to Section 409A of the Code, and further clarifies that Dr.

Mazzo may receive such severance payments as a lump sum payment on the next payroll period following the date of his termination from employment;

and (viii) clarifies other technical terms for compliance with Section 409A of the Code.

Amended and Restated Employment Agreement

On June 10, 2025, the Company entered into an amended and restated employment agreement with Kristen K.

Buck, M.D., the Company’s Vice President, R&D and Chief Medical Officer (the “Buck Amended and Restated Employment Agreement”).

The Buck Amended and Restated Employment Agreement supplements and amends the Employment Agreement, dated and effective as of July 26, 2021, between Dr.

Buck and the Company.

The Buck Amended and Restated Employment Agreement:

(i) amends Dr.

Buck’s base salary to $ 599,342 from $ 550,000 , (ii) clarifies that a material reduction in Dr.

Buck’s base salary is included in the definition of “Good Reason”, (iii) amends that in the event of Dr.

Buck’s termination from the Company within two years following a Change in Control (as defined therein), any determination on (a) whether Dr.

Buck’s termination constitutes a termination with or without Cause (as defined therein) or with or without Good Reason (as defined therein) and (b) Dr.

Buck’s entitlement to the separation benefits and payments described therein, will be determined by the board of directors of the Company as constituted immediately prior to such Change in Control, which board may delegate its authority to a qualified independent third party, (iv) amends Dr.

Buck’s COBRA benefit coverage after the date of termination to monthly reimbursement payments for the cost of Dr.

Buck group health plan coverage, except in the event that such payment would incur tax penalties to the Company, violate applicable nondiscrimination requirements or in the event that the Company terminates the group health plan, in which case the Company will pay Dr.

Buck a lump-sum cash payment equal to the aggregate cost of the remaining reimbursement payments less required withholdings, (v) amends Dr.

Buck’s bonus payments in the event of a termination not in connection to a Change in Control such that the amount will not be pro-rated for the number of days Dr.

Buck was employed in the year of termination of employment, (vi) amends the definition of “Change in Control” therein to include the approval by the shareholders of the Company of any plan of complete liquidation of the Company, provided that the Change in Control meets all of the requirements of a “change in control” within the meaning of Treasury Regulation §1.409A-3(i)(5), (vii) clarifies that the base salary severance payments, to the extent that the payments are in the aggregate less than or equal to twice the compensation limit under Section 401(a)(17) of the Code comply with the involuntary separation pay plan exception to Section 409A of the Code, and further clarifies that Dr.

Buck may receive such severance payments as a lump sum payment on the next payroll period following the date of her termination from employment;

and (viii) clarifies other technical terms for compliance with Section 409A of the Code.

Amended and Restated Separation Benefits Agreement

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.

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

Nisco and the Company, dated and effective as of September 12, 2016, and further amended on March 25, 2022.

The Nisco Amendment:

(i) amends the definition of “Change in Control” therein to include the approval by the shareholders of the Company of any plan of complete liquidation of the Company, provided that the Change in Control meets all of the requirements of a “change in control” within the meaning of Treasury Regulation §1.409A-3(i)(5), (ii) includes a condition that Mr.

Nisco’s right to the severance payments and benefits described therein are subject to Mr.

Nisco’s timely execution and non-revocation of a general release of claims within sixty days following Mr.

Nisco’s termination or such shorter time period set forth therein, (iii) amends Mr.

Nisco’s COBRA benefit coverage after the date of termination to monthly reimbursement payments for the cost of Mr.

Nisco’s group health plan coverage, except in the event that such payment would incur tax penalties to the Company, violate applicable nondiscrimination requirements or in the event that the Company terminates the group health plan, in which case the Company will pay Mr.

Nisco a lump-sum cash payment equal to the aggregate cost of the remaining reimbursement payments less required withholdings, (iv) amends that in the event of Mr.

Nisco’s termination from the Company within two years following a Change in Control (as defined therein), any determination on (a) whether Mr.

Nisco’s termination constitutes a termination with or without Cause (as defined therein) or with or without Good Reason (as defined therein) and (b) Mr.

Nisco’s entitlement to the separation benefits and payments described therein, will be determined by the board of directors of the Company as constituted immediately prior to such Change in Control, which board may delegate its authority to a qualified independent third party, (v) clarifies that the base salary severance payments, to the extent that the payments are in the aggregate less than or equal to twice the compensation limit under Section 401(a)(17) of the Code, comply with the involuntary separation pay plan exception to Section 409A of the Code, and further clarifies that Mr.

Nisco may receive such severance payments as a lump sum payment on the next payroll period following the date of his termination from employment;

and (vi) clarifies other technical terms for compliance with Section 409A of the Code.

Amended and Restated Separation Benefits Agreement

On June 10, 2025, the Company entered into an amended and restated separation benefits agreement (the “Imam Amendment”) with Tariq Imam, Senior Vice President, Business Development and Operations and General Counsel of the Company.

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

Imam, dated as of December 24, 2024, effective as of February 1, 2025 (the “Imam Non-Change in Control Separation Pay Agreement”) and the severance agreement between Mr.

Imam and the Company, dated as of March 25, 2022 (the “Imam Severance Agreement”).

Imam Severance Agreement

Pursuant to the Imam Severance Agreement, Mr.

Imam is entitled to receive certain payments following his termination from the Company in specific circumstances.

Imam terminates his employment for Good Reason (as defined in the Imam Severance Agreement) during the period commencing on the effective date of a Change in Control (as defined in the Imam Severance Agreement) and ending on the second anniversary of the effective date of a Change in Control (as defined in the Imam Severance Agreement), or the Company terminates Mr.

Imam’s employment without Cause (as defined in the Imam Severance Agreement) (other than by reason of his death or disability), the Company will (a) continue to pay Mr.

Imam’s current base salary of $ 356,000 (the “Imam Salary Payment”) for 12 months following the date the termination becomes effective (the "Imam Severance Period"), commencing on the next payroll period following the date the termination becomes effective and (b) pay Mr.

Imam a lump-sum equal to 100 % of Mr.

Imam’s then annual target bonus on the next payroll period following the date the termination becomes effective (the “Imam Cash Severance”) and (c) pay monthly the monthly premium amount for continued COBRA coverage.

If the Company may not pay Mr.

Imam’s COBRA premiums without incurring tax penalties or violating any requirement of law, the Company shall use its commercially reasonable best efforts to provide Mr.

Imam with substantially similar assistance in an alternative manner (the “Imam COBRA Payments”), provided that the cost of doing so does not exceed the cost that the Company would have incurred had the Company been able to pay the COBRA premiums on Mr.

Imam’s behalf.

In addition to the Imam Salary Payment, Imam Cash Severance and the Imam COBRA Payments, the Company shall (i) fully vest as of the date the termination becomes effective, all outstanding unvested equity awards, including options granted to Mr.

and (ii) extend the exercise date of the options to the earlier of the one-year anniversary of the date the termination becomes effective and the original expiration date of the options.

Imam Non-Change in Control Separation Pay Agreement

Pursuant to the Imam Non-Change in Control Separation Pay Agreement, Mr.

Imam is entitled to a salary continuation of his current base salary of $ 356,000 for 12 months from the date of his termination, as well as a lump-sum cash payment of 100 % of his then annual target bonus on the next payroll period following the date the termination becomes effective.

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 Amendment:

Imam’s right to the severance payments and benefits described therein are subject to Mr.

Imam’s timely execution and non-revocation of a general release of claims within sixty days following Mr.

Imam’s termination or such shorter time period set forth therein, (iii) amends Mr.

Imam’s COBRA benefit coverage after the date of termination to monthly reimbursement payments for the cost of Mr.

Imam’s group health plan coverage, except in the event that such payment would incur tax penalties to the Company, violate applicable nondiscrimination requirements or in the event that the Company terminates the group health plan, in which case the Company will pay Mr.

Imam a lump-sum cash payment equal to the aggregate cost of the remaining reimbursement payments less required withholdings, (iv) clarifies that in the event of Mr.

Imam’s termination from the Company within two years following a Change in Control (as defined therein), any determination on (a) whether Mr.

Imam’s termination constitutes a termination with or without Cause (as defined therein) or with or without Good Reason (as defined therein) and (b) Mr.

Imam’s entitlement to the separation benefits and payments described therein, will be determined by the board of directors of the Company as constituted immediately prior to such Change in Control, which board may delegate its authority to a qualified independent third party, (v) clarifies that the base salary severance payments, to the extent that the payments are in the aggregate less than or equal to twice the compensation limit under Section 401(a)(17) of Code, comply with the involuntary separation pay plan exception to Section 409A of the Code, and further clarifies that Mr.

Imam may receive such severance payments as a lump sum payment on the next payroll period following the date of his termination from employment and (vi) clarifies other technical terms for compliance with Section 409A of the Code.

Legal Proceedings and Claims

From time to time, the Company is subject to legal proceedings and claims, either asserted or unasserted, that arise in the ordinary course of business.

16 unchanged sentences

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

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

As of June 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.

14 unchanged sentences

The agreement may be terminated in its entirety by SBP if the Company, at any time, defaults in the payment of any sum when due and fails to make such payment within thirty days after receipt of written notice.

involuntarily petitioned with, bankruptcy (other than dissolution or winding up for the purposes of reconstruction or amalgamation), (b) makes an assignment of all or substantially all of its assets for the benefit of creditors, or (c) has a receiver or trustee is appointed and is unable to secure a dismissal, stay or other suspension of such proceedings within thirty days.

The agreement may be terminated in its entirety by either SBP or the Company (i) in the event of an uncured material breach by the other party, or (ii) in the event the other party (a) files for, or is involuntarily petitioned with, bankruptcy (other than dissolution or winding up for the purposes of reconstruction or amalgamation), (b) makes an assignment of all or substantially all of its assets for the benefit of creditors, or (c) has a receiver or trustee is appointed and is unable to secure a dismissal, stay or other suspension of such proceedings within thirty days.

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 March 31, 2025.

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

Note 17 – Research Collaboration and License Agreements

Exclusive License and Collaboration Agreement - Qilu Pharmaceuticals

Exclusive License and Collaboration Agreement - Qilu Pharmaceutical

In February 2021, Cend entered into an Exclusive License and Collaboration Agreement (the “Qilu Agreement”) in which Cend granted an exclusive license to Qilu for the development and commercialization of certepetide in the Territory (defined as the Greater Area of China including China, Macau, Hong Kong, and Taiwan).

3 unchanged sentences

The Company is eligible to receive additional development and commercial milestone payments up to $ 96.0 million and $ 125.0 million, respectively, tiered royalties on net sales ranging from 10 % to 15 %, and tiered sublicensing revenues ranging from 12 % to 35 %.

On March 25, 2024, the Company entered into a settlement agreement with Lingmed whereby Lingmed is entitled to 5.0 % of any future milestone payments received by the Company under the Qilu Agreement, in addition, Lingmed is also entitled to a sum of $ 250 thousand with respect to the first future milestone received by the Company.

On March 25, 2024, the Company entered into a settlement agreement with Lingmed whereby Lingmed is entitled to 5.0 % of any future milestone payments received by the Company under the Qilu Agreement.

In addition, Lingmed is entitled to a sum of $ 250 thousand with respect to the first future milestone received by the Company.

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.

6 unchanged sentences

The Company is eligible to receive additional development and commercial milestone payments up to $ 1.5 million and $ 17.5 million, respectively, a 5.0 % percent royalty on net sales, and sublicensing revenues of 50 %.

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.

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