What changed in this filing

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Item 1. Financial Statements

2025-05-08 compared with 2024-11-06 · 311 added, 289 removed, 454 unchanged (57% of the section changed)

Financial Statements.

AADI BIOSCIENCE, INC.

WHITEHAWK THERAPEUTICS, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share data and par value)

September 30,

2025 December 31,

15 unchanged sentences

Operating lease liabilities, current portion — 268

Due to licensor payable (Note 7) — 5,757

Total current liabilities 12,274 17,074

5 unchanged sentences

Preferred stock, $ 0.0001 par value, 10,000,000 shares authorized;

issued and outstanding as of September 30, 2024 and December 31, 2023

issued and outstanding as of March 31, 2025 and December 31, 2024

Common stock, $ 0.0001 par value;

300,000,000 shares authorized;

and 24,554,205 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

and 24,680,708 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively.

Additional paid-in capital 481,361 385,114

4 unchanged sentences

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

AADI BIOSCIENCE, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

WHITEHAWK THERAPEUTICS, INC.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(In thousands, except share data and earnings per share amounts)

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

2024 2023 2024 2023

Three Months Ended March 31,

Product sales, net $ 7,145 $ 5,353

3 unchanged sentences

Research and development 8,788 13,593

Restructuring charges 2,638 — 2,638 —

Cost of goods sold 760 652

2 unchanged sentences

Other income (expense)

Gain on sale of business 87,443 —

Foreign exchange loss — ( 1 )

2 unchanged sentences

Total other income (expense), net 88,234 1,223

Net loss $ ( 12,546 ) $ ( 16,302 ) $ ( 45,418 ) $ ( 49,496 )

Other comprehensive loss:

Unrealized gain on available-for-sale debt securities 66 28 12 99

Comprehensive loss $ ( 12,480 ) $ ( 16,274 ) $ ( 45,406 ) $ ( 49,397 )

Net loss per share, basic and diluted $ ( 0.46 ) $ ( 0.60 ) $ ( 1.68 ) $ ( 1.84 )

Weighted average number of common shares outstanding, basic and diluted 27,041,327 26,946,683 27,010,791 26,901,810

Net income (loss) $ 73,016 $ ( 18,289 )

Other comprehensive income (loss):

Unrealized loss on investments, net of tax ( 15 ) ( 35 )

Comprehensive income (loss) 73,001 ( 18,324 )

Net income (loss) per share:

Basic $ 1.84 $ ( 0.68 )

Diluted $ 1.83 $ ( 0.68 )

Weighted average shares outstanding:

Basic 39,640,826 26,980,698

Diluted 39,932,539 26,980,698

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

AADI BIOSCIENCE, INC.

WHITEHAWK THERAPEUTICS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, including share amounts)

For the Three and Nine Months Ended September 30, 2024

For the Three Months Ended March 31, 2025

Stockholders' Equity

Common Stock Additional Paid-In

Capital Accumulated Other Comprehensive Income (Loss) Accumulated

Capital Accumulated Other Comprehensive Income Accumulated

Deficit Total

2 unchanged sentences

Share-based compensation expense — — 1,680 — — 1,680

Issuance of common stock upon exercise of warrants 426 — — — — —

Issuance of common stock upon exercise of stock options 22 — 21 — — 21

Issuance of common stock in conjunction with vesting of restricted stock units 63 — — — — —

Private placement, net of transaction costs 21,592 2 94,546 — — 94,548

Unrealized loss on investments, net of tax — — — ( 15 ) — ( 15 )

Net loss — — — — ( 18,289 ) ( 18,289 )

Net income — — — — 73,016 73,016

Balance at March 31, 2025 46,784 $ 4 $ 481,361 $ 1 $ ( 259,638 ) $ 221,728

Share-based compensation expense — — 2,839 — — 2,839

Issuance of shares under the employee stock purchase plan 61 — 94 — — 94

Unrealized loss on investments, net of tax — — — ( 19 ) — ( 19 )

Net loss — — — — ( 14,583 ) ( 14,583 )

Balance at June 30, 2024 24,615 $ 2 $ 380,651 $ ( 27 ) $ ( 301,835 ) $ 78,791

Share-based compensation expense — — 2,557 — — 2,557

Unrealized gain on investments, net of tax — — — 66 — 66

Net loss — — — — ( 12,546 ) ( 12,546 )

Balance at September 30, 2024 24,615 $ 2 $ 383,208 $ 39 $ ( 314,381 ) $ 68,868

For the Three and Nine Months Ended September 30, 2023

For the Three Months Ended March 31, 2024

Stockholders' Equity

5 unchanged sentences

Share-based compensation expense — — 3,589 — — 3,589

Issuance of common stock upon exercise of stock options 2 — 8 — — 8

Unrealized gain on investments, net of tax — — — 83 — 83

Net loss — — — — ( 15,223 ) ( 15,223 )

Balance at March 31, 2023 24,437 $ 2 $ 364,437 $ ( 32 ) $ ( 218,421 ) $ 145,986

Share-based compensation expense — — 3,054 — — 3,054

Issuance of common stock upon exercise of stock options 34 — 68 — — 68

Issuance of shares under the employee stock purchase plan 49 — 294 — — 294

Unrealized loss on investments, net of tax — — — ( 35 ) — ( 35 )

Net loss — — — — ( 18,289 ) ( 18,289 )

Balance at June 30, 2023 24,520 $ 2 $ 367,853 $ ( 44 ) $ ( 236,392 ) $ 131,419

Share-based compensation expense — — 3,049 — — 3,049

Issuance of common stock upon exercise of stock options 6 — 2 — — 2

Unrealized gain on investments, net of tax — — — 28 — 28

Net loss — — — — ( 16,302 ) ( 16,302 )

Balance at September 30, 2023 24,526 $ 2 $ 370,904 $ ( 16 ) $ ( 252,694 ) $ 118,196

Balance at March 31, 2024 24,554 $ 2 $ 377,718 ( 8 ) $ ( 287,252 ) $ 90,460

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

AADI BIOSCIENCE, INC.

WHITEHAWK THERAPEUTICS, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

Nine Months Ended September 30,

Three Months Ended March 31,

Cash flows from operating activities:

Net loss $ ( 45,418 ) $ ( 49,496 )

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

Net income (loss) $ 73,016 $ ( 18,289 )

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

Share-based compensation expense 1,680 3,589

Amortization of premiums and discounts on short-term investments, net ( 1,118 ) ( 2,650 )

Gain on sale of business ( 87,443 ) —

Discount amortization on short-term investments 19 ( 422 )

Non-cash interest expense — 58

7 unchanged sentences

Operating lease liabilities ( 89 ) ( 126 )

Accounts payable, accrued liabilities, and other current liabilities ( 10,365 ) ( 4,947 )

Accounts payable and accrued liabilities 975 ( 6,764 )

Other liabilities ( 202 ) —

1 unchanged sentence

Cash flows from investing activities:

Proceeds from sale of business, net cash, cash equivalents, and restricted cash 101,356 —

Purchases of property and equipment ( 551 ) ( 739 )

3 unchanged sentences

Cash flows from financing activities:

Proceeds from sale of common stock and prefunded warrants in PIPE financing 100,002 —

Issuance of common stock upon exercise of stock options 21 —

Proceeds from issuance of common stock under employee stock purchase plan 94 294

Payment of PIPE financing related transaction costs ( 4,822 ) —

Deferred offering costs paid for financing — ( 10 )

Net cash provided by financing activities 77 246

Net (decrease) increase in cash, cash equivalents and restricted cash ( 32,351 ) 29,784

Cash, cash equivalents and restricted cash, beginning of year 62,952 39,083

Net cash provided by (used in) financing activities 95,201 ( 10 )

Net decrease in cash, cash equivalents and restricted cash 198,835 ( 9,108 )

Cash, cash equivalents and restricted cash at beginning of period 28,734 62,952

Cash, cash equivalents and restricted cash, end of period $ 227,569 $ 53,844

2 unchanged sentences

Supplemental disclosure of non-cash activities:

Costs incurred in connection with Private Placement included in accounts payable $ 632 $ —

Deferred transaction costs included in accounts payable and accrued liabilities $ 167 $ —

3 unchanged sentences

Nature of Organization and Operations

Aadi Bioscience, Inc.

(together with its subsidiaries, the “Company” or “Aadi”) is a biopharmaceutical company focused on developing and commercializing precision therapies for cancers with alterations in the mTOR pathway, a key regulator of cell growth and cancer progression.

Aadi’s lead drug product, FYARRO ® , combines two established technologies — nanoparticle albumin-bound ( nab ) technology and the anti-cancer agent, sirolimus.

Nab -sirolimus is a potent inhibitor of the mTOR biological pathway with demonstrated anti-cancer activity in Aadi's lead indication, advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (“PEComa”), a rare cancer.

In November 2021, the U.S.

Food and Drug Administration (the “FDA”) approved FYARRO sirolimus protein-bound particles for injectable suspension (albumin-bound) for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa.

On February 22, 2022, Aadi launched FYARRO in the United States for treatment of advanced malignant PEComa.

FYARRO is licensed to Aadi by Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of Bristol-Myers Squibb Company ("BMS").

The Company’s historical operations have consisted principally of sales of FYARRO after receiving FDA approval, performing research and development activities and raising capital.

The Company’s activities are subject to significant risks and uncertainties, including failing to secure additional funding before sustainable revenues and profit from operations are achieved.

Whitehawk Therapeutics, Inc.

(the "Company") is an oncology therapeutics company applying advanced technologies to established tumor biology that are intended to efficiently deliver improved cancer treatments .

The Company has a deep experience in chemistry, formulation, and drug delivery, as well as research, clinical, and commercial pharmaceutical development, and taking product candidates from the clinic to approval, launch, and commercialization.

Current ADC Business

On December 19, 2024, the Company entered into an intellectual property license agreement (the “WuXi License Agreement”) with WuXi Biologics (Shanghai FX) Co., Ltd.

(“WuXi Biologics”) for the development and global commercialization of a portfolio of three next generation antibody drug conjugates (“ADCs”) targeting clinically validated, broadly overexpressed tumor antigens in high potential cancer indications with significant unmet need.

Refer to Note 12 for further information on the WuXi Biologics License Agreement and its terms.

Legacy FYARRO Business .

For the periods presented and through the FYARRO Divestiture (as defined below), the Company's lead drug product was FYARRO ® (sirolimus protein-bound particles for injectable suspension (albumin-bound);

nab-sirolimus), which combines two established technologies - nanoparticle albumin-bound (nab) technology and the anti-cancer agent, sirolimus.

The Company exclusively licensed FYARRO, previously called ABI-009, nab-sirolimus, from Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation, which is a wholly owned subsidiary of Bristol-Myers Squibb Company (“BMS”).

The Company refers to the development, production and commercial sale of FYARRO herein as the “FYARRO Business”.

On February 22, 2022, the Company launched FYARRO in the United States for treatment of advanced malignant perivascular epithelioid cell tumor PEComa.

On December 19, 2024, the Company entered into a Stock Purchase Agreement (the “Divestiture Agreement”) with KAKEN INVESTMENTS INC., a Delaware corporation (“KAKEN”), KAKEN PHARMACEUTICAL CO., LTD, and Aadi Subsidiary, Inc., a Delaware corporation and the Company's former wholly owned subsidiary and the operating company for the FYARRO Business (“Aadi Subsidiary”).

Under the Divestiture Agreement, KAKEN acquired 100 % of the outstanding shares of capital stock of Aadi Subsidiary from the Company for a cash payment of $ 102.4 million (following applicable purchase price adjustments under the Divestiture Agreement) (the "FYARRO Divestiture").

The FYARRO Divestiture closed on March 25, 2025 and, as a result, the Company no longer operates the FYARRO Business.

Company Name Change .

In connection with the FYARRO Divestiture, the Company changed its name from "Aadi Bioscience, Inc." to "Whitehawk Therapeutics, Inc." and the Company changed its ticker symbol on the Nasdaq Capital Market to "WHWK".

Merger with Aerpio Pharmaceuticals, Inc.

On August 26, 2021 (the “Closing Date”), Aadi Bioscience, Inc., a Delaware corporation (f/k/a Aerpio Pharmaceuticals, Inc.), completed its business combination with Aadi Subsidiary, Inc.

(f/k/a as Aadi Bioscience, Inc., or “Private Aadi”), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated May 16, 2021, by and among Aadi, Aspen Merger Subsidiary, Inc.

(“Merger Sub”) and Private Aadi (the “Merger Agreement”), pursuant to which Merger Sub merged with and into Private Aadi, with Private Aadi surviving as a wholly owned subsidiary of ours (the “Merger”).

Since inception, the Company has devoted substantially all of its resources to research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital and providing general and administrative support for these operations and has only recently begun to realize revenues from its planned principal operations commencing with the commercial sale of FYARRO.

On August 26, 2021 (the “Closing Date”), the Company completed its business combination with Aadi Subsidiary, Inc.

(f/k/a Aadi Bioscience, Inc., or “Private Aadi”), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated May 16, 2021, by and among the Company, Aspen Merger Subsidiary, Inc.

Prior to the FYARRO Divestiture, the Company also realized revenues from the commercial sale of FYARRO.

The Company has experienced net losses since its inception and expects to continue to incur net losses into the foreseeable future.

The Company had an accumulated deficit of $ 314.4 million as of September 30, 2024.

For the three months ended September 30, 2024 and 2023 , the Company had a net loss of $ 12.5 million and $ 16.3 million, respectively.

For the nine months ended September 30, 2024 and 2023 , the Company had a net loss of $ 45.4 million and $ 49.5 million, respectively.

To date, these operating losses have been funded primarily from outside sources of invested capital through the issuance of convertible promissory notes, grant funding, the sale of securities, and proceeds from license agreements.

The Company had cash, cash equivalents and short-term investments of $ 62.6 million at September 30, 2024.

Management believes the Company’s current cash, cash equivalents and short-term investments will provide sufficient funds to enable the Company to meet its obligations for at least twelve months from the filing date of this report.

The Company had an accumulated deficit of $ 259.6 million as of March 31, 2025 and net income of $ 73.0 million and a net loss of $ 18.3 million for the three months ended March 31, 2025 and 2024, respectively.

The net income recorded as of March 31, 2025 is primarily attributable to the gain on sale related to the FYARRO Divestiture.

Prior to the FYARRO Divestiture, these operating losses were funded primarily from outside sources of invested capital through the issuance of convertible promissory notes, grant funding, the sale of securities, and proceeds from license agreements.

The Company had cash, cash equivalents and short-term investments of $ 231.1 million at March 31, 2025.

The Company paid $ 38.0 million, the balance of the up-front license fee, plus a 6 % VAT fee on April 16, 2025 to Wuxi Biologics for the

in-licensing of Mucin-16 (“MUC16”), Protein Tyrosine Kinase 7 (“PTK7”) and Seizure Related 6 Homolog (“SEZ6”) (each an “ADC Therapy,” and collectively, the “ADC Therapies”) .

Management believes the Company’s cash, cash equivalents and short-term investments will provide sufficient funds to enable the Company to meet its obligations for at least twelve months from the issuance of these financial statements.

If the Company is unable to achieve and maintain profitability, it will need additional financing to support its continuing operations and pursue its strategic objectives.

1 unchanged sentence

The Company may be unable to raise additional funds or enter into such other agreements when needed on favorable terms or at all.

On March 17, 2022, the Company entered into a Sales Agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”), pursuant to which the Company may offer and sell, from time to time at the Company’s sole discretion, subject to limitations under applicable securities laws, shares of its common stock having an aggregate offering price of up to $ 75.0 million through Cowen as its sales agent for an at-the-marketing-offering.

On March 17, 2022, the Company entered into a Sales Agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”), pursuant to which the Company may offer and sell, from time to time at the Company’s sole discretion, shares of its common stock having an aggregate offering price of up to $ 75.0 million through Cowen as its sales agent for an at-the-marketing-offering.

Any sales under the Sales Agreement may result in dilution to existing shareholders.

As of September 30, 2024 , no shares of common stock had been sold under this Sales Agreement.

As of March 31, 2025 , no shares of common stock had been sold under this Sales Agreement.

Summary of Significant Accounting Policies

3 unchanged sentences

Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).

All adjustments are of a normal recurring nature.

The financial statements noted above reflect the financial position and results of operations of the Company, including Aadi Subsidiary, Inc., for the comparative periods prior to its sale on March 25, 2025.

The transaction did not meet the criteria for discontinued operations under ASC 205-20, and therefore no reclassification has been made to prior period statements.

The condensed consolidated balance sheet as of March 31, 2025 excludes the assets and liabilities of Aadi Subsidiary, which were divested as of the sale date.

Comparative information as of December 31, 2024 includes balances related to the divested business, such as accounts receivable, inventory, and customer concentration disclosures.

The Company’s condensed consolidated financial statements are stated in U.S.

Certain prior year amounts have been reclassified to conform to the current year presentation.

See Note 14 for additional information.

Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted.

Accordingly, the accompanying unaudited interim financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2023, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2024.

Comprehensive Loss

Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on short-term investments.

Comprehensive loss has been reflected in the condensed consolidated statements of operations and comprehensive loss for all periods presented.

Segment Information

Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.

The Company has identified its Chief Executive Officer as the chief operating decision maker and the Company views its operations and manages its business in one operating segment, which is the business of developing and commercializing proprietary therapeutics.

All the assets and operations of the Company’s sole operating and reportable segment are located in the United States.

Accordingly, the accompanying unaudited condensed interim financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2024, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2025.

Risks and Uncertainties

Following the FYARRO Divestiture, the Company is a preclinical-stage biopharmaceutical company with a limited operating history and three preclinical products in development.

The Company's ability to generate revenue and achieve profitability depends significantly on the ability to achieve several objectives relating to the discovery, development and commercialization of the ADC Therapies and any other product candidates that may be developed in the future.

Comprehensive Income (Loss)

Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on short-term investments.

Comprehensive income (loss) has been reflected in the condensed consolidated statements of operations and comprehensive income (loss) for all periods presented.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s condensed consolidated financial statements and accompanying notes.

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the Company’s consolidated condensed financial statements and accompanying notes.

In the opinion of management, all adjustments that are considered necessary for fair presentation have been included.

The most significant estimates in the Company’s condensed consolidated financial statements relate to gross-to-net accruals, share-based compensation expense and accrued research and development costs.

Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions.

The most significant estimates in the Company’s consolidated condensed financial statements relate to gross-to-net accruals, share-based compensation expense and accrued research and development costs.

Although these estimates are based on the Company’s

knowledge of current events and actions it may undertake in the future, actual results may materially differ from these estimates and assumptions.

Restructuring Charges

8 unchanged sentences

Management believes that the Company is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held.

While the Company has not experienced any losses in such deposits, the 2023 failure of Silicon Valley Bank, at which the Company holds cash and cash equivalents in multiple accounts, exposed the Company to credit risk prior to the resolution by the

Federal Deposit Insurance Corporation in a manner that fully protected all depositors.

The Company has not experienced any losses on deposits since inception.

The Company’s accounts receivable are derived from customers located in the United States.

The Company performs ongoing credit evaluations of its customers and maintains allowances for potential credit losses on customers’ accounts when deemed necessary.

The Company does not typically require collateral from its customers.

Credit losses historically have not been material.

The Company continuously monitors customer payments and maintains an allowance for credit losses based on its assessment of various factors including historical experience, age of the receivable balances, and other current economic conditions or other factors that may affect customers’ ability to pay.

Customer Concentration

For the three months ended September 30, 2024 and 2023, two customers represented 54 % and 44 %, and 56 % and 44 % of the Company's revenue, respectively.

For the nine months ended September 30, 2024 and 2023, two customers represented 55 % and 44 % , and 54 % and 46 % of the Company’s revenue, respectively.

Additionally, two customers accounted for 60 % and 40 % of net accounts receivable as of September 30, 2024.

For the three months ended March 31, 2025, two customers represented 37 % and 60 % of the Company’s revenue.

For the three months ended March 31, 2024, two customers represented 48 % and 52 % of the Company’s revenue.

Additionally, two customers accounted for 51 % and 49 % of net accounts receivable as of March 31, 2024.

The Company did not have accounts receivable as of March 31, 2025.

See Note 14 for further information.

Cash, Cash Equivalents and Restricted Cash

The Company considers all highly liquid marketable securities purchased with original maturities of three months or less at the time of purchase date to be cash equivalents.

Restricted cash consists of a letter of credit secured by restricted cash in connection with one of the Company's office leases and is included in other assets on the condensed consolidated balance sheets.

Refer to Note 6 for further information on the Company's leases.

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets (in thousands):

September 30, 2024 December 31, 2023

Restricted cash consists of a letter of credit secured by restricted cash in connection with the Morristown, New Jersey office lease described in Note 6, and is included in other assets on the condensed consolidated balance sheets as of December 31, 2024.

The Company did not have restricted cash as of March 31, 2025 as the Morristown lease was assumed by KAKEN.

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheet (in thousands):

March 31, 2025 December 31, 2024

Cash and cash equivalents $ 227,569 $ 28,670

10 unchanged sentences

Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement.

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

The Company’s assessment of the significance of a particular input to the fair value measurement

requires judgment and may affect the valuation of fair value assets and liabilities and their placement within the fair value hierarchy levels.

In determining the fair value of its financial instruments, the Company considers the source of observable market data inputs, liquidity of the instrument, the credit risk of the counterparty to the contract, and its risk of nonperformance.

In the case fair value is not observable, for the items subject to fair value measurements, the Company applies valuation techniques deemed the most appropriate under the GAAP guidance based on the nature of the assets and liabilities being measured.

The carrying amounts of cash equivalents, accounts receivable, accounts payable, accrued liabilities, and due to licensor payable are reasonable estimates of their fair value because of the short maturity of these items.

The carrying amounts of cash equivalents, accounts payable, and accrued liabilities are reasonable estimates of their fair value because of the short maturity of these items.

Short-Term Investments

1 unchanged sentence

The Company classifies its investments as available-for-sale and records them at fair value based upon market prices at period end.

Unrealized gains and losses that are deemed temporary in nature are recorded in accumulated other comprehensive loss as a separate component of stockholders' equity.

Unrealized gains and losses that are deemed temporary in nature are recorded in accumulated other comprehensive income as a separate component of stockholders' equity.

Dividend and interest income are recognized when earned.

3 unchanged sentences

At each balance sheet date, the Company assesses available-for-sale securities in an unrealized loss position to determine whether the decline in fair value below amortized cost is a result of credit losses or other factors, whether the Company expects to recover the amortized cost of the security, the Company's intent to sell and if it is more likely than not that the Company will be required to sell the securities before the recovery of amortized cost.

The Company records changes in allowance for expected credit loss in other income (expense), net.

The Company records changes in allowance for expected credit loss in other income (expense).

There has been no allowance for expected credit losses recorded during any of the periods presented.

5 unchanged sentences

Receivables are recorded to an allowance for credit loss when it is probable that amounts will not be collected based on terms of the customer contracts.

As of September 30, 2024 and December 31, 2023, recorded customer allowances for chargebacks were $ 32,000 and $ 0.2 million, respectively.

There were no allowances for credit losses and no receivables were written off for the periods ended September 30, 2024 and December 31, 2023, respectively.

Accounts receivable are net of $ 0.1 million, of customer allowances for chargebacks as of December 31, 2024.

There were no allowances for credit losses and no receivables were written off for the periods ended March 31, 2025 and December 31, 2024.

As of December 31, 2024, accounts receivable included balances associated with Aadi Subsidiary, Inc.

which was sold on March 25, 2025.

Accounts receivable related to Aadi Subsidiary was removed from the consolidated condensed balance sheet as of March 25, 2025.

See Note 14 for more information.

Inventory is stated at the lower of cost or estimated net realizable value.

2 unchanged sentences

otherwise, such costs are expensed.

As of December 31, 2024, inventory included balances associated with Aadi Subsidiary, Inc., which was sold on March 25, 2025.

Inventory related to Aadi Subsidiary, Inc.

was removed from the consolidated condensed balance sheet as of the sale date.

See Note 14 for more information.

Details of inventory are presented as follows (in thousands):

September 30, 2024 December 31, 2023

March 31, 2025 December 31, 2024

Raw materials $ — $ 3,533

7 unchanged sentences

Details of property and equipment are presented as follows (in thousands):

September 30, 2024 December 31, 2023

March 31, 2025 December 31, 2024

Computers and Software $ 341 $ 470

6 unchanged sentences

Property and equipment, net $ 25 $ 6,846

Construction in process mainly consists of lab, production, and testing equipment.

Depreciation expense on property, plant, and equipment amounted to $ 47,000 and $ 44,000 for the three months ended September 30, 2024 and 2023, respectively.

Depreciation expense on property, plant, and equipment amounted to $ 0.1 million and $ 0.1 million for the nine months ended September 30, 2024 and 2023, respectively.

Depreciation expense on property, plant, and equipment amounted to $ 57,000 and $ 50,000 for the three months ended March 31, 2025 and 2024, respectively.

At the inception of a contractual arrangement, the Company determines whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time.

14 unchanged sentences

Commitments and Contingencies

The Company recognizes a liability with regard to loss contingencies when it believes it is probable a liability has been incurred, and the amount can be reasonably estimated.

The Company recognizes a liability with regard to loss contingencies when it believes it is probable that a liability has been incurred, and the amount can be reasonably estimated.

If some amount within a range of loss appears at the time to be a better estimate than any other amount within the range, the Company accrues that amount.

When no amount within the range is a better estimate than any other amount the Company accrues the minimum amount in the range.

The Company has no t recorded any such liabilities as of September 30, 2024 and December 31, 2023 .

The Company has no t recorded any such liabilities as of March 31, 2025 and December 31, 2024 .

Revenue Recognition and Related Allowances

36 unchanged sentences

In arriving at its estimate, the Company also considers historical product returns, the underlying product demand, and industry data specific to the specialty pharmaceutical distribution industry.

The total amount deducted from gross product sales for the allowances described above for the three months ended September 30, 2024, and 2023, was $ 1.7 million and $ 1.3 million, respectively, and for the nine months ended September 30, 2024 and 2023 was $ 4.7 million and $ 3.4 million, respectively.

Revenue and allowances described above were recorded through the FYARRO divestiture date of March 25, 2025.

The total amount deducted from gross product sales for the allowances described above for the three months ended March 31, 2025, and 2024, was $ 2.1 million and $ 1.1 million, respectively.

The following table sets forth the changes in the accrued revenue allowances (in thousands):

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

2024 2023 2024 2023

As of March 31,

Balance at beginning of period $ 1,411 $ 1,065

1 unchanged sentence

Payments ( 1,686 ) ( 1,292 )

Allowances transferred in sale of Aadi Subsidiary, Inc.

Balance at end of period $ — $ 857

Cost of Goods Sold

Cost of goods sold consist primarily of royalties paid to BMS, costs incurred on sales of FYARRO and costs to manufacture and prepare the product for sales subsequent to the FDA approval in November 2021.

Costs incurred prior to the FDA approval were expensed when incurred .

Research and Development

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As actual expenses become known, the Company adjusts its accrued expenses.

The Company determines the accounting classification of warrants it issues as either liability or equity classified by first assessing whether the warrants meet the liability classification in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (“ASC 480”), then in accordance with ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815”).

If warrants do not meet liability classification under ASC 480-10, the Company assesses the requirements under ASC 815-40.

In order for a warrant to be classified in stockholders’ equity, the warrant must be (a) indexed to the Company’s equity and (b) meet the conditions for equity classification in ASC 815-40, Derivatives and Hedging - Contracts in an Entity’s Own Equity.

If a warrant does not meet the conditions for equity classification, it is carried on the consolidated balance sheet as a warrant liability measured at fair value, with subsequent changes in the fair value of the warrant recorded in the statement of operations as change in fair value of warrants in other income (expense).

If a warrant meets both conditions for equity classification, the warrant is initially recorded in additional paid-in capital on the consolidated balance sheets, and the amount initially recorded is not subsequently remeasured at fair value.

The Company has classified its pre-funded warrants as equity.

Share-Based Compensation

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Employee Stock Purchase Plan

Share-based compensation expense for employee stock purchases under the Company’s 2021 Employee Stock Purchase Plan (the “2021 ESPP”) is recorded at the estimated fair value of the purchase as of the plan enrollment date and is recognized as an expense on a straight-line basis over the applicable six-month 2021 ESPP offering period.

Stock-based compensation expense for employee stock purchases under the Company’s 2021 Employee Stock Purchase Plan (the “2021 ESPP”) is recorded at the estimated fair value of the purchase as of the plan enrollment date and is recognized as an expense on a straight-line basis over the applicable six-month 2021 ESPP offering period.

Income taxes have been accounted for using the asset and liability method.

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The Company recognizes interest and penalties related to uncertain tax positions, if any exist, in income tax expense.

Net Loss per Share

Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period.

Basic and diluted weighted average shares of common stock outstanding for the three and nine months ended September 30, 2024, includes the weighted average effect of 2,426,493 Pre-Funded Warrants (as defined below), which were issued in September 2022, for the purchase of shares of common stock, for which the remaining unfunded exercise price is $ 0.0001 per share.

Net Income (Loss) per Share

Basic net income (loss) per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period.

Basic and diluted weighted average shares of common stock outstanding for the three months ended March 31, 2025, includes the weighted average effect of 20,076,500 and 2,426,493 Pre-Funded Warrants, which were issued in March 2025 and September 2022, respectively, for the purchase of shares of common stock, for which the remaining unfunded exercise price is $ 0.0001 per share.

See Note 8 for more information on the Pre-Funded Warrants.

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Common stock equivalents are only included when their effect is dilutive.

The Company’s potentially dilutive securities, which include outstanding stock options, restricted stock units, and warrants have been excluded from the computation of diluted net loss per share as they would be anti-dilutive.

The following table sets forth the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive:

Nine Months Ended September 30,

Options to purchase common stock 5,256,229 4,116,510

Restricted Stock Units to acquire common stock 317,408 —

Warrants to purchase common stock 29,167 29,167

For the three months ended March 31, 2025, options to purchase common stock totaling 3,435,449 shares, were excluded from the calculation of diluted net loss per share as their effect would have been anti-dilutive.

The Company incurred net losses for the three months ended March 31, 2024 and therefore did not include potentially dilutive common stock equivalents in the computation of diluted net loss per share.

The computations for basic and diluted EPS were as follows (in thousands, except shares and per share amounts):

Three Months Ended March 31,

Net income (loss) for basic and diluted EPS $ 73,016 $ ( 18,289 )

Weighted-average shares for basic EPS 39,640,826 26,980,698

Effect of dilutive stock options 192,692 —

Effect of dilutive restricted stock units 99,021 —

Weighted-average shares for diluted EPS 39,932,539 26,980,698

Net income (loss) per share:

Basic EPS $ 1.84 $ ( 0.68 )

Diluted EPS $ 1.83 $ ( 0.68 )

Recent Accounting Pronouncements

In November 2023, the Financial Accounting Standards Board, or FASB, issued ASU 2023-07, “Segment Reporting (Topic 280) - Improvements to Reportable Segment Disclosures”, which requires enhanced disclosures about significant segment expenses.

The amendments are effective retrospectively to all prior periods presented in the financial statements, for fiscal years beginning after December 15, 2023.

The new guidance is not expected to have a material impact on our financial statement disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures.

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The standard is effective for the Company beginning in fiscal year 2025, with early adoption permitted.

The Company does not expect to early adopt the new standard.

The new standard is expected to be applied prospectively, but retrospective application is permitted.

The Company is currently evaluating the impact of ASU 2023-09 on the consolidated financial statements and related disclosures.

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The following table sets forth the recurring fair value of the Company’s financial assets and liabilities, allocated into the Level 1, Level 2 and Level 3 hierarchy that were measured at fair value on a recurring basis (in thousands):

Fair Value Measurements as of September 30, 2024

Fair Value Measurements as of March 31, 2025

Level 1 Level 2 Level 3 Total

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government treasury bills 1,517 — — 1,517

Commercial paper — 1,723 — 1,723

Corporate bonds — 1,976 — 1,976

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Corporate bonds — 4,261 — 4,261

Government agency — 5,482 — 5,482

Total financial assets $ 40,047 $ 6,005 $ — $ 46,052

(1) Included in cash and cash equivalents in the accompanying condensed consolidated balance sheets.

(2) Includes investments classified as cash and cash equivalents in the accompanying consolidated balance sheets.

All marketable securities had a contractual maturity of less than one year as of September 30, 2024.

As of March 31, 2025, marketable securities had a contractual maturity of less than one year.

Short-Term Investments and Cash Equivalents

The following table summarizes the Company's short-term investments (in thousands):

As of September 30, 2024

As of March 31, 2025

Maturity (In Years) Amortized Cost Unrealized Gains Unrealized Losses Fair Value

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government treasury bills Less than 1 1,517 — — 1,517

Commercial paper Less than 1 1,721 2 — 1,723

Corporate bonds Less than 1 1,975 1 — 1,976

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Corporate bonds Less than 1 4,256 5 — 4,261

Government agency Less than 1 5,486 — ( 4 ) 5,482

Total $ 46,037 $ 15 $ — $ 46,052

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Details of accrued liabilities are presented as follows (in thousands):

September 30,

2025 December 31,

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Included in the Pacific Palisades Lease Amendment were nine months of rent abatement and a rent escalation clause.

The Pacific Palisades Lease expired on February 28, 2025.

In April 2022, the Company entered into a lease agreement for office space in Morristown, New Jersey (the “Morristown Lease”).

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Included in the Morristown Lease are fixed rent escalations of approximately 2 % on each anniversary year of the lease term.

In connection with the FYARRO Divestiture, KAKEN assumed the Morristown Lease.

The Company has entered into a short-term sublease for six months with KAKEN and has elected the short-term lease exemption under ASC 842.

As such, this lease is not recorded on the balance sheet.

Lease payments made are recognized on a straight-line basis over the lease term in the income statement.

The following table summarizes information related to the Company’s leases (in thousands):

September 30, 2024 December 31, 2023

March 31, 2025 December 31, 2024

Operating lease right-of-use assets $ — $ 787

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Total operating lease liabilities $ — $ 833

Rent expense for the three and nine months ended September 30, 2024 and 2023 is presented on the following table (in thousands):

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

2024 2023 2024 2023

Operating leases rent expense $ 115 $ 115 $ 345 $ 346

Cash paid for leases and included in operating cash flows for the nine months ended September 30, 2024 and 2023 is presented on the following table (in thousands):

Nine Months Ended September 30,

Rent expense for the three months ended March 31, 2025 and 2024 is presented on the following table (in thousands):

Three Months Ended March 31,

Operating lease rent expense $ 74 $ 115

Cash paid for leases and included in operating cash flows for the three months ended March 31, 2025 and 2024 is presented on the following table (in thousands):

Three Months Ended March 31,

Cash paid included in operating cash flows $ 99 $ 126

The future minimum lease payments required under the operating leases as of September 30, 2024, are summarized below (in thousands):

Future Minimum Lease Payments:

Total minimum lease payments $ 1,070

amount representing interest ( 124 )

Present value of operating lease liabilities $ 946

operating lease liabilities, current ( 322 )

Operating lease liabilities, non-current $ 624

Remaining lease term (in years) 3.33

Incremental borrowing rate 7.62 %

The Company includes the option to renew the lease as part of the right of use lease asset and liability when it is reasonably certain the Company will exercise the option.

In general, the Company is not reasonably certain to exercise such options.

L icense Agreements

Bristol Myers Squibb Company License Agreement

Former Bristol-Myers Squibb Company License Agreement

On April 9, 2014, the Company entered into a license agreement (as amended the “BMS License Agreement”) with BMS for exclusive rights for certain patents and a non-exclusive license for certain technology and know-how pertaining to FYARRO.

The BMS License Agreement will remain in effect from the effective date of April 9, 2014 until expiration of all milestone and royalty payment obligations under the agreement, unless terminated by either of the parties upon giving advance notice

as specified in the BMS License Agreement.

Under the terms of the BMS License Agreement, BMS agreed to supply the Company with licensed products of FYARRO necessary for clinical or non-clinical development.

Under the terms of the BMS License Agreement, BMS is entitled to receive certain development milestone payments, royalties on net sales from licensed products under the agreement and any sublicense fees.

During the three months ended September 30, 2024 and 2023, royalties on net product sales were $ 0.5 million and $ 0.4 million, respectively.

During the nine months ended September 30, 2024 and 2023, royalties on net product sales were $ 1.4 million and $ 1.3 million, respectively.

No payments related to sublicense fees were paid during the three and nine months ended September 30, 2024 or 2023.

Under the terms of the BMS License Agreement, BMS is entitled to receive royalties on net sales from licensed products under the agreement and any sublicense fees.

During the three months ended March 31, 2025 and 2024, royalties on net product sales were $ 0.5 million and $ 0.4 million, respectfully.

No payments related to sublicense fees were paid during the three months ended March 31, 2025 or 2024.

On August 30, 2021, the Company and BMS entered into Amendment No.

1 (the “Amendment”) to the BMS License Agreement related to certain intellectual property rights of BMS pertaining to the compound known as FYARRO.

Under the terms of the Amendment, the Company paid BMS $ 5.8 million representing 50 % of the previously outstanding payment obligation under the terms of the BMS License Agreement, following the effective time of the Company's 2021 private investment in public equity financing (the “2021 PIPE Financing”).

Pursuant to the terms of the Amendment, the remaining previously outstanding payment obligation of $ 5.8 million, is due on the third anniversary of the effective time of the 2021 PIPE Financing, or August 26, 2024 plus any accrued and unpaid interest due thereon (the “Balloon Payment”).

The Balloon Payment accrued interest, beginning August 26, 2021 until paid in full, at a rate equal to 4.00 % per annum based on the weighted average amount outstanding during the applicable calendar quarter, with interest payable quarterly in arrears.

Under the terms of the Amendment, the Company paid BMS $ 5.8 million representing 50 % of the previously outstanding payment obligation under the terms of the BMS License Agreement, following the effective time of the 2021 private investment in public equity financing (the “2021 PIPE Financing”).

Pursuant to the terms of the Amendment, the remaining previously outstanding payment obligation of $ 5.8 million became due on the third anniversary of the effective time of the 2021 PIPE Financing, or August 26, 2024 plus any accrued and unpaid interest due thereon (the “Balloon Payment”).

which was payable quarterly in arrears.

In accordance with the terms of the Amendment, the Company paid the outstanding payment obligation of $ 5.8 million by the due date.

In addition, under the Amendment the parties agreed to amend the royalty rates payable to BMS based on net sales of products subject to the BMS License Agreement.

EOC License Agreement

On December 8, 2020, the Company entered into a license agreement (“EOC License Agreement”) with EOC Pharma (Hong Kong) Limited (“EOC”) under which the Company received $ 14.0 million in January 2021 in non-refundable upfront consideration as partial payment for the rights and licenses granted to EOC by the Company for the further development and commercialization of FYARRO in the People’s Republic of China, Hong Kong Special Administration Region, Macao Special Administrative Region and Taiwan (the “Licensed Territory”).

In accordance with the BMS License Agreement, the Company is required to pay 20 % of all sublicense fees to BMS.

The Company assessed the EOC License Agreement and concluded that EOC was a customer and identified the license of FYARRO provided to EOC as the sole performance obligation.

The $ 14.0 million upfront payment received from EOC is non-refundable and non-creditable and is considered fixed consideration.

The Company recognized revenue of $ 14.0 million in December 2020 when the EOC License Agreement was signed, and the $ 14.0 million upfront payment was received in January 2021.

The potential milestone payments and royalty payments under the EOC License Agreement were considered variable consideration and were constrained with respect to revenue recognition notification from EOC that the milestone and royalty payments had been achieved.

The Company was eligible to receive an additional $ 257.0 million in the aggregate upon achievement of certain development, regulatory, and sales milestones, as well as tiered royalties on net sales in the Licensed Territory.

Under the terms of the EOC License Agreement, EOC was obligated to fund all research, development, regulatory, marketing and commercialization activities in the defined Licensed Territory.

The Company earned $ 1.0 million in milestone revenue upon achievement of the FDA approval milestone on November 22, 2021.

EOC paid the $ 1.0 million milestone payment in December 2021.

In accordance with the BMS License Agreement, 20 % of the $ 1.0 million payment, or $ 0.2 million, was accrued at December 21, 2021, and paid in January 2022.

On June 27, 2022, the Company received written notice from EOC that EOC elected to terminate the EOC License Agreement, effective immediately, due to alleged material breaches by the Company under such agreement.

The Company disputed EOC’s allegations of material breach.

See Note 12 for information regarding the subsequent arbitration between EOC and the Company regarding this dispute.

As part of its purchase of the FYARRO Business, KAKEN acquired the Company's rights and responsibilities under the BMS License Agreement.

Stockholders’ Equity

Preferred Stock

As of September 30, 2024 and December 31, 2023 , under the Company’s certificate of incorporation, as amended and restated, the Company has 10,000,000 shares of authorized preferred stock, par value $ 0.0001 per share, with no shares outstanding.

As of March 31, 2025 and December 31, 2024 , under the Company’s certificate of incorporation, as amended and restated, the Company has 10,000,000 shares of preferred stock, par value $ 0.0001 per share, in authorized capital with no shares outstanding.

Common Stock and Pre-Funded Warrants

As of September 30, 2024 and December 31, 2023, the Company had 300,000,000 shares of authorized common stock, par value of $ 0.0001 per share, under the Company's certificate of incorporation, as amended and restated.

As of September 30, 2024 and December 31, 2023, the shares of common stock outstanding were 24,614,834 and 24,554,205 , respectively.

In March 2022, the Company entered into a Sales Agreement (the "Sales Agreement") with Cowen , with respect to an “at the market offering” program pursuant to which the Company may offer and sell, from time to time at its sole discretion, subject to limitations under applicable securities laws, shares of common stock having aggregate gross proceeds of up to $ 75.0 million through Cowen as its sales agent .

As of March 31, 2025 and December 31, 2024, the Company had 300,000,000 shares of authorized common stock, par value of $ 0.0001 per share, under the Company's certificate of incorporation, as amended and restated.

As of March 31, 2025 and December 31, 2024, the shares of common stock outstanding were 46,784,618 and 24,680,708 , respectively.

In March 2022, the Company entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company LLC (“Cowen”) , with respect to an “at the market offering” program pursuant to which the Company may offer and sell, from time to time at its sole discretion, shares of common stock having aggregate gross proceeds of up to $ 75.0 million through Cowen as its sales agent .

The Company will pay Cowen 3.0 % of the aggregate gross proceeds from each sale of shares of common stock under the Sales Agreement.

As of September 30, 2024 , no shares of common stock had been sold pursuant to the Sales Agreement.

On September 22, 2022, the Company entered into a securities purchase agreement (the “Purchase Agreement”) for a private investment in public equity financing (the “2022 PIPE Financing”) with certain investors (the “2022 PIPE Investors”) for the sale by the Company of (i) 3,373,526 shares of the Company’s common stock for a price of $ 12.50 per share and (ii) pre-funded warrants to purchase an aggregate of 2,426,493 shares of the Company's common stock (the "Pre-Funded Warrants") at a purchase price of $ 12.4999 per Pre-Funded Warrant.

As of March 31, 2025 , no shares of common stock had been sold pursuant to the Sales Agreement.

On September 22, 2022, the Company entered into a securities purchase agreement (the “Purchase Agreement”) for a private investment in public equity financing (the “2022 PIPE Financing”) with certain investors (the “2022 PIPE Investors”) for the sale by the Company of (i) 3,373,526 shares of the Company’s common stock for a price of $ 12.50 per share and (ii) pre-funded warrants (the "Pre-Funded Warrants") to purchase an aggregate of 2,426,493 shares of the Company's common stock at a purchase price of $ 12.4999 per Pre-Funded Warrant.

The Pre-Funded Warrants are exercisable at an exercise price of $ 0.0001 and will be exercisable until exercised in full.

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On September 26, 2022, the Company and the 2022 PIPE Investors entered into a Registration Rights Agreement (the “2022 PIPE Registration Rights Agreement”) providing for the registration for resale of the securities sold under the Purchase Agreement, including the shares issuable upon the exercise of the Pre-Funded Warrants, that are not then registered on an effective registration statement, pursuant to a registration statement filed with the SEC.

The Company filed a Form S-3 registration statement to register the resale of such securities on October 26, 2022, which became effective on November 4, 2022.

The Pre-Funded Warrants meet the criteria to be classified within stockholders’ equity.

As of September 30, 2024, all Pre-Funded Warrants are still outstanding.

As of March 31, 2025, 2,000,037 Pre-Funded Warrants are still outstanding.

On December 19, 2024, the Company entered into the Subscription Agreement for a private investment in public equity financing (the "2024 PIPE Financing") with certain investors (the "2024 PIPE Investors"), pursuant to which the Company agreed to sell to the 2024 PIPE Investors (i) 21,592,000 shares of the Company’s common stock, par value $ 0.0001 per share, at a purchase price of $ 2.40 per share, and (ii) 20,076,500 Pre-Funded Warrants, at a purchase price of $ 2.3999 per Pre-Funded Warrant, for aggregate net proceeds of $ 94.5 million, after deducting certain expenses incurred of $ 5.5 million related to the issuance of shares.

The 2024 PIPE Financing was conditioned upon the Company's shareholders approving the transaction and closed on March 4, 2025 after such approval was obtained.

The Pre-Funded Warrants are indexed to the Company's common stock and meet the conditions for equity classification in accordance with ASC 815-40.

As such, the Pre-Funded Warrants are classified as additional paid-in capital within stockholders' equity on the Company's condensed consolidated balance sheets.

The Pre-Funded Warrants are exercisable at an exercise price of $ 0.0001 per share of the Company's common stock and will be exercisable until exercised in full.

The holders of Pre-Funded Warrants may not exercise a Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 4.99 % or 9.99 %, at the election of the holder, of the number of shares of the Company's common stock outstanding immediately after giving effect to such exercise.

The holders of Pre-Funded Warrants may increase or decrease such percentages not in excess of 19.99 % by providing at least 61 days’ prior notice to the Company.

As of March 31, 2025, all 20,076,500 Pre-Funded Warrants are still outstanding.

The holders of common stock are entitled to receive cash dividends, if and when declared by the board of directors of the Company (the “board of directors”).

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2014 Plan (as amended and restated in February 2017, the “Private Aadi Plan”)

In connection with the Merger, the Company assumed the Private Aadi Plan, which was amended and restated in February 2017, and the issued and outstanding stock options under the Private Aadi Plan (the Private Aadi common stock underlying the awards was adjusted for shares of the Company’s common stock pursuant to the Merger Agreement).

In connection with the Reverse Merger, the Company assumed the Private Aadi Plan, which was amended and restated in February 2017, and the issued and outstanding stock options under the Private Aadi Plan (the Private Aadi common stock underlying the awards was adjusted for shares of the Company’s common stock pursuant to the Merger Agreement).

The Private Aadi Plan allowed for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock unit awards and other stock awards.

In connection with the closing of the Merger and the adoption of the 2021 Plan (as defined below), no further awards may be issued under the Private Aadi Plan.

In connection with the closing of the Reverse Merger and the adoption of the 2021 Plan (as defined below), no further awards will be issued under the Private Aadi Plan.

The options that are granted from the Private Aadi Plan are exercisable at various dates as determined upon grant and will expire no more than ten years from their date of grant.

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2011 Plan and 2017 Plan

In connection with the closing of the Merger, the Company assumed the Aerpio 2011 Equity Incentive Plan (the “2011 Plan”) and the Aerpio 2017 Stock Option and Incentive Plan (the “2017 Plan,” and together with the 2011 Plan, the “Prior Plans”).

No new awards may be granted under the Prior Plans effective as of the closing of the Merger and the adoption of the 2021 Plan (as defined below).

At the closing of the Merger, the Company adopted the Aadi Bioscience, Inc.

In connection with the closing of the Reverse Merger, the Company assumed the Aerpio 2011 Equity Incentive Plan (the “2011 Plan”) and the Aerpio 2017 Stock Option and Incentive Plan (the “2017 Plan,” and together with the 2011 Plan, the “Prior Plans”).

No new awards will be granted under the Prior Plans effective as of the closing of the Reverse Merger and the adoption of the 2021 Plan (as defined below).

At the closing of the Reverse Merger, the Company adopted the Aadi Bioscience, Inc.

2021 Equity Incentive Plan, which is now named the Whitehawk Therapeutics, Inc.

2021 Equity Incentive Plan (the “2021 Plan”), which permits the award of stock options, stock appreciation rights, restricted stock, restricted stock units, performance units and performance grants to employees, members of the board of directors, and outside consultants.

Subject to the adjustment provisions contained in the 2021 Plan and the evergreen provision described below, a total of 2,070,784 shares of common stock was initially reserved for issuance pursuant to the 2021 Plan.

In addition, the shares reserved for issuance under the 2021 Plan include any shares of common stock (i) subject to awards of stock options or other awards granted under the Prior Plans that expire or otherwise terminate without having been exercised in full and shares of common stock granted under the Prior Plans that are forfeited or repurchased by the Company, and (ii) any shares of common stock subject to stock options or similar awards granted under the Private Aadi Plan that were assumed in the Merger (provided that the maximum number of shares that may be added to the 2021 Plan pursuant to this sentence is 764,154 shares).

Subject to the adjustment provisions contained in the 2021 Plan and the evergreen provision described below, a total of 2,070,784 shares of common stock were initially reserved for issuance pursuant to the 2021 Plan.

In addition, the shares reserved for issuance under the 2021 Plan include any shares of common stock (i) subject to awards of stock options or other awards granted under the Prior Plans that expire or otherwise terminate without having been exercised in full and shares of common stock granted under the Prior Plans that are forfeited or repurchased by the Company, and (ii) any shares of common stock subject to stock options or similar awards granted under the Private Aadi Plan that were assumed in the Reverse Merger (provided that the maximum number of shares that may be added to the 2021 Plan pursuant to this provision is 764,154 shares).

The number of shares available for issuance under the 2021 Plan will include an annual increase, or the evergreen feature, on the first day of each of the Company’s fiscal years, beginning with the Company’s fiscal year 2022, equal to the least of:

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• such number of shares as the board of directors or its designated committee may determine.

As a result of the evergreen increase, a total of 982,168 shares were added to the 2021 Plan on January 1, 2024 and 977,400 shares of common stock were added to the 2021 Plan on January 1, 2023.

As a result of the evergreen increase, a total of 987,228 shares of common stock were added to the 2021 Plan on January 1, 2025 and 982,168 shares of common stock were added to the 2021 Plan on January 1, 2024.

On February 28, 2025, the Company’s stockholders approved the amendment and restatement of the 2021 Plan to (i) increase the number of shares available for future grant under the 2021 Plan from 2,000,284 shares to 8,300,284 shares and (ii) increase the 2021 Plan’s default annual automatic share reserve increase occurring on January 1 of each year from 4 % of outstanding shares on the last day of the immediately preceding fiscal year to 5 %.

Upon stockholder approval, such amendment and restatement of the 2021 Plan became effective.

Shares issuable under the 2021 Plan are authorized, but unissued, or reacquired shares of common stock.

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The only persons eligible to receive awards under the Inducement Plan are individuals who are new employees and satisfy the standards for inducement grants under applicable Nasdaq listing rules.

As of September 30, 2024, 255,029 , 37,921 , 4,790,687 and 490,000 shares were outstanding under the 2014 Private Aadi Plan, 2017 Plan, 2021 Plan, and 2023 Inducement Plan, respectively.

As of September 30, 2024, no shares were outstanding under the 2011 Plan.

The following table summarizes the stock option activity during the nine months ended September 30, 2024:

As of March 31, 2025, 161,534 , 15,036 , 4,660,249 , and 490,000 shares were outstanding under the Private Aadi Plan, 2017 Plan, 2021 Plan, and 2023 Inducement Plan, respectively.

The following table summarizes the stock option activity during the three months ended March 31, 2025:

Shares Weighted Average

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Value (in thousands)

Outstanding, January 1, 2024 4,579,659 $ 14.11 8.37 $ 25

Outstanding, December 31, 2024 4,950,016 $ 10.82 7.99 $ 1,818

Granted 687,979 2.31

Exercised ( 22,204 ) 0.95

Expired/cancelled ( 785,145 ) 11.79

Outstanding as of September 30, 2024 5,256,229 $ 10.99 8.15 $ 290

Options exercisable as of September 30, 2024 2,629,899 $ 14.04 7.57 $ 78

Vested and expected to vest as of September 30, 2024 5,256,229 $ 10.99 8.15 $ 290

As of September 30, 2024, there was $ 14.5 million of unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 1.9 years.

The total intrinsic value of the options exercised during the three months ended September 30, 2024 and 2023, was $ 0 and $ 31,000 , respectively.

The total intrinsic value of the options exercised during the nine months ended September 30, 2024 and 2023 was $ 0 and $ 0.2 million, respectively.

As of September 30, 2024, and December 31, 2023, 678,482 and 657,734 shares were reserved for issuance under the 2021 Plan, respectively.

As of September 30, 2024, and December 31, 2023, 110,000 shares were reserved for issuance under the 2023 Inducement Plan.

Cancelled/Forfeited ( 288,972 ) 11.52

Outstanding as of March 31, 2025 5,326,819 $ 9.72 8.06 $ 29

Options exercisable as of March 31, 2025 2,996,934 $ 13.26 7.41 $ —

Vested and expected to vest as of March 31, 2025 5,326,819 $ 9.72 8.06 $ 29

As of March 31, 2025, there was $ 8.4 million of unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted average period of 1.92 years.

The total intrinsic value of the options exercised during the three months ended March 31, 2025, and 2024, was $ 43,000 and $ 0 , respectively

As of March 31, 2025, and December 31, 2024, 1,632,796 and 1,013,055 shares were reserved for future awards under the 2021 Plan, respectively.

As of March 31, 2025 and December 31, 2024, 110,000 shares were reserved for future awards under the 2023 Inducement Plan.

Restricted Stock Units

The value of restricted stock unit awards (RSUs) is based on the Company’s stock price on the date of grant.

Restricted stock consists of restricted stock unit awards (RSUs) which have been granted to employees.

The value of an RSU award is based on the Company’s stock price on the date of grant.

Employee grants vest over four years .

Forfeitures of RSUs are recognized as they occur.

of RSUs are recognized as they occur.

The shares underlying the RSU awards are not issued until the RSUs vest.

Upon vesting, each RSU converts into one share of the Company’s common stock.

Activity with respect to the Company’s restricted stock units during the nine months ended September 30, 2024 is as follows:

Activity with respect to the Company’s restricted stock units during the three months ended March 31, 2025 is as follows:

Shares Weighted Average

Grant Date Fair Value

Nonvested shares at January 1, 2024 32,558 $ 4.30

Granted 308,700 1.92

Nonvested shares at December 31, 2024 256,490 $ 1.92

Vested/Issued ( 63,250 ) 1.92

Forfeited ( 31,519 ) 1.92

Nonvested shares at current period end 317,408 $ 2.16

As of September 30, 2024 there was $ 0.5 million of unrecognized compensation cost related to restricted stock units, which is expected to be recognized over a weighted average period of 3.4 years.

Nonvested shares at March 31, 2025 161,721 $ 1.92

As of March 31, 2025, there was $ 0.3 million of unrecognized compensation cost related to restricted stock units, which is expected to be recognized over a weighted average period of 2.92 years.

Compensation Expense Summary

The Company recognized the following compensation cost related to employee and non-employee share-based compensation activity for the periods presented (in thousands):

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

2024 2023 2024 2023

Three Months Ended March 31,

Selling, general and administrative $ 983 $ 2,342

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The calculation was based on the following assumptions:

Three Months Ended September 30, (1) Nine Months Ended September 30,

2023 2024 2023

Three Months Ended March 31,

Weighted average grant date fair value (per share) $ 1.76 $ 1.43

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4.13 % - 4.14 %

3.42 % - 4.33 %

Expected volatility 89.48 % - 89.48 %

89.22 % - 91.46 %

89.94 % - 101.03 %

Expected term (in years) 6.1 - 6.1

Expected dividend yield — —

(1) No awards were granted during the three months ended September 30, 2024

The Company determines the assumptions used in the option pricing model in the following manner:

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Expected Dividend – The expected dividend yield is assumed to be zero because the Company has never paid dividends and does not have current plans to pay any dividends on its common stock.

Expected Term – The Company estimates the expected term of its stock options granted to employees and non-employee directors using the simplified method, whereby, the expected term equals the average of the vesting term and the original contractual term of the option.

contractual term of the option.

The Company utilizes this method since it does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate the expected term.

Merger Warrants to Purchase Common Stock

The Company had warrants outstanding for the purchase of 29,167 shares of the Company’s common stock at both September 30, 2024, and December 31, 2023.

These warrants were assumed in the Merger and were issued by Aerpio in October 2019, for the purchase of 40,000 shares (after taking into account the reverse stock split of the Company’s common stock at a ratio of 15:1 effected on August 26, 2021 immediately prior to the closing of the Merger (the "Reverse Stock Split")) of the Company’s common stock at an exercise price of $ 7.29 per share (after taking into account the Reverse Stock Split).

These warrants were fully vested as of the date of the Merger and expire on October 24, 2024.

No warrants were exercised during the nine months ended September 30, 2024.

At the grant date, the fair value of these awards was determined using a Black-Scholes option pricing model.

The number of shares and the exercise price shall be adjusted for standard anti-dilution events such as stock splits, combinations, reorganizations, or issue shares as part of a stock dividend.

The warrants meet the criteria to be classified within stockholders’ equity.

Employee Stock Purchase Plan

On August 17, 2021, a special meeting of the Company’s stockholders was held to approve the Merger and related matters, at which the Company's stockholders considered and approved the Company’s 2021 ESPP which permits participants to contribute up to 15 % of their eligible compensation during defined rolling six-month offering periods to purchase the Company's common stock.

On August 17, 2021, a special meeting of the Company’s stockholders was held to approve the Reverse Merger and related matters, at which the Company's stockholders considered and approved the Company’s 2021 ESPP which permits participants to contribute up to 15 % of their eligible compensation during defined rolling six-month offering periods to purchase the Company's common stock.

The purchase price of the shares will be 85 % of the lower of the fair market value of the Company's common stock on the first day of trading of the offering period or on the applicable purchase date.

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An aggregate of 519,563 shares of common stock was initially reserved for issuance under the 2021 ESPP.

( 1 %) of the outstanding shares of all classes of common stock on the last day of the immediately preceding fiscal year, or (iii) an amount to be determined by the board of directors or its designated committee no later than the last day of the immediately preceding fiscal year.

The number of shares of common stock available for issuance under the 2021 ESPP is increased on the first day of each fiscal year beginning with the 2022 fiscal year in an amount equal to the least of (i) 310,617 shares of common stock, (ii) one percent ( 1 %) of the outstanding shares of all classes of common stock on the last day of the immediately preceding fiscal year, or (iii) an amount to be determined by the board of directors or its designated committee no later than the last day of the immediately preceding fiscal year.

On January 1, 2025, 246,807 shares of common stock were added to the 2021 ESPP.

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The calculation was based on the following assumptions:

Three and Nine Months Ended September 30, 2024 Three and Nine Months Ended September 30, 2023

Three Months Ended March 31, 2025

Strike price (per share) $ 2.11

$ 5.98 - $ 11.40

Risk-free interest rate 4.44 %

4.40 % - 5.24 %

Expected volatility 55.26 %

105.68 % - 176.11 %

Expected term (in years) 0.5

As of September 30, 2024, and December 31, 2023, 844,059 and 659,146 shares of common stock were available for issuance under the 2021 ESPP, respectively.

The Company had an outstanding liability of $ 0.1 million and $ 0.1 million as of September 30, 2024, and December 31, 2023, respectively, which will be recognized over six months .

As of September 30, 2024 and December 31, 2023, 60,629 and 77,565 shares were issued under the 2021 ESPP, respectively.

The Company recorde d no income tax expense for the three months ended September 30, 2024 and 2023.

The Company recorded no income tax expense for the nine months ended September 30, 2024 and 2023.

Expected dividend yield —

As of March 31, 2025, and December 31, 2024, 1,057,550 and 810,743 shares of common stock were available for issuance under the 2021 ESPP, respectively.

The Company had an outstanding liability of $ 0.1 million and $ 37,000 as of March 31, 2025, and December 31, 2024 , respectively, which will be recognized over six months .

No shares were issued under the 2021 ESPP during the three months ended March 31, 2025, and 2024 , respectively.

The Company recorded income tax expense of zero for the three months ended March 31, 2025 and 2024, respectively.

The Company continues to maintain a full valuation allowance.

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Regardless of the outcome, legal proceedings can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors.

On June 27, 2022, EOC filed a Request for Arbitration with the International Chamber of Commerce’s International Court of Arbitration against the Company.

In the Request for Arbitration, EOC claimed that the Company breached certain provisions of the EOC License Agreement, including failing to provide certain manufacturing information to EOC.

As a result, EOC was seeking monetary damages.

On September 26, 2024, the arbitration panel issued a Final Award which concluded that the Company did not breach the EOC License Agreement and accordingly is not liable for any damages to EOC.

See Note 7 for more information about the EOC License Agreement and its termination.

Purchase Commitments

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These contracts are generally cancellable, with notice, at the Company’s option.

The Company recorded accrued expenses of $ 5.7 million for expenditures incurred by clinical and contract manufacturing vendors as of September 30, 2024, and December 31, 2023.

At September 30, 2024, the Company was party to a Negotiated Purchase Order Terms and Conditions for Clinical and Commercial Product, as amended effective as of August 1, 2022, March 31, 2024, and July 31, 2024 (the "Fresenius Agreement"), with Fresenius Kabi that contains specific activities including non-cancellable commitments, minimum purchase commitments, and binding annual forecasts.

As of September 30, 2024, there were non-cancellable purchase commitments under the Fresenius Agreement related to the purchase of inventory for $ 4.4 million to be paid in the remainder of 2024.

The Fresenius Agreement expired pursuant to its terms on September 30, 2024.

The Company recorded accrued expenses of $ 1.3 million and $ 3.6 million for expenditures incurred by clinical and contract manufacturing vendors as of March 31, 2025, and December 31, 2024, respectively.

Mirati Collaboration

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In May 2024, the Company announced the mutually agreed upon termination of the collaboration and supply agreement with Mirati and the discontinuation of the Phase 1/2 study.

Under the terms of the agreement, Mirati was responsible for sponsoring and operating the Phase 1/2 study and the Company supplied study drug and jointly shared the cost of the study, which will continue during the winding down process.

For the three and nine months ended September 30, 2024, the Company incurred $ 0.3 million and $ 1.0 million in expenses related to the Mirati collaboration.

For the three and nine months ended September 30, 2023, the Company incurred $ 0.1 million and $ 0.7 million in expenses related to the Mirati collaboration.

Under the terms of the agreement, Mirati was responsible for sponsoring and operating the Phase 1/2 study and the Company supplied study drug and jointly shared the cost of the study.

For the three months ended March 31, 2025 and 2024, the Company incurred zero and $ 0.2 million in expenses related to the Mirati collaboration, respectively.

WuXi Biologics License Agreement

On December 19, 2024, the Company entered into an Intellectual Property License Agreement (the “License Agreement”) with WuXi Biologics (Shanghai FX) Co., Ltd.

(“WuXi Biologics”) for exclusive rights to certain patents and know-how pertaining to WuXi Biologics’ preclinical antibody drug conjugate programs leveraging Hangzhou DAC Biotechnology Co., Ltd.’s (“Hangzhou DAC”) linker-payload technology targeting each of the ADC Therapies.

Under the License Agreement, the Company paid WuXi Biologics a non-refundable, partial upfront payment of $ 6.0 million on December 20, 2024.

An additional non-refundable, upfront payment of $ 38.0 million was due within one-hundred twenty ( 120 ) days after the effective date of the License Agreement for the rights and licenses granted to the Company by WuXi Biologics and was paid on April 16, 2025.

The Company did not accrue the $ 38.0 million as of March 31, 2025 in accordance with the License Agreement because the Company was not obligated to pay WuXi Biologics the additional non-refundable, upfront paymen t, nor had any liability to WuXi Biologics with respect to the such payme nt, if the Company elected, in its sole discretion, not to make the additional upfront payment and continue with the License Agreement.

In accordance with the License Agreement, WuXi Biologics is eligible to receive from the Company (a) up to an aggregate of $ 265.0 million upon the achievement of certain development milestones, and (b) up to an aggregate of $ 540.0 million upon the achievement of certain commercial milestones, across all ADC Therapies.

WuXi Biologics is also entitled to running royalties ranging from low-single-digit to upper-single-digit percentages of annual net sales of licensed products in the territory on a product-by product and region-by-region basis from the first commercial sale of the applicable licensed product in a particular region until the date which is the later of (i) expiration of the last to expire valid claim of a license patent in such region covering the sale of such licensed product in such region or (ii) ten years after the first commercial sale of such licensed product in such region.

Each party may terminate the License Agreement in its entirety, or on a program-by-program basis, as applicable, if the other party remains in material breach of the License Agreement following a cure period to remedy the material breach or if the other party is declared insolvent or in similar financial distress.

In addition, WuXi Biologics may terminate the License Agreement on a program-by-program basis if the Company does not meet certain development due diligence milestones.

The Company may terminate the License Agreement in its entirety, or on a program-by-program basis, as applicable, with or without cause.

Restructuring

On August 21, 2024, the Company announced a restructuring plan to reduce the Company’s workforce by approximately 32 % in response to the Company's announcement on August 20, 2024 that it will halt the registration-intended PRECISION1 trial of nab-sirolimus in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations.

On August 21, 2024, the Company announced a restructuring plan to reduce the Company’s workforce by approximately 32 % in response to the Company's announcement on August 20, 2024 that it planned to halt the registration-intended PRECISION1 trial of nab-sirolimus in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations.

The Company recorded a total restructuring charge of $ 2.6 million, which consists of one-time termination benefits such as severance costs and related benefits.

For the three and nine months ended September 30, 2024, the Company made cash payments related to the restructuring of $ 0.4 million.

As of September 30, 2024, the $ 2.2 million one-time termination benefits remain payable and are recorded within the accrued expenses and other liabilities line item on the Company's condensed balance sheet.

Restructuring payments commenced in September 2024 and will extend through December 2024.

As of March 31, 2025, $ 1.1 million of one-time termination benefits remain payable and are recorded within the accrued liabilities on the Company's condensed consolidated balance sheet.

As of December 31, 2024, $ 1.5 million of one-time termination benefits remain payable and are recorded within the accrued liabilities and other liabilities line items on the Company's condensed consolidated balance sheet.

The Company paid $ 0.4 million of the liability during the three months ended March, 31, 2025.

There were no restructuring charges for the three months ended, March 31, 2025 and 2024.

Restructuring payments commenced in September 2024 and will extend through March 2026.

Divestiture of FYARRO

On December 19, 2024, the Company entered into the Divestiture Agreement with KAKEN, KAKEN PHARMACEUTICAL CO., LTD, and Aadi Subsidiary for the sale to KAKEN of 100 % of the outstanding shares of capital stock of Aadi Subsidiary and thereby all of the Company’s assets related to the FYARRO Business.

Per the terms and subject to the conditions of the Divestiture Agreement, KAKEN paid to the Company a cash payment of $ 102.4 million (following applicable purchase price adjustments under the Divestiture Agreement) at the closing of the FYARRO Divestiture on March 25, 2025.

We recorded a net gain on the sale of the divestiture of $ 87.4 million during the three months ended March 31, 2025 which has been recorded on the unaudited condensed consolidated statement of operations and comprehensive income (loss).

The $ 87.4 million gain represents the aggregate consideration of $ 102.4 million, less the assets and liabilities transferred, which are listed below (in thousands):

March 25, 2025

Current assets:

Cash and cash equivalents $ ( 1,000 )

Accounts receivable, net ( 6,903 )

Inventory ( 5,141 )

Prepaid expenses and other current assets ( 866 )

Total current assets ( 13,910 )

Property and equipment, net ( 6,836 )

Operating lease right-of-use assets ( 707 )

Other assets ( 64 )

Total assets $ ( 21,517 )

Current liabilities:

Accounts payable $ ( 852 )

Accrued liabilities ( 4,951 )

Operating lease liabilities, current portion ( 201 )

Total current liabilities ( 6,004 )

Operating lease liabilities, net of current portion ( 536 )

Total liabilities ( 6,540 )

Net assets disposed of $ ( 14,977 )

The Company evaluated various qualitative and quantitative factors related to the disposition of the FYARRO Business and determined the transaction did not meet the criteria for discontinued operations under ASC 205-20, and therefore no reclassification has been made to prior period statements.

Segment Information

The Company has identified its Chief Executive Officer as the chief operating decision maker and the Company views its operations and manages its business in one operating segment, applying advanced technologies to established tumor biology that are intended to efficiently deliver improved cancer treatments .

The CODM assesses performance for the Company's single operating segment and decides how to allocate resources primarily based on research and development expenses incurred, which is a component of the Company's consolidated net income (loss) as reported on the consolidated statement of operations and comprehensive income (loss).

The measure of segment assets is reported on the balance sheet as total consolidated assets.

Further, segment depreciation expense and segment asset additions are consistent with consolidated amounts reported within the consolidated statement of cash flows given the Company's operations are aggregated within a single reportable segment.

The Company's revenues relate to sales of FYARRO, which was divested as of March 25, 2025.

All the assets and operations of the Company’s sole operating and reportable segment are located in the United States.

Significant segment expenses which are regularly reported to the CODM for purposes of making decisions regarding the allocation of resources are included within the table below and are reconciled to consolidated net loss (in thousands):

Three Months Ended March 31,

Product sales, net $ 7,145 $ 5,353

FYARRO - research and development expenses 5,313 10,271

FYARRO - contract manufacturing expenses — 3,322

ADC assets - contract manufacturing 3,475 —

FYARRO - commercial and marketing expenses 294 601

Finance and accounting expenses (1) 3,216 3,692

Legal expenses 2,587 1,258

Other segment items (2) 7,478 5,780

Interest income ( 791 ) ( 1,282 )

Gain on sale of business ( 87,443 ) —

Net loss $ 73,016 $ ( 18,289 )

(1) Finance and accounting expenses primarily include shared-based compensation, insurance, salaries and wages, and other outside consulting services.

(2) Other segment items primarily include other SGA departmental expenses, cost of sales, interest expense, and foreign exchange loss.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

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Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements.

Forward-looking statements in this Quarterly Report include, but are not limited to, statements about:

• our assessment of strategic options and our ability to identify and implement any strategic transactions;

• the period over which we anticipate our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements;

• our ability to maintain regulatory approval for FYARRO ® in advanced malignant perivascular epithelioid cell tumor (“PEComa”), or to obtain and maintain regulatory approval for FYARRO in additional indications, or any other product candidates we may develop in the future, and any related restrictions, limitations or warnings in the label of an approved product candidate;

• our belief that we presently have sufficient supply of FYARRO for at least the next two years based on our estimated demand for PEComa sales;

• our plans and potential for success relating to commercializing FYARRO, or any other product candidate that we may develop, if approved;

Forward-looking statements in this Quarterly Report may include, but are not limited to, statements about:

• our estimates regarding expenses, capital requirements, needs for additional financing and the period over which we anticipate our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements, including our belief that, based on our current plans, our existing cash, cash equivalents and short-term investments will enable us to conduct our planned operations into 2028;

• our ability to obtain and maintain regulatory approval for our portfolio of three next generation antibody drug conjugates (the “ADC Therapies”) or any other product candidates we may develop in the future, and any related restrictions, limitations or warnings in the label of an approved product candidate;

• the timing, progress and results of preclinical studies and clinical trials for our programs and product candidates (including our anticipated timing of submitting three investigational new drug (“IND”) applications for the ADC Therapies with the U.S.

Food and Drug Administration by mid-2026) , the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

• the anticipated timing of releasing data for current or future clinical trials;

• the anticipated timing of commencement, enrollment, and completion of any current or future clinical trials for FYARRO in additional indications, or any other product candidates we may develop in the future;

• our plans related to the further development and manufacturing of FYARRO;

• the timing, scope or likelihood of regulatory filings and approvals for FYARRO for advanced malignant PEComa in foreign jurisdictions and any additional indications we may pursue and any other product candidates we may develop in the future;

• our commercialization, marketing and manufacturing capabilities and strategy;

• the pricing and reimbursement of FYARRO and any other product candidates we may develop in the future, if approved;

• the rate and degree of market acceptance of FYARRO and any other product candidates we may develop in the future, if approved;

• the timing, progress and results of preclinical studies and clinical trials for our programs and product candidates, the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

• our ability to recruit and enroll suitable patients in our clinical trials;

• the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of FYARRO and any other product candidates that we may develop in the future;

• our ability to develop and advance product candidates into, and successfully complete, clinical studies;

• the anticipated timing of commencement, enrollment, and completion of any current or future clinical trials for the ADC Therapies or any other product candidates we may develop;

• our belief that, with the three ADC Therapies, we have the ability to pursue multiple cancer indications with high potential in large addressable patient populations, including and beyond those indications currently expected to be targeted in the upcoming Phase 1 trials;

• our belief that the ADC Therapies will be able to target cancers expressing specified tumor markers precisely and deliver the potent, cytotoxic Topoisomerase I ("TOPO1") inhibitor at the site of cancer;

• our view that we are positioned to unlock the high potential of the ADC Therapies due to our track record of strong execution of novel drug formulation, research, clinical development, and commercialization in oncology, combined with our deep understanding of antibody drug conjugates ("ADCs") ;

• our belief that our team is well positioned to execute on our strategy to develop and, if approved, commercialize the ADC Therapies and future pipeline assets to ultimately bring broad benefit to cancer patients worldwide;

• our manufacturing capabilities and strategy;

• the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of the ADC Therapies and any other product candidates that we may develop;

• the implementation of our business model and our strategic plans for our business;

• our ability to establish or maintain collaborations or strategic relationships or obtain additional funding;

• our ability to contract with and rely on third parties to assist in conducting our clinical trials and manufacturing FYARRO and any other product candidates we may develop in the future;

• the size and growth potential of the markets for FYARRO and any other product candidates we may develop in the future, if approved, and our ability to serve those markets, either alone or in partnership with others;

• our ability to obtain funding for our operations, including funding necessary to commercialize FYARRO and to complete further development, approval and, if approved, commercialization of FYARRO in additional indications and any other product candidates we may develop in the future;

• our ability to contract with and rely on third parties to assist in conducting our clinical trials and manufacturing the ADC Therapies and any other product candidates we may develop in the future;

• the size and growth potential of the markets for the ADC Therapies and any other product candidates we may develop, if approved, and our ability to serve those markets, either alone or in partnership with others;

• our ability to obtain funding for our operations, including funding necessary to complete development, approval and, if approved, commercialization of the ADC Therapies and any other product candidates we may develop;

• the potential for our business development efforts to maximize the potential value of our portfolio;

• our ability to compete with other companies currently marketing or engaged in the development of treatments for the indications that we are pursuing for FYARRO and any other product candidates we may develop in the future;

• our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates;

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• our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals.

• our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

• other factors including but not limited to those detailed under the section entitled “ Risk Factors .”

Forward-looking statements are not historical facts, but rather are based on current expectations, estimates, assumptions, and projections about the business and future financial results of the pharmaceutical industry, and other legal, regulatory and economic developments.

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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