What changed in this filing

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Item 1. Financial Statements

2026-05-07 compared with 2025-11-06 · 269 added, 477 removed, 1013 unchanged (42% of the section changed)

5 unchanged sentences

( unaudited )

September 30, 2025

March 31, 2026

December 31, 2025

4 unchanged sentences

65,352 67,893

Accounts receivable, net of allowance for credit loss of $ 0 and $ 362

Accounts receivable

26,329 53,654

8 unchanged sentences

38,957 41,392

Restricted cash, long-term

Deferred tax assets

5 unchanged sentences

$ 8,166 $ 5,056

Accrued expenses, current

Accrued expenses

38,378 50,031

7 unchanged sentences

Lease liabilities, long-term

Post-marketing commitment liability, long-term

Long-term debt, net

Other liabilities, long-term

Total liabilities

4 unchanged sentences

100,000,000 shares authorized;

50,384,274 shares issued and outstanding at September 30, 2025 and 49,105,834 issued and outstanding at December 31, 2024

50,879,204 shares issued and outstanding at March 31, 2026 and 50,408,023 issued and outstanding at December 31, 2025

Additional paid-in capital

1,415,970 1,414,074

Accumulated other comprehensive income

Accumulated other comprehensive (loss) income

Accumulated deficit

10 unchanged sentences

( unaudited )

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Product revenue, net

$ 51,902 $ 56,136 $ 144,194 $ 140,810

Royalty revenue

2,573 24,406 8,724 30,581

Total revenue

54,475 80,542 152,918 171,391

Operating costs and expenses:

Cost of sales

12,173 29,097 35,030 50,483

Selling, general and administrative

16,817 16,819 52,468 63,541

Research and development

15,912 12,547 45,227 39,766

Total operating costs and expenses

44,902 58,463 132,725 153,790

Income from operations

9,573 22,079 20,193 17,601

(Loss) income from operations

Other income (expenses):

Interest income

1,044 1,282 3,101 3,498

Interest expense

( 1,489 ) ( 3,100 ) ( 5,503 ) ( 9,831 )

115 347 884 594

Total other expenses, net

( 330 ) ( 1,471 ) ( 1,518 ) ( 5,739 )

Net income before income taxes

$ 9,243 $ 20,608 $ 18,675 $ 11,862

Total other income (expenses), net

Net (loss) income before income taxes

Income tax expense

( 399 ) ( 291 ) ( 1,002 ) ( 889 )

$ 8,844 $ 20,317 $ 17,673 $ 10,973

Net income per share of common stock—basic

$ 0.18 $ 0.41 $ 0.35 $ 0.23

Net income per share of common stock—diluted

$ 0.17 $ 0.41 $ 0.35 $ 0.22

Net (loss) income

Net (loss) income per share of common stock—basic

Net (loss) income per share of common stock—diluted

Weighted-average shares of common stock outstanding—basic

50,339,456 49,008,464 49,881,181 48,498,579

Weighted-average shares of common stock outstanding—diluted

50,929,893 49,173,361 50,334,553 49,025,103

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

1 unchanged sentence

AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME

(in thousands)

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

$ 8,844 $ 20,317 $ 17,673 $ 10,973

Other comprehensive income:

Unrealized gain on available-for-sale securities, net of tax of $ 0

Comprehensive income

$ 8,877 $ 20,375 $ 17,686 $ 11,003

For the Three Months Ended March 31,

Net (loss) income

Other comprehensive loss:

Unrealized loss on available-for-sale securities, net of tax of $0

Comprehensive (loss) income

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

3 unchanged sentences

(in thousands, except share data)

For the Three Months Ended September 30, 2025

Comprehensive

Income (Loss)

Balance at June 30, 2025

Stock-based compensation

Shares issued or restricted stock units vested under employee stock plans

Unrealized gain on available-for-sale securities

Balance at September 30, 2025

For the Three Months Ended September 30, 2024

For the Three Months Ended March 31, 2026

Comprehensive

Income (Loss)

Balance at June 30, 2024

Stock-based compensation

Shares issued or restricted stock units vested under employee stock plans

Unrealized gain on available-for-sale securities

Balance at September 30, 2024

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

PUMA BIOTECHNOLOGY, INC.

AND SUBSIDIARY

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS ’ EQUITY

(in thousands, except share data)

For the Nine Months Ended September 30, 2025

Comprehensive

Balance at December 31, 2025

1 unchanged sentence

Shares issued or restricted stock units vested under employee stock plans

Unrealized gain on available-for-sale securities

Balance at September 30, 2025

For the Nine Months Ended September 30, 2024

Unrealized loss on available-for-sale securities

Balance at March 31, 2026

For the Three Months Ended March 31, 2025

Comprehensive

3 unchanged sentences

Shares issued or restricted stock units vested under employee stock plans

Unrealized gain on available-for-sale securities

Balance at September 30, 2024

Unrealized loss on available-for-sale securities

Balance at March 31, 2025

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

3 unchanged sentences

(in thousands)

For the Nine Months Ended September 30,

For the Three Months Ended March 31,

Operating activities:

$ 17,673 $ 10,973

Adjustments to reconcile net income to net cash provided by operating activities:

Net (loss) income

Adjustments to reconcile net (loss) income to net cash provided by operating activities:

Depreciation and amortization

1 unchanged sentence

Provision for credit loss recovery

( 362 ) ( 121 )

Disposal of property and equipment

Loss on disposal of property and equipment

Changes in operating assets and liabilities:

Accounts receivable, net

( 1,192 ) ( 6,685 )

Inventory, net

( 752 ) 4,407

Prepaid expenses and other

2 unchanged sentences

Operating lease assets and liabilities, net

( 1,266 ) ( 1,164 )

Accrued expenses and other

279 ( 2,059 )

Post-marketing commitment liability

( 1,740 ) ( 894 )

Net cash provided by operating activities

27,383 23,311

Investing activities:

Purchase of property and equipment

( 107 ) ( 40 )

Purchase of available-for-sale securities

( 61,204 ) ( 60,956 )

Maturity of available-for-sale securities

52,100 42,878

Net cash used in investing activities

( 9,211 ) ( 18,118 )

Net cash provided by investing activities

Financing activities:

Net proceeds from shares issued under employee stock plans

Payment of debt

( 33,330 ) ( 22,220 )

Payment of exit costs

( 666 ) ( 445 )

Net cash used in financing activities

( 33,866 ) ( 22,515 )

Net decrease in cash, cash equivalents and restricted cash

( 15,694 ) ( 17,322 )

Net increase (decrease) in cash, cash equivalents and restricted cash

Cash, cash equivalents and restricted cash, beginning of period

71,310 86,676

Cash, cash equivalents and restricted cash, end of period

55,616 69,354

Supplemental disclosures of non-cash investing and financing activities:

Property and equipment purchases in accounts payable

Supplemental disclosure of cash flow information:

Interest paid

$ 4,838 $ 8,483

Income taxes paid

$ 1,277 $ 1,170

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

11 unchanged sentences

This subsidiary was established for the purpose of legal representation in the European Union (“EU”).

The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary.

The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary.

All intercompany accounts and transactions have been eliminated.

The accompanying consolidated financial statements of the Company and its subsidiary have been prepared in accordance with generally accepted accounting principles in the United States (“U.S.

The Company has incurred significant operating losses since its inception.

While the Company has previously reported net income, we cannot assure that we will continue to do so and will need to continue to generate significant revenue to sustain operations and successfully commercialize neratinib.

While the Company has previously reported net income, the Company cannot ensure that it will continue to do so and will need to continue to generate significant revenue to sustain operations and successfully commercialize neratinib.

In 2017, the Company received U.S.

4 unchanged sentences

The Company is required to make substantial payments to Pfizer upon the achievement of certain milestones and has contractual obligations for clinical trial contracts.

The Company has entered into other exclusive sub-license agreements with various parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved, in many regions outside the United States, including Europe, Australia, Canada, China, Southeast Asia, Israel, South Korea, Russia and various countries and territories in Central America, South America, Africa and the Middle East.

The Company has entered into other exclusive sub-license agreements with various parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved, in many regions outside the United States, including Europe (excluding Ukraine), Australia, Canada, China, Southeast Asia, Israel, South Korea, Russia and various countries and territories in Central America, South America, Africa and the Middle East.

The Company plans to continue to pursue commercialization of NERLYNX in other countries outside the United States, if approved.

4 unchanged sentences

The Company paid Takeda an upfront license fee of $ 7.0 million in October 2022, and Takeda is eligible to receive potential future milestone payments of up to $ 287.3 million upon the Company’s achievement of certain regulatory and commercial milestones over the course of the exclusive license agreement, as well as tiered royalty payments for any net sales of alisertib.

As of September 30, 2025 , no milestones had been accrued as the underlying contingencies were not probable or estimable.

The Company has reported net income of approximately $ 17.7 million and cash provided by operations of approximately $ 27.4 million for the nine months ended September 30, 2025 .

The Company’s commercialization, research and development or marketing efforts may require funding in addition to the cash and cash equivalents and marketable securities totaling approximately $ 94.4 million at September 30, 2025 .

The Company believes that its existing cash and cash equivalents and marketable securities as of September 30, 2025 and proceeds that will become available to the Company through product sales and sub-license payments are sufficient to satisfy its operating cash needs, including amounts due under the Company’s Note Purchase Agreement with Athyrium Opportunities IV Co-Invest 1 LP (“Athyrium”) (see Note 9—Debt ), for at least one year after the filing of the Quarterly Report on Form 10 -Q in which these financial statements are included.

As of March 31, 2026 , no milestones had been accrued as the underlying contingencies were not probable.

The Company has reported net loss of approximately $ 3.8 million and cash provided by operations of approximately $ 15.4 million for the three months ended March 31, 2026 .

The Company believes that its existing cash and cash equivalents and marketable securities as of March 31, 2026 and proceeds that are expected to become available to the Company through product sales and sub-license payments are sufficient to satisfy its operating cash needs, including amounts due under the Company’s Note Purchase Agreement with Athyrium Opportunities IV Co-Invest 1 LP (“Athyrium”) (see Note 9—Debt ), for at least one year after th e filing of the Quarterly Report on Form 10 -Q in which these financial statements are included.

The Company continues to remain dependent, in part, on its ability to obtain sufficient funding to sustain operations and continue to successfully commercialize neratinib in the United States.

3 unchanged sentences

Additionally, the terms of the Company’s Note Purchase Agreement place restrictions on the Company’s ability to operate the business and on the Company’s financial flexibility, and the Company may be unable to achieve the revenue necessary to satisfy the minimum revenue and cash balance covenants as specified in the agreement.

Since its inception through September 30, 2025 , the Company’s financing has primarily consisted of proceeds from product, royalty and license revenue, public offerings of its common stock, private equity placements, and various debt instruments.

In the opinion of management, the included disclosures are adequate, and the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary for a fair statement of our consolidated financial position as of September 30, 2025 .

Since its inception through March 31, 2026 , the Company’s financing has primarily consisted of proceeds from product, royalty and license revenue, public offerings of its common stock, private equity placements, and various debt instruments.

In the opinion of management, the included disclosures are adequate, and the accompanying unaudited condensed consolidated financial statements contain all adjustments necessary for a fair statement of its consolidated financial position as of March 31, 2026 .

Such adjustments are of a normal and recurring nature.

The condensed consolidated balance sheet as of December 31, 2025 was derived from audited annual financial statements but does not contain all of the footnote disclosures from the audited annual financial statements.

The condensed consolidated results of operations for the quarter ended September 30, 2025 are not necessarily indicative of the consolidated results of operations that may be expected for the fiscal year ending December 31, 2025 .

The Company does not believe that tariffs imposed or proposed to be imposed by the United States, particularly with the EU and China, will have a material impact on our product costs or results of operations.

The condensed consolidated results of operations for the quarter ended March 31, 2026 are not necessarily indicative of the consolidated results of operations that may be expected for the fiscal year ending December 31, 2026 .

The Company does not believe that tariffs imposed or proposed to be imposed by the United States, particularly with the EU and China, will have a material impact on its product costs or results of operations.

However, shifts in trade policies in the United States and other countries have been rapidly evolving and are difficult to predict.

The ultimate impact of any announced or future tariffs will depend on various factors, including what tariffs are ultimately implemented, the timing of implementation and the amount, scope and nature of such tariffs and potential exclusions from the application of those tariffs.

On April 2, 2026, the U.S.

government issued a proclamation under Section 232 of the Trade Expansion Act of 1962, imposing new tariffs on imported patented pharmaceutical products and associated active pharmaceutical ingredients (APIs).

Any potential impact of the proclamation on the Company is uncertain and under review.

Note 2 — Significant Accounting Policies:

5 unchanged sentences

Management has determined that the Company operates in one reporting segment, which is the development and commercialization of innovative products to enhance cancer care.

The Company derives our global product, license and royalty revenue through the sales of NERLYNX®.

The majority of our roya lty revenue is derived from our sub-licensee sales into China.

The Company derives its global product, license and royalty revenue through the sales of NERLYNX®.

The majority of the Company's roya lty revenue is derived from its sub-licensee sales into China.

The accounting policies of this operating segment are the same as those described below in Note 2—Significant Accounting Policies.

Our Chief Operating Decision Maker (“CODM”) is our President, Chief Executive Officer and Chairman of the Board, Alan H.

The CODM primarily uses our Consolidated Statement of Operations and related revenues, expenses and net income (loss) in evaluating the performance of the single operating segment and determining how to allocate resources of the Company as a whole, including our sales force and related marketing, research and development programs, including alisertib, and licensing strategy.

Consolidated revenue, expenses and net income are also used to monitor budget versus actual results.

In addition to the significant expense categories included within consolidated n et income presented on the Company's Condensed Consolidated Statements of Operations, see below for disaggregated amounts that comprise operating expenses:

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

The Company's Chief Operating Decision Maker (“CODM”) is its President, Chief Executive Officer and Chairman of the Board, Alan H.

The CODM primarily uses the Company's Consolidated Statement of Operations and related revenues, expenses and net (loss) income in evaluating the performance of the single operating segment and determining how to allocate resources of the Company as a whole, including its sales force and related marketing, research and development programs, including alisertib, and licensing strategy.

Consolidated revenue, expenses and net (loss) income are also used to monitor budget versus actual results.

In addition to the significant expense categories included within consolidated n et (loss) income presented on the Company's Condensed Consolidated Statements of Operations, see below for disaggregated amounts that comprise operating expenses:

For the Three Months Ended March 31,

Cost of sales

1 unchanged sentence

General and administrative

6,142 6,136 18,860 30,074

Commercialization

2 unchanged sentences

Clinical research and development

7,789 5,667 21,881 16,547

Medical affairs

1,323 1,220 4,107 3,414

Other research and development (1)

6,179 5,048 17,190 17,640

Operating costs and expenses

1 unchanged sentence

Stock based compensation

1,673 2,054 5,327 6,493

Total operating costs and expenses

$ 48,642 $ 42,023

( 1 ) Other research and development expense include regulatory affairs, pharmacovigilance, quality assurance, chemical manufacturing and other costs.

( 1 ) Other research and development expense includes regulatory affairs, pharmacovigilance, quality assurance, chemical manufacturing and other costs.

Use of Estimates:

4 unchanged sentences

Other significant estimates include those related to the valuation of deferred income taxes, legal and other expense accruals.

Net In come per S hare of Common Stock:

Basic net income per share of common stock is computed by dividing net income available to common stockholders by the weighted-average number of shares of common stock outstanding during the periods presented, as required by Accounting Standards Codification (“ASC”), ASC 260, Earnings per Share .

For purposes of calculating diluted net income per share of common stock, the denominator includes both the weighted-average number of shares of common stock outstanding and the number of dilutive common stock equivalents, such as stock options, restricted stock units (“RSUs”) and warrants.

Net (Loss) In come per S hare of Common Stock:

Basic net (loss) income per share of common stock is computed by dividing net (loss) income available to common stockholders by the weighted-average number of shares of common stock outstanding during the periods presented, as required by Accounting Standards Codification (“ASC”), ASC 260, Earnings per Share .

For purposes of calculating diluted net (loss) income per share of common stock, the denominator includes both the weighted-average number of shares of common stock outstanding and the number of dilutive common stock equivalents, such as stock options, restricted stock units (“RSUs”) and warrants.

A common stock equivalent is not included in the denominator when calculating diluted earnings per common share if the effect of such common stock equivalent would be anti-dilutive.

Our potentially dilutive securities include potential common shares related to our stock options and RSUs granted in connection with the Puma Biotechnology, Inc.

2011 Incentive Award Plan and the Puma Biotechnology, Inc.

2017 Employment Inducement Incentive Award Plan.

The Company's potentially dilutive securities include potential common shares related to its stock options and RSUs granted in connection with the Puma Biotechnology, Inc.

2011 Incentive Award Plan ( “2011 Plan”) and the Puma Biotechnology, Inc.

2017 Employment Inducement Incentive Award Plan ( “2017 Plan”).

Diluted earnings per share (“Diluted EPS”) considers the impact of potentially dilutive securities except in periods in which there is a loss because the inclusion of the potential common shares would have an anti-dilutive effect.

Diluted EPS excludes the impact of potential common shares related to our stock options in periods in which the option exercise price is greater than the average market price of our common stock for the period.

The following potentially dilutive outstanding common stock equivalents for the respective periods were excluded from diluted net income per share because of their anti-dilutive effect:

Diluted EPS excludes the impact of potential common shares related to the Company's stock options in periods in which the option exercise price is greater than the average market price of its common stock for the period.

The following potentially dilutive outstanding common stock equivalents for the respective periods were excluded from diluted net (loss) income per share because of their anti-dilutive effect:

For the Three Months Ended

For the Nine Months Ended

September 30,

Options outstanding

5 unchanged sentences

3,873,053 6,851,313

The 2,116,250 shares underlying the warrant will not have an impact on our diluted net income per share until the average market price of our common stock exceeds the exercise price of $ 16 per share (see Note 10—Stockholders’ Equity).

A reconciliation of the numerators and denominators of the basic and diluted net income per share of common stock computations is as follows (in thousands, except share and per share amounts):

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

The 2,116,250 shares underlying the warrant will not have an impact on the Company's diluted net (loss) income per share until the average market price of its common stock exceeds the exercise price of $ 16 per share (see Note 10—Stockholders’ Equity).

A reconciliation of the numerators and denominators of the basic and diluted net (loss) income per share of common stock computations is as follows (in thousands, except share and per share amounts):

For the Three Months Ended March 31,

Net (loss) income

$ ( 3,753 ) $ 2,974

Weighted average common stock outstanding for basic net income per share

Weighted average common stock outstanding for basic net (loss) income per share

50,845,130 49,595,697

Net effect of dilutive common stock equivalents

590,437 164,897 453,372 526,524

Weighted average common stock outstanding for diluted net income per share

Weighted average common stock outstanding for diluted net (loss) income per share

50,845,130 49,906,341

Net income per share of common stock

Net (loss) income per share of common stock

$ ( 0.07 ) $ 0.06

13 unchanged sentences

The Company’s payment terms range between 10 and 68 days.

Product revenue also consists of product sales under sub-license agreements to our sub-licensees, who then sell into their respective international territories.

Product revenue also consists of product sales under sub-license agreements to the Company's sub-licensees, who then sell into their respective international territories.

Shipping and handling costs for product shipments occur prior to the customer obtaining control of the goods and are recorded in cost of sales.

1 unchanged sentence

The Company expenses incremental costs of obtaining a contract when incurred if the expected amortization period of the asset that the Company would have recognized is one year or less.

However, no such costs were incurred during the nine months ended September 30, 2025 and 2024 , respectively.

However, no such costs were incurred during the three months ended March 31, 2026 and 2025 .

Reserves for Variable Consideration:

6 unchanged sentences

The amount of variable consideration that is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period.

The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a significant reversal of revenue would not likely occur in a future period for the estimates detailed below as of September 30, 2025 , and, therefore, the transaction price was not reduced further during the quarter ended September 30, 2025 .

The Company’s analyses also contemplated application of the constraint in accordance with the guidance, under which it determined a significant reversal of revenue would not likely occur in a future period for the estimates detailed below as of March 31, 2026 , and, therefore, the transaction price was not reduced further during the quarter ended March 31, 2026 .

Actual amounts of consideration ultimately received may differ from the Company’s estimates.

42 unchanged sentences

License fees under the sub-license agreements include one -time upfront payments when each sub-license agreement was executed and potential additional one -time milestone payments due to the Company upon successful completion of certain performance obligations, such as achieving regulatory approvals or sales target thresholds, and potential double-digit royalties on sales of the licensed product, calculated as a percentage of net sales of the licensed product throughout each sub-licensee’s respective territory.

As of September 30, 2025 , the total potential milestone payments that would be due to the Company upon achievement of all respective performance obligations under the sub-license agreements is approximately $ 579.8 million.

As of March 31, 2026 , the total potential milestone payments that would be due to the Company upon achievement of all respective performance obligations under the sub-license agreements is approximately $ 579.8 million.

A t this time, the Company cannot estimate if or when these milestone-related performance obligations might be achieved.

14 unchanged sentences

Research and development expenses are charged to operations as incurred.

The major components of research and development costs include clinical manufacturing costs, clinical trial expenses, consulting and other third -party costs, salaries and employee benefits, stock-based compensation expense, supplies and materials, and allocations of various overhead costs.

The major components of research and development cos ts include clinical manufacturing costs, clinical trial expenses, consulting and other third -party costs, salaries and employee benefits, stock-based compensation expense, supplies and materials, and allocations of various overhead costs.

Clinical trial expenses include, but are not limited to, investigator fees, site costs, comparator drug costs, and CRO costs.

13 unchanged sentences

The fair value of each option award is estimated on the grant date using the Black-Scholes Option Pricing Method.

As allowed by ASC 718, the Company’s estimate of expected volatility is based on its average volatility using its expective life, or approximately the last six years of publicly traded history.

The Company’s estimate of expected volatility is based on its average volatility using its expected life, or approximately the last six years of publicly traded history.

The risk-free rate for periods within the contractual life of the option is based on the U.S.

21 unchanged sentences

When the terms of the warrant become fixed, the Company values the warrant using the Black-Scholes Option Pricing Method.

As allowed by ASC 718, the Company’s estimate of expected volatility is based on its average volatility using its past nine years of publicly traded history.

The Company’s estimate of expected volatility is based on its average volatility using its past nine years of publicly traded history.

The risk-free rate for periods within the contractual life of the warrant is based on the U.S.

12 unchanged sentences

ASC 740 also provides guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures.

As of September 30, 2025 , the Company’s uncertain tax positions include a reserve for its research and development credits.

On July 4, 2025, the “One Big Beautiful Bill” was signed into law, which includes significant changes to federal tax law and other regulatory provisions that may impact the Company.

As of the date of these financial statements, the Company has evaluated the impact of the changes to Section 174 – Amortization of research and experimental expenditures on the valuation allowance release.

The Company intends to deduct the capitalized costs over two years.

This deduction reduces the amount of net operating losses being utilized but results in a net zero change to the deferred tax asset balance.

Therefore, the Company has concluded that it remains reasonable to maintain the $7.0 million estimate for the valuation allowance release as of September 30, 2025 as the facts and circumstances supporting the deferred tax asset have not materially changed.

As of March 31, 2026 , the Company’s uncertain tax positions include a reserve for its research and development credits.

Financial Instruments:

6 unchanged sentences

The lease-related letters of credit will lapse at the end of the respective lease terms through 2 026.

At each of the periods ended September 30, 2025 and December 31, 2024 , the Company had restricted cash in the amount of approximately $ 2.1 million.

At each of the periods ended March 31, 2026 and December 31, 2025 , the Company had restricted cash of approximately $ 2.1 million.

Investment Securities:

20 unchanged sentences

Valuations derived from valuation techniques in which one or more significant inputs are unobservable.

Following are the major categories of assets measured at fair value on a recurring basis as of September 30, 2025 and December 31, 2024 , using quoted prices in active markets for identical assets (Level 1 ), significant other observable inputs (Level 2 ), and significant unobservable inputs (Level 3 ) (in thousands):

September 30, 2025

Following are the major categories of assets measured at fair value on a recurring basis as of March 31, 2026 and December 31, 2025 , using quoted prices in active markets for identical assets (Level 1 ), significant other observable inputs (Level 2 ), and significant unobservable inputs (Level 3 ) (in thousands):

March 31, 2026

Cash equivalents

3 unchanged sentences

Corporate Bonds

— 7,380 — 7,380

Commercial paper

6 unchanged sentences

27,903 14,873 — 42,776

Corporate Bonds

— 6,865 — 6,865

Commercial paper

1 unchanged sentence

$ 32,963 $ 58,700 $ — $ 91,663

The Company’s investments in commercial pa per a n d U.S.

The Company’s investments in commercial pa per, corporate bonds and U.S.

government securities are exposed to price fluctuations.

2 unchanged sentences

The following tables summarize the Company’s cash equivalents and short-term investments (in thousands):

September 30, 2025

March 31, 2026

Cash equivalents

3 unchanged sentences

Corporate Bonds

7,387 — ( 7 ) 7,380

Commercial paper

6 unchanged sentences

42,739 37 — 42,776

Corporate Bonds

6,866 1 ( 2 ) 6,865

Commercial paper

3 unchanged sentences

Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash and cash equivalents, marketable securities, and accounts receivable, net.

The Company’s cash and cash equivalents and restricted cash in excess of the Federal Deposit Insurance Corporation and the Securities Investor Protection Corporation insured limits at September 30, 2025 were approximately $ 54.9 million.

The Company does not believe it is exposed to any significant credit risk due to the quality nature of the financial instruments in which the money is held.

24 unchanged sentences

Starter kits, provided to patients prior to insurance approval, are expensed by the Company to selling, general and administrative expense as incurred.

Of the total inventory amounts noted below, approximately $ 4.8 million is located at contract manufacturing organizations in Europe as of September 30, 2025 .

Of the total inventory amounts noted below, approxim ately $ 8.1 million i s located at contract manufacturing organizations in Europe as of March 31, 2026 .

The Company’s inventory balances are as follows:

September 30, 2025

March 31, 2026

December 31, 2025

1 unchanged sentence

$ 5,998 $ 3,212

Work-in-process (materials, labor and overhead)

Finished goods (materials, labor and overhead)

Work-in-process

Finished goods

Total inventories

9 unchanged sentences

If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would then determine the fair value of the long-lived asset and recognize an impairment loss for the amount in excess of the carrying value.

No impairments were recorded during the three months ended September 30, 2025 and 2024 .

No impairments were recorded during the three months ended March 31, 2026 and 2025 .

ASC Topic 842, Leases , as adopted in the first quarter of 2019, requires lessees to recognize most leases on the balance sheet with a corresponding right-of-use asset (“ROU asset”).

22 unchanged sentences

The incremental borrowing rate (“IBR”) represents the rate of interest the Company would expect to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms.

As the implicit rate on the Company’s leases are not readily determinable, the Company uses its IBR based on the information available at the commencement date in determining the present value of lease payments.

The Company’s average IBR for existing lea ses as of September 30, 2025 is 12.4 % .

As the implicit rate on the Company’s leases is not readily determinable, the Company uses its IBR based on the information available at the commencement date in determining the present value of lease payments.

The Company’s average IBR for existing lea ses as of March 31, 2026 is 12.4 % .

License Fees and Intangible Assets:

13 unchanged sentences

Recently Issued Accounting Standar ds:

In December 2023, the FASB issued ASU 2023 - 09, Income Taxes (Topic 740 ):

Improvements to Income Tax Disclosures .

The ASU requires the annual financial statements to include consistent categories and greater disaggregation of information in the rate reconciliation, and income taxes paid disaggregated by jurisdiction.

ASU 2023 - 09 is effective for the Company’s annual reporting periods beginning after December 15, 2024.

Adoption is either with a prospective method or a fully retrospective method of transition.

Early adoption is permitted.

The Company is currently evaluating the effect that adoption of ASU 2023 - 09 will have on its consolidated financial statements.

In November 2024, the FASB issued ASU 2024 - 03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures :

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The amendments may be applied either ( 1 ) prospectively to financial statements issued for reporting periods after the effective date of this ASU or ( 2 ) retrospectively to all prior periods presented in the financial statements.

We are currently evaluating the impact of adopting this ASU on its consolidated financial statements and related disclosures.

The Company is currently evaluating the impact of adopting this ASU on its consolidated financial statements and related disclosures.

Note 3 — Accounts Receivable, Net:

Accounts receivable, net consisted of the following (in thousands):

September 30, 2025

March 31, 2026

December 31, 2025

Trade accounts receivable

$ 30,811 $ 26,362

Royalty revenue receivable

Total accounts receivable

$ 33,565 $ 32,373

Allowance for credit losses

Total accounts receivable, net

$ 33,565 $ 32,011

Trade accounts receivable consist entirely of amounts owed from the Company’s customers related to product sales.

Royalty revenue receivable represents amounts owed related to royalty revenue recognized based on the Company’s sub-licensees’ sales in their respective territories in the periods ended September 30, 2025 and December 31, 2024 .

For all accounts receivable, the Company recognizes credit losses based on lifetime expected losses to selling, general and administrative expense in the condensed consolidated statements of operations.

In determining estimated credit losses, the Company evaluates its historical loss rates, current economic conditions and reasonable and supportable forecasts of future economic conditions .

The Company recorded a recovery to the provision for credit loss of $ 0.1 million for each of the three months ended September 30, 2025 and 2024 .

The Company recorded a recovery to the provision for credit loss of $ 0.4 and $ 0.1 million for the nine months ended September 30, 2025 and 2024 , respectively.

The Company did not record a provision for credit loss (recovery) for the three months ended March 31, 2026 , compared to a provision for credit loss of $ 0.2 million for the three months ended March 31, 2025 .

Note 4 — Prepaid Expenses and Other:

Prepaid expenses and other consisted of the following (in thousands):

September 30, 2025

March 31, 2026

December 31, 2025

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Other clinical development

$ 5,758 $ 6,151

Other current prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions and software, and prefunding of reimbursement claims.

Other current prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions and software.

Other long-term prepaid amounts consist primarily of funding for commercial copay support programs.

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The initial term of the lease was for seven years and commenced on December 10, 2011.

Concurrent with the execution of the lease, the Company provided the landlord an automatically renewable stand-by letter of credit in the amount of $ 1.0 million.

The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, long-term on the accompanying consolidated balance sheets.

As amended, the Company rents approximately 65,656 square feet.

The term of the lease runs until March 2026.

In July 2025, the Company executed an amendment to its office space in Los Angeles, California to surrender certain suites effective March 31, 2026 and extend the lease term for the remaining 26,700 rentable square feet for an additional five years and five months through August 31, 2031.

In July 2025, the Company executed an amendment to its office space in Los Angeles, California to surrender certain suites effect ive March 31, 2026 and e xtend the lease term for the remaining 26,700 rentable square feet for an additional five years and five months through August 31, 2031.

Base rent escalates annually and is abated from April 2026 through August 2026.

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Management determined that the renewal option is not reasonably certain to occur.

The Company accounted for this amendment as a lease modification.

There was no change in the lease classification as a result of this modification and the Company continues to recognize such a lease as an operating lease.

The Company remeasured its ROU assets and operating lease liabilities using an updated incremental borrowing rate.

The change in ROU assets and operating lease liabilities related to this lease modification amounted to $ 4.1 million.

In June 2012, the Company entered into a long-term lease agreement for office space in South San Francisco, California, which was subsequently amended in May 2014 and July 2015.

As amended, the Company rents approximately 29,470 square feet.

The term of this lease runs until March 2026, with the option to extend for an additional five -year term, and rents payable by the Company increase approximately 3 % per year.

The term of this lease expired on March 31, 2026 .

The Company provided the landlord an automatically renewable stand-by letter of credit in the amount of $ 1.1 million.

The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, current on the accompanying consolidated balance sheets.

Total rent expense for the three and nine months ended September 30, 2025 was approximately $ 1.1 million and $ 3.4 million, respectively.

Total rent expense for the three and nine months ended September 30, 2024 was approximately $ 1.2 million and $ 3.7 million, respectively.

The stand-by letter of credit is collateralized by a high-yield savings account, which is classified as restricted cash, current on the accompanying consolidated balance sheets until 60 days after the expiration of the lease.

Total rent expense for the three months ended March 31, 2026 and 2025 was approximately $ 1.1 million and $ 1.2 million, respectively.

For purposes of determining straight-line rent expense, the lease term is calculated from the date the Company first takes possession of the facility, including any periods of free rent and any renewal option periods that the Company is reasonably certain of exercising.

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Such amounts are generally variable and therefore not included in the measurement of the ROU asset and related lease liability but are instead recognized as variable lease expense in selling, general and administrative costs in the condensed consolidated statements of operations when they are incurred.

Supplemental cash flow information related to leases for the nine months ended September 30, 2025:

Supplemental cash flow information related to leases for the three months ended March 31, 2026:

Operating cash flows used for operating leases (in thousands)

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Weighted average discount rate

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

2025 (remaining)

Future minimum lease payments as of March 31, 2026 were as follows (in thousands):

Total minimum lease payments

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Total lease liabilities

In February 2019, the Company entered into a long-term sublease agreement for 12,429 square feet of the office space in Los Angeles, California.

The term of the lease ran until March 2026 and rent amounts payable to the Company increased approximately 3 % per year.

The February 2019 sublease was terminated in December 2024.

As a result, the Company received $ 0.7 million, which approximated the sublease rental payments on the remaining lease term.

During the three month period ended March 31, 2025, the Company signed another sublease agreement for the 12,429 square feet of office space with a sublease commencement date of April 1, 2025.

During the three month period ended March 31, 2025, the Company signed a sublease agreement for the 12,429 square feet of office space with a sublease commencement date of April 1, 2025.

This sublease expired on March 31, 2026.

In August 2023, the Company entered into a long-term sublease agreement for 13,916 square feet of the office space in Los Angeles, California, which commenced in November 2023.

The term of the lease runs until March 2026 and the rent amounts payable to the Company increase approximately 3 % per year.

The Company has recorded sublease income in other income (expenses) in the condensed consolidated statements of operations since November 2023.

The Company recorded operatin g sublease income of $ 0.2 million for each of the three months ended September 30, 2025 and 2024 , and approximately $ 0.7 million for each of the nine months ended September 30, 2025 and 2024 , respectively, in other income (expenses) in the co ndensed consolidated statements of operations.

The f uture minimum lease payments to be received as of September 30, 2025 , were as follows (in thousands):

This sublease expired on March 31, 2026.

The Company rec orded operating sublease income of $ 0.2 million for each of the three months ended March 31, 2026 and 2025 , in other income (expenses) in the co ndensed consolidated statements of operations.

Note 6 — Property and Equipment, Net:

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

September 30, 2025

March 31, 2026

December 31, 2025

Leasehold improvements

$ 3,779 $ 3,779

Computer equipment

Telephone equipment

Furniture and fixtures

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accumulated depreciation

( 6,589 ) ( 7,868 )

Property and equipment, net

For the three and nine months ended September 30, 2025 and 2024 , the Company incurred depreciation expense of $ 0.1 million and $ 0.3 million, respectively.

For the three months ended March 31, 2026 and 2025 , the Company incurred depreciation expense of $ 0.1 million and $ 0.1 million, respectively.

Note 7 — Intangible Assets, Net:

Intangible assets, net consisted of the following (in thousands):

September 30, 2025

March 31, 2026

December 31, 2025

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$ 38,957 $ 41,392

For each of the three and nine months ended September 30, 2025 and 2024 , the Company incurred amortization expe nse of $ 2.4 million and $ 7.3 million, respectively.

The estimated remaining useful life of the intangible assets as of September 30, 2025 is 4.5 years.

Company reached a commercial milestone by achieving aggregate worldwide net sales of $ 250.0 million in calendar year 2022, resulting in a payment to Pfizer of $ 12.5 million during the three months ended March 31, 2023.

The Company capitalized the milestones as intangible assets and is amortizing the assets to cost of sales on a straight-line basis over the estimated useful life of the licensed patent through 2030.

The Company recorded amortization expense related to its intangible assets of approximately $ 2.4 million and $ 7.3 million for the three and nine months ended September 30, 2025 and 2024 , respectively.

As of September 30, 2025 , estimated future amortization expense related to the Company’s intangible assets is approximately $ 2.4 million for the remainder of 2025 and $ 9.7 million for each year starting 2026 through 2029, and $ 2.4 million for 2030.

For each of the three months ended March 31, 2026 and 2025 , the Company incurred amortization expe nse of $ 2.4 million and $ 2.4 million, respectively.

The estimated remaining useful life of the inta ngible assets as of March 31, 2026 is 4.0 years.

As of March 31, 2026 , estimated future amortization expense related to the Company’s intangible assets is approximately $ 7.3 million for the remainder of 2026 and $ 9.7 million for each year starting 2027 through 2029, and $ 2.4 million for 2030.

Note 8 — Accrued Expenses:

Accrued expenses consisted of the following (in thousands):

September 30, 2025

March 31, 2026

December 31, 2025

Accrued royalties

$ 8,901 $ 10,169

Accrued CRO services

Accrued variable consideration

11,301 10,829

Accrued bonus

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Accrued manufacturing costs

$ 37,116 $ 36,898

Accrued other liabilities

$ 37,116 $ 37,019

Accrued variable consideration represents estimates of adjustments to product revenue, net for which reserves are established.

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Long term debt consisted of the following (in thousands):

September 30, 2025

March 31, 2026

Maturity Date

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The Company incurred $ 1.9 million of deferred financing costs with the initial borrowing of the Athyrium Notes.

Interest on the Athyrium Notes is calculated in part based on the Secured Overnight Financing Rate (“SOFR”), which replaced the “London Interbank Offering Rate” as the floating benchmark for interest rate calculations applicable to the Athyrium Notes pursuant to the terms of the Third Amendment to Note Purchase Agreement dated as of September 16, 2022.

The modification of the Note Purchase Agreement pursuant to the Third Amendment did not meet the requirements of a debt extinguishment under ASC Topic 470 - 50— Debt Modifications and Exchanges and no gain or loss was recognized.

The Company performed a quantitative analysis and determined that the terms of the new debt and original debt instrument were not substantially different.

Accordingly, the Third Amendment is accounted for as a debt modification.

Following the effectiveness of the Third Amendment, the Athyrium Notes bear interest at an annual rate equal to the sum of (a) eight percent ( 8.00 %) plus (b) the lesser of (i) the sum of ( x ) three -month term SOFR for an interest period of three months plus (y) 0.26161 % ( 26.161 basis points) and (ii) three and one -half of one percent ( 3.50 %) per annum.

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Each quarterly principal payment approximates $ 11.1 million, and each quarterly exit fee payment approximates $ 0.2 million.

As of September 30, 2025, the effective interest rate for the loan was 12.99 %.

As of September 30, 2025, the Company may prepay the outstanding principal balance of the notes, in whole or in part, without premium or penalty.

As of March 31, 2026 , the effective interest rate for the loan was 12.99 %.

As of March 31, 2026, the Company may prepay the outstanding principal balance of the notes, in whole or in part, without premium or penalty.

The Athyrium Notes include affirmative and negative covenants applicable to the Company.

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The Company is also required to maintain minimum cash balances and achieve certain minimum product revenue targets, measured as of the last day of each fiscal quarter on a trailing year-to-date basis.

As of September 30, 2025 , the Company was in compliance with such covenants.

As of September 30, 2025 , the principal balance outstanding under the Athyrium Notes was $ 33.3 million and exit fees were $ 0.7 million, representing all of the Company’s debt.

The future minimum principal and exit payments under the Athyrium Notes as of September 30, 2025 are as follows (in thousands):

As of March 31, 2026 , the Company was in compliance with such covenants.

As of March 31, 2026 , the principal balance outstanding under the Athyrium Notes was $ 11.1 million and exit fees were $ 0.2 million, representing all of the Company’s debt.

The future minimum principal and exit payments under the Athyrium Notes as of March 31, 2026 are as follows (in thousands):

Debt Issuance Costs and Discounts:

Debt issuance costs and discounts consist of the following (in thousands):

September 30, 2025

March 31, 2026

December 31, 2025

Debt issuance costs and discounts (Athyrium Notes)

$ 5,410 $ 5,410

accumulated amortization

( 5,119 ) ( 4,454 )

Included in current portion of debt

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Amortization of debt issuance costs is expensed using the effective interest method and is included in interest expense in the condensed consolidated statement of operations.

For the three and nine months ended September 30, 2025 , the Company recorded approxi mately $ 0.1 million and $ 0.5 million of interest expense, respectively.

For the three and nine months ended September 30, 2024 , the Company recorded approximately $ 0.2 million and $ 0.7 million of interest expense, respectively.

For each of the three months ended March 31, 2026 and 2025, t he Company recorded approximately $ 0.1 million and $ 0.2 million of interest expense, respectively.

Note 10 — Stockholders ’ Equity:

Common Stock:

The Company issued 55,882 and 64,118 shares of common stock upon exercise of stock options during the nine months ended September 30, 2025 and 2024 , respectively.

The Company issued 1,222,558 and 1,356,443 shares of common stock upon vesting of RSUs during the nine months ended September 30, 2025 and 2024 , respectively.

The Company did not issue any shares of common stock upon exercise of stock options during the three months ended March 31, 2026 and 2025 .

The Company issued 471,181 and 509,340 shares of common stock upon vesting of RSUs during the three months ended March 31, 2026 and 2025 , respectively.

Authorized Shares:

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In October 2011, the Company issued an anti-dilutive warrant to Alan H.

Auerbach, the Company’s founder and Chief Executive Officer.

The warrant was issued to provide Mr.

Auerbach, the Company’s founder and Chief Executive Officer (the “Auerbach Warrant”).

The Auerbach Warrant was issued to provide Mr.

Auerbach with the right to maintain ownership of at least 20 % of the Company’s common stock in the event that the Company raised capital through the sale of its securities in the future.

In connection with the closing of a public offering in October 2012, the exercise price and number of shares underlying the warrant issued to Mr.

Auerbach were established and, accordingly, the final value of the warrant became fixed.

Pursuant to the terms of the warrant, as amended in June 2021, Mr.

Auerbach may exercise the warrant to acquire 2,116,250 shares of the Company’s common stock at $ 16 per share until October 4, 2026.

In connection with the closing of a public offering in October 2012, the exercise price and number of shares underlying the Auerbach Warrant were established and, accordingly, the final value of the Auerbach Warrant became fixed.

Pursuant to the terms of the Auerbach Warrant, as amended in June 2021, Mr.

Auerbach may exercise the Auerbach Warrant to acquire 2,116,250 shares of the Company’s common stock at $ 16 per share until October 4, 2026.

The Board of Directors is submitting for stockholder approval a second amendment (the “Auerbach Warrant Amendment”) to the Auerbach Warrant, as amended by the first amendment on April 1, 2021.

The Auerbach Warrant Amendment was approved by the Company’s Compensation Committee and Board of Directors on March 13, 2026 and March 20, 2026, respectively, and in each case, is subject to approval by the Company’s stockholders at the Annual Meeting.

Stock Options and Restricted Stock Units:

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The exercise price of incentive stock options granted under the 2011 Plan must be at least equal to the fair value of such shares on the date of grant .

On April 1, 2021, the Board of Directors adopted an amendment to the 2011 Plan to increase the number of shares of the Company's common stock reserved for issuance thereunder by 2,000,000 shares.

The amendment was approved by the Company's stockholders on June 15, 2021.

On June 18, 2024, the stockholders of the Company approved an amendment to the Company ’ s 2011 Plan, increasing the number of authorized shares of the Company’s common stock, par value $ 0.0001 per share, that may become issuable under the 2011 Plan by 3,000,000 shares and extending the period during which incentive stock options may be granted.

As of September 30, 2025 a total of 17,529,412 shares of the Company’s common stock have been reserved for issuance under the 2011 Plan.

As of March 31, 2026 , a total of 17,529,412 shares of the Company’s common stock have been reserved for issuance under the 2011 Plan.

All of the options awarded by the Company have been “plain vanilla options” as determined by the SEC Staff Accounting Bulletin 107 — Share Based Payment.

As of September 30, 2025 , 4,518,398 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2011 Plan and 3,310,878 shares of the Company’s common stock are available for future issuance under the 2011 Plan.

The fair value of options granted to employees and nonemployees was estimated using the Black-Scholes Option Pricing Method (see Note 2—Significant Accounting Policies) with the following weighted-average assumptions used during the nine months ended September 30, 2025 :

As of March 31, 2026 , 5,201,704 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2011 Plan and 2,174,925 shares of the Company’s common stock are available for future issuance under the 2011 Plan.

Dividend yield

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On July 15, 2021, the Board of Directors adopted an amendment to the 2017 Plan to increase the number of shares of the Company ’ s common stock reserved for issuance thereunder by 1,000,000 share s.

As of September 30, 2025 a total of 3,000,000 shares of the Company’s common stock have been reserved for issuance under the 2017 Plan.

As of September 30, 2025 , a total of 393,800 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2017 Plan and 1,328,505 shares of the Company’s common stock are available for future issuance under the 2017 Plan.

As of March 31, 2026 , a total of 397,974 shares of the Company’s common stock are issuable upon the exercise of outstanding stock options and vesting of RSUs granted under the 2017 Plan and 1,282,048 shares of the Company’s common stock are available for future issuance under the 2017 Plan.

Stock-based compensation expense was as follows (in thousands):

For the Three Months Ended

For the Nine Months Ended

September 30,

Stock-based compensation:

Selling, general, and administrative

$ 236 $ 386 $ 781 $ 1,247

Research and development

31 57 124 234

Restricted stock units:

Selling, general, and administrative

815 1,056 2,497 3,081

Research and development

591 555 1,925 1,931

Total stock-based compensation expense

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Stock Option Roll Forward:

Weighted Average Exercise Price

Weighted Average Remaining Contractual Term (years)

Aggregate Intrinsic Value (in thousands)

Intrinsic Value

(in thousands)

Outstanding at December 31, 2025

3,217,289 $ 16.13

( 84,954 ) 3.57

( 55,882 ) 2.33

( 850,176 ) 60.00

Outstanding at September 30, 2025

Outstanding at March 31, 2026

3,581,625 $ 15.17 5.6 $ 4,193

Vested and expected to vest at September 30, 2025

Vested and expected to vest at March 31, 2026

3,581,625 $ 15.17 5.6 $ 4,193

3,004,142 $ 17.08 4.9 $ 3,424

At September 30, 2025 , total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $ 0.7 million , which is expected to be recognized over a weighted-average period o f 1.1 years .

At September 30, 2025 , the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $ 3.8 million , which is expected to be recognized over a weighted-average period of 1.3 years .

The weighted-average grant date fair value of options granted during the nine months ended September 30, 2025 and 2024 was $ 1.95 and $ 4.57 per share, respectively.

The weighted average grant date fair value of RSUs awarded during the nine months ended September 30, 2025 and 2024 was $ 3.34 and $ 5.89 per share, respecti vely.

At March 31, 2026 , total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $ 1.7 million , which is expected to be recognized over a weighted-average period o f 1.7 years .

At March 31, 2026 , the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $ 8.8 million , which is expected to be recognized over a weighted-average period of 1.7 years .

The weighted-average grant date fair value of options granted during the three months ended March 31, 2026 and 2025 was $ 4.37 and $ 1.95 per share, respectively.

The weighted-average grant date fair value of RSUs awarded during the three months ended March 31, 2026 and 2025 was $ 6.79 and $ 3.28 per share, respecti vely.

Restricted Stock Unit Roll Forward:

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( 471,181 ) $ 4.70

Nonvested shares at September 30, 2025

Nonvested shares at March 31, 2026

2,018,053 $ 5.37

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The Company is required to make matching contributions to the 401 (k) plan equal to 100 % of the fi rst 3% of wages deferred by each participating employee and 50 % on the next 2% of wages deferred by each participating employee.

The Company incurred expenses for employer matching contributions of approximately $ 1.4 million and $ 1.4 million for the nine months ended September 30, 2025 and 2024 , respectively.

The Company incurred expenses for employer-matching contributions of approximately $ 0.6 million and $ 0.5 million for the three months ended March 31, 2026 and 2025 , respectively.

Note 12 — Commitments and Contingencies:

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Contractual obligations represent future cash commitments and liabilities under agreements with third parties and exclude contingent liabilities for which the Company cannot reasonably predict future payment.

The Company’s contractual obligations result primarily from obligations for various contract manufacturing organizations and clinical research organizations, which include potential payments we may be required to make under our agreements.

The contracts also contain variable costs and milestones that are hard to predict as they are based on such things as patients enrolled and clinical trial sites.

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Takeda received an upfront license fee of $ 7.0 million in October 2022 and is eligible to receive potential future milestone payments of up to $ 287.3 million upon the Company’s achievement of certain regulatory and commercial milestones over the course of the exclusive license agreement, as well as tiered royalty payments for any net sales of alisertib.

No milestones were achieved as of September 30, 2025.

No milestones were achieved as of March 31, 2026 .

Legal Proceedings:

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The jury further rejected AstraZeneca’s challenges to the validity of the patents, finding that they are not invalid.

The jury awarded damages to Wyeth for past acts of infringement through December 31, 2023, in the amount of $ 107,500,000 .

The jury awarded damages to Wyeth for past acts of infringement through December 31, 2023, in the amount of $ 107.5 million.

A separate bench trial related to certain equitable claims and defenses raised by AstraZeneca was held before Judge Kennelly on June 20 and 25, 2024.

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and Sanofi-Aventis U.S.

LLC filed a motion for leave to file an amicus curiae brief in the Federal Circuit appeal.

That motion was granted on May 16, 2025.

LLC filed a motion for leave to file an amicus curiae brief in the Federal Circuit.

The motion was granted on May 16, 2025.

On June 6, 2025, Wyeth filed its reply brief.

Briefing on the appeal is now complete, and the parties await further order from the Court.

Briefing on the appeal is now complete, and the Court has scheduled oral arguments for May 7, 2026.

Acebright China Litigation

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On January 10, 2025, the Court conducted a hearing of party experts on the evaluation of evidence.

On July 14, 2025, the Court conducted a hearing for examining evidence and debating merits of party arguments.

On July 14, 2025, the Court conducted a hearing to examine evidence and debate merits of party arguments.

On September 28, 2025, the Court issued a first -instance decision, deciding that Acebright’s product does not fall within the scope of the patent-in-suit, and Acebright did not infringe the NERLYNX® Patents.

The Court also decided that the Company’s enforcement efforts were not malicious and did not amount to unfair competition.

Aosaikang China Litigation

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On March 18, 2025, the Company filed a request with the NMPA to set up a nine -month stay on Demai’s ANDA.

On November 4, 2025, the NMPA approved Demai’s ANDA to market a generic version of Puma’s NERLYNX® in China with the approval number of GuoYaoZhunZi H20255844.

Hexal European Patent Opposition

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EP2416774 which was licensed from Pfizer in 2011, and which claims neratinib for use in a method for treating HER- 2/neu overexpressed/amplified cancer and improving IDFS, wherein the method comprises delivering neratinib therapy to HER- 2/neu overexpressed/amplified cancer patients following the completion of at least one year of trastuzumab adjuvant therapy, and wherein the neratinib therapy comprises treating the cancer patients with neratinib for at least twelve months.

An oral hearing was held December 8, 2017, wherein the patent was maintained as granted.

An oral hearing was held on December 8, 2017, wherein the patent was maintained as granted.

Following an appeal filed by Hexal, the Board of Appeal of the European Patent Office rejected the claims as granted and all pending auxiliary requests during the oral hearing of September 2, 2021.

Before issuance of a decision, we withdrew approval of the text in which the patent was granted and all pending auxiliary requests, thereby revoking the patent and concluding the appeal.

Before issuance of a decision, the Company withdrew approval of the text in which the patent was granted and all pending auxiliary requests, thereby revoking the patent and concluding the appeal.

One European divisional application, namely EP15188350.1, was granted with the European patent number EP3000467 on March 1, 2023.

Oppositions against EP3000467 were filed by Hexal AG (“Hexal”) on November 3, 2023, by Alfred E.

Oppositions against EP3000467 were filed by Hexal on November 3, 2023, by Alfred E.

Tiefenbacher (GmbH & Co.

KG) on November 28, 2023 and by Generics (UK) Limited (“Generics”) on December 1, 2023.

EP3000467 is used as the basic patent for Supplementary Protection Certificate applications for the EMA-approved NERLYNX® product, 17 of which have been granted, three proceedings have been stayed, and eleven are in active prosecution.

The patentee response to the notice of opposition was filed on April 15, 2024, following which, all three opponents filed additional arguments in reply to the patentee’s submission.

On February 6, 2025, the Company filed its response to the summons to attend oral proceedings, including six auxiliary requests.

Tiefenbacher and Hexal AG filed their responses to the summons to oral proceedings on February 6 and 7, 2025, respectively.

Tiefenbacher and Hexal filed their responses to the summons to oral proceedings on February 6 and 7, 2025, respectively.

Hexal filed a further brief on March 19, 2025.

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EP3000467 was upheld as amended after the first instance hearing based on Auxiliary Request 1, which covers the EMA approved indication for NERLYNX® as an extended adjuvant therapy for treating early stage hormone receptor-positive HER- 2 -overexpressed/amplified breast cancer.

The first instance decision may be appealed.

Hexal filed an appeal on June 6, 2025, Generics [UK] Limited filed an appeal on June 20, 2025 and Wyeth filed an appeal on June 30, 2025.

Hexal filed an appeal on June 6, 2025, Generics filed an appeal on June 20, 2025 and Wyeth filed an appeal on June 30, 2025.

On September 5, 2025, Wyeth filed its grounds of appeal, including nine auxiliary requests.

On the same day, Hexal filed its grounds of appeal.

Generics filed its grounds of appeal on September 4, 2025, and Alfred E.

Tiefenbacher filed its grounds of appeal on September 1, 2025.

On December 16, 2025, Alfred E.

Tiefenbacher withdrew its appeal.

Wyeth responded to the opponents’ grounds of appeal on January 12, 2026.

On March 2, 2026, Hexal withdrew its request for oral proceedings, but remains a party to the proceedings.

One European divisional application is pending in the same family, namely EP 23157078.8.

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The first office action was issued on January 28, 2025 with a response to the first office action filed on July 22, 2025.

Note 13 — Subsequent Event

On May 4, 2026, the Company paid $ 11.5 million to Athyrium Opportunities IV Co-Invest 1 LP, consisting of principal, interest and exit fees due under the 2021 Note Purchase Agreement.

This payment was made ahead of the maturity date of July 23, 2026, reduces the principal balance outstanding under the Athyrium Notes to zero and terminates all remaining obligations of the Company under the 2021 Note Purchase Agreement, other than customary continuing indemnification obligations.

MANAGEMENT ’ S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy and for use in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

We currently market NERLYNX in the United States using our direct specialty sales force consisting of approxima tely 38 sales specialists.

Our sales specialists are supported by an experienced sales leadership team consisting of several regional business leaders and a Vice President of sales, as well as experienced professionals in marketing, managed markets, access and reimbursement, research, and sales planning and operations.

We currently market NERLYNX in the United States using our direct specialty sales force consisting of approximately 35 sales specialists as of December 31, 2025.

Our sales specialists are supported by an experienced sales leadership team consisting of regional managers and directors, as well as a commercial team of experienced professionals in marketing, access and reimbursement, managed markets, marketing research, commercial operations and sales force planning and management.

Outside the United States, we seek to enter into exclusive sub-license agreements with third parties to pursue regulatory approval, if necessary, and commercialize NERLYNX, if approved.

As of September 30, 2025, NERLYNX has received approval for the treatment of certain patients with extended adjuvant or metastatic HER2-positive breast cancer in over 40 countries outside the United States.

We are currently party to several sub-licenses in various regions outside the United States, including Europe, Australia, Canada, China, Southeast Asia, Israel, South Korea, Russia and various countries and territories in Central America, South America, Africa and the Middle East.

As of March 31, 2026, NERLYNX has received approval for the treatment of certain patients with extended adjuvant or metastatic HER2-positive breast cancer in over 60 countries outside the United States.

We are currently party to several sub-licenses in various regions outside the United States, including Europe (excluding Ukraine), Australia, Canada, China, Southeast Asia, Israel, South Korea, Russia and various countries and territories in Central America, South America, Africa and the Middle East.

In September 2022, we entered into an exclusive license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) to license the worldwide research and development and commercial rights to alisertib.

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In clinical trials to date, alisertib has shown single agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancers, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer and head and neck cancer.

We initiated the ALISertib in CAncer (ALISCA™ -Lung1) Phase II trial (PUMA-ALI-4201) of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer in February 2024, and we commenced the ALISCA™ -Breast1 Phase II trial (PUMA-ALI-1201) in November of 2024.

Under the terms of the exclusive license agreement, we assumed sole responsibility for the global development and commercialization of alisertib.

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We recorded in-process research and development expense of $7.0 million during the year ended December 31, 2022 in connection with the upfront payment related to the asset acquisition.

As of September 30, 2025, no milestones had been accrued as the underlying contingencies were not probable or estimable.

As of March 31, 2026, no milestones had been accrued as the underlying contingencies were not probable.

Our expenses to date have been related to hiring staff, commencing company-sponsored clinical trials, building out of our corporate infrastructure and, since 2017, the commercial launch of NERLYNX.

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Accordingly, our success depends not only on the safety and efficacy of our drug candidates, but also on our ability to finance product development.

To date, our major sources of working capital have been proceeds from product and license revenue, public offerings of our common stock, proceeds from our credit facility and sales of our common stock in private placements.

We intend to satisfy our near-term liquidity requirements through a combination of our existing cash and cash equivalents and marketable securities as of September 30, 2025, and proceeds that will become available to us through product sales, royalties and sub-license milestone payments.

To date, our major sources of working capital have been proceeds from product and license revenue, public and private offerings of our common stock, and proceeds from debt financings.

We intend to satisfy our near-term liquidity requirements through a combination of our existing cash and cash equivalents and marketable securities as of March 31, 2026, and proceeds that we expect to become available to us through product sales, royalties and sub-license milestone payments.

However, this intention is based on assumptions that may prove to be wrong.

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Critical Accounting Policies

As of the date of the filing of this Quarterly Report, we believe there have been no material changes to our critical accounting policies and estimates during the nine months ended September 30, 2025 from our accounting policies at December 31, 2024, as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024.

As of the date of the filing of this Quarterly Report, we believe there have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2026 from our accounting policies at December 31, 2025, as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.

Summary of Income and Expenses

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Research and development expenses (“R&D expenses”) include costs associated with services provided by consultants who conduct and perform clinical services on our behalf and contract organizations for the manufacturing of clinical materials.

During the three and nine months ended September 30, 2025 and 2024, our R&D expenses consisted primarily of clinical research organization (“CRO fees”);

During the three months ended March 31, 2026 and 2025, our R&D expenses consisted primarily of clinical research organization (“CRO fees”);

fees paid to consultants;

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Internal R&D expenses primarily consist of payroll-related costs and also include equipment costs, travel expenses and supplies.

We do not believe that tariffs imposed or proposed to be imposed by the United States, particularly with the European Union and China, will have a material impact on our product costs or results of operations.

However, shifts in trade policies in the United States and other countries have been rapidly evolving and are difficult to predict.

We do not believe that tariffs imposed or proposed to be imposed by the United States, particularly with the EU and China, will have a material impact on our product costs or results of operations.

However, shifts in trade policies in the United States and other countries have been rapidly evolving and are difficult to

On July 4, 2025, the “One Big Beautiful Bill” was signed into law, which includes significant changes to federal tax law and other regulatory provisions that may impact us.

As of the date of these financial statements, we have evaluated the impact of the changes to Section 174 – Amortization of research and experimental expenditures on the valuation allowance release.

We intend to deduct the capitalized costs over two years.

This deduction reduces the amount of net operating losses being utilized but results in a net zero change to the deferred tax asset balance.

Therefore, we have concluded that it remains reasonable to maintain the $7.0 million estimate for the valuation allowance release as of September 30, 2025 as the facts and circumstances supporting the deferred tax asset have not materially changed.

On April 2, 2026, the U.S.

government issued a proclamation under Section 232 of the Trade Expansion Act of 1962, imposing new tariffs on imported patented pharmaceutical products and APIs.

Any potential impact of the proclamation on the Company is uncertain and under review.

Results of Operations

Three Months Ended September 30, 2025 Compared to Three Months Ended September 30, 2024

Three Months Ended March 31, 2026 Compared to Three Months Ended March 31, 2025

Total revenue:

Total revenue for the three months ended September 30, 2025 was approximately $54.5 million, compared to $80.5 million for the three months ended September 30, 2024.

This decrease in total revenue was due to a decrease in product revenue, net of approximately $4.2 million and a decrease in royalty revenue of $21.8 million.

Total revenue for the three months ended March 31, 2026 was approximately $44.8 million, compared to $46.0 million for the three months ended March 31, 2025.

This decrease in total revenue was due to a decrease in product revenue, net of approximately $1.1 million and a slight decrease in royalty revenue.

Product revenue, net:

Product revenue, net was approximately $51.9 million for the three months ended September 30, 2025, compared to $56.1 million for the three months ended September 30, 2024.

This decrease in product revenue, net, compared to the three months ended September 30, 2024, was attributable to a decrease in product supply revenue to our international licensees (reduction in China sales), partially offset by an increase in domestic sales resulting from an 8% increase in b ottles of NERLYNX sold in the U.S.

market and an increase in net selling price.

This increase in gross domestic sales was partially offset by greater deductions to gross revenue for variable consideration, primarily related to government chargebacks.

Product revenue, net was approximately $42.0 million for the three months ended March 31, 2026, compared to $43.1 million for the three months ended March 31, 2025.

This decrease in product revenue, net, compared to the three months ended March 31, 2025, was primarily attributable to a greater deduction to gross revenue for variable consideration, primarily related to government chargebacks and payor mix, partially offset by an increase in selling price.

Royalty revenue:

Royalty revenue was approximately $2.6 million for the three months ended September 30, 2025 , compared to approximately $24.4 million for the three months ended September 30, 2024.

The decrease was primarily due to timing of sales made into China by our sub-licensee.

Royalty revenue was approximately $2.9 million for each of the three months ended March 31, 2026 and 2025 as sales were relatively consistent to our international partners.

Cost of sales:

Cost of sales was approximately $12.2 million for the three months ended September 30, 2025 , compared to approximately $29.1 million for the three months ended September 30, 2024.

The decrease was primarily due to timing of sales made into China by our sub-licensee and the related cost of products shipped and royalty expense.

Cost of sales was approximately $10.4 million for the three months ended March 31, 2026 , compared to approximately $10.6 million for the three months ended March 31, 2025.

Cost of sales was relatively consistent year-over-year as sales of our product bottles were relatively consistent.

Selling, general and administrative expenses:

SG&A expenses were approximately $16.8 million for the three months ended September 30, 2025, compared to approximately $16.8 million for the three months ended September 30, 2024.

SG&A expenses for the three months ended September 30, 2025 and 2024 were as follows:

SG&A expenses were approximately $18.4 million for the three months ended March 31, 2026, compared to approximately $17.6 million for the three months ended March 31, 2025.

SG&A expenses for the three months ended March 31, 2026 and 2025 were as follows:

Selling, general, and administrative expenses

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(in thousands)

September 30,

Payroll and related costs

Provision for credit loss recovery

Provision for credit loss

Professional fees and expenses

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Stock-based compensation

SG& A expenses remained virtually unchanged for the three months ended September 30, 2025 , compared to the same period in 2024 , primarily attributable to the following:

an increase in credit loss recovery of approximately $0.2 million, primarily related to the payment history of a customer receivable;

a decrease in professional fees and expenses of approximately $0.3 million, pri marily related to legal fees associated with the AstraZeneca litigation in the prior year;

a decrease in stock-based compensation expense of approximately $0.4 million, primarily due to newer awards at a lower grant price.

SG& A expenses increased approximately $0.8 million the three months ended March 31, 2026 , compared to the same period in 2025 , primarily attributable to the following:

an increase in payroll and related cost s of $0.9 million due primarily to increases in employee compensation;

an increase in professional fees and expenses of approximately $0.4 million, primarily related to marketing and market access costs.

Partially offset by:

an increase in payroll and related costs of approximately $0.8 million, primarily due to an increase in bonus related payroll costs as well as increases in our healthcare insurance premiums.

a decrease in credit loss of approximately $0.2 million, primarily related to the payment history of a customer receivable.

Research and development expenses:

R&D expenses were approxi mately $15.9 million for the three months ended September 30, 2025, compared to approximately $12.6 million for the three months ended September 30, 2024.

R&D expenses for the three months ended September 30, 2025 and 2024, were as follows:

R&D expenses were approxi mately $19.8 million for the three months ended March 31, 2026, compared to approximately $13.9 million for the three months ended March 31, 2025.

R&D expenses for the three months ended March 31, 2026 and 2025 were as follows:

Research and development expenses

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(in thousands)

September 30,

Clinical trial expense

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Stock-based compensation

R&D exp enses increased by a pproxim ately $3.4 million for the three m onths ended September 30, 2025, compared to the same period in 2024, primarily attributable to the following:

R&D exp enses increased by a pproxim ately $5.9 million for the three m onths ended March 31, 2026, compared to the same period in 2025, primarily attributable to the following:

an increase in clinical trial expense of approximately $5.2 million, primarily due to increased alisertib study activity;

an increase in internal R&D expense of approximatel y $0.9 million, primarily due to increased payroll and healthcare costs;

an increase in consultants and contractors expense of approximately $0.6 million, primarily due to increased alisertib study activity.

an increase in internal R&D expense of approximately $0.7 million, primarily due to increased employee compensation.

Other income (expenses):

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(in thousands)

September 30,

Interest income

Interest expense

Interest income:

For the three months ended September 30, 2025 , we recognized approximately $1.0 million in interest income, compared to approximately $1.3 million of interest income for the three m onths ended September 30, 2024 .

The decreas e in interest incom e was primarily the result of lower investment balances and timing of investments.

Interest expense:

For the three months ended

September 30, 2025

March 31, 2026

, we recognized approximately $0.7 million in interest expense, compared to approximately $2.2 million of interest expense for the three m onths ended

September 30, 2024

The decrease in interest expense was primarily related to a lower debt balance as we began paying down our debt principal during the three months ended September 30, 2024.

March 31, 2025

The decrease in interest expense was primarily related to a lower debt balance as we continue paying down our debt principal.

Other income:

For the three months ended

September 30, 2025

, we recognized approximately $0.1 million in other income, compared to approximately $0.3 million of other income for the three m onths ended

September 30, 2024

The decrease in other income was

primarily due to unfavorable exchange rates in Euro-denominated transactions.

Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024

Total revenue:

Total revenue for the nine months ended September 30, 2025 was approximately $152.9 million, compared to $171.4 million for the nine months ended September 30, 2024.

This $18.5 million decrease in total revenue was due to a decrease in royalty revenue of $21.9 million, partially offset by an increase in product revenue, net of approximately $3.4 million.

Product revenue, net:

Product revenue, net was app roximately $144.2 millio n for the nine months ended September 30, 2025, compared t o $140.8 million for the nine months ended September 30, 2024.

This increase in product revenue, net, compared to the nine months ended September 30, 2024, was attributable to an increase in domestic sales resulting from a 3% increase in b ottles of NERLYNX sold in the U.S.

market and an increase in net selling price, partially offset by an increase in deductions to gross r evenue for variable consideration, primarily related to government chargebacks.

Royalty revenue:

Royalty revenue was approximately $8.7 million and $30.6 million for the nine months ended September 30, 2025 and September 30, 2024 respectively.

The decrease in royalty revenue was primarily due to a decrease in sales to our international licensees (reduction in China sales).

Cost of sales:

Cost of sales was approximately $35.0 million for the nine months ended September 30, 2025 , compared to approximately $50.5 million for the nine months ended September 30, 2024 .

The decrease was primarily due to timing of sales made into China by our sub-licensee and the related cost of products shipped and royalty expense.

Selling, general and administrative expenses:

SG&A expenses were approximately $52.5 million for the nine months ended September 30, 2025, compared to approximately $63.5 million for the nine months ended September 30, 2024.

SG&A expenses for the nine months ended September 30, 2025 and 2024 were as follows:

Selling, general, and administrative expenses

For the Nine Months Ended

(in thousands)

September 30,

Payroll and related costs

Provision for credit loss recovery

Professional fees and expenses

Travel and meetings

Facilities and equipment costs

Stock-based compensation

SG& A expenses decreased by approximately $11.1 million for the nine months ended September 30, 2025 , compared to the same period in 2024 , primarily attributable to the following:

an increase in provision for credit loss of approximately $0.2 million, primarily related to the payment history of a customer receivable;

a decrease in professional fees and expenses of approximately $11.3 million, primarily related to legal fees associated with the AstraZeneca litigation in the prior year;

a decrease in stock-based compensation expense of approximately $1.1 million, primarily due to newer awards at a lower grant price.

Partially offset by:

an increase in payroll and related costs of approximately $2.0 million, primarily due to the severance costs related to the departure of our Chief Commercial Officer , increased headcount in our sales team as well as increases in our healthcare insurance premiums.

Research and development expenses:

R&D expenses were approxi mately $45.2 million for the nine months ended September 30, 2025, compared to approximately $39.8 million for the nine months ended September 30, 2024.

R&D expenses for the nine months ended September 30, 2025 and 2024, were as follows:

Research and development expenses

For the Nine Months Ended

(in thousands)

September 30,

Clinical trial expense

Consultant and contractors

Stock-based compensation

R&D exp enses increased by a pproxim ately $5.5 million compared to the nine m onths ended September 30, 2024, primarily attributable to the following:

an increase in clinical trial expense of approximately $3.4 million, primarily due to increased alisertib study activity;

an increase in consultants and contractors expense of approximately $1.2 million, primarily due to increased alisertib stud y activity.

Other income (expenses):

Other income (expenses)

For the Nine Months Ended

(in thousands)

September 30,

Interest income

Interest expense

Interest income:

For the nine months ended September 30, 2025 , we recognized approximately $3.1 million in interest income, compared to approximately $3.5 million of interest income for the nine m onths ended September 30, 2024 .

The decreas e in interest income was prima rily the result of lower investment balances and timing of investments.

Interest expense:

September 30, 2025

, we recognized approximately $5.5 million in interest expense, compared to approximately $9.8 million of interest expense for the

m onths ended

September 30, 2024

The decrease in interest expense was primarily related to a lower debt balance as we began paying down our debt principal during the

months ended September 30, 2024.

Other income:

September 30, 2025

, we recognized approximately $0.9 million in other income, compared to approximately $0.6 million of other income for the

m onths ended

September 30, 2024

The increase in other income was

primarily due to favorable exchange rates in Euro-denominated transactions.

March 31, 2026

, we recognized approximately

million in other income, compared to approximately

million of other income for the three months ended

March 31, 2025

The decrease in other income was primarily due to unfavorable exchange rates in Euro-denominated transactions.

Liquidity and Capital Resources

The following table, which summarizes our liquidity and capital resources as of September 30, 2025 and December 31, 2024 and for the nine months ended September 30, 2025 and 2024, is intended to supplement the more detailed discussion that follows:

The following table, which summarizes our liquidity and capital resources as of March 31, 2026 and December 31, 2025 and for the three months ended March 31, 2026 and 2025, is intended to supplement the more detailed discussion that follows:

Liquidity and capital resources (in thousands)

September 30, 2025

March 31, 2026

December 31, 2025

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Current portion of long-term debt

Long-term debt

Stockholders’ equity

Nine Months Ended

September 30, 2025

September 30, 2024

Three Months Ended

March 31, 2026

March 31, 2025

Cash provided by (used in):

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Financing activities

Net decrease in cash, cash equivalents and restricted cash

On October 26, 2023, we implemented a reduction in our workforce of approximately 5% across the Company.

We incurred approximately $0.4 million in related costs, which included severance payments and insurance premiums.

These costs were recorded in the fourth quarter of 2023.

All payments related to this plan were paid as of June 30, 2024.

Net increase (decrease) in cash, cash equivalents and restricted cash

Operating Activities:

Cash provided by operating activities for the nine months ended September 30, 2025 was $27.4 million and consisted of net income of approximately $17.7 million, adjusted for non-cash items of approximately $13.2 million, which included stock-based compensation of $5.3 million, depreciation and amortization of $8.3 million and provision for credit loss recovery of $0.4 million.

Total changes in cash flows from operations were due to an increase in working capital, primarily related to an increase in accounts receivable of $1.2 million, an increase in inventory of $0.8 million, a decrease of post-marketing commitment liability of $1.7 million, a decrease in operating lease assets and liabilities, net, of $1.3 million and an increase in accrued expenses and other of approximately $0.3 million, partially offset by a decrease in prepaid and other expenses of $0.4 million and an increase in accounts payable of $0.9 million.

Cash provided by operating activities for the nine months ended September 30, 2024 was $23.3 million and consisted of net income of approximately $11.0 million, adjusted for non-cash items of approximately $15.1 million, including stock-based compensation of $6.5 million, depreciation and amortization of $8.7 million and provision for credit loss of $0.1 million.

Total changes in cash flows from operations were due to a decrease in working capital, primarily related to an increase in accounts receivable of approximately $6.7 million (primarily sales to China) and a decrease in accrued expenses and other of approximately $2.1 million, partially offset by a decrease in inventory of $4.4 million (primarily sales to China) and a decrease in prepaid expenses and other of $2.4 million.

Cash provided by operating activities for the three months ended March 31, 2026 was $15.4 million and consisted of net loss of approximately $3.8 million, adjusted for non-cash items of approximately $4.5 million, which included stock-based compensation of $1.9 million and depreciation and amortization of $2.6 million.

Total changes in cash flows from operations were due to an increase in working capital, primarily related to a decrease in accounts receivable of $27.3 million, primarily due to royalty receipts related to China sales and an increase in accounts payable of $3.1 million, partially offset by decrease in accrued expenses and other of approximately $11.7 million related primarily to the payment of royalties, an increase in inventory of $3.2 million related to a receipt of raw material inventory, a decrease in operating lease assets and liabilities, net, of $0.6 million and a decrease of post-marketing commitment liability of $0.5 million.

Cash provided by operating activities for the three months ended March 31, 2025 was $3.6 million and consisted of net income of approximately $3.0 million, adjusted for non-cash items of approximately $5.0 million, which included stock-based compensation of $2.0 million, depreciation and amortization of $2.8 million and provision for credit loss of $0.2 million.

Total changes in cash flows from operations were due to an increase in working capital, primarily related to a decrease in accrued expenses and other of approximately $9.9 million, a decrease in operating lease assets and liabilities, net, of $0.4 million and a decrease of post-marketing commitment liability of $0.4 million and an increase in prepaid and other expenses of $0.8 million, partially offset by a decrease in accounts receivable of approximately $6.6 million and an increase in acc ounts payable of $0.5 million.

Investing Activities:

Cash used in investing activities for the nine months ended September 30, 2025 was approximately $9.2 million, compared to net cash used in investing activities of approximately $18.1 million for the same period in 2024 .

Cash used in investing activities for the nine months ended September 30, 2025 was primarily due to the purchase of available-for-sale securities of approximately $61.2 million, partially offset by the maturity of available-for-sale securities of approximately $52.1 million.

Cash used in investing activities for the nine months ended September 30, 2024 was approximately $18.1 million, compared to net cash used in investing activities of approximately $11.0 million for the same period in 2023.

Cash used in investing activities was primarily due to the purchase of available-for-sale securities of approximately $61.0 million, offset by the maturity of available-for-sale securities of approximately $42.9 million.

Cash provided by investing activities for the three months ended March 31, 2026 was approximately $2.5 million, compared to net cash provided by investing activities of approximately $1.5 million for the same period in 2025 .

Cash provided by investing activities for the three months ended March 31, 2026 was primarily due to the maturity of available-for-sale securities of approximately $27.3 million, partially offset by the purchase of available-for-sale securities of approximately $24.9 million.

Cash provided by investing activities for the three months ended March 31, 2025 was approximately $1.5 million.

Cash provided by investing activities was primarily due to maturity of available-for-sale securities of approximately $14.1 million, partially offset by the purchase of available-for-sale securities of approximately $12.5 million.

Financing Activities:

Cash used in financing activities for the nine months ended September 30, 2025 was approximately $33.9 million, including $33.3 million related to the payment of principal and $0.7 million related exit fees, on our debt with Athyrium, partially offset by $0.1 million in proceeds from shares issued under employee stock plans.

Cash used in financing activities for the nine months ended September 30, 2024 was approximately $22.5 million.

Of this amount, $22.7 million related to the payment of principal, as well as exit fees, on our debt with Athyrium, partially offset by approximately $0.2 million of proceeds from employee stock options exercised.

Cash used in financing activities for the three months ended March 31, 2026 and 2025 was approximately $11.3 million, including $11.1 million related to the payment of principal and $0.2 million related to exit fees, on our debt with Athyrium.

Athyrium Note Purchase Agreement:

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We incurred $1.9 million of deferred financing costs with the initial borrowing of the Athyrium Notes.

Interest on the Athyrium Notes is calculated in part based on the Secured Overnight Financing Rate (“SOFR”), which replaced the “London Interbank Offering Rate” as the floating benchmark for interest rate calculations applicable to the Athyrium Notes pursuant to the terms of the Third Amendment to the Note Purchase Agreement dated as of September 16, 2022 (the “Third Amendment”).

Following the effectiveness of the Third Amendment, the Athyrium Notes bear interest at an annual rate equal to the sum of (a) eight percent (8.00%) plus (b) the lesser of (i) the sum of (x) three-month term SOFR for an interest period of three months plus (y) 0.26161% (26.161 basis points) and (ii) three and one-half of one percent (3.50%) per annum.

Interest on the Athyrium Notes was calculated in part based on the Secured Overnight Financing Rate (“SOFR”), which replaced the “London Interbank Offering Rate” as the floating benchmark for interest rate calculations applicable to the Athyrium Notes pursuant to the terms of the Third Amendment to the Note Purchase Agreement dated as of September 16, 2022 (the “Third Amendment”).

Following the effectiveness of the Third Amendment, the Athyrium Notes bore interest at an annual rate equal to the sum of (a) eight percent (8.00%) plus (b) the lesser of (i) the sum of (x) three-month term SOFR for an interest period of three months plus (y) 0.26161% (26.161 basis points) and (ii) three and one-half of one percent (3.50%) per annum.

Interest is payable quarterly on the last business day of March, June, September and December each year.

In the second quarter of 2024, we began paying the principal payments required to be made quarterly at 11.11% of the original face amount.

The remaining balance will be paid at maturity.

Each principal payment also includes a 2.0% exit payment.

Each quarterly principal payment approximates $11.1 million, and each quarterly exit fee payment approximates $0.2 million.

As of September 30, 2025, the effective interest rate for the loan was 12.99%.

As of September 30, 2025, we may prepay the outstanding principal balance of the notes, in whole or in part, without premium or penalty.

The Athyrium Notes include affirmative and negative covenants applicable to us.

The affirmative covenants include, among others, covenants requiring us to maintain our legal existence and governmental approvals, deliver certain financial reports, maintain insurance coverage, and satisfy certain requirements regarding deposit accounts.

The negative covenants include, among others, restrictions on our transferring collateral, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, selling assets and suffering a change in control, in each case subject to certain exceptions.

We are also required to maintain minimum cash balances and achieve certain minimum product revenue targets, measured as of the last day of each fiscal quarter on a trailing year-to-date basis.

As of September 30, 2025, we were in compliance with such covenants.

As of September 30, 2025 , the principal balance outstanding under the Athyrium Notes was $33.3 million and represents all of our debt.

We are in compliance with all applicable covenants under the Athyrium Notes.

As of March 31, 2026 , the effective interest rate for the loan was 12.99%.

As of March 31, 2026, we may prepay the outstanding principal balance of the notes, in whole or in part, without premium or penalty.

As of March 31, 2026, the principal balance outstanding under the Athyrium Notes was $11.1 million and represented all of our debt.

We were in compliance with all applicable covenants under the Athyrium Notes as of March 31, 2026.

On May 4, 2026, we paid $11.5 million under the Note Purchase Agreement, ahead of the scheduled maturity date of July 23, 2026.

This payment reduced the principal balance outstanding under the Athyrium Notes to zero and terminated all of our remaining obligations under the Note Purchase Agreement, other than customary continuing indemnification obligations.

Current and Future Financing Needs:

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For example, we in-licensed alisertib from Takeda in 2022 and assumed sole responsibility for its global development and commercialization.

These efforts will require funding in addition to the cash and cash equivalents totaling approximately $53.5 million and approximately $40.9 million in marketable securities available at September 30, 2025 .

While our consolidated financial statements have been prepared on a going concern basis, we may incur significant losses in the future and will need to generate significant revenue to sustain operations and successfully commercialize neratinib and develop alisertib.

These efforts will require funding in addition to the cash and cash equivalents totaling approximately $36.2 million and approximately $65.4 million in marketable securities available at March 31, 2026 .

While our condensed consolidated financial statements have been prepared on a going concern basis, we may incur significant losses in the future and will need to generate significant revenue to sustain operations and successfully commercialize neratinib and develop alisertib.

While we have been successful in raising financing in the past, there can be no assurance that we will be able to do so in the future.

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The outcome of these matters cannot be predicted at this time.

We believe that our existing cash and cash equivalents and marketable securities as of September 30, 2025, and proceeds that will become available to us through product sales and sub-license payments are sufficient to satisfy our operating cash and capital needs for at least one year after the filing of this Quarterly Report.

In addition, we have based our estimate of capital needs on assumptions that may prove to be wrong.

Changes may occur that would consume our available capital faster than anticipated, including changes in and progress of our development activities, the impact of commercialization efforts, acquisitions of additional drug candidates and changes in regulation.

Potential sources of financing include strategic relationships, public or private sales of equity or debt and other sources of funds.

We may seek to access the public or private equity markets when conditions are favorable due to our long-term capital requirements.

If we raise funds by selling additional shares of common stock or other securities convertible into common stock, the ownership interests of our existing stockholders will be diluted.

If we are not able to obtain financing when needed, we may be unable to carry out our business plan.

As a result, we may have to significantly limit our operations, and our business, financial condition and results of operations would be materially harmed.

In such an event, we will be required to undertake a thorough review of our programs, and the opportunities presented by such programs, and allocate our resources in the manner most prudent.

We believe that our existing cash and cash equivalents and marketable securities as of March 31, 2026, and proceeds that will become available to us through product sales and sub-license payments are sufficient to satisfy our operating cash and capital needs for at least one year after the filing of this Quarterly Report.

Non-GAAP Financial Measures

In addition to our operating results, as calculated in accordance with Generally Accepted Accounting Principles (“GAAP”) we use certain non-GAAP financial measures when planning, monitoring, and evaluating our operational performance.

The following table presents our net income and net income per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation.

For the three and nine months ended September 30, 2025 , stock-based compensation represented approximately 5.1% and 5.5% of our operating expenses, respectively, compared to 7.0% and 6.3% for the same respective periods in 2024 , in each case excluding cost of s ales.

The following table presents our net (loss) income and net (loss) income per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation.

For the three months ended March 31, 2026 , stock-based compensation represented approximately 5.0% of our operating expenses, compared to 6.4% for the same respective period in 2025 , in each case excluding cost of s ales.

Our management believes that these non-GAAP financial measures are useful to enhance understanding of our financial performance, are more indicative of our operational performance and facilitate a better comparison among fiscal periods.

These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.

Reconciliation of GAAP Net Income to Non-GAAP Adjusted Net Income and

GAAP Net Income Per Share to Non-GAAP Adjusted Net Income Per Share

Reconciliation of GAAP Net (Loss) Income to Non-GAAP Adjusted Net (Loss) Income and

GAAP Net (Loss) Income Per Share to Non-GAAP Adjusted Net (Loss) Income Per Share

(in thousands except share and per share data)

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

GAAP net income

For the Three Months Ended March 31,

GAAP net (loss) income

Stock-based compensation -

1 unchanged sentence

Research and development (2)

Non-GAAP adjusted net income

GAAP net income per share—basic

Adjustment to net income (as detailed above)

Non-GAAP adjusted basic net income per share

GAAP net income per share—diluted

Non-GAAP adjusted net (loss) income

GAAP net (loss) income per share—basic

Adjustment to net income (as detailed above)

Non-GAAP adjusted diluted net income per share

Non-GAAP adjusted basic net (loss) income per share

GAAP net (loss) income per share—diluted

Adjustment to net (loss) income (as detailed above)

Non-GAAP adjusted diluted net (loss) income per share

(1) To reflect a non-cash charge to operating expense for selling, general, and administrative stock-based compensation.

(2) To reflect a non-cash charge to operating expense for research and development stock-based compensation.

(3) Non-GAAP adjusted basic net income per share was calculated based on 50,339,456 and 49,881,181 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2025, respectively.

(4) Non-GAAP adjusted basic net income per share was calculated based on 49,008,464 and 48,498,579 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2024, respectively.

(5) Non-GAAP adjusted diluted net income per share was calculated based on 50,929,893 and 50,334,553 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2025, respectively.

(6) Non-GAAP adjusted diluted net income per share was calculated based on 49,173,361 and 49,025,103 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2024, respectively.

(3) Non-GAAP adjusted basic net (loss) income per share was calculated based on 50,845,130 and 49,595,697 weighted-average shares of common stock outstanding for the three months ended March 31, 2026 and 2025, respectively.

(4) Potentially dilutive common stock equivalents (stock options restricted stock units and warrants) were not included in this non-GAAP adjusted diluted net loss per share for the three months ended March 31, 2026, as these shares would be considered anti-dilutive.

(5) Non-GAAP adjusted diluted net income per share was calculated based on 49,906,341 weighted-average shares of common stock outstanding for the three months ended March 31, 2025.

Off-Balance Sheet Arrangements

3 unchanged sentences

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