# EDGAR Filing Document

**Accession Number:** 0001401667
**File Stem:** 0001437749-25-025470
**Filing Date:** 2025-8
**Character Count:** 299340
**Document Hash:** 08bb365dec4fb74e3f7193d513932f52
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001437749-25-025470.hdr.sgml**: 20250807

**ACCESSION NUMBER**: 0001437749-25-025470

**CONFORMED SUBMISSION TYPE**: 10-Q

**PUBLIC DOCUMENT COUNT**: 82

**CONFORMED PERIOD OF REPORT**: 20250630

**FILED AS OF DATE**: 20250807

**DATE AS OF CHANGE**: 20250807

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** PUMA BIOTECHNOLOGY, INC.
- **CENTRAL INDEX KEY:** 0001401667
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 770683487
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 10-Q
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-35703
- **FILM NUMBER:** 251194879

**BUSINESS ADDRESS:**
- **STREET 1:** 10880 WILSHIRE BLVD.
- **STREET 2:** SUITE 2150
- **CITY:** LOS ANGELES
- **STATE:** CA
- **ZIP:** 90024
- **BUSINESS PHONE:** (424) 248-6500

**MAIL ADDRESS:**
- **STREET 1:** 10880 WILSHIRE BLVD.
- **STREET 2:** SUITE 2150
- **CITY:** LOS ANGELES
- **STATE:** CA
- **ZIP:** 90024

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** INNOVATIVE ACQUISITIONS CORP
- **DATE OF NAME CHANGE:** 20070601

?xml version='1.0' encoding='ASCII'? pbyi20250630_10q.htm

[**Table of Contents**](#toc)

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**UNITED STATES** 

**SECURITIES AND EXCHANGE COMMISSION** 

**Washington, D.C. 20549** 

------

**FORM 10-Q** 

------

☒ **QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934** 

**For the quarterly period ended June 30, 2025**

**OR** 

☐ **TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934** 

**For the transition period from**&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **to** 

**Commission File Number: 001-35703** 

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## PUMA BIOTECHNOLOGY, INC.
**(Exact name of registrant as specified in its charter)** 

------

---

| | |
|:---|:---|
| **Delaware** | **77-0683487** |
| **(State or other jurisdiction of**<br> **incorporation or organization)** | **(I.R.S. Employer**<br> **Identification Number)** |

---

**10880 Wilshire Boulevard, Suite 2150, Los Angeles, CA 90024** 

**(Address of principal executive offices) (Zip code)** 

**(424) 248-6500** 

**(Registrant**'**s telephone number, including area code)** 

Securities registered pursuant to Section 12(b) of the Exchange Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br> **Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock, par value $0.0001 per share | PBYI | The NASDAQ Stock Market LLC<br> (NASDAQ Global Select Market) |

---

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.&nbsp;&nbsp;&nbsp;&nbsp;Yes ☒&nbsp;&nbsp;&nbsp;&nbsp;No ☐.

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).&nbsp;&nbsp;&nbsp;&nbsp;Yes ☒&nbsp;&nbsp;&nbsp;&nbsp;No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act.

---

| | | | |
|:---|:---|:---|:---|
| Large accelerated filer | ☐ | Accelerated filer | ☒ |
| Non-accelerated filer | ☐ | Smaller reporting company | ☒ |
| Emerging growth company | ☐ |  |  |

---

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).&nbsp;&nbsp;&nbsp;&nbsp;Yes ☐&nbsp;&nbsp;&nbsp;&nbsp;No ☒.

------

Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date. 50,370,723 shares of Common Stock, par value $0.0001 per share, were outstanding as of August 4, 2025.

------

[**Table of Contents**](#toc)

**PUMA BIOTECHNOLOGY, INC.** 

**- INDEX -** 

---

| | | |
|:---|:---|:---|
| | | **Page** |
| [**<u>PART I</u>** – **<u>FINANCIAL INFORMATION:</u>**](#parti) | [**<u>PART I</u>** – **<u>FINANCIAL INFORMATION:</u>**](#parti) | [1](#parti) |
| Item 1. | [<u>Financial Statements (Unaudited):</u>](#parti) | [1](#parti) |
|  | [<u>Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024</u>](#parti) | [1](#parti) |
|  | [<u>Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2025 and 2024</u>](#income) | [2](#income) |
|  | [<u>Condensed Consolidated Statements of Comprehensive Income for the Three and Six Months Ended June 30, 2025 and 2024</u>](#compinc) | [3](#compinc) |
|  | [<u>Condensed Consolidated Statements of Stockholders</u>' <u>Equity for the Three and Six Months Ended June 30, 2025 and 2024</u>](#she) | [4](#she) |
|  | [<u>Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2025 and 2024</u>](#cf) | [6](#cf) |
|  | [<u>Notes to the Unaudited Condensed Consolidated Financial Statements</u>](#notes) | [7](#notes) |
| Item 2. | [<u>Management</u>'<u>s Discussion and Analysis of Financial Condition and Results of Operations</u>](#mda) | [27](#mda) |
| Item 3. | [<u>Quantitative and Qualitative Disclosures About Market Risk</u>](#qqdmr) | [35](#qqdmr) |
| Item 4. | [<u>Controls and Procedures</u>](#cp) | [35](#cp) |
| [**<u>PART II</u>** – **<u>OTHER INFORMATION:</u>**](#partii) | [**<u>PART II</u>** – **<u>OTHER INFORMATION:</u>**](#partii) | [36](#partii) |
| Item 1. | [<u>Legal Proceedings</u>](#legal) | [36](#legal) |
| Item 1A. | [<u>Risk Factors</u>](#risks) | [38](#risks) |
| Item 2. | [<u>Unregistered Sales of Equity Securities and Use of Proceeds</u>](#uses) | [38](#uses) |
| Item 3. | [<u>Defaults Upon Senior Securities</u>](#duss) | [38](#duss) |
| Item 4. | [<u>Mine Safety Disclosures</u>](#msd) | [39](#msd) |
| Item 5. | [<u>Other Information</u>](#oi) | [39](#oi) |
| Item 6. | [<u>Exhibits</u>](#exs) | [40](#exs) |
| [<u>Signatures</u>](#sigs) | [<u>Signatures</u>](#sigs) | [41](#sigs) |

---

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[**Table of Contents**](#toc)

**CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS** 

This Quarterly Report on Form 10-Q, (this "Quarterly Report"), contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Any statements about our expectations, beliefs, plans, objectives, assumptions, future events or performance are not historical facts and may be forward looking. These forward-looking statements include, but are not limited to, statements about:

• the commercialization of NERLYNX® (neratinib) tablets ("NERLYNX");

• the development of our drug candidates, including when we expect to undertake, initiate and complete clinical trials of our drug candidates;

• the anticipated timing of regulatory filings;

• the regulatory approval of our drug candidates;

• our use of clinical research organizations ("CRO") and other contractors;

• our ability to find collaborative partners for research, development and commercialization of potential products;

• efforts of our sub-licensees to obtain regulatory approval and commercialize NERLYNX in areas outside the United States;

• our ability to market any of our products;

• our expectations regarding our costs and expenses;

• our anticipated capital requirements and estimates regarding our needs for additional financing;

• our ability to compete against other companies and research institutions;

• our ability to secure adequate protection for our intellectual property;

• our intention and ability to vigorously defend against any litigation to which we are or may become party;

• our ability to in-license additional drugs;

• our ability to attract and retain key personnel; and

• our ability to obtain adequate financing on favorable terms or at all.

These statements are often, but not always, made through the use of words or phrases such as "anticipate," "estimate," "plan," "project," "continuing," "ongoing," "expect," "believe," "intend" and similar words or phrases. Accordingly, these statements involve estimates, assumptions and uncertainties that could cause actual results to differ materially from those expressed in them. Discussions containing these forward-looking statements may be found throughout this Quarterly Report, including, in Part I, the section entitled "Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations." These forward-looking statements involve risks and uncertainties, including the risks discussed in Part I, Item 1A. "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2024, and this Quarterly Report on Form 10-Q, that could cause our actual results to differ materially from those in the forward-looking statements. Such risks should be considered in evaluating our prospects and future financial performance. We undertake no obligation to update the forward-looking statements or to reflect events or circumstances after the date of this document.

------

[**Table of Contents**](#toc)

**Part I – FINANCIAL INFORMATION**

**Item 1.** **FINANCIAL STATEMENTS**

**PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY**

**CONDENSED CONSOLIDATED BALANCE SHEETS** 

**(in thousands, except share and per share data)**

**(unaudited)** 

---

| | | |
|:---|:---|:---|
|  | ***June 30, 2025*** | ***December 31, 2024*** |
| ***ASSETS*** |  |  |
| Current assets: |  |  |
| Cash and cash equivalents | $54662 | $69219 |
| Marketable securities | 41362 | 31746 |
| Accounts receivable, net of allowance for credit loss of $213 and $362 | 25910 | 32011 |
| Inventory | 8591 | 8724 |
| Prepaid expenses, current | 3889 | 5867 |
| Restricted cash, current | 2091 |  |
| Other assets, current | 73 | 91 |
| Total current assets | 136578 | 147658 |
| Lease right-of-use assets, net | 2828 | 4579 |
| Property and equipment, net | 388 | 515 |
| Intangible assets, net | 46262 | 51131 |
| Restricted cash, long-term |  | 2091 |
| &nbsp;&nbsp;&nbsp; Deferred tax assets | 7075 | 7075 |
| Prepaid expenses and other, long-term | 1785 | 284 |
| Total assets | $194916 | $213333 |
| ***LIABILITIES AND STOCKHOLDERS' EQUITY*** |  |  |
| Current liabilities: |  |  |
| Accounts payable | $5424 | $5509 |
| Accrued expenses, current | 31797 | 36898 |
| Lease liabilities, current | 4364 | 5540 |
| Post-marketing commitment liability | 3294 | 2835 |
| &nbsp;&nbsp;&nbsp; Current portion of long-term debt | 33997 | 45329 |
| &nbsp;&nbsp;&nbsp; Other liabilities, current | 223 |  |
| Total current liabilities | 79099 | 96111 |
| Lease liabilities, long-term |  | 1494 |
| Post-marketing commitment liability, long-term | 230 | 1763 |
| Long-term debt, net | 10869 | 21719 |
| Other liabilities, long-term |  | 121 |
| Total liabilities | 90198 | 121208 |
| Commitments and contingencies (Note 12) |  |  |
| Stockholders' equity: |  |  |
| Common stock - $.0001 par value per share; 100,000,000 shares authorized; 49,892,725 shares issued and outstanding at June 30, 2025 and 49,105,834 issued and outstanding at December 31, 2024 | 5 | 5 |
| Additional paid-in capital | 1410784 | 1407000 |
| &nbsp;&nbsp;&nbsp; Accumulated other comprehensive (loss) income | (14) | 6 |
| Accumulated deficit | (1306057) | (1314886) |
| Total stockholders' equity | 104718 | 92125 |
| Total liabilities and stockholders' equity | $194916 | $213333 |

---

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 1

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[**Table of Contents**](#toc)

**PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY**

**CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS** 

**(in thousands, except share and per share data)** 

**(unaudited)** 

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | ***For the Three Months Ended June 30,*** | ***For the Three Months Ended June 30,*** | ***For the Six Months Ended June 30,*** | ***For the Six Months Ended June 30,*** |
|  | ***2025*** | ***2024*** | ***2025*** | ***2024*** |
| Revenues: |  |  |  |  |
| Product revenue, net | $49188 | $44395 | $92292 | $84674 |
| Royalty revenue | 3248 | 2688 | 6151 | 6175 |
| Total revenue | 52436 | 47083 | 98443 | 90849 |
| Operating costs and expenses: |  |  |  |  |
| Cost of sales | 12301 | 10658 | 22857 | 21386 |
| Selling, general and administrative | 18047 | 24972 | 35651 | 46722 |
| Research and development | 15452 | 13632 | 29315 | 27219 |
| Total operating costs and expenses | 45800 | 49262 | 87823 | 95327 |
| Income (loss) from operations | 6636 | (2179) | 10620 | (4478) |
| Other income (expenses): |  |  |  |  |
| Interest income | 956 | 1244 | 2057 | 2216 |
| Interest expense | (1837) | (3372) | (4014) | (6731) |
| Other income | 410 | 156 | 769 | 247 |
| Total other expenses, net | (471) | (1972) | (1188) | (4268) |
| Net income (loss) before income taxes | $6165 | $(4151) | $9432 | $(8746) |
| Income tax expense | (310) | (378) | (603) | (598) |
| Net income (loss) | $5855 | $(4529) | $8829 | $(9344) |
| Net income (loss) per share of common stock—basic | $0.12 | $(0.09) | $0.18 | $(0.19) |
| Net income (loss) per share of common stock—diluted | $0.12 | $(0.09) | $0.18 | $(0.19) |
| Weighted-average shares of common stock outstanding—basic | 49700217 | 48292414 | 49648246 | 48240835 |
| Weighted-average shares of common stock outstanding—diluted | 50144704 | 48292414 | 50003709 | 48240835 |

---

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 2

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[**Table of Contents**](#toc)

**PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY**

**CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)**

**(in thousands)** 

**(unaudited)** 

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | ***For the Three Months Ended June 30,*** | ***For the Three Months Ended June 30,*** | ***For the Six Months Ended June 30,*** | ***For the Six Months Ended June 30,*** |
|  | ***2025*** | ***2024*** | ***2025*** | ***2024*** |
| Net income (loss) | $5855 | $(4529) | $8829 | $(9344) |
| Other comprehensive income (loss): |  |  |  |  |
| Unrealized loss on available-for-sale securities, net of tax of $0 | (3) | (6) | (20) | (28) |
| Comprehensive income (loss) | $5852 | $(4535) | $8809 | $(9372) |

---

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 3

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[**Table of Contents**](#toc)

**PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY**

**CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS**' **EQUITY**

**(in thousands, except share data)** 

**(unaudited)** 

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| ***For the Three Months Ended June 30, 2025*** | ***For the Three Months Ended June 30, 2025*** | ***For the Three Months Ended June 30, 2025*** | ***For the Three Months Ended June 30, 2025*** |  |  |  |
|  |  |  |  | ***Accumulated*** |  |  |
|  |  |  | ***Additional*** | ***Other*** |  |  |
|  | ***Common Stock*** | ***Common Stock*** | ***Paid-in*** | ***Comprehensive*** | ***Accumulated*** |  |
|  | ***Shares*** | ***Amount*** | ***Capital*** | ***Loss*** | ***Deficit*** | ***Total*** |
| Balance at March 31, 2025 | 49615174 | $5 | 1409026 | (11) | (1311912) | 97108 |
| Stock-based compensation | *—* |  | 1628 |  |  | 1628 |
| Shares issued or restricted stock units vested under employee stock plans | 277551 |  | 130 |  |  | 130 |
| &nbsp;&nbsp;&nbsp; Unrealized loss on available-for-sale securities | *—* |  |  | (3) |  | (3) |
| Net income | *—* |  |  |  | 5855 | 5855 |
| Balance at June 30, 2025 | 49892725 | $5 | $1410784 | $(14) | $(1306057) | $104718 |

---

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| ***For the Three Months Ended June 30, 2024*** | ***For the Three Months Ended June 30, 2024*** | ***For the Three Months Ended June 30, 2024*** | ***For the Three Months Ended June 30, 2024*** | ***For the Three Months Ended June 30, 2024*** |  |  |
|  |  |  |  | ***Accumulated*** |  |  |
|  |  |  | ***Additional*** | ***Other*** |  |  |
|  | ***Common Stock*** | ***Common Stock*** | ***Paid-in*** | ***Comprehensive*** | ***Accumulated*** |  |
|  | ***Shares*** | ***Amount*** | ***Capital*** | ***Loss*** | ***Deficit*** | ***Total*** |
| Balance at March 31, 2024 | 48214663 | $5 | $1400982 | $(26) | $(1349979) | 50982 |
| &nbsp;&nbsp;&nbsp; Stock-based compensation | *—* |  | 2062 |  |  | 2062 |
| &nbsp;&nbsp;&nbsp; Shares issued or restricted stock units vested under employee stock plans | 245457 |  |  |  |  |  |
| &nbsp;&nbsp;&nbsp; Unrealized loss on available-for-sale securities | *—* |  |  | (6) |  | (6) |
| &nbsp;&nbsp;&nbsp; Net loss | *—* |  |  |  | (4529) | (4529) |
| Balance at June 30, 2024 | 48460120 | $5 | $1403044 | $(32) | $(1354508) | $48509 |

---

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 4

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[**Table of Contents**](#toc)

**PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY**

**CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS**' **EQUITY**

**(in thousands, except share data)** 

**(unaudited)** 

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| ***For the Six Months Ended June 30, 2025*** | ***For the Six Months Ended June 30, 2025*** | ***For the Six Months Ended June 30, 2025*** | ***For the Six Months Ended June 30, 2025*** | ***For the Six Months Ended June 30, 2025*** | ***For the Six Months Ended June 30, 2025*** | ***For the Six Months Ended June 30, 2025*** |
|  |  |  |  | ***Accumulated*** |  |  |
|  |  |  | ***Additional*** | ***Other*** |  |  |
|  | ***Common Stock*** | ***Common Stock*** | ***Paid-in*** | ***Comprehensive*** | ***Accumulated*** |  |
|  | ***Shares*** | ***Amount*** | ***Capital*** | ***Income (Loss)*** | ***Deficit*** | ***Total*** |
| Balance at December 31, 2024 | 49105834 | $5 | $1407000 | $6 | $(1314886) | $92125 |
| Stock-based compensation | *—* |  | 3654 |  |  | 3654 |
| Shares issued or restricted stock units vested under employee stock plans | 786891 |  | 130 |  |  | 130 |
| Unrealized loss on available-for-sale securities | *—* |  |  | (20) |  | (20) |
| Net income | *—* |  |  |  | 8829 | 8829 |
| Balance at June 30, 2025 | 49892725 | $5 | $1410784 | $(14) | $(1306057) | $104718 |

---

---

| | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|
| ***For the Six Months Ended June 30, 2024*** | ***For the Six Months Ended June 30, 2024*** | ***For the Six Months Ended June 30, 2024*** | ***For the Six Months Ended June 30, 2024*** | ***For the Six Months Ended June 30, 2024*** | ***For the Six Months Ended June 30, 2024*** | ***For the Six Months Ended June 30, 2024*** |
|  |  |  |  | ***Accumulated*** |  |  |
|  |  |  | ***Additional*** | ***Other*** |  |  |
|  | ***Common Stock*** | ***Common Stock*** | ***Paid-in*** | ***Comprehensive*** | ***Accumulated*** |  |
|  | ***Shares*** | ***Amount*** | ***Capital*** | ***Loss*** | ***Deficit*** | ***Total*** |
| Balance at December 31, 2023 | 47646787 | $5 | $1398605 | $(4) | $(1345164) | $53442 |
| Stock-based compensation | *—* |  | 4439 |  |  | 4439 |
| Shares issued or restricted stock units vested under employee stock plans | 813333 |  |  |  |  |  |
| Unrealized loss on available-for-sale securities | *—* |  |  | (28) |  | (28) |
| Net loss | *—* |  |  |  | (9344) | (9344) |
| Balance at June 30, 2024 | 48460120 | $5 | $1403044 | $(32) | $(1354508) | $48509 |

---

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 5

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[**Table of Contents**](#toc)

**PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY**

**CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS** 

**(in thousands)** 

**(unaudited)** 

---

| | | |
|:---|:---|:---|
|  | ***For the Six Months Ended June 30,*** | ***For the Six Months Ended June 30,*** |
|  | ***2025*** | ***2024*** |
| Operating activities: |  |  |
| Net income (loss) | $8829 | $(9344) |
| Adjustments to reconcile net income (loss) to net cash provided by operating activities: |  |  |
| Depreciation and amortization | 5559 | 5805 |
| Stock-based compensation | 3654 | 4439 |
| &nbsp;&nbsp;&nbsp; Provision for credit loss recovery | (149) | (73) |
| Changes in operating assets and liabilities: |  |  |
| Accounts receivable, net | 6250 | 19805 |
| Inventory, net | 133 | (1969) |
| Prepaid expenses and other | 477 | 1379 |
| Other current assets | 18 | 671 |
| Accounts payable | (85) | 6611 |
| Operating lease assets and liabilities, net | (919) | (750) |
| Accrued expenses and other | (4999) | (13716) |
| Post-marketing commitment liability | (1074) | (585) |
| Net cash provided by operating activities | 17694 | 12273 |
| Investing activities: |  |  |
| &nbsp;&nbsp;&nbsp; Purchase of property and equipment | (81) | (20) |
| Purchase of available-for-sale securities | (34420) | (44892) |
| Maturity of available-for-sale securities | 24784 | 26535 |
| Net cash used in investing activities | (9717) | (18377) |
| Financing activities: |  |  |
| Net proceeds from shares issued under employee stock plans | 130 |  |
| &nbsp;&nbsp;&nbsp; Payment of debt | (22220) | (11110) |
| &nbsp;&nbsp;&nbsp; Payment of exit costs | (444) | (222) |
| Net cash used in financing activities | (22534) | (11332) |
| Net decrease in cash, cash equivalents and restricted cash | (14557) | (17436) |
| Cash, cash equivalents and restricted cash, beginning of period | 71310 | 86676 |
| Cash, cash equivalents and restricted cash, end of period | 56753 | 69240 |
| Supplemental disclosures of non-cash investing and financing activities: |  |  |
| Property and equipment purchases in accounts payable | $10 | $10 |
| Supplemental disclosure of cash flow information: |  |  |
| &nbsp;&nbsp;&nbsp; Interest paid | $3532 | $5814 |
| &nbsp;&nbsp;&nbsp; Income taxes paid | $1030 | $922 |

---

See Accompanying Notes to the Unaudited Condensed Consolidated Financial Statements

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 6

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[**Table of Contents**](#toc)

**PUMA BIOTECHNOLOGY, INC. AND SUBSIDIARY**

**<u>NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS</u>**

**Note *1***—**Business and Basis of Presentation:** 

**Business and Liquidity:** 

Puma Biotechnology, Inc., (the "Company") is a biopharmaceutical company based in Los Angeles, California that develops and commercializes innovative products to enhance cancer care and improve treatment outcomes for patients. The Company is currently commercializing NERLYNX®, an oral version of neratinib ("NERLYNX"), for the treatment of *HER2*-positive breast cancer. Additionally, the Company in-licensed, and is responsible for the global development and commercialization of, alisertib. Alisertib is a selective, small molecule inhibitor of Aurora Kinase A that is designed to disrupt mitosis leading to apoptosis of rapidly proliferating tumor cells dependent on Aurora Kinase. The Company believes alisertib has potential application in the treatment of a range of different cancer types, including hormone receptor positive breast cancer, triple-negative breast cancer and small cell lung cancer.

The Company has one subsidiary, Puma Biotechnology, B.V., a Netherlands company. 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. All intercompany accounts and transactions have been eliminated.

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. In *2017,* the Company received U.S. Food and Drug Administration ("FDA") approval for its *first* product, NERLYNX® (neratinib), formerly known as *PB272* (neratinib, oral), for the extended adjuvant treatment of adult patients with early stage *HER2*-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy. Following FDA approval in *July 2017,* NERLYNX became available by prescription in the United States, and the Company commenced commercialization.

In *February 2020,* NERLYNX was also approved by the FDA 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.

In *2018,* the European Commission ("EC") granted marketing authorization for NERLYNX in the EU for the extended adjuvant treatment of adult patients with early stage hormone receptor positive *HER2*-overexpressed/amplified breast cancer and who are less than *one* year from the completion of prior adjuvant trastuzumab-based therapy.

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

In *September 2022,* the Company entered into an exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited ("Takeda") to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of Aurora Kinase A. Alisertib is an adenosine triphosphate–competitive and reversible inhibitor of Aurora Kinase A and results in disruption of mitosis, leading to apoptosis of rapidly proliferating tumor cells that are dependent on Aurora Kinase A. Alisertib has been tested in clinical trials in patients with metastatic cancers, including breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma and acute myeloid leukemia. Under the terms of the exclusive license agreement, the Company assumed sole responsibility for the global development and commercialization of alisertib. 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. The Company 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 *June 30, 2025*, *no* milestones had been accrued as the underlying contingencies were *not* probable or estimable.

The Company has reported net income of approximately $8.8 million and cash provided by operations of approximately $17.7 million for the *six* months ended *June 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 $96.0 million at *June 30, 2025*.

The Company believes that its existing cash and cash equivalents and marketable securities as of *June 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. The Company continues to remain dependent on its ability to obtain sufficient funding to sustain operations and continue to successfully commercialize neratinib in the United States. While the Company has been successful in raising capital in the past, there can be *no* assurance that it will be able to do so in the future. The Company's ability to obtain funding *may* be adversely impacted by uncertain market and economic conditions, including the Company's success in commercializing neratinib and unfavorable decisions of regulatory authorities or adverse clinical trial results. The outcome of these matters cannot be predicted at this time. 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.

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Since its inception through *June 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 *June 30, 2025*. Such adjustments are of a normal and recurring nature. The condensed consolidated balance sheet as of *December 31, 2024* 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 *June 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. 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.

**Note *2***—**Significant Accounting Policies:** 

The significant accounting policies followed in the preparation of these unaudited consolidated financial statements are as follows:

**Principles of Consolidation:** 

The consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation.

**Segment Reporting:**

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 royalty revenue is derived from our 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. Auerbach. 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 (loss) are also used to monitor budget versus actual results.

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

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| | | | | |
|:---|:---|:---|:---|:---|
|  | ***For the Three Months Ended June 30,*** | ***For the Three Months Ended June 30,*** | ***For the Six Months Ended June 30,*** | ***For the Six Months Ended June 30,*** |
|  | ***2025*** | ***2024*** | ***2025*** | ***2024*** |
| Cost of sales | $12301 | $10658 | $22857 | $21387 |
| General and administrative | 6538 | 13969 | 12718 | 23938 |
| Commercialization | 10517 | 9568 | 20707 | 19899 |
| Research and development: |  |  |  |  |
| Clinical research and development | 7679 | 5094 | 14093 | 10880 |
| Medical affairs | 1631 | 933 | 2784 | 2194 |
| Other research and development (1) | 5506 | 6978 | 11010 | 12592 |
| Operating costs and expenses | 44172 | 47200 | 84169 | 90889 |
| Stock based compensation | 1628 | 2062 | 3654 | 4439 |
| Total operating costs and expenses | $45800 | $49262 | $87823 | $95327 |

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

**Use of Estimates:** 

The preparation of consolidated financial statements in conformity with Generally Accepted Accounting Principles ("GAAP") in the United States, requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the date of the balance sheet, and reported amounts of revenues and expenses for the period presented. Accordingly, actual results could differ from those estimates.

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Significant estimates include estimates for variable consideration for which reserves were established. These estimates are included in the calculation of net revenues and include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company's sale of its products. Other significant estimates include those related to the valuation of deferred income taxes, legal and other expense accruals.

**Net Income (loss) per Share of Common Stock:** 

Basic net income (loss) per share of common stock is computed by dividing net income (loss) 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 (loss) 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. 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 (loss) per share because of their anti-dilutive effect:

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| | | | | |
|:---|:---|:---|:---|:---|
|  | ***For the Three Months Ended*** | ***For the Three Months Ended*** | ***For the Six Months Ended*** | ***For the Six Months Ended*** |
|  | ***June 30,*** | ***June 30,*** | ***June 30,*** | ***June 30,*** |
|  | ***2025*** | ***2024*** | ***2025*** | ***2024*** |
| Options outstanding | 3865148 | 4645280 | 3993693 | 4645280 |
| Warrant outstanding | 2116250 | 2116250 | 2116250 | 2116250 |
| Unvested restricted stock units | 525067 | 999608 | 519545 | 999608 |
| Totals | 6506465 | 7761138 | 6629488 | 7761138 |

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The 2,116,250 shares underlying the warrant will *not* have an impact on our diluted net income (loss) 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 (loss) per share of common stock computations is as follows (in thousands, except share and per share amounts):

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| | | | | |
|:---|:---|:---|:---|:---|
|  | ***For the Three Months Ended June 30,*** | ***For the Three Months Ended June 30,*** | ***For the Six Months Ended June 30,*** | ***For the Six Months Ended June 30,*** |
|  | ***2025*** | ***2024*** | ***2025*** | ***2024*** |
| Numerator: |  |  |  |  |
| Net income (loss) | $5855 | $(4529) | $8829 | $(9344) |
| Denominator: |  |  |  |  |
| Weighted average common stock outstanding for basic net income (loss) per share | 49700217 | 48292414 | 49648246 | 48240835 |
| Net effect of dilutive common stock equivalents | 444487 |  | 355463 |  |
| Weighted average common stock outstanding for diluted net income (loss) per share | 50144704 | 48292414 | 50003709 | 48240835 |
| Net income (loss) per share of common stock |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Basic | $0.12 | $(0.09) | $0.18 | $(0.19) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Diluted | $0.12 | $(0.09) | $0.18 | $(0.19) |

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**Revenue Recognition:**

Under ASC Topic *606, Revenue from Contracts with Customers* ("ASC *606"*), the Company recognizes revenue when its customer obtains control of the promised goods or services, in an amount that reflects the consideration that the entity expects to be entitled in exchange for those goods or services. The Company had *no* contracts with customers until the FDA approved NERLYNX on *July 17, 2017.* Subsequent to receiving FDA approval, the Company entered into a limited number of arrangements with specialty pharmacies and specialty distributors in the United States to distribute NERLYNX. These arrangements are the Company's initial contracts with customers. The Company has determined that these sales channels with customers are similar.

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***Product Revenue, Net:***

The Company sells NERLYNX to a limited number of specialty pharmacies and specialty distributors in the United States. These customers subsequently resell the Company's products to patients and certain medical centers or hospitals. In addition to distribution agreements with these customers, the Company enters into arrangements with healthcare providers and payors that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of the Company's products.

The Company recognizes revenue on product sales when the specialty pharmacy or specialty distributor, as applicable, obtains control of the Company's product, which occurs at a point in time (upon delivery). Product revenue is recorded net of applicable reserves for variable consideration, including discounts and allowances. 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.

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

If taxes relating to product sales should be collected from customers and remitted to governmental authorities, they will be excluded from revenue. 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 *six* months ended *June 30, 2025* and *2024*, respectively.

***Reserves for Variable Consideration:***

Revenue from product sales is recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the Company's sale of its products. These reserves, as detailed below, are based on the related sales, and are classified as reductions of accounts receivable, net when the right of offset exists in accordance with Accounting Standards Update ("ASU") ASU *2013*-*1, Balance Sheet (Topic *210*): Clarifying the Scope of Disclosures about Offsetting Assets and Liabilities,* or as a current liability. These estimates take into consideration a range of possible outcomes that are probability-weighted in accordance with the expected value method in ASC *606* for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.

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 *June 30, 2025*, and, therefore, the transaction price was *not* reduced further during the quarter ended *June 30, 2025*. Actual amounts of consideration ultimately received *may* differ from the Company's estimates. If actual results in the future vary from the Company's estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.

***Trade Discounts and Allowances:***

The Company generally provides customers with discounts, which include incentive fees that are explicitly stated in the Company's contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. The reserve for discounts is established in the same period that the related revenue is recognized, together with reductions to accounts receivable, net on the consolidated balance sheets. In addition, the Company compensates its customers for sales order management, data, and distribution services. The Company has determined such services received to date are *not* distinct from the Company's sale of products to its customers and, therefore, these payments have been recorded as a reduction of revenue within the condensed consolidated statements of operations.

***Product Returns:***

Consistent with industry practice, the Company offers the specialty pharmacies and specialty distributors that are its customers limited product return rights for damaged and expiring product, provided it is within a specified period around the product expiration date as set forth in the applicable individual distribution agreement. The Company estimates the amount of its product sales that *may* be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as a reduction to accounts receivables, net on the consolidated balance sheets. The Company currently estimates product returns using its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has an insignificant number of returns to date and believes that returns of its products will continue to be minimal.

***Provider Chargebacks and Discounts:***

Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to its customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. The reserve for chargebacks is established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and a reduction to accounts receivable, net on the consolidated balance sheets. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by customers, and the Company generally issues credits for such amounts within a few weeks of the customer's notification to the Company of the resale. Chargebacks consist of credits the Company expects to issue for units that remain in the distribution channel at each reporting period end that the Company expects will be sold to qualified healthcare providers and chargebacks that customers have claimed, but for which the Company has *not* yet issued a payment.

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***Government Rebates:***

The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue, net and the establishment of a current liability, which is included in accrued expenses on the condensed consolidated balance sheets. The Company's liability for these rebates consists of invoices received for claims from prior quarters that have *not* been paid or for which an invoice has *not* yet been received, estimates of claims for the current quarter, and estimates of future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel at the end of each reporting period.

***Payor Rebates:***

The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue, net and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheets.

***Other Incentives:***

Other incentives the Company offers include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified commercially insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue but remains in the distribution channel at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included as a component of accrued expenses on the consolidated balance sheets.

***License Revenue:***

The Company also recognizes license revenue under certain of the Company's sub-license agreements that are within the scope of ASC *606.* The terms of these agreements *may* contain multiple performance obligations, which *may* include licenses and research and development activities. The Company evaluates these agreements under ASC *606* to determine the distinct performance obligations. Non-refundable, upfront fees that are *not* contingent on any future performance and require *no* consequential continuing involvement by the Company, are recognized as revenue when the license term commences and the licensed data, technology or product is delivered. The Company defers recognition of non-refundable upfront license fees if the performance obligations are *not* satisfied. The Company's payment terms range between the execution date of the sub-license agreement and *45* days.

Prior to recognizing revenue, the Company makes estimates of the transaction price, including variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will *not* occur and when the uncertainty associated with the variable consideration is subsequently resolved.

If there are multiple distinct performance obligations, the Company allocates the transaction price to each distinct performance obligation based on its relative standalone selling price. The standalone selling price is generally determined based on the prices charged to customers or using expected cost-plus margin. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure.

Since *2018,* the Company has entered into sub-license agreements with certain sub-licensees in territories outside of the United States. These sub-licensing agreements grant certain intellectual property rights and set forth various obligations with respect to actions such as development, pursuit and maintenance of regulatory approvals, commercialization and supply of NERLYNX in the sub-licensees' respective territories.

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

***Royalty Revenue:***

For sub-license agreements that are within the scope of ASC *606,* the Company recognizes revenue when the related sales occur in accordance with the sales-based royalty exception under ASC *606*-*10*-*55*-*65.*

Royalty revenue consists of consideration earned related to international sales of NERLYNX made by the Company's sub-licensees in their respective territories. The Company recognizes royalty revenue when the performance obligations have been satisfied. The Company's payment terms range between *10* and *60* days.

***Royalty Expenses:***

Royalties incurred in connection with the Company's license agreement with Pfizer, as disclosed in Note *12—Commitments* and Contingencies, are expensed to cost of sales as revenue from product sales is recognized.

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**Legal Contingencies and Expense:**

For legal contingencies, the Company accrues a liability for an estimated loss if the potential loss from any claim or legal proceeding is considered probable and the amount can be reasonably estimated. Legal fees and expenses are expensed as incurred based on invoices or estimates provided by legal counsel. The Company periodically evaluates available information, both internal and external, relative to such contingencies and adjusts the accrual as necessary. The Company determines whether a contingency should be disclosed by assessing whether a material loss is deemed reasonably possible. In determining whether a loss should be accrued, the Company evaluates, among other factors, the degree of probability of an unfavorable outcome and the ability to make a reasonable estimate of the amount of the loss (see Note *12—Commitments* and Contingencies).

**Research and Development Expenses:** 

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. Clinical trial expenses include, but are *not* limited to, investigator fees, site costs, comparator drug costs, and CRO costs. In the normal course of business, the Company contracts with *third* parties to perform various clinical trial activities in the ongoing development of potential products. The financial terms of these agreements are subject to negotiation and variations from contract to contract and *may* result in uneven payment flows. Payments under the contracts depend on factors such as the achievement of certain events, the successful enrollment of patients and the completion of portions of the clinical trial or similar conditions. The Company's accruals for clinical trials are based on estimates of the services received and efforts expended pursuant to contracts with numerous clinical trial sites, cooperative groups and CROs. As actual costs become known, the Company adjusts its accruals in that period.

In instances where the Company enters into agreements with *third* parties for clinical trials and other consulting activities, upfront amounts are recorded to prepaid expenses and other in the accompanying consolidated balance sheets and expensed as services are performed or as the underlying goods are delivered. If the Company does *not* expect the services to be rendered or goods to be delivered, any remaining capitalized amounts for non-refundable upfront payments are charged to expense immediately. Amounts due under such arrangements *may* be either fixed fee or fee for service, and *may* include upfront payments, monthly payments and payments upon the completion of milestones or receipt of deliverables.

Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development costs.

**Stock-Based Compensation:** 

***Stock Option Awards***:

ASC Topic *718, Compensation-Stock Compensation* ("ASC *718"*) requires the fair value of all share-based payments to employees and non-employees, including grants of stock options, to be recognized in the statement of operations over the requisite service period. Under ASC *718,* employee and non-employee option grants are generally valued at the grant date and those valuations do *not* change once they have been established. 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 risk-free rate for periods within the contractual life of the option is based on the U.S. Treasury yield curve in effect at the time of grant valuation. Option forfeitures are estimated when the option is granted to reduce the option expense to be recognized over the life of the award. The estimated forfeiture rate considers historical employee turnover rates stratified into employee pools, actual forfeiture experience and other factors. The option expense is adjusted upon the actual forfeiture of a stock option grant and the Company periodically revises the estimated forfeiture rate in subsequent periods if actual forfeitures differ from those estimates. Due to its limited history of stock option exercises, the Company uses the simplified method to determine the expected life of the option grants. Compensation expense related to modified stock options is measured based on the fair value for the awards as of the modification date. Any incremental compensation expense arising from the excess of the fair value of the awards on the modification date compared to the fair value of the awards immediately before the modification date is recognized at the modification date or ratably over the requisite service period, as appropriate.

***Restricted Stock Units:***

RSUs are valued on the grant date and the fair value of the RSUs is equal to the market price of the Company's common stock on the grant date. The RSU expense is recognized over the requisite service period. When the requisite service period begins prior to the grant date (because the service inception date occurs prior to the grant date), the Company is required to begin recognizing compensation cost before there is a measurement date (i.e., the grant date). The service inception date is the beginning of the requisite service period. If the service inception date precedes the grant date, accrual of compensation cost for periods before the grant date shall be based on the fair value of the award at the reporting date. In the period in which the grant date occurs, cumulative compensation cost shall be adjusted to reflect the cumulative effect of measuring compensation cost based on fair value at the grant date rather than the fair value previously used at the service inception date (or any subsequent reporting date). RSU forfeitures are estimated when the RSU is granted to reduce the RSU expense to be recognized over the life of the award. The estimated forfeiture rate considers historical employee turnover rates stratified into employee pools, actual forfeiture experience and other factors. The RSU expense is adjusted upon the actual forfeiture of an RSU grant and the Company periodically revises the estimated forfeiture rate in subsequent periods if actual forfeitures differ from those estimates. Compensation expense related to modified RSUs is measured based on the fair value for the awards as of the modification date. Any incremental compensation expense arising from the excess of the fair value of the awards on the modification date compared to the fair value of the awards immediately before the modification date is recognized at the modification date or ratably over the requisite service period, as appropriate.

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***Warrants*:**

Warrants (see Note *10—Stoc*kholders' Equity for further details) granted to employees and non-employees are normally valued at the fair value of the instrument on the grant date and are recognized in the statement of operations over the requisite service period. When the requisite service period precedes the grant date and a market condition exists in the warrant, the Company values the warrant using the Monte Carlo Simulation Method. 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 risk-free rate for periods within the contractual life of the warrant is based on the U.S. Treasury yield curve in effect at the time of grant valuation. In determining the value of the warrant until the terms are fixed, the Company factors in the probability of the market condition occurring and several possible scenarios. When the requisite service period precedes the grant date and is deemed to be complete, the Company records the fair value of the warrant at the time of issuance as an equity stock-based compensation transaction. The grant date is determined when all pertinent information, such as exercise price and quantity are known.

**Income Taxes:** 

The Company follows ASC Topic *740, Income Taxes* ("ASC *740"*) which requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Under this method, deferred tax assets and liabilities are based on the differences between the consolidated financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance to the extent management concludes it is more likely than *not* that the asset will *not* be realized. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

The standard addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the consolidated financial statements. Under ASC *740,* the Company *may* recognize the tax benefit from an uncertain tax position only if it is more likely than *not* that the tax position will be sustained on examination by the tax authorities, based on the technical merits of the position. The tax benefits recognized in the consolidated financial statements from such a position should be measured based on the largest benefit that has a greater than *50%* likelihood of being realized upon ultimate settlement. 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 *June 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. The Company is currently evaluating the provisions of the new law and the potential effects on its financial position, results of operations, and cash flows. As of the date of these financial statements, the Company has *not* completed its assessment, and therefore *no* adjustments have been made. Additional disclosures will be provided in future periods as the impact of the legislation is determined.

**Financial Instruments:**

The carrying value of financial instruments, such as cash equivalents, accounts receivable and accounts payable, approximate their fair value because of their short-term nature. The carrying value of long-term debt approximates its fair value as the principal amounts outstanding are subject to variable interest rates that are based on market rates that are regularly reset.

**Cash and Cash Equivalents:**

The Company classifies all highly liquid instruments with an original maturity of *three* months or less as cash equivalents.

**Restricted Cash:**

Restricted cash represents cash held at financial institutions that is pledged as collateral for stand-by letters of credit for office leases. The lease-related letters of credit will lapse at the end of the respective lease terms through *2 026.* At each of the periods ending *June 30, 2025* and *December 31, 2024*, the Company had restricted cash in the amount of approximately $2.1 million.

**Investment Securities:** 

The Company classifies all investment securities (short-term and long-term) as available-for-sale, as the sale of such securities *may* be required prior to maturity to implement management's strategies. These securities are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income in stockholders' equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. In accordance with ASU *2016*-*13, Financial Instruments* – *Credit Losses (Topic *326*): Measurement of Credit Losses on Financial Instruments*, credit losses on available-for-sale securities are reported using an expected loss model and recorded to an allowance. Premiums and discounts are amortized or accreted over the life of the related security as an adjustment to yield using the straight-line method. Interest income is recognized when earned.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *13*

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**Assets Measured at Fair Value on a Recurring Basis:** 

ASC Topic *820, Fair Value Measurement* ("ASC *820"*) provides a single definition of fair value and a common framework for measuring fair value as well as disclosure requirements for fair value measurements used in financial statements. Under ASC *820,* fair value is determined based upon the exit price that would be received by a company to sell an asset or paid by a company to transfer a liability in an orderly transaction between market participants, exclusive of any transaction costs. Fair value measurements are determined by either the principal market or the most advantageous market. The principal market is the market with the greatest level of activity and volume for the asset or liability. Absent a principal market to measure fair value, the Company uses the most advantageous market, which is the market from which the Company would receive the highest selling price for the asset or pay the lowest price to settle the liability, after considering transaction costs. However, when using the most advantageous market, transaction costs are only considered to determine which market is the most advantageous and these costs are then excluded when applying a fair value measurement. ASC *820* creates a *three*-level hierarchy to prioritize the inputs used in the valuation techniques to derive fair values. The basis for fair value measurements for each level within the hierarchy is described below, with Level *1* having the highest priority and Level *3* having the lowest.

---

| | |
|:---|:---|
| Level *1:* | Quoted prices in active markets for identical assets or liabilities. |

---

---

| | |
|:---|:---|
| Level *2:* | Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar instruments in markets that are *not* active; and model-derived valuations in which all significant inputs are observable in active markets. |

---

---

| | |
|:---|:---|
| Level *3:* | 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 *June 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):

---

| | | | | |
|:---|:---|:---|:---|:---|
| **<u>June 30, 2025</u>** | ***Level 1*** | ***Level 2*** | ***Level 3*** | ***Total*** |
| Cash equivalents | $16027 | $31338 | $– $| 47365 |
| U.S. Government securities | 19474 |  | – | 19474 |
| Corporate Bonds |  | 154 | – | 154 |
| Commercial paper |  | 21734 | – | 21734 |
|  | $35501 | $53226 | $– $| 88727 |

---

---

| | | | | |
|:---|:---|:---|:---|:---|
| **<u>December 31, 2024</u>** | ***Level 1*** | ***Level 2*** | ***Level 3*** | ***Total*** |
| Cash equivalents | $16996 | $38102 | $– $| 55098 |
| U.S. Government securities | 17568 |  | – $| 17568 |
| Commercial paper |  | 14178 | – | 14178 |
| Totals | $34564 | $52280 | $– $| 86844 |

---

The Company's investments in commercial paper and U.S. government securities are exposed to price fluctuations. The fair value measurements for commercial paper, corporate bonds and U.S. government securities are based upon the quoted prices of similar items in active markets multiplied by the number of securities owned.

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

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
|  | ***Maturity*** | ***Amortized*** | ***Unrealized*** | ***Unrealized*** | ***Estimated*** |
| **<u>June 30, 2025</u>** | ***(in years)*** | ***Cost*** | ***Gains*** | ***Losses*** | ***Fair Value*** |
| *Cash equivalents* | *Cash equivalents* | $47369 | $1 | $(5) | $47365 |
| U.S. Government securities | *Less than 1* | 19478 | 1 | (5) | 19474 |
| Corporate Bonds | *Less than 1* | 154 |  |  | 154 |
| Commercial paper | *Less than 1* | 21740 |  | (6) | 21734 |
| *Totals* | *Totals* | $88741 | $2 | $(16) | $88727 |

---

---

| | | | | | |
|:---|:---|:---|:---|:---|:---|
|  | ***Maturity*** | ***Amortized*** | ***Unrealized*** | ***Unrealized*** | ***Estimated*** |
| **<u>December 31, 2024</u>** | ***(in years)*** | ***Cost*** | ***Gains*** | ***Losses*** | ***Fair Value*** |
| *Cash equivalents* | *Cash equivalents* | $55095 | $3 | $— | $55098 |
| U.S. Government securities | *Less than 1* | 17564 | $6 | $(2) | $17568 |
| Commercial paper | *Less than 1* | 14179 | 7 | (8) | 14178 |
| *Totals* | *Totals* | $86838 | $16 | $(10) | $86844 |

---

**Concentration of Risk:** 

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 *June 30, 2025* were approximately $54.4 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. Pursuant to the Company's internal investment policy, investments must be rated A-*1/P*-*1* or better by Standard and Poor's Rating Service and Moody's Investors Service at the time of purchase.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *14*

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The Company sells its products in the United States primarily through specialty pharmacies and specialty distributors. Therefore, wholesale distributors and large pharmacy chains account for a large portion of its accounts receivables, net and product revenues, net. The creditworthiness of its customers is continuously monitored, and the Company has internal policies regarding customer credit limits. The Company estimates an allowance for credit loss primarily based on the creditworthiness of its customers, historical payment patterns, aging of receivable balances and general economic conditions.

The Company's success depends on its ability to successfully commercialize NERLYNX. The Company currently has a single product and limited commercial sales experience, which makes it difficult to evaluate its current business, predict its future prospects and forecast financial performance and growth. The Company has invested a significant portion of its efforts and financial resources in the development and commercialization of the lead product, NERLYNX, and expects NERLYNX to constitute the vast majority of product revenue for the foreseeable future.

The Company relies exclusively on *third* parties to formulate and manufacture NERLYNX and its drug candidates. The commercialization of NERLYNX and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those *third* parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company has *no* experience in drug formulation or manufacturing and does *not* intend to establish its own manufacturing facilities. The Company lacks the resources and expertise to formulate or manufacture NERLYNX and other drug candidates. While the drug candidates were developed by Pfizer, both the drug substance and drug product are manufactured by *third*-party contractors. The Company is using the same *third*-party contractors to manufacture, supply, store and distribute drug supplies for clinical trials and the commercialization of NERLYNX. If the Company is unable to continue its relationships with *one* or more of these *third*-party contractors, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company intends to rely on *one* or more *third*-party contractors to manufacture the commercial supply of drugs.

**Inventory:**

The Company values its inventories at the lower of cost and estimated net realizable value. The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a *first*-in, *first*-out basis and uses standard costing. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is *first* identified. Such impairment charges, should they occur, are recorded within the cost of sales in the condensed consolidated statements of operations. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory *may* be required, which would be recorded as a cost of sales in the condensed consolidated statements of operations.

The Company capitalizes inventory costs associated with the Company's products after regulatory approval, if any, when, based on management's judgment, future commercialization is considered probable, and the future economic benefit is expected to be realized. Inventory that can be used in either the production of clinical or commercial product is recorded as research and development expense when selected for use in a clinical trial. 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 $7.9 million is located at contract manufacturing organizations in Europe as of *June 30, 2025*.

The Company's inventory balances are as follows:

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| | | |
|:---|:---|:---|
|  | ***June 30, 2025*** | ***December 31, 2024*** |
| Raw materials | $6500 | $7183 |
| Work-in-process (materials, labor and overhead) | 1329 | 758 |
| Finished goods (materials, labor and overhead) | 762 | 783 |
| Total inventories | $8591 | $8724 |

---

**Property and Equipment, Net:**

Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the useful lives of the assets, which is generally three years for computer hardware and software, three years for phone equipment, and seven years for furniture and fixtures. Leasehold improvements are amortized using the straight-line method over the lesser of the useful life or the lease term. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are eliminated from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred.

The Company reviews its long-lived assets used in operations for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset *may not* be recoverable, as required by ASC Topic *360, Property, Plant, and Equipment* ("ASC *360"*)*.* The Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows over the life of the asset to its carrying value on the consolidated balance sheet. 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 *June 30, 2025* and *2024*.

**Leases:**

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"). ROU assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. The assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term. ROU assets are evaluated for impairment using the long-lived assets impairment guidance, as required by ASC *360 .* A significant indication of impairment of an ROU asset would include a change in the extent or manner in which the asset is being used. The Company must make assumptions that underlie the most significant and subjective estimates in determining whether any impairment exists. Those estimates, and the underlying assumptions, include estimates of future cash flow utilizing market lease rates and determination of fair value. If an ROU asset related to an operating lease is impaired, the carrying value of the ROU asset post-impairment should be amortized on a straight-line basis through the earlier of the end of the useful life of the ROU asset or the end of the lease term. Post impairment, a lessee must calculate the amortization of the ROU asset and interest expense on the lease liability separately, although the sum of the *two* continues to be presented as a single lease cost. If a lease is planned to be abandoned with *no* intention of subleasing, the ROU asset should be assessed for impairment.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *15*

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Leases are classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them. For additional information, see Note *5—Leases.*

The Company leases office space and copy machines, all of which are operating leases. Most leases include the option to renew, and the exercise of the renewal options is at the Company's sole discretion. Options to extend or terminate a lease are considered in the lease term to the extent that the option is reasonably certain of exercise. The leases do *not* include options to purchase the leased property. The depreciable life of assets and leasehold improvements is limited by the expected lease term. Covenants imposed by the leases include letters of credit required to be obtained by the lessee.

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 leases as of *June 30, 2025* is 10.9%.

**License Fees and Intangible Assets:**

The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has *no* alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon the asset achieving technological feasibility in accordance with management's assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its drug candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale. The Company capitalizes technology licenses upon reaching technological feasibility.

The Company maintains definite-lived intangible assets related to the license agreement with Pfizer. These assets are amortized over their remaining useful lives, which are estimated based on the shorter of the remaining patent life or the estimated useful life of the underlying product. Intangible assets are amortized using the economic consumption method if anticipated future revenues can be reasonably estimated. The straight-line method is used when future revenues cannot be reasonably estimated. Amortization costs are recorded as part of cost of sales.

The Company assesses its intangible assets for impairment if indicators are present or changes in circumstance suggest that impairment *may* exist. Events that could result in an impairment, or trigger an interim impairment assessment, include the receipt of additional clinical or non-clinical data regarding *one* of the Company's drug candidates or a potentially competitive drug candidate, changes in the clinical development program for a drug candidate, or new information regarding potential sales of the drug. If impairment indicators are present or changes in circumstance suggest that impairment *may* exist, the Company performs a recoverability test by comparing the sum of the estimated undiscounted cash flows of each asset to its carrying value on the consolidated balance sheet. If the undiscounted cash flows used in the recoverability test are less than the carrying value, the Company would determine the fair value of the intangible asset and recognize an impairment loss if the carrying value of the intangible asset exceeds its fair value.

**Recently Issued Accounting Standards:**

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: The ASU requires more detailed information about specified categories of expenses included in certain expense captions presented on the face of the income statement. This ASU is effective for fiscal years beginning after *December 15, 2026,* and for interim periods within fiscal years beginning after *December 15, 2027.* Early adoption is permitted. 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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *16*

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**Note *3***—**Accounts Receivable, Net:**

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

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| | | |
|:---|:---|:---|
|  | ***June 30, 2025*** | ***December 31, 2024*** |
| Trade accounts receivable | $22488 | $26362 |
| Royalty revenue receivable | 3635 | 6011 |
| Total accounts receivable | $26123 | $32373 |
| Allowance for credit losses | (213) | (362) |
| Total accounts receivable, net | $25910 | $32011 |

---

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 *June 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 $0.3 million and $0.2 million for the *three* months ended *June 30, 2025* and *2024*, respectively. The Company recorded a recovery to the provision of credit loss of $0.1 million for each of the *six* months ended *June 30, 2025* and *2024*, respectively.

**Note *4***—**Prepaid Expenses and Other:** 

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

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| | | |
|:---|:---|:---|
|  | ***June 30, 2025*** | ***December 31, 2024*** |
| Current: |  |  |
| CRO services | $74 | $81 |
| Other clinical development | 348 | 347 |
| Insurance | 537 | 1078 |
| Professional fees | 606 | 731 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Prepaid Taxes | 722 | 21 |
| Other | 1602 | 3609 |
|  | 3889 | 5867 |
| Long-term: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; CRO services | 15 | 52 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Insurance | 10 | 11 |
| Other clinical development | 102 | 102 |
| Other | 1658 | 119 |
|  | 1785 | 284 |
| Totals | $5674 | $6151 |

---

Other current prepaid amounts consist primarily of deposits, signing bonuses, licenses, subscriptions and software, and prefunding of reimbursement claims. Other long-term prepaid amounts consist primarily of funding for commercial copay support programs.

**Note *5***—**Leases:**

In *December 2011,* the Company entered into a non-cancelable operating lease for office space in Los Angeles, California, which was subsequently amended in *November 2012, December 2013, March 2014, July 2015,* and *December 2017.* The initial term of the lease was for *seven* years and commenced on *December 10, 2011.* As amended, the Company rents approximately 65,656 square feet. The term of the lease runs until *March 2026* and rent amounts payable by the Company increase approximately 3% per year. 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, current on the accompanying consolidated balance sheets.

In *July 2025,* we amended our existing lease agreement for our Los Angeles office to extend the lease term from *April 1, 2026* to *August 31 2031.* We have an option to extend the lease for an additional five-year period. The total future lease payments under the amendment are approximately $6.6 million. A letter of credit will *not* be required with the extended lease and the current letter of credit of $1.0 million will be returned to the Company.

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 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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *17*

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Total rent expense for the *three* and *six* months ended *June 30, 2025* was approximately $1.0 million and $2.2 million, respectively. Total rent expense for the *three* and *six* months ended *June 30, 2024* was approximately $1.2 million and $2.4 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. The Company's office leases generally have contractually specified minimum rent and annual rent increases that are included in the measurement of the ROU asset and related lease liability. Additionally, under these lease arrangements, the Company *may* be required to pay directly, or reimburse the lessors, for real estate taxes, insurance, utilities, maintenance and other operating costs. 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.

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| | |
|:---|:---|
| Supplemental cash flow information related to leases for the six months ended June 30, 2025: |  |
| Operating cash flows used for operating leases (in thousands) | $3147 |
| Right-of-use assets obtained in exchange for new operating lease liabilities |  |
| Weighted-average remaining lease term (in years) | 0.8 |
| Weighted average discount rate | 10.9% |

---

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

---

| | |
|:---|:---|
|  | ***Amount*** |
| 2025 | $3016 |
| 2026 | 1508 |
| Total minimum lease payments | $4524 |
| Less: imputed interest | (160) |
| Total lease liabilities | $4364 |

---

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* months ending *March 31, 2025,* the Company signed another sublease agreement for the 12,429 square feet of the office space with a sublease commencement date of *April 1, 2025.*

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 operating sublease income of $0.2 million for each of the *three* months ended *June 30, 2025* and *2024*, and $0.5 million for each of the *six* months ended *June 30, 2025* and *2024*, respectively, in other income (expenses) in the condensed consolidated statements of operations.

The future minimum lease payments to be received as of *June 30, 2025*, were as follows (in thousands):

---

| | |
|:---|:---|
|  | ***Amount*** |
| 2025 | $261 |
| 2026 | 133 |
| Total | $394 |

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**Note *6***—**Property and Equipment, Net:** 

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

---

| | | |
|:---|:---|:---|
|  | ***June 30, 2025*** | ***December 31, 2024*** |
| Leasehold improvements | $3779 | $3779 |
| Computer equipment | 2230 | 2150 |
| Telephone equipment | 96 | 95 |
| Furniture and fixtures | 2359 | 2359 |
| Total property and equipment | 8464 | 8383 |
| Less: accumulated depreciation | (8076) | (7868) |
| Property and equipment, net | $388 | $515 |

---

For the *three* and *six* months ended *June 30, 2025* and *2024*, the Company incurred depreciation expense of $0.1 million and $0.2 million, respectively.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *18*

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**Note *7***—**Intangible Assets, Net:**

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

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| | | |
|:---|:---|:---|
|  | ***June 30, 2025*** | ***December 31, 2024*** |
| Acquired and in-licensed rights | $102500 | $102500 |
| Less: accumulated amortization | (56238) | (51369) |
| Total intangible assets, net | $46262 | $51131 |

---

For each of the *three* and *six* months ended *June 30, 2025* and *2024*, the Company incurred amortization expense of $2.4 million and $4.9 million, respectively. The estimated remaining useful life of the intangible assets as of *June 30, 2025* is 4.8 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 $4.9 million for the *three* and *six* months ended *June 30, 2025* and *2024*, respectively. As of *June 30, 2025*, estimated future amortization expense related to the Company's intangible assets is approximately $4.9 million for the remainder of *2025* and $9.7 million for each year starting *2026* through *2029,* and $2.4 million for *2030.*

**Note *8***—**Accrued Expenses:** 

Accrued expenses consisted of the following (in thousands):

---

| | | |
|:---|:---|:---|
|  | ***June 30, 2025*** | ***December 31, 2024*** |
| Current: |  |  |
| Accrued royalties | $8827 | $10169 |
| Accrued CRO services | 1741 | 1035 |
| Accrued variable consideration | 8362 | 10829 |
| Accrued bonus | 3354 | 7976 |
| Accrued compensation | 5781 | 4368 |
| Accrued other clinical development | 1184 | 935 |
| Accrued professional fees | 674 | 341 |
| Accrued legal fees | 1320 | 1095 |
| Accrued manufacturing costs | 416 | 39 |
| Other | 138 | 111 |
|  | $31797 | $36898 |
| Long-term: |  |  |
| Accrued other liabilities |  | 121 |
|  |  | 121 |
| Totals | $31797 | $37019 |

---

Accrued variable consideration represents estimates of adjustments to product revenue, net for which reserves are established. Accrued royalties represent royalties incurred in connection with the Company's license agreement with Pfizer. Accrued CRO services, accrued other clinical development expenses, and accrued legal fees represent the Company's estimates of such costs and are recognized as incurred. Accrued compensation includes severance, commissions and vacation.

**Note *9***—**Debt:** 

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

---

| | | |
|:---|:---|:---|
|  | ***June 30, 2025*** | ***Maturity Date*** |
| Total debt, inclusive of $2.0 million exit payment | $102000 | July 23, 2026 |
| Less: unamortized debt issuance costs and discounts | (473) |  |
| Less: current portion | (33997) |  |
| Less: debt repayment | (56661) |  |
| Total long-term debt, net | $10869 |  |

---

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *19*

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*Athyrium Note Purchase Agreement:*

The Company issued senior notes for an aggregate principal amount of $100.0 million pursuant to a note purchase agreement dated *July 23, 2021* by the Company, and its subsidiary, and Athyrium, as Administrative Agent, and certain other investor parties (the "Note Purchase Agreement"), with an initial maturity date of *July 23, 2026 (*the "Athyrium Notes"). The Athyrium Notes were issued for face amount of $100.0 million net of an original issue discount of $1.5 million. The Athyrium Notes also require a 2.0% exit payment to be made on each payment of principal. The borrowings under the Athyrium Notes, together with cash on hand, were used to repay the Company's outstanding indebtedness, including the applicable exit and prepayment fees owed to lenders under its prior credit facility with Oxford. The Athyrium Notes are secured by substantially all of the Company's assets. 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.*

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 is payable quarterly on the last business day of *March, June, September* and *December* each year. In the *second* quarter of *2024,* the Company 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 *June 30, 2025,* the effective interest rate for the loan was 12.99%.

As of *June 30, 2025,* 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. The affirmative covenants include, among others, covenants requiring the Company to maintain its 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 the Company's 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. 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 *June 30, 2025*, the Company was in compliance with such covenants.

As of *June 30, 2025*, the principal balance outstanding under the Athyrium Notes was $44.5 million and exit fees were $0.9 million, representing all of the Company's debt.

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

---

| | |
|:---|:---|
|  | ***Amount*** |
| 2025 | 22664 |
| 2026 | 22675 |
| Total | $45339 |

---

*Debt Issuance Costs and Discounts:*

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

---

| | | |
|:---|:---|:---|
|  | ***June 30, 2025*** | ***December 31, 2024*** |
| Debt issuance costs and discounts (Athyrium Notes) | $5410 | $5410 |
| Less: accumulated amortization | (4937) | (4454) |
| Included in long-term debt | $473 | $956 |

---

Debt issuance costs and discounts are financing costs related to the Company's outstanding debt. 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 *six* months ended *June 30, 2025*, the Company recorded approximately *$0.1* million and $0.3 million of interest expense, respectively. For the *three* and *six* months ended *June 30, 2024*, the Company recorded approximately $0.2 million and $0.5 million of interest expense, respectively.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *20*

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**Note *10***—**Stockholders**' **Equity:** 

**Common Stock:** 

The Company issued 55,882 and 0 shares of common stock upon exercise of stock options during the *six* months ended *June 30, 2025* and *2024*, respectively. The Company issued 731,009 and 813,333 shares of common stock upon vesting of RSUs during the *six* months ended *June 30, 2025* and *2024*, respectively.

**Authorized Shares:** 

The Company has 100,000,000 shares of stock authorized for issuance, all of which are common stock, par value $0.0001 per share.

**Warrants:**

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 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.*

**Stock Options and Restricted Stock Units:** 

The Company's *2011* Plan, as amended, was adopted by the Company's Board of Directors on *September 15, 2011.* Pursuant to the *2011* Plan, the Company *may* grant incentive stock options and nonqualified stock options, as well as other forms of equity-based compensation. Incentive stock options *may* be granted only to employees, while consultants, employees, officers, and directors are eligible for the grant of nonqualified options under the *2011* Plan. The maximum term of stock options granted under the *2011* Plan is *10* years and the awards generally vest over a *three*-year period. 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 *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 *June 30, 2025* 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 *June 30, 2025*, 5,326,457 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 2,975,277 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 *six* months ended *June 30, 2025*:

---

| | | |
|:---|:---|:---|
|  | ***2025*** | ***2024*** |
| Dividend yield | 0.0% | 0.0% |
| Expected volatility | 81.5% | 85.8% |
| Risk-free interest rate | 4.4% | 4.1% |
| Expected life in years | 5.55 | 5.55 |

---

The Company's *2017* Plan, as amended, was adopted by the Company's Board of Directors on *April 27, 2017.* Pursuant to the *2017* Plan, the Company *may* grant stock options and RSUs, as well as other forms of equity-based compensation, to employees as an inducement to join the Company. The maximum term of stock options granted under the *2017* Plan is 10 years and the awards generally vest over a three-year period. The exercise price of stock options granted under the *2017* Plan must be at least equal to the fair market value of such shares on the date of grant. 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 shares. As of *June 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 *June 30, 2025*, a total of 672,266 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 1,069,130 shares of the Company's common stock are available for future issuance under the *2017* Plan.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *21*

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

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | ***For the Three Months Ended*** | ***For the Three Months Ended*** | ***For the Six Months Ended*** | ***For the Six Months Ended*** |
|  | ***June 30,*** | ***June 30,*** | ***June 30,*** | ***June 30,*** |
|  | ***2025*** | ***2024*** | ***2025*** | ***2024*** |
| Stock-based compensation: |  |  |  |  |
| Options: |  |  |  |  |
| Selling, general, and administrative | $235 | $429 | $545 | $861 |
| Research and development | 46 | (1) | 93 | 177 |
| Restricted stock units: |  |  |  |  |
| Selling, general, and administrative | 757 | 1006 | 1682 | 2024 |
| Research and development | 590 | 628 | 1334 | 1377 |
| Total stock-based compensation expense | $1628 | $2062 | $3654 | $4439 |

---

Activity with respect to options granted under the *2011* Plan and *2017* Plan is summarized as follows:

**Stock Option Roll Forward:**

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | ***Shares*** | ***Weighted Average Exercise Price*** | ***Weighted Average Remaining Contractual Term (years)*** | ***Aggregate Intrinsic Value (in thousands)*** |
| Outstanding at December 31, 2024 | 4051928 | $33.80 | *\* |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Granted | 492514 | 2.78 |  |  |
| (Forfeited) | (84954) | 3.57 |  |  |
| (Exercised) | (55882) | 2.33 |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(Expired) | (218246) | 116.00 |  |  |
| Outstanding at June 30, 2025 | 4185360 | $22.64 | 4.6 | $726 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Vested and expected to vest at June 30, 2025 | 4185360 | $22.64 | 4.6 | $726 |
| Exercisable | 3584279 | $25.80 | 3.8 | $447 |

---

At *June 30, 2025*, total estimated unrecognized employee compensation cost related to non-vested stock options granted prior to that date was approximately $1.0 million, which is expected to be recognized over a weighted-average period of 1.2 years. At *June 30, 2025*, the total estimated unrecognized employee compensation cost related to non-vested RSUs was approximately $5.0 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 *six* months ended *June 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 *six* months ended *June 30, 2025* and *2024* was $3.31 and $5.90 per share, respectively.

**Restricted Stock Unit Roll Forward:**

---

| | | |
|:---|:---|:---|
|  | ***Shares*** | ***Weighted Average Grant-Date Fair Value*** |
| Nonvested shares at December 31, 2024 | 1289449 | $5.14 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Granted | 1345461 | $3.31 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(Forfeited) | (90538) | $3.96 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(Vested) | (731009) | $4.51 |
| Nonvested shares at June 30, 2025 | 1813363 | $4.09 |

---

**Note *11***—***401*(k) Savings Plan:** 

During *2012,* the Company adopted a *401*(k) savings plan for the benefit of its employees. The Company is required to make matching contributions to the *401*(k) plan equal to 100% of the first *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 $1.0 million and $0.9 million for the *six* months ended *June 30, 2025* and *2024*, respectively.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *22*

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**Note *12***—**Commitments and Contingencies:**

**Contractual Obligations:**

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. The timing of payments and actual amounts paid under contract manufacturing organization ("CMO") and CRO agreements *may* be different depending on the timing of receipt of goods or services or changes to agreed-upon terms or amounts for some obligations. Also, those agreements are cancelable upon written notice by the Company and, therefore, *not* long-term liabilities.

**License Agreements:**

*Pfizer License Agreement*

In *August 2011,* the Company entered into an agreement pursuant to which Pfizer agreed to grant it a worldwide license for the development, manufacture and commercialization of *PB272* (neratinib, oral), *PB272* (neratinib, intravenous) and *PB357,* and certain related compounds. The license is exclusive with respect to certain patent rights owned by or licensed to Pfizer. Under the agreement, the Company is obligated to commence a new clinical trial for a product containing *one* of these compounds within a specified period of time and to use commercially reasonable efforts to complete clinical trials and to achieve certain milestones as provided in a development plan. From the closing date of the agreement through *December 31, 2011,* Pfizer continued to conduct the existing clinical trials on behalf of the Company at Pfizer's sole expense. At the Company's request, Pfizer agreed to continue to perform certain services in support of the existing clinical trials at the Company's expense. These services would continue through the completion of the transitioned clinical trials. The license agreement "capped" the out-of-pocket expense the Company would incur to complete the then existing clinical trials. All agreed upon costs incurred by the Company above the "cost cap" would be reimbursed by Pfizer. The Company exceeded the "cost cap" during the *fourth* quarter of *2012.* In accordance with the license agreement, the Company billed Pfizer for agreed upon costs above the "cost cap" until *December 31, 2013.*

On *July 18, 2014,* the Company entered into an amendment to the license agreement with Pfizer. The amendment amends the agreement to (*1*) reduce the royalty rate payable by the Company to Pfizer on sales of licensed products; (*2*) release Pfizer from its obligation to pay for certain out-of-pocket costs incurred or accrued on or after *January 1, 2014* to complete certain ongoing clinical studies; and (*3*) provide that Pfizer and the Company will continue to cooperate to effect the transfer to the Company of certain records, regulatory filings, materials and inventory controlled by Pfizer as promptly as reasonably practicable.

As consideration for the license, the Company is required to make substantial payments upon the achievement of certain milestones totaling approximately $187.5 million if all such milestones are achieved. In connection with the FDA approval of NERLYNX in *July* of *2017,* the Company triggered a *one*-time milestone payment pursuant to the agreement. In *June 2020,* the Company entered into a letter agreement (the "Letter Agreement") with Pfizer relating to the method of payment associated with a *one*-time milestone payment under the license agreement with Pfizer. The Letter Agreement permitted the Company to make the milestone payment in installments with the remaining amount payable to Pfizer (including interest). The milestone payment accrued interest at 6.25% per annum. The milestone payment including accrued interest of $1.8 million was paid in full in *September 2021.* In addition, the 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.* Should the Company commercialize any more of the compounds licensed from Pfizer or any products containing any of these compounds, the Company will be obligated to pay Pfizer annual royalties at a fixed rate in the low-to-mid teens of net sales of all such products, subject to certain reductions and offsets in some circumstances. The Company's royalty obligation continues, on a product-by-product and country-by-country basis, until the later of (*1*) the last to expire licensed patent covering the applicable licensed product in such country, or (*2*) the earlier of generic competition for such licensed product reaching a certain level in such country or expiration of a certain time period after *first* commercial sale of such licensed product in such country. In the event that the Company sub-licenses the rights granted to the Company under the license agreement with Pfizer to a *third* party, the same milestone and royalty payments are required. The Company can terminate the license agreement at will, or for safety concerns, in each case upon specified advance notice.

*Takeda License Agreement*

In *September 2022,* the Company entered into an exclusive license agreement with Takeda to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of aurora kinase A. Under the terms of the exclusive license agreement, the Company will assume sole responsibility for the global development and commercialization of alisertib. 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 *June 30, 2025.*

**Legal Proceedings:**

The Company and certain of its executive officers were named as defendants in the lawsuits detailed below. The Company records a liability in the consolidated financial statements for loss contingencies when a loss is known or considered probable and the amount can be reasonably estimated. If the reasonable estimate of a known or probable loss is a range, and *no* amount within the range is a better estimate than any other, the minimum amount of the range is accrued. If a loss is reasonably possible but *not* known or probable, and can be reasonably estimated, the estimated loss or range of loss is disclosed. When determining the estimated loss or range of loss, significant judgment is required to estimate the amount and timing of a loss to be recorded.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *23*

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***Legal Malpractice Suit***

On *September 17, 2020,* the Company filed a lawsuit against Hedrick Gardner Kincheloe & Garofalo, L.L.P. and David L. Levy, the attorneys who previously represented the Company in *Eshelman v. Puma Biotechnology, Inc., et al*. in the Superior Court of Mecklenburg County, North Carolina. The Company is alleging legal malpractice based on the defendants' negligent handling of the defense of the Company in *Eshelman v. Puma Biotechnology, Inc., et al*. The Company is seeking recovery of the entire amount awarded in *Eshelman v. Puma Biotechnology, Inc., et al*. and all legal fees and expenses incurred in appealing from the judgment and retrying the damages phase of the trial. On *November 23, 2020,* the defendant filed an answer to the complaint denying the allegations of negligence. On *August 19, 2022,* the Company filed a voluntary dismissal of the legal malpractice action, without prejudice, to allow the *Eshelman v. Puma Biotechnology, Inc., et al*. to conclude before proceedings. On *June 2, 2023,* the Company re-filed the lawsuit against Hedrick Gardner Kincheloe & Garofalo, L.L.P. and David L. Levy, the attorneys who previously represented the Company in *Eshelman v. Puma Biotechnology, Inc., et al.* in the Superior Court of Mecklenburg County, North Carolina. On *August 22, 2023,* the defendants filed motions to dismiss the case. These motions were presented at a hearing on *February 20, 2024.* The Superior Court Judge granted the motions to dismiss on *March 20, 2024.* The Company appealed this ruling to the North Carolina Court of Appeals. The Court of Appeals heard the appeal on *April 3, 2025,* but has *not* yet issued a ruling.

***Patent-Related Proceedings***

*AstraZeneca Litigation*

On *September 22, 2021,* the Company filed suit against AstraZeneca Pharmaceuticals, LP, AstraZeneca AB, and AstraZeneca PLC for infringement of United States Patent Nos. *10,603,314* ("the *'314* patent") and *10,596,162* ("the *'162* patent") (*Puma Biotechnology, Inc. et al. v. AstraZeneca Pharmaceuticals LP et al*., *1:21CV01338* (D. Del. *Sep. 22, 2021)).* The Company's complaint alleges that AstraZeneca's commercial manufacture, use, offer for sale, sale, distribution, and/or importation of Tagrisso® (osimertinib) products for the treatment of gefitinib and/or erlotinib-resistant non-small cell lung cancer infringes the *'314* and *'162* patents. The Company is an exclusive licensee of the *'314* and *'162* patents under the Pfizer Agreement. Wyeth is a co-plaintiff. Plaintiffs seek a judgment that AstraZeneca's product infringes the asserted patents and an award of monetary damages in an amount to be proven at trial. AstraZeneca AB and AstraZeneca Pharmaceuticals LP filed an answer and counterclaims on *November 5, 2021,* including claims challenging the asserted patents as *not* infringed and/or invalid, and accusing plaintiffs of unclean hands and patent misuse. The parties stipulated to dismiss AstraZeneca PLC as a defendant and Pfizer as a Counterclaim Defendant on *December 10, 2021,* which the Court so ordered on *December 13, 2021.* The Company filed its answer to AstraZeneca's counterclaims on *December 17, 2021,* denying those claims. The case was reassigned to visiting Judge Matthew Kennelly of the Northern District of Illinois. A Markman Hearing was conducted on *March 17, 2023,* and the Court issued its claim construction decision on *March 29, 2023.* Fact discovery closed on *May 19, 2023,* and expert discovery closed on *November 17, 2023.* The Court denied the parties' respective motions for summary judgment and Daubert motions, other than to clarify that Plaintiffs' damages cannot extend to any time period before the asserted patents were issued. The Court granted AstraZeneca's motion to dismiss the Company as a Plaintiff on constitutional standing grounds but denied the motion to dismiss Wyeth as a Plaintiff on constitutional standing grounds. On *April 29, 2024,* the Court granted AstraZeneca's motion to dismiss AstraZeneca's counterclaims against the Company, which removed the Company from the case. Wyeth remained in the case as a Plaintiff and counterclaim-defendant. Under the Company's worldwide exclusive license agreement with Pfizer, Inc. (the parent of Wyeth) as amended, the Company also maintains contractual rights to recover monetary damages in the AstraZeneca litigation, and those contractual rights are unaffected by the court's *March 18, 2024* and *April 29, 2024* orders. A jury trial was held *May 13-17, 2024.* The jury found in favor of Wyeth and against AstraZeneca. In particular, the jury found that use of Tagrisso® according to each of the *three* FDA-approved indications infringes the asserted claims of the *'314* and *'162* patents, and that AstraZeneca induces that infringement. 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. 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.* On *August 6, 2024,* Judge Kennelly issued his ruling on the issues that were tried in the bench trial, finding for Wyeth and against AstraZeneca on all claims and defenses. The Court found that AstraZeneca had *not* proved its claim that Wyeth's asserted patents were invalid as indefinite, or that Wyeth had committed acts that would give rise to findings of unclean hands, implied waiver, or patent misuse. AstraZeneca filed a motion challenging the jury's verdict and requesting a new trial. Wyeth filed a motion requesting supplemental damages for past infringement from *January 1, 2024,* through the date of judgment; pre-and-post judgment interest, and ongoing royalties through the remaining term of the patents. Briefing on these motions from both sides was completed on *July 16, 2024.* On *August 14, 2024,* Judge Kennelly ruled on AstraZeneca's motion challenging the jury's verdict, granting it in part and denying it in part. The Court granted AstraZeneca's motion for judgment as a matter of law that the *'314* and *'162* patents are invalid under *35* U.S.C. § *112* for lacking enablement and adequate written description as to a particular claim limitation. In all other respects, the Court denied AstraZeneca's motion. The Court entered its final and appealable judgment accordingly. The Company respectfully disagrees with the Court's ruling regarding invalidity with respect to the particular claim limitation. Wyeth filed a notice of appeal on *September 12, 2024,* appealing the District Court's judgment as a matter of law, as well as other rulings and opinions of the Court adverse to Wyeth. On *December 18, 2024,* Wyeth filed its opening brief. On *March 13, 2025,* AstraZeneca filed its response brief. On *March 20, 2025,* non-parties Regeneron Pharmaceuticals, Inc. 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.* 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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *24*

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*Acebright China Litigation*

On *January 18, 2022,* Shanghai Acebright Pharmaceuticals Group Co., Ltd. ("Acebright") filed an abbreviated new drug application ("ANDA") with the National Medical Products Administration in China ("NMPA") seeking approval to market a generic version of the Company's NERLYNX® (neratinib) tablet, *40mg* in China. Acebright seeks approval prior to the expiration of *three* patents listed on the China Patent Information Registration Platform for Marketed Drugs ("Chinese Orange Book"), namely, Chinese Patent Nos. *ZL201410082103.7, ZL201080060546.6,* and *ZL200880118789.3* (the *"'789* patent" and collectively, the "NERLYNX® Patents"), alleging in a Type *4.2* patent declaration that its generic version of NERLYNX does *not* fall within the scope of the claims of NERLYNX® Patents listed in the Chinese Orange Book. The patent declaration of Acebright was published in the Chinese Orange Book on *January 19, 2022.* On *March 2, 2022,* the Company filed petitions with the China National Intellectual Property Administration ("CNIPA") and requested administrative determination that Acebright's generic neratinib tablet falls within the scope of the claims of NERLYNX® Patents listed in the Chinese Orange Book. The Company's request for administrative determination was accepted by CNIPA on *March 18, 2022.* The Company has notified NMPA of the acceptance of the request for administrative determination for NMPA to institute a stay of Acebright's ANDA for *nine* months. On *July 11, 2022,* CNIPA decided that claims *5* and *6* of Patent *No. ZL200880118789.3* are *not* eligible for registration in the Chinese Orange Book on the ground that these *two* pharmaceutical method-of-use claims fall within the scope of "patents of crystalline forms," which are *not* eligible for listing in the Chinese Orange Book. On *September 9, 2022,* CNIPA decided that the generic drug in Acebright's ANDA does *not* fall within the protection scope of claims *1, 3, 5* and *6* of Patent *No. ZL201410082103.7* and claims *1*-*4, 7* and *9*-*13* of Patent *No. ZL201080060546.6.* The *three* CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Acebright's ANDA by NMPA. The Company has appealed each CNIPA administrative decision in *January 2023* at the Beijing Intellectual Property Court ("BJIPC"). The *three* appeals were accepted by BJIPC on *February 20, 2023.* The Company also filed *three* civil complaints based on the *three* NERLYNX® Patents against Acebright with the BJIPC in *July 2022* and requested court determination that Acebright's generic neratinib tablet falls within the scope of the claims of NERLYNX® Patents. On *May 6, 2023,* the Company withdrew *two* civil lawsuits and *two* appeals in relation to Chinese Patent Nos. *ZL201410082103.7* and *ZL201080060546.6* at the BJIPC. On *May 24, 2023,* the BJIPC accepted the Company's withdrawal request. On *July 24, 2023,* the Company withdrew the *one* remaining civil lawsuit and *one* appeal in relation to Chinese Patent *No. ZL200880118789.3* at the BJIPC. On *August 15, 2023,* the BJIPC accepted the Company's withdrawal request. On *September 12, 2023,* the NMPA approved Acebright's ANDA to market a generic version of the Company's NERLYNX® in China with the approval number of GuoYaoZhunZi *H20234141.*

On *December 28, 2023,* the Company filed a civil lawsuit against Acebright for infringement of the *'789* patent under Article *11* of the Chinese Patent Law before Jiangsu Nanjing Intermediate People's Court. The Company's complaint alleges that Acebright's offer for sale of a generic version of the Company's NERLYNX® product infringes the *'789* patent. The Company seeks a judgment that Acebright's product infringes the *'789* patent and Acebright's act of offer for sale shall be enjoined. On *January 2, 2024,* Jiangsu Nanjing Intermediate People's Court accepted the civil complaint. An oral hearing was held on *June 19, 2024,* during which the Company amended its complaint to allege that Acebright making, selling and offering to sell the generic version of NERLYNX® infringes the *'789* patent. On *July 24, 2024,* the Company submitted a request to withdraw the lawsuit. On *August 8, 2024,* Jiangsu Nanjing Intermediate People's Court accepted the withdrawal request.

On *September 27, 2024,* the Company filed an additional patent infringement claim against Acebright at Jiangsu Nanjing Intermediate People's Court. On *October 14, 2024,* the Court accepted the complaint and designated case number (*2024*) Su *01* Min Chu *2192* to this case. On *December 16, 2024,* the Court conducted an evidence exchange hearing. 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.

*Aosaikang China Litigation*

On *November 17, 2022,* Jiangsu Aosaikang Pharmaceutical Co. Ltd. ("Aosaikang") filed an ANDA with NMPA in China seeking approval to market a generic version of the Company's NERLYNX®. The ANDA application *No.* is *CYHS2202006.* Aosaikang made Type *4.2* declarations against the *four* Orange Book Patents *ZL201410082103.7, ZL201080060546.6, ZL200880118789.3* and *ZL201710057547.9,* alleging that its generic version of NERLYNX does *not* fall within the scope of the claims of the Orange Book patents. Aosaikang also alleged that Patents *ZL200880118789.3* and *ZL201710057547.9* are *not* eligible for Chinese Orange Book listing.

On *December 28, 2022,* the Company submitted *four* Article *76* petitions against the Aosaikang ANDA with the CNIPA and requested administrative determination that Aosaikang's generic neratinib tablet falls within the scope of the claims of the *four* Orange Book patents. On *January 6, 2023,* the CNIPA accepted the Company's request for administrative determination in relation to Patent Nos. *ZL201410082103.7* and *ZL201080060546.6.* Also on *January 6, 2023,* the CNIPA declined to accept the Company's request for administrative determination in relation to Patent Nos. *ZL200880118789.3* and *ZL201710057547.9,* alleging that the listed claims are *not* eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of "patents of crystalline forms," which are *not* eligible for listing in the Chinese Orange Book. On *January 28, 2023,* the Company requested the NMPA to institute a *nine*-month stay against Aosaikang ANDA starting from the CNIPA's acceptance of the Company's request for administrative determination. On *June 2, 2023,* CNIPA decided that the generic drug in Aosaikang's ANDA does *not* fall within the protection scope of claims *1, 3, 5* and *6* of Patent *No. ZL201410082103.7* and claims *1*-*4, 7* and *9*-*13* of Patent *No. ZL201080060546.6.* The *two* CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Aosaikang's ANDA by NMPA. On *October 22, 2024,* the NMPA approved Aosaikang's ANDA to market a generic version of the Company's NERLYNX® in China with the approval number of GuoYaoZhunZi *H20249180.*

*Convalife China Litigation*

Convalife Pharmaceuticals (Shanghai) Co., Ltd ("Convalife") filed an ANDA with NMPA in China seeking approval to market a generic version of the Company's NERLYNX®. The ANDA application *No.* is *CYHS2202095.* On *December 23, 2022,* Convalife made Type *4.2* declarations against the *four* Orange Book Patents *ZL201410082103.7, ZL201080060546.6, ZL200880118789.3* and *ZL201710057547.9,* alleging that its generic version of NERLYNX does *not* fall within the scope of the claims of the Orange Book patents. Convalife also alleged that Patents *ZL200880118789.3* and *ZL201710057547.9* are *not* eligible for Chinese Orange Book listing.

On *February 1, 2023,* the Company submitted *four* Article *76* petitions against the Convalife ANDA with the CNIPA and requested administrative determination that Convalife's generic neratinib tablet falls within the scope of the claims of the *four* Orange Book patents. On *February 3, 2023,* the CNIPA accepted the Company's request for administrative determination in relation to Patent Nos. *ZL201410082103.7* and *ZL201080060546.6.* Also on *February 3, 2023,* the CNIPA declined to accept the Company's request for administrative determination in relation to Patent Nos. *ZL200880118789.3* and *ZL201710057547.9,* alleging that the listed claims are *not* eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of "patents of crystalline forms," which are *not* eligible for listing in the Chinese Orange Book. On *February 24, 2023,* the Company requested the NMPA to institute a *nine*-month stay against Convalife ANDA starting from the CNIPA's acceptance of the Company's request for administrative determination. On *June 2, 2023,* CNIPA decided that the generic drug in Convalife's ANDA does *not* fall within the protection scope of claims *1, 3, 5* and *6* of Patent *No. ZL201410082103.7* and claims *1*-*4, 7* and *9*-*13* of Patent *No. ZL201080060546.6.* The *two* CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Convalife's ANDA by NMPA. On *June 28, 2024,* the NMPA approved Convalife's ANDA to market a generic version of the Company's NERLYNX® in China with the approval number of GuoYaoZhunZi *H20244222.*

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*Kelun China Litigation*

Hunan Kelun Pharmaceutical Co., Ltd. ("Kelun") filed an ANDA with NMPA in China seeking approval to market a generic version of the Company's NERLYNX®. The ANDA application *No.* is *CYHS2300221.* On *January 28, 2023,* Kelun made Type *4.2* declarations against the *four* Orange Book Patents *ZL201410082103.7, ZL201080060546.6, ZL200880118789.3* and *ZL201710057547.9,* alleging that its generic version of NERLYNX does *not* fall within the scope of the claims of the Orange Book patents. Kelun also alleged that Patents *ZL200880118789.3* and *ZL201710057547.9* are *not* eligible for Chinese Orange Book listing.

On *March 13, 2023,* the Company submitted *four* Article *76* petitions against the Kelun ANDA with the CNIPA and requested administrative determination that Kelun's generic neratinib tablet falls within the scope of the claims of the *four* Orange Book patents. On *March 21, 2023,* the CNIPA declined to accept the Company's request for administrative determination in relation to Patent Nos. *ZL200880118789.3* and *ZL201710057547.9,* alleging that the listed claims are *not* eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of "patents of crystalline forms," which are *not* eligible for listing in the Chinese Orange Book. On *March 24, 2023,* the CNIPA accepted the Company's request for administrative determination in relation to Patent Nos. *ZL201410082103.7* and *ZL201080060546.6.* On *April 17, 2023,* the Company requested the NMPA to institute a *nine*-month stay against Kelun's ANDA starting from the CNIPA's acceptance of the Company's request for administrative determination. On *September 14, 2023,* the Company withdrew the *two* requests for administrative determination in relation to Chinese Patent Nos. *ZL201410082103.7* and *ZL201080060546.6* at the CNIPA. On *September 25, 2023,* the CNIPA accepted the Company's withdrawal request.

*Demai Litigation*

Zhengzhou Demai Pharmaceutical Co., Ltd ("Demai") filed an ANDA with NMPA in China seeking approval to market a generic version of the Company's NERLYNX®. The ANDA application *No.* is *CYHS2402776.* On *August 26, 2024,* Demai made a Type *4.2* declaration against Orange Book Patent *ZL201410082103.7,* alleging that its generic version of NERLYNX does *not* fall within the scope of the claims of this Orange Book patent. On *September 30, 2024,* the Company filed a lawsuit against Demai at the BJIPC based on Nerlynx Patent *No. ZL201080060546.6* and on *October 8, 2024,* the Company filed a lawsuit against Demai at the BJIPC based on Nerlynx Patent *No. ZL201410082103.7.* On *February 13, 2025,* the Company withdrew the lawsuits from BJIPC, filed an Article *76* petition with the CNIPA against the Demai ANDA and requested administrative determination that Demai's generic neratinib maleate tablet falls within the scope of the claims of Nerlynx Patent *No. ZL201080060546.6.* On *February 21, 2025,* the CNIPA accepted the Company's petition and started examination. On *March 18, 2025,* the Company filed a request with the NMPA to set up a *nine*-month stay on Demai's ANDA.

*Hexal European Patent Opposition*

An Opposition was filed by Hexal AG ("Hexal") on *August 3, 2016* against European Patent *No. 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. 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. 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. 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. Alfred E. Tiefenbacher and Hexal AG 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.* Oral proceedings took place on *April 9* and *10, 2025. 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.* One European divisional application is pending in the same family, namely EP *23157078.8.* A response to the European Search Opinion (ESO) for this application was filed *February 14, 2024.* The *first* office action was issued on *January 28, 2025* with a response to the *first* office action filed on *July 22, 2025.*

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| **Item 2.** | **MANAGEMENT**'**S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS**  |

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The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and the notes thereto included in Item 1 in this Quarterly Report on Form 10-Q, (this "Quarterly Report"). The following discussion should also be read in conjunction with our audited consolidated financial statements and the notes thereto and "Management's Discussion and Analysis of Financial Condition and Results of Operations" included in our Annual Report on Form 10-K for the year ended December 31, 2024.

Unless otherwise provided in this Quarterly Report, references to the "Company," "we," "us," and "our" refer to Puma Biotechnology, Inc., a Delaware corporation, together with its wholly owned subsidiary.

**Overview** 

We are a biopharmaceutical company that develops and commercializes innovative products to enhance cancer care and improve treatment outcomes for patients. We are currently commercializing NERLYNX, an oral version of neratinib, for the treatment of certain HER2-positive breast cancers. Additionally, in 2022, we in-licensed and became responsible for the global development and commercialization of alisertib. Alisertib is a selective, small-molecule inhibitor of Aurora Kinase A that is designed to disrupt mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on Aurora Kinase A. Prior to our licensing alisertib from Takeda, alisertib was tested in over 1,300 patients who were treated across 22 company-sponsored trials resulting in a large, well-characterized clinical safety database. Based on information in this database, we believe alisertib has potential application in the treatment of a range of different cancer types, including hormone receptor-positive breast cancer, triple-negative breast cancer and small cell lung cancer. We intend to pursue development of alisertib initially in small cell lung cancer and hormone receptor-positive breast cancer.

NERLYNX is currently approved in the United States for two indications: 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 approximately 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. 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 June 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.

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. Alisertib is an investigational, reversible, ATP-competitive inhibitor that is designed to be highly selective for Aurora Kinase A. Inhibition of Aurora Kinase A can lead to disruption of mitotic spindle apparatus assembly, disruption of chromosome segregation, and inhibition of cell proliferation. 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. We paid Takeda an upfront license fee of $7.0 million in October 2022<u>,</u> and it is eligible to receive potential future milestone payments of up to $287.3 million upon our 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. 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 June 30, 2025, no milestones had been accrued as the underlying contingencies were not probable or estimable.

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. Going forward, we anticipate significant expenses as we continue to develop alisertib in 2025. 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 June 30, 2025, and proceeds that will 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. 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, acquisition of additional drug candidates and changes in regulation. Some of these developments have had and may continue to have an adverse effect on our revenue and thus could have an adverse effect on our ability to satisfy the minimum revenue and cash balance covenants contained in the Athyrium Notes.

**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 six months ended June 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.

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**Summary of Income and Expenses**

*Product revenue, net:*

Product revenue, net consists of revenue from sales of NERLYNX. We sell NERLYNX to a limited number of specialty pharmacies and specialty distributors in the United States. We record revenue at the net sales price, which includes an estimate for variable consideration for which reserves are established. Variable consideration consists of trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates and other incentives.

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

*License revenue:*

License revenue consists of consideration earned for performance obligations satisfied pursuant to our sub-license agreements.

*Royalty revenue:*

Royalty revenue consists of consideration earned related to product sales made by our sub-licensees in their respective territories pursuant to our sub-license agreements.

*Cost of sales:*

Cost of sales consists of third-party manufacturing costs, freight, and indirect overhead costs associated with sales of NERLYNX. Cost of product sales also includes period costs related to royalty charges payable to Pfizer, the amortization of milestone payments made under our license agreement with Pfizer, certain inventory manufacturing services, inventory adjustment charges, unabsorbed manufacturing and overhead costs, and manufacturing variances. Cost of sales includes applicable license termination fees.

*Selling, general and administrative expenses:*

Selling, general and administrative expenses ("SG&A expenses") consist primarily of salaries and payroll-related costs, stock-based compensation expense, professional fees, business insurance, rent, general legal activities, credit loss expense and other corporate expenses. We expense SG&A expenses as they are incurred.

*Research and development expenses:* 

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 six months ended June 30, 2025 and 2024, our R&D expenses consisted primarily of clinical research organization ("CRO fees"); fees paid to consultants; salaries and related personnel costs; and stock-based compensation. We expense our R&D expenses as they are incurred. Internal R&D expenses primarily consist of payroll-related costs and also include equipment costs, travel expenses and supplies.

*Tariffs:*

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. 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.

*Taxes:*

On July 4, 2025, the One Big Beautiful Bill Act was signed into law, which includes significant changes to federal tax law and other regulatory provisions that may impact us. We are currently evaluating the provisions of the new law and the potential effects on our financial position, results of operations, and cash flows. As of the date of these financial statements, we have not completed our assessment, and therefore no adjustments have been made. Additional disclosures will be provided in future periods as the impact of the legislation is determined.

**Results of Operations** 

<u>*Three Months Ended June 30, 2025 Compared to Three Months Ended June 30, 2024*</u>

*Total revenue:*

Total revenue for the three months ended June 30, 2025 was approximately $52.4 million, compared to $47.1 million for the three months ended June 30, 2024. This increase in total revenue was due to an increase in product revenue, net of approximately $4.8 million and an increase in royalty revenue of $0.6 million.

*Product revenue, net:*

Product revenue, net was approximately $49.2 million for the three months ended June 30, 2025, compared to $44.4 million for the three months ended June 30, 2024. This increase in product revenue, net, compared to the three months ended June 30, 2024, was attributable to a 4% increase in bottles of NERLYNX sold in the U.S. market and an increase in net selling price, partially offset by a slight increase in deductions to gross revenue for variable consideration, primarily related to government chargebacks.

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*Royalty revenue:*

Royalty revenue was approximately $3.2 million for the three months ended June 30, 2025, compared to approximately $2.7 million for the three months ended June 30, 2024. The increase was primarily due to increased international sales made by our sub-licensees.

*Cost of sales:*

Cost of sales was approximately $12.3 million for the three months ended June 30, 2025, compared to approximately $10.7 million for the three months ended June 30, 2024. The increase was primarily due to higher royalty expense and product costs resulting from increased worldwide net sales.

*Selling, general and administrative expenses:* 

SG&A expenses were approximately $18.0 million for the three months ended June 30, 2025, compared to approximately $25.0 million for the three months ended June 30, 2024. SG&A expenses for the three months ended June 30, 2025 and 2024 were as follows:

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| | | | |
|:---|:---|:---|:---|
| **Selling, general, and administrative expenses** | **For the Three Months Ended** | **For the Three Months Ended** | **Change** |
| **<u>(in thousands)</u>** | **June 30,** | **June 30,** | **%** |
|  | **2025** | **2024** | **2025/2024** |
| Payroll and related costs | $9064 | $7596 | 19.3% |
| Provision for credit loss recovery | (362) | (183) | 97.8% |
| Professional fees and expenses | 4974 | 12364 | -59.8% |
| Travel and meetings | 1357 | 1578 | -14.0% |
| Facilities and equipment costs | 1132 | 1234 | -8.3% |
| Stock-based compensation | 992 | 1435 | -30.9% |
| Other | 890 | 948 | -6.1% |
|  | $18047 | $24972 | -27.7% |

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SG&A expenses decreased by approximately $6.9 million for the three months ended June 30, 2025, compared to the same period in 2024, primarily attributable to the following:

● a decrease 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 $7.4 million primarily related to legal fees associated with the AstraZeneca litigation in the prior year;

● a decrease in travel and meetings of approximately $0.2 million primarily related to the cost of sales meetings; and

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

Partially offset by:

● an increase in payroll and related costs of approximately $1.5 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 an increase in our healthcare insurance premiums.

*Research and development expenses:*

R&D expenses were approximately $15.5 million for the three months ended June 30, 2025, compared to approximately $13.6 million for the three months ended June 30, 2024. R&D expenses for the three months ended June 30, 2025 and 2024, were as follows:

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| | | | | |
|:---|:---|:---|:---|:---|
| **Research and development expenses** | **For the Three Months Ended** | **For the Three Months Ended** | **Change** | **Change** |
| **<u>(in thousands)</u>** | **June 30,** | **June 30,** | $**%** | **%** |
|  | **2025** | **2024** | **2025/2024** | **2025/2024** |
| Clinical trial expense | $5647 | $4304 |  | 31.2% |
| Internal R&D | 8076 | 7985 |  | 1.1% |
| Consultant and contractors | 1093 | 716 |  | 52.7% |
| Stock-based compensation | 636 | 627 |  | 1.4% |
|  | $15452 | $13632 |  | 13.4% |

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R&D expenses increased by approximately $1.8 million for the three months ended June 30, 2025, compared to the same period in 2024, primarily attributable to the following:

● an increase in clinical trial expense of approximately $1.3 million, primarily due to increased alisertib study activity; and

● an increase in consultants and contractors expense of approximately $0.4 million, primarily due to increased alisertib study activity.

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*Other income (expenses):*

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| **Other income (expenses)** | **For the Three Months Ended** | **For the Three Months Ended** | **Change** |
| **<u>(in thousands)</u>** | **June 30,** | **June 30,** | **%** |
|  | **2025** | **2024** | **2025/2024** |
| Interest income | $956 | $1244 | -23.2% |
| Interest expense | (1837) | (3372) | -45.5% |
| Other income | 410 | 156 | 162.8% |
|  | $(471) | $(1972) | -76.1% |

---

*Interest income:*

For the three months ended June 30, 2025, we recognized approximately $1.0 million in interest income, compared to approximately $1.2 million of interest income for the three months ended June 30, 2024. The decrease in interest income was primarily the result of lower investment balances and timing of investments.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *Interest expense:*

For the three months ended June 30, 2025 , we recognized approximately $1.8 million in interest expense, compared to approximately $3.4 million of interest expense for the three months ended June 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 June 30, 2024.

 *Other income:*

For the three months ended June 30, 2025 , we recognized approximately $0.4 million in other income, compared to approximately $0.2 million of other income for the three months ended June 30, 2024 . The increase in other income was primarily due to favorable exchange rates in Euro-denominated transactions.

<u>*Six Months Ended June 30, 2025 Compared to Six Months Ended June 30, 2024*</u>

*Total revenue:*

Total revenue for the six months ended June 30, 2025 was approximately $98.4 million, compared to $90.8 million for the six months ended June 30, 2024. This increase in total revenue was due to an increase in product revenue, net of approximately $7.6 million.

*Product revenue, net:*

Product revenue, net was approximately $92.3 million for the six months ended June 30, 2025, compared to $84.7 million for the six months ended June 30, 2024. This increase in product revenue, net, compared to the six months ended June 30, 2024, was attributable to an increase in net selling price, partially offset by a decrease of approximately 1.0% in deductions to gross revenue for variable consideration, primarily related fewer Medicaid charges.

*Royalty revenue:*

Royalty revenue was approximately $6.2 million for each of the six months ended June 30, 2025 and June 30, 2024.

*Cost of sales:*

Cost of sales was approximately $22.9 million for the six months ended June 30, 2025, compared to approximately $21.4 million for the six months ended June 30, 2024. The increase was primarily due to higher royalty expense and product costs resulting from increased global sales.

*Selling, general and administrative expenses:* 

SG&A expenses were approximately $35.7 million for the six months ended June 30, 2025, compared to approximately $46.7 million for the six months ended June 30, 2024. SG&A expenses for the six months ended June 30, 2025 and 2024 were as follows:

---

| | | | |
|:---|:---|:---|:---|
| **Selling, general, and administrative expenses** | **For the Six Months Ended** | **For the Six Months Ended** | **Change** |
| **<u>(in thousands)</u>** | **June 30,** | **June 30,** | % |
|  | **2025** | **2024** | **2025/2024** |
| Payroll and related costs | $17304 | $16057 | 7.8% |
| Provision for credit loss recovery | (149) | (73) | 104.1% |
| Professional fees and expenses | 9584 | 20616 | -53.5% |
| Travel and meetings | 2748 | 3040 | -9.6% |
| Facilities and equipment costs | 2341 | 2483 | -5.7% |
| Stock-based compensation | 2227 | 2885 | -22.8% |
| Other | 1596 | 1714 | -6.9% |
|  | $35651 | $46722 | -23.7% |

---

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

● a decrease in professional fees and expenses of approximately $11.0 million primarily related to legal fees associated with the AstraZeneca litigation in the prior year as well as some decrease in our insurance costs; and

● a decrease in stock-based compensation expense of approximately $0.7 million, primarily due to newer awards at a lower grant price;

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Partially offset by:

● an increase in payroll and related costs of approximately $1.2 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 approximately $29.3 million for the six months ended June 30, 2025, compared to approximately $27.2 million for the six months ended June 30, 2024. R&D expenses for the six months ended June 30, 2025 and 2024, were as follows:

---

| | | | |
|:---|:---|:---|:---|
| **Research and development expenses** | **For the Six Months Ended** | **For the Six Months Ended** | **Change** |
| **<u>(in thousands)</u>** | **June 30,** | **June 30,** | % |
|  | **2025** | **2024** | **2025/2024** |
| Clinical trial expense | $9279 | $7689 | 20.7% |
| Internal R&D | 16636 | 16615 | 0.1% |
| Consultant and contractors | 1973 | 1361 | 45.0% |
| Stock-based compensation | 1427 | 1554 | -8.2% |
|  | $29315 | $27219 | 7.7% |

---

R&D expenses increased by approximately $2.1 million compared to the six months ended June 30, 2025, compared to the same period in 2024, primarily attributable to the follow:

● an increase in clinical trial expense of approximately $1.6 million, primarily due to increased alisertib study activity; an

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

*Other income (expenses):*

---

| | | | |
|:---|:---|:---|:---|
| **Other income (expenses)** | **For the Six Months Ended** | **For the Six Months Ended** | **Change** |
| **<u>(in thousands)</u>** | **June 30,** | **June 30,** | % |
|  | **2025** | **2024** | **2025/2024** |
| Interest income | $2057 | $2216 | -7.2% |
| Interest expense | (4014) | (6731) | -40.4% |
| Other income | 769 | 247 | 211.3% |
|  | $(1188) | $(4268) | -72.2% |

---

*Interest income:*

For the six months ended June 30, 2025, we recognized approximately $2.1 million in interest income, compared to approximately $2.2 million of interest income for the six months ended June 30, 2024. The decrease in interest income was primarily the result of lower investment balances and timing of investments.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *Interest expense:*

For the six months ended June 30, 2025 , we recognized approximately $4.0 million in interest expense, compared to approximately $6.7 million of interest expense for the six months ended June 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 six months ended June 30, 2024.

 *Other income:*

For the six months ended June 30, 2025 , we recognized approximately $0.8 million in other income, compared to approximately $0.2 million of other income for the six months ended June 30, 2024 . The increase in other income was primarily due to favorable exchange rates in Euro-denominated transactions.

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**Liquidity and Capital Resources** 

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

---

| | | |
|:---|:---|:---|
|  | **As of** | **As of** |
| **<u>Liquidity and capital resources (in thousands)</u>** | **June 30, 2025** | **December 31, 2024** |
| Cash and cash equivalents | $54662 | $69219 |
| Marketable securities | $41362 | $31746 |
| Working capital | $57479 | $51547 |
| Current portion of long-term debt | $33997 | $45329 |
| Long-term debt | $10869 | $21719 |
| Stockholders' equity | $104718 | $92125 |

---

---

| | | |
|:---|:---|:---|
|  | **Six Months Ended** | **Six Months Ended** |
|  | **June 30, 2025** | **June 30, 2024** |
| Cash provided by (used in): |  |  |
| Operating activities | $17694 | $12273 |
| Investing activities | (9717) | (18377) |
| Financing activities | (22534) | (11332) |
| Net decrease in cash, cash equivalents and restricted cash | $(14557) | $(17436) |

---

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.

*Operating Activities:*

Cash provided by operating activities for the six months ended June 30, 2025 was $17.7 million and consisted of net income of approximately $8.8 million, adjusted for non-cash items of approximately $9.1 million, which included stock-based compensation of $3.7 million, depreciation and amortization of $5.6 million and provision for credit loss recovery of $0.1 million. Total changes in cash flows from operations were due to a slight decrease in working capital, primarily related to a decrease in accrued expenses and other of approximately $5.0 million, a decrease in operating lease assets and liabilities, net, of $0.9 million and a decrease of post-marketing commitment liability of $1.1 million, partially offset by a decrease in prepaid and other expenses of $0.5 million, a decrease in accounts receivable of approximately $6.3 million and a decrease in inventory of $0.1 million.

Cash provided by operating activities for the six months ended June 30, 2024 was $12.3 million and consisted of a net loss of approximately $9.3 million, adjusted for non-cash items of approximately $10.2 million, including stock-based compensation of $4.4 million, depreciation and amortization of $5.8 million and provision for credit loss recovery of $0.1 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 approximately $19.8 million, a decrease in prepaid expenses and other of $1.4 million and an increase in accounts payable of approximately $6.6 million, partially offset by a decrease in accrued expenses and other of approximately $13.7 million and an increase in inventory of approximately $2.0 million.

*Investing Activities:* 

Cash used in investing activities for the six months ended June 30, 2025 was approximately $9.7 million, compared to net cash used in investing activities of approximately $18.4 million for the same period in 2024. Cash used in investing activities for the six months ended June 30, 2025 was primarily due to the purchase of available-for-sale securities of approximately $34.4 million, partially offset by the maturity of available-for-sale securities of approximately $24.8 million.

Cash used in investing activities for the six months ended June 30, 2024 was approximately $18.4 million, compared to net cash used by investing activities of approximately $22.1 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 $44.9 million, offset by the maturity of available-for-sale securities of approximately $26.5 million.

*Financing Activities:*

Cash used in financing activities for the three months ended June 30, 2025 was approximately $22.5 million, including $22.2 million related to the payment of principal and $0.4 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 three months ended June 30, 2024 was approximately $11.3 million, including $11.1 million related to the payment of principal and $0.2 million related exit fees, on our debt with Athyrium.

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*Athyrium Note Purchase Agreement:*

We issued senior notes for an aggregate principal amount of $100.0 million pursuant to the note purchase agreement dated July 23, 2021 by us, and our subsidiary, and Athyrium, as Administrative Agent, and certain other investor parties (the "Note Purchase Agreement"), with an initial maturity date of July 23, 2026 (the "Athyrium Notes"). The Athyrium Notes were issued for face amount of $100.0 million net of an original issue discount of $1.5 million. The Athyrium Notes also require a 2.0% exit payment to be made on each payment of principal. The borrowings under the Athyrium Notes, together with cash on hand, were used to repay our outstanding indebtedness, including the applicable exit and prepayment fees owed to lenders under our prior credit facility with Oxford. The Athyrium Notes are secured by substantially all of our assets. 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 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 June 30, 2025, the effective interest rate for the loan was 12.99%.

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

As of June 30, 2025, the principal balance outstanding under the Athyrium Notes was $44.5 million and represents all of our debt. We are in compliance with all applicable covenants under the Athyrium Notes.

*Current and Future Financing Needs:* 

We have spent, and expect to continue to spend, substantial amounts in connection with implementing our business strategy, including our planned product development efforts, our clinical trials, our R&D efforts and our commercialization efforts.

We may choose to begin new R&D efforts, or we may choose to launch additional marketing efforts. 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 $54.7 million and approximately $41.4 million in marketable securities available at June 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. 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. Our ability to obtain funding may be adversely impacted by uncertain market conditions, our success in commercializing neratinib, our success in developing alisertib, unfavorable decisions of regulatory authorities or adverse clinical trial results. 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 June 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.

**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 (loss) and net income (loss) per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation. For the three and six months ended June 30, 2025, stock-based compensation represented approximately 4.9% and 5.6% of our operating expenses, respectively, compared to 5.3% and 6.0% for the same respective periods in 2024, in each case excluding cost of sales. 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.

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

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

**(in thousands except share and per share data)**

---

| | | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|:---|
|  | **For the Three Months Ended June 30,** | **For the Three Months Ended June 30,** | **For the Three Months Ended June 30,** |  | **For the Six Months Ended June 30,** | **For the Six Months Ended June 30,** | **For the Six Months Ended June 30,** |  |
|  | **2025** |  | **2024** |  | **2025** |  | **2024** |  |
| GAAP net income (loss) | $5855 |  | $(4529) |  | $8829 |  | $(9344) |  |
| Adjustments: |  |  |  |  |  |  |  |  |
| Stock-based compensation - |  |  |  |  |  |  |  |  |
| Selling, general and administrative (1) | 992 |  | 1435 |  | 2227 |  | 2885 |  |
| Research and development (2) | 636 |  | 627 |  | 1427 |  | 1554 |  |
| Non-GAAP adjusted net income (loss) | $7483 |  | $(2467) |  | $12483 |  | $(4905) |  |
| GAAP net income (loss) per share—basic | $0.12 |  | $(0.09) |  | $0.18 |  | $(0.19) |  |
| Adjustment to net income (loss) (as detailed above) | 0.03 |  | 0.04 |  | 0.07 |  | 0.09 |  |
| Non-GAAP adjusted basic net income (loss) per share | $0.15 | (3) | $(0.05) | (4) | $0.25 | (3) | $(0.10) | (4) |
| GAAP net income (loss) per share—diluted | $0.12 |  | $(0.09) |  | $0.18 |  | $(0.19) |  |
| Adjustment to net income (loss) (as detailed above) | 0.03 |  | 0.04 |  | 0.07 |  | 0.09 |  |
| Non-GAAP adjusted diluted net income (loss) per share | $0.15 | (5) | $(0.05) | (6) | $0.25 | (5) | $(0.10) | (6) |

---

---

| |
|:---|
| (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 49,700,217 and 49,648,246 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2025, respectively. |
| (4) Non-GAAP adjusted basic net loss per share was calculated based on 48,292,414 and 48,240,835 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2024, respectively. |
| (5) Non-GAAP adjusted diluted net income per share was calculated based on 50,144,704 and 50,003,709 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2025, respectively. |
| (6) 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 and six months ended June 30, 2024, as these shares would be considered anti-dilutive. |

---

**Off-Balance Sheet Arrangements**

We do not have any "off-balance sheet arrangements," as defined by SEC regulations.

**Contractual Obligations**

There have been no material changes outside the ordinary course of business to our contractual obligations and commitments as described in "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year ended December 31, 2024.

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| | |
|:---|:---|
| **Item 3.** | **QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK**  |

---

Some of the securities that we invest in have market risk in that a change in prevailing interest rates may cause the principal amount of the cash equivalents to fluctuate. Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash and cash equivalents. We invested our excess cash primarily in cash equivalents such as money market investments as of June 30, 2025. The primary objectives of our investment activities are to ensure liquidity and to preserve principal while at the same time maximizing the income we receive from our cash and cash equivalents without significantly increasing risk. Additionally, we established guidelines regarding approved investments and maturities of investments, which are designed to maintain safety and liquidity.

Because of the short-term maturities of our cash equivalents, we do not believe that a 10% increase in interest rates would have a material effect on the realized value of our cash equivalents.

We also have interest rate exposure as a result of borrowings outstanding under the Athyrium Notes. As of June 30, 2025 the aggregate outstanding principal amounts of the Athyrium Notes was $44.5 million. The Athyrium Notes bear interest at a rate per annum equal to the sum of 8.00% plus the adjusted three-month term SOFR and the lesser of (a) the sum of (i) three-month term SOFR and (ii) 0.26161% (26.161 basis points) and (b) three and one-half of one percent (3.50%) per annum. If overall interest rates had increased by one hundred basis points during the quarter ended June 30, 2025, our interest expense would have increased by $0.4 million.

---

| | |
|:---|:---|
| **Item 4.** | **CONTROLS AND PROCEDURES**  |

---

**Evaluation of Disclosure Controls and Procedures** 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Exchange Act, is recorded, processed, summarized and reported within the timelines specified in the SEC's rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives and in reaching a reasonable level of assurance, management was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we have evaluated the effectiveness of our disclosure controls and procedures (as defined under Exchange Act Rule 13a-15(e)), as of June 30, 2025. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that these disclosure controls and procedures were effective as of June 30, 2025.

**Changes in Internal Control over Financial Reporting** 

There were no changes in our internal control over financial reporting during the three months ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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**PART II** – **OTHER INFORMATION** 

---

| | |
|:---|:---|
| **Item 1.** | **LEGAL PROCEEDINGS**  |

---

***Legal Malpractice Suit***

On September 17, 2020, the Company filed a lawsuit against Hedrick Gardner Kincheloe & Garofalo, L.L.P. and David L. Levy, the attorneys who previously represented the Company in *Eshelman v. Puma Biotechnology, Inc., et al*. in the Superior Court of Mecklenburg County, North Carolina. The Company is alleging legal malpractice based on the defendants' negligent handling of the defense of the Company in *Eshelman v. Puma Biotechnology, Inc., et al*. The Company is seeking recovery of the entire amount awarded in *Eshelman v. Puma Biotechnology, Inc., et al*. and all legal fees and expenses incurred in appealing from the judgment and retrying the damages phase of the trial. On November 23, 2020, the defendant filed an answer to the complaint denying the allegations of negligence. On August 19, 2022, the Company filed a voluntary dismissal of the legal malpractice action, without prejudice, to allow the *Eshelman v. Puma Biotechnology, Inc., et al*. to conclude before proceedings. On June 2, 2023, the Company re-filed the lawsuit against Hedrick Gardner Kincheloe & Garofalo, L.L.P. and David L. Levy, the attorneys who previously represented the Company in *Eshelman v. Puma Biotechnology, Inc., et al.* in the Superior Court of Mecklenburg County, North Carolina. On August 22, 2023, the defendants filed motions to dismiss the case. These motions were presented at a hearing on February 20, 2024. The Superior Court Judge granted the motions to dismiss on March 20, 2024. The Company appealed this ruling to the North Carolina Court of Appeals. The Court of Appeals heard the appeal on April 3, 2025, but has not yet issued a ruling.

***Patent-Related Proceedings***

*AstraZeneca Litigation*

On September 22, 2021, the Company filed suit against AstraZeneca Pharmaceuticals, LP, AstraZeneca AB, and AstraZeneca PLC for infringement of United States Patent Nos. 10,603,314 ("the '314 patent") and 10,596,162 ("the '162 patent") (*Puma Biotechnology, Inc. et al. v. AstraZeneca Pharmaceuticals LP et al*., 1:21CV01338 (D. Del. Sep. 22, 2021)). The Company's complaint alleges that AstraZeneca's commercial manufacture, use, offer for sale, sale, distribution, and/or importation of Tagrisso® (osimertinib) products for the treatment of gefitinib and/or erlotinib-resistant non-small cell lung cancer infringes the '314 and '162 patents. The Company is an exclusive licensee of the '314 and '162 patents under the Pfizer Agreement. Wyeth is a co-plaintiff. Plaintiffs seek a judgment that AstraZeneca's product infringes the asserted patents and an award of monetary damages in an amount to be proven at trial. AstraZeneca AB and AstraZeneca Pharmaceuticals LP filed an answer and counterclaims on November 5, 2021, including claims challenging the asserted patents as not infringed and/or invalid, and accusing plaintiffs of unclean hands and patent misuse. The parties stipulated to dismiss AstraZeneca PLC as a defendant and Pfizer as a Counterclaim Defendant on December 10, 2021, which the Court so ordered on December 13, 2021. The Company filed its answer to AstraZeneca's counterclaims on December 17, 2021, denying those claims. The case was reassigned to visiting Judge Matthew Kennelly of the Northern District of Illinois. A Markman Hearing was conducted on March 17, 2023, and the Court issued its claim construction decision on March 29, 2023. Fact discovery closed on May 19, 2023, and expert discovery closed on November 17, 2023. The Court denied the parties' respective motions for summary judgment and Daubert motions, other than to clarify that Plaintiffs' damages cannot extend to any time period before the asserted patents were issued. The Court granted AstraZeneca's motion to dismiss the Company as a Plaintiff on constitutional standing grounds but denied the motion to dismiss Wyeth as a Plaintiff on constitutional standing grounds. On April 29, 2024, the Court granted AstraZeneca's motion to dismiss AstraZeneca's counterclaims against the Company, which removed the Company from the case. Wyeth remained in the case as a Plaintiff and counterclaim-defendant. Under the Company's worldwide exclusive license agreement with Pfizer, Inc. (the parent of Wyeth) as amended, the Company also maintains contractual rights to recover monetary damages in the AstraZeneca litigation, and those contractual rights are unaffected by the court's March 18, 2024 and April 29, 2024 orders. A jury trial was held May 13-17, 2024. The jury found in favor of Wyeth and against AstraZeneca. In particular, the jury found that use of Tagrisso® according to each of the three FDA-approved indications infringes the asserted claims of the '314 and '162 patents, and that AstraZeneca induces that infringement. 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. 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. On August 6, 2024, Judge Kennelly issued his ruling on the issues that were tried in the bench trial, finding for Wyeth and against AstraZeneca on all claims and defenses. The Court found that AstraZeneca had not proved its claim that Wyeth's asserted patents were invalid as indefinite, or that Wyeth had committed acts that would give rise to findings of unclean hands, implied waiver, or patent misuse. AstraZeneca filed a motion challenging the jury's verdict and requesting a new trial. Wyeth filed a motion requesting supplemental damages for past infringement from January 1, 2024, through the date of judgment; pre-and-post judgment interest, and ongoing royalties through the remaining term of the patents. Briefing on these motions from both sides was completed on July 16, 2024. On August 14, 2024, Judge Kennelly ruled on AstraZeneca's motion challenging the jury's verdict, granting it in part and denying it in part. The Court granted AstraZeneca's motion for judgment as a matter of law that the '314 and '162 patents are invalid under 35 U.S.C. § 112 for lacking enablement and adequate written description as to a particular claim limitation. In all other respects, the Court denied AstraZeneca's motion. The Court entered its final and appealable judgment accordingly. The Company respectfully disagrees with the Court's ruling regarding invalidity with respect to the particular claim limitation. Wyeth filed a notice of appeal on September 12, 2024, appealing the District Court's judgment as a matter of law, as well as other rulings and opinions of the Court adverse to Wyeth. On December 18, 2024, Wyeth filed its opening brief. On March 13, 2025, AstraZeneca filed its response brief. On March 20, 2025, non-parties Regeneron Pharmaceuticals, Inc. 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. 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.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 36

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*Acebright China Litigation*

On January 18, 2022, Shanghai Acebright Pharmaceuticals Group Co., Ltd. ("Acebright") filed an abbreviated new drug application ("ANDA") with the National Medical Products Administration in China ("NMPA") seeking approval to market a generic version of the Company's NERLYNX® (neratinib) tablet, 40mg in China. Acebright seeks approval prior to the expiration of three patents listed on the China Patent Information Registration Platform for Marketed Drugs ("Chinese Orange Book"), namely, Chinese Patent Nos. ZL201410082103.7, ZL201080060546.6, and ZL200880118789.3 (the "'789 patent" and collectively, the "NERLYNX® Patents"), alleging in a Type 4.2 patent declaration that its generic version of NERLYNX does not fall within the scope of the claims of NERLYNX® Patents listed in the Chinese Orange Book. The patent declaration of Acebright was published in the Chinese Orange Book on January 19, 2022. On March 2, 2022, the Company filed petitions with the China National Intellectual Property Administration ("CNIPA") and requested administrative determination that Acebright's generic neratinib tablet falls within the scope of the claims of NERLYNX® Patents listed in the Chinese Orange Book. The Company's request for administrative determination was accepted by CNIPA on March 18, 2022. The Company has notified NMPA of the acceptance of the request for administrative determination for NMPA to institute a stay of Acebright's ANDA for nine months. On July 11, 2022, CNIPA decided that claims 5 and 6 of Patent No. ZL200880118789.3 are not eligible for registration in the Chinese Orange Book on the ground that these two pharmaceutical method-of-use claims fall within the scope of "patents of crystalline forms," which are not eligible for listing in the Chinese Orange Book. On September 9, 2022, CNIPA decided that the generic drug in Acebright's ANDA does not fall within the protection scope of claims 1, 3, 5 and 6 of Patent No. ZL201410082103.7 and claims 1-4, 7 and 9-13 of Patent No. ZL201080060546.6. The three CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Acebright's ANDA by NMPA. The Company has appealed each CNIPA administrative decision in January 2023 at the Beijing Intellectual Property Court ("BJIPC"). The three appeals were accepted by BJIPC on February 20, 2023. The Company also filed three civil complaints based on the three NERLYNX® Patents against Acebright with the BJIPC in July 2022 and requested court determination that Acebright's generic neratinib tablet falls within the scope of the claims of NERLYNX® Patents. On May 6, 2023, the Company withdrew two civil lawsuits and two appeals in relation to Chinese Patent Nos. ZL201410082103.7 and ZL201080060546.6 at the BJIPC. On May 24, 2023, the BJIPC accepted the Company's withdrawal request. On July 24, 2023, the Company withdrew the one remaining civil lawsuit and one appeal in relation to Chinese Patent No. ZL200880118789.3 at the BJIPC. On August 15, 2023, the BJIPC accepted the Company's withdrawal request. On September 12, 2023, the NMPA approved Acebright's ANDA to market a generic version of the Company's NERLYNX® in China with the approval number of GuoYaoZhunZi H20234141.

On December 28, 2023, the Company filed a civil lawsuit against Acebright for infringement of the '789 patent under Article 11 of the Chinese Patent Law before Jiangsu Nanjing Intermediate People's Court. The Company's complaint alleges that Acebright's offer for sale of a generic version of the Company's NERLYNX® product infringes the '789 patent. The Company seeks a judgment that Acebright's product infringes the '789 patent and Acebright's act of offer for sale shall be enjoined. On January 2, 2024, Jiangsu Nanjing Intermediate People's Court accepted the civil complaint. An oral hearing was held on June 19, 2024, during which the Company amended its complaint to allege that Acebright making, selling and offering to sell the generic version of NERLYNX® infringes the '789 patent. On July 24, 2024, the Company submitted a request to withdraw the lawsuit. On August 8, 2024, Jiangsu Nanjing Intermediate People's Court accepted the withdrawal request.

On September 27, 2024, the Company filed an additional patent infringement claim against Acebright at Jiangsu Nanjing Intermediate People's Court. On October 14, 2024, the Court accepted the complaint and designated case number (2024) Su 01 Min Chu 2192 to this case. On December 16, 2024, the Court conducted an evidence exchange hearing. 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.

*Aosaikang China Litigation*

On November 17, 2022, Jiangsu Aosaikang Pharmaceutical Co. Ltd. ("Aosaikang") filed an ANDA with NMPA in China seeking approval to market a generic version of the Company's NERLYNX®. The ANDA application No. is CYHS2202006. Aosaikang made Type 4.2 declarations against the four Orange Book Patents ZL201410082103.7, ZL201080060546.6, ZL200880118789.3 and ZL201710057547.9, alleging that its generic version of NERLYNX does not fall within the scope of the claims of the Orange Book patents. Aosaikang also alleged that Patents ZL200880118789.3 and ZL201710057547.9 are not eligible for Chinese Orange Book listing.

On December 28, 2022, the Company submitted four Article 76 petitions against the Aosaikang ANDA with the CNIPA and requested administrative determination that Aosaikang's generic neratinib tablet falls within the scope of the claims of the four Orange Book patents. On January 6, 2023, the CNIPA accepted the Company's request for administrative determination in relation to Patent Nos. ZL201410082103.7 and ZL201080060546.6. Also on January 6, 2023, the CNIPA declined to accept the Company's request for administrative determination in relation to Patent Nos. ZL200880118789.3 and ZL201710057547.9, alleging that the listed claims are not eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of "patents of crystalline forms," which are not eligible for listing in the Chinese Orange Book. On January 28, 2023, the Company requested the NMPA to institute a nine-month stay against Aosaikang ANDA starting from the CNIPA's acceptance of the Company's request for administrative determination. On June 2, 2023, CNIPA decided that the generic drug in Aosaikang's ANDA does not fall within the protection scope of claims 1, 3, 5 and 6 of Patent No. ZL201410082103.7 and claims 1-4, 7 and 9-13 of Patent No. ZL201080060546.6. The two CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Aosaikang's ANDA by NMPA. On October 22, 2024, the NMPA approved Aosaikang's ANDA to market a generic version of the Company's NERLYNX® in China with the approval number of GuoYaoZhunZi H20249180.

*Convalife China Litigation*

Convalife Pharmaceuticals (Shanghai) Co., Ltd ("Convalife") filed an ANDA with NMPA in China seeking approval to market a generic version of the Company's NERLYNX®. The ANDA application No. is CYHS2202095. On December 23, 2022, Convalife made Type 4.2 declarations against the four Orange Book Patents ZL201410082103.7, ZL201080060546.6, ZL200880118789.3 and ZL201710057547.9, alleging that its generic version of NERLYNX does not fall within the scope of the claims of the Orange Book patents. Convalife also alleged that Patents ZL200880118789.3 and ZL201710057547.9 are not eligible for Chinese Orange Book listing.

On February 1, 2023, the Company submitted four Article 76 petitions against the Convalife ANDA with the CNIPA and requested administrative determination that Convalife's generic neratinib tablet falls within the scope of the claims of the four Orange Book patents. On February 3, 2023, the CNIPA accepted the Company's request for administrative determination in relation to Patent Nos. ZL201410082103.7 and ZL201080060546.6. Also on February 3, 2023, the CNIPA declined to accept the Company's request for administrative determination in relation to Patent Nos. ZL200880118789.3 and ZL201710057547.9, alleging that the listed claims are not eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of "patents of crystalline forms," which are not eligible for listing in the Chinese Orange Book. On February 24, 2023, the Company requested the NMPA to institute a nine-month stay against Convalife ANDA starting from the CNIPA's acceptance of the Company's request for administrative determination. On June 2, 2023, CNIPA decided that the generic drug in Convalife's ANDA does not fall within the protection scope of claims 1, 3, 5 and 6 of Patent No. ZL201410082103.7 and claims 1-4, 7 and 9-13 of Patent No. ZL201080060546.6. The two CNIPA administrative decisions on NERLYNX® Patents have lifted the stay of Convalife's ANDA by NMPA. On June 28, 2024, the NMPA approved Convalife's ANDA to market a generic version of the Company's NERLYNX® in China with the approval number of GuoYaoZhunZi H20244222.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 37

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*Kelun China Litigation*

Hunan Kelun Pharmaceutical Co., Ltd. ("Kelun") filed an ANDA with NMPA in China seeking approval to market a generic version of the Company's NERLYNX®. The ANDA application No. is CYHS2300221. On January 28, 2023, Kelun made Type 4.2 declarations against the four Orange Book Patents ZL201410082103.7, ZL201080060546.6, ZL200880118789.3 and ZL201710057547.9, alleging that its generic version of NERLYNX does not fall within the scope of the claims of the Orange Book patents. Kelun also alleged that Patents ZL200880118789.3 and ZL201710057547.9 are not eligible for Chinese Orange Book listing.

On March 13, 2023, the Company submitted four Article 76 petitions against the Kelun ANDA with the CNIPA and requested administrative determination that Kelun's generic neratinib tablet falls within the scope of the claims of the four Orange Book patents. On March 21, 2023, the CNIPA declined to accept the Company's request for administrative determination in relation to Patent Nos. ZL200880118789.3 and ZL201710057547.9, alleging that the listed claims are not eligible for registration in the Chinese Orange Book on the ground that these pharmaceutical method-of-use claims fall within the scope of "patents of crystalline forms," which are not eligible for listing in the Chinese Orange Book. On March 24, 2023, the CNIPA accepted the Company's request for administrative determination in relation to Patent Nos. ZL201410082103.7 and ZL201080060546.6. On April 17, 2023, the Company requested the NMPA to institute a nine-month stay against Kelun's ANDA starting from the CNIPA's acceptance of the Company's request for administrative determination. On September 14, 2023, the Company withdrew the two requests for administrative determination in relation to Chinese Patent Nos. ZL201410082103.7 and ZL201080060546.6 at the CNIPA. On September 25, 2023, the CNIPA accepted the Company's withdrawal request.

*Demai Litigation*

Zhengzhou Demai Pharmaceutical Co., Ltd ("Demai") filed an ANDA with NMPA in China seeking approval to market a generic version of the Company's NERLYNX®. The ANDA application No. is CYHS2402776. On August 26, 2024, Demai made a Type 4.2 declaration against Orange Book Patent ZL201410082103.7, alleging that its generic version of NERLYNX does not fall within the scope of the claims of this Orange Book patent. On September 30, 2024, the Company filed a lawsuit against Demai at the BJIPC based on Nerlynx Patent No. ZL201080060546.6 and on October 8, 2024, the Company filed a lawsuit against Demai at the BJIPC based on Nerlynx Patent No. ZL201410082103.7. On February 13, 2025, the Company withdrew the lawsuits from BJIPC, filed an Article 76 petition with the CNIPA against the Demai ANDA and requested administrative determination that Demai's generic neratinib maleate tablet falls within the scope of the claims of Nerlynx Patent No. ZL201080060546.6. On February 21, 2025, the CNIPA accepted the Company's petition and started examination. On March 18, 2025, the Company filed a request with the NMPA to set up a nine-month stay on Demai's ANDA.

*Hexal European Patent Opposition*

An Opposition was filed by Hexal AG ("Hexal") on August 3, 2016 against European Patent No. 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. 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. 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. 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, Puma filed its response to the summons to attend oral proceedings, including six auxiliary requests. Alfred E. Tiefenbacher and Hexal AG 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. Oral proceedings took place on April 9 and 10, 2025. 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. One European divisional application is pending in the same family, namely EP 23157078.8. A response to the European Search Opinion (ESO) for this application was filed February 14, 2024. The first office action was issued on January 28, 2025 with a response to the first office action filed on July 22, 2025.

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| | |
|:---|:---|
| **Item 1A.** | **RISK FACTORS**  |

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Under Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024, we identified important factors that could affect our financial performance and could cause our actual results for future periods to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statements made in this Quarterly Report. Except as described below, there has been no material change in our risk factors subsequent to the filing of our prior reports referenced above. However, the risks described in our reports are not the only risks we face. Additional risks and uncertainties that we currently deem to be immaterial or not currently known to us, as well as other risks reported from time to time in our reports to the SEC, also could cause our actual results to differ materially from our anticipated results or other expectations*.*

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| | |
|:---|:---|
| **Item 2.** | **UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS**  |

---

**Recent Sales of Unregistered Securities** 

None.

**Purchases of Equity Securities by the Issuer and Affiliated Purchasers** 

None.

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| | |
|:---|:---|
| **Item 3.** | **DEFAULTS UPON SENIOR SECURITIES**  |

---

None.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 38

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| | |
|:---|:---|
| **Item 4.** | **MINE SAFETY DISCLOSURES**  |

---

Not applicable.

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| | |
|:---|:---|
| **Item *5.*** | **OTHER INFORMATION**  |

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**Trading Plans**

During the *three* months ended *June 30, 2025, no* director or officer (as defined in Rule *16a*-*1*(f) under the Exchange Act) of the Company adopted or terminated a "Rule *10b5*-1 trading arrangement" or "non-Rule *10b5*-*1* trading arrangement," as each term is defined in Item *408*(a) of Regulation S-K.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; *39*

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| | |
|:---|:---|
| **Item 6.** | **EXHIBITS** |

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(a) Exhibits required by Item 601 of Regulation S-K.

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| | |
|:---|:---|
| **Exhibit**<br> **Number** | **Description** |
| 3.1 | [<u>Second Amended and Restated Certificate of Incorporation of the Company, as filed with the Secretary of State of the State of Delaware on June 14, 2016 (filed as Exhibit 3.1 to the Company</u>'<u>s Current Report on Form 8-K filed with the SEC on June 15, 2016, and incorporated herein by reference)</u>](http://www.sec.gov/Archives/edgar/data/1401667/000119312516622448/d178772dex31.htm) |
| 3.2 | [<u>Fifth Amended and Restated Bylaws of the Company (filed as Exhibit 3.1 to the Company</u>'<u>s Current Report on Form 8-K filed with the SEC on June 24, 2025, and incorporated herein by reference)</u>](http://www.sec.gov/Archives/edgar/data/1401667/000143774925021153/ex_833086.htm) |
| 10.1+ | [Fifth Amendment to Office Lease, dated as of October 27, 2017, by and between the Company and DE PARK AVENUE 10880, LLC](ex_849252.htm) |
| 10.2+ | [Sixth Amendment to Office Lease, dated as of July 23, 2025, by and between the Company and DE PARK AVENUE 10880, LLC](ex_848952.htm) |
| 31.1+ | [<u>Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 with respect to the registrant</u>'<u>s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025</u>](ex_831929.htm) |
| 31.2+ | [<u>Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, with respect to the registrant</u>'<u>s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025</u>](ex_831930.htm) |
| 32.1++ | [<u>Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002</u>](ex_831931.htm) |
| 32.2++ | [<u>Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002</u>](ex_831932.htm) |
| 101.INS+ | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
| 101.SCH+ | Inline XBRL Taxonomy Extension Schema Document |
| 101.CAL+ | Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| 101.DEF+ | Inline XBRL Taxonomy Extension Definition Linkbase Document |
| 101.LAB+ | Inline XBRL Taxonomy Extension Label Linkbase Document |
| 101.PRE+ | Inline XBRL Taxonomy Extension Linkbase Document |
| 104+ | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
| + | Filed herewith |
| ++ | Furnished herewith |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 40

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**<u>SIGNATURES</u>**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

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| | | |
|:---|:---|:---|
|  | **PUMA BIOTECHNOLOGY, INC.** | **PUMA BIOTECHNOLOGY, INC.** |
| Date: August 7, 2025 | By: | /s/ Alan H. Auerbach  |
|  |  | Alan H. Auerbach |
|  |  | President and Chief Executive Officer |
|  |  | (Principal Executive Officer) |
| Date: August 7, 2025 | By: | /s/ Maximo F. Nougues  |
|  |  | Maximo Nougues |
|  |  | Chief Financial Officer |
|  |  | (Principal Financial and Accounting Officer) |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 41

## Exhibit 10.1

**Exhibit 10.1**

**FIFTH AMENDMENT TO OFFICE LEASE**

**This Fifth Amendment to Office Lease** (this **"Fifth Amendment"),** dated October 27, 2017, is made by and between DE PARK AVENUE 10880, LLC, a Delaware limited liability company **("Landlord"),** with offices at 808 Wilshire Boulevard, Suite 200, Santa Monica, California 90401, and PUMA BIOTECHNOLOGY, INC., a Delaware corporation **("Tenant"),** with offices at 10880 Wilshire Boulevard, Suite 2150, Los Angeles, California 90024.

**WHEREAS,**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**A.** CA-I 0880 Wilshire Limited Partnership, a Delaware limited partnership **("CA-10880"),** Landlord's predecessor-in-interest, pursuant to the provisions of that ce1tain Office Lease dated October 4, 2011 (the **"Original Lease"),** as amended by that ce1tain Lease Term Commencement Letter dated January 10, 2012 (the **"Term Commencement Letter 1"),** that certain First Amendment dated November 28, 2012 (the **"First Amendment"),** that certain Lease Term Commencement Letter dated January 9, 2013 (the **"Term Commencement Letter 2"),** that certain Second Amendment dated December 3, 2013 (the **"Second Amendment"),** that certain Lease Term Commencement Letter dated January 14, 2014 (the **"Term Commencement Letter 3"),** that certain Third Amendment dated March 18, 2014 (the **"Third Amendment"),** and that certain Fou1th Amendment dated July 31, 2015 (the **"Fourth Amendment"),** leased to Tenant and Tenant leased from CA-10880 space in the prope1ty located at 10880 Wilshire Boulevard, Los Angeles, California 90024 (the **"Building"),** commonly known as Suites 1700, 2000, 2020, and 2150 (collectively, the **"Existing Premises");**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**B.** Landlord subsequently acquired all of CA-10880's interest, right and title in and to the real prope1ty and Building in which the Premises are located, becoming successor-in-interest to CA I 0880 and landlord under the Original Lease, as amended;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**C.** Tenant wishes to expand its occupancy within the Building to include additional office space commonly known as Suite 2100 (the **"Expansion Space")** and consisting of approximately 13,916 rentable square feet, as shown on Exhibit A attached hereto, which expansion Landlord has conditionally permitted, contingent upon Landlord obtaining legal possession of the Expansion Space from the tenant currently in possession of the Expansion Space; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**D.** Landlord and Tenant, for their mutual benefit, wish to revise certain other covenants and provisions of the Original Lease, as amended.

**NOW, THEREFORE,** in consideration of the covenants and provisions contained herein, and other good and valuable consideration, the sufficiency of which Landlord and Tenant hereby acknowledge, Landlord and Tenant agree:

**1. Confirmation of Defined Terms.** Unless modified herein, all terms previously defined and capitalized in the Original Lease, as amended, shall hold the same meaning for the purposes of this Fifth Amendment. The Original Lease, as modified by the Term Commencement Letter 1, the First Amendment, the Term Commencement Letter 2, the Second Amendment, the Term Commencement Letter 3, the Third Amendment, the Fourth Amendment and this Fifth Amendment, shall hereinafter be referred to as the **"Lease."**

**2. Delivery of the Expansion Space; Expansion Date and Expansion Term.** Landlord shall deliver the Expansion Space to Tenant on February 1, 2018, contingent upon Landlord obtaining legal possession of the Expansion Space from the tenant currently in possession of the Expansion Space. The term of the lease by Tenant of the Expansion Space (the **"Expansion Term")** and Tenant's obligation to pay Monthly Base Rent shall commence on the earlier of the date Tenant commences operation of its business in the Premises or May l, 20 I 8 (the **"Expansion Date"),** and shall expire, unless otherwise sooner terminated pursuant to the terms of the Lease, at 11:59 p.m. on March 31, 2026 (the **"Termination Date").** Tenant shall accept possession of the Expansion Space in its "as-is" condition without any representations or warranties from Landlord as to the condition of the Expansion Space. Tenant shall be permitted to construct improvements in the Expansion Space in accordance with Exhibit B attached hereto. Tenant shall be entitled to a Tenant Improvement Allowance (as defined in Exhibit B) from Landlord to be disbursed in accordance with Exhibit B attached hereto. Tenant shall deliver to Landlord a copy of its ce1tificate of insurance prior to Landlord delivering the Expansion Space to Tenant, which certificate of insurance shall evidence the insurance for the Expansion Space consistent with Tenant's insurance required for the Existing Premise.

------

**FIFTH AMENDMENT TO OFFICE LEASE**

**3. Expansion of Premises.** Effective as of the Expansion Date, the rentable area of the Premises shall be increased from 51,740 square feet to 65,656 square feet, and the definition of the Premises shall be revised to include both the Existing Premises and the Expansion Space, and wherever in the Lease the word "Premises" is found, it shall thereafter refer to both the Existing Premises and the Expansion Space together, as if the same had been originally included in said Lease.

**4. Monthly Base Rent** - Expansion Space. As of the Expansion Date, Tenant shall pay the Monthly Base Rent as follows:

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| | |
|:---|:---|
| **Period** | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; **Monthly Base Rent** |
| May 1, 2018 through April 30, 2019 | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; $62622.00 |
| May 1, 2019 through April 30, 2020 | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; $64813.77 |
| May 1, 2020 through April 30, 2021 | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; $67082.25 |
| May 1, 2021 through April 30, 2022 | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; $69430.13 |
| May 1, 2022 through April 30, 2023 | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; $71860.19 |
| May 1, 2023 through April 30, 2024 | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; $74375.29 |
| May 1, 2024 through April 30, 2025 | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; $76978.43 |
| May 1, 2025 through March 31, 2026 | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; $79672.67 |

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Concurrent with Tenant's execution and delivery to Landlord of this Fifth Amendment, Tenant shall pay to Landlord the Monthly Base Rent due for the first month of the Expansion Term. All payments of Monthly Base Rent shall be made in immediately available funds.

Notwithstanding the foregoing, Tenant shall be permitted to abate fifty percent (50%) of the Monthly Base Rent due for the months of August 2018, September 2018, August 2019 and September 2019 (collectively, the amount of Monthly Base Rent deferred shall be referred to herein as the **"Rent Abatement Amount").** So long as Tenant is not in Default (as defined in Section 19 of the Original Lease) during the Expansion Term, the entire Rent Abatement Amount shall be abated and forgiven as of September 30, 2019; provided, however, that if Tenant is in Default prior to September 30, 2019, then Tenant shall pay to Landlord upon demand the entire Rent Abatement Amount due for the Expansion Space for the month(s) of the Expansion Term prior to the occurrence of such Default, and Tenant shall not be entitled to any additional or future abatement of Monthly Base Rent for the Expansion Space.

**5. Security Deposit; Letter of Credit.** Landlord acknowledges that it currently holds the sum of $36,434.00 as a Security Deposit under the Lease, which amount Landlord shall continue to hold throughout the Expansion Term, unless otherwise applied pursuant to the provisions of the Lease. Tenant hereby waives the provisions of Section 1950.7 of the California Civil Code, and all other laws, statutes, ordinances or other governmental rules, regulations or requirements now in force or which may hereafter be enacted or promulgated, which (i) establish the time frame by which Landlord must refund a security deposit under a lease, and/or (ii) provide that Landlord may claim from the Security Deposit only those sums reasonably necessary to remedy defaults in the payment of rent, to repair damage caused by Tenant or to clean the Premises, it being agreed that Landlord may, in addition, claim those sums specified in Article I 9 of the Original Lease, and/or those sums reasonably necessary to compensate Landlord for any loss or damage caused by Tenant's breach of the Lease or the acts or omission of Tenant or any Tenant Patty. As used in the Lease a **"Tenant Party"** shall mean Tenant, any employee of Tenant, or any agent, authorized representative, design consultant or construction manager engaged by or under the control of Tenant.

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**FIFTH AMENDMENT TO OFFICE LEASE**

Landlord is the beneficiary under a ce1tain Letter of Credit as defined in Section 6 of Exhibit F to the Original Lease. The Letter of Credit Amount was amended pursuant to Section 4.2 A. of the Fou1th Amendment and is now $2,500,000. Subject to the Reduction Conditions (as defined in Section 4.2 B. of the Fomth Amendment), the schedule for reductions of the Letter of Credit Amount in Section 4.2 B of the Fourth Amendment is hereby amended as follows: the Letter of Credit Amount shall reduce to (a) $2,000,000.00 effective April I, 2020; (b) $1,500,000 effective as of April I, 2021; and (c) $1,000,000 effective as of April 1, 2023, which amount shall remain the Letter of Credit Amount through the remainder of the Term.

**6. Base Year.** As of the Expansion Date, the Base Year shall be calendar year 2018.

**7. Tenant's Share for Expansion Space.** As of the Expansion Date, Tenant's Share as it relates to the Expansion Space, shall be 2.33%.

**8. Parking.** As of the Expansion Date, Tenant shall have thirty-one (31) additional unreserved parking permits for the Expansion Space. The rates chargeable to Tenant for Building parking permits shall be at the posted monthly parking rates and charges then in effect, plus any and all applicable taxes, provided that such rates may be changed from time to time, in Landlord's sole discretion. All other terms of Tenant's parking shall be as provided in Lease.

**9. Lobby Renovation.** Landlord is contemplating the renovation of the lobby of the Building and certain exterior street level renovations **("Lobby Renovation").** Notwithstanding anything in the Lease to the contrary, in addition to and without limiting Landlord's other rights under the Lease, Landlord reserves the right to close temporarily, make alterations or additions to, or change the location of elements of the Building and the Common Areas. Tenant acknowledges that Landlord shall not be obligated to commence the Lobby Renovation until receiving all required governmental approvals and permits; provided, however, that once commenced, Landlord will prosecute the Lobby Renovation to completion in a diligent manner. Landlord shall complete the Lobby Renovation (a) in a good and workmanlike manner, (b) in compliance with all applicable laws, and (c) lien free. Notwithstanding any provision of this Lease to the contrary, Tenant shall not be entitled to any abatement, deduction or setoff against the Rent payable under the Lease as a result of the Lobby Renovation. In addition, Tenant acknowledges and agrees that construction of the Lobby Renovation may cause, among other things, noise, vibration, dust and odors, and in recognition of the foregoing, Tenant hereby agrees that none of the activities and conditions described hereinabove shall be grounds for any claim by Tenant or any patty claiming through Tenant that Landlord has breached any provision of the Lease.

**10. Acceptance of Premises.** Tenant acknowledges that it has been in possession of the Existing Premises for approximately six (6) years, and to Tenant's actual knowledge as of the date hereof Tenant has no claim against Landlord, in connection with the Existing Premises or the Lease. Tenant has made its own inspection of and inquiries regarding the Expansion Space. Therefore, Tenant accepts the Expansion Space in its "as-is" condition. Tenant further acknowledges that Landlord has made no currently effective representation or warranty, express or implied regarding the condition, suitability or usability of the Existing Premises, Expansion Space or the Building for the purposes intended by Tenant except as set fotth in the Lease.

**11. Warranty of Authority.** If Landlord or Tenant signs as a corporation or limited liability company or a partnership, each of the persons executing this Fifth Amendment on behalf of Landlord or Tenant hereby covenants and warrants that the applicable entity executing herein below is a duly authorized and existing entity that is qualified to do business in California; that the person(s) signing on behalf of either Landlord or Tenant have full right and authority to enter into this Fifth Amendment; and that each and every person signing on behalf of either Landlord or Tenant are authorized in writing to do so.

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**FIFTH AMENDMENT TO OFFICE LEASE**

**13. Confidentiality.** Landlord and Tenant agree that the covenants and provisions of this Fifth Amendment shall not be divulged to anyone not directly involved in the management, administration, ownership, lending against, or subleasing of the Premises, other than Tenant's or Landlord's counsel-of record or leasing or sub-leasing broker of record.

**14. Governing Law.** The provisions of this Fifth Amendment shall be governed by the laws of the State of California.

**15. Reaffirmation.** Landlord and Tenant acknowledge and agree that the Lease, as amended herein, constitutes the entire agreement by and between Landlord and Tenant relating to the Premises, and supersedes any and all other agreements written or oral between the patties hereto. Fu1thermore, except as modified herein, all other covenants and provisions of the Lease shall remain unmodified and in full force and effect.

**16. Civil Code Section 1938 Disclosure.** Pursuant to California Civil Code Section 1938, Landlord hereby discloses that the Premises have not undergone an inspection by a Ce1tified Access Specialist to determine whether the Premises meet all applicable construction-related accessibility standards. A Certified Access Specialist ("CASp") can inspect the Premises and determine whether the Premises comply with all of the applicable construction-related accessibility standards under California law. Although California law does not require a CASp inspection of the Premises, Landlord may not prohibit the Tenant from obtaining a CASp inspection of the Premises for the occupancy or potential occupancy of Tenant, if requested by Tenant. Landlord and Tenant shall mutually agree on the arrangements for the time and manner of the CASp inspection, the payment of the fee for the CASp inspection, and the cost of making any repairs necessary to correct violations of construction-related accessibility standards within the Premises.

**17. Submission of Document.** The submission of this Fifth Amendment to Tenant shall be for examination purposes only, and does not constitute a reservation of or an option for Tenant to lease, or otherwise create any interest by Tenant in the Premises or any other offices or space situated in the Building. Regardless of whether or not (a) Landlord has delivered to Tenant an unexecuted draft or final version of this Fifth Amendment for Tenant's review and/or signature, (b) this Fifth Amendment has been executed by Tenant only and delivered to Landlord for its review and signature, and/or (c) Tenant has made payments of rent and/or security deposit to Landlord pursuant to this Fifth Amendment, it is understood and agreed that no contractual or other rights shall exist between Landlord and Tenant with respect to the Premises, nor shall this Fifth Amendment be valid, binding on the patties and/or in effect unless and until this Fifth Amendment has been fully executed by Landlord and Tenant and such fully executed Fifth Amendment has been delivered to Tenant.

**18. Digital Counterparts.** This Fifth Amendment may be executed in several counterparts, each of which when executed and delivered shall be deemed an original, and all of which when taken together shall constitute one and the same agreement. The patties agree that a digital image of this Fifth Amendment as fully-executed (such as in a po1table document format (.pdf)) when sent to the email address of Tenant, its broker (if any), its attorney (if any), or its authorized agent (if any) shall be deemed delivery of a true and correct original of this Fifth Amendment, and such digital image of this Fifth Amendment shall be admissible as best evidence for the purposes of state law, Federal Rule of Evidence 1002, and the like statutes and regulations.

**[Signatures Appear on the Following Page]**

------

**FIFTH AMENDMENT TO OFFICE LEASE**

**IN WITNESS WHEREOF,** Landlord and Tenant have duly executed this document, effective as of the later of the date(s) written below.

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| | |
|:---|:---|
| **LANDLORD:** | **TENANT:** |
| DE PARK AVENUE 10880, LLC, | PUMA BIOTECHNOLOGY, INC., |
| a Delaware limited liability company | a Delaware corporation |
| By: /s/ Andrew B. Goodman | By: /s/ Charles R. Eyler |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Andrew B. Goodman | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Charles R. Eyler |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Senior Vice President | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SVP Finance & Admin |
| Dated: 12/6/17 | Dated: 1 December 2017 |

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| |
|:---|
| By:  |
| Name: |
| Title: |
| Dated: |

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**EXHIBIT A** 

**EXPANSION SPACE PLAN**

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**EXHIBIT B**

**TENANT CONSTRUCTION ADDENDUM**

This Tenant Construction Addendum is made by PUMA BIOTECHNOLOGY, INC., a Delaware corporation **("Tenant")** and DE PARK AVENUE 10880, LLC, a Delaware limited liability company **("Landlord")** in connection with, and as a part of, that ce1tain Lease dated as of October 27, 2017 (the **"Lease").** Capitalized terms not defined in this Tenant Construction Addendum shall be as defined in the Lease.

**1. Tenant to Complete Improvements.** Tenant shall cause its general contractor **("Contractor")** to furnish and install within the Expansion Space those items of general construction shown on any Plans and Specifications approved by Landlord hereunder (the **"Improvements").** Landlord shall pay to Tenant an allowance for the Improvements, not to exceed the sum of $20.00 per square foot of Rentable Area in the Expansion Space (the **"Tenant Improvement Allowance"),** provided, however, Tenant acknowledges Landlord shall have no obligation to disburse any portion of the Tenant Improvement Allowance prior to February I, 2018 or subsequent to December 31, 2018. Out of the Tenant Improvement Allowance (and not in addition to it) Tenant may incur costs of up to $10.00 per square foot of Rentable Area in the Expansion Space for furniture, fixtures and equipment, data cabling and out of pocket relocation costs.

**2. s Reimbursement of Costs.** Provided Tenant is not then in Default under the Lease and otherwise complies with this Tenant Construction Addendum, Landlord shall pay to Tenant (or apply against amounts due to Landlord in connection with the completion of the Improvements) an amount equal to the amount reasonably expended by Tenant with respect to the construction of the Improvements, but not to exceed the amount of the Tenant Improvement Allowance. If the cost of the Improvements is anticipated to be greater than the Tenant Improvement Allowance, Landlord shall not be obligated to disburse any po1tion of the Tenant Improvement Allowance until Tenant has covered the excess costs. If the Improvements actually constructed by Tenant's Contractor cost less than the Tenant Improvement Allowance, there shall be no monetary adjustment between Landlord and Tenant or offset against Rent or other sums owed by Tenant to Landlord under the Lease and the entire cost savings shall be retained by Landlord and relinquished by Tenant.

**3. Conditions for Payment of Tenant Improvement Allowance.** Landlord will not be obligated to disburse any po1tion of the Tenant Improvement Allowance unless all of the following have occurred: (i) Tenant shall have delivered to Landlord (a) invoices from Contractor for all labor rendered and materials delivered to the Expansion Space or used in the Improvements; and (b) executed unconditional mechanic's lien waiver and releases which comply with California Civil Code Section 8138 from all persons providing goods or services in connection with the Tenant Change. Landlord shall use commercially reasonable effo1ts to disburse any portion of the Tenant Improvement Allowance payable hereunder within thirty (30) days after all conditions have been met. Landlord's disbursement of any amounts shall not be deemed Landlord's approval or acceptance of the work furnished or materials supplied as set forth in Tenant's payment request, and Landlord shall not be required execute any release forms or other documents as a condition to such delivery. Landlord shall only be obligated to make one disbursement from the Tenant Improvement Allowance.

**4. Process**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**a)** **Architect.** Within five (5) days after the execution of this Lease by both patties, Tenant shall submit for the reasonable approval of Landlord the name of a qualified architect/space planner (the **"Architect")** to prepare a space plan (the **"Space Plan")** for the Improvements.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**b)** **Contractor.** Within ten (10) days after the execution of this Lease by both parties, Tenant shall submit for the reasonable approval of Landlord the name of a qualified contractor to serve as Contractor for the Improvements. Tenant shall cause Contractor to execute and deliver to Landlord the Contractor Inducement Letter attached hereto as Schedule 1.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**c)** **Space Plan.** Tenant shall promptly cause the Architect to complete the Space Plan and, before any architectural working drawings or engineering drawings have been commenced, shall submit two (2) copies of the Space Plan signed by Tenant to Landlord for Landlord's reasonable approval. The Space Plan shall include a layout and designation of all offices, rooms and other partitioning, their intended use, and equipment to be contained therein. Landlord shall advise Tenant within five (5) business days after Landlord's receipt of the Space Plan for the Expansion Space if the same is unsatisfactory in any respect. Landlord may also request clarification or more specific drawings for special use items not included in the Space Plan. Tenant shall promptly revise the Space Plan to correct any deficiencies or other matters Landlord may reasonably require.

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**EXHIBIT B**

**TENANT CONSTRUCTION ADDENDUM**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**d)** **Plans and Specifications.** Upon approval of the Space Plan by Landlord and Tenant, Tenant shall promptly cause the Architect to complete the architectural and engineering drawings for the Expansion Space (the **"Plans and Specifications").** The Plans and Specifications a fully coordinated set of architectural, structural, mechanical, electrical and plumbing working drawings in a form that is complete to allow subcontractors to bid on the work and to obtain all applicable permits. Tenant shall submit for Landlord's reasonable approval two (2) copies of such Plans and Specifications certified by the Architect to Landlord. Tenant may concurrently submit such Plans and Specifications to the appropriate municipal authorities for building permits (provided that such submission shall be at Tenant's sole risk and shall not alter or modify Landlord's right to approve the Plans and Specifications in accordance with the terms hereof). Landlord shall advise Tenant within ten (I 0) business days after Landlord's receipt of the Plans and Specifications for the Expansion Space if the same is unsatisfactory in any respect. Tenant shall promptly revise the Plans and Specifications to correct any deficiencies or other matters Landlord may reasonably require. Tenant will not commence construction of the Expansion Space until the Plans and Specifications have been fully approved by Landlord.

**5. Space Plan.** Tenant shall promptly revise the Space Plan to correct any deficiencies or other matters Landlord may reasonably require. **Ownership of Improvements.** All Improvements shall be deemed Landlord's prope1ty under the terms of the Lease.

**6. Ancillary Work.** If Tenant shall contracts for any ancillary work not shown in the Plans and Specifications, such as data and telephone cabling and equipment, furnishings, installation of Tenant's trade fixtures or cabinetry (collectively **"Ancillary Work"),** Tenant shall (i) obtain Landlord's approval as required by the Lease, (ii) pay for any such Ancillary Work without reimbursement from the Tenant Improvement Allowance , and (iii) cause the Ancillary Work to be conducted in accordance with the Lease in all respects and in such a way as to not hinder or delay the Improvements.

**7. Effect of Reviews and Approvals.** Landlord's reviews and approvals shall be solely for its own purposes, and Tenant shall not rely on Landlord's review or approval or any information, whether for quality, design, Code compliance or other matters. Landlord and its agents shall not have any liability whatsoever arising from any review of, or omissions or errors in, any Plans and Specifications or any comments, suggestions, advice or assistance provided to Tenant. Tenant shall be solely responsible for verifying, in the field, dimensions and conditions on the base building plans.

**8. Indemnity.** Tenant shall indemnify and hold harmless Landlord and its affiliates and its and their affiliates, members, interest holders, managers, officers, directors, partners, employees, agents, predecessors, successors and assigns from and against all claims, causes of action, liabilities, losses, demands, damages, fines, penalties, judgments and reasonable costs and expenses (including attorneys' fees and costs incurred in the defense thereof), whether for injury to or death of any person or persons, or for damage to property (including any loss of use thereof), or otherwise. that arise out of or in connection with the use of, work in, construction to, or actions in, on, upon or about the Expansion Space by Tenant, Contractor or their respective agents, contractors, directors, employees, licensees, officers, partners or shareholders, including any actions relating to the installation, placement, removal or financing of any Tenant Change, improvements, fixtures and/or equipment in, on, upon or about the Expansion Space.

**9. Communication Protocol.** During the planning and construction process, the Landlord Representative and the Tenant Representative shall (i) have full authority and responsibility to act on its behalf with respect to this Tenant Construction Addendum and (ii) hold meetings regarding the progress of the construction of the Improvements on a regular basis (which shall be weekly if deemed reasonably necessary) at reasonable times. Either party may change its representative at any time on notice to the other party.

**10. Insurance Requirements.** Tenant shall either obtain and maintain public liability and worker's compensation insurance adequate to fully protect Landlord as well as Tenant from and against any and all liability for death or injury to persons or damage to property caused in or about the Expansion Space by reason completion of any Ancillary Work, or shall cause Tenant's contractors or subcontractors to provide such insurance.

**11. Compliance with Construction Policies.**Except as expressly modified in this Tenant Construction Addendum, all of the requirements applicable to Alterations under the Lease.

------

**SCHEDULE 1**

**Contractor Inducement Letter**

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| | |
|:---|:---|
| **<sup>"Landlord":</sup>** | DE Park Avenue I 0880, LL<br> c/o Douglas Emmett Management, LLC<br> Director of Prope1ty Management<br> 808 Wilshire Boulevard, Suite 200<br> Santa Monica, California 90401 |
| **"Contractor"**: |  |

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| | |
|:---|:---|
| Re: | PUMA BIOTECHNOLOGY, INC., a Delaware corporation **("Tenant")**<br> 2100 **("Suite")**<br> 10880 Wilshire Boulevard, Los Angeles, California 90024 (the **"Building")** |

---

Contractor has been engaged by Tenant to perform work (the **"Work")** in or on the Building, which is owned by Landlord. Contractor understands and agrees that, prior to Contractor commencing the Work, Landlord requires that Contractor provide this Contractor Inducement Letter as a material inducement to Landlord's consent to allowing Contractor to perform the Work at the Building. Accordingly, Contractor agrees:

&nbsp;&nbsp;&nbsp;&nbsp;1. Contractor shall comply, and shall cause its subcontractors, agents and employees to comply, with (i) the "General Rules for Construction" (attached to the Lease between Landlord and Tenant relating to the Expansion Space), a copy of which has been read by Contractor and which shall be applicable to Contractor as though set forth herein in full and (ii) any reasonable written guidelines or instructions regarding performance of the Work given to Contractor on behalf of Landlord.

&nbsp;&nbsp;&nbsp;&nbsp;2. Contractor shall indemnify and hold harmless Landlord and its affiliates and its and their affiliates, members, interest holders, managers, officers, directors, pa1tners, employees, agents, predecessors, successors and assigns (the **"Landlord Parties")** from and against all liabilities, claims, damages, losses, liens, causes of actions, judgments, costs and expenses, of whatever kind or nature, including without limitation, bodily injury or death (whether or not those injured or deceased are performing work under this Contractor Inducement Letter or are affiliated with the parties hereto), property damage, costs of litigation (including, without limitation, actual fees and costs for attorneys retained by the Landlord Parties), fines and penalties (collectively, **"Claims")** based on or alleging the Work, including any Claims alleging (1) any breach of this Contractor Inducement Letter by Contractor, its subcontractors, agents or employees, (2) any negligent acts or omissions of Contractor, its subcontractors, agents or employees, including negligence in the screening, hiring and training of employees, contractors and subcontractors, (3) any failure by Contractor, its subcontractors, agents or employees to comply with any applicable law, regulation, building code or governmental order, (4) any liens against the Building or the Expansion Space based on the Work or (5) any person performing any pa1t of the Work not being paid in full. This indemnification obligation shall not be limited in any way by any limitation on the amount or types of damages, compensation or benefits payable by or for Contractor or its subcontractors under workers compensation or disability laws.

&nbsp;&nbsp;&nbsp;&nbsp;3. If any liens arise against the Expansion Space or the Building based on the Work, Contractor shall immediately cause such liens to be removed and provide Landlord evidence that the title to the Building and Expansion Space have been cleared of such lien. If Contractor fails to do so, in additional to any other remedies available to Landlord, Landlord may, but is not obligated to use whatever means it may deem appropriate to cause said lien to be removed and any loss, cost damage or expense incidental thereto, together with attorneys' fees, shall be immediately due and payable by Contractor to Landlord.

------

**SCHEDULE 1**

&nbsp;&nbsp;&nbsp;&nbsp;4. Without limiting any other available remedies, and in addition to any retention amounts, Landlord and Manager shall have the right to withhold out of any amounts due Contractor (as in for example, disbursements of any tenant improvement allowance) an amount sufficient to satisfy any lien or Claim and to completely indemnify the Landlord Parties against any damage or costs from such lien or Claim. Any such withholding shall be released if Contractor (at its expense) posts a reasonably acceptable bond or other security in an amount which is sufficient (in the reasonable judgment of the withholding patty) to fully indemnify the Landlord Parties against any lien or Claim involved.

&nbsp;&nbsp;&nbsp;&nbsp;5. As the Work is for the direct benefit of Landlord as the owner of the Building, Landlord will have the right to pursue rights and remedies directly against Contractor. In any dispute to enforce this Letter, the prevailing party in such litigation shall be entitled to receive its costs (not limited to court costs), expenses and reasonable attorneys' fees from the non-prevailing party as the same may be awarded by the court. Contractor waives any right to consequential, special or indirect damages or loss of anticipated profits. Notwithstanding anything else contained herein to the contrary, Contractor shall look solely to Landlord's interest in the Building and any proceeds from a sale of the Building that actually remain undistributed, for satisfaction of any liabilities or obligations of Landlord under this Agreement. No Landlord Party shall be personally liable for any such liabilities or obligations whatsoever.

The foregoing provisions shall survive the termination or expiration of any agreement between Contractor and Tenant.

ALL OF THE ABOVE TERMS ARE AGREED TO AND ACKNOWLEDGED BY:

CONTRACTOR

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| |
|:---|
| Signature |
| Title |

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## Exhibit 10.2

**Exhibit 10.2**

**SIXTH AMENDMENT TO OFFICE LEASE**

**This Sixth Amendment to Office Lease** (this "**Sixth Amendment**"), dated July 23, 2025 (the "**Sixth Amendment Effective Date**"), is made by and between DE PARK AVENUE 10880, LLC, a Delaware limited liability company ("**Landlord**"), with offices at 1299 Ocean Avenue, Suite 1000, Santa Monica, California 90401, and PUMA BIOTECHNOLOGY, INC., a Delaware corporation ("**Tenant**"), with offices at 10880 Wilshire Boulevard, Suite 1700, Los Angeles, California 90024.

**WHEREAS,**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**A.** Landlord, pursuant to the provisions of that certain Office Lease dated October 4, 2011 (the "**Original Lease**"), as amended by that certain Lease Term Commencement Letter dated January 10, 2012 (the "**Term Commencement Letter 1**"), that certain First Amendment dated November 28, 2012 (the "**First Amendment**"), that certain Lease Term Commencement Letter dated January 9, 2013 (the "**Term Commencement Letter 2**"), that certain Second Amendment dated December 3, 2013 (the "**Second Amendment**"), that certain Lease Term Commencement Letter dated January 14, 2014 (the "**Term Commencement Letter 3**"), that certain Third Amendment dated March 18, 2014 (the "**Third Amendment**"), that certain Fourth Amendment dated July 31, 2015 (the "**Fourth Amendment**"), and that certain Fifth Amendment to Office Lease dated October 27, 2017 (the "**Fifth Amendment**"), leases to Tenant and Tenant leases from Landlord space in the property located at 10880 Wilshire Boulevard, Los Angeles, California 90024 (the "**Building**"), commonly known as Suites 1700, 2000, 2020, 2050, 2100 and 2150 (collectively, the "**Existing Premises**");

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**B.** The Extended Term of the Original Lease, as amended, expires at 11:59 p.m. on March 31, 2026, which Extended Term Landlord and Tenant wish to hereby extend;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**C.** Tenant wishes to reduce its occupancy within the Building to exclude office space from the Existing Premises, commonly known as Suites 2000, 2020, 2050, 2100 and 2150 (the "**Returned Premises**"), and continue to lease Suite 1700, which consists of approximately 26,679 square feet of Rentable Area (the "**Remaining Premises**") as shown on Exhibit A, which reduction Landlord has conditionally permitted, contingent upon Tenant's acceptance of and compliance with the provisions of this Sixth Amendment; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**D.** Landlord and Tenant, for their mutual benefit, wish to revise certain other covenants and provisions of the Original Lease, as amended.

**NOW, THEREFORE,** in consideration of the covenants and provisions contained herein, and other good and valuable consideration, the sufficiency of which Landlord and Tenant hereby acknowledge, Landlord and Tenant agree:

**1. Confirmation of Defined Terms.** Unless modified herein, all terms previously defined and capitalized in the Original Lease, as amended, shall hold the same meaning for the purposes of this Sixth Amendment. The Original Lease, as modified by the Term Commencement Letter 1, the First Amendment, the Term Commencement Letter 2, the Second Amendment, the Term Commencement Letter 3, the Third Amendment, the Fourth Amendment, the Fifth Amendment and this Sixth Amendment, shall hereinafter be referred to as the "**Lease**."

**2. Extension of Extended Term.** The Extended Term of the Lease (with respect to the Remaining Premises) is hereby extended for a period of five (5) years and five (5) months (the "**Second Extended Term**"), from and including April 1, 2026 (the "**Effective Date**"), through and including 11:59 p.m. on August 31, 2031 (the "**Termination Date**").

**3. Surrender of Returned Premises.** Tenant shall vacate the Returned Premises no later than March 31, 2026 (the "**Surrender Date**"), and shall tender possession thereof to Landlord in accordance with Article 15 of the Original Lease. If Tenant vacates the Returned Premises, but leaves any property, trash or debris therein, or if there is any damage to the Returned Premises beyond reasonable wear and tear, then the costs incurred by Landlord in the removal or repair of such items, as the case may be, shall be billed directly to Tenant as Additional Rent or, at Landlord's option, deducted from Tenant's Security Deposit.

Page 1 of 12

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**SIXTH AMENDMENT TO OFFICE LEASE**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.1. Mutual Release of Liability and Claims.** Contingent upon Landlord and Tenant fully performing the covenants and provisions contained herein and, in the Lease, then, except as otherwise contained herein, on the Surrender Date, Landlord and Tenant shall be fully and unconditionally released and discharged from their respective obligations arising from or connected with the Lease with respect to the Returned Premises.

Tenant, for itself, and on behalf of any third party claiming by, on behalf of or after Tenant, hereby releases any rights or claims to occupancy of the Returned Premises and/or any benefit thereof, arising out of or in connection with the Lease after the Surrender Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.2. Disclaimer.** The Original Lease provides in Article 4 for payment of the amount due for Tenant's Share of Expenses and Taxes periodically on an estimated basis with adjustment to the actual amounts due at some time in the future. Tenant has not received a final calculation of the actual amount due for the period of time ending on the Surrender Date with respect to the Returned Premises. Accordingly, Tenant understands and agrees that:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**a)** Landlord's estimate or allocation of anticipated increases in the amount due for Tenant's Share of Expenses and Taxes is only an estimate by Landlord and is not intended nor shall be construed as a limitation or ceiling upon the actual amounts which may be due;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**b)** Tenant shall be solely responsible for payment of Tenant's Share of Expenses and Taxes with respect to the Returned Premises through and including the Surrender Date by virtue of such adjustments and shall be solely entitled to any refunds resulting from such adjustments, even if such calculations are rendered to Tenant by Landlord after the Surrender Date; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**c)** The final reconciliation of the amount due for Tenant's Share of Expenses and Taxes shall not be completed until after the year end of the calendar year for which such computations are to be made, after which computation has been completed, Landlord shall notify Tenant of any adjustment in Additional Rent due for the balance of the Term with respect to the Returned Premises, computed to and including the Surrender Date.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**3.3. Subleases.** The parties acknowledge and agree that Landlord has consented to the following active subleases affecting the Existing Premises according to the following "Subleases Table":

**Subleases Table**

---

| | | |
|:---|:---|:---|
| **Subtenant** | **Space** | **Sublease Termination Date** |
| Sunset West Legal Group, PC | Suite 2100 | March 31, 2026 |
| Quill and Arrow LLP | Suites 2000, 2020, 2050 | March 31, 2026 |

---

**4. Reduction of Existing Premises.** As of the Effective Date, (i) the Usable Area of the Existing Premises shall decrease from approximately 55,607 square feet to approximately 22,900 square feet and the Rentable Area of the Existing Premises shall decrease from approximately 67,236 square feet to approximately 26,679 square feet, and (ii) the definition of the Existing Premises shall be revised to exclude the Returned Premises, and wherever in the Lease the word Premises is found, it shall thereafter refer to the Remaining Premises. The Base Rent and Tenant's Share of increases in Expenses and Taxes for the Remaining Premises shall be revised subject to the terms of this Sixth Amendment.

Landlord engaged an independent third-party space plan audit firm to measure the Usable Area of the Remaining Premises using the 2017 ANSI/BOMA Standard published collectively by the AmericanNational Standards Institute and the Building Owners' and Managers' Association ("**ANSI/BOMA Standard**") as a guideline. Based upon such re-measurement Landlord has been advised that the accurate Usable Area of the Remaining Premises is approximately 22,900 square feet. Based on Landlord's deemed load factor as indicated herein below, the Rentable Area of the Remaining Premises is hereby agreed to be approximately 26,679 square feet.

Page 2 of 12

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**SIXTH AMENDMENT TO OFFICE LEASE**

Landlord and Tenant agree that Landlord is utilizing an add-on factor of 16.50% to compute the Rentable Area of the Remaining Premises. Rentable Area herein is calculated as 1.1650 times the estimated Usable Area, regardless of what the actual square footage of the common areas of the Building may be, and whether or not they are more or less than 16.50% of the total estimated Usable Area of the Building. The purpose of this calculation is solely to provide a general basis for comparison and pricing of this space in relation to other spaces in the market area.

**5. Base Rent.** The Base Rent payable by Tenant for the Remaining Premises shall be as follows:

---

| | |
|:---|:---|
| **Period** | **Monthly Installment of Base Rent** |
| April 1, 2026 through March 31, 2027 | $101380.20 |
| April 1, 2027 through March 31, 2028 | $104928.51 |
| April 1, 2028 through March 31, 2029 | $108601.00 |
| April 1, 2029 through March 31, 2030 | $112402.04 |
| April 1, 2030 through March 31, 2031 | $116336.11 |
| April 1, 2031 through August 31, 2031 | $120407.88 |

---

All payments of Base Rent shall be made in immediately available funds.

Tenant shall be permitted to defer one hundred percent (100%) of the Base Rent due for the months of April 2026, May 2026, June 2026, July 2026 and August 2026 (collectively, the amount of Base Rent deferred shall be referred to herein as the "**Rent Deferral Amount**"). So long as Tenant has not committed a material default during the Second Extended Term, which material default continues after the expiration of any notice and cure periods, the entire Rent Deferral Amount shall be abated and forgiven as of the Termination Date; provided, however, that if Tenant does commit a material default during the Second Extended Term, which material default continues after the expiration of any notice and cure periods, and whether or not such material default is cured after the expiration of any notice and cure periods, then (a) Tenant shall pay to Landlord upon demand the entire Rent Deferral Amount due for the months of the Second Extended Term prior to the occurrence of such material default, and (b) Tenant shall not be entitled to any additional or future deferral of Base Rent.

**6. Security Deposit.** Landlord acknowledges that it currently holds the sum of $36,434.00 as a Security Deposit under the Lease, which amount Landlord shall continue to hold throughout the Second Extended Term, unless otherwise applied pursuant to the provisions of the Lease. Concurrent with Tenant's execution and tendering to Landlord of this Sixth Amendment, Tenant shall tender the sum of $83,973.88, which amount Landlord shall add to the Security Deposit already held by Landlord, so that thereafter, throughout the Second Extended Term, provided the same is not otherwise applied, Landlord shall hold a total of $120,407.88 as a Security Deposit on behalf of Tenant.

Tenant hereby waives the provisions of Section 1950.7 of the California Civil Code, and all other laws, statutes, ordinances or other governmental rules, regulations or requirements now in force or which may hereafter be enacted or promulgated, which (i) establish the time frame by which Landlord must refund a security deposit under a lease, and/or (ii) provide that Landlord may claim from the Security Deposit only those sums reasonably necessary to remedy defaults in the payment of rent, to repair damage caused by Tenant or to clean the Premises, it being agreed that Landlord may, in addition, claim those sums specified in Article 19 of the Original Lease, and/or those sums reasonably necessary to compensate Landlord for any loss or damage caused by Tenant's breach of the Lease or the acts or omission of Tenant or any Tenant Party. As used herein a "Tenant Party" shall mean Tenant, any employee of Tenant, or any agent, authorized representative, design consultant or construction manager engaged by or under the control of Tenant.

Page 3 of 12

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**SIXTH AMENDMENT TO OFFICE LEASE**

**7. Letter of Credit.** Landlord is the beneficiary under a certain Letter of Credit as defined in Section 6 of Exhibit F to the Original Lease. Within thirty (30) days following the Effective Date, and provided Tenant is not then in material uncured default after the expiration of time and the opportunity to cure, Landlord shall return the Letter of Credit to the issuing bank for cancellation and the Letter of Credit shall have no further force or effect after such date of cancellation.

**8. Allowance for FF&E.** Landlord shall provide Tenant with a reimbursement allowance of up to $40,000.00 (the "**FF&E Allowance**"), which amount may be used solely for (i) the purchase and installation of furniture, fixtures and equipment (including a card reader system) reasonably required by Tenant for its use and occupancy of the Remaining Premises, (ii) the purchase and installation of technology-related materials and services reasonably required by Tenant for its use and occupancy of the Remaining Premises, such as computer, data, and telephone cabling and wiring, and (iii) costs associated with relocating Tenant's furniture, fixtures and equipment to the Remaining Premises. Landlord shall disburse the FF&E Allowance within thirty (30) days after Landlord's receipt of paid invoices for the materials and services purchased by Tenant (the "**FF&E Invoices**"), except that the FF&E Allowance shall not be available to Tenant until the Effective Date. Tenant shall submit a single request for reimbursement and such request shall be submitted in writing not later than ninety (90) days after Tenant purchases such materials and services. If any portion of the FF&E Allowance is not used by Tenant, Landlord shall retain such amount and Tenant shall relinquish any right to such amount not used. Landlord shall not have the obligation to disburse the FF&E Allowance (or any portion thereof) to Tenant for any FF&E Invoices received by Landlord on or after October 1, 2026 or at any time a default has occurred and is continuing.

**9. Base Year.** As of the Effective Date, the Base Year shall be calendar year 2026; provided Tenant shall not be obligated to pay, nor shall Tenant accrue charges for Tenant's Share of Expenses and Taxes until the first calendar day of the thirteenth (13<sup>th</sup>) full calendar month of the Second Extended Term. In determining the Base Year expenses, the Base Year expenses shall be calculated as if the Building were ninety-five percent (95%) occupied.

**10. Tenant**'**s Share.** As of the Effective Date, Tenant's Share for the Remaining Premises shall be 4.70% (based upon a total of 487,701 usable square feet in the Building).

**11. Parking.** Notwithstanding any provision of the Lease to the contrary, as of the Effective Date, Tenant shall have right, but not the obligation, to purchase up to two (2) reserved parking permits and sixty- seven (67) unreserved parking permits. The rates chargeable to Tenant for Building parking permits shall be at the posted monthly parking rates and charges then in effect, plus any and all applicable taxes, provided that such rates may be changed from time to time, in Landlord's sole discretion. All other terms of Tenant's parking shall be as provided in Article 24 of the Original Lease, as supplemented by the Building rules and regulations specified in the Lease. Notwithstanding the foregoing, Tenant will reserve the right to convert one (1) unreserved parking permit into one (1) additional reserved parking permit, on a month-to-month basis, subject to availability.

**12. Option to Extend Term.** The Extension Option to extend the Term of the Lease set forth in Section 3 of Exhibit F to the Original Lease shall continue to apply during the Second Extended Term. References in said Section 3 to "Expiration Date" shall mean and refer to the Termination Date and references to "Extension Term" shall mean and refer to the "Third Extended Term."

**13. Acceptance of Premises.** Tenant acknowledges that (i) it is in possession of the Existing Premises, and (ii) to Tenant's actual knowledge, as of the date hereof, it has no claim against Landlord in connection with the Existing Premises or the Lease. Tenant has made its own inspection of and inquiries regarding the Remaining Premises, which is already improved. Therefore, except as provided under the Lease and this Sixth Amendment, including, but not limited to, the Improvements to be completed as set forth in Exhibit B attached hereto, Tenant accepts the Remaining Premises in its "as-is" condition; provided, that Landlord's installation of the Improvements shall not entitle Tenant to any set-off or rent abatement other than as stipulated in this Sixth Amendment. Tenant further acknowledges that Landlord has made no currently effective representation or warranty, express or implied regarding the condition, suitability or usability of the Existing Premises, Remaining Premises or the Building for the purposes intended by Tenant other than expressly provided under the Lease, including, but not limited to, this Sixth Amendment.

Page 4 of 12

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**SIXTH AMENDMENT TO OFFICE LEASE**

**14. Allowance for Cosmetic Improvements.** Landlord shall provide Tenant with a reimbursement allowance of up to $133,395.00 (the "**Cosmetic Improvements Allowance**"), which amount may be used solely for cosmetic improvements in the Remaining Premises that shall not require a permit or structural work. Landlord shall disburse the Cosmetic Improvements Allowance within thirty (30) days after Landlord's receipt of paid invoices for the materials and services purchased by Tenant and such other documentation reasonably requested by Landlord (the "**Cosmetic Improvement Invoices**"), except that the Cosmetic Improvements Allowance shall not be available to Tenant until the Effective Date. Tenant shall submit a single request for reimbursement and such request shall be submitted in writing not later than ninety (90) days after Tenant purchases such materials and services. If any portion of the Cosmetic Improvements Allowance is not used by Tenant, Landlord shall retain such amount and Tenant shall relinquish any right to such amount not used. Landlord shall not have the obligation to disburse the Cosmetic Improvements Allowance (or any portion thereof) to Tenant for any Cosmetic Improvement Invoices received after April 1, 2028 (the "Cosmetic Allowance Reimbursement Deadline") or at any time a default has occurred and is continuing.

**15. Warranty of Authority.** If Landlord or Tenant signs as a corporation or limited liability company or a partnership, each of the persons executing this Sixth Amendment on behalf of Landlord or Tenant hereby covenants and warrants that the applicable entity executing herein below is a duly authorized and existing entity that is qualified to do business in California; that the person(s) signing on behalf of either Landlord or Tenant have full right and authority to enter into this Sixth Amendment; and that each and every person signing on behalf of either Landlord or Tenant are authorized in writing to do so. Each party represents that it has obtained any third party consents that it is required to obtain in order to enter into this Sixth Amendment.

**17. Confidentiality.** Landlord and Tenant agree that the covenants and provisions of this Sixth Amendment shall not be divulged to anyone not directly involved in the management, administration, ownership, lending against, or subleasing of the Premises, other than Tenant's or Landlord's counsel-of- record or leasing or sub-leasing broker of record.

**18. Governing Law.** The provisions of this Sixth Amendment shall be governed by the laws of the State of California.

**19. Reaffirmation.** Landlord and Tenant acknowledge and agree that the Lease constitutes the entire agreement by and between Landlord and Tenant relating to the Existing Premises and the Reduction Premises, and supersedes any and all other agreements written or oral between the parties hereto. Furthermore, except as modified herein, all other covenants and provisions of the Lease shall remain unmodified and in full force and effect.

Page 5 of 12

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**SIXTH AMENDMENT TO OFFICE LEASE**

**20. Civil Code Section 1938 Disclosure.** Pursuant to California Civil Code Section 1938, Landlord hereby discloses that the Premises have not undergone an inspection by a Certified Access Specialist to determine whether the Premises meet all applicable construction-related accessibility standards. A Certified Access Specialist ("**CASp**") can inspect the Premises and determine whether the Premises comply with all of the applicable construction-related accessibility standards under California law. Although California law does not require a CASp inspection of the Premises, Landlord may not prohibit the Tenant from obtaining a CASp inspection of the Premises for the occupancy or potential occupancy of Tenant, if requested by Tenant. Landlord and Tenant shall mutually agree on the arrangements for the time and manner of the CASp inspection, the payment of the fee for the CASp inspection, and the cost of making any repairs necessary to correct violations of construction-related accessibility standards within the Premises.

**21. Estoppel**. Landlord affirms by execution of this Sixth Amendment that to the actual knowledge of Landlord, without any implied, imputed, or constructive knowledge of the undersigned, and without any independent investigation or inquiry having been made or any implied duty to investigate, make any inquiries, or review any materials, as of the Sixth Amendment Effective Date: (i) the Lease is in full force and effect and Landlord does not have any presently existing claims against Tenant or any offsets against any amounts due under the Lease, and (ii) there are no defaults of Tenant under the Lease and there are no existing circumstances which with the passage of time or giving of notice (or both the passage of time and giving of notice) would give rise to a default by Tenant under the Lease.

**23. Submission of Document.** The submission of this Sixth Amendment to Tenant shall be for examination purposes only, and does not constitute a reservation of or an option for Tenant to lease, or otherwise create any interest by Tenant in the Premises or any other offices or space situated in the Building. Regardless of whether or not (a) Landlord has delivered to Tenant an unexecuted draft or final version of this Sixth Amendment for Tenant's review and/or signature, (b) this Sixth Amendment has been executed by Tenant only and delivered to Landlord for its review and signature, and/or (c) Tenant has made payments of rent and/or security deposit to Landlord pursuant to this Sixth Amendment, it is understood and agreed that no contractual or other rights shall exist between Landlord and Tenant with respect to the Premises, nor shall this Sixth Amendment be valid, binding on the parties and/or in effect unless and until this Sixth Amendment has been fully executed by Landlord and Tenant and such fully-executed Sixth Amendment has been delivered to Tenant.

**24. Digital Counterparts.** This Sixth Amendment may be executed in several counterparts, each of which when executed and delivered shall be deemed an original, and all of which when taken together shall constitute one and the same agreement. The parties agree that a digital image of this Sixth Amendment as fully-executed (such as in a portable document format (.pdf)) or DocuSign when sent to the email address of Tenant, its broker (if any), its attorney (if any), or its authorized agent (if any) shall be deemed delivery of a true and correct original of this Sixth Amendment, and such digital image of this Sixth Amendment shall be admissible as best evidence for the purposes of state law, Federal Rule of Evidence 1002, and the like statutes and regulations.

**25. Notices.** The address of Landlord for notices shall be the following:

1299 Ocean Avenue, Suite 1000

Santa Monica, California 90401

Attention: Senior Vice President of Property Management

**[Signatures Appear on the Following Page]**

Page 6 of 12

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**SIXTH AMENDMENT TO OFFICE LEASE**

**IN WITNESS WHEREOF**, Landlord and Tenant have duly executed this document, effective the later of the date(s) written below.

---

| | |
|:---|:---|
| **LANDLORD:** | **TENANT:** |
| DE PARK AVENUE 10880, LLC,<br> a Delaware limited liability company | PUMA BIOTECHNOLOGY, INC.,<br> a Delaware corporation |
| By: Andrew Goodman | By: /s/ Alan Auerbach |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SVP, Leasing | Name: Alan Auerbach |
|  | Title: CEO |
| Dated: 7/24/2025 |  |
|  | Dated: 7/23/2025 |

---

Page 7 of 12

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**EXHIBIT A** – **REMAINING PREMISES PLAN**

------

**EXHIBIT B**

**IMPROVEMENT CONSTRUCTION AGREEMENT**

This Exhibit B shall set forth the terms and conditions relating to the renovation of the tenant improvements in the Remaining Premises. This Exhibit B is essentially organized chronologically and addresses the issues of the construction of the Remaining Premises, in sequence, as such issues will arise.

**<u>SECTION 1</u>** 

**<u>PLANS</u>**

Landlord's contractor shall construct certain improvements in the Remaining Premises pursuant to that certain space plan attached hereto as Schedule 1 (collectively, the "Plans"), which has been approved by Landlord and Tenant. The work described in the Plans shall be referred to as the "Improvements". Unless specifically noted to the contrary on the Plans, the Improvements shall be constructed using Building- standard quantities, specifications and materials as determined by Landlord. If determined by Landlord to be necessary based upon the Plans, Landlord shall cause its architect to prepare detailed plans and specifications for the Improvements ("Working Drawings"). Landlord shall forward the Working Drawings, if any, to Tenant for Tenant's approval. Tenant shall approve or reasonably disapprove any draft of the Working Drawings within three (3) business days after Tenant's receipt thereof; provided, however, that (i) Tenant shall not be entitled to disapprove any portion, component or aspect of the Working Drawings which are consistent with the Plans unless Tenant agrees to pay for the additional cost (if any) resulting from such change in the Plans as part of the Over-Allowance Amount pursuant to Section 2 below, and (ii) any disapproval of the Working Drawings by Tenant shall be accompanied by a detailed written explanation of the reasons for Tenant's disapproval. Failure of Tenant to reasonably disapprove any draft of the Working Drawings within said three (3) business day period shall be deemed to constitute Tenant's approval thereof. The Working Drawings, as approved by Landlord and Tenant, may be referred to herein as the "Approved Working Drawings" Tenant shall make no changes or modifications to the Plans or the Approved Working Drawings without the prior written consent of Landlord, which consent may be withheld in Landlord's sole discretion if such change or modification would directly or indirectly delay the substantial completion of the Improvements in the Remaining Premises or increase the cost of designing or constructing the Improvements.

**<u>SECTION 2</u>**

**<u>OVER-ALLOWANCE AMOUNT</u>**

In the event any revisions, changes, or substitutions are made at the request of Tenant or with Tenant's consent to the Plans or the Approved Working Drawings (if any) or the Improvements, any additional costs which arise in connection with such revisions, changes or substitutions shall be considered to be an "**Over- Allowance Amount**." The Over-Allowance Amount shall be paid by Tenant to Landlord, as Additional Rent, within three (3) business days after Tenant's receipt of invoice therefor. The Over-Allowance Amount shall be disbursed by Landlord prior to the disbursement of any portion of Landlord's contribution to the construction of the Improvements.

**<u>SECTION 3</u>**

**<u>RETENTION OF CONTRACTOR;</u>** 

**<u>WARRANTIES AND GUARANTIES</u>**

Landlord hereby assigns to Tenant, on a non-exclusive basis, to the extent assignable, all warranties and guaranties by the contractor who constructs the Improvements (the "**Contractor**") relating to the Improvements, and Tenant hereby waives all claims against Landlord relating to, or arising out of the construction of, the Improvements. The Contractor shall be designated and retained by Landlord to construct the Improvements.

------

**<u>SECTION 4</u>**

**<u>TENANT'S COVENANTS; TENANT DELAY</u>**

Tenant shall cooperate with Landlord, Landlord's Building management and Landlord's space planner (or the person acting in the capacity of space planner) as reasonably required by Landlord, the architect or any of Landlord's contractors. As used in this Sixth Amendment, "Tenant Delay" shall mean any delay in the design or construction of the Improvements which is due to any act or omission of Tenant or any Tenant Party, and which directly impacts the critical path of construction of the Improvements, regardless of whether such act or omission is wrongful, negligent or otherwise. A "Tenant Delay" shall include, but shall not be limited to (i) the failure of Tenant or Tenant Party to comply with any design or construction schedule or other provision expressly set forth in this Sixth Amendment (including, without limitation, this Exhibit B) requiring Tenant or any Tenant Party to respond to, review, authorize or approve any matter, or perform an obligation (including, without limitation, the obligation to pay, when due, any amounts required to be paid by Tenant pursuant to the Lease or to participate in any design or construction meetings or inspections of which Tenant or the Tenant Party had reasonable notice) within the time period specified in this Sixth Amendment or in any written notice; (ii) any delay attributable to any changes in or additions to the Plans;

(iii) any delay attributable to the inclusion in the Improvements or changes requested or approved by Tenant or finishes, fixtures, millwork, carpet and other materials or services that are not locally available, or are above standard office improvements; (iv) any delay caused by any Tenant Work (as such term is defined in Section 6.3 below) or (v) the failure to comply with any of the terms of this Exhibit B.

**<u>SECTION 5</u>** 

**<u>INTENTIONALLY OMITTED</u>** 

**<u>SECTION 6</u>** 

**<u>MISCELLANEOUS</u>**

6.1 <u>Tenant's Representative</u>. Tenant has designated Keith Harding, Director of Human Resources as its sole representative with respect to the matters set forth in this Exhibit B, who, until further notice to Landlord, shall have full authority and responsibility to act on behalf of the Tenant as required in this Exhibit B.

6.2 <u>Landlord's Representative</u>. Landlord has designated Jason Gold as its sole representative with respect to the matters set forth in this Exhibit B, who, until further notice to Tenant, shall have full authority and responsibility to act on behalf of the Landlord as required in this Exhibit B.

6.3 <u>Tenant Work</u>. Any work not shown in the Plans, including but not limited to, data and telephone cabling and equipment, furnishings, installation of Tenant's trade fixtures or cabinetry (collectively "Tenant Work"), shall be separately contracted and paid for by Tenant. Tenant shall obtain Landlord's prior written approval of Tenant's suppliers and contractors prior to commencement of any of Tenant Work, which approval shall not be unreasonably withheld, conditioned, or delayed. If Landlord's consent is granted, then as a condition to such consent and prior to the commencement of any Tenant Work, Tenant shall submit a schedule to Landlord for its review and approval, which schedule shall detail the timing and purpose (e.g., a description of the work proposed to be performed) of Tenant Work. Tenant shall comply with any reasonable adjustments to Tenant's proposed schedule requested by Landlord. If the performance of any Tenant Work interferes with the construction of the Improvements or otherwise delays completion of the Improvements, the same shall be deemed a Tenant Delay under this Sixth Amendment. Subject to the foregoing, Landlord shall give reasonable access to Tenant's suppliers and contractors so as to achieve timely completion of any Tenant Work, provided that such suppliers and contractors shall be under the reasonable administrative control and supervision of Landlord. During completion of any Tenant Work, neither Tenant or Tenant's contractor shall permit any sub-contractors, workmen, laborers, material or equipment to come into or upon the Building if the use thereof, in Landlord's reasonable judgment, would violate Landlord's agreement with any union providing work, labor or services in or about the Building or disturb labor harmony with the workforce or trades engaged in performing other work, labor or services in or about the Building or the Common Areas. If any material violation, disturbance, interference or conflict occurs, Tenant, upon demand by Landlord, shall immediately cause all contractors or subcontractors or all materials causing the violation, disturbance, interference, difficulty or conflict, to leave or be removed from the Building or the Common Areas immediately. Except to the extent arising out of Landlord's gross negligence or willful misconduct, Tenant shall indemnify and hold Landlord harmless from and against all claims, suits, demands, damages, judgments, costs, interest and expenses (including attorneys fees and costs incurred in the defense thereof) to which Landlord may be subject or suffer when the same arise out of or in connection with the use of, work in, construction to, or actions in, on, upon or about the Remaining Premises by Tenant or Tenant's agents, contractors, directors, employees, licensees, officers, partners or shareholders, involving any actions relating to the installation, placement, removal or financing of any Tenant Work, improvements, fixtures and/or equipment in, on, upon or about the Remaining Premises.

------

6.4 <u>Time of the Essence</u>. Time is of the essence with respect to Tenant's obligations under this Exhibit B. Unless otherwise indicated, all references herein to a "number of days" shall mean and refer to calendar days.

6.5 <u>Completion of Punchlist</u>. Upon completion of the Improvements, the representatives of each of Landlord and Tenant as specified above, shall conduct a joint inspection of the Remaining Premises for the purpose of developing a written "punchlist" of Improvement items, if any, that do not conform to the Plans (the "Punchlist"). Provided that said items were included within Approved Working Drawings, as the case may be (or any change orders approved by Landlord and Tenant), Landlord shall use commercially reasonable efforts to correct those items not yet completed within thirty (30) days after creation of the Punchlist. Tenant's failure or refusal to participate in such inspection in a timely manner (provided Tenant has received reasonable notice of the readiness of the Remaining Premises for such inspection) or to sign off on the Punchlist, shall constitute Tenant's waiver of its rights pursuant to this Section 6.5 and the Punchlist as prepared by Landlord, if any, shall be the approved Punchlist hereunder.

------

**SCHEDULE 1** 

**PLANS**

## Exhibit 31.1

**Exhibit 31.1** 

**CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER** 

**PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002** 

I, Alan H. Auerbach, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Puma Biotechnology, Inc. for the quarter ended June 30, 2025;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

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| | |
|:---|:---|
| Date: August 7, 2025 | /s/ Alan H. Auerbach |
|  | Alan H. Auerbach<br> Principal Executive Officer |

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## Exhibit 31.2

**Exhibit 31.2** 

**CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER** 

**PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002** 

I, Maximo F. Nougues, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Puma Biotechnology, Inc. for the quarter ended June 30, 2025;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

5. The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

---

| | |
|:---|:---|
| Date: August 7, 2025 | /s/ Maximo F. Nougues |
|  | Maximo F. Nougues<br> Principal Financial and Accounting Officer |

---

## Exhibit 32.1

**Exhibit 32.1** 

**CERTIFICATION** 

**PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO** 

**SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002** 

The following certification is being furnished solely to accompany the Quarterly Report on Form 10-Q of Puma Biotechnology, Inc. for the quarter ended June 30, 2025, pursuant to 18 U.S.C. § 1350 and in accordance with SEC Release No. 33-8238. This certification shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference in any filing of Puma Biotechnology, Inc. under the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

**Certification of Principal Executive Officer** 

I, Alan H. Auerbach, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report on Form 10-Q of Puma Biotechnology, Inc. for the quarter ended June 30, 2025, fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended, and that the information contained in such report fairly presents, in all material respects, the financial condition and results of operations of Puma Biotechnology, Inc.

---

| | |
|:---|:---|
| Date: August 7, 2025 | /s/ Alan H. Auerbach |
|  | Alan H. Auerbach<br> Principal Executive Officer |

---

A signed original of this written statement required by Section 906 has been provided to Puma Biotechnology, Inc. and will be retained by Puma Biotechnology, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

## Exhibit 32.2

**Exhibit 32.2** 

**CERTIFICATION** 

**PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO** 

**SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002** 

The following certification is being furnished solely to accompany the Quarterly Report on Form 10-Q of Puma Biotechnology, Inc. for the quarter ended June 30, 2025, pursuant to 18 U.S.C. § 1350 and in accordance with SEC Release No. 33-8238. This certification shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference in any filing of Puma Biotechnology, Inc. under the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

**Certification of Principal Financial Officer** 

I, Maximo F. Nougues, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that the Quarterly Report on Form 10-Q of Puma Biotechnology, Inc. for the quarter ended June 30, 2025, fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended, and that the information contained in such report fairly presents, in all material respects, the financial condition and results of operations of Puma Biotechnology, Inc.

---

| | |
|:---|:---|
| Date: August 7, 2025 | /s/ Maximo F. Nougues |
|  | Maximo F. Nougues<br> Principal Financial and Accounting Officer |

---

A signed original of this written statement required by Section 906 has been provided to Puma Biotechnology, Inc. and will be retained by Puma Biotechnology, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.