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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)


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

For the quarterly period ended June 30, 2025


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

Commission File Number: 001-40881

Pyxis Oncology, Inc.

(Exact Name of Registrant as Specified in its Charter)


Delaware	83-1160910
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
321 Harrison Avenue Boston, Massachusetts	02118
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (617) 453-3596

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

     Title of each class

     Trading
Symbol(s)

     Name of each exchange on which registered

     Common Stock, par value $0.001 per share

     PYXS

     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. Yes ☒ 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). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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). Yes ☐ No ☒

As of August 13, 2025, the registrant had 62,018,135 shares of common stock, $0.001 par value per share, outstanding.

Table of Contents


		Page
Summary Risk Factors		1
PART I.	FINANCIAL INFORMATION	2
Item 1.	Financial Statements (Unaudited)	2
	Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024	2
	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2025 and 2024	3
	Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2025 and 2024	4
	Condensed Consolidated Statements of Cash Flows for the Three Months Ended June 30, 2025 and 2024	5
	Notes to Condensed Consolidated Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	26
Item 4.	Controls and Procedures	26
PART II.	OTHER INFORMATION	28
Item 1.	Legal Proceedings	28
Item 1A.	Risk Factors	28
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	64
Item 3.	Defaults Upon Senior Securities	64
Item 4.	Mine Safety Disclosures	64
Item 5.	Other Information	64
Item 6.	Exhibits	65
Signatures		66

SUMMARY RISK FACTORS

You should consider carefully the risks described under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q. References to “Pyxis Oncology,” the “Company,” “we,” “us,” and “our” in this section titled “Summary Risk Factors” refer to Pyxis Oncology, Inc. and its wholly owned subsidiaries. A summary of the risks that could materially and adversely affect our business, financial condition, operating results and prospects include the following:

•

We are a clinical stage oncology company with a limited operating history and have incurred significant losses since our inception and anticipate that we will continue to incur losses over at least the next several years and may never achieve or maintain profitability.

•

We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce or eliminate one or more of our research and product development programs or future commercialization efforts.

•

We are heavily dependent on the success of our product candidate, micvotabart pelidotin, which is in the early stages of clinical development. If our product candidate is not successful in clinical trials or does not receive regulatory approval or licensure or is not successfully commercialized, our business will be materially and adversely affected.

•

Our product candidate may fail in development or suffer delays that materially and adversely affect its commercial viability. If we or our existing or future collaborators are unable to initiate and complete clinical development of, obtain regulatory approval or licensure for or commercialize our product candidate or experience significant delays in doing so, our business will be materially harmed.

•

Our product candidate may cause undesirable and unforeseen side effects or have other properties impacting safety that could halt its clinical development, delay or prevent its regulatory licensure, limit its commercial potential or result in significant negative consequences.

•

We face significant competition from other biotechnology and pharmaceutical entities, and our operating results will suffer if we fail to compete effectively.

•

Clinical testing and product development is a lengthy and expensive process with an uncertain outcome. We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the clinical testing and the development and commercialization of our product candidate.

•

The regulatory licensure and approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable and, if we are unable to obtain marketing licensure or approval for our product candidate, our business will be substantially harmed.

•

If we fail to attract and retain qualified senior management and key scientific personnel, our business may be materially and adversely affected.

•

We rely on third parties to manufacture our product candidate. Any failure by a third party manufacturer to produce acceptable raw materials or product candidate for us or to obtain authorization from the FDA or comparable foreign regulatory authorities relating thereto may delay or impair our ability to initiate or complete our clinical trials, obtain regulatory licensure or approvals or commercialize approved products.

•

If we are unable to obtain or protect our intellectual property in and to our product candidates, we may not be able to compete effectively in our markets.

•

If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our product candidate or we could lose certain rights to grant sublicenses.

•

Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. If we breach our Pfizer license agreement or any of the other agreements under which we acquired, or will acquire, intellectual property rights covering our product candidate, we could lose the ability to continue the development and commercialization of the related product candidate(s).

•

Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, operations and financial condition.

•

Our information technology systems, or those of any of our existing or future CROs, manufacturers, other contractors, consultants, or collaborators, may be compromised, which could result in additional costs, significant liabilities, harm to our reputation and material disruption of our operations.

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

PYXIS ONCOLOGY, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)


	June 30, 2025			December 31, 2024
Assets
Current assets:
Cash and cash equivalents	$	10,733		$	19,473
Marketable debt securities, short-term		78,211			107,458
Restricted cash		1,472			1,472
Accounts receivable		3,000			—
Prepaid expenses and other current assets		6,540			4,037
Total current assets		99,956			132,440
Property and equipment, net		8,924			9,899
Intangible assets, net		2,488			2,600
Operating lease right-of-use asset		11,847			12,242
Total assets	$	123,215		$	157,181
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	9,412		$	4,859
Accrued expenses and other current liabilities		6,698			11,371
Operating lease liabilities, current portion		1,568			1,450
Total current liabilities		17,678			17,680
Operating lease liabilities, net of current portion		17,832			18,650
Financing lease liabilities, net of current portion		62			100
Total liabilities		35,572			36,430
Commitments and contingencies (Note 13)
Stockholders’ equity:
Preferred stock, par value $0.001 per share, 10,000,000 shares authorized; zero shares issued and outstanding		—			—
Common stock, $0.001 par value per share; 190,000,000 shares authorized; 62,018,135 and 59,967,814 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively.		62			60
Additional paid-in capital		490,654			484,077
Accumulated other comprehensive (loss) income		(5	)		170
Accumulated deficit		(403,068	)		(363,556	)
Total stockholders’ equity		87,643			120,751
Total liabilities and stockholders’ equity	$	123,215		$	157,181

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

PYXIS ONCOLOGY, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)


	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Revenues
Milestone revenue	$	2,820		$	—		$	2,820		$	—
Sale of royalty rights		—			—			—			8,000
Royalty revenues		—			—			—			8,146
Total revenues		2,820			—			2,820			16,146
Costs and operating expenses
Cost of revenues		—			—			—			475
Research and development		17,133			13,953			34,177			26,982
General and administrative		5,437			6,079			11,307			14,326
Total costs and operating expenses		22,570			20,032			45,484			41,783
Loss from operations		(19,750	)		(20,032	)		(42,664	)		(25,637	)
Other income, net:
Interest and investment income		995			2,023			2,236			3,573
Sublease income		684			708			1,199			1,507
Total other income, net		1,679			2,731			3,435			5,080
Loss before income taxes		(18,071	)		(17,301	)		(39,229	)		(20,557	)
Income tax expense		283			—			283			—
Net loss	$	(18,354	)	$	(17,301	)	$	(39,512	)	$	(20,557	)
Net loss per common share - basic and diluted	$	(0.30	)	$	(0.29	)	$	(0.64	)	$	(0.37	)
Weighted average shares of common stock outstanding - basic and diluted		61,918,826			60,495,675			61,486,290			55,892,479
Other comprehensive loss:
Net unrealized loss on marketable debt securities		(54	)		(42	)		(175	)		(165	)
Other comprehensive loss		(54	)		(42	)		(175	)		(165	)
Comprehensive loss	$	(18,408	)	$	(17,343	)	$	(39,687	)	$	(20,722	)

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

PYXIS ONCOLOGY, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands, except share amounts)

(Unaudited)


								Accumulated
					Additional			Other						Total
	Common Stock				Paid-In			Comprehensive			Accumulated			Stockholders’
	Shares		Amount		Capital			Income (Loss)			Deficit			Equity
Balance at December 31, 2024		59,967,814	$	60	$	484,077		$	170		$	(363,556	)	$	120,751
Exercise of pre-funded warrants		1,611,215		2		—			—			—			2
Issuance of restricted common stock, net of tax withholdings		22,728		—		(2	)		—			—			(2	)
Issuance of common stock under employee stock purchase plan (ESPP)		29,619		—		—			—			—			—
Stock-based compensation		—		—		3,631			—			—			3,631
Net unrealized loss on marketable debt securities		—		—		—			(121	)		—			(121	)
Net loss		—		—		—			—			(21,158	)		(21,158	)
Balance at March 31, 2025		61,631,376	$	62	$	487,706		$	49		$	(384,714	)	$	103,103
Issuance of restricted common stock, net of tax withholdings		386,759		—		(67	)		—			—			(67	)
Stock-based compensation		—		—		3,015			—			—			3,015
Net unrealized loss on marketable debt securities		—		—		—			(54	)		—			(54	)
Net loss		—		—		—			—			(18,354	)		(18,354	)
Balance at June 30, 2025		62,018,135	$	62	$	490,654		$	(5	)	$	(403,068	)	$	87,643

								Accumulated
					Additional			Other						Total
	Common Stock				Paid-In			Comprehensive			Accumulated			Stockholders’
	Shares		Amount		Capital			Income (Loss)			Deficit			Equity
Balance at December 31, 2023		44,754,853	$	45	$	411,821		$	63		$	(286,225	)	$	125,704
Issuance of common stock in private placement, net of offering costs		8,849,371		9		39,163			—			—			39,172
Issuance of common stock pursuant to at-the-market (ATM) program, net of offering costs		3,600,000		4		10,586			—			—			10,590
Issuance of pre-funded warrants in private placement, net of offering costs		—		—		7,700			—			—			7,700
Issuance of restricted common stock, net of tax withholdings		1,497,921		1		(197	)		—			—			(196	)
Stock options exercised		100,981		—		245			—			—			245
Stock-based compensation		—		—		4,320			—			—			4,320
Net unrealized loss on marketable debt securities		—		—		—			(123	)		—			(123	)
Net loss		—		—		—			—			(3,256	)		(3,256	)
Balance at March 31, 2024		58,803,126		59		473,638			(60	)		(289,481	)		184,156
Issuance of common stock under ESPP		59,882		—		105			—			—			105
Issuance of restricted common stock, net of tax withholdings		30,553		—		(43	)		—			—			(43	)
Stock options exercised		21,151		—		48			—			—			48
Stock-based compensation		—		—		2,871			—			—			2,871
Net unrealized loss on marketable debt securities		—		—		—			(42	)		—			(42	)
Net loss		—		—		—			—			(17,301	)		(17,301	)
Balance at June 30, 2024		58,914,712	$	59	$	476,619		$	(102	)	$	(306,782	)	$	169,794

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

PYXIS ONCOLOGY, INC.

Condensed Consolidated Statements of Cash Flows (In thousands)

(Unaudited)


	Six Months Ended June 30,
	2025			2024
Operating activities
Net loss	$	(39,512	)	$	(20,557	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization		1,087			1,701
Stock-based compensation		6,646			7,191
Non-cash lease expense		395			335
Accretion of discount on marketable debt securities		(2,053	)		(2,924	)
Changes in operating assets and liabilities:
Accounts receivable		(3,000	)		—
Prepaid expenses and other current assets		(2,503	)		(8	)
Accounts payable		4,553			1,812
Accrued expenses and other current liabilities		(4,673	)		(2,951	)
Operating lease liabilities		(700	)		(594	)
Deferred revenues		—			(7,660	)
Other		(38	)		(62	)
Net cash used in operating activities		(39,798	)		(23,717	)
Investing activities
Redemption of marketable debt securities		123,573			113,848
Purchase of marketable debt securities		(92,448	)		(132,105	)
Purchase of property and equipment		—			(237	)
Net cash provided by (used in) investing activities		31,125			(18,494	)
Financing activities
Proceeds from issuance of common stock and pre-funded warrants in private placement, net of offering costs		2			46,872
Proceeds from issuance of common stock pursuant to ATM program, net of offering costs		—			10,590
Tax withholding payments related to net settlement of restricted common stock		(69	)		(239	)
Proceeds from the exercise of stock options		—			293
Proceeds from issuance of common stock under ESPP		—			105
Net cash (used in) provided by financing activities		(67	)		57,621
Net (decrease) increase in cash, cash equivalents and restricted cash		(8,740	)		15,410
Cash, cash equivalents and restricted cash at beginning of year		20,945			11,136
Cash, cash equivalents and restricted cash at end of period	$	12,205		$	26,546
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	$	10,733		$	25,074
Restricted cash		1,472			1,472
Total cash, cash equivalents and restricted cash shown in the statement of cash flows	$	12,205		$	26,546

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

PYXIS ONCOLOGY, INC.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Description of Business

Nature of Business

Pyxis Oncology, Inc. (the “Company”), a Delaware corporation, was founded in June 2018 and launched its operations in July 2019. The Company is a clinical stage oncology company executing on a development strategy designed to address unmet medical needs in patients with solid tumors with a specific focus on head and neck squamous cell carcinoma (HNSCC) tumors.

2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

The Company’s fiscal year ends on December 31 and its first three fiscal quarters end on March 31, June 30 and September 30. The accompanying condensed consolidated financial statements are unaudited. The unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States of America (GAAP) and follow the requirements of the Securities and Exchange Commission (SEC) for interim financial reporting. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements as certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. The unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements. The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. The Company has no unconsolidated subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB).

In the opinion of management, the unaudited condensed consolidated financial statements include all normal and recurring adjustments that are considered necessary for the fair statement of results for the interim periods. The results for the three and six months ended June 30, 2025 are not necessarily indicative of those expected for the year ending December 31, 2025 or for any future period. The condensed consolidated balance sheet as of December 31, 2024 included herein was derived from the audited consolidated financial statements as of that date. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the related notes thereto for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 18, 2025 (Fiscal 2024 10-K).

Liquidity

As of June 30, 2025, the Company had an accumulated deficit of $403.1 million. The Company has incurred losses and negative cash flows from operations since inception, including net losses of $39.5 million and $20.6 million for the six months ended June 30, 2025 and 2024, respectively.

The Company has not generated any revenues from product sales to date and does not anticipate generating any revenues from product sales unless and until it successfully completes development and obtains regulatory approval for its current or any future product candidates. The Company expects that its operating losses and negative cash flows will continue for the foreseeable future as the Company continues to expand its research and development programs and develop its product candidates.

The Company currently expects that its existing cash, cash equivalents, and short-term investments of $88.9 million as of June 30, 2025 will fund its operating expenses and capital requirements for at least twelve months from the date these unaudited condensed consolidated financial statements are issued. Additional funding may be necessary to fund future clinical and preclinical activities.

The Company plans to continue to fund its losses from operations and capital funding needs through public or private equity, convertible or debt financing or other sources. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations and future prospects.

Use of Estimates

The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, expense and related disclosures. The Company regularly evaluates estimates and assumptions related to assets, liabilities, stock-based compensation, operating leases, assessment of the useful lives of property and equipment, marketable debt securities, fair value of intangible assets and research and development costs, including clinical trial accruals. The Company bases its estimates and assumptions on historical experience and on various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

Actual results could differ from those estimates and there may be changes to management’s estimates in future periods.

Risks and Uncertainties

The Company is subject to risks common to early clinical stage companies in the biopharmaceutical industry including, but not limited to, uncertainties related to commercialization of products, regulatory approvals, dependence on key suppliers for active ingredients and third party service providers such as contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs), protection of intellectual property rights and the ability to make milestone, royalty or other payments due under any license, collaboration or supply agreements.

Concentration of Credit Risks

Financial instruments which potentially subject the Company to significant concentration of credit risk consist of cash and cash equivalents, restricted cash and short-term investments.

The Company invests its excess cash primarily in money market funds and highly liquid United States (U.S.) Treasury securities. The Company has adopted an investment policy that includes guidelines relative to credit quality, diversification and maturities to preserve principal and liquidity.

Significant Accounting Policies

There have been no significant changes to the Company’s significant accounting policies disclosed in “Note 2 – Basis of Presentation and Summary of Significant Accounting Policies” of the Company’s Fiscal 2024 10-K.

Recently Issued Accounting Pronouncements

In December 2023, the FASB issued ASU 2023-09, Income Taxes - Improvements to Income Tax Disclosures. The amendment requires (i) enhanced disclosures in connection with an entity's effective tax rate reconciliation and (ii) income taxes paid disaggregated by jurisdiction. The amendments are effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of the new standard on the Company's consolidated financial statements and related disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. The amendment requires disaggregated disclosure of (i) certain costs and expenses, (ii) certain already required disclosures must be included in the same disclosure as the new disaggregation requirements and (iii) a qualitative description of the amounts not separately disaggregated. The amendments are effective for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, early adoption is permitted. The Company is currently evaluating the impact of the new standard on the Company's consolidated financial statements and related disclosures.

3. Fair Value Measurements

The following tables present the financial instruments carried at fair value on a recurring basis as of June 30, 2025 and December 31, 2024, respectively, in accordance with the FASB ASC 820 hierarchy (in thousands):


	June 30, 2025
	Level 1		Level 2		Level 3		Total
Cash equivalents
Money market funds	$	7,265	$	—	$	—	$	7,265
Marketable debt securities
U.S. Treasury securities		78,211		—		—		78,211
Total	$	85,476	$	—	$	—	$	85,476

	December 31, 2024
	Level 1		Level 2		Level 3		Total
Cash Equivalents
Money market funds	$	9,491	$	—	$	—	$	9,491
Marketable debt securities
U.S. Treasury securities		107,458		—		—		107,458
Total	$	116,949	$	—	$	—	$	116,949

The Company’s cash equivalents represent deposits in a short-term money market fund quoted in an active market and are classified as Level 1 assets. Marketable debt securities include investments in United States Treasury securities and are classified as Level 1 assets as they are valued using quoted prices in active markets. There were no transfers between Level 1 and Level 2 of the fair value hierarchy during the periods presented.

4. Marketable Debt Securities

Marketable debt securities, all of which were classified as available-for-sale, consist of the following (in thousands):


	June 30, 2025
	Amortized Cost		Unrealized Gains		Unrealized Losses			Aggregate Fair Value
Marketable debt securities
U.S. Treasury securities	$	78,216	$	5	$	(10	)	$	78,211

	December 31, 2024
	Amortized Cost		Unrealized Gains		Unrealized Losses			Aggregate Fair Value
Marketable debt securities
U.S. Treasury securities	$	107,288	$	170	$	—		$	107,458

As of June 30, 2025, the remaining contractual terms of the U.S. Treasury securities were less than 12 months.

To date, the Company has not recognized any allowances for credit losses or impairments in relation to its marketable securities as these securities are comprised of high credit quality, investment grade securities that the Company does not intend or expect to be required to sell prior to their anticipated recovery, and the decline in fair value of these securities is attributable to factors other than credit losses.

Interest and investment income consists of the following (in thousands):


	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
Interest income	$	99	$	387	$	183	$	649
Accretion of discount, net		896		1,636		2,053		2,924
Total interest and investment income	$	995	$	2,023	$	2,236	$	3,573

5. Segment disclosure

Operating segments are defined as components of an enterprise for which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources in assessing performance. The Company has one reportable segment related to the development of clinical and preclinical product candidates focused on addressing unmet medical needs in patients with solid tumors with a specific focus on HNSCC tumors. The Company’s chief operating decision maker (CODM) is the Chief Executive Officer.

The accounting policies of the single segment are the same as those described in the Company’s significant accounting policies disclosed in “Note 2 – Basis of Presentation and Summary of Significant Accounting Policies” of the Company’s Fiscal 2024 10-K. The CODM assesses performance for the segment based on net loss, which is reported on the condensed consolidated statements of operations and comprehensive loss as net loss. The measure of segment assets is reported on the condensed consolidated balance sheets as total assets.

To date, the Company has not generated any product revenue. The Company expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances the product candidate through all stages of development and clinical trials and, ultimately, seek regulatory approval.

As such, the CODM uses cash forecast models in deciding how to allocate resources. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results is used in assessing performance of the segment and in establishing management’s compensation, along with cash forecast models.

The table below summarizes segment net loss, including significant expenses for the three and six months ended June 30, 2025 and 2024 (in thousands):


	Three Months Ended June 30,						Six Months Ended June 30,
	2025			2024			2025			2024
Milestone revenue, royalty revenue and sale of royalty rights	$	2,820		$	—		$	2,820		$	16,146
Costs and operating expenses
Cost of revenues		—			—			—			475
Research and development
Clinical product candidates		4,388			3,786			9,534			7,760
Clinical product manufacturing		6,194			3,657			9,578			6,220
Personnel-related expenses excluding stock-based compensation		3,490			3,482			8,229			6,986
Stock-based compensation		569			771			1,691			1,449
Depreciation and amortization		458			224			931			539
Other (i)		2,034			2,033			4,214			4,028
Total research and development expenses		17,133			13,953			34,177			26,982
General and administrative
Personnel-related expenses excluding stock-based compensation		1,060			1,235			2,551			3,154
Stock-based compensation		2,446			2,100			4,955			5,742
Professional and consultant fees		863			1,134			1,677			2,214
Other (ii)		1,068			1,610			2,124			3,216
Total general and administrative expenses		5,437			6,079			11,307			14,326
Total costs and operating expenses		22,570			20,032			45,484			41,783
Other segment income (iii)		1,679			2,731			3,435			5,080
Income tax expense		283			—			283			—
Segment net loss	$	(18,354	)	$	(17,301	)	$	(39,512	)	$	(20,557	)
Reconciliation of profit or loss
Adjustments and reconciling items		—			—			—			—
Consolidated net loss	$	(18,354	)	$	(17,301	)	$	(39,512	)	$	(20,557	)

(i)

Other research and development segment items include facilities expenses, lab services, professional services and technology costs.

(ii)

Other general and administrative segment items include facilities expenses, technology costs, insurance and depreciation.

(iii)

Other segment income for the three months ended June 30, 2025 and 2024 consisted of $1.0 million and $2.0 million of interest and investment income and $0.7 million and $0.7 million of sublease income, respectively and for six months ended June 30, 2025 and 2024 consisted of $2.2 million and $3.6 million of interest and investment income and $1.2 million and $1.5 million of sublease income, respectively.

6. Licensing Agreements

The University of Chicago Agreement

In April 2020, the Company entered into a license agreement (the “University License Agreement”), as well as a sponsored research agreement, with the University of Chicago (the “University”). Under the terms of the license, the Company has the global right to develop and commercialize products that are covered by a valid claim of a licensed patent, incorporate or use the licensed know-how and materials or are known to assess, modulate or utilize the activity of certain specified biological targets. In partial consideration for the license from the University, the Company issued to the University 48,919 shares of its common stock in 2020.

Pursuant to the University License Agreement, the Company is obligated to pay potential development and commercial milestones as well as running royalties on net sales of licensed products at varying rates. The Company assessed the milestone and royalty events under the University License Agreement as of June 30, 2025 and 2024, and determined that no such amounts were required.

Pfizer Inc. Agreement

In December 2020, the Company entered into a license agreement (as amended, the “Pfizer License Agreement”) with Pfizer Inc. (“Pfizer”) for worldwide development and commercialization rights to ADC product candidates directed to certain licensed targets, including micvotabart pelidotin and PYX-203, and products containing the ADC product candidates. The Company’s rights are exclusive with respect to certain patents owned or controlled by Pfizer covering the licensed ADCs. The initial licensed targets include CD123 and Extradomain-B Fibronectin (“EDB+FN”) and the Company has the option to expand the scope of its license to add additional licensed targets that have not been licensed to a third party or are not the subject of a Pfizer ADC development program. The Pfizer License Agreement became effective in March 2021 and the Company paid a combined $25.0 million for the license fee, consisting of an upfront cash payment of $5.0 million and issued 12,152,145 shares of Series B convertible preferred stock, which was converted into 1,911,015 shares of its common stock upon the initial public offering (“IPO”) in October 2021, with a value of $20.0 million to Pfizer.

On October 6, 2022, the Company entered into an amended and restated license agreement (the “A&R License Agreement”) with Pfizer, which amends and restates the Pfizer License Agreement. Pursuant to the A&R License Agreement, Pfizer granted to the Company exclusive worldwide rights under Pfizer’s Flexible Antibody Conjugation Technology (“FACT”) Platform technology to develop and commercialize ADC product candidates directed to certain licensed targets, including micvotabart pelidotin and PYX-203, and products containing the ADC product candidates. Additional ADC targets may be licensed for a nominal upfront payment and milestones. In accordance with the terms of the A&R License Agreement, the Company issued 2,229,654 shares of its common stock to Pfizer in October 2022, paid $8.0 million to Pfizer in January 2023 and issued 1,811,594 shares of its common stock to Pfizer in March 2023.

Further, pursuant to the A&R License Agreement, the Company is obligated to pay future contingent payments including development, regulatory and commercial milestones as well as running royalties on net sales of licensed products at varying rates. The Company assessed the milestone and royalty events under the A&R License Agreement as of June 30, 2025 and 2024, and determined that no such amounts were required.

License Agreement with Biosion USA, Inc.

On March 28, 2022, the Company entered into a license agreement (the “Biosion License Agreement”) with Biosion USA, Inc. (“Biosion”), pursuant to which the Company obtained an exclusive, worldwide (other than Greater China (mainland China, Hong Kong, Macau and Taiwan)) license for development, manufacturing and commercialization rights for BSI-060T, a Siglec-15 targeting antibody, an IO product candidate (now referred to as PYX-106), and products containing the licensed compound.

Pursuant to the Biosion License Agreement, the Company paid an upfront license fee of $10.0 million in March 2022. Further, the Company is also obligated to pay future contingent payments including development, regulatory and commercial milestones as well as running royalties on net sales of licensed products and sublicensing revenues at varying rates. In December 2024, the Company paused the clinical development of PYX-106. The Company assessed the milestone and royalty events involving the Biosion License Agreement as of June 30, 2025 and 2024, and determined that no such amounts were required.

Acquired Out-Licensing Agreements

In August 2023, the Company completed the acquisition of Apexigen, Inc. ("Apexigen") and assumed all out-licensing agreements of Apexigen upon the Merger.

Simcere License and Collaboration Agreement

In December 2008, Epitomics, Inc. (“Epitomics”) (Apexigen’s predecessor) and Jiangsu Simcere Pharmaceutical R&D Co., Ltd. (“Simcere”) entered into a license and collaboration agreement (the “Simcere Agreement”) for the development and commercialization of Suvemcitug (BD0801) for oncology in China.

Simcere is obligated to pay the Company milestone payments for achievement of certain clinical development milestones and low to high single-digit percentage royalties on net sales of Suvemcitug in China until 15 years after the first commercial sale of Suvemcitug.

On June 30, 2025, the National Medical Products Administration (NMPA) of China (formerly SFDA) granted final regulatory approval for Suvemcitug in China. Upon Suvemcitug approval by NMPA, the Company is entitled to a $3 million regulatory approval milestone under the Simcere Agreement. Accordingly, the Company recognized $2.8 million of milestone revenue ($3 million upon achievement of the regulatory milestone less $0.2 million of withholding tax) within the accompanying unaudited condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025.

The Company assessed the royalty events involving Simcere as of June 30, 2025 and determined that no such amounts were receivable.

T-Mab/Mabwell Agreement

In May 2008, Epitomics and Jiangsu T-Mab Biotechnology Ltd., Co. (“T-Mab”) entered into a license, co-development and contract manufacture agreement (the “T-Mab Agreement”) for the development and commercialization of therapeutic candidates, each directed to a specified target for specified fields, including VEGF for the treatment of ocular diseases, in China. Mabwell (Shanghai) Bioscience Co., Ltd. (“Mabwell”) acquired T-Mab in 2015.

Under the agreement, Mabwell was granted an exclusive, royalty-bearing, perpetual license (without the right to sublicense) to rights in certain intellectual property to develop and commercialize such therapeutic candidates. Mabwell is obligated to pay the Company a mid-single-digit percentage royalty on net sales of such therapeutic candidates in China. The Company assessed the milestone and royalty events involving Mabwell as of June 30, 2025 and determined that no such amounts were receivable.

Toray Sublicense Agreement

In May 2012, Epitomics and Toray Industries, Inc. (“Toray”), entered into a non-exclusive sublicense agreement (the “Toray Agreement”) under which Epitomics granted Toray a non-exclusive, worldwide sublicense, with the right to grant further sublicenses, to develop and commercialize drug product candidates that Toray developed using antibodies created using Apexigen’s antibody-discovery platform (the “APXiMAB Platform”) that target certain molecules to use in the development of its drug product candidates. Under the Toray Agreement, Toray paid an upfront fee, and agreed to pay certain development- and regulatory-related milestone payments and a low single-digit percentage royalty on net sales of licensed products and sublicense revenues by Toray or its affiliates. The Company assessed the milestone and royalty events involving Toray as of June 30, 2025 and determined that no such amounts were receivable.

7. Stockholders’ Equity

Shelf Registration Statement and ATM Offering Program

On November 1, 2022, the Company filed a registration statement on Form S-3 with the SEC for the issuance of common stock, preferred stock, warrants, debt securities, rights and units up to an aggregate of $250.0 million. On November 14, 2022, the registration statement was declared effective by the SEC. The registration statement includes an ATM offering program for the sale of up to $125.0 million of shares of the Company’s common stock.

During the three and six months ended June 30, 2025, the Company did not sell any shares of common stock under the ATM offering program. As of June 30, 2025, the Company had $106.2 million of remaining capacity available under the ATM facility.

Preferred Stock

There were no issued and outstanding shares of preferred stock as of June 30, 2025 and December 31, 2024.

Common Stock

Voting, dividend and liquidation rights of the holders of the common stock are subject to and qualified by the rights, powers and preferences of the holders of the preferred stock.

Voting—Each holder of outstanding shares of common stock shall be entitled to one vote in respect of each share.

Reserved Shares—The Company reserved the following shares of common stock for issuance:


	June 30, 2025		December 31, 2024
Stock options outstanding		12,717,406		9,711,075
Restricted stock units outstanding		1,942,478		2,463,601
Shares reserved for future issuance		4,987,940		4,295,342
Pre-Funded Warrant Shares		—		1,611,215
Apexigen replacement warrants		1,003,191		1,003,191
Employee stock purchase plan		653,777		573,316
Total		21,304,792		19,657,740

8. Common Stock Warrants

Apexigen Replacement Warrants

Upon the Merger, each outstanding warrant issued by Apexigen was assumed and converted into a warrant to acquire the Company’s common stock, on substantially similar terms and conditions as were applicable under such Apexigen warrant agreements. The Company replaced approximately 5,815,613 Apexigen warrants with approximately 1,003,191 Pyxis Oncology warrants.

As of June 30, 2025, there were 344,259 warrants outstanding with an exercise price of $8.12 per share, 17,212 warrants outstanding with an exercise price of $10.14 per share and 641,720 warrants with an exercise price of $66.67 per share. Each of the warrants with an exercise price of $66.67 per share will expire on the fifth anniversary of July 29, 2022, or earlier upon redemption or liquidation. Each of the warrants with an exercise price of $8.12 per share and $10.14 per share will expire on July 30, 2028, or earlier upon redemption or liquidation.

Private Placement Warrants

In February 2024, the Company received gross proceeds of $50 million via private placement with certain institutional and accredited investors by issuing (i) 8,849,371 shares of the Company’s common stock, par value $0.001 per share, at a purchase price of $4.78 per share, and (ii) pre-funded warrants (‘Pre-Funded Warrant’) to purchase up to an aggregate of 1,611,215 shares of the Company’ common stock at a purchase price of $4.779 per Pre-Funded Warrant.

In January 2025, the pre-funded warrant holder exercised their right to convert the Pre-Funded Warrants to common stock and accordingly, the Company issued 1,611,215 shares of the Company’s common stock to the warrant holder.

9. Stock-Based Compensation

The Company grants stock-based incentive awards pursuant to the 2021 Equity and Incentive Plan (the ‘2021 Plan’), 2019 Equity Incentive Plan (the ‘2019 Plan’), Apexigen Equity Incentive Plans (the ‘Apexigen Plan’) and the 2022 Equity Inducement Plan (the ‘2022 Inducement Plan’). As of June 30, 2025, there were 3,788,154 shares, 132,705 shares, 638,222 shares and 428,859 shares available for future issuance under the 2021 Plan, 2019 Plan, Apexigen Plan and 2022 Inducement Plan, respectively.

Stock Options

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


	Number of Options			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term (Years)		Aggregate Intrinsic Value (in thousands)
Outstanding at January 1, 2025		9,711,075		$	5.04		8.2	$	44
Granted		4,036,836			0.99
Expired		(333,268	)		3.70
Forfeited		(697,237	)		2.05
Outstanding at June 30, 2025		12,717,406		$	3.95		8.3	$	497
Options exercisable June 30, 2025		4,594,965		$	6.83		6.4	$	52

The aggregate intrinsic value is calculated as the difference between the exercise price of all outstanding and exercisable stock options and the fair value of the Company’s common stock of $1.10 per share as of June 30, 2025. The aggregate intrinsic value of stock options exercised during the six months ended June 30, 2025 and 2024 was $0 and $0.2 million, respectively, as no stock options were exercised during the three and six months ended June 30, 2025.

The Company has an aggregate $8.3 million of gross unrecognized stock-based compensation expense as of June 30, 2025, remaining to be amortized over a weighted average period of 2.0 years.

The weighted-average grant-date fair value of options granted during the three and six months ended June 30, 2025, were $0.78 and $0.78 per share, respectively, and $3.57 and $3.90 per share for the three and six months ended June 30, 2024, respectively, and was calculated using the following key input assumptions in the Black-Scholes option-pricing model:


	Three months ended June 30,		Six Months Ended June 30,
	2025	2024	2025	2024
Expected volatility	99.43% - 101.51%	100.20% - 100.34%	93.92% - 101.51%	99.41% - 102.27%
Risk-free interest rate	3.75% - 4.11%	4.33% - 4.75%	3.75% - 4.45%	4.06% - 4.75%
Expected dividend yield	0.00%	0.00%	0.00%	0.00%
Expected term (in years)	5.25 - 6.08	6.00 - 6.08	5.00 - 6.08	5.00 - 6.08

Restricted Stock Units ('RSU')

The following table summarizes restricted stock units activity for the six months ended June 30, 2025:


	Number of Units			Weighted Average Grant Date Fair Value
Outstanding at January 1, 2025		2,533,650		$	3.26
Granted		24,260			0.92
Forfeited		(128,686	)		3.24
Vested and settled		(486,746	)		3.48
Outstanding at June 30, 2025(1)		1,942,478		$	2.97

(1) Includes 38,426 RSUs which are vested but not settled at June 30, 2025.

During the six months ended June 30, 2025, the Company issued 409,487 shares of its common stock from the settlement of 486,746 restricted common units, with the remaining shares withheld for taxes. The Company has an aggregate $3.8 million of gross unrecognized restricted stock-based compensation expense as of June 30, 2025, remaining to be amortized over a weighted average period of 2.2 years.

Summary of Stock-Based Compensation Expense

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


	Three Months Ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
General and administrative	$	2,446	$	2,100	$	4,955	$	5,742
Research and development		569		771		1,691		1,449
Total	$	3,015	$	2,871	$	6,646	$	7,191

2021 Employee Stock Purchase Plan (“2021 ESPP”)

The Company has the 2021 ESPP in force. The Company issued 29,619 shares under the 2021 ESPP during the six months ended June 30, 2025, the Company did not issue any shares during the three months ended June 30, 2025. During the three and six months ended June 30, 2024, the Company issued 59,882 shares of common stock pursuant to the ESPP. As of June 30, 2025, 653,777 shares are available for issuance under the 2021 ESPP.

10. Operating Leases

The Company leases its office and facilities in Boston, Massachusetts under a non-cancellable operating lease agreement that continues through December 31, 2032. Cash paid for operating lease liabilities were $1.6 million and $1.6 million during the six months ended June 30, 2025 and 2024, respectively and $0.8 million and $0.8 million during the three months ended June 30, 2025 and 2024, respectively, which is included in operating cash flows within the accompanying unaudited condensed consolidated statements of cash flows.

The components of operating lease expense were as follows (in thousands):


	Three months ended June 30,				Six Months Ended June 30,
	2025		2024		2025		2024
Lease cost
Operating lease cost	$	655	$	663	$	1,327	$	1,327
Variable lease cost		375		412		430		957
Total operating lease cost	$	1,030	$	1,075	$	1,757	$	2,284

The Company subleases approximately 17,729 square feet of office and laboratory space in the building located at 321 Harrison Avenue, Boston, Massachusetts. The Company remains jointly and severally liable under the head lease and accounts for the sublease as an operating lease. The lease term commenced on March 24, 2023 and is expected to end in March 2026. The Company recognized sublease income of $0.7 million and $0.7 million for the three months ended June 30, 2025 and 2024, respectively and $1.2 million and $1.5 million for the six months ended June 30, 2025 and 2024, respectively.

11. Income Taxes

The Company’s effective tax rate from continuing operations was 0% for the three and six months ended June 30, 2025 and 2024. The Company has not recorded a federal income tax provision for the three and six months ended June 30, 2025 and 2024. The Company recorded $0.3 million of foreign tax related to the Simcere milestone revenue in China and a nominal state and local income tax provision for the three and six months ended June 30, 2025 and 2024.

The Company assesses the realizability of the deferred tax assets at each reporting date. The Company continues to maintain a full valuation allowance for its U.S. federal and state deferred tax assets, which significantly consists of net operating losses and tax credits. If certain substantial changes in the entity’s ownership occur, there may be an annual limitation on the amount of the carryforwards that can be utilized. The Company will continue to assess the need for a valuation allowance on its deferred tax assets.

On July 4, 2025, President Donald Trump signed the One Big Beautiful Bill Act (“OBBBA”) into law. Key corporate tax provisions include the restoration of 100% bonus depreciation, immediate expensing for domestic research and experimental expenditures, changes to Section 163(j) interest limitations, and expanded Section 162(m) aggregation requirements. In accordance with ASC 740, the effects of the new tax law will be recognized in the period of enactment. The Company is currently evaluating the impact of the OBBBA but does not anticipate a material impact to the unaudited condensed consolidated financial statements.

12. Net Loss per Common Share

The following potentially dilutive securities have been excluded from the calculation of diluted net loss per common share due to their anti-dilutive effect:


	June 30,
	2025		2024*
Stock options outstanding		12,717,406		6,956,497
Restricted stock units outstanding		1,942,478		3,053,833
Shares reserved for future issuance		4,987,940		1,578,783
Apexigen replacement warrants		1,003,191		1,003,191
Employee stock purchase plan		653,777		615,603
Total		21,304,792		13,207,907

*Pre-Funded Warrant Shares of 1,611,215 shares are included in the computation of basic and diluted net loss per common share for the three and six months ended June 30, 2024 as the Pre-Funded Warrants were issuable for nominal consideration.

13. Commitments and Contingencies

Legal Proceedings

From time to time, the Company may become involved in various legal proceedings that arise in the ordinary course of business. The Company is not currently a party to any material legal proceedings and is not aware of any pending or threatened legal proceeding against it that the Company believes could have an adverse effect on its business, operating results or financial condition.

Commitments

In the normal course of business, the Company enters into agreements with various third parties for clinical trials, preclinical research studies and testing, manufacturing and other services and products for operating purposes, which are generally cancellable by the Company at any time, subject to payment of remaining obligations under binding purchase orders and, in certain cases, nominal early-termination fees. These commitments are not deemed significant.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our (1) unaudited condensed consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q, and (2) consolidated financial statements and related notes and management’s discussion and analysis of financial condition and results of operations for the fiscal year ended December 31, 2024, included in our Fiscal 2024 10-K. Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Pyxis Oncology,” the “Company,” “we,” “us,” and “our” refer to Pyxis Oncology, Inc. and its subsidiaries.

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements.

Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Part II, Item 1A. of this Quarterly Report on Form 10-Q and in our other filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

Overview

Pyxis Oncology is a clinical stage oncology company executing on a development strategy designed to address unmet medical needs in patients with solid tumors with an immediate focus on head and neck squamous cell carcinoma (HNSCC) tumors.

Our product candidate, micvotabart pelidotin, formerly referred to as PYX-201, is an investigational novel antibody-drug conjugate (ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM). The tumor ECM is a complex network of fibrous proteins and molecules with unique composition that play an important role in cell development and tumor growth and in some instances, in supporting metastasis. The fibronectin strands within the ECM give the tumor shape and support the clustering of tumor cells.

Fibronectin is a key component of the ECM and its downstream signaling pathways regulate cell adhesion, migration, differentiation and wound healing. EDB+FN is an alternatively spliced form of fibronectin. EDB+FN regulates blood vessel morphogenesis, which provides the tumor access to nutrition and oxygen, and provides a means to remove waste and a pathway for cells to metastasize. EDB+FN is a compelling target for cancer therapeutics as the physiological expression of EDB+FN is very low in healthy adult tissues, yet it is found to be highly expressed in a large variety of solid tumor tissues. EDB+FN is also found to be expressed during embryogenesis.

By targeting EDB+FN, our goal is to destabilize the barrier that protects, feeds, and provides structure to the tumor, in addition to killing tumor cells directly while sparing healthy cells.

Our ADC, micvotabart pelidotin, consists of human Immunoglobulin G1 (IgG1) and is site-specifically conjugated with a cleavable linker and a microtubule inhibitor (optimized auristatin) payload. Micvotabart pelidotin is designed to optimize linker stability to enable delivery of the next generation auristatin payload that can be cleaved and released in the ECM and penetrate through the tumor cell membrane to kill tumor cells directly without the need for cell surface antigen-mediated internalization of the ADC. Unlike conventional ADCs which bind to the tumor cell surface antigens, micvotabart pelidotin is designed to deliver the auristatin payload to the extracellular environment and release the free payload to kill tumor cells as well as activated fibroblasts and vascular endothelial cells that support tumor growth. We believe the free payload kills the tumor cells through a combination of bystander effect directly killing highly proliferative cells and through stimulation of the local immune cells.

We conducted a Phase 1 dose escalation (Part 1) study, referred to as PYX-201-101 to evaluate micvotabart pelidotin monotherapy in patients with advanced solid tumors predicted to express EDB+FN. A total of 80 patients were dosed across nine solid tumor types during the PYX-201-101 (Part 1) study. In November 2024, we announced positive preliminary data from Part 1 of our Phase 1 dose escalation study of PYX-201-101 with a data cut-off date of October 4, 2024.

The recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients were observed to show the strongest tumor regression response during this Part 1 phase of the study. Among the six efficacy evaluable patients with R/M HNSCC at the therapeutically active dose response range of 3.6 mg/kg – 5.4 mg/kg IV Q3W, the study achieved a confirmed 50% objective response rate (ORR) based on RECIST 1.1 criteria including one confirmed complete response (cCR) and two confirmed partial responses (cPRs) and yielded a disease control rate (DCR) of 100%. These six heavily pre-treated patients with R/M HNSCC had either HPV-positive (HPV+) or HPV-negative (HPV-) tumors and a median of four prior lines of systemic therapy in the advanced disease setting.

While we observed evidence of tumor regression across all nine solid tumor types that were enrolled in the Phase 1 Part 1 dose escalation study, dose responses were most pronounced in six solid tumor types of interest, including R/M HNSCC, hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer, locally advanced / metastatic non-small cell lung cancer (NSCLC), ovarian cancer, sarcoma and triple negative breast cancer (TNBC), at the therapeutically active dose response range of 3.6 mg/kg – 5.4 mg/kg IV Q3W. Micvotabart pelidotin achieved a 26% ORR (n=31) in patients with these six solid tumor types dosed at 3.6 mg/kg – 5.4 mg/kg IV Q3W.

Preclinical Data

In April 2025, we presented preclinical data at the 2025 American Association for Cancer Research (AACR), Annual Meeting in Chicago. We observed broad anti-tumor activity for micvotabart pelidotin across ten solid tumor indications in PDX models, attributed to EDB+FN target expression, proteolytic activity for micvotabart pelidotin linker cleavage and tumor responsiveness to the optimized cytotoxic Auristatin0101 payload. The preclinical data is summarized below:

•

45% of models demonstrated strong to very strong tumor growth inhibition (TGI%) activity (70%<TGI<90% or TGI>90% respectively), with only 25% of models showing no response (TGI<25%).

•

PDX models with very strong activity (TGI>90%) were found across nine out of ten solid tumor indications.

•

Complete responses to micvotabart pelidotin (tumor volume reached 0mm3 for at least two consecutive measurements) were found across several tumor indications, consistent with previous analysis.

•

micvotabart pelidotin was observed to be well-tolerated (3mg/kg, Q4Dx4).

We also performed differential gene expression analysis, which enabled us to identify gene signatures linked to anti-tumor activity consistent with our extracellular ADC hypothesis. We observed that enzyme and tumor stroma gene signatures were the gene sets with the greatest number of differentially expressed genes. Further, the preclinical data shows upregulation of certain proteases that may contribute to increased linker cleavage and subsequent increased anti-tumor activity for micvotabart pelidotin, supporting our extracellular hypothesis.

We also conducted preclinical studies combining a mouse analog of micvotabart pelidotin with anti-PD-1 therapy. The combination of a mouse analog of micvotabart pelidotin with anti-PD-1 therapy inhibited EMT6 tumor growth and improved survival compared to either treatment alone, suggesting potential benefit for combination therapy to deepen anti-tumor responses in solid tumors. The preclinical studies combining a mouse analog of micvotabart pelidotin with anti-PD-1 therapy is summarized below:

•

Monotherapy of mouse analog of micvotabart pelidotin inhibited dose-dependent tumor outgrowth of EDB+FN expressing EMT6 tumors and was well-tolerated at 6 mg/kg.

•

The mouse analog of micvotabart pelidotin boosted the immune response by activating dendritic cells and increasing CD45+ immune cell infiltration, including PD-1+ T cells, into tumors, transforming EMT6 tumors into immune-infiltrated, "hot" tumors.

•

Significant TGI observed with mouse analog of micvotabart pelidotin (TGI=94%) and anti-PD-1 therapy (TGI=54%) as monotherapies.

•

The combination of the mouse analog of MICVO and anti-PD-1 therapy resulted in TGI of 91% and complete response was seen in 9/15 animals – greater tumor regression and clearance than either treatment alone.

•

Mouse analog of micvotabart pelidotin in combination with anti-PD1 therapy induced lasting immunological memory, enhancing tumor clearance and protecting against tumor recurrence in rechallenged mice.

The preclinical data indicated micvotabart pelidotin alone may be eliciting immune responses in previously unresponsive tumors, as observed with the infiltration of T cells into the tumor, representing potential for micvotabart pelidotin to drive immunogenic cell death. Together, these preclinical data further support the three-pronged mechanism of action of micvotabart pelidotin driving anti-tumor activity via direct tumor killing, bystander effect and immunogenic cell death.

We believe the totality of our preliminary clinical and preclinical data supports further development of both micvotabart pelidotin monotherapy expansion and combination therapy trials.

Our Clinical Pipeline

In February 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to micvotabart pelidotin for the monotherapy treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.

Based on the strength of the HNSCC signal that emerged in the Part 1 dose escalation study of PYX-201-101, we have decided to prioritize our resources to focus the next stage of development on characterizing the R/M HNSCC efficacy signal.

The following table summarizes our clinical pipeline:

In early January 2025, we initiated the dose expansion phase (Part 2) of the PYX-201-101 monotherapy study with a prioritized focus to confirm the preliminary efficacy signals in R/M HNSCC seen in Part 1. We are enrolling and dosing patients for two monotherapy R/M HNSCC expansion cohorts. The Part 2 dose expansion phase includes the following two R/M HNSCC cohorts across sites in the United States (US), European Union (EU) and other countries:

•

micvotabart pelidotin monotherapy for second line (2L) and third line (3L) R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort at the 5.4 mg/kg IV Q3W dose, a pharmacologically active dose identified during Part 1 of this trial where we have seen clinically meaningful anti-tumor activity with manageable safety. We anticipate having preliminary data in the second half of 2025; and

•

micvotabart pelidotin monotherapy for 2L and 3L R/M HNSCC patients who have received prior epidermal growth factor receptor (EGFR) directed therapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort also at the 5.4 mg/kg IV Q3W dose and anticipate having preliminary data in the first half of 2026.

We are planning to hold a discussion with the FDA to align on our approach for finding the optimal monotherapy dose, as required under Project Optimus and expect the dose optimization phase to commence in 2026.

In November 2024, we announced a Clinical Trial Collaboration and Supply Agreement with Merck & Co, Inc. or Merck (known as MSD outside of the US and Canada), for a Pyxis Oncology-sponsored study of micvotabart pelidotin in combination with Merck’s anti-PD-(L)1 therapy, KEYTRUDA® (pembrolizumab).

In early January 2025, we initiated the Phase 1/2 combination study with KEYTRUDA® now called PYX-201-102 and are actively recruiting patients in this study. PYX-201-102 is a Phase 1/2 open label, global, multicenter dose escalation and dose expansion study to evaluate the safety, tolerability, PK, PD and preliminary efficacy of micvotabart pelidotin in combination with pembrolizumab in patients with advanced solid tumors. Patients with histologically or cytologically confirmed advanced solid tumors, including 1L R/M HNSCC, 2L+ R/M HNSCC, cervical cancer, gastric cancer, HR+/HER2- breast cancer, sarcoma and locally advanced or metastatic TNBC, are eligible to enroll.

We initiated Part 1 dose escalation phase of PYX-201-102 covering multiple tumor types with an aim to identify the Recommended Phase 2 Dose (RP2D) of micvotabart pelidotin in combination with pembrolizumab. Currently, we are enrolling and dosing patients to clear the three doses that will be tested in combination with pembrolizumab. During Part 1 dose escalation, we anticipate testing a fixed dose of pembrolizumab in combination with 3 different doses of micvotabart pelidotin ranging from 3.6 mg/kg – 5.4 mg/kg IV Q3W. Pembrolizumab (standard dose at 200 mg IV) will be given with escalating doses of micvotabart pelidotin with a starting dose of 3.6 mg/kg IV every 3 weeks (Q3W). Upon clearance of the initial dose level of 3.6 mg/kg IV Q3W by the Dose Escalation and Steering Committee (DESC), and depending on observed safety data, we may escalate to 4.4 mg/kg IV Q3W of micvotabart pelidotin with 200 mg IV of pembrolizumab, with a potential of dosing at 5.4 mg/kg IV Q3W of micvotabart pelidotin with 200 mg IV of pembrolizumab. We aim to select a dose of micvotabart pelidotin in combination with pembrolizumab by mid-year 2025, which will guide our discussion with the FDA about potential RP2D for further combination study.

Concurrently to the Part 1 dose escalation and assuming each dose clears the escalation step, the Phase 1/2 combination study will evaluate micvotabart pelidotin and pembrolizumab in patients with 1L and 2L+ R/M HNSCC. We expect to enroll approximately 20 patients, which will be enrolled for each dose in their respective backfill cohort upon clearance of the dose by the DESC. Pembrolizumab (standard dose at 200 mg IV) will be given with escalating doses of micvotabart pelidotin with a starting dose of 3.6 mg/kg IV every 3 weeks, followed by dose of 4.4 mg/kg IV Q3W, if DESC clears it and then a dose of 5.4 mg/kg IV Q3W, if DESC clears it. We anticipate having preliminary data on at least a subset of these R/M HNSCC patients in the second half of 2025. Timing of data availability from the full recruitment and dosing of R/M HNSCC patients is dependent on the timing of activation of additional clinical trial sites and patient enrollment. Further guidance on anticipated timing of the full preliminary data readout will be provided in the fall of 2025.

Since our inception, we have focused substantially all of our resources on conducting research and development activities, undertaking preclinical studies and clinical trials, organizing and staffing our company, business planning, raising capital, establishing and maintaining our intellectual property portfolio and identifying potential product candidates. We do not have any products approved for sale and have not generated any revenue from product sales. We have incurred significant operating losses since our inception. We reported net losses of $39.5 million and $20.6 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $403.1 million, net equity of $87.6 million, and cash, cash equivalents, restricted cash and short-term investments of $90.4 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We expect that our expenses and capital expenditures will increase substantially in connection with our ongoing activities. Our operations to date have been financed primarily through sales of convertible preferred stock and sale of equity securities and additional funding may be necessary to fund future clinical and preclinical activities.

Components of Our Results of Operations

Revenues

To date, we have not generated any revenues from product sales and do not expect to generate any revenues from product sales in the foreseeable future. We record revenues from research and development agreements, including amounts related to upfront receipt for license fees, royalties, milestones and other contingent receipts and fees for research and development services.

Our ability to generate product revenues will depend upon our ability to successfully develop, obtain regulatory approval and commercialize our product candidate. Due to the numerous risks and uncertainties associated with product development and regulatory approval, we are unable to predict the amount, timing or whether we will be able to obtain product revenues.

Operating Expenses

Cost of Revenues

The components of our cost of revenues are expenses directly attributable to revenues. During the three and six months ended June 30, 2025, we have not incurred any costs with respect to revenue.

Research and Development Expenses

Research and development expenses consist of costs incurred for our research work to support clinical development, and the development of our programs. Research and development expenses are separated into program-specific costs and unallocated costs.

Program-specific costs include:

•

direct third party costs, which include expenses incurred under agreements with contract research organizations (CROs), and the cost of consultants who assist with the development of our product candidate on a program-specific basis, investigator grants, sponsored research, and any other third party expenses directly attributable to the development of the product candidate;

•

costs of acquiring, developing, and manufacturing and testing clinical and preclinical materials, including costs incurred under agreements with contract development and manufacturing organizations (CDMOs) to the extent they can be allocated to a specific program;

•

license fees and milestone payments related to the acquisition and retention of certain licensed technology and intellectual property rights for a specific product candidate; and

•

costs associated with preclinical activities that are directly attributable to the development of the product candidate.

Unallocated costs include:

•

employee-related expenses for research and development personnel, including salaries, bonus, payroll taxes, related benefits, severance and other staff-related expenses;

•

stock-based compensation expenses for employees engaged in research and development activities;

•

facilities and other costs, which include allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, laboratory supplies, third party cost for research and the cost of consultants who assist with our research and development and costs related to contract manufacturing, but are not allocated to a specific program.

We expense research and development costs as incurred. Non-refundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered, or the services rendered.

We expect that our research and development expenses will increase substantially in connection with our ongoing and planned preclinical and clinical development activities in the near term and in the future. The successful development of our product candidate is highly uncertain. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of our product candidate and we may never succeed in obtaining regulatory approval for our product candidate.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and personnel-related costs, including stock-based compensation, and severance for our personnel in executive, legal, finance and accounting, human resources, information technology and other administrative functions. General and administrative expenses also include professional fees for auditing, tax, and legal services, as well as insurance, board of director compensation, consulting, other administrative expenses and facility costs not otherwise included in research and development expenses.

Other Income, Net

Other income, net primarily consists of interest earned on our invested cash and cash equivalent balances, accretion of discounts associated with our marketable debt securities and sublease income under our sublease.

Results of Operations

Comparison of the Three Months Ended June 30, 2025 and 2024

The following table summarizes our results of operations for the three months ended June 30, 2025 and 2024 (in thousands):


	For the Three Months Ended June 30,
	2025			2024			Change
Milestone revenue	$	2,820		$	—		$	2,820
Costs and operating expenses
Research and development		17,133			13,953			3,180
General and administrative		5,437			6,079			(642	)
Total costs and operating expenses		22,570			20,032			2,538
Loss from operations		(19,750	)		(20,032	)		282
Other income, net
Interest and investment income		995			2,023			(1,028	)
Sublease income		684			708			(24	)
Total other income, net		1,679			2,731			(1,052	)
Loss before income taxes		(18,071	)		(17,301	)		(770	)
Income tax expense		283			—			283
Net loss	$	(18,354	)	$	(17,301	)	$	(1,053	)

Revenues

Revenues for the three months ended June 30, 2025, were $2.8 million, compared to $0 for the quarter ended June 30, 2024. During the quarter, we recognized $2.8 million of milestone revenue ($3.0 million of milestone less $0.2 million of tax in China) related to regulatory approval of Suvemcitug in China. The regulatory milestone was pursuant to out-licensing and collaboration agreement between of our subsidiary company, Apexigen and Jiangsu Simcere Pharmaceutical R&D Co., Ltd. (“Simcere”), for the development and commercialization of Suvemcitug for oncology in China.

Costs and Operating Expenses

Research and Development Expenses

The following table summarizes our research and development expenses for the three months ended June 30, 2025 and 2024 (in thousands):


	For the Three Months Ended June 30,
	2025		2024		Change
Program-specific costs:
Micvotabart pelidotin	$	9,673	$	5,367	$	4,306
PYX-106		588		1,646		(1,058	)
Other program costs		321		430		(109	)
Total program costs		10,582		7,443		3,139
Unallocated costs:
Personnel-related expenses including stock-based compensation		4,059		4,253		(194	)
Other costs		2,492		2,257		235

Pyxis Oncology, Inc. 10-Q