Pyxis Oncology Reports Second Quarter 2025 Financial Results and Provides Business Update

Rhea-AI Summary

Pyxis Oncology (Nasdaq: PYXS) reported Q2 2025 financial results and provided updates on its clinical programs. The company's lead antibody-drug conjugate (ADC) candidate, micvotabart pelidotin (MICVO), is advancing in clinical trials with preliminary data expected in H2 2025 and H1 2026.

Key financial highlights include $90.4 million in cash and investments, providing runway into H2 2026. Q2 revenues were $2.8 million from a milestone payment from Simcere, with a net loss of $18.4 million ($0.30 per share). R&D expenses increased to $17.1 million, while G&A expenses decreased to $5.4 million.

The company is progressing with two key clinical trials: a Phase 1 monotherapy study for head and neck cancer and a Phase 1/2 combination study with KEYTRUDA®, both showing promising potential in treating advanced solid tumors.

Positive

• Received $2.8M milestone payment from Simcere for suvemcitug approval in China
• Strong cash position of $90.4M providing runway through H2 2026
• Advancing two promising clinical trials with data readouts expected in H2 2025
• Eligible for future mid to high single-digit royalties on suvemcitug sales in China

Negative

• Net loss increased to $18.4M from $17.3M year-over-year
• R&D expenses increased by $3.1M to $17.1M compared to Q2 2024
• Clinical development of PYX-106-101 was paused in December 2024

Insights

Oncology Clinical Trials Expert

Pyxis reports promising MICVO ADC trials for head/neck cancer with $90.4M cash extending runway through upcoming data releases into 2026.

Pyxis Oncology's clinical program for micvotabart pelidotin (MICVO) is advancing on schedule with multiple data readouts expected within the next year. The company is pursuing a dual-track strategy with MICVO: a monotherapy expansion study in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients who failed prior treatments, and a combination study with pembrolizumab. This approach maximizes the potential clinical applications of their lead antibody-drug conjugate.

The focus on head and neck cancer is strategically sound given the high unmet medical need in this indication. Despite therapeutic advances, R/M HNSCC remains difficult to treat, particularly in second and third-line settings after patients have progressed on platinum chemotherapy and PD-1 inhibitors. MICVO's extracellular targeting mechanism differentiates it from other ADCs, which typically target cell surface receptors.

The company's clinical timeline is well-structured, with preliminary monotherapy data expected in H2 2025 for the 2L/3L cohort who received prior platinum/PD-1 therapy, followed by data in H1 2026 for patients who received prior EGFR inhibitor/PD-1 therapy. Additionally, the combination study with KEYTRUDA will yield preliminary results in H2 2025. This staggered data release approach provides multiple potential catalysts while allowing the company to refine its development strategy based on emerging results.

Biotechnology Financial Analyst

Pyxis secures financial stability with $90.4M cash runway through 2026, bolstered by milestone payments, while advancing critical clinical programs.

Pyxis Oncology's financial position shows stability with $90.4 million in cash and investments as of June 30, 2025, providing runway into the second half of 2026. This timeline strategically aligns with their upcoming clinical data readouts, giving them sufficient capital to reach these crucial inflection points without immediate financing pressure.

The company reported quarterly revenue of $2.8 million from a milestone payment tied to the Chinese approval of suvemcitug, highlighting the value of their partnership strategy. This regulatory milestone from Simcere demonstrates validation of their technology platform while providing non-dilutive capital. Importantly, Pyxis retains mid to high single-digit percentage royalties on future sales in China, creating a potential recurring revenue stream.

R&D expenses increased to $17.1 million (up from $14.0 million year-over-year), reflecting investment in manufacturing and clinical trials for MICVO. This 22% increase signals appropriate resource allocation toward their lead program. Meanwhile, G&A expenses decreased to $5.4 million (from $6.1 million), demonstrating cost discipline in non-research areas. The quarterly net loss of $18.4 million ($0.30 per share) remains manageable relative to their cash position.

With 62 million outstanding shares, the company has maintained a reasonable capital structure. The extended cash runway removes near-term financing risk, allowing management to focus on clinical execution and potential value-creating milestones through multiple data readouts before requiring additional capital.

–  Phase 1 monotherapy expansion study of micvotabart pelidotin (MICVO) for recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients progressing well with preliminary data in second half of 2025 and first half of 2026

–  Phase 1/2 combination study of MICVO and KEYTRUDA® (pembrolizumab) progressing well with preliminary data in second half of 2025

–  Received a $2.8 million, net of tax, milestone payment from Simcere Pharmaceutical Group Limited for approval of suvemcitug (BD0801) in China by the National Medical Products Administration

–  Expected cash runway through data milestones and into second half of 2026

BOSTON, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing antibody-drug conjugate (ADC) therapeutics for difficult-to-treat cancers, today reported financial results for the quarter ended June 30, 2025, and provided a business update.

“We are invigorated by the progress we’re making, particularly in our ongoing clinical trials, where we’re seeing that MICVO’s unique mechanism as an extracellular targeted ADC has the potential to transform the treatment of advanced solid tumors,” said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. “The encouraging clinical and preclinical data observed to date suggest that MICVO may offer a differentiated treatment approach as both a monotherapy and in combination with pembrolizumab for HNSCC and other advanced solid tumors. We look forward to evaluating the emerging clinical data as we continue to advance this novel ADC.”

Pipeline Updates

• Pyxis Oncology anticipates having preliminary data from the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial evaluating MICVO in 2L and 3L R/M HNSCC patients who have received prior platinum and PD-1 inhibitor therapy in the second half of 2025. Preliminary data from the trial in 2L and 3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy are anticipated in the first half of 2026. R/M HNSCC continues to be an area of high medical need despite potential improvements in treatment options.

• Pyxis Oncology anticipates having preliminary data from the Phase 1/2 combination study of MICVO in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in R/M HNSCC and other advanced solid tumors in the second half of 2025.

• In July 2025, Pyxis Oncology received a $2.8 million ($3 million milestone payment, less $0.2 million of tax in China) milestone payment from Simcere Pharmaceutical Group Limited (“Simcere”) for the approval of suvemcitug (BD0801) in China by the National Medical Products Administration. The Company is eligible to receive mid to high single-digit percentage royalties on net sales of suvemcitug in China, under the terms of the Company’s license and collaboration agreement. In addition to suvemcitug, Pyxis Oncology retains rights to two other antibodies in development by Apexigen’s licensees, discovered through the APXiMAB platform.
  
  

Second Quarter 2025 Financial Results

• As of June 30, 2025, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $90.4 million. The Company believes that its current cash, cash equivalents, restricted cash and short-term investments will be sufficient to fund its operations into the second half of 2026.

• Revenues for the quarter 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 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 an out-licensing and collaboration agreement between our subsidiary company, Apexigen, and Simcere, for the development and commercialization of suvemcitug for oncology in China.

• Research and development expenses were $17.1 million for the quarter ended June 30, 2025, compared to $14.0 million for the quarter ended June 30, 2024. The increase in expenses of $3.1 million was due to increased manufacturing of drug product and drug substance and clinical trial-related expenses for monotherapy and combination therapy of MICVO aggregating to $3.8 million, partially offset by reduction in expenses related to PYX-106 by $1.1 million as the clinical development of PYX-106-101 was paused in December 2024.

• General and administrative expenses were $5.4 million for the quarter ended June 30, 2025, compared to $6.1 million for the quarter ended June 30, 2024. The decrease was primarily due to lower corporate insurance costs, lower facilities costs and decrease in legal, professional, and consulting fees.

• Net loss was $18.4 million, or ($0.30) per common share, for the quarter ended June 30, 2025, compared to $17.3 million, or ($0.29) per common share, for the quarter ended June 30, 2024. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended June 30, 2025 was $15.3 million, compared to net loss of $14.4 million for the quarter ended June 30, 2024.

• As of August 13, 2025, the outstanding number of shares of Common Stock of Pyxis Oncology was 62,018,135.
  
  

About Pyxis Oncology, Inc.
Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers. The Company is efficiently building therapeutics that hold the potential for monotherapy and combination indications. Its lead candidate, micvotabart pelidotin (MICVO, formerly PYX-201), has been evaluated in ongoing Phase 1 clinical studies in multiple types of solid tumors with a go-forward development focus on treating patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) based on the strength of the HNSCC signal that emerged. Additionally, the Company initiated a Phase 1/2 combination study of MICVO and Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors.

To learn more, visit www.pyxisoncology.com or follow us on Twitter and LinkedIn.

Forward Looking Statements
This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. 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 the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 14, 2025, and our other filings, each of which is on file with the Securities and Exchange Commission. 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 hereof 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.

Pyxis Oncology Contact
Jitu Wadhane
Principal Financial and Accounting Officer
IR@pyxisoncology.com

Media
Cailyn McCutcheon
Real Chemistry
cmccutcheon@realchemistry.com

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

PYXIS ONCOLOGY, INC. Condensed Consolidated Balance Sheets (In thousands, 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
Stockholders’ equity:
Preferred stock			—				—
Common stock			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

FAQ

What were Pyxis Oncology's (PYXS) Q2 2025 financial results?

Pyxis reported $2.8M in revenue, a net loss of $18.4M ($0.30 per share), and ended Q2 with $90.4M in cash and investments. R&D expenses were $17.1M, and G&A expenses were $5.4M.

When will Pyxis Oncology (PYXS) report preliminary data for MICVO in head and neck cancer?

Preliminary data from the Phase 1 monotherapy expansion cohorts is expected in H2 2025 for 2L/3L R/M HNSCC patients with prior platinum and PD-1 therapy, and H1 2026 for patients with prior EGFRi and PD-1 therapy.

What milestone payment did Pyxis Oncology (PYXS) receive from Simcere?

Pyxis received a $2.8M net milestone payment ($3M less $0.2M tax) from Simcere for the approval of suvemcitug (BD0801) in China by the National Medical Products Administration.

How long will Pyxis Oncology's (PYXS) current cash runway last?

The company's current cash position of $90.4M is expected to fund operations into the second half of 2026.

What are the main clinical trials Pyxis Oncology (PYXS) is currently conducting?

Pyxis is conducting a Phase 1 monotherapy expansion study of MICVO for head and neck cancer and a Phase 1/2 combination study of MICVO with KEYTRUDA® (pembrolizumab), both with preliminary data expected in H2 2025.