Pyxis Oncology (PYXS) posts $23.3M Q1 loss and advances MICVO trials
Rhea-AI Filing Summary
Pyxis Oncology, Inc. reported first quarter 2026 results and highlighted progress in its lead antibody-drug conjugate, micvotabart pelidotin (MICVO), for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Updated MICVO Phase 1 monotherapy data in 2L+ R/M HNSCC are planned for mid‑2026, focusing on patients treated at or below a dose cap introduced in December 2025, while updated Phase 1/2 combination data with KEYTRUDA in 1L R/M HNSCC are expected in the second half of 2026. The company also presented supportive preclinical data at the 2026 AACR meeting and completed target enrollment in the Phase 1 monotherapy dose expansion study.
Financially, Pyxis Oncology reported a Q1 2026 net loss of $23.3 million, or ($0.37) per share, compared with a net loss of $21.2 million, or ($0.35) per share, a year earlier. Research and development expenses rose to $20.0 million, while general and administrative expenses declined to $4.4 million. The company ended March 31, 2026 with $42.5 million in cash, cash equivalents, restricted cash, and short‑term investments and expects this to fund operations into the fourth quarter of 2026.
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Insights
Pipeline advancing, cash runway into Q4 2026 but losses widening.
Pyxis Oncology is concentrating resources on MICVO, its lead ADC for R/M HNSCC, with multiple Phase 1 and Phase 1/2 readouts planned in mid‑2026 and the second half of 2026. Completed target enrollment in the monotherapy expansion study de‑risks near‑term data delivery.
Financially, net loss increased to $23.3M in Q1 2026 as research and development spending climbed to $20.0M, reflecting heavier clinical and CMC investment, while general and administrative costs fell. Cash, equivalents, restricted cash and short‑term investments of $42.5M are expected to support operations into the fourth quarter of 2026, limiting visibility beyond that point.
Key near‑term value drivers are the mid‑2026 MICVO monotherapy update, which will assess outcomes under the new dose cap strategy, and the second‑half 2026 combination data with KEYTRUDA in 1L R/M HNSCC. These clinical results, together with any subsequent financing or partnership activity disclosed in future filings, will shape the company’s outlook.
8-K Event Classification
Key Figures
Key Terms
antibody drug conjugate medical
Fast Track Designation regulatory
Phase 1/2 clinical study medical
dose escalation medical
adjusted ideal bodyweight (AIBW) dosing medical
recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) medical
Earnings Snapshot
The company expects its current cash, cash equivalents, restricted cash, and short-term investments to fund operations into the fourth quarter of 2026.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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.
Item 2.02 Results of Operations and Financial Condition.
On May 14, 2026, Pyxis Oncology, Inc. (“the Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026 and provided a corporate update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in Item 2.02 of this Current Report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing with the U.S. Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filings.
Item 9.01 Financial Statements and Exhibits.
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Description |
99.1 |
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Press Release dated May 14, 2026 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Pyxis Oncology, Inc. |
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May 14, 2026 |
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/s/ Jitendra Wadhane |
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Jitendra Wadhane |
Exhibit 99.1
Pyxis Oncology Reports First Quarter 2026 Financial Results and Advances MICVO Toward Key 2026 Clinical Milestones
Updated micvotabart pelidotin (MICVO) Phase 1 monotherapy data in 2L+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) on track for mid-year 2026; update to include analyses focused on patients treated at or below a dose cap
Completed target enrollment in Phase 1 monotherapy dose expansion study of MICVO in 2L+ R/M HNSCC in the first quarter of 2026
Updated data from MICVO Phase 1/2 dose escalation study in combination with pembrolizumab in 1L R/M HNSCC on track for the second half of 2026
Presented new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2026 that support the clinical development of MICVO as both a monotherapy and in combination with pembrolizumab for the treatment of R/M HNSCC
Announced the appointment of Nelson Azoulay as Chief Business Officer
Expected cash runway into the fourth quarter of 2026
BOSTON, May 14, 2026 (GLOBE NEWSWIRE) — Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today reported financial results for the quarter ended March 31, 2026, and highlighted continued advancement of the micvotabart pelidotin (MICVO) clinical development program.
“Our team’s exceptional clinical and operational execution in the first quarter of 2026, combined with growing investigator enthusiasm for MICVO’s potential to positively impact the lives of patients with cancer, has positioned us to deliver key milestones for the MICVO program this year,” said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. “We remain on track to share updated monotherapy data in mid-year 2026 and updated combination data in the second half of 2026. The mid-year 2026 monotherapy update will focus on 2L+ R/M HNSCC patients treated at or below a dose cap, which we implemented in December 2025. The goal of moving to a dose cap was to maintain MICVO’s strong efficacy profile while improving safety and tolerability. In the Phase 1/2 dose escalation combination study with pembrolizumab, we have refined our focus to 1L R/M HNSCC patients. We believe these two datasets will help establish MICVO’s broad potential as a novel ADC for patients with difficult-to-treat cancers and substantial unmet need.”
Pipeline & Corporate Updates
First Quarter 2026 Financial Results
About Pyxis Oncology, Inc.
Pyxis Oncology, Inc. is a clinical-stage biopharmaceutical company developing therapeutics for difficult-to-treat cancers. The Company’s lead candidate, micvotabart pelidotin (MICVO), is a first-in-concept antibody drug conjugate (ADC) that targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM). EDB+FN is selectively overexpressed in the tumor microenvironment of a wide range of solid tumors and largely absent from normal adult tissues. MICVO is designed to treat solid tumors through a three-pronged mechanism of action: direct cancer cell killing, bystander effect and immunogenic cell death. MICVO is currently being evaluated as monotherapy in a Phase 1 clinical study in patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in a Phase 1/2 clinical study in patients with R/M HNSCC and other solid tumors. Pyxis Oncology is focused on advancing MICVO, with the goal of improving outcomes for patients living with R/M HNSCC and contributing to meaningful progress in cancer treatment.
MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
To learn more, visit www.pyxisoncology.com or follow us on 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 SEC on May 14, 2026, 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
Alex Kane
IR@pyxisoncology.com
PYXIS ONCOLOGY, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
19,983 |
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$ |
17,044 |
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General and administrative |
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4,377 |
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5,870 |
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Total operating expenses |
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24,360 |
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22,914 |
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Loss from operations |
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(24,360 |
) |
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(22,914 |
) |
Other income, net: |
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Interest and investment income, net |
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457 |
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1,241 |
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Sublease income |
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631 |
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515 |
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Total other income, net |
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1,088 |
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1,756 |
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Net loss |
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$ |
(23,272 |
) |
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$ |
(21,158 |
) |
Net loss per common share - basic and diluted |
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$ |
(0.37 |
) |
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$ |
(0.35 |
) |
Weighted average shares of common stock outstanding - basic and diluted |
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63,469,850 |
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61,048,948 |
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Other comprehensive loss: |
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Net unrealized loss on marketable debt securities |
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(53 |
) |
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(121 |
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Other comprehensive loss |
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(53 |
) |
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(121 |
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Comprehensive loss |
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$ |
(23,325 |
) |
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$ |
(21,279 |
) |
PYXIS ONCOLOGY, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
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March 31, 2026 |
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December 31, 2025 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
5,766 |
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$ |
15,422 |
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Marketable debt securities |
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35,252 |
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51,435 |
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Restricted cash |
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1,472 |
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1,472 |
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Prepaid expenses and other current assets |
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3,082 |
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3,776 |
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Total current assets |
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45,572 |
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72,105 |
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Property and equipment, net |
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7,538 |
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7,997 |
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Operating lease right-of-use asset |
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11,190 |
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11,418 |
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Total assets |
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$ |
64,300 |
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$ |
91,520 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
4,989 |
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$ |
10,885 |
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Accrued expenses and other current liabilities |
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9,786 |
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8,554 |
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Operating lease liabilities, current portion |
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1,757 |
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1,692 |
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Total current liabilities |
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16,532 |
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21,131 |
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Operating lease liabilities, net of current portion |
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16,497 |
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16,958 |
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Financing lease liabilities, net of current portion |
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3 |
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23 |
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Total liabilities |
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33,032 |
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38,112 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock |
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— |
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— |
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Common stock |
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63 |
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63 |
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Additional paid-in capital |
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497,654 |
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496,469 |
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Accumulated other comprehensive income |
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— |
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53 |
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Accumulated deficit |
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(466,449 |
) |
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(443,177 |
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Total stockholders’ equity |
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31,268 |
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53,408 |
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Total liabilities and stockholders’ equity |
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$ |
64,300 |
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$ |
91,520 |
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[i] SyBing, Andrew B., and Diane D. Wang. "Optimizing Body Size‐Based Dosing Approaches for Antibody–Drug Conjugates." Clinical Pharmacology & Therapeutics (2025).