- Preliminary data from ongoing Phase 1 clinical studies of micvotabart pelidotin (MICVO) in patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) expected in the fourth quarter of 2025
- Clinical update to focus on preliminary data from Phase 1 monotherapy dose expansion study of MICVO in 2L/3L R/M HNSCC patients, including from both post platinum & PD-1 and post EGFR & PD-1 arms, and preliminary data from Phase 1/2 combination dose escalation study of MICVO and KEYTRUDA$(R)$ (pembrolizumab) in 1L/2L+ R/M HNSCC patients
- Presented translational data at ESMO 2025 and AACR-NCI-EORTC providing meaningful insights into MICVO's first-in-concept non-cellular targeting antibody drug conjugate $(ADC)$ mechanism of action
- Expected cash runway through data milestones and into the second half of 2026
BOSTON, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today provided a business update, and reported financial results for the quarter ended September 30, 2025.
"In the dynamic landscape of emerging clinical-stage therapies for patients with recurrent and metastatic head and neck squamous cell carcinoma, a significant unmet medical need remains despite the potential improvements in treatment options," said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. "We look forward to presenting our preliminary data from the ongoing clinical studies evaluating MICVO as a novel potential treatment option for recurrent and metastatic head and neck squamous cell carcinoma. We believe that the breadth of the MICVO clinical program, encompassing monotherapy and combination approaches, holds significant promise and this inflection point will further underscore our first-in-concept ADC's potential to improve outcomes across multiple lines of therapy."
Pipeline & Corporate Updates
-- Pyxis Oncology expects to report preliminary data from the ongoing Phase
1 clinical studies of micvotabart pelidotin (MICVO) in patients with
recurrent and metastatic head and neck squamous cell carcinoma (R/M
HNSCC) in 4Q25.
-- Clinical update to focus on preliminary data from the Phase 1
monotherapy dose expansion study of MICVO for 2L/3L R/M HNSCC
patients, including both the post platinum and anti-PD(L)-1
experienced arm and the post EGFRi and anti-PD(L)-1 experienced
arm.
-- Additional preliminary clinical data from the Phase 1/2
combination dose escalation study of MICVO and KEYTRUDA(R)
(pembrolizumab) for 1L/2L+ R/M HNSCC patients will also be
provided. The combination study is part of a Clinical Trial
Collaboration Agreement with Merck (known as MSD outside of the US
and Canada).
-- Pyxis Oncology expects to announce next steps in the clinical
development plan for MICVO for R/M HNSCC along with the
preliminary data update.
-- Pyxis Oncology presented new translational data in October 2025 in two
posters at the European Society for Medical Oncology (ESMO) Congress 2025
and in six posters at the AACR-NCI-EORTC International Conference, as
well as three clinical trial in progress posters at ESMO. The
presentation posters at ESMO and AACR-NCI-EORTC provided deeper insights
into the pharmacodynamic responses of tumors to MICVO as well as MICVO's
unique mechanism of action and its potential to exert anti-tumor activity
through three mechanisms: direct tumor cell killing, bystander killing
and immunogenic cell death.
-- Translational findings highlighted MICVO's effects on tumor
microenvironment remodeling and immune activation, further
reinforcing the potential benefit of MICVO as both a monotherapy
and in combination with anti-PD1 therapy.
-- Observations included changes in circulating tumor DNA (ctDNA)
tumor fraction (TF) to the vast majority of 37 clinical samples
tested. Notably, reduction in ctDNA TF after treatment with MICVO,
particularly in HNSCC and at the 5.4 mg/kg dose, support a
positive molecular response to MICVO and strengthen rationale for
continued development for this tumor type and dose in the
monotherapy dose expansion study.
-- Additionally, features observed in nonclinical samples of the
stromal architecture detected using AI-enabled hyper-resolution
digital pathology may correlate with sensitivity to MICVO - a
finding that may be unique compared to tumor cell surface
targeting ADCs, due to MICVO's targeting of a non-cellular
structural component of the extracellular matrix.
Third Quarter 2025 Financial Results
-- As of September 30, 2025, Pyxis Oncology had cash and cash equivalents,
including restricted cash, and short-term investments, of $77.7 million.
The Company believes that its current cash, cash equivalents, and
short-term investments will be sufficient to fund its operations into the
second half of 2026.
-- Research and development expenses were $17.8 million for the quarter
ended September 30, 2025, compared to $17.7 million for the quarter ended
September 30, 2024. MICVO program-specific research and development costs
increased by $2.0 million, primarily due to a $1.0 million increase in
contract manufacturing costs and a $1.3 million increase in clinical
trial related expenses related to monotherapy and combination therapy of
MICVO. The increase in expenses was partially offset by a $1.8 million
reduction in expenses related to PYX-106, as the clinical development of
PYX-106 was paused in December 2024.
-- General and administrative expenses were $5.6 million for the quarter
ended September 30, 2025, compared to $6.0 million for the quarter ended
September 30, 2024. The decrease was primarily due to lower corporate
insurance costs and a decrease in legal, professional and consulting
fees.
-- Net loss was $22.0 million, or ($0.35) per common share, for the quarter
ended September 30, 2025, compared to $21.2 million, or ($0.35) per
common share, for the quarter ended September 30, 2024. Excluding
non-cash stock-based compensation expense, the net loss for the quarter
ended September 30, 2025 was $18.9 million, compared to a net loss of
$18.2 million for the quarter ended September 30, 2024.
-- As of October 31, 2025, the outstanding number of shares of Common Stock
of Pyxis Oncology was 62,264,215.
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 tumor cell killing, bystander effect and immunogenic cell death. MICVO is currently being evaluated in Phase 1 clinical studies in patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) and other solid tumors, both as monotherapy and in combination with Merck's anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab). 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(R) 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 November 3, 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
Alex Kane
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 Nine Months Ended September
September 30, 30,
------------------------- ----------------------------
2025 2024 2025 2024
----------- ----------- ----------- --------------
Revenues
Milestone
revenue $ -- $ -- $ 2,820 $ --
Royalty revenues -- -- -- 8,146
Sale of royalty
rights -- -- -- 8,000
---------- ---------- ---------- -------------
Total revenues -- -- 2,820 16,146
Costs and
operating
expenses
Cost of revenues -- -- -- 475
Research and
development 17,808 17,741 51,985 44,723
General and
administrative 5,653 6,013 16,960 20,339
Total costs
and operating
expenses 23,461 23,754 68,945 65,537
---------- ---------- ---------- -------------
Loss from
operations (23,461) (23,754) (66,125) (49,391)
Other income, net:
Interest and
investment
income 774 1,846 3,010 5,419
Sublease income 684 705 1,883 2,212
---------- ---------- ---------- -------------
Total other
income, net 1,458 2,551 4,893 7,631
---------- ---------- ---------- -------------
Loss before income
taxes (22,003) (21,203) (61,232) (41,760)
---------- ---------- ---------- -------------
Income tax
expense -- -- 283 --
---------- ---------- ---------- -------------
Net loss $ (22,003) $ (21,203) $ (61,515) $ (41,760)
========== ========== ========== =============
Net loss per common
share - basic and
diluted $ (0.35) $ (0.35) $ (0.99) $ (0.73)
---------- ---------- ---------- -------------
Weighted average
shares of common
stock outstanding
- basic and
diluted 62,557,386 60,715,041 61,847,245 57,511,997
========== ========== ========== =============
PYXIS ONCOLOGY, INC.
Condensed Consolidated Balance Sheets
(In thousands, Unaudited)
September 30, 2025 December 31, 2024
-------------------- -------------------
Assets
Current assets:
Cash and cash
equivalents $ 8,919 $ 19,473
Marketable debt
securities,
short-term 67,337 107,458
Restricted cash 1,472 1,472
Prepaid expenses and
other current assets 5,345 4,037
Total current assets 83,073 132,440
Property and equipment,
net 8,460 9,899
Intangible assets, net 2,434 2,600
Operating lease
right-of-use asset 11,637 12,242
---------------- ---------------
Total assets $ 105,604 $ 157,181
================ ===============
Liabilities and
Stockholders' Equity
Current liabilities:
Accounts payable $ 9,756 $ 4,859
Accrued expenses and
other current
liabilities 7,996 11,371
Operating lease
liabilities, current
portion 1,630 1,450
Total current
liabilities 19,382 17,680
Operating lease
liabilities, net of
current portion 17,400 18,650
Financing lease
liabilities, net of
current portion 43 100
Total liabilities 36,825 36,430
---------------- ---------------
Commitments and
contingencies
Stockholders' equity:
Preferred stock -- --
Common stock 62 60
Additional paid-in
capital 493,719 484,077
Accumulated other
comprehensive income 69 170
Accumulated deficit (425,071) (363,556)
---------------- ---------------
Total stockholders'
equity 68,779 120,751
---------------- ---------------
Total liabilities and
stockholders' equity $ 105,604 $ 157,181
================ ===============
(END) Dow Jones Newswires
November 03, 2025 07:00 ET (12:00 GMT)