Completed target enrollment in Phase 1 monotherapy dose expansion study of micvotabart pelidotin (MICVO) in 2L+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) in the first quarter of 2026
Updated data from MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC on track for mid-year 2026; to include patients treated with modified weight-based dosing and patients treated with total body weight dosing
Updated data from MICVO Phase 1/2 dose escalation study in combination with KEYTRUDA$(R)$ in 1L/2L+ R/M HNSCC on track for the second half of 2026
Announced appointment of Thomas Civik as Interim Chief Executive Officer
Expected cash runway into the fourth quarter of 2026
BOSTON, March 23, 2026 (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 year and quarter ended December 31, 2025.
"The completion of target enrollment in the Phase 1 monotherapy study of MICVO in patients with recurrent/metastatic head and neck squamous cell carcinoma is an important milestone for the Company and reflects the incredible effort of the Pyxis Oncology team," said Thomas Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. "We are laser focused on clinical execution and operations so that we can deliver a robust dataset in mid-2026 that will allow us to further assess the potential of MICVO as monotherapy. Following the preliminary results shared last December, we implemented a modified weight-based dosing approach that is expected to deliver optimal drug exposure for patients across all weight ranges to further improve the benefit-risk profile for MICVO. We look forward to sharing these results mid-year, and plan to provide an assessment of whether the dosing modification achieved these intended goals. We also expect to share updated combination data in 2H26 as we continue to evaluate the potential of MICVO in the front-line setting, building on the encouraging initial combination data shared last December."
Pipeline Updates
-- Pyxis Oncology announced positive preliminary data for micvotabart
pelidotin (MICVO) in recurrent/metastatic head and neck squamous cell
carcinoma (R/M HNSCC) in December 2025.
-- Monotherapy: 46% confirmed objective response rate $(ORR)$ and 92%
disease control rate (DCR) observed with MICVO as monotherapy in
2L+ R/M HNSCC (N=13, efficacy evaluable). MICVO as monotherapy was
generally well tolerated, with no Grade 4 ADC payload
treatment-related adverse events (TRAEs) of interest observed. No
Grade 5 events occurred. Preliminary results shared in December
2025 included all Phase 1 patients (N=18) dosed at 5.4 mg/kg IV
Q3W total body weight (TBW).
-- Combination: 71% confirmed ORR and 100% DCR observed with MICVO in
combination with a fixed dose of 200 mg of KEYTRUDA(R)
(pembrolizumab) in 1L/2L+ R/M HNSCC at 3.6 mg/kg (N=4) and 4.4
mg/kg (N=3) IV Q3W. MICVO in combination with KEYTRUDA(R) was
generally well tolerated, with no Grade 3 or Grade 4 ADC payload
TRAEs of interest observed. No Grade 5 events occurred. The
combination study is part of a Clinical Trial Collaboration
Agreement with Merck (known as MSD outside of the US and Canada).
-- During the fourth quarter of 2025, the Company obtained feedback
and alignment from the U.S. Food and Drug Administration (FDA)
regarding the clinical trial design for a planned pivotal
monotherapy study in 2L+ R/M HNSCC.
-- Pyxis Oncology expects to report updated data from the ongoing MICVO
Phase 1 monotherapy study in 2L+ R/M HNSCC mid-year 2026.
-- The ongoing MICVO Phase 1 monotherapy study is a two-part study.
Part 1 was a dose escalation study across multiple doses and tumor
types, with initial results shared in November 2024. Part 2, a
dose expansion study at 5.4 mg/kg IV Q3W in 2L+ R/M HNSCC, is
currently ongoing.
-- The dose expansion study of the ongoing MICVO Phase 1 monotherapy
study includes two arms: post platinum & anti-PD(L)-1 experienced
patients (Arm 1) and post EGFRi and/or anti-PD(L)-1 experienced
patients (Arm 2). Target enrollment for each arm of the study was
n=20. Total study target enrollment of n=40 was completed in
1Q26.
-- MICVO Phase 1 monotherapy data in 2L+ R/M HNSCC expected mid-year 2026
will include patients dosed at 5.4 mg/kg IV Q3W with a dose cap for
patients with higher body weight, in addition to patients previously
treated at 5.4 mg/kg IV Q3W TBW. Results are anticipated to include
detailed analyses of the impact of the modified weight-based dosing
approach on safety and efficacy. Adjusted Ideal Body weight (AIBW) dosing,
which has demonstrated improved tolerability without sacrificing activity
in clinical studies of other ADCs1, is being implemented in ongoing
clinical studies as well.
-- In the preliminary results shared in December 2025, there were no
treatment-related adverse events (TRAEs) leading to
discontinuation for patients at or below adjusted ideal body
weight. Grade 3 auristatin ADC payload related TRAEs of interest
were more frequent for high body weight2 patients and TRAEs
leading to discontinuation occurred exclusively in high body
weight patients.
-- New PK simulation data presented in the Pyxis Oncology March 2026
corporate presentation and its 2025 Form 10-K show that modified
weight-based dosing approaches, dose capping and AIBW, result in a
decrease in drug exposure (Cavg) relative to TBW dosing,
specifically for higher body weight patients. This reduction in
exposure is expected to decrease the incidence and severity of
auristatin ADC payload related TRAEs of interest and TRAEs leading
to discontinuation, while preserving efficacy. Comparable drug
exposure is predicted for dose capping and AIBW across all weight
categories, including for higher body weight patients.
-- Pyxis Oncology expects to report updated data from the ongoing Phase 1/2
combination dose escalation study of MICVO and KEYTRUDA(R) for 1L/2L+ R/M
HNSCC patients in 2H26.
-- The ongoing MICVO Phase 1/2 study evaluating MICVO in combination
with KEYTRUDA(R) is currently in dose escalation across multiple
doses for the treatment of 1L/2L+ R/M HNSCC. Preliminary positive
results were shared in the December 2025 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 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.
-- In April 2026, Pyxis Oncology will present novel preclinical data at the
2026 American Association for Cancer Research (AACR) Annual Meeting. The
study abstract highlights the anti-tumor activity of a murine analog of
MICVO (maMICVO) in the poorly immunogenic, immunotherapy-refractory mouse
oral carcinoma 2 (MOC2) syngeneic HNSCC model. Notably, image analysis
suggested modulation of the immune landscape post-maMICVO treatment,
providing scientific rationale to test the combination of maMICVO with
anti-PD-1 in this refractory model.
Corporate Updates
-- Pyxis Oncology continues to build out its senior leadership team and
internal capabilities:
-- Pyxis Oncology announced the appointment of Thomas Civik as
Interim Chief Executive Officer in February 2026. Mr. Civik has
been a member of Pyxis Oncology's Board of Directors since October
2021 and is a highly experienced biotechnology executive with a
proven track record in advancing cancer therapeutics. He most
recently served as President and Chief Executive Officer of Five
Prime Therapeutics, where he led the company through its
acquisition by Amgen for $1.9 billion in April 2021. Mr. Civik
previously served as Chairperson of the Board of ImCheck
Therapeutics and Repare Therapeutics through their respective
acquisitions by Ipsen and XOMA.
-- Pyxis Oncology appointed Heather Knowles as Senior Vice President,
Head of Global Clinical Operations in January 2026. Ms. Knowles is
a highly accomplished clinical development operations leader with
more than 20 years of experience guiding global oncology programs
across the full development continuum from first-in-human studies
through registration. She has worked across solid tumors and
hematologic malignancies and brings deep expertise spanning
multiple modalities, including mRNA therapeutics, immune
modulators, cell therapies, and small molecules. Ms. Knowles most
recently served as Vice President, Clinical Operations,
Therapeutics & Oncology at Moderna, where she built and scaled
Moderna's global clinical operations organization.
-- The Company announced the appointment of Alex Kane as Senior Vice
President, Investor Relations and Capital Markets in October 2025.
Mr. Kane brings 20 years of experience and a proven track record
in investor relations, strategic communications, and equity
capital markets across the life sciences sector. Mr. Kane most
recently served as Vice President of Equity Capital Markets at
Guggenheim Securities, advising biotechnology clients on financing
strategies and equity transactions. Previously, Mr. Kane held
senior investor relations and communications roles at Praxis
Precision Medicines and PTC Therapeutics, successfully managing
IPOs, secondary offerings, and long-term investor engagement.
-- Pyxis Oncology appointed Brian Freeman as Senior Vice President,
Global Program Leader for MICVO in May 2025. Mr. Freeman brings
deep expertise in program leadership and commercialization across
a broad range of modalities, including ADCs, degraders, DACs,
monoclonal antibodies, and small molecules, with a focus in
Oncology and Immunology. His portfolio experience includes notable
therapies such as pivekimab sunirine, Kadcyla, Xolair, Avastin,
Herceptin, and Tarceva. Before joining Pyxis Oncology, Mr. Freeman
led the pivekimab sunirine (IMGN-632) program at ImmunoGen/AbbVie
and served as Head of Commercial Strategy at Foghorn
Therapeutics.
-- In December 2025, Pyxis Oncology completed sale of its rights to
royalties from the commercialization of Enzeshu(R) (Suvemcitug for
Injection) for a one-time cash payment of $11 million and four
semi-annual installments of $175,000 each. This non-dilutive funding will
support the development of MICVO. As part of Pyxis Oncology's acquisition
of Apexigen, Inc. in August 2023, the Company acquired rights to
royalties on Enzeshu and another asset discovered using APXiMAB,
Apexigen's proprietary antibody discovery platform.
Full Year 2025 Financial Results
-- As of December 31, 2025, Pyxis Oncology had cash and cash equivalents,
including restricted cash, and short-term investments, of $68.3 million.
The Company believes that its current cash, cash equivalents, and
short-term investments will be sufficient to fund its operations into the
fourth quarter of 2026.
-- Revenues were $13.9 million for the year ended December 31, 2025,
compared to $16.1 million for the year ended December 31, 2024. Revenues
for 2025 consist of the regulatory milestone related to approval of
suvemcitug in China and the sale of royalty rights for Enzeshu(R) to
Simcere. Revenues for 2024 consist of the settlement and sale of royalty
rights for Beovu(R) to Novartis.
-- Research and development expenses were $73.7 million for the year ended
December 31, 2025, compared to $58.7 million for the year ended December
31, 2024. The increase was primarily due to a $6.1 million increase in
contract manufacturing costs and a $7.5 million increase in clinical
trial related expenses related to monotherapy and combination therapy of
MICVO.
-- General and administrative expenses were $22.2 million for the year ended
December 31, 2025, compared to $25.4 million for the year ended December
31, 2024. The decrease was primarily due to lower employee-related costs
including stock-based compensation, lower corporate insurance costs and a
decrease in legal, professional and consulting fees.
-- Net loss was $79.6 million, or ($1.28) per common share, for the year
ended December 31, 2025, compared to $77.3 million, or ($1.32) per common
share, for the year ended December 31, 2024. Excluding non-cash
stock-based compensation expense and impairment loss, the net loss for
the year ended December 31, 2025 was $67.8 million, compared to a net
loss of $43.4 million for the year ended December 31, 2024.
-- As of March 20, 2026, the outstanding number of shares of Common Stock of
Pyxis Oncology was 62,831,246.
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 Annual Report on Form 10-K filed with SEC on March 23, 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
Media
Cailyn McCutcheon
Real Chemistry
cmccutcheon@realchemistry.com
PYXIS ONCOLOGY, INC.
Consolidated Statements of Operations and Comprehensive
Loss
(In thousands, except share and per share amounts)
Year Ended December 31,
-------------------------
2025 2024
----------- -----------
Revenues
Sale of royalty rights $ 11,038 $ 8,000
Milestone revenue 2,820 --
Royalty revenues -- 8,146
---------- ----------
Total revenues 13,858 16,146
Costs and operating expenses
Cost of revenues 2,388 475
Research and development 73,696 58,747
General and administrative 22,194 25,420
Impairment of in-process research
and development intangible asset -- 20,964
---------- ----------
Total costs and operating
expenses 98,278 105,606
---------- ----------
Loss from operations (84,420) (89,460)
Other income, net
Interest and investment income, net 3,610 7,039
Sublease income 2,575 2,926
---------- ----------
Total other income, net 6,185 9,965
---------- ----------
Loss before income taxes (78,235) (79,495)
Income tax expense (benefit) 1,386 (2,164)
---------- ----------
Net loss $ (79,621) $ (77,331)
========== ==========
Net loss per common share - basic and
diluted $ (1.28) $ (1.32)
---------- ----------
Weighted average shares of common
stock outstanding - basic and
diluted 62,143,166 58,445,765
========== ==========
PYXIS ONCOLOGY, INC.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
December 31, December 31,
2025 2024
-------------- --------------
Assets
Current assets:
Cash and cash equivalents $ 15,422 $ 19,473
Marketable debt securities 51,435 107,458
Restricted cash 1,472 1,472
Prepaid expenses and other
current assets 3,776 4,037
---------- ----------
Total current assets 72,105 132,440
Property and equipment, net 7,997 9,899
Intangible assets, net -- 2,600
Operating lease right-of-use asset 11,418 12,242
---------- ----------
Total assets $ 91,520 $ 157,181
========== ==========
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable $ 10,885 $ 4,859
Accrued expenses and other
current liabilities 8,554 11,371
Operating lease liabilities,
current portion 1,692 1,450
---------- ----------
Total current liabilities 21,131 17,680
Operating lease liabilities, net of
current portion 16,958 18,650
Financing lease liabilities, net of
current portion 23 100
---------- ----------
Total liabilities 38,112 36,430
---------- ----------
Commitments and contingencies
Stockholders' equity:
Preferred stock -- --
Common stock 63 60
Additional paid-in capital 496,469 484,077
Accumulated other comprehensive
income 53 170
Accumulated deficit (443,177) (363,556)
---------- ----------
Total stockholders' equity 53,408 120,751
---------- ----------
Total liabilities and stockholders'
equity $ 91,520 $ 157,181
========== ==========
(1) SyBing, Andrew B., and Diane D. Wang. "Optimizing Body Size--Based Dosing Approaches for Antibody--Drug Conjugates." Clinical Pharmacology & Therapeutics (2025).
(2) High body weight defined as total body weight > 10% of AIBW; AIBW calculated using Devine formula (Devine et al, 1974)
(END) Dow Jones Newswires
March 23, 2026 07:00 ET (11:00 GMT)
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