Micvotabart pelidotin

- 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® (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® (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® (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® 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 StatementsThis 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 ContactAlex KaneIR@pyxisoncology.com MediaCailyn McCutcheonReal Chemistrycmccutcheon@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 September 30, Nine Months Ended September 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

Oral Presentation to be Featured on Initial Results of a First-in-Human Study for a Promising Targeted Therapy for Advanced/Metastatic Solid Tumors. ESMO 2025 abstracts featuring FCS research: 965P, 967P, 981P, 1014eP, 1031eTiP, 1068P, 1070P, 1073P, 1073P, 1113P, 1153P, 1166P, 1172P, 1196P, 1221TiP, 1239eTiP, 1349P, 158P, 2604P FORT MYERS, Fla., Oct. 18, 2025 /PRNewswire/ -- Breakthrough clinical research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) will be in the spotlight this week in Berlin at the European Society of Medical Oncology (ESMO) Congress 2025. Among the 23 studies co-authored by FCS physician investigators selected for presentation to oncology experts worldwide, one has earned the distinction of being featured as an oral presentation and four as poster presentations by FCS first authors. Continue Reading 23 Florida Cancer Specialists & Research Institute abstracts are being presented at the European Society of Medical Oncology Congress 2025 in Berlin, Germany including one oral presentation by FCS Director of Drug Development Manish R. Patel, MD, and four additional poster presentations by FCS first-authors. "FCS is engaged in significant and transformative scientific discoveries that are driving new possibilities and better outcomes for patients everywhere," said Lucio N. Gordan, MD, FCS president & managing physician. The following physician leader is first author of an oral presentation at the ESMO Congress: Manish R. Patel, MD, FCS director of drug development, will participate in an oral presentation followed by expert discussion and perspectives of initial results of a first-in human study: A tumor-associated Mucin 1 (TA-MUC1)–directed Antibody–drug Conjugate (ADC), in Patients (pts) with Advanced/Metastatic (adv/met) Solid Tumors. The following physician leaders are first authors of poster presentations at the ESMO Congress: Bradley Monk, MD, FCS medical director of late-phase clinical research, will present the following abstracts: Post hoc survival outcomes based on initial and subsequent treatment in patients (pts) with mismatch repair proficient/microsatellite stable (MMRp/MSS) primary advanced or recurrent endometrial cancer (pA/R EC) in the ENGOT-EN6-NSGO/GOG-3031/RUBY trial. Tisotumab Vedotin Plus Carboplatin or Pembrolizumab in Recurrent or Metastatic Cervical Cancer: 5-Year Results From the innovaTV 205/GOG-3024/ENGOT-cx8 Study. Cesar Augusto Perez, MD, FCS, director of drug development, Sarah Cannon Research Institute (SCRI) at FCS, will review and discuss in a poster presentation, Phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumours. Judy S. Wang, MD, FCS associate director of drug development will present and discuss the findings of the following abstract: Histological biomarker analysis of nonclinical and baseline tumor samples from the phase 1 dose escalation study assessing micvotabart peliodotin (MICVO) in advanced solid tumors. Dr. Patel, who oversees early phase research at FCS' three drug development units, said, "Our team is proud to be at the forefront of oncology research, leading first-in-human studies and advancing cutting-edge targeted therapies." Dr. Monk leads initiatives to expand and deploy late-phase clinical trials. He noted, "By pushing the boundaries of what's possible, we're helping bring the next generation of treatments to patients who need them most and are dedicated to increasing clinical trial accessibility to patients worldwide." FCS researchers have also co-authored numerous abstracts that will also be featured in poster presentations throughout the annual international symposium: Barry Berman, MD, MS: Clinical and biomarker results from E7386 study 102: Global dose-expansion cohort of E7386 + envatinib in patients with advanced/recurrent endometrial cancer that progressed on platinum-based chemotherapy and an anti−PD-(L)1 immunotherapy Bradley Monk, MD: Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. (Simultaneous publication in the Annals of Oncology.) Human papillomavirus integration site mapping in advanced cervical cancer: The NRG Oncology/GOG-0240 NIH Cancer Moonshot. Second progression-free survival (PFS2) and subsequent treatment in patients (pts) with folate receptor alpha (FR⍺)-positive platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator's choice chemotherapy (ICC): Phase III MIRASOL trial. 5-year progression-free survival (PFS) with rucaparib (RUCA) maintenance in patients with newly diagnosed advanced ovarian cancer in ATHENA-MONO (GOG-3020/ENGOT-ov45). (Simultaneous publication in the Annals of Oncology.) The relationship between patient-reported outcomes and clinician-rated toxicity in participants with locally advanced cervix cancer in the OUTBACK trial. GOG-3119/ENGOT-en29/TroFuse-033: A Phase 3, Randomized Study of Sacituzumab Tirumotecan Plus Pembrolizumab vs Pembrolizumab Alone as First-Line Maintenance Therapy for Mismatch Repair-Proficient Endometrial Cancer. BELLA: A Phase 2 Study of Relacorilant Plus Nab-Paclitaxel +/- Bevacizumab in Patients with Gynecologic Cancers. Manish R. Patel, MD: A phase 1 study of the next-generation farnesyltransferase inhibitor (FTI) KO-2806 as monotherapy in advanced solid tumors. COM701 in ovarian cancer: A pooled analysis of 3 phase I clinical trials. Farnesyltransferase inhibitor (FTI) KO-2806 in combination with cabozantinib (cabo) in renal cell carcinoma (RCC): Preliminary results from FIT-001 Phase 1 trial. Single-agent divarasib experience in patients with KRAS G12C-positive pancreatic adenocarcinoma (panc), cholangiocarcinoma (cholangio), and other solid tumors. Cesar Augusto Perez, MD: Tipifarnib (TIP) and alpelisib (ALP) in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC): Phase 1 results from KURRENT-HN. Phase 1 global study of Iza-Bren (BL-B01D1), an EGFR × HER3 bispecific antibody–drug conjugate (ADC), in patients with metastatic or unresectable NSCLC and other solid tumours. Judy S. Wang, MD: First- in- Human Study of the First-in-class Non-cellular Targeting Antibody-Drug Conjugate (ADC), MICVO, in Patients with Select Solid Tumors. Phase 1 Expansion Study of the First-in-class Non-cellular Targeting Antibody-Drug Conjugate (ADC), Micvotabart Pelidotin (MICVO), in Patients with Select Advanced Solid Tumors. FCS provides access to advanced clinical trial options across 29 locations in Florida, bringing promising therapies closer to home for cancer patients. Over 110 new early-phase and 40 late-phase studies are launched annually. FCS has played a vital role in the development of numerous cancer drugs approved by the U.S. Food and Drug Administration (FDA). A longstanding partnership with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, provides patients with access to a comprehensive listing of clinical trials available in the U.S. Additionally, a partnership with Paradigm Health, Inc. helps streamline and accelerate matching patients to available clinical trials. Representing more than 45,000 members globally, ESMO is a reference for oncology education and information. The ESMO Congress is a globally influential oncology platform for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. All of the accepted abstracts will be published online at ESMO. About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. In fact, before receiving FDA approval, the majority of new cancer drugs in the U.S. were first made available to patients through participation in clinical trials at FCS. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. 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