PYXS

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 Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monothe...

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® 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 contro...

- 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 ex...

– 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 tumor...

- Announced robust preclinical data supporting the unique three-pronged mechanism of action of micvotabart pelidotin (MICVO, formerly PYX-201), driving anti-tumor activity via direct tumor killing, bystander effect and immunogenic cell death - On track to report preliminary data from Phase 1 monotherapy expansion cohorts of MICVO for 2L/3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy in second half of 2025, and 2L/3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy in first half of 2026 - On track to report preliminary data from Phase 1 trial of MICVO in combination with pembrolizumab targeting multiple tumor types including 1L/2L HNSCC patients in second half of 2025 - Expected cash runway through data milestones and into second half of 2026 BOSTON, May 15, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation ADC therapeutics for difficult-to-treat cancers, today reported financial results for the quarter ended March 31, 2025, and provided a business update. “We are enthusiastic about the progress we are making with micvotabart pelidotin, particularly our recent preclinical data that validate its unique three-pronged mechanism of action and indicate that MICVO monotherapy may be eliciting immune responses in previously unresponsive tumors,” said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. “Our focus remains on delivering durable and efficacious therapies for patients with recurrent or metastatic head and neck squamous cell carcinoma and other advanced solid tumors, building on the tremendous potential of our next generation ADC. We look forward to reporting data from our ongoing Phase 1 trials evaluating MICVO as a monotherapy and in combination with pembrolizumab later this year.” Pipeline Updates Pyxis Oncology presented promising preclinical data at the 2025 American Association for Cancer Research Annual Meeting supporting the unique three-pronged mechanism of action of MICVO driving anti-tumor activity via direct tumor killing, bystander effect and immunogenic cell death. These data further reinforce the potential patient benefit of MICVO as a monotherapy and in combination with an anti-PD-1 therapy. MICVO demonstrated broad anti-tumor activity a...

Gene signatures associated with increased efficacy of micvotabart pelidotin (MICVO) due to greater linker cleavage were identified based on differential gene expression analysis of PDX responders/non-responders Mouse analog of MICVO in a syngeneic model indicated strong activity of the cytotoxic Auristatin0101 payload and potential for MICVO monotherapy to drive immunogenic cell death, a key hypothesis for MICVO’s mechanism Combination of a mouse analog of MICVO and anti-PD-1 therapy in a syngeneic model resulted in enhanced tumor clearance and longer immunological memory compared to either treatment alone Totality of pre-clinical data presented at AACR 2025 strongly support MICVO’s unique, three-pronged mechanism of action of driving anti-tumor activity via direct tumor killing, bystander effect and immunogenic cell death, further reinforcing the potential patient benefit for MICVO as a monotherapy and in combination with an anti-PD-1 therapy BOSTON, April 25, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation ADC therapeutics for difficult-to-treat cancers, announced today robust preclinical data supporting the unique extracellular linker payload cleaving mechanism of action of micvotabart pelidotin (MICVO, formerly referred to as PYX-201) and validating MICVO’s ongoing clinical development. MICVO is a first-in-concept antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix. This is a compelling target for cancer therapeutics as the physiological expression of EDB+FN is very low in healthy adult tissues while found to be highly expressed in a variety of solid tumor tissues. Data will be presented in two poster sessions on Monday, April 28 from 2:00 PM to 5:00 PM CT at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, Illinois. "Our lead therapeutic candidate micvotabart pelidotin has shown remarkably sustained efficacy in tumor clearance and immune activation across multiple models in preclinical studies, supporting our hypothesis that by targeting EDB+FN and releasing a potent payload in the tumor extracellular matrix, MICVO can potentially destabilize the barrier protecting and feeding the tumor structure while killing other tumor cells,” said Lara S. Sullivan, M.D.,...

- Recently reported positive preliminary data from Phase 1 dose escalation trial of micvotabart pelidotin (“MICVO,” formerly PYX-201), including a confirmed 50% objective response rate by RECIST 1.1 in recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) - Received Fast Track Designation from the U.S. Food and Drug Administration for MICVO 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 - Initiated monotherapy expansion cohorts of MICVO for 2L and 3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy with preliminary data expected in 2H25 and 2/3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy with preliminary data expected 1H26 - Initiated MICVO in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in 1/2L+ R/M HNSCC patients as part of a recently announced Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada) with preliminary data expected in 2H25 - Streamlined organization and implemented operational initiatives to focus resources on the execution of the MICVO clinical program, including workforce reduction of approximately 20% - Expected cash runway into 2H26 BOSTON, March 18, 2025 (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 year and quarter ended December 31, 2024, and provided a business update. “We are committed to the development of a novel therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma who will progress following platinum-based therapies and prior PD-(L)1 therapy, and those that progress after current and emerging EGFRi therapies,” said Lara S. Sullivan, M.D., President and Chief Executive Officer. “We look forward to expanding upon the encouraging safety and efficacy results observed from our Phase 1 trial evaluating micvotabart pelidotin, and we believe targeting Extradomain-B Fibronectin (EDB+FN) will offer a novel approach to addressing the limitations of existing therapies.” “Given the positive micvotabart pelidotin data, it is critical that we ensure the flawless execution of our...