Welcome to our dedicated page for Pyxis Oncology news (Ticker: PYXS), a resource for investors and traders seeking the latest updates and insights on Pyxis Oncology stock.
Pyxis Oncology, Inc. develops clinical-stage cancer therapeutics, with news centered on micvotabart pelidotin, or MICVO, an investigational antibody-drug conjugate targeting extradomain-B fibronectin in the tumor extracellular matrix. Company updates focus on MICVO in solid tumors, including recurrent or metastatic head and neck squamous cell carcinoma, and on monotherapy and pembrolizumab combination development.
Recurring developments include clinical and preclinical data presentations, translational research on MICVO’s mechanism of action, quarterly and annual financial results, corporate presentations, leadership changes, business development appointments, and capital actions tied to funding the company’s oncology pipeline.
Pyxis Oncology (NASDAQ: PYXS) has reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical programs. The company's lead candidate, micvotabart pelidotin (MICVO), showed promising results with a 50% objective response rate in head and neck cancer patients during Phase 1 trials. MICVO received FDA Fast Track Designation for treating recurrent/metastatic head and neck squamous cell carcinoma.
The company has initiated multiple expansion cohorts and combination studies, with preliminary data expected throughout 2025-2026. To optimize resources, Pyxis implemented a 20% workforce reduction and suspended PYX-106 development.
Financial highlights include:
- Cash position of $128.4M as of December 31, 2024
- Expected runway into 2H 2026
- R&D expenses increased to $58.7M from $49.6M in 2023
- G&A expenses decreased to $25.4M from $32.6M in 2023
- Net loss of $77.3M ($1.32 per share) compared to $73.8M ($1.85 per share) in 2023
Pyxis Oncology (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics for difficult-to-treat cancers, has announced its participation in the Leerink Partners Global Healthcare Conference in Miami, Florida.
The company's President and CEO, Dr. Lara S. Sullivan, will engage in a fireside chat scheduled for March 10, 2025, at 2:20 PM EST. Investors and interested parties can access both the live webcast and replay of the presentation through the Events & Presentations page in the Investor Relations section of Pyxis Oncology's website at ir.pyxisoncology.com.
Pyxis Oncology (PYXS) has received FDA Fast Track Designation for PYX-201, targeting the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). This designation applies specifically to patients whose disease has progressed after treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.
PYX-201 is a pioneering antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN), a structural component within the tumor extracellular matrix highly expressed in various tumor types. The Fast Track status is designed to expedite the development and review process of new drugs addressing serious or life-threatening conditions with unmet medical needs.
Pyxis Oncology (NASDAQ: PYXS) has announced significant progress in its clinical program for PYX-201, a first-in-concept antibody-drug conjugate targeting Extradomain-B Fibronectin. The company has initiated two major developments:
1. A Phase 1/2 combination trial of PYX-201 with Merck's KEYTRUDA® in multiple solid tumors, set to begin dosing in Q1 2025. The trial will target first-line and second-line+ recurrent/metastatic head and neck squamous cell carcinoma, hormone receptor-positive and HER2-negative breast cancer, and advanced triple-negative breast cancer.
2. The expansion of its ongoing Phase 1 monotherapy trial to include cohorts for second and third-line recurrent/metastatic head and neck squamous cell carcinoma patients who have received prior treatments.
Pyxis Oncology (NASDAQ: PYXS) announced a strategic portfolio prioritization to focus resources on PYX-201, its lead clinical program. PYX-201, a first-in-concept antibody-drug conjugate targeting Extradomain-B Fibronectin, showed promising results in Phase 1 trials with a 50% objective response rate in head and neck squamous cell carcinoma patients and 26% ORR across six solid tumor types.
The company will suspend investment in PYX-106, its second clinical program, to concentrate on PYX-201's development. Multiple expansion studies are planned for early 2025, including monotherapy and combination trials with pembrolizumab. The company's current cash position is expected to fund operations into the second half of 2026.
Pyxis Oncology (NASDAQ: PYXS) announced positive preliminary data from its Phase 1 clinical trial of PYX-201, a novel antibody-drug conjugate targeting Extradomain-B Fibronectin. The drug achieved a 50% objective response rate including one complete response in head and neck cancer patients, and 26% overall response rate across six solid tumor types. PYX-201 demonstrated a favorable safety profile and dose-dependent responses. The company also announced a new clinical trial collaboration with Merck to evaluate PYX-201 in combination with KEYTRUDA®, with dosing expected to begin in Q1 2025.
Pyxis Oncology (NASDAQ: PYXS) reported Q3 2024 financial results and provided updates on its clinical programs. The company ended Q3 with $146.3 million in cash and investments, expecting runway into 2H 2026. The company has enrolled 80 patients in the PYX-201 Phase 1 trial and 45 patients in the PYX-106 trial. Q3 net loss was $21.2 million ($0.35 per share), compared to $23.0 million ($0.56 per share) in Q3 2023. R&D expenses increased to $17.7 million from $14.7 million, while G&A expenses decreased to $6.0 million from $10.7 million year-over-year.
Pyxis Oncology (Nasdaq: PYXS) announced an upcoming investor event on November 20, 2024, to present preliminary data from their Phase 1 clinical trial of PYX-201. The event will be held both in-person in New York City and virtually. The presentation will cover data from approximately 80 patients, including safety, preliminary efficacy, and pharmacokinetics results for PYX-201, a first-in-concept antibody-drug conjugate targeting Extradomain-B Fibronectin in solid tumors. Executive management will be joined by physician thought leaders Dr. Anthony Tolcher and Dr. Glenn Hanna to discuss the findings and future development plans.
Pyxis Oncology (Nasdaq: PYXS), a clinical-stage company developing next-generation cancer therapeutics, has announced its participation in two upcoming investor conferences. CEO Lara S. Sullivan will engage in fireside chats at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 6 at 12:20 PM ET and the H.C. Wainwright 26th Annual Global Investment Conference on September 9 at 2:00 PM ET, both in New York.
Management will also participate in one-on-one meetings during these events. Investors can access live webcasts and replays of the presentations through the Events & Presentations page in the Investor Relations section of Pyxis Oncology's website at ir.pyxisoncology.com.
Pyxis Oncology (PYXS) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
- Preliminary data from PYX-201 Phase 1 trial expected in fall 2024
- Preliminary data from PYX-106 Phase 1 trial expected by year-end 2024
- Cash runway extended into 2H 2026
- $157.2 million in cash and investments as of June 30, 2024
- 72 subjects dosed in PYX-201 trial, 33 in PYX-106 trial
- Q2 2024 R&D expenses: $13.9 million (up from $11.4 million in Q2 2023)
- Q2 2024 net loss: $17.3 million or ($0.29) per share
The company remains focused on developing next-generation therapeutics for difficult-to-treat cancers, with ongoing clinical trials for PYX-201 and PYX-106.