Pyxis Oncology, Inc. Stock Price, News & Analysis

Pyxis Oncology (NASDAQ: PYXS), a clinical-stage company focused on developing next-generation ADC therapeutics for difficult-to-treat cancers, has announced its participation in two upcoming investor conferences. The company's President, CEO, and CMO, Dr. Lara S. Sullivan, will engage in fireside chats at:

- The 2025 RBC Capital Markets Global Healthcare Conference in New York on May 21 at 2:05 p.m. ET

- The Jefferies Global Healthcare Conference in New York on June 5 at 4:55 p.m. ET

Investors can access live webcasts and replays of both presentations through the Events & Presentations page in the Investor Relations section of Pyxis Oncology's website.

Pyxis Oncology (NASDAQ: PYXS) presented promising preclinical results for micvotabart pelidotin (MICVO), their first-in-concept antibody-drug conjugate targeting Extradomain-B Fibronectin. The data, presented at AACR 2025, demonstrated:

• 45% of PDX models showed strong to very strong tumor growth inhibition
• Complete responses were observed across multiple tumor indications
• The drug was well-tolerated at 3mg/kg dosing
• Combination therapy with anti-PD-1 achieved 91% tumor growth inhibition with complete response in 9/15 animals

MICVO's three-pronged mechanism of action includes direct tumor killing, bystander effect, and immunogenic cell death. The drug is currently in Phase 1 trials as both monotherapy and in combination with KEYTRUDA for advanced solid tumors.

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 upcoming Stifel 2025 Virtual Targeted Oncology Forum. Dr. Lara S. Sullivan, who serves as President, CEO and Chief Medical Officer, will engage in a fireside chat on Wednesday, April 9, 2025, at 11:30 a.m. ET.

The company will also conduct one-on-one investor meetings during the event. Investors and interested parties can access both the live webcast and replay of the fireside chat through the Events & Presentations page in the Investor Relations section of Pyxis Oncology's website at ir.pyxisoncology.com.

Pyxis Oncology (NASDAQ: PYXS) announced new preclinical data for micvotabart pelidotin (MICVO), their first-in-concept antibody-drug conjugate targeting EDB+FN in the tumor microenvironment. The data will be presented at AACR 2025 in Chicago.

Key highlights include:

• Patient-derived xenograft mouse models showed gene signatures associated with MICVO efficacy
• Combination of MICVO analog with anti-PD-1 therapy demonstrated enhanced tumor regression
• Phase 1 studies showed significant tumor regression across multiple tumor types

The company is advancing MICVO in clinical trials:

• Phase 1 monotherapy expansion for recurrent/metastatic head and neck cancer with preliminary data expected in 2H2025 and 1H2026
• Phase 1/2 combination study with Keytruda® with preliminary data expected in 2H2025

MICVO has received Fast Track Designation from the FDA for treating adult patients with recurrent/metastatic head and neck squamous cell carcinoma after platinum-based chemotherapy and anti-PD-(L)1 therapy.

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.