Pyxis Oncology Inc（PYXS）のニュースとイベントPYXSPyxis Oncology Inc

Pyxis Oncology Plans to Initiate Global Phase 3 Trial in 2027

"The September monotherapy data reinforce our confidence in MICVO's potential to serve a significant population of patients with previously treated recurrent/metastatic head and neck cancer," said Tom Civik, Chief Executive Officer and Chairman of Pyxis Oncology. "We have aligned with feedback received from the U.S. Food and Drug Administration and the European Medicines Agency on the design of the global Phase 3 Headliner trial and plan to initiate it in mid-2027, with FDA feedback on dose selection expected in the first quarter of 2027. We look forward to presenting MICVO monotherapy data, along with two preclinical posters, at the EORTC-NCI-AACR Symposium in November, and providing a comprehensive update on our head and neck cancer strategy in December, including updated efficacy and safety data from MICVO in combination with pembrolizumab in the first-line setting. Our strengthened balance sheet positions us to execute on these priorities, continue evaluating MICVO's broader potential and advance toward becoming a pre-commercial organization."

Pyxis Oncology Closes $110 Million Public Offering

Pyxis Oncology announced that it closed its previously announced registered public offering on October 1, 2026. The Offering generated approximately $110.0 million in upfront gross proceeds, before deducting underwriting discounts and commissions and other offering expenses. The Offering consisted of 36,047,919 shares of common stock at a public offering price of $2.90 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,883,121 shares of common stock at a public offering price of $2.899 per pre-funded warrant, in each case, accompanied by common warrants to purchase an aggregate of 49,310,352 shares of common stock. The clinical milestone-linked common warrants are tied to Pyxis Oncology's public disclosure of overall survival data rom its ongoing Phase 1 monotherapy study of micvotabart pelidotin in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma, which is expected to occur in the first half of 2027. The warrants have an exercise price of $3.50 per common share, a 21% premium to the $2.90 public offering price. If all milestone-linked warrants are exercised in full for cash, the Offering would provide Pyxis Oncology with approximately $172.6 million in additional gross proceeds, for a total of approximately $282.6 million in gross proceeds, before deducting applicable expenses. Leerink Partners, Guggenheim Securities and Wells Fargo Securities acted as joint bookrunning managers for the Offering. Pyxis Oncology intends to use the net proceeds from the Offering to advance its lead clinical program, MICVO, through key clinical milestones, including Headliner, its planned Phase 3 trial in 2L+ R/M HNSCC, and for working capital and general corporate purposes.

Leerink, Guggenheim and Wells Fargo Jointly Manage Offering

Leerink, Guggenheim and Wells Fargo acted as joint book running managers for the offering.