Pyxis Oncology (NasdaqGS:PYXS) FY Conference Transcript

Summary of Pyxis Oncology FY Conference Call Company Overview - Company: Pyxis Oncology (NasdaqGS:PYXS) - Focus: Clinical-stage oncology company targeting head and neck cancer and advanced solid tumors - Lead Candidate: Micutorbopilidotin (MICO), investigated for monotherapy and combination therapy with pembrolizumab [1][2] Core Points and Arguments Business Strategy - Pyxis Oncology's strategy centers on MICO, an antibody-drug conjugate (ADC) licensed from Pfizer, which has a strong development history [2] - Initial data indicated a strong signal in head and neck cancer among nine solid tumor types [2] - Two ongoing programs: - Monotherapy program with two arms targeting different patient populations - Combination program with pembrolizumab [3][4] Upcoming Catalysts - Major catalysts expected in the next 12 to 18 months: - Monotherapy trial results for PD-1 plus platinum-resistant population in the second half of the year - Results for EGFR-resistant population in the first half of next year [4][10] - Combo trial data from dose escalation involving multiple tumor types [10][11] Mechanism of Action - MICO targets EDB, a novel extracellular domain B splice variant of fibronectin, which is expressed across various tumor types [6][8] - The ADC mechanism involves cleavage in the extracellular matrix, contributing to a bystander effect, which is becoming recognized as significant in ADC efficacy [9] Efficacy Expectations - Efficacy benchmarks set by competitors: - Monotherapy: 36% overall response rate (ORR) from Merus - Combination therapy: 63% ORR from Merus - Pyxis aims for competitive efficacy in the 30s for monotherapy and 60s for combination therapy [12] Safety Profile - Safety concerns include neutropenia, neuropathy, ocular toxicity, and pneumonitis, with Pyxis showing comparable or better safety profiles than existing ADCs [16][17] Market Opportunity - The EGFR-resistant population is seen as a distinct market opportunity, with potential for patients who do not respond to existing therapies [18][19] - The company is cautious about quantifying market sizes until more data is available [19] Future Indications - Pyxis is currently focused on head and neck cancer but sees potential for MICO in other tumor types due to its broad applicability [24][25] Financial Position - Current cash position is approximately $90 million, providing a runway through the second half of next year, allowing the company to fund upcoming catalysts without immediate need for additional capital [28][29] Additional Important Points - The company is prioritizing head and neck cancer due to strong signals observed, while remaining open to exploring other indications in the future [25] - The global market for cetuximab varies, with different standards of care in the U.S. and Europe [34]