On November 1, 2022 Pyxis Oncology, Inc. (Nasdaq: PYXS) reported financial results for the third quarter and nine months ended September 30, 2022 and provided a corporate update (Press release, Pyxis Oncology, NOV 1, 2022, View Source [SID1234622711]).
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"The expansion of our exclusive in-licensing agreement with Pfizer continues to strengthen our development and partnership capabilities through exclusive access to Pfizer’s ADC technology platform and toolkit with first right of access to all available Pfizer ADC targets and associated technology," said Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "As Pfizer’s exclusive sublicensing agent for its ADC technology, our team has already concluded the first multi-target sublicensing agreement with a stealth ADC company demonstrating the durable value of this platform as well as industry interest in the technology. We look forward to further collaborating with other industry partners to fully leverage the potential of this intellectual property."
Jeff Settleman, Ph.D., Senior Vice President and Chief Scientific Officer for Oncology Research and Development at Pfizer, added, "We are proud to strengthen our agreement with Pyxis Oncology. Pyxis Oncology has assembled a talented team, and we are confident in their ability to fully realize the platform’s clinical potential."
Corporate Development Highlights
•Pfizer exclusively out-licensed the entirety of its ADC technology platform and toolkit to Pyxis Oncology: Under the terms of the agreement, Pyxis Oncology has exclusive access to Pfizer’s ADC technology platform and toolkit (excluding antibodies) to develop and commercialize ADCs directed to all available Pfizer ADC targets. The amended agreement provides Pyxis Oncology with the flexibility to sublicense either the full platform or certain components of the platform to third parties. Pyxis Oncology has concluded its first multi-target sublicensing agreement under the new arrangement with a stealth ADC company. This expansion builds on the former agreement, which provided Pyxis Oncology with a worldwide, royalty-bearing license to develop and commercialize multiple ADC candidates.
•Pyxis Oncology continues to advance lead programs toward the clinic with near-term catalysts: Pyxis Oncology remains on track with its IND plans for PYX-106 and PYX-201 by the end of this year. The company remains confident in the clinical and commercial opportunity for both programs based on the in vivo preclinical data to date and looks forward to working with the FDA to advance both programs into clinical development. PYX-201 is a novel, non-internalized ADC directed against a first-in-class target (EDB), which is selectively expressed in a large population of non-small cell lung cancer, breast cancer, and other solid tumors. PYX-106 is a highly potent immunotherapy that blocks the activity of Siglec-15, an emerging immune suppressor expressed across a broad range of tumors.
"Our team believes in the potential of marrying internal and external development strategies to accelerate promising therapeutics for patients with difficult-to-treat cancers," continued Dr. Sullivan. "In addition to strengthening our current partnerships, we see a significant opportunity to leverage our strong balance sheet and our team’s extensive industry networks to explore new avenues of scientific and therapeutic advancement."
Financial Update for Quarter Ended September 30, 2022
•Pyxis Oncology had cash and cash equivalents (including restricted cash) of $200.0 million as of September 30, 2022, which is expected to fund operations into the end of 2024.
•Research and development expenses were $19.0 million for the three months ended September 30, 2022, compared to $7.8 million for the three months ended September 30, 2021. The increase was primarily due to increased expenses associated with contract manufacturing of drug products and drug substance, preclinical cost related to toxicity studies and an increase in employee headcount to support research and development activities.
•General and administrative expenses were $9.4 million for the three months ended September 30, 2022, compared to $3.8 million for the three months ended September 30, 2021. The increase was primarily due to a higher personnel-related expenses (including stock-based compensation), and an increase in legal and professional fees, rent and directors and officers insurance expense to support our growth and operations.
•Net loss was $27.7 million, or $(0.85) per common share, for the three months ended September 30, 2022, compared to $14.2 million, or $(8.96) per common share, for the three months ended September 30, 2021. Net loss for the three months ended September 30, 2022 and 2021 included $4.4 million and $0.3 million, respectively, related to non-cash stock-based compensation expense.
•As of November 1, 2022, the outstanding number of shares of Common Stock of Pyxis Oncology was 35,097,256.