On May 11, 2023 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, reported financial results for the quarter ended March 31, 2023, and provided a corporate update (Press release, Pyxis Oncology, MAY 11, 2023, View Source [SID1234631531]).

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Pyxis Oncology ended the first quarter of 2023 with approximately $150.8 million in cash, cash equivalents, restricted cash and short-term investments, which is expected to provide a runway into the first half of 2025, enabling the Company to evaluate early signs of potential clinical activity for PYX-201 and PYX-106 and initiate tumor-specific expansion cohorts following dose selection. Clinical sites are active and patient screening continues in the Phase 1 trial of PYX-106, referred to as PYX-106-101, and dosing is expected to begin during the second quarter of 2023. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for PYX-201 in pancreatic cancer, and subject dosing is underway in the Phase 1 trial of PYX-201, known as PYX-201-101.

"The first quarter of 2023 was marked by the transition of Pyxis Oncology to a clinical-stage company as we initiated two Phase 1 trials for PYX-201 and PYX-106," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "Receipt of ODD for PYX-201 in pancreatic cancer is an important achievement highlighting the need for new treatment options, and we remain focused on execution as our two clinical programs advance. We continue to anticipate preliminary data, including biomarker results and early signs of potential clinical activity, from both trials in the late-2023 to early-2024 timeframe."

Q1 2023 Financial Results

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As of March 31, 2022, Pyxis Oncology had cash and cash equivalents (including restricted cash) and short-term investments of $150.8 million (preliminary, unaudited), which is expected to fund operations into the first half of 2025. This cash balance reflects a one-time, $8 million payment to Pfizer, Inc. made during the first quarter related to the expansion of the license agreement for our Flexible Antibody Conjugation Technology (FACT) platform, which was announced in the fourth quarter of 2022.

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Research and development expenses were $11.9 million for the three months ended March 31, 2023, compared to $20.1 million for the three months ended March 31, 2022. The period-over-period decline was primarily due to inclusion of a $10 million license fee for PYX-106 in the first quarter of 2022 and lower contract manufacturing and preclinical costs, which were partially offset by increased clinical trial-related costs and personnel-related expenses due to higher clinical headcount.
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General and administrative expenses were $9.1 million for the three months ended March 31, 2023, compared to $11.3 million for the three months ended March 31, 2022. The period-over-period decrease was primarily due to a reduction in professional and consultant fees, which were mainly related to the first quarter 2022 build-out of our general and administrative function.
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Net loss was $19.2 million, or $0.54 per common share, for the three months ended March 31, 2023, compared to $31.4 million, or $0.97 per common share, for the three months ended March 31, 2022. Net losses for the quarters ended March 31, 2023 and 2022 included $4.9 million and $3.4 million, respectively, related to non-cash stock-based compensation expense.
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As of May 10, 2023, the outstanding number of shares of common stock of Pyxis Oncology was 38,245,287.