On March 22, 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 full year ended December 31, 2022, and provided a corporate update (Press release, Pyxis Oncology, MAR 22, 2023, View Source [SID1234629167]).

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"Over the past year, our team has made significant progress in advancing PYX-201, our antibody-drug conjugate (ADC) product candidate, and PYX-106, our immunotherapy product candidate, into Phase 1 clinical trials," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "Our strong balance sheet gives us a cash runway into the first half of 2025 as we continue to advance these programs for patients. We anticipate preliminary data from both trials, including biomarker results and potential early signs of clinical activity, in late 2023 to early 2024."

Recent Corporate Updates

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Two Phase 1 trials initiated: Clinical sites are being activated and patient screening is ongoing in the Phase 1 trial of PYX-106, referred to as PYX-106-101, and dosing is expected to begin early in the second quarter of 2023. Subject dosing is underway in the Phase 1 trial of PYX-201, known as PYX-201-101. Preliminary data are anticipated from both trials in the late-2023 to early-2024 timeframe.
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PYX-201 nonclinical data published: A peer-reviewed article titled "Quantification of antibody-drug conjugate PYX-201 in rat and monkey plasma via ELISA and its application in preclinical studies" was published online in Bioanalysis. This publication described the ELISA assay that was successfully validated for the measurement of PYX-201 concentrations in rat and monkey plasma in support of the Company’s successful IND application.
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Abstracts submitted to ASCO (Free ASCO Whitepaper): Abstracts for trial in progress (TIP) posters describing the PYX-106-101 and PYX-201-101 Phase 1 clinical trials were submitted to the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 2-6, 2023, in Chicago.
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Two INDs cleared by FDA: In November 2022, clearance for the PYX-106 and PYX-201 Investigational New Drug (IND) applications was received from the U.S. Food and Drug Administration (FDA).

Full-Year 2022 Financial Results

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As of December 31, 2022, Pyxis Oncology had cash and cash equivalents (including restricted cash) of $180.7 million, which is expected to fund operations into the first half of 2025.
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Research and development expenses were $86.1 million for the year ended December 31, 2022, compared to $51.0 million for the year ended December 31, 2021. The increase was primarily due to increased expenses associated with contract manufacturing of drug products and drug substance, preclinical costs related to toxicity studies and preclinical work in support of IND filings, clinical trial costs, and an increase in employee headcount to support research and development activities.
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General and administrative expenses were $37.4 million for the year ended December 31, 2022, compared to $18.7 million for the year ended December 31, 2021. The increase was primarily due to higher personnel-related expenses, including stock-based compensation, and increases in legal and professional fees, rent and directors and officers insurance expenses to support our growth and operations.
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Net loss was $120.7 million, or ($3.65) per common share, for the year ended December 31, 2022, compared to $76.0 million, or ($8.95) per common share, for the year ended December 31, 2021. Net losses for the years ended December 31, 2022 and 2021 included $15.8 million and $6.4 million, respectively, related to non-cash stock-based compensation expense.
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As of March 21, 2023, the outstanding number of shares of Common Stock of Pyxis Oncology was 36,980,621.

Pam Connealy, Chief Financial Officer of Pyxis Oncology, added, "As our clinical programs have advanced, our team has established a strong financial foundation with no debt and a cash runway into the first half of 2025. We expect our balance sheet will enable us to evaluate early signs of clinical activity in our two clinical programs and initiate tumor-specific expansion cohorts following dose selection."