March 29, 2022 Pyxis Oncology, Inc. (Nasdaq: PYXS), a multi-asset, multi-modality company focused on developing next-generation therapeutics for difficult to treat cancers, reported financial results for the full year ended December 31, 2021 (Press release, Pyxis Oncology, MAR 29, 2022, View Source [SID1234611160]).
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"We have had a highly productive start to 2022, advancing our lead programs toward first-in-human clinical trials while executing our strategy of identifying the most promising scientific breakthroughs and therapeutics in the treatment of cancers," said Lara Sullivan, M.D., Chief Executive Officer of Pyxis Oncology. "The in-licensing of Biosion’s anti-Siglec-15 (PYX-106) and the introduction of our first internally developed candidate anti-KLRG1 (PYX-102) further validate our approach to portfolio and pipeline expansion by identifying and progressing some of the most promising scientific and clinical advances from either our internal discovery engines or external sources."
"We are excited to partner with Pyxis Oncology and its experienced management team for the development of this promising asset," said Hugh M. Davis, Ph.D., Chief Operating Officer, Biosion, Inc. and President, Biosion USA, Inc. "While immunotherapies have improved the lives of many patients, only a fraction respond to treatment, suggesting that our understanding of how cancer is able to evade the immune system is incomplete. We believe that anti-Siglec-15 may represent a breakthrough and that targeting siglec-15 could extend the benefits of immunotherapies to broader patient populations, including those who have failed PD-(L)1 targeting therapies."
Corporate Development Highlights
•License agreement with Biosion adds anti-Siglec-15 to Pyxis Oncology’s IO pipeline: Pyxis Oncology announced today it has in-licensed anti-Siglec-15,now referred to as PYX-106, a potentially best-in-class monoclonal antibody which is a novel immune checkpoint. In pre-clinical studies, PYX-106 is broadly expressed across a range of solid tumors among difficult-to-treat cancers. The American Academy for Cancer Research (AACR) (Free AACR Whitepaper) has accepted an abstract submitted by Biosion for PYX-106. The poster will be made available at the start of the AACR (Free AACR Whitepaper) Annual Meeting on April 8, 2022. Pyxis Oncology expects to file an IND for PYX-106 in the second half of 2022.
•Pipeline expansion with the addition of Company’s first internally developed candidate: Pyxis Oncology announced today the declaration of its first internally developed candidate, an anti-KLRG1 monoclonal antibody program now referred to as PYX-102. PYX-102 originated as part of the Company’s proprietary IO target catalog and work out of Pyxis Oncology founder Tom Gajewski’s lab at the University of Chicago. The Company expects to provide further updates closer to the planned IND submission for PYX-102 in the second half of 2023.
•Additional GLP study underway for PYX-202: Pyxis Oncology’s anti-DLK1 ADC, PYX-202, was licensed in from LegoChem Biosciences, Inc. in December 2020. In preparation for an IND filing and based on observation of the Company’s GLP studies to date, management has decided to conduct additional GLP and non-GLP toxicity studies to determine whether PYX-202 is a viable clinical candidate. The Company will continue to monitor the progress of its PYX-202 program and expects to provide an update about PYX-202 in mid-2022.
•Advancing programs toward the clinic with near-term catalysts: Pyxis Oncology expects to file INDs for anti-EDB, PYX-201, and anti-CD123, PYX-203, in the second half of 2022 and in the second half of 2023, respectively.
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Financial Update
•As of March 29, 2022, Pyxis Oncology had cash and cash equivalents of approximately $253 million (preliminary, unaudited), which is expected to fund operations into the third quarter of 2024.
"With a solid balance sheet and cash runway sufficient to deliver multiple catalysts through the third quarter of 2024, we remain focused on building and advancing our pipeline through a multi-asset, multi-modality approach that we believe will unlock benefits for patients," said Pam Connealy, Chief Financial Officer.
•Research and development expenses for the full year ended December 31, 2021 were $51.1 million, compared to $9.1 million for the full year ended December 31, 2020. The increase in research and development expenses was primarily attributed to increased expenses associated with the addition of three antibody-drug conjugates to the Company’s portfolio and an increase in employee headcount to support research and development activities.
•General and administrative expenses for the full year ended December 31, 2021 were $18.6 million, compared to $3.8 million for the year ended December 31, 2020. The increase was primarily attributed to higher personnel-related expenses (including stock-based compensation), and costs incurred to support the growth and expansion of the business, overhead and facilities.
•Net loss for the full year ended December 31, 2021 was $76.0 million ($8.95 per common share), compared to $12.8 million ($12.45 per common share) for the year ended December 31, 2020. The increase in net loss is primarily attributed to the addition of three antibody-drug conjugates to the Company’s portfolio and the Company’s preparations to initiate human clinical trials for PYX-201.
•As of March 25, 2022, the outstanding number of shares of Common Stock of Pyxis Oncology was 32,841,747.
Conference Call and Webcast Details
Pyxis Oncology management will host a conference call and live webcast on Tuesday, March 29, 2022, at 8:00 a.m. ET to discuss recent corporate updates. The live call can be accessed by dialing (833) 945-2461 (domestic) or (520) 809-9726 (international) using the conference ID 5458057. A live webcast can be accessed at View Source or on the Investors section of the Pyxis Oncology website at ir.pyxisoncology.com. A replay of the webcast will be available approximately two hours after completion of the call and will be archived on the Company’s website for up to 45 days.