On February 24, 2022 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers, reported financial results for the fourth quarter and full year ended December 31, 2021 and highlighted recent corporate accomplishments (Press release, Zentalis Pharmaceuticals, FEB 24, 2022, View Source [SID1234608995]).
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"In 2021, we made significant headway advancing the development of our programs, culminating in an R&D Day in December where we highlighted key updates to our pipeline," commented Dr. Anthony Sun, Chairman and Chief Executive Officer of Zentalis. "At the R&D Day, we discussed the addition of new capabilities to our Integrated Discovery Engine, reinforced ZN-c3 as the cornerstone of our value proposition and provided evidence supporting ZN-c5 and ZN-d5’s potential as differentiated oncology agents. Additionally, we unveiled a new candidate—a preclinical heterobifunctional degrader targeting BCL-xL—which is expected to enter IND-enabling studies this year. We continue to be guided by our expertise in medicinal chemistry, cancer biology and technology to generate best-in-class treatments and look forward to achieving our upcoming milestones across our portfolio in 2022."
Program Highlights:
In December 2021, Zentalis’ management team, along with three Key Opinion Leaders, held a virtual Research and Development Day. Specific highlights include: the addition of a preclinical BCL-xL heterobifunctional degrader candidate to its pipeline; the initiation of two additional studies with ZN-c3; the preclinical exploration of ZN-c3 into breast cancer, colorectal cancer and immunotherapy combinations; preliminary efficacy data of ZN-d5 in diffuse large B-cell lymphoma and acute myeloid leukemia; and ZN-c5’s differentiated safety and tolerability profile in breast cancer patients.
In November 2021, the FDA granted Fast Track designation to ZN-c3 for the treatment of recurrent or persistent USC. The potentially registrational Phase 2 trial of ZN-c3 in USC is underway, with an initial enrollment and safety update expected in the second half of 2022.
In December 2021, the Company presented a poster at the San Antonio Breast Cancer Symposium, held from December 7-10, 2021. The poster provided an updated interim analysis from the Phase 1/2 trial of its oral SERD, ZN-c5, in combination with palbociclib (marketed as Ibrance by Pfizer) in ER+/HER2- advanced breast cancer.
Fourth Quarter and Full Year 2021 Financial Results
Cash and Marketable Securities Position: As of December 31, 2021, Zentalis had cash, cash equivalents and marketable securities of $339.9 million. The Company believes that its existing cash, cash equivalents and marketable securities as of December 31, 2021 will be sufficient to fund its operating expenses and capital expenditures requirements into the third quarter of 2023.
Research and Development Expenses: Research and development expenses for the year ended December 31, 2021 were $175.6 million, compared to $84.9 million for the year ended December 31, 2020. The increase was primarily due to increases in external research and development expenses related to Zentalis’ lead product candidates, as the Company advanced its clinical pipeline in 2021. In addition, in 2021, Zentalis conducted additional preclinical studies, incurred additional manufacturing costs, and incurred increased costs for study and lab materials.
General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2021 were $40.9 million, compared to $33.9 million during the year ended December 31, 2020. The increase was primarily attributable to an increase of $8.7 million in employee-related costs, of which $4.5 million was driven by non-cash stock-based compensation from incentive grants issued during the period and increased headcount to support its growth.