On March 1, 2022 Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for people living with cancer, reported pipeline and business progress and reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Xilio Therapeutics, MAR 1, 2022, View Source [SID1234609247]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Xilio made significant pipeline and business progress in 2021, becoming a clinical-stage organization and transitioning to a publicly traded company through the successful completion of our IPO," said René Russo, Pharm.D., president and chief executive officer of Xilio. "As we look to 2022, I am excited about the many opportunities ahead of us, including anticipated initial clinical data readouts for XTX101, our tumor-selective anti-CTLA-4 monoclonal antibody, and XTX202, our tumor-selective IL-2. In addition, we plan to submit an IND for XTX301, our tumor-selective IL-12, in the second half of the year and continue to generate new research programs by leveraging our robust platform. With our exceptional team and strong financial position, we believe we have the resources in place to advance our vision of bringing transformative immuno-oncology therapies to people living with cancer."
Pipeline and Business Progress
Cytokine Programs
●Xilio continues to advance enrollment in the Phase 1 portion of its Phase 1/2 clinical trial evaluating XTX202 for the treatment of patients with solid tumors. XTX202, a modified form of interleukin-2 (IL-2), is designed to localize activity in the tumor microenvironment, with the goal of overcoming the known tolerability challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity. Xilio expects to report preliminary data from the Phase 1 portion of the trial in the second half of 2022.
●Xilio continues to progress preclinical studies for XTX301, a tumor-selective IL-12. The company plans to submit an investigational new drug application (IND) for XTX301 as a potential treatment for patients with solid tumors in the second half of 2022.
Checkpoint Inhibitor Program
●Xilio continues to advance enrollment in the Phase 1 portion of its Phase 1/2 clinical trial evaluating XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, as a monotherapy and in combination with pembrolizumab, an anti-PD-1, for the treatment of patients with advanced solid tumors. Xilio expects to report preliminary data from the monotherapy cohort of the Phase 1 portion of the trial in the middle of 2022 and preliminary data from the combination cohort of the Phase 1 portion of the trial in the second half of 2022.
Recent Business Highlights
●In January 2022, Xilio appointed Yuan Xu, Ph.D., to its board of directors.
Fourth Quarter and Full Year 2021 Financial Results
●Cash Position: Cash and cash equivalents were $198.1 million as of December 31, 2021, compared to $19.2 million as of December 31, 2020. The increase was primarily related to $144.9 million in net proceeds received from convertible preferred stock financings in the first quarter of 2021 and $116.4 million in net proceeds received from Xilio’s initial public offering in the fourth quarter of 2021. Net cash proceeds from financings were partially offset by operating uses of cash for the year ended December 31, 2021.
●Research & Development (R&D) Expenses: R&D expenses were $11.4 million for the quarter ended December 31, 2021, compared to $17.7 million for the quarter ended December 31, 2020. R&D expenses were $51.2 million for the year ended December 31, 2021, compared to $43.9 million for the year ended December 31, 2020. The year-over-year increase was primarily driven by higher personnel-related costs due to increased headcount and expenses associated with R&D programs.
●General & Administrative (G&A) Expenses: G&A expenses were $8.2 million for the quarter ended December 31, 2021, compared to $2.9 million for the quarter ended December 30, 2020. G&A expenses were $23.9 million for the year ended December 31, 2021, compared to $10.7 million for the year ended December 31, 2020. The year-over-year increase was primarily driven by higher personnel-related costs due to increased headcount and professional and consulting fees related to transitioning to and operating as a publicly traded company.
●Net Loss: Net loss was $19.7 million for the quarter ended December 31, 2021 and $75.8 million for the year ended December 31, 2021.
Financial Guidance
Xilio continues to believe that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.