On December 2, 2021 Xilio Therapeutics, Inc. (Nasdaq: XLO), a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, reported recent pipeline and business progress and third quarter 2021 financial results (Press release, Xilio Therapeutics, DEC 2, 2021, View Source [SID1234596393]).
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"Xilio made significant progress in 2021 as we transitioned to a clinical stage organization with XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, and XTX202, a tumor-selective IL-2, in clinical development," said René Russo, Pharm. D., president and chief executive officer of Xilio. "With the recent completion of our IPO and a strong and experienced team in place, we are well-positioned to leverage our geographically precise solutions (GPS) platform to advance our pipeline of immuno-oncology therapies that have the potential to achieve meaningful anti-tumor activity while minimizing serious, systemic effects for the benefit of cancer patients."
Recent Pipeline and Business Progress
Cytokine Programs
In October 2021, the U.S. Food and Drug Administration (FDA) cleared Xilio’s investigational new drug application (IND) to evaluate XTX202, a tumor-selective interleukin-2 (IL-2), as a potential treatment for patients with solid tumors. XTX202 is designed to localize activity in the tumor microenvironment, with the goal of overcoming the known toxicity challenges of existing IL-2 therapies while achieving enhanced anti-tumor activity.
In November 2021, at the Society for Immunotherapy in Cancer’s 36th Annual Meeting, Xilio reported data from preclinical studies for XTX301, a tumor-selective interleukin-12 (IL-12). Findings demonstrated selective anti-tumor activity and favorable tolerability with minimal systemic effects observed in mouse models evaluating a murine surrogate for XTX301 and non-human primate models evaluating XTX301.
Checkpoint Inhibitor Program
In September 2021, Xilio initiated patient dosing in its Phase 1/2 clinical trial evaluating XTX101, a tumor-selective anti-CTLA-4 monoclonal antibody, for the treatment of solid tumors as a monotherapy and in combination with pembrolizumab, an anti-PD-1. XTX101 is designed to improve upon the therapeutic index of existing anti-CTLA-4 therapies by overcoming their historical potency and tolerability limitations, as well as the inability to use existing anti-CTLA-4 therapies at their full dose in combination with other immuno-oncology therapies.
Recent Business Highlights
On October 26, 2021, Xilio closed its initial public offering (IPO). In connection with the IPO, Xilio issued and sold 7,353,000 shares of common stock at a public offering price of $16.00 per share, and on November 1, 2021, Xilio issued and sold an additional 766,106 shares of common stock at a public offering price of $16.00 per share pursuant to the partial exercise by the underwriters of their option to purchase additional shares. Xilio received aggregate gross proceeds of approximately $129.9 million or aggregate net proceeds of approximately $116.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by Xilio.
Appointed Tim Hunt as Xilio’s chief culture and corporate affairs officer in October 2021.
Appointed Sara Bonstein, chief financial officer of Insmed, Inc., to Xilio’s board of directors in August 2021.
Anticipated Milestones in 2022
Xilio currently anticipates the following milestones in 2022:
Initiation of a Phase 1/2 clinical trial to evaluate XTX202 in multiple solid tumor types in the first quarter of 2022
Presentation of preliminary data for the monotherapy cohort of the Phase 1/2 clinical trial evaluating XTX101 in patients with advanced solid tumors in the middle of 2022
Presentation of preliminary Phase 1 data for XTX202 in patients with multiple solid tumor types in the second half of 2022
Presentation of preliminary data from the combination cohort for the Phase 1/2 clinical trial evaluating XTX101 in patients with advanced solid tumors in the second half of 2022
Submission of an IND for XTX301 in the second half of 2022
Third Quarter 2021 Financial Results
Cash Position and Guidance: Cash and cash equivalents were $99.8 million as of September 30, 2021, compared to $19.2 million as of December 31, 2020. Cash and cash equivalents as of September 30, 2021 do not include $116.3 million in estimated net proceeds from Xilio’s October 2021 IPO. Xilio believes that its existing cash and cash equivalents, together with the net proceeds from its IPO, will enable it to fund its operating expenses and capital expenditure requirements into 2024.
Research & Development (R&D) Expenses: R&D expenses were $10.5 million for the third quarter of 2021, compared to $11.5 million for the third quarter of 2020. This decrease was primarily driven by lower comparable costs associated with manufacturing development activities for the XTX101 and XTX202 programs, partially offset by higher personnel-related costs due to increased headcount and preclinical research and clinical development expenses.
General & Administrative (G&A) Expenses: G&A expenses were $5.5 million for the third quarter of 2021, compared to $3.2 million for the third quarter of 2020. This increase was primarily driven by higher personnel-related costs due to increased headcount and higher professional fees related to ongoing business activities and preparations related to operating as a public company.
Net Loss: Net loss was $16.3 million for the third quarter of 2021, compared to $14.8 million for the third quarter of 2020.