XLO - Xilio Therapeutics Announces $11.3 Million Private Placement Equity Financing | Benzinga
Announces strategic portfolio reprioritization focused on rapid advancement of clinical-stage programs for XTX301, a tumor-activated, IL-12, and XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4, and leveraging the company's promising research platform for tumor-activated bispecific and cell engager molecules
Reports additional Phase 2 data for XTX202, a tumor-activated, beta-gamma biased IL-2, supporting potential as combination therapy; plans to discontinue monotherapy development and evaluate collaboration opportunities to advance development
Anticipates cash runway into Q2 2025
Xilio to host conference call today at 8:00 a.m. ET
WALTHAM, Mass., March 28, 2024 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (NASDAQ:XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced that it has entered into a securities purchase agreement with certain existing accredited investors, including Bain Capital Life Sciences and Rock Springs Capital, to issue and sell an aggregate of 1,953,125 shares of Xilio common stock at a price of $0.64 per share and prefunded warrants to purchase up to an aggregate of 15,627,441 shares of Xilio common stock at a purchase price of $0.6399 per prefunded warrant share, through a private investment in public equity financing. The prefunded warrants will have an exercise price of $0.0001 per share of common stock, be immediately exercisable and remain exercisable until exercised in full. Xilio anticipates receiving aggregate gross proceeds from the private placement of approximately $11.3 million, before deducting placement agent fees and expenses payable by the company. The private placement is expected to close on April 2, 2024, subject to the satisfaction of customary closing conditions. Xilio expects to use the proceeds from the private placement to fund working capital and other general corporate purposes.
"Together with our partnership announced with Gilead today for XTX301, our tumor-activated IL-12, this financing enables us to prioritize clinical development for XTX301 as well as XTX101, our tumor-activated, Fc-enhanced anti-CTLA-4, while making focused investments in our promising research-stage pipeline for tumor-activated bispecific and cell engager molecules," said René Russo, Pharm.D., president and chief executive officer of Xilio. "We are grateful for our investors' confidence in the potential of our pipeline and platform to develop tumor-activated immuno-oncology therapies for people living with cancer."
Dr. Russo continued, "We believe our decision to reprioritize Xilio's clinical- and research-stage investments and resources best positions us to achieve near-term clinical milestones and value-drivers while seeking to deliver on the long-term promise of our differentiated research platform and capabilities. I extend sincere gratitude to each employee impacted by this difficult decision, as their contributions and dedication have played a critical role in working toward Xilio's mission to improve the lives of patients with cancer."
Exclusive License Agreement with Gilead
As previously announced today, Xilio entered into an exclusive license agreement with Gilead Sciences, Inc. (Gilead) for Xilio's tumor-activated IL-12 program, including XTX301. Under the terms of the agreement:
- Xilio will receive $43.5 million in upfront payments, including a cash payment of $30.0 million and an initial equity investment by Gilead of $13.5 million in Xilio common stock at a purchase price of $1.97 per share.
- Xilio will be eligible to receive up to $604.0 million in additional contingent payments, including proceeds from up to three additional equity investments by Gilead, a $75.0 million transition fee and specified development, regulatory and sales-based milestones. Xilio will also be eligible to receive tiered royalties ranging from high single digits to mid-teens on annual global net product sales.
- Prior to the potential transition fee, Xilio is eligible to receive up to a total of $29.0 million in additional equity investments and a development milestone payment.
- Xilio will be responsible for conducting clinical development for XTX301 in the ongoing Phase 1 clinical trial through dose expansion. Following the delivery by Xilio of a specified clinical data package for XTX301, Gilead can elect to transition responsibilities for the development and commercialization of XTX301 to Gilead, subject to the terms of the agreement and payment by Gilead of the $75.0 million transition fee. If Gilead elects not to transition responsibilities for development and commercialization of the licensed products and pay the transition fee, then the license agreement will automatically terminate.
For more information on the Gilead transactions, read the press release here.
Additional Data from Phase 2 Clinical Trial for XTX202
Xilio today also announced additional data from its Phase 2 clinical trial evaluating XTX202, a tumor-activated, beta-gamma biased IL-2, in patients with metastatic renal cell carcinoma (RCC) or unresectable or metastatic melanoma.
As of a data cutoff date of March 6, 2024:
- A total of 17 RCC patients and 20 melanoma patients were administered XTX202 in the Phase 2 trial in an outpatient setting at dose levels of 1.4 mg/kg once every three weeks (Q3W) or 4 mg/kg Q3W.
- In 26 patients evaluable for anti-tumor activity at both dose levels, stable disease (SD) continued to be the best response. Investigators reported SD of at least nine-weeks duration in 7 RCC patients (70% disease control rate) and in 9 melanoma patients ...