Xilio Therapeutics’ XLO shares surged 79.8% in a month, driven by the company’s decision to enter into an exclusive license agreement with Gilead Sciences GILD to develop and commercialize XLO’s investigational oncology candidate, XTX301.
XTX301 is Xilio’s tumor-activated IL-12, developed using the company’s proprietary tumor-activation platform, which is expected to have potential therapeutic benefit, both as a monotherapy and in combination therapy to treat a variety of solid tumors.
XTX301 is currently being evaluated in a phase I dose-escalation study in patients with advanced solid tumors.
The licensing agreement seeks to leverage Gilead Sciences’ deep expertise in developing and commercializing novel immuno-oncology products to accelerate the development timeline of XTX301. On the other hand, the addition of XTX301 to GILD’s pipeline of difficult-to-treat cancer therapies is expected to expand its immuno-oncology portfolio.
Year to date, shares of Xilio have skyrocketed 121.8% against the industry’s 7.9% decline.
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Per the terms of the agreement, upfront payments payable by Gilead Sciences to Xilio are $43.5 million, partly in cash and as an initial equity investment, for the XTX301 global license grant. XLO has already received the initial equity investment of $13.5 million. The $30 million upfront cash payment is payable by GILD shortly after the closing of the license agreement.
Furthermore, Xilio remains eligible to receive up to $604 million in additional contingent payments from GILD, which comprise additional equity investments, a transition fee and certain pre-specified development, regulatory and sales-based milestones.
Upon potential commercialization of XTX301, XLO will also be eligible to receive tiered royalties ranging from high single digits to mid-teens on annual global net product sales.
Currently, Xilio is responsible for conducting clinical development of XTX301 in the ongoing phase I study in patients with advanced solid tumors.
If the company succeeds in providing a specified clinical data package for XTX301, it will trigger additional equity investments and a development milestone payment from Gilead Sciences. Based on such phase I results, GILD will have the option to transition responsibilities for the development and commercialization of XTX301 to itself, subject to the terms of the agreement and payment of transition fees to Xilio.
XLO anticipates reporting phase I safety, pharmacokinetic and pharmacodynamic data for XTX301 in patients with advanced solid tumors in the fourth quarter of 2024.
Other than XTX301, the company has two other candidates in its clinical-stage pipeline, XTX101 and XTX202, undergoing development.
A phase I study is currently evaluating XTX101 in combination with Roche’s Tecentriq (atezolizumab) in patients with advanced solid tumors.
XTX202, on the other hand, is being developed in a phase II study to treat patients with metastatic renal cell carcinoma or unresectable or metastatic melanoma.
Xilio has decided to discontinue further investments in the development of XTX202 as monotherapy for kidney and skin cancer indications under its strategic reprioritization efforts. The company is likely to further cut down its expenses and streamline its operations, including a 21% reduction of its current workforce.
However, XLO believes in the potential of XTX202 and its unique mechanism of action, which could yield benefits as a combination therapy across a broad range of solid tumor indications. The company plans to explore strategic opportunities to continue to develop XTX202 in combination with other agents.
Xilio Therapeutics, Inc. Price and Consensus
Xilio Therapeutics, Inc. price-consensus-chart | Xilio Therapeutics, Inc. Quote
Zacks Rank & Other Stocks to Consider
Xilio currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the drug/biotech industry worth mentioning are FibroGen FGEN and Annovis Bio ANVS, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have rallied 47.8%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.49 to $3.35. The estimate for Annovis’ 2025 loss per share is currently pegged at $2.82. Year to date, shares of ANVS have plunged 40.2%.
ANVS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.
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