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UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

WASHINGTON, D.C. 20549

FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

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Date of report (Date of earliest event reported): February 10, 2025

Xilio Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

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Delaware

   

001-40925

   

85-1623397

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

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828 Winter Street, Suite 300

Waltham, Massachusetts

   

02451

(Address of Principal Executive Offices)

 

(Zip Code)

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Registrant’s telephone number, including area code: (857) 524-2466

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Not applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

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☐       Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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☐       Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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☐       Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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☐       Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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Securities registered pursuant to Section 12(b) of the Act:

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Title of each class

   

Trading symbol(s)

   

Name of each exchange

on which registered

Common stock, par value $0.0001 per share

 

XLO

 

Nasdaq Global Select Market

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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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Emerging growth company  ☒

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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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Item 1.01. Entry into a Material Definitive Agreement. 

 

Collaboration, License and Option Agreement 

 

On February 10, 2025, Xilio Development, Inc. (“Xilio Development”), a wholly-owned subsidiary of Xilio Therapeutics, Inc. (the “Company”), entered into a collaboration, license and option agreement (the “Agreement”) with AbbVie Group Holdings Limited (“AbbVie”) for up to four programs leveraging the Company’s proprietary tumor-activation technology and platform, consisting of (i) an exclusive option for (a) an initial program to discover, develop and commercialize masked T cell engager molecules for an agreed upon initial target and backup target (the “Initial Option Program”), and (b) subject to the terms of the Agreement, up to two additional programs to discover, develop, and commercialize masked T cell engager molecules for an initial target and backup target determined at the time of program initiation (each, an “Additional Option Program” and together with the Initial Option Program, the “Option Programs”) and (ii) an exclusive license for a program to develop and commercialize a masked antibody-based immunotherapy (the “Collaboration Program”).  

 

Initial Option Program and Additional Option Programs. Under the Agreement, Xilio Development granted AbbVie an option to obtain an exclusive global license to exploit products discovered and developed under the Initial Option Program. During the three-year period following the effective date of the Agreement, AbbVie has the right to initiate up to two Additional Option Programs by (a) selecting an initial target and backup target for each such Additional Option Program (excluding the target known as prostate-specific membrane antigen (“PSMA”) and any other target for which Xilio Development has completed specified activities prior to lead selection) and (b) paying Xilio Development an additional program nomination fee for each Additional Option Program. In addition, on an Option Program-by-Option Program basis, prior to the initiation of specified activities related to lead optimization and selection for the initial target for such Option Program, AbbVie has a one-time right to substitute the initial target with the backup target agreed upon by the parties at the time of Option Program initiation, subject to the payment by AbbVie of a one-time substitution fee with respect to such substituted target and the other terms of the Agreement.  

 

For the Initial Option Program, AbbVie’s option right is exercisable beginning on the effective date of the Agreement, and for each Additional Option Program, AbbVie’s option right is exercisable following delivery of written notice of nomination of such Additional Option Program. For each Option Program, prior to option exercise, Xilio Development will be responsible for conducting preclinical discovery and development up to the completion of investigational new drug application (“IND”) enabling studies, subject to AbbVie paying Xilio Development option extension fees upon completion of specified stages of preclinical discovery and development. Unless AbbVie elects to extend preclinical development through the next stage and pays the applicable option extension fee, AbbVie’s option right terminates within a specified time period following completion of each stage of preclinical development. Upon exercising its option for an Option Program, AbbVie will be responsible for any remaining preclinical development, if applicable, and all clinical development, regulatory and commercialization activities with respect to licensed products under the applicable Option Program. 

 

Collaboration Program. In connection with the Collaboration Program, Xilio Development granted AbbVie an exclusive global license to exploit products discovered and developed under the Collaboration Program. Xilio Development is responsible for conducting all preclinical development through lead generation, and AbbVie is responsible for all further development and commercialization activities for any licensed products generated under the Collaboration Program.  

 

Financial Consideration. Under the Agreement, the Company will receive $52.0 million in upfront payments, consisting of a cash payment of $42.0 million and an equity investment of $10.0 million in the Company’s common stock, $0.0001 par value per share (the “Common Stock”), at a purchase price of $2.30 per share. In addition, the Company will be eligible to receive up to approximately $2.1 billion in additional contingent payments, consisting of (i) up to $305.0 million in aggregate program nomination fees, preclinical development option extension fees and option fees for the Option Programs and (ii) up to $1.8 billion in aggregate development, regulatory and sales-based milestones for all Option Programs and the Collaboration Program. In addition, the Company is eligible to receive tiered royalties ranging in the high single digits on annual global net product sales for the Option Program and is eligible to receive tiered royalties ranging in the mid single digits on annual global net product sales for the Collaboration Program.  

 

Exclusivity. Subject to the terms, conditions and specified exceptions set forth in the Agreement, until the Agreement is terminated or expires with respect to an Option Program or the Collaboration Program, Xilio Development

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has agreed to work exclusively with AbbVie with respect to the target for (i) each Option Program and (ii) the Collaboration Program. In addition, Xilio Development has agreed to work exclusively with AbbVie with respect to the backup target for each Option Program until the expiration of the applicable target substitution period.  

 

Term and Termination. Unless earlier terminated in accordance with its terms, the Agreement will expire upon expiration of the last royalty term for the last licensed product. AbbVie may terminate the Agreement for convenience upon specified time periods. On an Option Program-by-Option Program basis, if AbbVie elects not to pay the applicable option extension fee following completion of each stage of preclinical development, or if AbbVie elects not to exercise its option right and pay the option exercise fee for the applicable Option Program, then the Agreement will automatically terminate with respect to such Option Program. Subject to the terms and specified exceptions set forth in the Agreement, either party may terminate the Agreement for the other party’s uncured material breach or insolvency.  

 

The foregoing description of the Agreement is qualified in its entirety by reference to the complete text of the Agreement, which the Company intends to file with the Securities and Exchange Commission (the “SEC”) as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ending March 31, 2025. 

 

Stock Purchase Agreement and Investor Rights Agreement with AbbVie 

 

In connection with the execution of the Agreement, on February 10, 2025, the Company entered into a stock purchase agreement with AbbVie Inc. (the “Stock Purchase Agreement”) pursuant to which the Company agreed to issue and sell 4,347,826 of its shares of Common Stock to AbbVie Inc. in a private placement at a purchase price of $2.30 per share for an aggregate purchase price of $10.0 million (the “AbbVie Private Placement”).  

 

The AbbVie Private Placement closed on February 11, 2025. The Stock Purchase Agreement contains customary terms and conditions, including closing conditions, mutual representations, warranties and covenants for each of the Company and AbbVie.  

 

Pursuant to the terms of an investor rights agreement (the “AbbVie Investor Rights Agreement”) entered into by and between AbbVie Inc. and the Company in connection with the Stock Purchase Agreement, AbbVie agreed to certain transfer and standstill restrictions. In addition, AbbVie is entitled to certain registration rights with respect to the shares issued pursuant to the Stock Purchase Agreement following termination of the transfer restrictions. The Company and AbbVie each granted the other party customary indemnification rights in connection with the registration of the shares issued pursuant to the Stock Purchase Agreement. 

 

The foregoing description of the Stock Purchase Agreement and the Investor Rights Agreement are qualified in their entirety by reference to the complete text of the Stock Purchase Agreement and the Investor Rights Agreement, which the Company intends to file with the SEC as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarterly period ending March 31, 2025. 

 

Item 3.02. Unregistered Sales of Equity Securities. 

 

Sale of Shares to AbbVie 

 

The description of the issuance and sale of the shares of Common Stock pursuant to the Stock Purchase Agreement set forth under Item 1.01 above under the caption “Stock Purchase Agreement with AbbVie” is incorporated by reference into this Item 3.02. The issuance and sale has not been registered under the Securities Act of 1933, as amended (the “Securities Act”) or any state securities laws. Based in part upon the representations of AbbVie in the Stock Purchase Agreement, the Company has relied on the exemption from the registration requirements of the Securities Act under Section 4(a)(2) thereof for a transaction by an issuer not involving any public offering. 

 

Neither this Current Report on Form 8-K nor any exhibit attached hereto is an offer to sell or a solicitation of an offer to purchase the Securities or other securities of the Company. 

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Item 7.01 Regulation FD Disclosure.

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On February 12, 2025, the Company issued a press release regarding the transactions contemplated by the Agreement and the Stock Purchase Agreement. In addition, on February 12, 2025, the Company issued a press release

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announcing new internal masked T cell engager programs and related development timelines. Copies of the press releases are furnished as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K.  

 

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing. 

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Item 8.01. Other Events.

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Financial Guidance 

 

Based on its current operating plans, the Company anticipates that its cash and cash equivalents, together with the upfront payment under the Agreement and the proceeds from the AbbVie Private Placement, will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2026. 

 

Cautionary Note Regarding Forward Looking Statements 

 

This Form 8-K contains forward-looking statements that involve estimates, assumptions, risks and uncertainties. Forward-looking statements include, but are not limited to, statements related to the amount of proceeds expected from the Stock Purchase Agreement and AbbVie Private Placement; the transactions contemplated by the Stock Purchase Agreement, including the filing of a registration statement to register the resale of the registrable securities being sold in connection therewith; the receipt of contingent future payments, including any option-related fees, milestone payments or royalty payments; the potential benefits of any of the Company’s current or future product candidates; the period in which the Company expects to have, and the sufficiency of, cash to fund its operations; and the Company’s strategy, goals and anticipated financial performance, milestones, business plans and focus. The risks and uncertainties relating to the Company and the transactions include general market conditions, and other risks detailed from time to time in the Company’s filings with the SEC, including in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024. Any forward-looking statements contained in this Current Report on Form 8-K represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, the Company explicitly disclaims any obligation to update any forward-looking statements.

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Item 9.01 Financial Statements and Exhibits.

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(d) Exhibits.

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Exhibit No.

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Description

99.1

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Press release issued by Xilio Therapeutics, Inc. on February 12, 2025 

99.2

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Press release issued by Xilio Therapeutics, Inc. on February 12, 2025 

104

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Cover Page Interactive Data File (embedded within the Inline XBRL document and incorporated as Exhibit 101)

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SIGNATURES

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Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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XILIO THERAPEUTICS, INC.

 

 

 

Date: February 12, 2025

By:

/s/ Christopher Frankenfield

 

 

Christopher Frankenfield

 

 

Chief Financial Officer and Chief Operating Officer

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Exhibit 99.1

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AbbVie and Xilio Therapeutics Announce Collaboration and Option Agreement to Develop
Novel Tumor-Activated Immunotherapies

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Collaboration will combine AbbVie’s oncology expertise and Xilio’s proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers

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Xilio to host investor conference call and webcast today at 8:30 am EST

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NORTH CHICAGO, IL and WALTHAM, MA, February 12, 2025 – AbbVie (NYSE: ABBV) and 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 a  collaboration and option-to-license agreement to develop novel tumor-activated, antibody-based immunotherapies, including masked T-cell engagers, leveraging Xilio’s proprietary technology.

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Xilio has developed a proprietary, clinically-validated platform technology for tumor-activated biologics. The company is advancing a pipeline of novel, clinical and pre-clinical immunotherapies, including masked multispecific molecules, designed to achieve tumor-selective activation by leveraging masking and other unique components that are optimized for the specific target. This allows focused activity within the tumor microenvironment with the goal of minimizing systemic adverse events.

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“AbbVie is committed to expanding our R&D efforts in oncology. This includes investigation of novel immunotherapy approaches that aim to generate improved next-generation cancer treatments for patients in need,” said Theodora S. Ross, M.D., Ph.D., vice president, early oncology research and development, AbbVie. “This partnership with the Xilio team, further exemplifies our commitment.”

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“This collaboration with AbbVie, a global leader in developing and commercializing oncology therapies, allows us to accelerate the expansion of our technology to next-generation immunotherapies, including T-cell engagers,” said Uli Bialucha, Ph.D., chief scientific officer of Xilio. “We look forward to working with the AbbVie team to apply our deep protein engineering expertise coupled with tumor-selective activation through our novel formats for masked T-cell engagers.”

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Under the terms of the agreement, Xilio will receive $52.0 million in total upfront payments, including a $10.0M equity investment, and will be eligible to receive up to approximately $2.1 billion in total contingent payments for option-related fees and milestones plus tiered royalties.

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Xilio Investor Conference Call Information

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Xilio will host a conference call and webcast today at 8:30 am EST. Viewers can access the webcast by using this link. Listeners who require dial-in access should register here to receive a unique PIN and information to join the call. Listeners are encouraged to join at least 15 minutes prior to the scheduled start time. The webcast will also be accessible under “Events & Presentations” in the Investors & Media section of the Xilio Therapeutics website at https://ir.xiliotx.com. A replay of the webcast will be archived on the website for 30 days following the presentation.

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About AbbVie

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AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please

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visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube.

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About AbbVie in Oncology

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At AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and in situ CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.

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Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.

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About Xilio Therapeutics

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Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines, antibodies, bispecifics and immune cell engagers. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.).

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AbbVie Forward-Looking Statements

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Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie

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undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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Xilio Cautionary Note Regarding Forward-Looking Statements

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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the development of novel tumor-activated, antibody-based immunotherapies, the expansion of Xilio’s platform technology, Xilio’s receipt of future contingent milestones, option fees and/or royalties; and Xilio’s strategy, goals, business plans and focus. The words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, general market conditions; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio’s current or future product candidates; Xilio’s ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; Xilio’s advancement of multiple early-stage immune cell engager programs; interim or preliminary preclinical or clinical data or results, which may not be replicated in or predictive of future preclinical or clinical data or results; Xilio’s ability to successfully demonstrate the safety and efficacy of product candidates and gain approval of product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for product candidates, which may not support further development of such product candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of current or future clinical trials; Xilio’s ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio’s ability to obtain and maintain sufficient cash resources to fund its operations; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; Xilio’s ability to maintain its collaboration and partnership agreements with Roche, Gilead and AbbVie. These and other risks and uncertainties are described in greater detail in the sections entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s filings with the U.S. Securities and Exchange Commission (SEC), including Xilio’s most recent Quarterly Report on Form 10-Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements.

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This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

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AbbVie Investor and Media Contacts

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Media

Sourojit (Jit) Bhowmick, Ph.D.

jit.bhowmick@abbvie.com

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Investors

Liz Shea

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liz.shea@abbvie.com

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Xilio Investor and Media Contact 

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Scott Young
Vice President, Investor Relations and Corporate Communications
investors@xiliotx.com

Exhibit 99.2

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Xilio Therapeutics Announces Multiple Masked T Cell Engager Programs

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Also entered into collaboration and option agreement with AbbVie to develop novel tumor-activated
immunotherapies, including masked T cell engagers, with $52.0 million in upfront payments

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Extended anticipated cash runway into the first quarter of 2026

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Company to host investor conference call and webcast today at 8:30 am ET

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WALTHAM, Mass., February 12, 2025 – 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 three wholly-owned preclinical programs for masked T cell engagers targeting prostate-specific membrane antigen (PSMA), claudin 18.2 (CLDN18.2) and six-transmembrane epithelial antigen of prostate 1 (STEAP1). In addition, as announced earlier today, Xilio entered into a collaboration, license and option agreement with AbbVie leveraging Xilio’s proprietary tumor-activation technology and platform to discover and develop novel tumor-activated immunotherapies, including masked T cell engagers. Under the collaboration, Xilio will receive $52.0 million in upfront payments and be eligible for additional option-related fees and milestones, as well as tiered royalties.

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“Today, we are excited to announce the next phase of Xilio’s tumor-activation platform with multiple internal masked T cell engager programs, as well as a multi-program collaboration with AbbVie,” said René Russo, Pharm.D., president and chief executive officer of Xilio. “T cell engagers have demonstrated meaningful clinical activity, yet many promising targets for solid tumors remain out of reach due to toxicity limitations. Leveraging our clinically-validated masking technology, we aim to lead the next wave of innovation in cancer immunotherapy by developing masked T cell engagers designed to improve tolerability through tumor-selective activation. In addition, we are able to incorporate co-stimulatory signaling into our T cell engager designs with the goal of further enhancing T cell activation, persistence and anti-tumor activity. We look forward to collaborating with AbbVie as we advance our pipeline of novel tumor-activated immunotherapies.”

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Masked T Cell Engager Programs

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T cell engagers are designed to redirect immune effector cells against cancer cells by simultaneously binding to a specific tumor-associated antigen expressed on the cancer cells and the T cell receptor complex on T cells, resulting in T cell-mediated killing of tumor cells. To date, T cell engagers have demonstrated significant promise as cancer immunotherapies in a variety of advanced solid tumors, but their potential has been limited by toxicity.

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Xilio is leveraging its proprietary, clinically-validated tumor-activation platform to advance a pipeline of wholly-owned, novel masked T cell engager molecules with conditional half-life modulation designed to enable potent, localized T cell activation and tumor cell destruction together with an improved therapeutic index. These programs include bispecific molecules designed using Xilio’s advanced tumor-activated cell engager (ATACR) format, which consists of a T cell engager with a masked CD3 targeting domain, and tri-specific molecules designed using Xilio’s selective effector-enhanced cell engager (SEECR) format. The SEECR format builds upon the ATACR format by adding co-stimulatory signaling designed to further enhance potency and T cell activation.

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Xilio is currently advancing three wholly-owned preclinical programs for masked T cell engager molecules targeting the following tumor-associated antigens: PSMA, CLDN18.2 and STEAP1.

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PSMA has demonstrated potential as a T cell engager target for prostate cancer. Xilio anticipates nominating a development candidate for its PSMA program in the ATACR format in the third quarter of 2025 and submitting an investigational new drug application (IND) in the first quarter of 2027.

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CLDN18.2 has broad potential as a T cell engager target for gastric, pancreatic, esophageal and lung cancers. Xilio anticipates nominating a development candidate for its CLDN18.2 program in the ATACR format in the fourth quarter of 2025 and submitting an IND in the second quarter of 2027.

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STEAP1 has broad potential as a T cell engager target for prostate, colorectal and lung cancers. Xilio anticipates nominating a development candidate for its STEAP1 program in the SEECR format in the first half of 2026 and submitting an IND in the second half of 2027.

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Anticipated milestones beyond the first quarter of 2026 are subject to obtaining sufficient additional capital.

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Collaboration, License and Option Agreement with AbbVie

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Under the terms of the collaboration, license and option agreement announced earlier today with AbbVie:

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Xilio will receive $52.0 million in upfront payments, consisting of a cash payment of $42.0 million and an equity investment by AbbVie of $10.0 million in Xilio common stock at a premium.

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Xilio granted AbbVie (i) an exclusive option for an initial program to discover and develop masked cell engager molecules (and subject to the terms of the agreement, the right to initiate up to two additional masked cell engager programs) and (ii) an exclusive license for a program to discover and develop a masked antibody-based immunotherapy.

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Xilio will be eligible to receive up to approximately $2.1 billion in additional contingent payments, consisting of option-related fees and development, regulatory and sales-based milestones. Xilio is also eligible to receive tiered royalties ranging in the mid to high single digits on annual global net product sales for licensed products.

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Financial Guidance

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Based on its current operating plans, Xilio anticipates that its existing cash and cash equivalents, together with the upfront payments under the agreement with AbbVie, will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2026.

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Investor Conference Call Information

Xilio will host a conference call and webcast today (Wednesday, February 12, 2025) at 8:30 am ET. Viewers can access the webcast by using this link. Listeners who require dial-in access should register here to receive a unique PIN and information to join the call. Listeners are encouraged to join at least 15 minutes prior to the scheduled start time. The webcast will also be accessible under “Events & Presentations” in the Investors & Media section of the Xilio Therapeutics website at https://ir.xiliotx.com. A replay of the webcast will be archived on the website for 30 days following the presentation.

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About Xilio Therapeutics

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Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.).

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Cautionary Note Regarding Forward-Looking Statements

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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the development timelines for the masked T cell engager programs; the receipt of future contingent payments from AbbVie; the potential benefits of any of Xilio’s current or future product candidates in any indication; the sufficiency of, and the period in which Xilio expects to have, cash to fund its operations and additional development milestones; the availability of additional capital to fund future development; and Xilio’s strategy, goals and anticipated financial performance, milestones, business plans and focus. The words “aim,” “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “seek,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, general market conditions; risks and uncertainties related to ongoing and planned research and development activities, including initiating, conducting or completing preclinical studies and clinical trials and the timing and results of such preclinical studies or clinical trials; the delay of any current or planned preclinical studies or clinical trials or the development of Xilio’s current or future product candidates; Xilio’s ability to obtain and maintain sufficient preclinical and clinical supply of current or future product candidates; Xilio’s advancement of multiple early-stage masked T cell engager programs; initial, preliminary or interim preclinical or clinical data or results, which may not be replicated in or predictive of future preclinical or clinical data or results; Xilio’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; results from preclinical studies or clinical trials for Xilio’s product candidates, which may not support further development of such product candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of current or future clinical trials; Xilio’s ability to obtain, maintain and enforce patent and other intellectual property protection for current or future product candidates; Xilio’s ability to obtain and maintain sufficient cash resources to fund its operations; the impact of international trade policies on Xilio’s business, including U.S. and China trade policies; Xilio’s ability to maintain its collaboration or partnership agreements with Roche, Gilead and AbbVie. These and other risks and uncertainties are described in greater detail in the sections entitled “Risk Factor Summary” and “Risk Factors” in Xilio’s filings with the U.S. Securities and Exchange Commission (“SEC”), including Xilio’s most recent Quarterly Report on Form 10-Q and any other filings that Xilio has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Xilio’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Xilio explicitly disclaims any obligation to update any forward-looking statements.

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This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

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Investor and Media Contact  

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Scott Young 
Vice President, Investor Relations and Corporate Communications 
investors@xiliotx.com

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v3.25.0.1
Document and Entity Information
Feb. 10, 2025
Document and Entity Information [Abstract]  
Document Type 8-K
Document Period End Date Feb. 10, 2025
Entity File Number 001-40925
Entity Registrant Name Xilio Therapeutics, Inc.
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 85-1623397
Entity Address, Address Line One 828 Winter Street
Entity Address, Adress Line Two Suite 300
Entity Address, City or Town Waltham
Entity Address State Or Province MA
Entity Address, Postal Zip Code 02451
City Area Code 857
Local Phone Number 524-2466
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common stock, par value $0.0001 per share
Trading Symbol XLO
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
Entity Central Index Key 0001840233
Amendment Flag false
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