Xilio Therapeutics (XLO) FY2025 10-K Risk Factors: 103 New, 14 Dropped

What the changes say

Xilio is developing masked immuno-oncology candidates, funded into 2027 with $137.5M cash plus recent equity and AbbVie milestone proceeds.

What changed since the prior 10-K

New

NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements
We will need to obtain substantial additional capital in the future to finance our operations and complete the development of any current or future product candidates
As of December 31, 2025, we had $137.5 million in cash, which we expect will fund operations through the end of 2027.
NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements
the costs of maintaining our operations and continuing to operate as a public company
Adverse economic conditions, inflation, or geopolitical tensions could impair our ability to raise additional capital on acceptable terms.
NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements
The recently implemented reverse stock split of our common stock may not achieve the intended benefits and could have a materially adverse effect on the market price of our common stock
Our recent reverse stock split may fail to increase our per share market price or prevent our delisting from the Nasdaq Capital Market.
NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements
incur additional costs associated with current and future research, development and commercialization efforts and operations as a public company
Exercising our outstanding prefunded and common stock warrants will result in immediate and substantial dilution to our existing stockholders.
NewRisks Related to Our Limited Operating History, Financial Position and Capital Requirements
enforce and defend intellectual property rights and claims
We may never achieve profitability, and any failure to do so would depress our company value and impair our operational capabilities.
NewRisks Related to the Discovery and Development of Our Product Candidates
regulators may revise the requirements for approving our product candidates, or such requirements may not be as we anticipate
Revised regulatory requirements or unfavorable clinical trial results could delay or prevent marketing approval of our product candidates.
NewRisks Related to the Discovery and Development of Our Product Candidates
experience damage to our reputation
Financial relationships with principal investigators could create conflicts of interest that affect regulatory interpretation of our clinical trials.
NewRisks Related to the Discovery and Development of Our Product Candidates
factors we may not be able to control that may limit the availability of patients, principal investigators or staff or clinical sites, such as public health crises, including epidemics and pandemics
Competition with other clinical trials for the same patient populations and sites could significantly delay our clinical trial patient enrollment.
NewRisks Related to the Discovery and Development of Our Product Candidates
the inability to commercialize any of our product candidates, if approved
Our product liability insurance may be inadequate to cover claims, and rising insurance costs could make coverage unaffordable.
NewRisks Relating to Manufacturing and Supply
the manufacture or release of our product candidates or other potential products. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business
We depend on single manufacturer WuXi Biologics in China, exposing us to U.S. export controls, potential sanctions, and trade restrictions.
NewRisks Relating to Manufacturing and Supply
or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended, which could have a material adverse effect on our business, financial condition, results of operations and prospects
Compliance with environmental, health, and safety laws may impose substantial costs, fines, or business disruptions on us and our CDMOs.
NewRisks Related to our Dependence on Third Parties
development, regulatory approval and commercialization described in this Annual Report on Form 10-K apply to the activities of our collaborators or licensors
Collaborations require complex negotiations and may increase expenditures, issue dilutive securities, or disrupt our management.
NewRisks Related to Commercialization
the securing of, costs related to, and timing issues associated with, commercial product manufacturing as well as sales and marketing activities
NewRisks Related to Commercialization
our ability to offer the product for sale at competitive prices
NewRisks Related to Our Intellectual Property
the priority of invention of patented technology
NewRisks Related to Our Intellectual Property
information will not be disclosed to publicly or to competitors. We cannot be certain that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques
NewRisks Related to Our Intellectual Property
redesigning our product candidates or processes so they do not infringe third-party intellectual property rights, which may not be possible or may require substantial monetary expenditures and time
NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
U.S. facing similar circumstances may adopt similar restrictions or other policy measures in response to a similar public health emergency and may also experience delays in their regulatory activities
NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
we could have the marketing approvals for our products withdrawn by regulatory authorities and our ability to market any products could be limited, which could adversely affect our ability to achieve or sustain profitability
NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
litigation involving patients using our products
NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug product candidates and affect the prices we may obtain for any products that are approved in the United States or foreign jurisdictions
NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
analogous state and foreign laws and regulations, such as state anti‑kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non‑governmental third‑party payors, including private insurers
NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and goodwill
NewRisks Related to Regulatory Approval and Other Legal Compliance Matters
our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations
NewRisks Related to Our Business Operations, Employee Matters and Managing Growth
business interruptions resulting from geopolitical actions, including war, armed conflicts and terrorism or natural disasters, including pandemics or other outbreaks of infectious disease, earthquakes, typhoons, floods and fires
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
other events or factors described in this “Risk Factors” section, many of which are beyond our control
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
require the approval of the holders of at least two-thirds of the votes that all our stockholders would be entitled to cast to amend or repeal specified provisions of our certificate of incorporation or bylaws
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
any action asserting a claim arising pursuant to any provision of our certificate of incorporation or bylaws (in each case, as they may be amended from time to time) or governed by the internal affairs doctrine
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Cybersecurity Risk Management and Strategy
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
committee is notified between such updates regarding significant new cybersecurity threats or incidents. The audit committee, in turn, periodically reports on its review to the board of directors
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
I tem 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Research and Development Expenses
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
depreciation, amortization and other direct and allocated expenses, including rent, maintenance of facilities and other operating costs, incurred as a result of our research and development activities
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
general economic conditions, including inflation and the imposition of new or revised global trade tariffs
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
General and Administrative Expenses
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Change in Fair Value of Common Stock Warrant Liabilities
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Comparison of the Years Ended December 31, 2025 and 2024
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Collaboration and License Revenue
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
At-the-Market Offering Program
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
to incur additional costs associated with operating as a public company. As a result, we expect to incur substantial operating losses and negative operating cash flows for the foreseeable future
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Other Contractual Obligations
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Critical Accounting Policies and Use of Estimates
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Our collaboration and license revenue to date is comprised of amounts recognized from our collaboration, license and option agreement with AbbVie and our license agreement with Gilead. We recognize revenue in accordance with ASC 606, Revenue from Contracts with Customers , or ASC 606
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Research and Development Expenses and Related Accruals and Prepaid Expenses
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Valuation of Common Stock Warrant Liabilities
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
period, with the change in fair value recorded as a component of other income, net, on the consolidated statements of operations and comprehensive loss
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
the expected dividend yield, which is zero as we do not have a history of paying dividends and have no plans to pay dividends in the future
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Emerging Growth Company and Smaller Reporting Company Status
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Ite m 8. Financial Statements and Supplementary Data
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Evaluation of Disclosure Controls and Procedures
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Management’s Annual Report on Internal Control over Financial Reporting
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the consolidated financial statements
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Changes in Internal Control over Financial Reporting
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Director and Officer Trading Arrangements
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
It em 10. Directors, Executive Officers, and Corporate Governance
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Ite m 11. Executive Compensation
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Ite m 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Ite m 13. Certain Relationships and Related Transactions, and Director Independence
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Ite m 14. Principal Accountant Fees and Services
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Portions of this exhibit have been omitted pursuant to Item 601 of Regulation S-K promulgated under the Securities Act because the information is not material and is a type of information that the registrant treats as private or confidential
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
President and Chief Executive Officer
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Opinion on the Financial Statements
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Preferred stock, $ 0.0001 par value; 5,000,000 shares authorized, no shares issued or outstanding
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Loss on disposal of property and equipment
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
1. Description of Business and Liquidity
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Principles of Consolidation
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Cash Equivalents and Restricted Cash
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Concentrations of Credit Risk and Significant Suppliers
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Level 3— Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Shorter of the useful life or the remaining term of the lease
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Impairment of Long-Lived Assets
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Research and Development Costs and Related Accruals and Prepaid Expenses
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Recently Adopted Accounting Pronouncements
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Recent Accounting Pronouncements Not Yet Adopted
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
3. Fair Value Measurements
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
4. Property and Equipment, Net
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Collaboration, License and Option Agreement with AbbVie
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Option Program; (iv) a material right to receive additional services related to the Initial Option Program; and (v) a material right related to AbbVie’s one-time right to substitute the initial target with the backup target for the Initial Option Program
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
License Agreement with Gilead Sciences, Inc
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Summary of Contract Assets and Liabilities
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Clinical Trial Collaboration with F. Hoffmann-La Roche Ltd
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
In August 2016, Xilio Development entered into an amended and restated exclusive license agreement with City of Hope pursuant to which City of Hope granted Xilio Development an exclusive worldwide license to specified patent rights related to the Company’s anti-CTLA-4 monoclonal antibody program
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
CTLA-4 Monoclonal Antibody License Agreement with WuXi Biologics
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Financing cash flows from finance leases
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Indemnification Agreements
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Undesignated Preferred Stock
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
June 2025 Follow-On Offering
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Each Series A warrant became exercisable on December 1, 2025 , with an exercise price of $ 10.50 per share of common stock, and will expire on June 5, 2030. During the year ended December 31, 2025 , no Series A warrants were exercised and 4,762,533 Series A warrants remain outstanding as of December 31, 2025
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
“At-The-Market” Offering Program
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Shares Reserved for Future Issuance
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
2020 Stock Incentive Plan
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
2021 Stock Incentive Plan
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
2025 Stock Incentive Plan
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
The first tranche (the "Tranche 1 Stock Options") vest in equal monthly installments over a period of three years , subject to the employee continuing to provide services to the Company on each vesting date
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
2021 Employee Stock Purchase Plan
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Stock-Based Compensation Expense
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
The weighted-average exercise price per share of the options outstanding and exercisable as of December 31, 2025 includes the impact of the repricing of 71,591 and 282,609 options on November 21, 2025 at $ 14.00 and $ 21.00 per share, respectively
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
The Company determined that the Tranche 2, Tranche 3 and Tranche 4 Stock Options contain performance conditions for which the likelihood of satisfying such performance conditions are considered probable as of December 31, 2025
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
The Company has no t recorded a current or deferred tax provision for years ended December 31, 2025 and 2024
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
State and local income taxes, net of federal income tax effect
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Effective income tax rate
NewRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
February 2026 Follow-On Offering

Dropped

DroppedRisks Related to Our Limited Operating History, Financial Position and Capital Requirements
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to product candidates or our technology
Raising additional capital may cause dilution or require relinquishing rights to product candidates.
DroppedRisks Relating to Manufacturing and Supply
cause reputational damage. In the event that raw materials required in our manufacturing process need to be derived from biologic sources, they may be difficult to procure and may be subject to contamination or recall
DroppedRisks Related to Commercialization
candidates. Competition may further increase with advances in the commercial applicability of technologies and greater availability of capital for investment in these industries
DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
Disruptions in the FDA and other government agencies for any reason could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business
DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
government agencies that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable
DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
the manufacturer is unable to assure sufficient quantity of the product to meet the needs of patients with the rare disease or condition
DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
unlawful promotion of a new intended use for the approved product. We will need to carefully navigate the FDA’s various regulations, guidance and policies, along with recently enacted legislation, to ensure compliance with restrictions governing promotion of our products
DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
Current and future legislation may increase the difficulty and cost for us to obtain reimbursement for any of our candidate products that do receive marketing approval
DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
implementing significant coverage barriers, or refusing to cover these products outright, arguing that accelerated approval drugs have insufficient or limited evidence despite meeting the FDA’s standards for accelerated approval
DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous year
DroppedRisks Related to Regulatory Approval and Other Legal Compliance Matters
be complex and may be subject to changing interpretation. These obligations may be applicable to some or all of our business activities now or in the future
DroppedRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that our stockholders may feel are in their best interest
DroppedRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
development expenditures currently and requires corporations to capitalize and amortize them over five years or fifteen years (for expenditures attributable to foreign research)
DroppedRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner

Reworded

100% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
Accordingly, any delay in obtaining or failure to obtain required approvals could negatively affect our ability or that of any future collaborators to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price
Expanded to specify that FDA and EMA disruptions can stem from funding cuts, personnel losses, regulatory reform, and government shutdowns.
99% rewrittenRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition
Updated to reference the Inflation Reduction Act of 2022, the OBBBA of 2025, and a 1% excise tax on stock repurchases.
97% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact our business and operating results
Updated to detail 2025 IEEPA tariffs, their invalidation by the Supreme Court in February 2026, and subsequent Section 122 temporary tariffs.
Was: Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results
86% rewrittenRisks Relating to Manufacturing and Supply
Manufacturing biologics is complex, and we may experience manufacturing problems that result in delays in our development or commercialization programs
Added adverse impacts from current or future trade sanctions, tariffs, or similar actions to biologics manufacturing risks.
84% rewrittenRisks Related to Our Limited Operating History, Financial Position and Capital Requirements
We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future
Updated financial figures showing net losses of $35.0M for 2025 and an accumulated deficit of $418.8M as of December 31, 2025.
82% rewrittenRisks Related to Our Limited Operating History, Financial Position and Capital Requirements
If we fail to regain and maintain compliance with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
Added specific 2025 dates for Nasdaq deficiency letters regarding minimum bid price and the $10.0 million stockholders' equity requirement.
Was: If in the future we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
80% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
Any product candidate for which we obtain marketing approval is subject to ongoing regulation and could be subject to restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements, when and if any of our product candidates are approved
Retained substantially identical ongoing regulatory compliance and post-marketing surveillance risk language.
69% rewrittenRisks Related to Commercialization
We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
Retained identical general competition risk language regarding immunotherapy development for cancer.
68% rewrittenRisks Related to Our Intellectual Property
Third-party claims of intellectual property infringement or violations may prevent or delay our discovery and development efforts
67% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
Current and future legislative efforts may limit the prices for our products, if and when they are licensed for marketing, and that could materially impact our ability to generate revenues
61% rewrittenRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Our principal stockholders and management own a significant percentage of our common stock and exert significant control over matters subject to stockholder approval
57% rewrittenRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
We are an “emerging growth company” and a “smaller reporting company” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors
56% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
We may not be able to obtain orphan drug designation or orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA or the EMA from approving competing products
55% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
We may encounter substantial delays in the commencement or completion, or termination or suspension, of our clinical trials, which could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects
54% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
If we experience delays or difficulties in the enrollment of patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected
54% rewrittenRisks Related to Regulatory Approval and Other Legal Compliance Matters
If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business
46% rewrittenRisks Relating to Manufacturing and Supply
Certain of our research and development and manufacturing activities take place in China through WuXi Biologics. A significant disruption in our ability to rely on WuXi Biologics could materially adversely affect our business, financial condition and results of operations
42% rewrittenRisks Related to Our Limited Operating History, Financial Position and Capital Requirements
We have no products approved for commercial sale and have not generated any revenue from product sales. We may never generate any revenue from product sales or become profitable and, if we achieve profitability, we may not be able to sustain it
36% rewrittenRisks Related to Our Intellectual Property
If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
36% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
Interim top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
35% rewrittenRisks Related to Our Business Operations, Employee Matters and Managing Growth
A variety of risks associated with marketing our product candidates internationally, if approved, could materially adversely affect our business
32% rewrittenRisks Relating to Manufacturing and Supply
If we or any CDMOs and suppliers we engage fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business
30% rewrittenRisks Related to Our Intellectual Property
We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world
29% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or following commercial sale, and any product liability insurance we may obtain may not cover all damages from such claims
29% rewrittenRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current directors and members of management
25% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
Our business is highly dependent on the success of our current product candidates, which are in the early stages of development and will require significant additional preclinical and clinical development before we can seek regulatory approval for and commercially launch a product
24% rewrittenRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
If securities or industry analysts do not publish research or reports about our company, or if they issue unfavorable or inaccurate research regarding our business, or if they publish negative evaluations of our stock, the price and trading volume of our stock could decline
20% rewrittenRisks Related to Ownership of Our Common Stock and Our Status as a Public Company
Our common stock may be subject to a low trading volume and volatile market price related or unrelated to our operations and purchasers of our common stock could have difficulty selling their shares or could suffer a decline in value

All 175 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Limited Operating History, Financial Position and Capital Requirements

01We will need to obtain substantial additional capital in the future to finance our operations and complete the development of any current or future product candidatesNew
02the costs of maintaining our operations and continuing to operate as a public companyNew
03If we fail to regain and maintain compliance with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted82% rewritten
04The recently implemented reverse stock split of our common stock may not achieve the intended benefits and could have a materially adverse effect on the market price of our common stockNew
05We have incurred significant operating losses since our inception and expect to incur significant losses for the foreseeable future84% rewritten
06incur additional costs associated with current and future research, development and commercialization efforts and operations as a public companyNew
07We have no products approved for commercial sale and have not generated any revenue from product sales. We may never generate any revenue from product sales or become profitable and, if we achieve profitability, we may not be able to sustain it42% rewritten
08enforce and defend intellectual property rights and claimsNew
09Our limited operating history may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability
10Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited

Risks Related to the Discovery and Development of Our Product Candidates

11Our business is highly dependent on the success of our current product candidates, which are in the early stages of development and will require significant additional preclinical and clinical development before we can seek regulatory approval for and commercially launch a product25% rewritten
12Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all, which would have an adverse effect on our business
13Preclinical studies and clinical trials are expensive, time-consuming and difficult to design and implement, and involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials
14We may encounter substantial delays in the commencement or completion, or termination or suspension, of our clinical trials, which could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects55% rewritten
15regulators may revise the requirements for approving our product candidates, or such requirements may not be as we anticipateNew
16experience damage to our reputationNew
17If we experience delays or difficulties in the enrollment of patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected54% rewritten
18factors we may not be able to control that may limit the availability of patients, principal investigators or staff or clinical sites, such as public health crises, including epidemics and pandemicsNew
19Our product candidates may cause undesirable or unexpectedly severe side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any
20Interim top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data36% rewritten
21We expect to develop certain of our product candidates in combination with third-party drugs and we will have limited or no control over the safety, supply, regulatory status or regulatory approval of such third-party drugs
22We may not be successful in our efforts to use our platform technology to enable the development of a pipeline of masked I-O product candidates
23We may not be successful in our efforts to identify or discover additional product candidates
24Our approach to the discovery and development of product candidates based on our technological approaches is unproven, and we do not know whether we will be able to develop any products of commercial value
25We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
26We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or following commercial sale, and any product liability insurance we may obtain may not cover all damages from such claims29% rewritten
27the inability to commercialize any of our product candidates, if approvedNew

Risks Relating to Manufacturing and Supply

28Manufacturing biologics is complex, and we may experience manufacturing problems that result in delays in our development or commercialization programs86% rewritten
29the manufacture or release of our product candidates or other potential products. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our businessNew
30Any of these events could lead to clinical trial delays or failure to obtain regulatory approval or impact our ability to successfully commercialize future products. Some of these events could be the basis for FDA action, including injunction, recall, seizure, import alert, or total or partial suspension of production
31Certain of our research and development and manufacturing activities take place in China through WuXi Biologics. A significant disruption in our ability to rely on WuXi Biologics could materially adversely affect our business, financial condition and results of operations46% rewritten
32If we or any CDMOs and suppliers we engage fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business32% rewritten
33or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended, which could have a material adverse effect on our business, financial condition, results of operations and prospectsNew

Risks Related to our Dependence on Third Parties

34We expect to rely on third parties to conduct, supervise and monitor IND-enabling studies and clinical trials, and to perform other functions for us, and if these third parties perform in an unsatisfactory manner, it may harm our business, reputation and results of operations
35development, regulatory approval and commercialization described in this Annual Report on Form 10-K apply to the activities of our collaborators or licensorsNew
36If we are not able to establish collaborations on commercially reasonable terms, we may have to alter our development and commercialization plans
37Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators

Risks Related to Commercialization

38We have never commercialized a product candidate and we may lack the necessary expertise, personnel and resources to successfully commercialize any products that receive regulatory approval, either on our own or together with collaborators
39We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do69% rewritten
40If we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, the commercialization of any of our product candidates may be delayed, and our business could be harmed
41the securing of, costs related to, and timing issues associated with, commercial product manufacturing as well as sales and marketing activitiesNew
42If approved, our product candidates that are licensed and regulated as biological products, or biologics, may face competition from biosimilars approved through an abbreviated regulatory pathway
43The sizes of the potential markets for our product candidates are difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be smaller than our estimates
44The successful commercialization of our product candidates will depend in part on the extent to which we obtain and maintain favorable insurance coverage, adequate reimbursement levels and cost-effective pricing policies with third-party payors
45Even if a product candidate we develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community necessary for commercial success
46our ability to offer the product for sale at competitive pricesNew

Risks Related to Our Intellectual Property

47Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
48Issued patents covering our product candidates or technology could be found invalid or unenforceable if challenged in court or the USPTO
49Changes to patent law in the U.S. and in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products
50We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world30% rewritten
51the priority of invention of patented technologyNew
52Biotechnology and pharmaceutical companies generally, and we in particular, compete in a crowded competitive space characterized by rapidly evolving technologies and aggressive development of intellectual property
53Our proprietary position depends upon patents that are manufacturing, formulation or method-of-use patents, which may not prevent a competitor or other third party from designing around or using the same product candidate for another use
54If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed36% rewritten
55information will not be disclosed to publicly or to competitors. We cannot be certain that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniquesNew
56Third-party claims of intellectual property infringement or violations may prevent or delay our discovery and development efforts68% rewritten
57redesigning our product candidates or processes so they do not infringe third-party intellectual property rights, which may not be possible or may require substantial monetary expenditures and timeNew
58We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses
59successfully obtain rights to required third-party intellectual property or to maintain the existing intellectual property rights we have, we may have to abandon development of such program and our business and financial condition could suffer
60We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful
61We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
62We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors
63If we do not obtain patent term extension for any of our current or future product candidates, our business may be materially harmed
64If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected
65Numerous factors may limit any potential competitive advantage provided by our intellectual property rights

Risks Related to Regulatory Approval and Other Legal Compliance Matters

66Accordingly, any delay in obtaining or failure to obtain required approvals could negatively affect our ability or that of any future collaborators to generate revenue from the particular product candidate, which likely would result in significant harm to our financial position and adversely impact our stock price100% rewritten
67U.S. facing similar circumstances may adopt similar restrictions or other policy measures in response to a similar public health emergency and may also experience delays in their regulatory activitiesNew
68We may not be able to obtain orphan drug designation or orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA or the EMA from approving competing products56% rewritten
69Any product candidate for which we obtain marketing approval is subject to ongoing regulation and could be subject to restrictions or withdrawal from the market, and we may be subject to substantial penalties if we fail to comply with regulatory requirements, when and if any of our product candidates are approved80% rewritten
70we could have the marketing approvals for our products withdrawn by regulatory authorities and our ability to market any products could be limited, which could adversely affect our ability to achieve or sustain profitabilityNew
71litigation involving patients using our productsNew
72Accelerated approval by the FDA, even if granted for any of our current or future product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval
73Recently enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our drug product candidates and affect the prices we may obtain for any products that are approved in the United States or foreign jurisdictionsNew
74Current and future legislative efforts may limit the prices for our products, if and when they are licensed for marketing, and that could materially impact our ability to generate revenues67% rewritten
75analogous state and foreign laws and regulations, such as state anti‑kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non‑governmental third‑party payors, including private insurersNew
764% of the total worldwide annual turnover of the preceding financial year, whichever is higher, as well as compensation claims by affected individuals, negative publicity, reputational harm and a potential loss of business and goodwillNew
77We are subject to U.S. and certain foreign export control, import, sanctions, anti-corruption, and anti-money laundering laws and regulations with respect to our operations and non-compliance with such laws can subject us to criminal and/or civil liability and harm our business
78Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact our business and operating results97% rewritten
79If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business54% rewritten
80our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulationsNew
81Our employees, independent contractors, CROs, consultants, commercial partners, vendors and principal investigators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements

Risks Related to Our Business Operations, Employee Matters and Managing Growth

82Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel
83A variety of risks associated with marketing our product candidates internationally, if approved, could materially adversely affect our business35% rewritten
84business interruptions resulting from geopolitical actions, including war, armed conflicts and terrorism or natural disasters, including pandemics or other outbreaks of infectious disease, earthquakes, typhoons, floods and firesNew
85We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management
86Our operations or those of the third parties upon whom we depend might be affected by the occurrence of a catastrophic event, such as a terrorist attack, war or other armed conflict, geopolitical tensions or trade wars, pandemic or natural disaster

Risks Related to Ownership of Our Common Stock and Our Status as a Public Company

87Our common stock may be subject to a low trading volume and volatile market price related or unrelated to our operations and purchasers of our common stock could have difficulty selling their shares or could suffer a decline in value20% rewritten
88other events or factors described in this “Risk Factors” section, many of which are beyond our controlNew
89If securities or industry analysts do not publish research or reports about our company, or if they issue unfavorable or inaccurate research regarding our business, or if they publish negative evaluations of our stock, the price and trading volume of our stock could decline24% rewritten
90Our principal stockholders and management own a significant percentage of our common stock and exert significant control over matters subject to stockholder approval61% rewritten
91We have broad discretion regarding use of our cash and cash equivalents, and we may not use them effectively
92We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock
93We are an “emerging growth company” and a “smaller reporting company” and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors57% rewritten
94exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approvedNew
95We cannot predict whether investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile
96We have incurred and will continue to incur substantial costs as a result of operating as a public company, and our management has devoted and will continue to be required to devote substantial time to new compliance initiatives and corporate governance practices
97Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud
98Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition99% rewritten
99Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current directors and members of management29% rewritten
100require the approval of the holders of at least two-thirds of the votes that all our stockholders would be entitled to cast to amend or repeal specified provisions of our certificate of incorporation or bylawsNew
101any action asserting a claim arising pursuant to any provision of our certificate of incorporation or bylaws (in each case, as they may be amended from time to time) or governed by the internal affairs doctrineNew
102Cybersecurity Risk Management and StrategyNew
103committee is notified between such updates regarding significant new cybersecurity threats or incidents. The audit committee, in turn, periodically reports on its review to the board of directorsNew
104I tem 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsNew
105Research and Development ExpensesNew
106depreciation, amortization and other direct and allocated expenses, including rent, maintenance of facilities and other operating costs, incurred as a result of our research and development activitiesNew
107general economic conditions, including inflation and the imposition of new or revised global trade tariffsNew
108General and Administrative ExpensesNew
109Change in Fair Value of Common Stock Warrant LiabilitiesNew
110Comparison of the Years Ended December 31, 2025 and 2024New
111Collaboration and License RevenueNew
112At-the-Market Offering ProgramNew
113to incur additional costs associated with operating as a public company. As a result, we expect to incur substantial operating losses and negative operating cash flows for the foreseeable futureNew
114Other Contractual ObligationsNew
115Critical Accounting Policies and Use of EstimatesNew
116Our collaboration and license revenue to date is comprised of amounts recognized from our collaboration, license and option agreement with AbbVie and our license agreement with Gilead. We recognize revenue in accordance with ASC 606, Revenue from Contracts with Customers , or ASC 606New
117Research and Development Expenses and Related Accruals and Prepaid ExpensesNew
118Valuation of Common Stock Warrant LiabilitiesNew
119period, with the change in fair value recorded as a component of other income, net, on the consolidated statements of operations and comprehensive lossNew
120the expected dividend yield, which is zero as we do not have a history of paying dividends and have no plans to pay dividends in the futureNew
121Emerging Growth Company and Smaller Reporting Company StatusNew
122Ite m 8. Financial Statements and Supplementary DataNew
123Evaluation of Disclosure Controls and ProceduresNew
124Management’s Annual Report on Internal Control over Financial ReportingNew
125provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the consolidated financial statementsNew
126Changes in Internal Control over Financial ReportingNew
127Director and Officer Trading ArrangementsNew
128It em 10. Directors, Executive Officers, and Corporate GovernanceNew
129Ite m 11. Executive CompensationNew
130Ite m 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder MattersNew
131Ite m 13. Certain Relationships and Related Transactions, and Director IndependenceNew
132Ite m 14. Principal Accountant Fees and ServicesNew
133 Portions of this exhibit have been omitted pursuant to Item 601 of Regulation S-K promulgated under the Securities Act because the information is not material and is a type of information that the registrant treats as private or confidentialNew
134President and Chief Executive OfficerNew
135Opinion on the Financial StatementsNew
136Preferred stock, $ 0.0001 par value; 5,000,000 shares authorized, no shares issued or outstandingNew
137Loss on disposal of property and equipmentNew
1381. Description of Business and LiquidityNew
139Principles of ConsolidationNew
140Cash Equivalents and Restricted CashNew
141Concentrations of Credit Risk and Significant SuppliersNew
142Level 3— Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniquesNew
143Shorter of the useful life or the remaining term of the leaseNew
144Impairment of Long-Lived AssetsNew
145Research and Development Costs and Related Accruals and Prepaid ExpensesNew
146Recently Adopted Accounting PronouncementsNew
147Recent Accounting Pronouncements Not Yet AdoptedNew
1483. Fair Value MeasurementsNew
1494. Property and Equipment, NetNew
150Collaboration, License and Option Agreement with AbbVieNew
151Option Program; (iv) a material right to receive additional services related to the Initial Option Program; and (v) a material right related to AbbVie’s one-time right to substitute the initial target with the backup target for the Initial Option ProgramNew
152License Agreement with Gilead Sciences, IncNew
153Summary of Contract Assets and LiabilitiesNew
154Clinical Trial Collaboration with F. Hoffmann-La Roche LtdNew
155In August 2016, Xilio Development entered into an amended and restated exclusive license agreement with City of Hope pursuant to which City of Hope granted Xilio Development an exclusive worldwide license to specified patent rights related to the Company’s anti-CTLA-4 monoclonal antibody programNew
156CTLA-4 Monoclonal Antibody License Agreement with WuXi BiologicsNew
157Financing cash flows from finance leasesNew
158Indemnification AgreementsNew
159Undesignated Preferred StockNew
160June 2025 Follow-On OfferingNew
161Each Series A warrant became exercisable on December 1, 2025 , with an exercise price of $ 10.50 per share of common stock, and will expire on June 5, 2030. During the year ended December 31, 2025 , no Series A warrants were exercised and 4,762,533 Series A warrants remain outstanding as of December 31, 2025New
162“At-The-Market” Offering ProgramNew
163Shares Reserved for Future IssuanceNew
1642020 Stock Incentive PlanNew
1652021 Stock Incentive PlanNew
1662025 Stock Incentive PlanNew
167The first tranche (the "Tranche 1 Stock Options") vest in equal monthly installments over a period of three years , subject to the employee continuing to provide services to the Company on each vesting dateNew
1682021 Employee Stock Purchase PlanNew
169Stock-Based Compensation ExpenseNew
170The weighted-average exercise price per share of the options outstanding and exercisable as of December 31, 2025 includes the impact of the repricing of 71,591 and 282,609 options on November 21, 2025 at $ 14.00 and $ 21.00 per share, respectivelyNew
171The Company determined that the Tranche 2, Tranche 3 and Tranche 4 Stock Options contain performance conditions for which the likelihood of satisfying such performance conditions are considered probable as of December 31, 2025New
172The Company has no t recorded a current or deferred tax provision for years ended December 31, 2025 and 2024New
173State and local income taxes, net of federal income tax effectNew
174Effective income tax rateNew
175February 2026 Follow-On OfferingNew

Other Xilio Therapeutics 10-Ks

FY2024 10-K risk factors
86 risks
Xilio is entirely dependent on its clinical-stage pipeline candidates, primarily vilastobart and XTX301, with no commercial products or revenue.
Filed Mar 11, 2025

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The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.