What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-12 compared with 2026-05-12 · 120 added, 52 removed, 210 unchanged (45% of the section changed)

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Our integrated biology and protein engineering approach enables us to design and develop highly potent, masked biologics that are activated, or unmasked, by tumor-specific proteases within the tumor microenvironment.

We are currently advancing multiple programs in preclinical and clinical development, including masked multi-specifics, and our clinically-validated masking technology has enabled us to establish top-tier strategic partnerships, including with AbbVie Group Holdings Limited, or AbbVie, and Gilead Sciences, Inc., or Gilead.

We are currently advancing multiple programs in preclinical and clinical development, including:

XTX501, a bispecific PD-1 / masked IL-2;

multi-specific masked T cell engagers, or TCEs;

and efarindodekin alfa, a masked IL-12.

Our clinically-validated masking technology has enabled us to establish top-tier strategic partnerships, including with AbbVie Group Holdings Limited, or AbbVie, and Gilead Sciences, Inc., or Gilead.

bispecific PD-1 / masked IL-2

XTX501 is a novel bispecific PD-1 / masked IL-2 that has the potential to be a foundational backbone therapy for solid tumors, including in combination with other agents.

XTX501 is designed to selectively stimulate PD-1 positive, antigen-experienced T cells and enhance their function while overcoming IL-2 receptor-mediated clearance, peripheral activity and tolerability issues associated with non-masked IL-2 agents.

We received clearance from the U.S.

Food and Drug Administration, or FDA, for our investigational new drug application, or IND, to proceed to a first-in-human, multi-center, open-label Phase 1/2 clinical trial for XTX501.

We expect to initiate dosing in the Phase 1 portion of the trial in patients with metastatic non-small cell lung cancer, or NSCLC, and select advanced solid tumors in the second half of 2026, and we plan to report initial Phase 1 data in patients with metastatic NSCLC in the second half of 2027.

Masked T Cell Engager Programs

We are leveraging our proprietary, clinically-validated masking technology and modular TCE architectures to advance two wholly-owned masked TCE programs, as well as an additional masked TCE program in collaboration with AbbVie.

Our masked TCEs are designed with a masked CD3 targeting domain and one or more tumor-associated antigen, or TAA, binding domains as part of the core molecule design.

In addition, our modular architecture enables the incorporation of a co-stimulatory domain designed to further enhance potency and durability of T cell response, as well as the potential to mask the TAA binding domain(s) and/or mask the co-stimulatory signaling domain.

Upon tumor-selective activation, our TCE molecules are designed to release a potent, short half-life TCE in the tumor microenvironment.

We are advancing IND-enabling studies for a potential first-in-class masked TCE program targeting CLDN18.2 and a potential first-in-class multi-specific, masked TCE program targeting PSMA and STEAP1 with built-in co-stimulatory signaling.

CLDN18.2 is a TAA expressed in gastrointestinal cancers (gastric, pancreatic and esophageal), and PSMA and STEAP1 are TAAs expressed in prostate cancer.

We plan to submit INDs for our CLDN18.2 and PSMA+STEAP1 programs in the second half of 2027.

Efarindodekin alfa:

We are evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors under our license agreement with Gilead and expect to deliver an option data package to Gilead in the first half of 2027.

Liquidity Overview

To date, we have financed our operations primarily from proceeds raised through private placements of equity securities, sales of common stock in our initial public offering, or IPO, and through “at-the-market” offerings;

To date, we have financed our operations primarily from proceeds raised through private placements of equity securities;

sales of common stock in our initial public offering, or IPO, and through “at-the-market” offerings;

the sale of prefunded warrants in our June 2025 and February 2026 follow-on offerings;

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Even if we are able to generate revenue from product sales, we may not become profitable.

Since inception, we have incurred significant operating losses, including net losses of $9.5 million and $13.3 million for the three months ended March 31, 2026 and 2025, respectively, and a net loss of $35.0 million for the year ended December 31, 2025.

As of March 31, 2026, we had an accumulated deficit of $428.3 million.

Since inception, we have incurred significant operating losses, including net losses of $15.9 million and $29.1 million for the six months ended June 30, 2026 and 2025, respectively, and a net loss of $35.0 million for the year ended December 31, 2025.

As of June 30, 2026, we had an accumulated deficit of $434.7 million.

We expect to continue to incur significant expenses and operating losses for the foreseeable future, particularly to the extent we:

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As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy.

As of March 31, 2026, we had cash and cash equivalents of $150.3 million.

In the second quarter of 2026, we achieved a $6.0 million development milestone related to the collaboration agreement with AbbVie.

Based on our current operating plans, we anticipate that our existing cash and cash equivalents as of March 31, 2026, together with the development milestone achieved under the AbbVie collaboration in the second quarter of 2026, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into early 2028.

This estimate excludes any potential additional milestone payments, option-related fees or other contingent payments under our existing collaboration and partnership agreements with AbbVie and Gilead and excludes the potential receipt of up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price.

As of June 30, 2026, we had cash and cash equivalents of $136.0 million.

In the second quarter of 2026, we achieved a $6.0 million development milestone related to the collaboration agreement with AbbVie, which we received in the third quarter of 2026.

Based on our current operating plans, we anticipate that our existing cash and cash equivalents as of June 30, 2026, together with the $6.0 million development milestone achieved under the AbbVie collaboration in the second quarter of 2026, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2028.

This estimate excludes up to $36.2 million in additional gross proceeds in the second half of 2026 if all outstanding Series C warrants are exercised at their current exercise price and any potential additional milestone payments, option-related fees or other contingent payments under our collaboration and license agreements with AbbVie and Gilead, including up to $31.0 million in near-term milestones and option extension fees that could be achieved under the AbbVie collaboration through the first half of 2027.

In addition, we have based our estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we anticipate.

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We record cost-sharing payments under our clinical trial collaboration with Roche as a reduction of research and development costs upon the achievement of each study development event specified in the clinical supply agreement.

Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized as assets, even when there is no alternative future use for the research and development.

Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized as assets, even when there is no alternative future use for the research and development.

The capitalized amounts are expensed as the related goods are delivered or the services are performed.

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We track these external costs, such as fees paid to CDMOs, CROs, preclinical study vendors and other third parties in connection with our manufacturing and manufacturing process development, clinical trials, preclinical studies and other research activities by program.

Due to the number of ongoing programs and our ability to use resources across several projects, personnel-related expenses and indirect or shared operating costs incurred for our research and development programs are not recorded or maintained on a program-by-program basis.

Due to the number of ongoing programs and our ability to use

resources across several projects, personnel-related expenses and indirect or shared operating costs incurred for our research and development programs are not recorded or maintained on a program-by-program basis.

Research and development activities are central to our business model.

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• our successful enrollment in and completion of clinical trials;

• our ability to successfully complete clinical trials with safety, potency and purity profiles that are satisfactory to the U.S.

Food and Drug Administration, or the FDA, or any comparable foreign regulatory authority;

• our ability to successfully complete clinical trials with safety, potency and purity profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;

• our receipt of regulatory approvals from applicable regulatory authorities;

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In the event we are unable to obtain sufficient additional capital in the future, we may need to implement cost reduction strategies that seek to reduce our general and administrative expenses while maintaining sufficient infrastructure to support our planned research and development activities and operations as a public company.

Other Income, Net

Other Income (Expense), Net

Change in Fair Value of Common Stock Warrant Liabilities

The change in fair value of common stock warrant liabilities consists of the change in the fair value of the common stock warrant liabilities from December 31, 2025 to March 31, 2026.

Other Income, Net

Other income, net consists primarily of interest income earned from our cash and cash equivalents.

The change in fair value of common stock warrant liabilities consists of the gain or loss recorded upon the revaluation at each reporting period of the common stock warrant liabilities in connection with the June 2025 follow-on offering.

Other Income (Expense), Net

Other income (expense), net consists primarily of interest income earned from our cash and cash equivalents, and for the three and six months ended June 30, 2025 also consists of the portion of the issuance costs we incurred in connection with the June 2025 follow-on offering, which were allocated to the common stock warrant liabilities.

Results of Operations

Comparison of the three months ended March 31, 2026 and 2025

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025 (in thousands):

Comparison of the three months ended June 30, 2026 and 2025

The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025 (in thousands):

Three Months Ended

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Loss from operations

Other income, net

Other income (expense), net

Change in fair value of common stock warrant liabilities

Other income, net

Total other income, net

Other income (expense), net

Total other income (expense), net

Collaboration and License Revenue

Collaboration and license revenue increased by $9.7 million from $2.9 million for the three months ended March 31, 2025 to $12.6 million for the three months ended March 31, 2026.

Collaboration and license revenue increased by $10.6 million from $8.1 million for the three months ended June 30, 2025 to $18.7 million for the three months ended June 30, 2026.

The increase was due to an increase in collaboration and license revenue recognized under our collaboration and license agreements with AbbVie and Gilead.

Research and Development Expenses

The following table summarizes our research and development expenses for the three months ended March 31, 2026 and 2025 (in thousands):

The following table summarizes our research and development expenses for the three months ended June 30, 2026 and 2025 (in thousands):

Three Months Ended

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Total research and development expenses

Research and development expenses increased by $11.6 million from $8.3 million for the three months ended March 31, 2025 to $19.8 million for the three months ended March 31, 2026.

Research and development expenses decreased by $0.8 million from $15.3 million for the three months ended June 30, 2025 to $14.6 million for the three months ended June 30, 2026.

The changes in research and development expenses were primarily due to the following:

• XTX501 costs increased by $5.7 million, primarily driven by an increase in manufacturing activities related to IND-enabling studies and preclinical development activities;

• other early programs and indirect research and development costs increased by $2.8 million, primarily driven by an increase in external expenses related to preclinical research and development activities, including costs related to our CLDN18.2 program, prostrate program and AbbVie collaboration;

• vilastobart costs increased by $1.3 million, primarily driven by a $2.0 million cost-sharing payment earned under our Roche clinical collaboration during the three months ended March 31, 2025, which we recorded as a reduction in research and development expenses and for which there was no corresponding cost-sharing payment during the three months ended March 31, 2026, partially offset by a $0.7 million decrease in clinical development activities related to our ongoing Phase 1/2 clinical trial evaluating vilastobart in combination with atezolizumab;

• other early programs and indirect research and development costs increased by $1.7 million, primarily driven by an increase in external expenses related to preclinical research and development activities, including costs related to our masked TCE programs targeting CLDN18.2 and PSMA+STEAP1 and our AbbVie collaboration;

• personnel-related costs increased by $0.8 million, primarily driven by a $0.6 million increase in salaries, bonuses and benefits due to higher research and development headcount and a $0.2 million increase in stock-based compensation;

• efarindodekin alfa costs increased by $0.4 million, primarily driven by an increase in clinical development activities related to our ongoing our Phase 2 clinical trial evaluating efarindodekin alfa as a monotherapy in patients with certain advanced solid tumors.

• efarindodekin alfa costs decreased by $0.2 million, primarily driven by a decrease in clinical development activities related to our ongoing Phase 2 clinical trial;

• XTX501 costs decreased by $0.3 million, primarily driven by a $0.3 million decrease in manufacturing activities related to IND-enabling studies and a $0.2 million decrease in preclinical development activities, partially offset by a $0.2 million increase in clinical trial startup activities related to our Phase 1/2 clinical trial for XTX501;

• vilastobart costs decreased by $2.8 million, primarily driven by a decrease in clinical development activities related to our Phase 1/2 clinical trial evaluating vilastobart in combination with atezolizumab.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the three months ended March 31, 2026 and 2025 (in thousands):

The following table summarizes our general and administrative expenses for the three months ended June 30, 2026 and 2025 (in thousands):

Three Months Ended

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Total general and administrative expenses

General and administrative expenses decreased by $1.6 million from $8.5 million for the three months ended March 31, 2025 to $6.9 million for the three months ended March 31, 2026.

General and administrative expenses increased by $0.5 million from $7.1 million for the three months ended June 30, 2025 to $7.6 million for the three months ended June 30, 2026.

The changes in general and administrative expenses were primarily due to the following:

• personnel-related costs decreased by $0.3 million, primarily driven by a decrease in severance costs and discretionary bonus costs;

• professional and consulting fees decreased by $1.2 million, primarily driven by a decrease in legal fees and other professional costs.

• personnel-related costs increased by $0.3 million, primarily driven by an increase in salary, severance and recruiting costs, partially offset by a decrease in discretionary bonus costs;

• professional and consulting fees increased by $0.2 million, primarily driven by an increase in other professional costs.

Change in Fair Value of Common Stock Warrant Liabilities

The change in fair value of common stock warrant liabilities for the three months ended March 31, 2026 was due to a gain of $3.3 million due to the decrease in the fair value of the common stock warrant liabilities between December 31, 2025 and March 31, 2026, which was primarily driven by a decrease in the price per share of our common stock.

Other Income, Net

Other income, net, increased by $0.7 million from $0.6 million for the three months ended March 31, 2025 to $1.3 million for the three months ended March 31, 2026.

The increase in other income, net was primarily due to an increase in interest income due to a higher average cash balance.

The change in fair value of common stock warrant liabilities for the three months ended June 30, 2026 was due to a loss of $3.9 million resulting from the increase in the fair value of the common stock warrant liabilities between March 31, 2026 and June 30, 2026, which was primarily driven by an, increase in the price per share of our common stock.

Other Income (Expense), Net

Other income (expense), net, increased by $2.5 million from other expense of $1.4 million for the three months ended June 30, 2025 to other income of $1.1 million for the three months ended June 30, 2026.

The increase in other income (expense), net was primarily due to an increase in interest income due to a higher average cash balance and the $2.3 million in issuance costs we incurred in connection with the June 2025 follow-on offering, which were allocated to the common stock warrant liabilities, for which there was no comparable cost for the three months ended June 30, 2026.

Comparison of the six months ended June 30, 2026 and 2025

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 (in thousands):

Six Months Ended

Collaboration and license revenue

Total revenue

Operating expenses

Research and development

General and administrative

Total operating expenses

Loss from operations

Other income (expense), net

Change in fair value of common stock warrant liabilities

Other income (expense), net

Total other income (expense), net

Collaboration and License Revenue

Collaboration and license revenue increased by $20.3 million from $11.0 million for the six months ended June 30, 2025 to $31.3 million for the six months ended June 30, 2026.

The increase was due to an increase in collaboration and license revenue recognized under our collaboration and license agreements with AbbVie and Gilead.

Research and Development Expenses

The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025 (in thousands):

Six Months Ended

efarindodekin alfa

Other early programs and indirect research and development

Personnel-related

Total research and development expenses

Research and development expenses increased by $10.8 million from $23.6 million for the six months ended June 30, 2025 to $34.4 million for the six months ended June 30, 2026.

The changes in research and development expenses were primarily due to the following:

• XTX501 costs increased by $5.4 million, primarily driven by a $2.6 million increase in manufacturing activities related to IND-enabling studies, a $1.6 million increase related to clinical trial startup activities for our Phase 1/2 clinical trial for XTX501 and a $1.0 million increase in preclinical development activities;

• other early programs and indirect research and development costs increased by $4.5 million, primarily driven by an increase in external expenses related to preclinical research and development activities, including costs related to our masked TCE programs targeting CLDN18.2 and PSMA+STEAP1 and our AbbVie collaboration;

• personnel-related costs increased by $2.2 million, primarily driven by a $1.6 million increase in salaries, bonuses and benefits due to higher research and development headcount and a $0.6 million increase in stock-based compensation;

• efarindodekin alfa costs increased by $0.2 million, primarily driven by an increase in clinical development activities related to our ongoing Phase 2 clinical trial;

• vilastobart costs decreased by $1.5 million, primarily driven by a decrease in clinical development activities related to our Phase 1/2 clinical trial evaluating vilastobart in combination with atezolizumab.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025 (in thousands):

Six Months Ended

Personnel-related

Professional and consulting fees

Facility-related and other general and administrative expenses

Total general and administrative expenses

General and administrative expenses decreased by $1.1 million from $15.6 million for the six months ended June 30, 2025 to $14.6 million for the six months ended June 30, 2026.

The changes in general and administrative expenses were primarily due to a decrease of $1.0 million in legal fees and other professional costs.

Change in Fair Value of Common Stock Warrant Liabilities

The change in fair value of common stock warrant liabilities for the six months ended June 30, 2026 was due to a loss of $0.6 million resulting from the increase in the fair value of the common stock warrant liabilities between December 31, 2025 and June 30, 2026, which was primarily driven by an increase in the price per share of our common stock.

Other Income (Expense), Net

Other income (expense), net, increased by $3.2 million from other expense of $0.8 million for the six months ended June 30, 2025 to other income of $2.3 million for the six months ended June 30, 2026.

The increase in other income (expense), net was primarily due to an increase in interest income due to a higher average cash balance, partially offset by the $2.3 million in issuance costs we incurred in connection with the June 2025 follow-on offering, which were allocated to the common stock warrant liabilities, for which there was no comparable cost for the three months ended June 30, 2026.

Liquidity and Capital Resources

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the sale of prefunded warrants in our June 2025 and February 2026 follow-on offerings;

the exercise of certain common stock warrants issued in

connection with our June 2025 follow-on offering;

development event payments under our co-funded clinical trial collaboration with Roche;

the exercise of certain common stock warrants issued in connection with our June 2025 follow-on offering;

development event payments under our co-funded clinical trial collaboration with Roche for vilastobart;

and upfront and milestone payments under our collaboration and license agreements with AbbVie and Gilead.

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In February 2026, we filed a prospectus supplement to our prospectus dated May 8, 2025 (333-285793) to reduce the amount of common stock we may offer and sell under the sales agreement to an aggregate offering price of up to $9.5 million.

In May 2026, we filed a universal shelf registration statement on Form S-3 with the SEC to register for sale up to $250.0 million of our common stock, preferred stock, debt securities, units and warrants, which we may issue and sell from time to time in one or more offerings, which became effective on May 29, 2026 (333-295785), or the 2026 Form S-3.

In May 2026, we filed a prospectus supplement to our prospectus in the 2026 Form S-3 to cover the offering, issuance and sale by us of up to a maximum of $14.5 million of our common stock that may be issued and sold from time to time under our sales agreement with Leerink.

During the three months ended June 30, 2026, we issued and sold 592,300 shares of our common stock pursuant to the sales agreement with Leerink at a weighted average price of $7.76 per share for aggregate gross proceeds of $4.6 million, before deducting underwriting discounts and commissions and any offering expenses.

The following table provides information regarding our cash flows for each period presented (in thousands):

Three Months Ended

Six Months Ended

Net cash (used in) provided by:

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Financing activities

Net increase in cash, cash equivalents and restricted cash

Net (decrease) increase in cash, cash equivalents and restricted cash

Operating Activities

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The cash used in operating activities resulted primarily from our net losses adjusted for non-cash charges, which are generally due to stock-based compensation, depreciation and amortization, as well as changes in components of operating assets and liabilities, which are generally due to increased expenses and timing of vendor payments.

During the three months ended March 31, 2026, net cash used in operating activities of $22.3 million was primarily driven by net changes in operating assets and liabilities of $12.1 million, our net loss of $9.5 million and the $3.3 million gain recorded on the change in fair value of our common stock warrant liabilities, partially offset by $2.2 million of stock-based compensation expense and $0.3 million of depreciation and amortization expense.

During the three months ended March 31, 2025, net cash provided by operating activities of $29.0 million was primarily driven by changes in operating assets and liabilities of $40.2 million, which includes the $49.1 million recorded as deferred revenue in connection with our collaboration, license and option agreement and stock purchase agreement with AbbVie, and net non-cash expenses of $2.0 million, partially offset by our net loss of $13.3 million.

During the six months ended June 30, 2026, net cash used in operating activities of $41.1 million was primarily driven by net changes in operating assets and liabilities of $30.3 million and our net loss of $15.9 million, partially offset by $3.8 million of stock-based compensation expense, the $0.6 million loss recorded on the change in fair value of our common stock warrant liabilities and $0.6 million of depreciation and amortization expense.

During the six months ended June 30, 2025, net cash provided by operating activities of $14.5 million was primarily driven by net changes in operating assets and liabilities of $37.5 million, which includes the $49.1 million recorded as deferred revenue in connection with our collaboration, license and option agreement and stock purchase agreement with AbbVie, and net non-cash expenses of $6.1 million, partially offset by our net loss of $29.1 million.

Investing Activities

During the three months ended March 31, 2026 and 2025, net cash used in investing activities consisted of purchases of property and equipment.

During the six months ended June 30, 2026 and 2025, net cash used in investing activities consisted of purchases of property and equipment.

Financing Activities

During the three months ended March 31, 2026, net cash provided by financing activities of $35.7 million primarily consisted of proceeds from the sale of prefunded warrants through a follow-on offering.

During the three months ended March 31, 2025, net cash provided by financing activities of $4.8 million consisted of proceeds from the sale and issuance of common stock to AbbVie in a private placement and proceeds from the sale and issuance of common stock through ATM offerings.

During the six months ended June 30, 2026, net cash provided by financing activities of $40.2 million primarily consisted of proceeds from the sale of prefunded warrants through a follow-on offering and proceeds from the sale and issuance of common stock through our ATM program.

During the six months ended June 30, 2025, net cash provided by financing activities of $52.2 million consisted of proceeds from the sale of prefunded warrants and common stock warrants through our June 2025 follow-on offering, proceeds from the sale and issuance of common stock to AbbVie in a private placement and proceeds from the sale and issuance of common stock through our ATM program.

Capital Requirements

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Additionally, the biotechnology industry is subject to a competitive wage environment that may also increase our operating costs in the future.

As of March 31, 2026, we had cash and cash equivalents of $150.3 million.

In the second quarter of 2026, we achieved a $6.0 million development milestone related to the collaboration agreement with AbbVie.

As of June 30, 2026, we had cash and cash equivalents of $136.0 million.

In the second quarter of 2026, we achieved a $6.0 million development milestone related to the collaboration agreement with AbbVie, which we received in the third quarter of 2026.

Based on our current operating plans, we anticipate that our existing cash and cash equivalents as of June 30, 2026, together with the $6.0 million development milestone achieved under our AbbVie collaboration in the second quarter of 2026, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2028.

In addition, we have based our estimates on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we anticipate.

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Our future capital requirements, both short-term and long-term, will depend on many factors, including, but not limited to:

• the scope, progress, results and costs of research and development for our current and future product candidates, including our current and planned clinical trials for our clinical-stage product candidates, vilastobart and efarindodekin alfa, and ongoing preclinical development for our current and future product candidates;

• the scope, progress, results and costs of research and development for our current and future product candidates, including our current and planned clinical trials for our clinical-stage product candidates, efarindodekin alfa and XTX501, and ongoing preclinical development for our current and future product candidates;

• our ability to maintain our collaboration and license agreements with AbbVie and Gilead;

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Contractual Obligations

During the three months ended March 31, 2026, there have been no material changes to our contractual obligations as reported in our Annual Report on Form 10-K for the year ended December 31, 2025.

During the six months ended June 30, 2026, there have been no material changes to our contractual obligations as reported in our Annual Report on Form 10-K for the year ended December 31, 2025.

Critical Accounting Policies and Use of Estimates

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis