Xilio Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001558370-25-011477
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001193125-25-278837
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsOverviewFinancial Operations OverviewResults of OperationsContractual ObligationsCritical Accounting Policies and Use of EstimatesEmerging Growth Company and Smaller Reporting Company StatusThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 90 previous paragraphs and 140 current paragraphs.
39 unchanged; 28 reworded; 72 added; 15 removed; 8 previous and 1 current paragraphs rearranged.
Tables are not compared: 75 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (72)
Current report
continue to advance our current research programs and conduct additional research programs;
Current report
advance our current product candidates and any future product candidates we may develop into preclinical and clinical development;
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seek marketing approvals for product candidates that successfully complete clinical trials, if any;
Current report
obtain, expand, maintain, defend and enforce our intellectual property;
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continue to discover, validate and develop additional product candidates;
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continue to manufacture increasing quantities of our current or future product candidates for use in preclinical studies, clinical trials and for any potential commercialization;
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acquire or in-license other product candidates, technologies or intellectual property;
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hire additional personnel to support current or future programs;
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establish a commercial and distribution infrastructure to commercialize products for which we may obtain marketing approval, if any; and
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incur additional costs associated with current and future research, development and commercialization efforts and operations as a public company.
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personnel-related expenses, including salaries, bonuses, benefits and stock-based compensation expense for employees engaged in research and development functions;
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costs incurred with third-party contract development and manufacturing organizations, or CDMOs, to acquire, develop and manufacture materials for both preclinical studies and current or future clinical trials;
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costs of funding research performed by third parties that conduct research and development and preclinical activities on our behalf;
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costs incurred with third-party contract research organizations, or CROs, and other third parties in connection with the conduct of our current or future clinical trials;
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costs of sponsored research agreements and outside consultants, including their fees and related expenses;
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costs incurred to maintain compliance with regulatory requirements;
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fees for maintaining licenses and other amounts due under our third-party licensing agreements;
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expenses incurred for the procurement of materials, laboratory supplies and non-capital equipment used in the research and development process; and
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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.
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the scope, timing, costs and progress of preclinical and clinical development activities;
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the number and scope of preclinical and clinical programs we decide to pursue;
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our ability to implement and maintain cost reduction strategies, as well as the timing of such cost reductions;
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our ability to maintain our current research and development programs;
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our ability to establish an appropriate safety profile for our product candidates with IND-enabling studies;
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our ability to hire and retain key research and development personnel;
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the costs associated with the development of any additional product candidates we acquire or develop through collaborations, partnerships, licenses or similar transactions;
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our successful enrollment in and completion of clinical trials;
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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;
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our receipt of regulatory approvals from applicable regulatory authorities;
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our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize, our product candidates;
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our ability to commercialize products, if and when approved, whether alone or in collaboration with others;
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the continued acceptable safety profiles of the product candidates following approval, if any;
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our ability to establish and maintain agreements with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if any of our product candidates are approved;
Current report
the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder, if any;
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our ability to obtain and maintain patent, trade secret and other intellectual property protection and regulatory exclusivity for our product candidates if and when approved; and
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general economic conditions, including inflation and the imposition of new or revised global trade tariffs.
Current report
vilastobart costs decreased by $3.7 million, primarily driven by $3.5 million in aggregate development milestones
Current report
that we incurred during the three months ended September 30, 2024 under our CTLA-4 monoclonal antibody
Current report
license agreement with WuXi Biologics (Hong Kong) Limited, or WuXi Biologics, and our amended and restated
Current report
efarindodekin alfa costs increased by $1.0 million, primarily driven by a $0.8 million increase in clinical development
Showing the first 40 of 72 passages. Open the source sections for the rest.
Removed paragraphs (15)
Previous report
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Previous report
Overview
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Financial Operations Overview
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Revenue
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Operating Expenses
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Results of Operations
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Comparison of the three months ended June 30, 2025 and 2024
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Comparison of the six months ended June 30, 2025 and 2024
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Sources of Liquidity
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Shelf, the registration of such offering under the Prior S-3 Shelf was terminated and such offering was registered under the New S-3 Shelf.
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Cash Flows
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Capital Requirements and Going Concern
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Contractual Obligations
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Critical Accounting Policies and Use of Estimates
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Emerging Growth Company and Smaller Reporting Company Status
Reworded paragraphs (28)
Previous wording
We are a clinical-stage biotechnology company discovering and developing tumor-activated, or masked, immuno-oncology, or I-O, therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. We are leveraging our proprietary platform to advance a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including masked antibodies, bispecifics, cytokines and immune cell engagers. Current I-O therapies have curative potential for patients with cancer. However, their potential is significantly curtailed by systemic toxicity that results from activity of the therapeutic molecule outside the tumor microenvironment. Our molecules are engineered to localize activity within the tumor microenvironment with minimal systemic effects, resulting in the potential to achieve enhanced anti-tumor activity and increasing the population of patients who may be eligible to receive our medicines. To date, we have presented data across our clinical-stage programs showing clinical validation for our tumor-activation platform. Our most advanced clinical-stage product candidates are vilastobart, an Fc-enhanced, tumor-activated, anti-CTLA-4 monoclonal antibody, or mAb, and XTX301, a tumor-activated, engineered interleukin 12, or IL-12, therapy. We are currently advancing clinical development for vilastobart in combination with atezolizumab (Tecentriq®) in a Phase 2 clinical trial in patients with metastatic microsatellite stable colorectal cancer, or metastatic MSS CRC, under a co-funded clinical trial collaboration with F. Hoffmann-La Roche Ltd, or Roche. In May 2025, we announced updated data from the ongoing Phase 2 clinical trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrating additional anti-tumor activity, further duration of responses and a generally well-tolerated safety profile and we anticipate reporting additional data from the Phase 2 trial in the first half of 2026. For XTX301, we have completed enrollment in Phase 1A monotherapy dose escalation and evaluation of those patients is ongoing, and we continue to enroll patients in Phase 1B monotherapy dose expansion of our ongoing Phase 1 clinical trial in patients with advanced solid tumors under our exclusive license agreement with Gilead Sciences, Inc., or Gilead. In addition to our clinical-stage product candidates, we are leveraging our proprietary tumor-activation platform to advance multiple preclinical programs for XTX501, a masked PD-1/IL-2 bispecific and masked T cell engager molecules, including wholly owned programs targeting the tumor-associated antigens for PSMA, CLDN18.2 and STEAP1 and an additional program under our collaboration, license and option agreement with AbbVie Group Holdings Limited, or AbbVie.
Current wording
We are a clinical-stage biotechnology company discovering and developing tumor-activated, or masked, immuno-oncology, or I-O, therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. We are leveraging our proprietary platform to advance a pipeline of novel, tumor-activated I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including masked antibodies, bispecifics, cytokines and immune cell engagers. Current I-O therapies have curative potential for patients with cancer. However, their potential is significantly curtailed by systemic toxicity that results from activity of the therapeutic molecule outside the tumor microenvironment. Our molecules are engineered to localize activity within the tumor microenvironment with minimal systemic effects, resulting in the potential to achieve enhanced anti-tumor activity and increasing the population of patients who may be eligible to receive our medicines. To date, we have presented data across our clinical-stage programs showing clinical validation for our tumor-activation platform. Our most advanced clinical-stage product candidates are vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4 monoclonal antibody, or mAb, and efarindodekin alfa (XTX301), a tumor-activated, engineered interleukin 12, or IL-12, therapy. We are currently advancing clinical development for vilastobart in combination with atezolizumab (Tecentriq®) in a Phase 2 clinical trial in patients with microsatellite stable metastatic colorectal cancer, or MSS mCRC, under a co-funded clinical trial collaboration with F. Hoffmann-La Roche Ltd, or Roche. In November 2025, we announced new data from the ongoing Phase 2 clinical trial at the Society for Immunotherapy of Cancer (SITC) 40 th Annual Meeting in patients with MSS mCRC without liver metastases and high plasma tumor mutational burden, or TMB, and we anticipate reporting additional data from the Phase 2 trial in the first half of 2026. Based on the promising clinical activity and safety profile demonstrated by vilastobart to date as a combination therapy, including in patients who had high plasma TMB, we are actively seeking a partner to develop vilastobart in combination with PD-(L)1 or PD1-VEGF in MSS mCRC and other tumor types. For efarindodekin alfa, in the third quarter of 2025, we initiated a Phase 2 trial in patients with advanced solid tumors and achieved a $17.5 million development milestone under our exclusive license agreement with Gilead Sciences, Inc., or Gilead. We have completed enrollment in the Phase 1A monotherapy dose escalation and Phase 1B monotherapy dose expansion portions of our ongoing Phase 1/2 clinical trial, and evaluation of patients is ongoing. In addition to our clinical-stage product candidates, we are leveraging our proprietary tumor-activation platform to advance multiple prec…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
In June 2025, we closed a follow-on public offering of prefunded warrants and accompanying common stock warrants and received net proceeds of $47.0 million after deducting underwriting discounts and commissions and offering expenses payable by us. In connection with the offering, we issued prefunded warrants to purchase 66,676,000 shares of common stock, accompanied by Series A warrants to purchase 66,676,000 shares of common stock (or, in certain circumstances, prefunded warrants), Series B warrants to purchase 66,676,000 shares of common stock (or, in certain circumstances, prefunded warrants) and Series C warrants to purchase 66,676,000 shares of common stock (or, in certain circumstances, prefunded warrants). If the Series B warrants and Series C warrants are exercised in cash at their initial exercise price of $0.75 per warrant, we will receive up to $100.0 million of additional gross proceeds by the second half of 2026. For more information, refer to Note 8 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Current wording
In June 2025, we closed a follow-on public offering of prefunded warrants and accompanying common stock warrants and received net proceeds of $47.0 million after deducting underwriting discounts and commissions and offering expenses payable by us. In connection with the offering, we issued prefunded warrants to purchase 66,676,000 shares of common stock, accompanied by Series A warrants to purchase 66,676,000 shares of common stock (or, in certain circumstances, prefunded warrants), Series B warrants to purchase 66,676,000 shares of common stock (or, in certain circumstances, prefunded warrants) and Series C warrants to purchase 66,676,000 shares of common stock (or, in certain circumstances, prefunded warrants). If all of the Series B warrants and Series C warrants are exercised in cash at their initial exercise price of $0.75 per warrant, we will receive up to $100.0 million of additional gross proceeds by the second half of 2026. For more information, refer to Note 8 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Previous wording
Since inception, we have incurred significant operating losses, including net losses of $29.1 million and $31.1 million for the six months ended June 30, 2025 and 2024, respectively, and a net loss of $58.2 million for the year ended December 31, 2024. As of June 30, 2025, we had an accumulated deficit of $412.9 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future, particularly to the extent we:
Current wording
Since inception, we have incurred significant operating losses, including net losses of $45.4 million and $45.1 million for the nine months ended September 30, 2025 and 2024, respectively, and a net loss of $58.2 million for the year ended December 31, 2024. As of September 30, 2025, we had an accumulated deficit of $429.1 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future, particularly to the extent we:
Previous wording
As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy. As of June 30, 2025, we had cash and cash equivalents of $121.6 million. Based on our current operating plans, we anticipate that our existing cash and cash equivalents as of June 30, 2025 will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through the end of the third quarter of 2026. However, 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. In addition, we expect our operating losses and negative operating cash flows to continue for the foreseeable future as we continue to advance our pipeline of novel, tumor-activated I-O molecules through preclinical and clinical development, maintain the infrastructure necessary to support these activities and continue to incur costs associated with operating as a public company. These conditions raise substantial doubt about our ability to continue as a going concern. In order to fund our operations, we will need to raise additional capital, which could be obtained through the cash exercise, if any, of the Series B warrants and Series C warrants issued in connection with our June 2025 follow-on public offering, the receipt of milestone payments, option-related fees or other contingent payments under our existing agreements with Gilead and AbbVie, additional public or private equity offerings, debt financings, additional collaborations, partnerships or licensing
Current wording
As a result, we will need substantial additional capital to support our continuing operations and pursue our strategy. As of September 30, 2025, we had cash and cash equivalents of $103.8 million. In the fourth quarter of 2025, we received a $17.5 million development milestone under our license agreement with Gilead. Based on our current operating plans, we anticipate that our existing cash and cash equivalents as of September 30, 2025, together with the $17.5 million development milestone received under our license agreement with Gilead, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027. However, 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. In addition, we expect our operating losses and negative operating cash flows to continue for the foreseeable future as we continue to advance our pipeline of novel, tumor-activated I-O molecules through preclinical and clinical development, maintain the infrastructure necessary to support these activities and continue to incur costs associated with operating as a public company. These conditions raise substantial doubt about our ability to continue as a going concern. In order to fund our operations, we will need to raise additional capital, which could be obtained through the cash exercise of the Series B warrants and Series C warrants issued in connection with our June 2025 follow-on public offering, the receipt of milestone payments, option-related fees or other contingent payments under our existing agreements with Gilead and AbbVie, additional public or private equity offerings, debt financings, additional collaborations, partnerships or licensing arrangements or other sources. However, there can be no assurance that we will receive additional proceeds from the exercise of the common stock warrants or from contingent payments under our existing agreements with Gilead or AbbVie or that we will be able to complete any such transaction on acceptable terms or otherwise. If we are not able to secure sufficient additional capital when needed, we may need to implement additional cost reduction strategies, which could include delaying, limiting, further reducing or eliminating both internal and external costs related to our operations and research and development programs.
Previous wording
Collaboration and license revenue increased by $8.7 million from $2.4 million for the six months ended June 30, 2024 to $11.0 million for the six months ended June 30, 2025. The increase was due to an increase in collaboration and license revenue recognized under the license agreement and stock purchase agreement with Gilead and collaboration and license revenue recognized under the collaboration, license and option agreement and stock purchase agreement that we entered into in February 2025 with AbbVie.
Current wording
Collaboration and license revenue increased by $16.8 million from $2.3 million for the three months ended September 30, 2024 to $19.1 million for the three months ended September 30, 2025. The increase was due to collaboration and license revenue recognized under the collaboration, license and option agreement and stock purchase agreement that we entered into in February 2025 with AbbVie and an increase in collaboration and license revenue recognized under the license agreement and stock purchase agreement with Gilead, which included a cumulative catch-up of collaboration and license revenue of $7.0 million related to the adjustment of the overall transaction price due to the achievement of the $17.5 million development milestone during the third quarter of 2025.
Previous wording
Research and development expenses increased by $4.1 million from $11.2 million for the three months ended June 30, 2024 to $15.3 million for the three months ended June 30, 2025. The changes in research and development expenses were primarily due to the following:
Current wording
Research and development expenses increased by $3.6 million from $10.8 million for the three months ended September 30, 2024 to $14.3 million for the three months ended September 30, 2025. The changes in research and development expenses were primarily due to the following:
Previous wording
General and administrative expenses increased by $1.3 million from $5.8 million for the three months ended June 30, 2024 to $7.1 million for the three months ended June 30, 2025. The changes in general and administrative expenses were primarily due to the following:
Current wording
General and administrative expenses increased by $0.4 million from $6.3 million for the three months ended September 30, 2024 to $6.7 million for the three months ended September 30, 2025. The changes in general and administrative expenses were primarily due to the following:
Previous wording
We did not recognize any restructuring expenses for the three months ended June 30, 2025. We recognized $0.1 million in restructuring expenses for the three months ended June 30, 2024, consisting of employee outplacement service costs related to the workforce reduction announced in March 2024.
Current wording
We did not recognize any restructuring expenses for the three months ended September 30, 2025. We recognized a credit of $41,000 in restructuring expenses for the three months ended September 30, 2024 related to a change in estimate for costs of continuation of certain employee benefits related to the workforce reduction announced in March 2024.
Previous wording
The change in fair value of common stock warrant liabilities for the three months ended June 30, 2025 was due to a loss of less than $0.1 million on the change in the fair value of the common stock warrant liabilities between the issuance date of June 5, 2025 and the quarter ended June 30, 2025.
Current wording
The change in fair value of common stock warrant liabilities for the three months ended September 30, 2025 was due to a loss of $15.4 million due to the increase in the fair value of the common stock warrant liabilities between June 30, 2025 and September 30, 2025, which was primarily driven by an increase in the price per share of our common stock.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
The following table summarizes our research and development expenses for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
Research and development expenses increased by $2.0 million from $21.6 million for the six months ended June 30, 2024 to $23.6 million for the six months ended June 30, 2025. The changes in research and development expenses were primarily due to the following:
Current wording
Research and development expenses increased by $5.5 million from $32.4 million for the nine months ended September 30, 2024 to $37.9 million for the nine months ended September 30, 2025. The changes in research and development expenses were primarily due to the following:
Previous wording
development activities related to our ongoing Phase 1/2 clinical trial evaluating vilastobart in combination with atezolizumab; in addition, for the six months ended June 30, 2024, research and development expenses included a $1.0 million development milestone under our CTLA-4 monoclonal antibody license agreement with WuXi Biologics, for which there was no comparable cost during the six months ended June 30, 2025;
Current wording
vilastobart costs decreased by $1.6 million, primarily driven by $4.5 million in aggregate development milestones that we incurred during the nine months ended September 30, 2024 under our CTLA-4 monoclonal antibody license agreement with WuXi Biologics and our amended and restated exclusive license agreement with City of Hope, for which there was no comparable costs during the nine months ended September 30, 2025, partially offset by a $2.8 million increase in clinical development activities related to our ongoing Phase 1/2 clinical trial evaluating vilastobart in combination with atezolizumab;
Previous wording
The following table summarizes our general and administrative expenses for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
General and administrative expenses increased by $3.7 million from $12.0 million for the six months ended June 30, 2024 to $15.6 million for the six months ended June 30, 2025. The changes in general and administrative expenses were primarily due to the following:
Current wording
General and administrative expenses increased by $4.0 million from $18.3 million for the nine months ended September 30, 2024 to $22.3 million for the nine months ended September 30, 2025. The changes in general and administrative expenses were primarily due to the following:
Previous wording
We did not recognize any restructuring expenses for the six months ended June 30, 2025. We recognized $1.0 million in restructuring expenses for the six months ended June 30, 2024. The restructuring expenses were associated with the
Current wording
We did not recognize any restructuring expenses for the nine months ended September 30, 2025. We recognized $0.9 million in restructuring expenses for the nine months ended September 30, 2024. The restructuring expenses were associated with the workforce reduction announced in March 2024 and consisted of employee severance, benefits continuation and outplacement service costs.
Previous wording
The change in fair value of common stock warrant liabilities for the six months ended June 30, 2025 was due to a loss of less than $0.1 million on the change in the fair value of the common stock warrant liabilities between the issuance date of June 5, 2025 and the quarter ended June 30, 2025.
Current wording
The change in fair value of common stock warrant liabilities for the nine months ended September 30, 2025 was due to a loss of $15.4 million due to an increase in the fair value of the common stock warrant liabilities between the issuance date of June 5, 2025 and September 30, 2025, which was primarily driven by an increase in the price per share of our common stock.
Previous wording
Other income (expense), net, of $1.4 million for the three months ended June 30, 2025 included $2.3 million of the issuance costs we incurred in connection with the sale and issuance of the prefunded warrants and common stock warrants in June 2025 in connection with our follow-on public offering, which were allocated to the common stock warrant liabilities and were partially offset by $0.9 million of interest income. Other income (expense), net of $0.8 million for the three months ended June 30, 2024 consisted of interest income.
Current wording
Other income (expense), net of $0.2 million for the nine months ended September 30, 2025 included $2.3 million of the issuance costs we incurred in connection with the sale and issuance of the prefunded warrants and common stock warrants in June 2025 in connection with our follow-on public offering, which were allocated to the common stock warrant liabilities and were partially offset by $2.5 million of interest income. Other income (expense), net of $1.8 million for the nine months ended September 30, 2024 consisted of interest income.
Previous wording
Since our inception, we have incurred significant operating losses and negative cash flows from operations. We have not yet commercialized any of our product candidates, which are in preclinical or early clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all. To date, we have financed our operations primarily from proceeds raised through private placements of preferred units, convertible preferred stock, common stock and prefunded warrants; sales of common stock in our IPO and through at-the-market offerings; the sale of prefunded warrants and common stock warrants in a follow-on public offering; and upfront payments under our collaboration and license agreements with AbbVie and Gilead. Through June 30, 2025, we have received an aggregate of $531.8 million in gross proceeds from such transactions, including $224.5 million in gross proceeds from the sale and issuance of preferred units and convertible preferred stock, $129.9 million in gross proceeds from our IPO, $72.0 million in upfront cash payments under our collaboration and license agreements with AbbVie and Gilead, $46.3 million in gross proceeds from the sale and issuance of common stock and prefunded warrants in private placements with certain existing accredited investors, Gilead and AbbVie, $9.1 million in gross proceeds from the sale and issuance of common stock through at-the-market offerings and $50.0 million in gross proceeds from the sale of prefunded warrants and common stock warrants through a follow-on public offering. As of June 30, 2025, we had cash and cash equivalents of $121.6 million.
Current wording
Since our inception, we have incurred significant operating losses and negative cash flows from operations. We have not yet commercialized any of our product candidates, which are in preclinical or early clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all. To date, we have financed our operations primarily from proceeds raised through private placements of preferred units, convertible preferred stock, common stock and prefunded warrants; sales of common stock in our IPO and through at-the-market offerings; the sale of prefunded warrants and common stock warrants in a follow-on public offering; and upfront payments under our collaboration and license agreements with AbbVie and Gilead. Through September 30, 2025, we have received an aggregate of $531.8 million in gross proceeds from such transactions, including $224.5 million in gross proceeds from the sale and issuance of preferred units and convertible preferred stock, $129.9 million in gross proceeds from our IPO, $72.0 million in upfront cash payments under our collaboration and license agreements with AbbVie and Gilead, $46.3 million in gross proceeds from the sale and issuance of common stock and prefunded warrants in private placements with certain existing accredited investors, Gilead and AbbVie, $9.1 million in gross proceeds from the sale and issuance of common stock through at-the-market offerings and $50.0 million in gross proceeds from the sale of prefunded warrants and common stock warrants through a follow-on public offering. As of September 30, 2025, we had cash and cash equivalents of $103.8 million. In the fourth quarter of 2025, we received a $17.5 million development milestone under our license agreement with Gilead. Based on our current operating plans, we anticipate that our existing cash and cash equivalents as of September 30, 2025, together with the $17.5 million development milestone received under our license agreement with Gilead, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027.
Previous wording
In November 2022, 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 could issue and sell from time to time in one or more offerings, which became effective on November 18, 2022 (333-268264), or the Prior S-3 Shelf. In November 2022, we entered into a sales agreement, or the Cowen Sales Agreement, with Cowen and Company LLC under which we could issue and sell shares of our common stock, from time to time, having an aggregate offering price of up to $75.0 million under a sales agreement prospectus filed as part of the Prior S-3 Shelf. During the year ended December 31, 2024, we issued and sold 7,000,000 shares of our common stock pursuant to the Cowen Sales Agreement at a price of $1.00 per share for aggregate gross proceeds of $7.0 million. During the three months ended March 31, 2025, we issued and sold an additional 1,550,000 shares of our common stock pursuant to the Cowen Sales Agreement at a weighted average price of $1.3348 per share for aggregate gross proceeds of approximately $2.1 million. In March 2025, 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 8, 2025 (333-285703), or the New S-3 Shelf. In March 2025, we terminated the Cowen Sales Agreement and we entered into a new sales agreement with Leerink Partners, LLC, or the Leerink Sales Agreement, under which we may issue and sell shares of our common stock from time to time at an aggregate offering price of up to $50.0 million. Prior to the effectiveness of the New S-3 Shelf, the offering of shares under the Leerink Sales Agreement was registered under the Prior S-3 Shelf. In connection with the effectiveness of the New S-3
Current wording
In March 2025, 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 8, 2025 (333-285703), or the S-3 Shelf. In March 2025, we entered into a sales agreement with Leerink Partners, LLC, under which we may issue and sell shares of our common stock from time to time at an aggregate offering price of up to $50.0 million. Please see Note 8 to our condensed consolidated financial statements appearing elsewhere in our Quarterly Report on Form 10-Q for additional information about our at-the-market offering program.
Previous wording
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.
Current wording
During the nine months ended September 30, 2025, net cash used in operating activities of $3.0 million was primarily driven by net changes in operating assets and liabilities of $19.5 million, which includes the $49.1 million received from AbbVie under the collaboration, license and option agreement and stock purchase agreement that was recorded as deferred revenue at the outset of the arrangement, and net non-cash expenses of $22.9 million, which includes the $15.4 million loss recorded on the change in fair value of our common stock warrant liabilities, partially offset by our net loss of $45.4 million.
Previous wording
During the six months ended June 30, 2024, net cash provided by operating activities of $9.5 million was primarily driven by the $39.1 million received from Gilead for the upfront payment under the license agreement and equity investments under the stock purchase agreement, which were recorded as deferred revenue at the outset of the arrangement and net non-cash expenses of $4.2 million, partially offset by our net loss of $31.1 million and remaining changes in operating assets and liabilities of $2.8 million.
Current wording
During the nine months ended September 30, 2024, net cash used in operating activities of $4.2 million was primarily driven by our net loss of $45.1 million, partially offset by changes in operating assets and liabilities of $34.8 million, which includes the $39.1 million received from Gilead under the license agreement and stock purchase agreement that was recorded as deferred revenue at the outset of the arrangement, and net non-cash expenses of $6.2 million.
Previous wording
During the six months ended June 30, 2025 and 2024, net cash used in investing activities consisted of purchases of property and equipment.
Current wording
During the nine months ended September 30, 2025 and 2024, net cash used in investing activities consisted of purchases of property and equipment.
Previous wording
During the six months ended June 30, 2025, net cash provided by financing activities of $52.1 million consisted of proceeds from the sale of prefunded warrants and common stock warrants through a follow-on public 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 ATM offerings.
Current wording
During the nine months ended September 30, 2025, net cash provided by financing activities of $51.9 million consisted of proceeds from the sale of prefunded warrants and common stock warrants through a follow-on public 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 ATM offerings.
Previous wording
During the six months ended June 30, 2024, net cash provided by financing activities of $21.0 million consisted of proceeds from the sale and issuance of common stock and prefunded warrants in private placements with certain existing accredited investors and Gilead and proceeds from the sale and issuance of common stock under our at-the-market offering program, partially offset by repayments of debt principal under our loan agreement with PacWest and payments on our finance lease for certain lab equipment.
Current wording
During the nine months ended September 30, 2024, net cash provided by financing activities of $21.0 million consisted of proceeds from the sale and issuance of common stock and prefunded warrants in private placements with certain existing accredited investors and Gilead and proceeds from the sale and issuance of common stock under our at-the-market offering program, partially offset by repayments of debt principal under our loan agreement with PacWest and payments on our finance lease for certain lab equipment.
Previous wording
As of June 30, 2025, we had cash and cash equivalents of $121.6 million. Based on our current operating plans, we anticipate that our existing cash and cash equivalents as of June 30, 2025 will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through the end of the third quarter of 2026. However, 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. In addition, we expect our operating losses and negative operating cash flows to continue for the foreseeable future as we continue to advance our pipeline of novel, tumor-activated I-O molecules through preclinical and clinical development, maintain the infrastructure necessary to support these activities and continue to incur costs associated with operating as a public company. These conditions raise substantial doubt about our ability to continue as a going concern. In order to fund our operations, we will need to raise additional capital, which could be obtained through the cash exercise, if any, of the Series B warrants and Series C warrants issued in connection with our June 2025 follow-on public offering, the receipt of milestone payments, option-related fees or other contingent payments under our existing agreements with Gilead and AbbVie, additional public or private equity offerings, debt financings, additional collaborations, partnerships or licensing arrangements or other sources. However, there can be no assurance that we will receive additional proceeds from the exercise of the common stock warrants or from contingent payments under our existing agreements with Gilead or AbbVie or that the we will be able to complete any such transaction on acceptable terms or otherwise. If we are not able to secure sufficient additional capital when needed, we may need to implement additional cost reduction strategies, which could include delaying, limiting, further reducing or eliminating both internal and external costs related to our operations and research and development programs. For more information regarding our liquidity and going concern, refer to Note 1 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. For more information regarding the terms of the warrants we issued in our June 2025 follow-on public offering, refer to Note 8 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Current wording
As of September 30, 2025, we had cash and cash equivalents of $103.8 million. Based on our current operating plans, we anticipate that our existing cash and cash equivalents as of September 30, 2025, together with the $17.5 million development milestone received under our license agreement with Gilead, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2027. However, 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. In addition, we expect our operating losses and negative operating cash flows to continue for the foreseeable future as we continue to advance our pipeline of novel, tumor-activated I-O molecules through preclinical and clinical development, maintain the infrastructure necessary to support these activities and continue to incur costs associated with operating as a public company. These conditions raise substantial doubt about our ability to continue as a going concern. In order to fund our operations, we will need to raise additional capital, which could be obtained through the cash exercise of the Series B warrants and Series C warrants issued in connection with our June 2025 follow-on public offering, the receipt of milestone payments, option-related fees or other contingent payments under our existing agreements with Gilead and AbbVie, additional public or private equity offerings, debt financings, additional collaborations, partnerships or licensing arrangements or other sources. However, there can be no assurance that we will receive additional proceeds from the exercise of the common stock warrants or from contingent payments under our existing agreements with Gilead or AbbVie or that we will be able to complete any such transaction on acceptable terms or otherwise. If we are not able to secure sufficient additional capital when needed, we may need to implement additional cost reduction strategies, which could include delaying, limiting, further reducing or eliminating both internal and external costs related to our operations and research and development programs. For more information regarding our liquidity and going concern, refer to Note 1 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. For more information regarding the terms of the warrants we issued in our June 2025 follow-on public offering, refer to Note 8 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Previous wording
Our expectation with respect to our ability to fund our currently planned operations is based on estimates that are subject to various risks and uncertainties. Our operating plan may change as a result of many factors currently unknown to
Current wording
Our expectation with respect to our ability to fund our currently planned operations is based on estimates that are subject to various risks and uncertainties. Our operating plan may change as a result of many factors currently unknown to management and there can be no assurance that our current operating plan will be achieved in the time frame anticipated by us, and we may exhaust our available capital resources sooner than we expect.
Previous wording
During the six months ended June 30, 2025, 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, 2024.
Current wording
During the nine months ended September 30, 2025, 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, 2024.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
exclusive license agreement with City of Hope, for which there was no comparable cost during the three months ended September 30, 2025;
Rearranged previous paragraphs (8)
Previous report — wording carried elsewhere
arrangements or other sources. However, there can be no assurance that we will receive additional proceeds from the exercise of the common stock warrants or from contingent payments under our existing agreements with Gilead or AbbVie or that we will be able to complete any such transaction on acceptable terms or otherwise. If we are not able to secure sufficient additional capital when needed, we may need to implement additional cost reduction strategies, which could include delaying, limiting, further reducing or eliminating both internal and external costs related to our operations and research and development programs.
Previous report — wording carried elsewhere
Change in Fair Value of Common Stock Warrant Liabilities
Previous report — wording carried elsewhere
Collaboration and license revenue increased by $5.7 million from $2.4 million for the three months ended June 30, 2024 to $8.1 million for the three months ended June 30, 2025. The increase was due to collaboration and license revenue recognized under the collaboration, license and option agreement and stock purchase agreement that we entered into in February 2025 with AbbVie.
Previous report — wording carried elsewhere
Change in Fair Value of Common Stock Warrant Liabilities
Previous report — wording carried elsewhere
workforce reduction announced in March 2024 and consisted of employee severance, benefits continuation and outplacement service costs.
Previous report — wording carried elsewhere
Change in Fair Value of Common Stock Warrant Liabilities
Previous report — wording carried elsewhere
Other income (expense), net of $0.8 million for the six months ended June 30, 2025 included $2.3 million of the issuance costs we incurred in connection with the sale and issuance of the prefunded warrants and common stock warrants in June 2025 in connection with our follow-on public offering, which were allocated to the common stock warrant liabilities and were partially offset by $1.4 million of interest income. Other income (expense), net of $1.1 million for the six months ended June 30, 2024 consisted of interest income.
Previous report — wording carried elsewhere
management and there can be no assurance that our current operating plan will be achieved in the time frame anticipated by us, and we may exhaust our available capital resources sooner than we expect.