Lyell Immunopharma, Inc.

Previous wording

We are a clinical-stage cell therapy company expecting to enter pivotal trials in 2025 and advancing a pipeline of proprietary next-generation autologous chimeric antigen receptor (CAR) T-cell product candidates for patients with hematologic malignancies and solid tumors. We are pioneering novel approaches designed to generate T-cell therapies that drive long-lasting clinical responses. The patient’s own living cells are the starting point for our investigational CAR T-cell therapies, and we enhance them with our innovative CAR constructs, technology and manufacturing protocols.

Current wording

We are a late-stage clinical cell therapy company advancing a pipeline of proprietary next-generation autologous chimeric antigen receptor (CAR) T-cell product candidates for patients with hematologic malignancies and solid tumors. The Company is currently conducting a pivotal clinical trial for its lead product candidate, LYL314, a dual-targeting CD19/CD20 CAR T‑cell therapy in development for large B-cell lymphoma in the third- or later-line (3L+) setting and in a Phase 1/2 study in the second-line (2L) setting. We are pioneering novel approaches designed to generate T‑cell therapies that drive long-lasting clinical responses. The patient’s own living cells are the starting point for our investigational CAR T-cell therapies, and we enhance them with our innovative CAR constructs, technology and manufacturing protocols.

Previous wording

In hematologic malignancies, we are focused on advancing to pivotal trials a product candidate designed to deliver improved outcomes over first-generation CD19 CAR T-cell therapies for patients with B-cell lymphomas. Our lead program, LYL314 (formerly IMPT-314), is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR T-cell therapies and is currently under evaluation in a Phase 1/2 clinical trial for the treatment of patients with relapsed and/or refractory large B‑cell lymphoma. LYL314 is designed with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity.

Current wording

In hematologic malignancies, we are focused on advancing our lead product candidate, LYL314, which is designed to deliver improved outcomes over first-generation CD19 CAR T-cell therapies for patients with B-cell lymphomas. LYL314 is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR T-cell therapies. The PiNACLE trial, which is the first of two planned pivotal trials of LYL314 for the treatment of patients with relapsed and/or refractory large B-cell lymphoma (LBCL), is now underway. LYL314 is designed with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency and is manufactured with a process that enriches for CD62L‑positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity.

Previous wording

To realize the potential of cell therapy for solid tumors, we are also developing next-generation CAR T-cell product candidates enhanced with our anti-exhaustion and additional arming technologies and manufactured with our proprietary protocols. These approaches are designed to endow CAR T cells with attributes needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment.

Current wording

To realize the potential of cell therapy for solid tumors, we are also developing next-generation CAR T-cell product candidates enhanced with our anti-exhaustion and additional arming technologies and manufactured with our proprietary protocols. These approaches are designed to endow CAR T cells with attributes needed to drive durable tumor cytotoxicity and achieve high rates of long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile solid tumor microenvironment.

Previous wording

Our lead program, LYL314, is targeting patients with aggressive relapsed and/or refractory large B-cell non‑Hodgkin lymphoma (NHL). Lymphoma is a blood cancer that begins in lymphocytes and spreads primarily in lymph nodes, but can also metastasize to the liver, kidney, brain and other organs. Lymphomas are broadly classified as either Hodgkin or non‑Hodgkin lymphoma, with NHL present in multiple groups of lymph nodes whereas Hodgkin lymphoma is typically located in a single group of lymph nodes, generally in the upper body. NHL is the more common form of lymphoma, representing approximately 90% of all lymphomas.

Current wording

Our lead program, LYL314, is targeting patients with aggressive relapsed and/or refractory large B-cell non‑Hodgkin lymphoma (NHL), more commonly referred to as LBCL. Lymphoma is a blood cancer that begins in lymphocytes and spreads primarily in lymph nodes, but can also metastasize to the liver, kidney, brain and other organs. Lymphomas are broadly classified as either Hodgkin or non‑Hodgkin lymphoma, with NHL present in multiple groups of lymph nodes whereas Hodgkin lymphoma is typically located in a single group of lymph nodes, generally in the upper body. NHL is the more common form of lymphoma, representing approximately 90% of all lymphomas.

Previous wording

While the first generation of CD19 CAR T-cell therapies delivered a major advance in treatment for patients with B-cell lymphoma, there remains a need for therapies that deliver more complete and durable responses. More than 40% of patients with aggressive large B-cell lymphoma treated in the third- or later-line setting with a CD19 CAR T-cell therapy are not disease-free after treatment and 30% of patients do not respond at all. Of these patients treated with an approved CD19 CAR T-cell therapy, approximately 50% of patients progress or die within six months, and the overall survival at one year for patients treated with a CD19 CAR T-cell therapy is only 50% to 60%.

Current wording

While the first generation of CD19 CAR T-cell therapies delivered a major advance in treatment for patients with B-cell lymphoma, there remains a need for therapies that deliver more complete and durable responses. More than 40% of patients with aggressive LBCL treated in the 3L+ setting with a CD19 CAR T-cell therapy are not disease-free after treatment and 30% of patients do not respond at all. Of these patients treated with an approved CD19 CAR T-cell therapy, approximately 50% of patients progress or die within six months, and the overall survival at one year for patients treated with a CD19 CAR T-cell therapy is only 50% to 60%.

Previous wording

•Ability to target lower or heterogeneous CD19 antigen density and result in a higher percentage of complete responses than with a single targeting CAR agent;

Current wording

•Ability to target lower or heterogeneous CD19 antigen density and result in a higher percentage of complete responses than with a single-targeting CAR construct;

Previous wording

Additionally, LYL314 is manufactured to produce a CAR T-cell product with higher proportions of naïve and central memory T cells through a process that enriches for CD62L-expressing cells. This manufacturing process is designed to generate CAR T cells with enhanced antitumor activity, which we believe could result in both increased complete response rates and more durable responses. Naïve T cells are mature T lymphocytes that have differentiated in the bone marrow and undergone central tolerance selection in the thymus, but have not interacted with their antigen. CAR T cells generated from these CD62L-positive less differentiated T cells have been associated with better engraftment, improved persistence, reduced exhaustion and lower cytokine production compared to CAR T cells generated from traditional processes. The enrichment of CD62L-expressing T cells does not increase the manufacturing time, which is similar to that of the approved CD19 CAR T-cell therapies. Data from the ZUMA-7 pivotal trial of axicabtagene ciloleucel in patients with relapsed and/or refractory large B-cell lymphoma demonstrated an improved overall survival in those patients with a higher median percentage of T cells with a naïve/stem memory phenotype in the administered cell product.

Current wording

Additionally, LYL314 is manufactured to produce a CAR T-cell product with higher proportions of naïve and central memory T cells through a process that enriches for CD62L-expressing cells. This manufacturing process is designed to generate CAR T cells with enhanced antitumor activity, which we believe could result in both increased complete response rates and more durable responses. Naïve T cells are mature T lymphocytes that have differentiated in the bone marrow and undergone central tolerance selection in the thymus, but have not interacted with their antigen. CAR T cells generated from these CD62L-positive less differentiated T cells have been associated with better engraftment, improved persistence, reduced exhaustion and lower cytokine production compared to CAR T cells generated from traditional processes. The enrichment of CD62L-expressing T cells does not increase the manufacturing time, which is similar to that of the approved CD19 CAR T-cell therapies. Data from the ZUMA-7 pivotal trial of axicabtagene ciloleucel in patients with relapsed and/or refractory LBCL demonstrated an improved overall survival in those patients with a higher median percentage of T cells with a naïve/stem memory phenotype in the administered cell product.

Previous wording

Our ongoing Phase 1/2 trial of LYL314 is a multi-center, open-label dose-escalation and dose-expansion clinical trial designed to evaluate the safety and clinical benefit of LYL314 and to determine a recommended Phase 2 dose in patients with relapsed and/or refractory aggressive large B-cell lymphoma. The trial is enrolling CAR T-cell therapy naïve patients in the third- or later-line and second-line settings with relapsed and/or refractory DLBCL, PMBCL, HGBCL, FL3B and tFL. If successful, we may expand into other types of B-cell NHL.

Current wording

Our Phase 1/2 trial of LYL314 is a multi-center, open-label dose-escalation and dose-expansion clinical trial designed to evaluate the safety and clinical benefit of LYL314 and to determine a recommended Phase 2 dose in patients with relapsed and/or refractory aggressive LBCL. Following our End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA), we initiated the pivotal PiNACLE trial, which is a seamless expansion of the 3L+ cohort of the Phase 1/2 trial. The PiNACLE trial is a single-arm pivotal trial evaluating LYL314 at a dose of 100 x 106 CAR T cells in patients with LBCL treated in the 3L+ setting. The trial is expected to enroll approximately 120 patients with relapsed and/or refractory DLBCL, PMBCL, HGBCL, FL3B or tFL who have not previously received CAR T-cell therapy. Patients may be treated with LYL314 in the outpatient setting, with observation near the site limited to 14 days. There is no upper age limit for eligibility, which broadens the addressable patient population. The primary endpoint of the trial is the overall response rate, including an evaluation of duration of response. More information about the PiNACLE trial can be found on clinicaltrials.gov (NCT05826535).

Previous wording

We reported initial data from the ongoing Phase 1/2 trial at the American Society of Hematology 2024 Annual Meeting (ASH). As of October 22, 2024 (the data cutoff date for the presentation at ASH), 23 patients with relapsed and/or refractory CAR T-naïve LBCL received LYL314 and comprised the safety population. The efficacy evaluable population consisted of 17 patients and was defined as patients with a response assessment at Day 84 or later or an earlier scan with a complete response or progressive disease. Of the six patients not included in the efficacy evaluable population presented at ASH, two were excluded because they had T-cell histiocyte-rich lymphoma, a histologic subtype with a poor prognosis that is not included in the clinical trial moving forward, and four patients who had not yet reached their Day 84 scan.

Current wording

We presented new data from the ongoing Phase 1/2 trial in an oral session at the 18 th International Conference on Malignant Lymphoma (ICML) in June 2025. As of April 15, 2025 (the data cutoff date for the presentation at ICML), 51 patients with relapsed and/or refractory CAR T-naïve LBCL received LYL314 and comprised the safety population. The efficacy evaluable population consisted of 36 patients with Day 84 assessments or prior disease progression or death, including 25 patients treated in the 3L+ setting and 11 patients treated in the 2L setting. Patient demographics and baseline disease characteristics were consistent with high-risk patient populations: median ages of 65 and 69 years in the 3L+ and 2L settings, respectively, 41% of 3L+ and 65% of 2L patients had Stage IV disease at trial entry, and 47% of 3L+ and 82% of 2L patients had primary refractory disease. There were 49 patients who received the recommended Phase 2 dose of 100 x 106 CAR T cells; two patients received a dose of 300 x 106 CAR T cells. CD19/CD20 screening was not required prior to enrollment. Of the patients not included in the efficacy evaluable population presented at ICML, two were excluded because they had T-cell histiocyte-rich lymphoma, a histologic subtype with a poor prognosis that is not included in the clinical trial moving forward, and 13 patients who had not yet reached their Day 84 scan.

Previous wording

Figure 4: Initial data from the Phase 1/2 trial in patients with relapsed and/or refractory aggressive large B-cell lymphoma treated with LYL314 were presented at American Society of Hematology 2024 Annual Meeting. The efficacy evaluable population consisted of 17 patients. The overall response rate was 94% (16/17 patients), with 71% (12/17 patients) achieving a complete response by three months. The median follow up was 6.3 months (range 1.2 – 12.5 months) and 71% of patients were experiencing a response when these data were reported.

Current wording

Figure 3: Data from the Phase 1/2 trial in patients with relapsed and/or refractory aggressive LBCL treated with LYL314 were presented at ICML. The efficacy evaluable population of patients treated in the 3L+ setting consisted of 25 patients. The overall response rate was 88% (22/25 patients), with 72% (18/25 patients) achieving a complete response. The median follow up was 9 months (17 maximum). When the data were reported, 71% (10/14) of patients with complete response remained in complete response at ≥ 6 months.

Previous wording

The Phase 1/2 clinical trial is ongoing and currently enrolling patients with relapsed and/or refractory LBCL who are being treated in the third- or later and second-line settings and have not previously received CAR T-cell therapy. LYL314 has received Regenerative Medicine Advanced Therapy (RMAT) as well as Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsed and/or refractory diffuse LBCL in the third- or later-line setting.

Current wording

LYL314 is currently under evaluation in the pivotal PiNACLE trial for patients with relapsed and/or refractory LBCL that has progressed on two or more prior lines of therapy (Phase 2 portion of ongoing Phase 1/2 multi-center clinical trial of LYL314). The Phase 1/2 clinical trial is ongoing and currently enrolling patients with relapsed and/or refractory LBCL who are receiving treatment in the 3L+ and 2L settings and have not previously received CAR T-cell therapy. LYL314 has received Regenerative Medicine Advanced Therapy (RMAT) as well as Fast Track designations from the FDA for the treatment of adults with relapsed and/or refractory diffuse LBCL in the 3L+ setting.

Previous wording

•New clinical data from the Phase 1/2 multi-center clinical trial of LYL314 in patients with relapsed and/or refractory LBCL will be presented at the 18 th International Conference on Malignant Lymphoma on June 18 th, including more mature data from patients treated in the third- or later-line setting and initial data from patients treated in the second-line setting. The data will be highlighted in an oral presentation titled “LYL314, a CD19/CD20 CAR T-cell candidate enriched for CD62L+ stem-like cells, achieves high rates of durable complete responses in R/R large B-cell lymphoma.”

Current wording

•We presented new clinical data from the Phase 1/2 multi-center clinical trial of LYL314 in patients with relapsed and/or refractory LBCL in an oral session at the ICML on June 18 th, including mature data from patients treated in the 3L+-line setting and initial data from patients treated in the 2L setting. The data demonstrated high rates of durable complete responses in high-risk patients with a manageable safety profile.

Previous wording

•We expect to present more mature data from the ongoing Phase 1/2 trial from patients in the second-line setting in late-2025.

Current wording

•We expect to present more mature data from the ongoing Phase 1/2 trial from patients receiving treatment in the 2L setting in late-2025.

Previous wording

•We expect to initiate a pivotal trial by early 2026 in patients with relapsed and/or refractory LBCL in the second-line setting who have not yet received CAR T-cell therapy.

Current wording

•We expect to initiate a Phase 3 randomized controlled trial in patients receiving treatment in the 2L setting with relapsed and/or refractory LBCL by early 2026.

Previous wording

At Lyell, we believe that careful selection and evaluation of our CAR targets is important to ensure we are aiming for larger markets with substantial unmet medical need and to ensure that binding to normal tissues is limited and manageable for safety. Selecting an appropriate antigen target and designing a potent CAR construct, however, are necessary but insufficient for most solid tumors. Based on nonclinical evidence and clinical data, we believe there are multiple mechanisms limiting the efficacy and durability of cell therapy for solid tumors. To address this need, we are advancing solid tumor CAR T‑cell product candidates with new CAR targets and that are armed with a suite of proprietary anti-exhaustion and durable stemness technologies, as well as new enhancements designed to overcome the hostile tumor microenvironment. Our next-generation CAR T-cell product candidates are fully-armed, meaning they incorporate multiple technologies, each designed to address different efficacy barriers to cell therapies for solid tumors, including T‑cell exhaustion, lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment. Our technologies and manufacturing approaches designed to generate CAR T cells that can achieve potent and durable anti‑tumor cytotoxicity are summarized in Table 3 described below.

Current wording

For our solid tumor pipeline, we are targeting large markets with substantial unmet medical need. We carefully evaluate and select CAR targets to ensure that binding to normal tissues is limited and manageable for safety. Selecting an appropriate antigen target and designing a potent CAR construct, however, are necessary but insufficient for achieving durable clinical responses in most solid tumors. Based on nonclinical evidence and clinical data, we believe there are multiple mechanisms limiting the efficacy and durability of cell therapy for solid tumors. To address this need, we are advancing solid tumor CAR T‑cell product candidates with new CAR targets and that are armed with a suite of our proprietary anti-exhaustion and durable stemness technologies, as well as new enhancements designed to overcome the hostile tumor microenvironment. Our next-generation CAR T-cell product candidates are fully-armed, meaning they incorporate multiple technologies, each designed to address different efficacy barriers to cell therapies for solid tumors, including T‑cell exhaustion, lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment. Our technologies and manufacturing approaches designed to generate CAR T cells that can achieve potent and durable anti‑tumor cytotoxicity are summarized in Table 4 described below.

Previous wording

Our LyFE Manufacturing Center™ located in Bothell, Washington is approximately 73,000 square feet and is comprised of manufacturing suites, laboratories and offices. At full staffing and capacity, we expect to be able to manufacture >1,000 patient CAR T‑cell products/year and support our clinical development needs for LYL314 and other pipeline programs, as well as early commercial launch of LYL314, if approved. LyFE was commissioned and designed to be in compliance with U.S. and EU current Good Manufacturing Practices (cGMP) standards and has a flexible and modular design enabling CAR T‑cell, TIL, TCR T-cell therapies and cGMP viral vector production to control and de‑risk the manufacturing sequence and timing of the major components of our supply chain. Owning our own facility has enabled seamless collaboration across research, process development and manufacturing for high-quality reproducibility at manufacturing scale.

Current wording

Our LyFE Manufacturing Center™ located in Bothell, Washington is approximately 73,000 square feet and is comprised of manufacturing suites, laboratories and offices. LyFE is manufacturing LYL314 for the pivotal PiNACLE trial and the ongoing Phase 1/2 clinical trial for patients with relapsed and/or refractory LBCL. At full staffing and capacity, we expect to be able to manufacture >1,200 patient CAR T‑cell products/year and support our clinical development needs for LYL314 and other pipeline programs, as well as early commercial launch of LYL314, if approved.

Previous wording

We are focused on maintaining a manufacturing strategy that is operationally efficient to maximize our capacity and avoid any disruption to clinical trial supply. Following a successful technology transfer and clearance by the FDA of an IND amendment, we have transitioned manufacturing from our West Hills facility that was acquired from ImmPACT to our LyFE manufacturing center in Bothell, Washington. LyFE is now manufacturing LYL314 to supply the ongoing Phase 1/2 clinical trial for relapsed and/or refractory LBCL. As a result, in March 2025, our Board of Directors approved the closure of the West Hills manufacturing facility and the related reduction in workforce in West Hills by approximately 73 employees.

Current wording

We are focused on maintaining a manufacturing strategy that is operationally efficient to maximize our capacity and avoid any disruption to clinical trial supply.

Previous wording

Our business and operations may be affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges such as the effects of disruption between the U.S. and its trading partners due to tariffs or other policies, the ongoing geopolitical conflicts in Ukraine, armed conflicts and turmoil in the Middle East, tensions in U.S.-China relations, inflationary pressures, fluctuations in the interest rate environment, instability in the banking industry, supply constraints and overall market volatility. Economic uncertainty may persist into the remainder of 2025, and the market dynamics discussed above and similar adverse conditions may negatively impact our business.

Current wording

Our business and operations may be affected by worldwide economic conditions, which may continue to be impacted by global macroeconomic challenges such as the effects of disruption between the U.S. and its trading partners due to tariffs or other policies, the ongoing geopolitical conflicts in Ukraine, armed conflicts and turmoil in the Middle East and related U.S. involvement, tensions in U.S.-China relations, inflationary pressures, fluctuations in the interest rate environment, instability in the banking industry, supply constraints and overall market volatility. Economic uncertainty may persist through the remainder of 2025 and beyond, and the market dynamics discussed above and similar adverse conditions may negatively impact our business.

Previous wording

Research and development expenses also include non-cash expenses related to the change in the estimated fair value of the success payment obligations over their respective requisite service terms granted to Fred Hutchinson Cancer Center (Fred Hutch) and The Board of Trustees of the Leland Stanford Junior University (Stanford). Fred Hutch and Stanford have provided the requisite service obligation to earn the potential success payment consideration under their collaboration agreements as of December 31, 2022 and September 30, 2024, respectively. For reporting periods beginning on January 1, 2023, for Fred Hutch, and October 1, 2024, for Stanford, the change in the success payment liability fair value is recognized in other income, net, as the requisite service obligation has been met. See Note 4, License, Collaboration and Success Payment Agreements, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10‑Q. Research and development expenses related to our success payment liabilities are unpredictable and may vary significantly from quarter‑to‑quarter and year‑to‑year due to changes in our assumptions used in the calculation.

Current wording

Research and development expenses also include non-cash expenses related to the change in the estimated fair value of the success payment obligations over their respective requisite service terms granted to Fred Hutchinson Cancer Center (Fred Hutch) and The Board of Trustees of the Leland Stanford Junior University (Stanford). Fred Hutch and Stanford have provided the requisite service obligation to earn the potential success payment consideration under their collaboration agreements as of December 31, 2022 and September 30, 2024, respectively. For reporting periods beginning on January 1, 2023, for Fred Hutch, and October 1, 2024, for Stanford, the change in the success payment liability fair value is recognized in other income (expense), net, as the requisite service obligations had been met. See Note 4, License, Collaboration and Success Payment Agreements, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10‑Q. Research and development expenses related to our success payment liabilities are unpredictable and may vary significantly from quarter‑to‑quarter and year‑to‑year due to changes in our assumptions used in the calculation.

Previous wording

Other operating income, net consists primarily of service and occupancy fees received associated with subleases as well as losses on the retirement of property and equipment.

Current wording

Other operating loss (income), net consists primarily of service and occupancy fees received associated with subleases as well as losses on the retirement of property and equipment.

Previous wording

Other income, net consists primarily of the change in fair value associated with our contingent consideration payable and success payment liabilities to Fred Hutch and Stanford for the three months ended March 31, 2025. Other income, net consists primarily of the change in fair value associated with our success payment liabilities to Fred Hutch and changes to the fair value of our marketable equity security that is publicly traded for the three months ended March 31, 2024.

Current wording

Other income (expense), net consists primarily of the change in fair value associated with our contingent consideration payable and success payment liabilities to Fred Hutch and Stanford for the three and six months ended June 30, 2025. Other income (expense), net consists primarily of the change in fair value associated with our success payment liabilities to Fred Hutch and changes to the fair value of our marketable equity security that is publicly traded for the three and six months ended June 30, 2024.

Previous wording

Research and development expenses were $43.4 million and $43.2 million for the three months ended March 31, 2025 and 2024, respectively. The $0.3 million increase was primarily due to a $3.1 million increase in personnel‑related expenses, primarily due to severance expenses resulting from the Company’s workforce reduction in the first quarter of 2025 related to the closure of the West Hills manufacturing facility. The increase in personnel-related expenses was partially offset by a $1.5 million reduction in research activities, collaborations and outside services due primarily to a reduction in costs associated with collaboration agreements, a $0.8 million reduction in facilities, technology and depreciation expenses primarily due to decreased depreciation on leasehold improvements in 2025 following the impairment of those assets in December 2024 and a decrease of $0.5 million in success payments due to recognizing the Stanford success payment liability fair value changes in other income, net for the three months ended March 31, 2025.

Current wording

Research and development expenses were $78.3 million and $83.4 million for the six months ended June 30, 2025 and 2024, respectively. The $5.1 million decrease was due primarily to a decrease of $4.4 million in research activities, collaborations and outside services due primarily to a reduction in costs associated with collaboration agreements and a decrease of $1.7 million in facilities and technology costs primarily due to decreased depreciation on leasehold improvements in 2025 following the impairment of those assets in December 2024. These decreases were partially offset by a $0.7 million increase in personnel-related expenses mainly due to severance expenses resulting from the Company’s workforce reduction related to the closure of the West Hills manufacturing facility, partially offset by decreased stock-based compensation expense and a change of $0.3 million in success payments due to recognizing the Stanford success payment liability fair value changes in other income (expense), net for the six months ended June 30, 2025.

Previous wording

$1.7 million decrease in stock-based compensation expense primarily related to a decrease in the value of new awards granted.

Current wording

General and administrative expenses were $9.8 million and $12.3 million for the three months ended June 30, 2025 and 2024, respectively. The $2.5 million decrease was primarily due to a $1.7 million decrease in stock-based compensation expense primarily related to a decrease in the value of new awards granted and a $0.8 million decrease in outside services primarily due to a $0.5 million reduction in legal expenses.

Previous wording

Other operating income, net was $0.1 million and $1.1 million for the three months ended March 31, 2025 and 2024, respectively. The $1.0 million decrease in other operating income, net is primarily due to $1.3 million in losses on property and equipment disposals, partially offset by increased sublease income for the three months ended March 31, 2025.

Current wording

Other operating loss (income), net was $1.1 million and $(1.0) million for the three months ended June 30, 2025 and 2024, respectively, and $0.9 million and $(2.1) million for the six months ended June 30, 2025 and 2024, respectively. The decreases in other operating loss (income), net of $2.0 million and $3.0 million for the three and six months ended June 30, 2025, respectively, are primarily due to losses on property and equipment disposals of $2.4 million and $3.7 million, respectively, associated with the Company’s closure of the West Hills facility, partially offset by increased sublease income for the three and six months ended June 30, 2025.

Previous wording

Interest income, net was $3.9 million and $6.8 million for the three months ended March 31, 2025 and 2024, respectively. The decrease in interest income, net for the three months ended March 31, 2025 was primarily driven by lower interest rates in 2025 coupled with lower cash equivalent and marketable securities balances.

Current wording

Interest income, net was $3.3 million and $6.4 million for the three months ended June 30, 2025 and 2024, respectively, and $7.1 million and $13.2 million for the six months ended June 30, 2025 and 2024, respectively. The decrease in interest income, net for the three and six months ended June 30, 2025 was primarily driven by decreased interest rates in 2025 coupled with lower cash equivalent and marketable securities balances.

Previous wording

Other income, net was approximately $1.3 million and $1.1 million for the three months ended March 31, 2025 and 2024, respectively. The increase in other income, net was primarily driven by a $1.2 million gain resulting from the change in the fair value of our contingent consideration payable related to the ImmPACT acquisition for the three months ended March 31, 2025 and $0.6 million in changes in the fair value of our success payment liabilities. These increases in other income, net were partially offset by a $1.6 million loss associated with the change in the fair value of our equity marketable security.

Current wording

Other income (expense), net was approximately $1.2 million and $(0.6) million for the three months ended June 30, 2025 and 2024, respectively, and $2.5 million and $0.4 million for the six months ended June 30, 2025 and 2024, respectively. The increase of $1.8 million in other income (expense), net for the three months ended June 30, 2025 was primarily driven by a $0.9 million gain resulting from the change in the fair value of our contingent consideration payable related to the ImmPACT acquisition and a $1.4 million change in the fair value of our equity marketable security, partially offset by $(0.6) million in changes in the fair value of our success payment liabilities. The increase of $2.0 million in other income (expense), net for the six months ended June 30, 2025 was primarily driven by a $2.1 million gain resulting from the change in the fair value of our contingent consideration payable related to the ImmPACT acquisition partially offset by a $(0.1) million change in the fair value of our success payment liabilities.

Previous wording

Impairment of other investments was zero for the three months ended March 31, 2025 and $13.0 million for the three months ended March 31, 2024, which consisted of the full impairment of one of our other investments. See Note 6, Other Investments, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10‑Q, for additional details regarding the impairments of other investments.

Current wording

Impairment of other investments was zero for both the three months ended June 30, 2025 and June 30, 2024, and zero and $13.0 million for the six months ended June 30, 2025 and 2024, respectively, which consisted of the full impairment of one of our other investments. See Note 6, Other Investments, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10‑Q, for additional details regarding the impairments of other investments.

Previous wording

Since our inception, we have funded our operations primarily through the sale and issuance of convertible preferred stock, the sale of common stock in connection with our IPO and business development activities. As of March 31, 2025, we had $330.1 million in cash, cash equivalents and marketable securities excluding restricted cash. Since our inception, we have incurred significant operating losses. We have not yet commercialized any product candidates, and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. We had an accumulated deficit of $1.4 billion as of March 31, 2025. From June 29, 2018 (inception) through March 31, 2025, we raised an aggregate of $1.4 billion in gross proceeds from sales of our convertible preferred stock and the IPO.

Current wording

Since our inception, we have funded our operations primarily through the sale and issuance of convertible preferred stock, the sale of common stock in connection with our IPO and in a private placement financing and business development activities. As of June 30, 2025, we had $296.8 million in cash, cash equivalents and marketable securities excluding restricted cash, which does not include the gross proceeds of approximately $50 million, before deducting transaction expenses, from the sale of our common stock in a private placement pursuant to a Securities Purchase Agreement (the Purchase Agreement) in July 2025. See Note 15, Subsequent Events, in the accompanying notes to the unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q, for additional details regarding the July 2025 private placement. Since our inception, we have incurred significant operating losses. We have not yet commercialized any product candidates, and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. We had an accumulated deficit of $1.4 billion as of June 30, 2025. From June 29, 2018 (inception) through June 30, 2025, we raised an aggregate of $1.4 billion in gross proceeds from sales of our convertible preferred stock and the IPO.

Previous wording

On February 28, 2024, we entered into a sales agreement (the Sales Agreement) with Cowen and Company, LLC as our sales agent (Agent) with respect to an at-the-market offering program. In accordance with the terms of the Sales Agreement, we may offer and sell from time to time through the Agent shares of our common stock having an aggregate offering amount of up to $150.0 million (the Placement Shares). Sales of the Placement Shares, if any, will be made at prevailing market prices on Nasdaq at the time of sale, or as otherwise agreed with the Agent, by any method permitted by law deemed to be an “at-the-market offering” as defined in Rule 415 of the Securities Act. We will pay commissions to the Agent of up to 3% of the gross proceeds of the sale of the Placement Shares sold under the Sales Agreement and reimburse the Agent for certain expenses. Neither us nor the Agent is obligated to sell any shares and, to date, we have not made any sales under the Sales Agreement.

Current wording

On February 28, 2024, we entered into a sales agreement (the Sales Agreement) with Cowen and Company, LLC as our sales agent (Agent) with respect to an at-the-market offering program. In accordance with the terms of the Sales Agreement, we may offer and sell from time to time through the Agent shares of our common stock having an aggregate offering amount of up to $150.0 million (the Placement Shares). Sales of the Placement Shares, if any, will be made at prevailing market prices on Nasdaq at the time of sale, or as otherwise agreed with the Agent, by any method permitted by law deemed to be an “at-the-market offering” as defined in Rule 415 of the Securities Act of 1933, as amended (the Securities Act). We will pay commissions to the Agent of up to 3% of the gross proceeds of the sale of the Placement Shares sold under the Sales Agreement and reimburse the Agent for certain expenses. Neither us nor the Agent is obligated to sell any shares and, to date, we have not made any sales under the Sales Agreement.

Previous wording

We expect to incur additional losses in the foreseeable future as we conduct and expand our research and development efforts, including conducting nonclinical studies and clinical trials, integrating ImmPACT into our business, developing new product candidates, establishing internal manufacturing capabilities and funding our operations generally. Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to meet our working capital and capital expenditure needs for at least the next 12 months. However, we anticipate that we will need to raise additional capital in the future to fund our operations, including further development of our product candidates and the commercialization of any approved product candidates. In addition, we regularly consider fund‑raising opportunities and may decide, from time to time, to raise additional capital, including pursuant to the Sales Agreement, based on various factors, including market conditions and our plans of operation. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

Current wording

We expect to incur additional losses in the foreseeable future as we conduct and expand our research and development efforts, including conducting nonclinical studies and clinical trials, integrating ImmPACT into our business, developing new product candidates, establishing, improving and maintaining internal manufacturing capabilities and funding our operations generally. Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to meet our working capital and capital expenditure needs for at least the next 12 months. However, we anticipate that we will need to raise additional capital in the future to fund our operations, including further development of our product candidates and the commercialization of any approved product candidates. In addition, we regularly consider fund‑raising opportunities and may decide, from time to time, to raise additional capital, including pursuant to the Sales Agreement, based on various factors, including market conditions and our plans of operation. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

Previous wording

•further investment to build additional manufacturing facilities or expand the capacity of our existing ones;

Current wording

•further investment to build additional manufacturing facilities or expand the capacity of our existing one;

Previous wording

Until such time as we complete nonclinical and clinical development and receive regulatory approval of our product candidates and can generate significant revenue from product sales, if ever, we expect to finance our operations from the sale of additional equity or debt financings, or other capital that comes in the form of strategic collaborations, licensing, or other arrangements. In the event that additional capital is required, we may not be able to raise it on terms acceptable to us, or at all. If we raise additional funds through the issuance of equity or convertible debt securities, including pursuant to the Sales Agreement, it may result in dilution to our existing stockholders. Debt financing or preferred equity financing, if available, may result in increased fixed payment obligations, and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that may restrict our operations. If we raise funds through strategic collaboration, licensing, or other arrangements, we may relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from tariffs, actual or perceived changes in interest rates and economic inflation, and otherwise. If we are unable to raise additional capital when desired, our business, results of operations and financial condition would be adversely affected.

Current wording

Until such time as we complete nonclinical and clinical development and receive regulatory approval of our product candidates and can generate significant revenue from product sales, if ever, we expect to finance our operations from the sale of additional equity or debt financings, or other capital that comes in the form of strategic collaborations, licensing, or other arrangements. In the event that additional capital is required, we may not be able to raise it on terms acceptable to us, or at all. If we raise additional funds through the issuance of equity or convertible debt securities, including pursuant to the Sales Agreement, it may result in dilution to our existing stockholders. Debt financing or preferred equity financing, if available, may result in increased fixed payment obligations, and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that may restrict our operations. If we raise funds through strategic collaboration, licensing, or other arrangements, we may relinquish significant rights or grant licenses on terms that are not favorable to us. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from tariffs, actual or perceived changes in interest rates and economic inflation, and otherwise. If we are unable to raise additional capital when desired, our business, results of operations and financial condition would be adversely affected.

Previous wording

During the three months ended March 31, 2025, net cash used in operating activities was $54.7 million, reflecting our net loss of $52.2 million, partially offset by $7.0 million of non-cash items primarily related to stock-based compensation expense of $6.0 million, depreciation and amortization expense of $3.4 million and losses on property and equipment disposals of $1.3 million, partially offset by net amortization and accretion on marketable securities of $1.7 million and the change in the fair value of our contingent consideration payable of $1.2 million. Net operating assets and liabilities decreased by $9.6 million primarily driven by a $9.8 million decrease in accrued liabilities and other current liabilities, which also contributed to the net cash used in operating activities.

Current wording

During the six months ended June 30, 2025, net cash used in operating activities was $89.2 million, reflecting our net loss of $94.9 million, partially offset by $16.1 million of non-cash items primarily related to stock-based compensation expense of $11.0 million, depreciation and amortization expense of $6.6 million and losses on property and equipment disposals of $3.8 million, partially offset by net amortization and accretion on marketable securities of $2.9 million and the change in the fair value of our contingent consideration payable of $2.1 million. Net operating assets and liabilities decreased by $10.4 million primarily driven by a $13.1 million decrease in accrued liabilities and other current liabilities, partially offset by a $4.8 million increase in prepaid expenses, other current assets and other assets, which also contributed to the net cash used in operating activities.

Previous wording

During the three months ended March 31, 2024, net cash used in operating activities was $42.0 million, reflecting our net loss of $60.7 million, partially offset by non-cash items primarily related to the impairment of other investments of $13.0 million, stock-based compensation expense of $9.2 million and depreciation and amortization of $5.0 million. Non‑cash net amortization and accretion on marketable securities of $4.4 million also contributed to net cash used in operating activities. Additionally, net operating assets and liabilities decreased $3.2 million primarily driven by a $3.6 million decrease in accrued liabilities and other current liabilities, partially offset by a $0.6 million increase in prepaid expenses, other current assets and other assets.

Current wording

During the six months ended June 30, 2024, net cash used in operating activities was $80.1 million, reflecting our net loss of $106.5 million, partially offset by $30.6 million of non-cash items primarily related to stock-based compensation expense of $17.4 million, the impairment of other investments of $13.0 million and depreciation and amortization expense of $9.9 million, partially offset by net amortization and accretion on marketable securities of $8.1 million. Additionally, net operating assets and liabilities decreased $4.2 million primarily driven by a $3.1 million decrease in accrued liabilities and other current liabilities.

Previous wording

During the three months ended March 31, 2025, cash provided by investing activities was $69.5 million, consisting primarily of net maturities and purchases of marketable securities.

Current wording

During the six months ended June 30, 2025, cash provided by investing activities was $82.1 million, consisting primarily of net maturities and purchases of marketable securities.

Previous wording

During the three months ended March 31, 2024, cash provided by investing activities was $22.0 million, consisting primarily of net maturities and purchases of marketable securities.

Current wording

During the six months ended June 30, 2024, cash provided by investing activities was $67.0 million, consisting primarily of net maturities and purchases of marketable securities.

Previous wording

During the three months ended March 31, 2025, cash provided by financing activities was approximately zero.

Current wording

During the six months ended June 30, 2025, cash provided by financing activities was approximately $0.2 million, consisting of proceeds from the employee stock purchase plan.

Previous wording

During the three months ended March 31, 2024, cash provided by financing activities was approximately zero as proceeds from the exercise of stock options of $0.1 million were offset by taxes paid related to the net share settlement of equity awards of $0.1 million.

Current wording

During the six months ended June 30, 2024, cash provided by financing activities was approximately $0.9 million, consisting of proceeds from the employee stock purchase plan of $0.8 million and proceeds from the exercise of stock options of $0.2 million, partially offset by taxes paid related to the net share settlement of equity awards of $0.1 million.