Lyell Immunopharma Inc
For the period ended Mar 31, 2025. Filed May 13, 2025.
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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.
Mar 31, 2025 · Filed May 13, 2025
LYEL$14.86-0.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001628280-24-046285
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-13.
0001628280-25-025135
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe 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 143 previous paragraphs and 153 current paragraphs.
65 unchanged; 39 reworded; 47 added; 36 removed; 3 previous and 2 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 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 (47)
Current report
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 report
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 report
Table 1: Lyell’s Pipeline
Current report
Our Pipeline Programs
Current report
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 report
We are initially focused on developing LYL314 for the treatment of patients with NHL subtypes representing approximately 35% of the over 80,000 patients estimated to be diagnosed with NHL in the United States in 2025 and 545,000 patients worldwide. The NHL subtypes we intend to initially pursue include diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (tFL) and Grade 3B follicular lymphoma (FL3B). DLBCL represents approximately 31% of patients diagnosed with NHL each year (of which approximately 5% are HGBCL). PMBCL represents approximately 3% and FL3B and tFL each represent approximately 1 to 2% of patients diagnosed with NHL each year. We may choose to further expand development to include additional NHL subtypes in the future.
Current report
Figure 1: NHL is comprised of over 90 distinct subtypes, of which DLBCL is the most common form accounting for ~31% of all patients diagnosed with NHL. We are initially focused on developing LYL314 for the treatment of patients with NHL subtypes representing approximately 35% of the patients estimated to be diagnosed with NHL. The NHL subtypes we intend to initially pursue include DLBCL, PMBCL, tFL and Grade 3B follicular lymphoma (FL3B).
Current report
A dual-targeting, or bispecific, CAR recognizes two targets. LYL314 is rationally designed with a true CD19/CD20 “OR” logic-gated CAR targeting either CD19 or CD20 with full potency, and the cell therapy product is enriched for naïve and central memory T cells. Together, this novel construct and the cell enrichment for naïve and central memory T cells are designed to provide multiple clinical benefits over CD19 CAR T-cell therapies, including:
Current report
•Increase in the duration of responses by preventing relapse due to CD19 antigen escape; and
Current report
•Better cell engraftment, persistence and reduced exhaustion to provide longer duration of responses.
Current report
LYL314 consists of autologous T cells that are genetically modified through transduction with a lentiviral vector expressing a CAR construct composed of anti-CD19 and anti-CD20 single-chain variable fragments (scFvs) in tandem and an intracellular portion that contains the T-cell signaling zeta chain (CD3-ζ) and the 4-1BB co-stimulatory domain (Figure 2). This differentiates LYL314 from cell therapies and other therapeutic modalities that singularly target CD19, CD20 or CD22.
Current report
CD19 antigen escape, a mechanism by which tumor cells evade the host immune system or targeted therapy through loss, downregulation or modification of target antigens, is a known mechanism contributing to disease relapse. LYL314’s dual-targeting of both CD19 and CD20 was designed to overcome CD19 antigen escape and potentially prolong the duration of responses, as well as to target malignant B cells with limited or no expression of CD19 to achieve a higher overall response rate. In a nonclinical xenograft model of mixed tumor cells (75% CD19-positive/CD20-positive, 25% CD19-negative/CD20-positive), mice treated with CAR T cells that targeted CD19 and CD20 in this manner eliminated tumors and overcame a subsequent tumor re-challenge, whereas CD19 CAR T-cell treatment failed to control the tumors.
Current report
UCLA licensed the CD19/CD20 dual-targeting CAR construct to ImmPACT, who developed a Good Manufacturing Practices (GMP) manufacturing process and initiated a Phase 1/2 clinical trial with its product candidate IMPT-314. We acquired ImmPACT in October 2024 and are continuing the development of LYL314 (formerly IMPT-314).
Current report
Phase 1/2 Clinical Trial of LYL314
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Phase 1/2 Clinical Data
Current report
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 report
The demographic and baseline characteristic data from the patients enrolled into the trial demonstrated a median age of 65 (range, 21 – 87) years. The majority (61%) were patients diagnosed with DLBCL, and patients that had experienced a median of three prior lines of therapy (range, 2 – 6) prior to enrollment. Approximately 50% of patients had elevated lactate dehydrogenase levels suggesting high disease burden and 53% of patients received bridging therapy.
Current report
The overall response rate for the efficacy evaluable patients was 94% (16/17 patients), with 71% (12/17 patients) achieving a complete response by three months (Table 2 and Figure 4). At the time the data were presented, three of those four patients were continuing on in the study. 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 report
Table 2: Best overall response in CAR T-cell therapy naïve patients in the third- or later-line cohort in the initial data presented at the 2024 American Society of Hematology annual meeting. Data cutoff October 22, 2024.
Current report
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 report
In the safety evaluable population of 23 patients, no Grade 3 or greater CRS was reported. Grade 3 ICANS was reported in 13% (3/23) of patients with a median time to complete ICANS resolution of five days, and rapid improvement to Grade 2 or lower with standard therapy. Four patients had Grade 3 infections including bacteremia not otherwise specified, tooth infection, urinary tract infection and a herpes zoster infection, all of which responded to treatment and resolved. Pharmacokinetic data were available from 16 of the efficacy-evaluable patients.
Current report
LYL314 demonstrated robust expansion and peak cell expansion occurred between Days 7 and 28 after LYL314 infusion (median Tmax = 10 days). Median peak of expansion (Cmax) was 93,723 copies/µg gDNA (range 2,338 – 555,284). LYL314 cells persisted multiple weeks post infusion across multiple patients with median expansion at Day 28 of 11,766 copies/µg gDNA (range 56 – 555,284). The median peak expansion of LYL314 is approximately four‑fold higher than the median peak expansion reported for lisocabtagene maraleucel, a CD19 CAR T-cell therapy approved for patients with relapsed and/or refractory LBCL. Greater CAR T-cell expansion has been associated with improved treatment response in patients with B-cell lymphoma. Additionally, the final drug product contained the desired naïve and central memory cell phenotype (median, 91%; range, 82 – 99%) that has been associated with improved overall survival in other CAR T‑cell clinical studies.
Current report
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 report
•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 report
•Received RMAT designation from the FDA for LYL314 for the treatment of relapsed and/or refractory DLBCL, in the third- or later-line setting. RMAT designation recognizes the potential of LYL314 to address significant unmet needs of patients with relapsed and/or refractory DLBCL and enables an increased frequency of communications with FDA on the development of LYL314.
Current report
•LYL314 clinical supply is now being manufactured at our LyFE Manufacturing Center TM (LyFE) in Bothell, Washington following successful technology transfer and clearance by the FDA of an Investigational New Drug (IND) amendment. LyFE is our state-of-the-art cell therapy manufacturing facility with the capacity to provide drug supply for the ongoing and planned pivotal trials and through potential commercial launch with a capacity of over 1,000 CAR T-cell therapy doses per year.
Current report
•We expect to present more mature data from the ongoing Phase 1/2 trial from patients in the second-line setting in late-2025.
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•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.
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Our Preclinical Programs
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Cell therapy has demonstrated profound results in some patients suffering from hematologic malignancies, but there remains a need for therapies that deliver more complete and durable responses. Solid tumors are even more complex and have evolved multiple mechanisms to evade and ultimately resist clearance by the immune system. This has limited the use of cell therapy in solid tumors, which account for 90% of cancer deaths. And while there has been recent progress with new cell therapies approved for solid tumors, overall response rates and the duration of response remain low.
Current report
We continue to invest in earlier stage cell therapy research and development utilizing our proprietary technologies. We are advancing a fully-armed solid tumor CAR T-cell product candidate with an undisclosed target, with the CAR T-cells incorporating multiple technologies, each designed to address different barriers to effective cell therapies, including T-cell exhaustion, lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment.
Current report
T-Cell Enhancement and Manufacturing Technologies for Solid Tumors
Current report
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.
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•The first IND submission for a fully-armed CAR T-cell product candidate with an undisclosed target for solid tumors is expected in 2026.
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•An abstract titled “Engineered T Cells Combining Stackable Reprogramming Technologies Enable Durable Anti‑tumor Activity in Xenograft Solid Tumors” has been accepted for an oral presentation at the 28th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) on May 16, 2025, in New Orleans, LA. The presentation will highlight preclinical data demonstrating that engineered T cells enhanced with c-Jun overexpression, a chimeric co-stimulatory receptor and localized cytokine signaling technologies demonstrated potent tumor cell killing in vitro, T-cell viability in vitro and in vivo without cytokine support and effective, durable antitumor activity in preclinical solid tumor models.
Current report
•An abstract titled “Optimizing Stim-R™, a synthetic stimulatory agent, for feeder-free tumor-infiltrating lymphocyte manufacturing” was presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. The presented work demonstrated that Stim-R, our customizable synthetic T-cell activation reagent designed to emulate natural antigen presentation, has the potential to overcome scalability limitations in tumor‑infiltrating lymphocyte manufacturing processes by providing a synthetic replacement for feeder cells.
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Table 3: Lyell has a suite of technologies designed to enhance the potency and durability of our CAR T-cell product candidates.
Current report
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 report
Other Income, Net
Current report
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.
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Removed paragraphs (36)
Previous report
We recently acquired ImmPACT Bio USA Inc. (ImmPACT), a privately-owned clinical stage biotechnology company developing next-generation CAR T-cell product candidates including a dual-targeting CD19/CD20 CAR T‑cell product candidate currently in Phase 1 clinical development for the treatment of aggressive B-cell non-Hodgkin lymphoma. In conjunction with this acquisition, we prioritized our pipeline to focus resources on our most differentiated next generation CAR T‑cell product candidates, including IMPT-314 for patients with aggressive B-cell lymphoma and
Previous report
LYL119. LYL119, our next-generation ROR1‑targeted CAR T‑cell product candidate, has received FDA clearance of its Investigational New Drug (IND) application and is entering a Phase 1 dose-escalation, dose-expansion clinical trial, initially in patients with platinum-resistant ovarian cancer or relapsed/refractory endometrial cancer. We do not have any products approved for sale.
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Pipeline Programs
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•Initial data from the ongoing multi-center Phase 1-2 trial of IMPT-314 will be presented at the American Society of Hematology (ASH) Annual Meeting in December 2024.
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LYL119 - A next-generation ROR1-targeted CAR T-cell product candidate enhanced with Lyell’s four stackable and complementary anti-exhaustion technologies
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LYL119 is an autologous CAR T‑cell investigational product targeting the receptor tyrosine kinase-like orphan receptor 1 (ROR1) protein and enhanced with four of Lyell’s novel reprogramming technologies: c-Jun overexpression, NR4A3 knockout, Epi-R manufacturing protocol and Stim‑RTM T-cell activation technology. These technologies are stackable and complementary and are designed to enable T cells to resist exhaustion and to improve antitumor potency and durability. LYL119 targets ROR1, a fetal protein expressed during embryogenesis and is believed to be important in cell migration, polarity and survival. Significant subsets of patients with common cancers express ROR1, including ovarian cancer, endometrial cancer, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and chronic lymphocytic leukemia (CLL), and is generally associated with a poor prognosis.
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LYL119 builds on what we learned from the preclinical and clinical development of LYL797, our first-generation ROR1-targeted CAR T‑cell product candidate that demonstrated dose-dependent clinical activity in the Phase 1 trial of patients with TNBC. LYL797 was enhanced with c-Jun overexpression and manufactured with our Epi-R protocol. A key pillar of our strategy is to continually innovate to develop and advance novel, breakthrough technologies that address key barriers to effective cell therapy for solid tumors and LYL119, our next-generation ROR1-targeted CAR T‑cell product candidate incorporates four technologies designed to further enhance the anti-exhaustion functionality and stem-like qualities of T cells. These technologies include c-Jun overexpression, NR4A3 knockout by gene editing, and manufacturing using our Epi-R protocol and Stim-R novel T-cell activation technology.
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The enhanced anti-exhaustion technology incorporated into LYL119 has the potential to achieve improved efficacy at lower cell doses with an acceptable safety profile. In a preclinical mouse model of non-small cell lung cancer, LYL119 demonstrated greater antitumor potency and complete tumor control at a very low cell dose of only 100,000 cells, as well as significantly enhanced sustained tumor cell killing in a repetitive cancer cell killing assay in vitro as compared to LYL797 (Figures 3 and 4). The lower doses used with LYL119 also resulted in much more gradual cell expansion as demonstrated in Figure 5 with a logarithmic scale on the y-axis.
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Figure 3: LYL119 demonstrated more potent anti-tumor activity in vivo in a NSCLC (H1975) xenograft model, with significantly improved elimination of tumors at the lower 0.1 x 106 CAR T-cell dose.
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Figure 4: LYL119 demonstrates superior tumor cell killing following serial antigen restimulation.
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Figure 5: More gradual cell in vivo expansion at lower doses of LYL119 suggests greater tolerability.
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The Phase 1 trial of LYL119 will initially include patients with platinum-resistant ovarian and endometrial cancers, where it is estimated in the literature that approximately 50% of patients have tumors in both indications that express ROR1.
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•The Phase 1 trial of LYL119 is designed as an open label dose escalation and expansion trial in patients with ROR1‑positive solid tumors and will initially enroll patients with ROR1‑positive platinum-resistant ovarian cancer or relapsed/refractory endometrial cancer. LYL119 is expected to enroll its first patient later this year or early next year and initial clinical data are expected in the second half of 2025.
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•Presenting a poster at the Society for Immunotherapy of Cancer (SITC) Annual Meeting titled “Multiomic profiling of LYL119: A Reprogrammed ROR1 CAR T Product Generates T cells with Reduced Exhaustion and Enhanced Memory Characteristics Associated with Increased AP-1 and Reduced NR4A Bindings.” In a validated preclinical xenograft model of NSCLC, LYL119 achieved complete tumor control and prolonged survival even at very low doses compared to LYL797, Lyell’s first generation ROR1-targeted CAR T‑cell product candidate. The study presented potential molecular mechanisms underlying the functional reduction of T-cell exhaustion and enhancement of memory‑related characteristics of LYL119 CAR T cells after antigen encounter in vitro and in vivo.
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Additional Pipeline and Business Updates
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In connection with the acquisition of ImmPACT, we acquired worldwide rights to ImmPACT’s pipeline, including the next-generation bispecific CD19/CD20 autologous CAR T-cell therapy (IMPT-314), currently in clinical development for B-cell lymphoma and autoimmune diseases, and an activating TGF-beta Claudin 18.2 CAR T-cell candidate, which is in preclinical development. We have prioritized our pipeline to focus on the development of IMPT-314 for patients with B-cell lymphoma and LYL119 for patients with solid tumors and have discontinued development of LYL797, our first-generation ROR1-targeted CAR T-cell product candidate.
Previous report
In June 2024, we reported initial clinical and translational data from our Phase 1 trial of LYL797, our first-generation ROR1‑targeting CAR T-cell product candidate enhanced with c-Jun overexpression and manufactured with Epi‑R protocol. These initial clinical data demonstrated dose-dependent clinical activity, including a 40% objective response rate at the 150 x 106 cell dose level, robust cell expansion and histologic evidence of CAR T-cell infiltration into on study tumor biopsies. In this study, CRS was generally mild (Grade 1 or 2 only), and there were no reports of ICANS attributed to LYL797. Pneumonitis was the most frequently reported Grade >3 related adverse event (17%) as well as the expected cytopenia from lymphodepletion (78%). Our manufacturing success was 100%. We believe these initial clinical and translational data provide early validation of our in vivo preclinical models. In our in vivo studies LYL797 ROR1 CAR T cells reprogrammed with our c-Jun overexpression and Epi-R anti-exhaustion technology enhanced tumor control resulting in prolonged survival as compared to control ROR1 CAR T cells without our technologies. Translational data from the LYL797 Phase 1 clinical trial are being presented at the 39th Annual Meeting of SITC in November 2024.
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While LYL797 achieved enhanced tumor cell killing over historical control clinical data, we subsequently discontinued development of this first-generation product candidate on October 31, 2024 due to continued events of pneumonitis despite dexamethasone prophylaxis, resulting in a narrow therapeutic window. We have prioritized our resources on the development of the next-generation product candidate, LYL119, which we believe has the potential for a broader therapeutic window as described above.
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We have also discontinued, LYL845, our TIL clinical program because it did not achieve our criteria for differentiation from the approved TIL product, as well as our next-generation TIL and rejuvenation programs that were in preclinical development.
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Acquisition of ImmPACT
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Pursuant to the Agreement and Plan of Merger (the Merger Agreement) by and among us, ImmPACT, Inspire Merger Sub Inc., a Delaware corporation and our indirect, wholly-owned subsidiary, and WT Representative LLC, a Delaware limited liability company, solely in its capacity as the representative, agent and attorney-in-fact of ImmPACT securityholders, dated October 24, 2024, we acquired all of the outstanding equity interests of ImmPACT in exchange for an upfront payment of $30.0 million in cash (as adjusted by approximately $12.0 million for ImmPACT’s existing cash balance) and the issuance of 37.5 million shares of our common stock at closing. Contingent consideration payable following the closing includes (a) additional equity consideration of 12.5 million shares of our common stock upon the achievement of the earlier to occur of (i) the demonstration of certain clinical milestones or (ii) the receipt of certain regulatory approvals and (b) a low single‑digit royalty on future net sales of IMPT-314 in the United States.
Previous report
As a result of the acquisition of ImmPACT, we assumed its rights and obligations under its license agreement with the Regents of the University of California, acting through The Technology Development Group of UCLA, dated February 18, 2021 (the UCLA License Agreement). Pursuant to the UCLA License Agreement, we are obligated to pay a nominal, tiered annual license maintenance fee each year of the term of the UCLA License Agreement until we make the first commercial sale of a licensed product and, upon the achievement of specified development, regulatory and commercial milestones, we are obligated to pay UCLA one-time milestone payments of up to an aggregate amount in the mid-single digit millions for each commercialized licensed product. In addition, we are obligated to pay UCLA a tiered royalty on worldwide annual net sales of any commercialized licensed products in the low- to mid-single digits percentage, subject to specified and capped reductions and a tiered minimum annual royalty payment of between a low-five figure and a low-six figure amount.
Previous report
At full staffing and capacity, we expect to be able to manufacture approximately 1,000 CAR T-cell products per year at LyFE depending on product candidate mix. While we believe this capacity is sufficient to support our pipeline programs into pivotal trials and, if approved, early commercialization, we are also advancing multiple strategic alternatives to innovate and scale manufacturing in the future. We are evaluating third-party manufacturing options as part of an overall CAR T‑cell manufacturing strategy to build scale and reduce cost.
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Other (Expense) Income, net
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Three and Nine Months Ended September 30, 2024 and 2023
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Research and development expenses were $122.9 million and $136.0 million for the nine months ended September 30, 2024 and 2023, respectively. The $13.0 million decrease was primarily due to a $14.2 million reduction in personnel-related expenses mainly due to a decrease in headcount associated with the Company’s November 2023 reduction in workforce and a decrease of $2.6 million in facilities and technology costs primarily driven by the reduction in workforce and lower software implementation costs. These decreases were partially offset by an increase of $2.8 million in research activities, collaborations and outside services primarily driven by clinical trials activity and a change of $0.9 million in success payment expense primarily driven by the change in our stock price.
Previous report
General and administrative expenses were $11.8 million and $15.5 million for the three months ended September 30, 2024 and 2023, respectively. The $3.7 million decrease was primarily due to a $3.3 million reduction in personnel costs, including a $2.0 million decrease in stock-based compensation expense, primarily related to significant awards being fully expensed in the previous periods and a decrease of $1.4 million in personnel‑related expenses mainly due to a decrease in headcount associated with the Company’s November 2023 reduction in workforce.
Previous report
General and administrative expenses were $37.5 million and $53.8 million for the nine months ended September 30, 2024 and 2023, respectively. The $16.3 million decrease was primarily due to a $14.6 million reduction in personnel costs, including a $10.4 million decrease in stock-based compensation expense, primarily related to significant awards being fully expensed in the previous periods and a decrease of $4.1 million in personnel-related expenses mainly due to a decrease in headcount associated with the Company’s November 2023 reduction in workforce. General and administrative expenses also decreased due to a reduction of $1.6 million in other administrative expenses.
Previous report
Other operating income, net was $0.7 million and $0.3 million for the three months ended September 30, 2024 and 2023, respectively, and $2.8 million and $2.1 million for the nine months ended September 30, 2024 and 2023, respectively.
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Other (Expense) Income, net
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•any future acquisitions, strategic investments, partnerships or alliances and the related financial terms and obligations, including liabilities assumed in connection with our acquisition of ImmPACT;
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Subsequent to September 30, 2024, we entered into the Merger Agreement with ImmPACT pursuant to which we acquired all of the outstanding equity interests of ImmPACT in exchange for an upfront payment of $30.0 million in cash (as adjusted by approximately $12.0 million for ImmPACT’s existing cash balance) and the issuance of 37.5 million shares of our common stock at closing and agreeing to issue an additional 12.5 million shares of our common stock upon the achievement of certain clinical or regulatory milestones. Pursuant to the Merger Agreement, we have also agreed to make cash royalty payments to the pre-closing stockholders of ImmPACT based on a low single-digit royalty on future net sales of IMPT-314 in the United States.
Previous report
In addition, as a result of the Merger, we assumed ImmPACT’s rights and obligations under the UCLA License Agreement, pursuant to which we are obligated to pay a nominal, tiered annual license maintenance fee each year of the term of the UCLA License Agreement until we make the first commercial sale of a licensed product and, upon the achievement of specified development, regulatory and commercial milestones, we are obligated to pay UCLA one‑time milestone payments of up to an aggregate amount in the mid-single digit millions for each commercialized licensed product. In addition, we are obligated to pay UCLA a tiered royalty on worldwide annual net sales of any commercialized licensed products in the low- to mid-single digits, subject to specified and capped reductions and a tiered minimum annual royalty payment of between a low-five figure and a low-six figure amount.
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Off-Balance Sheet Arrangements
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Since our inception, we have not had, and we do not currently have, any off-balance sheet arrangements as defined under the applicable rules and regulations of the SEC.
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Critical Accounting Policies and Significant Judgments and Estimates
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Previous wording
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited Condensed Consolidated Financial Statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion and analysis and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives and expectations for our business. Our actual results and the timing of selected events could differ materially from those described in or implied by these forward-looking statements as a result of several factors, including those set forth in the section titled “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q. See also the section titled “Special Note Regarding Forward-Looking Statements.”
Current wording
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited Condensed Consolidated Financial Statements and the related notes included elsewhere in this Quarterly Report on Form 10-Q , and our audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on March 11, 2025. This discussion and analysis and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements based upon current beliefs, plans and expectations related to future events and our future financial performance that involve risks, uncertainties and assumptions, such as statements regarding our intentions, plans, objectives and expectations for our business. Our actual results and the timing of selected events could differ materially from those described in or implied by these forward-looking statements as a result of several factors, including those set forth in the section titled “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q. See also the section titled “Special Note Regarding Forward-Looking Statements.”
Previous wording
We are a clinical-stage cell therapy company advancing a pipeline of proprietary next-generation chimeric antigen receptor (CAR) T-cell product candidates for patients with solid tumors or hematologic malignancies. We have developed novel technologies and manufacturing protocols designed to generate T cells that resist exhaustion and have qualities of durable stemness to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses. Our investigational therapies use the patient’s own living cells as the starting point. We incorporate our innovative technology and manufacturing protocols to expand and activate the patient’s T cells. Our technologies are designed to generate highly tumor‑reactive, longer-lasting functional T cells with enhanced ability to persist, self‑renew and kill cancer cells over time. Our technology can be applied in a target agnostic manner to multiple T‑cell modalities, including CAR, tumor-infiltrating lymphocytes (TIL) and T‑cell receptor (TCR) therapies.
Current 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.
Previous wording
We were incorporated in June 2018. Our primary activities to date have included clinical development of T‑cell therapies, conducting research and development, acquiring technology and product candidates, entering into strategic collaboration and license agreements, enabling and executing manufacturing activities in support of our product candidate development efforts, organizing and staffing our company, business planning, establishing our intellectual property portfolio, making regulatory submissions, executing clinical trials, raising capital and providing general and administrative support for these activities. We are early in our research and development efforts.
Current wording
We were incorporated in June 2018. Our primary activities to date have included clinical development of T‑cell therapies, conducting research and development, acquiring technology, entering into strategic collaboration and license agreements, enabling and executing manufacturing activities in support of our product candidate development efforts, executing clinical trials, organizing and staffing the company, business planning, establishing our intellectual property portfolio, regulatory submissions and other preparations to initiate and execute clinical trials, raising capital and providing general and administrative support for these activities.
Previous wording
Our pipeline of next-generation CAR T-cell product candidates target indications with large unmet need and provide opportunities to expand into additional indications beyond the patient populations we are initially evaluating. Our lead product candidates are summarized in Table 1 below:
Current wording
Our pipeline of next-generation CAR T-cell product candidates target cancers with large unmet need and is summarized in Table 1 below:
Previous wording
IMPT-314 - A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of the response as compared to the approved CD19‑targeted CAR therapies for the treatment of large B-cell lymphoma.
Current wording
LYL314 (formerly IMPT-314): A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of responses as compared to the approved CD19‑targeted CAR T-cell therapies for the treatment of large B-cell lymphoma.
Previous wording
Non-Hodgkin lymphoma (NHL) is a common blood cancer in the United States and worldwide. Annually, it is estimated that approximately 81,000 people in the United States and 545,000 worldwide will be diagnosed with NHL. B‑cell lymphoma is the most common type of non-Hodgkin lymphoma, comprising approximately 85% of all lymphomas in the United States. 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 treated with a CD19 CAR T-cell therapy are not disease-free after treatment and 30% of patients do not respond at all. Of patients treated with an approved CD19 CAR T-cell therapy, approximately 50% of patients progress or relapse within six months. The overall survival at one year for patients treated with a CD19 CAR 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 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%.
Previous wording
IMPT-314 is an autologous dual-targeting CD19/CD20 CAR T-cell therapy designed to kill B‑cells expressing CD19 and/or CD20 antigens for the treatment of patients with aggressive B-cell malignancies. We acquired this product candidate through our acquisition of ImmPACT in October 2024.
Current wording
LYL314 is an autologous dual-targeting CD19/CD20 CAR T-cell therapy designed to kill B cells expressing CD19 and/or CD20 antigens for the treatment of patients with aggressive B-cell malignancies. We acquired this product candidate through our acquisition of ImmPACT Bio USA Inc. (ImmPACT) in October 2024.
Previous wording
Figure 1: IMPT-314 contains separate, tandem single-chain variable fragment (scFV) antibody domains designed to target both CD19 and CD20 and is manufactured using a CAR that contains the 4-1BB costimulatory domain and a process to enrich for CD62-positive naïve and central memory T cells.
Current wording
Figure 2: LYL314 contains separate, tandem scFV antibody domains designed to target both CD19 and CD20 and is manufactured using a CAR construct that contains a 4-1BB costimulatory domain and is manufactured with a process to enrich for CD62-positive naïve and central memory T cells.
Previous wording
A dual-targeting, or bispecific, CAR recognizes two targets. IMPT-314 is rationally designed with an ‘OR’ logic gate to target B cells that express either CD19, CD20 or both (Figure 1). This differentiates IMPT-314 from cell therapies and other therapeutic modalities that singularly target only CD19 or only CD20. Preclinical data demonstrated that this optimized tandem CAR design is capable of killing target cells that express CD19 only, CD20 only or both antigens, thus it has the potential to achieve a higher percentage of complete responses than a single targeting agent, particularly in those patients with lymphoma who may have a lower or heterogeneous CD19 antigen density.
Current wording
Antigen heterogeneity, which refers to variation in the expression levels of tumor antigens across cancer cells, can limit the effectiveness of targeted therapies, including CD19 CAR T-cell therapy. Nonclinical data demonstrated that LYL314’s optimized tandem CAR design is capable of killing target cells that express CD19 only, CD20 only or both antigens with full potency, thus it has the potential to achieve a higher percentage of complete responses than a single targeting agent, particularly in those patients with malignant B cells with a lower or heterogeneous CD19 antigen density.
Previous wording
Additionally, IMPT-314 is manufactured to produce a CAR T-cell product with higher proportions of naïve and central memory T cells through a proprietary process that enriches for CD62L-expressing cells. This manufacturing process is designed to generate CAR T cells with enhanced antitumor activity, that 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 less differentiated T cells are known to have better engraftment, improved persistence, reduced exhaustion and lower cytokine production compared to CAR T cells generated from traditional processes. The enrichment of CD62L-positive naïve 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/refractory large B-cell lymphoma demonstrated an improved overall survival in those patients with a higher median percentage of T cells in the product with a naïve/stem memory phenotype (Westin JR, NEJM, 2023).
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 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.
Previous wording
ImmPACT licensed its dual-targeting CD19/CD20 CAR T-cell product candidate from the University of California Los Angeles (UCLA). Interim Phase 1 data in 13 patients with relapsed/refractory aggressive non-Hodgkin lymphoma treated in a UCLA‑sponsored clinical trial were presented at the 2024 American Association for Cancer Research (AACR) Special Conference in Cancer Research: Tumor Immunology and Immunotherapy (Figure 2). CAR T-cell naïve patients with relapsed/refractory diffuse large B-cell lymphoma or primary mediastinal B‑cell lymphoma after at least two lines of therapy or mantle cell lymphoma, follicular lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma after at least three lines of therapy were evaluated. Autologous T cells were obtained and enriched for CD14-/CD25-/CD62L+ naïve or memory T cells. Two doses were to be evaluated including 50 and 200 million cells. Three patients received cell doses below 50 million cells due to manufacturing issues. Twelve out of 13 patients achieved a complete or partial response (92% objective response rate), with ten achieving a confirmed complete response (77% complete response rate). The median progression-free survival was 50.1 months, and median overall survival was not reached with a median follow‑up of 32 months (range: 5.7 – not estimable). A favorable safety profile was observed with no case of cytokine release syndrome (CRS) above Grade 1 and no reported cases of immune effector cell‑associated neurotoxicity syndrome (ICANS).
Current wording
ImmPACT licensed its dual-targeting CD19/CD20 CAR T-cell product candidate from the University of California Los Angeles (UCLA). Interim Phase 1 data in 13 patients with relapsed and/or refractory aggressive NHL treated in a UCLA‑sponsored single-center clinical trial were presented (Figure 3). CAR T‑cell naïve patients with relapsed and/or refractory DLBCL, PMBCL, MCL or FL after at least two lines of therapy were evaluated. Autologous T cells were obtained and enriched for CD62L-positive naïve or memory T cells. Two doses were to be evaluated including 50 and 200 million cells. Three patients received cell doses below 50 million cells due to manufacturing issues. The overall response rate was 92% with a complete response rate of 77% (10/13 patients). The median progression-free survival was 50.1 months, and median overall survival was not reached with a median follow‑up of 32 months (range: 5.7 – not estimable). The overall survival at three years was 65%. A favorable safety profile was observed with no cases of cytokine release syndrome (CRS) above Grade 1 and no reported cases of immune effector cell‑associated neurotoxicity syndrome (ICANS). Two patients in this study who achieved a complete response but experienced disease progression after approximately 18 months and four years, respectively, were both successfully retreated with the UCLA CD19/CD20 CAR T-cell product and both patients again achieved a complete response.
Previous wording
Figure 2: Interim Phase 1 data in 13 patients with relapsed/refractory aggressive non-Hodgkin lymphoma treated with UCLA-314 in a UCLA-sponsored clinical trial were presented at the 2024 AACR Special Conference in Cancer Research: Tumor Immunology and Immunotherapy.
Current wording
Figure 3: Interim Phase 1 data in 13 patients with relapsed and/or refractory aggressive NHL treated with UCLA-314 in a UCLA‑sponsored clinical trial were presented at the 2024 American Association for Cancer Research Special Conference in Cancer Research: Tumor Immunology and Immunotherapy.
Previous wording
ImmPACT initiated a Phase 1-2 clinical trial of this dual-targeting CD19/CD20 CAR T-cell product candidate, IMPT-314, in 2023, and we are now advancing this trial. It is a multi-center, open-label dose-escalation and dose-expansion clinical trial designed to evaluate the safety and clinical benefit of IMPT-314 and to determine a recommended Phase 2 dose in patients with relapsed/refractory aggressive B-cell lymphoma. IMPT-314 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory aggressive B-cell lymphoma.
Current 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.
Previous wording
•We expect to initiate a pivotal trial in patients with relapsed/refractory large B-cell lymphoma in the 3rd line setting who have not yet been exposed to CAR T-cell therapy in 2025.
Current wording
•We expect to initiate a pivotal trial in mid-2025 in patients with relapsed and/or refractory LBCL in the third- or later‑line setting who have not yet received CAR T-cell therapy.
Previous wording
Our LyFE Manufacturing Center™ (LyFE) located in Bothell, Washington is approximately 73,000 square feet and is comprised of manufacturing suites, laboratories and offices. Our LyFE Manufacturing Center was designed to be in compliance with U.S. and European Union current Good Manufacturing Practices (cGMP) standards and has a flexible and modular design enabling CAR T-cell, TIL, TCR T-cell 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. Clinical supply for our Phase 1 trial of LYL119 will be produced at LyFE and clinical supply for our Phase 1-2 trial of IMPT-314 is currently manufactured in our wholly-owned manufacturing facility in Los Angeles, California, that we acquired in connection with the acquisition of ImmPACT. As we accelerate development of IMPT-314, we expect to supplement our Los Angeles manufacturing capacity and will evaluate options either at LyFE or through a contract development manufacturing organization. We are focused on maintaining a manufacturing strategy that is operationally efficient to maximize our capacity and avoid any disruption to clinical trial supply.
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. 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.
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 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 2024, 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, 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.
Previous wording
To date, research and development expenses consist of costs incurred by us for the discovery and development of our technology platforms and product candidates and include costs incurred in connection with strategic collaborations, costs to license technology, personnel-related costs, including stock-based compensation expense, facility and technology related costs, research and laboratory expenses, as well as other expenses, which include consulting fees and other costs. Upfront payments and milestones paid to third parties in connection with technology platforms that have not reached technological feasibility and do not have an alternative future use are expensed as incurred.
Current wording
To date, research and development expenses consist of costs incurred by us for the discovery and development of our technology platforms and product candidates and include costs incurred in connection with conducting and completing current and planned clinical trials, strategic collaborations, costs to license technology, personnel-related costs, including stock-based compensation expense, facility and technology related costs, research and laboratory expenses, as well as other expenses, which include consulting fees and other costs. Upfront payments and milestones paid to third parties in connection with technology platforms that have not reached technological feasibility and do not have an alternative future use are expensed as incurred.
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). As of December 31, 2022, Fred Hutch had provided the requisite service obligation to earn the potential success payment consideration under the continued collaboration. For the three and nine months ended September 30, 2023 and future periods, the change in the Fred Hutch success payment liability fair value is recognized in other (expense) income, net, as the requisite service obligation had been met. See Note 3, 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, 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.
Previous wording
General and administrative costs include personnel-related expenses, including stock-based compensation expense for personnel in executive, legal, finance and other administrative functions, legal costs, transaction costs related to collaboration and licensing agreements, as well as fees paid for accounting and tax services, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include those related to corporate, dispute and patent matters.
Current wording
General and administrative costs include personnel-related expenses, including stock-based compensation expense for personnel in executive, legal, finance and other administrative functions, legal costs, transaction costs related to licensing and collaboration agreements, as well as fees paid for accounting and tax services, consulting fees and facilities costs not otherwise included in research and development expenses. Legal costs include those related to corporate, dispute and patent matters.
Previous wording
Other (expense) income, net was approximately zero and $1.6 million for the three months ended September 30, 2024 and 2023, respectively, and $0.4 million and $2.4 million for the nine months ended September 30, 2024 and 2023, respectively. Other (expense) income, net consists primarily of the change in fair value associated with our success payment liabilities to Fred Hutch and for the three and nine months ended September 30, 2024, also includes adjustments to the fair value of our marketable equity security investment that is publicly traded.
Current 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.
Previous wording
Impairment of other investments consists of a reduction in the value of certain other investments.
Current wording
Impairment of other investments consists of reductions in the value of certain other investments.
Previous wording
Research and development expenses were $39.5 million and $43.8 million for the three months ended September 30, 2024 and 2023, respectively. The $4.3 million decrease was primarily due to a $4.9 million reduction in personnel‑related expenses, mainly due to a decrease in headcount associated with the Company’s November 2023 reduction in workforce. These decreases were partially offset by a change of $1.2 million in success payment expense primarily driven by the change in our stock price.
Current wording
Three Months Ended March 31, 2025 and 2024
Previous wording
Interest income, net was $6.0 million and $6.6 million for the three months ended September 30, 2024 and 2023, respectively, and $19.1 million and $16.4 million for the nine months ended September 30, 2024 and 2023, respectively. The increase in interest income, net for the nine months ended September 30, 2024 was primarily driven by higher interest rates in 2024.
Current 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.
Previous wording
Impairment of other investments was zero for both the three months ended September 30, 2024 and 2023, and $13.0 million and $12.9 million for the nine months ended September 30, 2024 and 2023, respectively, which consisted of the full impairment of one of our other investments for the nine months ended September 30, 2024 and the full impairment of two of our other investments for the nine months ended September 30, 2023. See Note 5, 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 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.
Previous wording
As of September 30, 2024, we had $460.7 million in cash, cash equivalents and marketable securities. To date we have raised an aggregate of $1.4 billion in gross proceeds from sales of common stock and convertible preferred stock.
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 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.
Previous wording
On February 28, 2024, we entered into a sales agreement (Sales Agreement) with Cowen and Company, LLC (Cowen) acting as our sales agent, pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $150.0 million from time to time in a series of one or more at-the-market equity offerings. We will pay Cowen commissions of up to 3.0% of the gross proceeds of the sale, and reimbursement of certain expenses, under this agreement. Neither us nor Cowen 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. 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, 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 into 2027. 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 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
•the cost of manufacturing clinical and commercial supplies of our current and future product candidates;
Current wording
•the cost of manufacturing clinical and commercial supplies of our current and future product candidates, including increases in these costs as a result of tariffs;
Previous wording
•the costs of operating as a public company, including legal, accounting and other related expenses as well as costs relating to maintaining or expanding our operational, financial and management systems and compliance programs;
Current wording
•the costs of operating as a public company, including legal, accounting and other related expenses as well as costs relating to maintaining or expanding our operational, financial and management systems;
Previous wording
•addressing or responding to any potential disputes or litigation; and
Current wording
•addressing or responding to any potential disputes or litigation;
Previous wording
•the extent to which we acquire or invest in businesses, products and technology platforms.
Current wording
•the extent to which we acquire or invest in businesses, products and technology platforms; and
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 is generated from 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 potentially unfavorable global economic conditions and any disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from actual or perceived changes in interest rates and economic inflation, the anticipated impact of any geopolitical instability 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 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.
Previous wording
We continually evaluate our liquidity and capital resources to ensure that we can adequately and efficiently finance our operations. As of September 30, 2024, our material cash requirements consisted primarily of paying salaries and benefits, administering clinical trials, conducting research, manufacturing products for our clinical trials, providing the technology and facilities necessary to support our operations, funding operating lease obligations and other payments related to our collaborative agreements. See Note 3, License, Collaboration and Success Payment Agreements, and Note 7, Leases, 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 information.
Current wording
We continually evaluate our liquidity and capital resources to ensure that we can adequately and efficiently finance our operations. As of March 31, 2025, our material cash requirements consisted primarily of paying salaries and benefits, administering clinical trials, conducting research, improving our manufacturing capabilities, providing the technology and facilities necessary to support our operations, funding operating lease obligations and other payments related to our license and collaboration agreements and the acquisition of ImmPACT. See Note 4, License, Collaboration and Success Payment Agreements, and Note 8, Leases, 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 information.
Previous wording
During the nine months ended September 30, 2023, net cash used in operating activities was $123.1 million, primarily reflecting our net loss of $181.7 million, partially offset by $56.9 million of non-cash items primarily related to stock-based compensation expense of $38.6 million, depreciation and amortization of $15.2 million and impairment of other investments of $12.9 million. Non-cash net amortization and accretion on marketable securities of $6.2 million also contributed to net cash used in operating activities.
Current 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.
Previous wording
During the nine months ended September 30, 2024, net cash used in operating activities was $115.2 million, reflecting our net loss of $151.1 million, partially offset by $39.1 million of non-cash items primarily related to stock-based compensation expense of $25.1 million, depreciation and amortization expense of $14.6 million and the impairment of other investments of $13.0 million, partially offset by net amortization and accretion on marketable securities of $11.7 million and non-cash lease income of $1.6 million. Net operating assets and liabilities decreased by $3.2 million, which also contributed to the net cash used in operating activities.
Current 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.
Previous wording
During the nine months ended September 30, 2024, cash provided by investing activities was $68.9 million, consisting primarily of net maturities and purchases of marketable securities.
Current 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.
Previous wording
During the nine months ended September 30, 2023, cash provided by investing activities was $284.7 million, consisting of net maturities and purchases of marketable securities of $287.4 million offset by purchases of property and equipment of $2.7 million.
Current 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.
Previous wording
During the nine months ended September 30, 2024, cash provided by financing activities was $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.
Current 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.
Previous wording
There have been no material changes to our critical accounting policies and estimates as compared to those described in our Annual Report on Form 10‑K for the year ended December 31, 2023 (Annual Report) other than our stock‑based compensation policy for performance-based restricted stock units. For information related to our stock‑based compensation policy for performance-based restricted stock units, see Note 2, Summary of Significant Accounting Policies, 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.
Current wording
There have been no material changes to our critical accounting policies and estimates as compared to those described in our Annual Report on Form 10‑K for the year ended December 31, 2024 (Annual Report).
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
•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 report — wording carried from elsewhere
During the three months ended March 31, 2025, cash provided by financing activities was approximately zero.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
Other (expense) income, net consists primarily of the change in fair value associated with our success payment liabilities to Fred Hutch and adjustments to the fair value of our marketable equity security that is publicly traded.
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
During the nine months ended September 30, 2023, cash provided by financing activities was $1.0 million, consisting of proceeds from the employee stock purchase plan of $1.2 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 $0.3 million.