On November 12, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported financial results and business highlights for the third quarter ended September 30, 2025.

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Lyell’s lead clinical program, rondecabtagene autoleucel (ronde-cel, or LYL314), is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate under evaluation in PiNACLE, a single-arm pivotal trial enrolling patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) in the third- or later-line (3L+) setting and in a Phase 1/2 trial in the 2L setting. A second pivotal trial, PiNACLE – H2H, which is a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial of ronde-cel for LBCL in the 2L, is expected to begin by early 2026. The U.S. Food and Drug Administration (FDA) granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of patients with R/R LBCL receiving treatment in the 2L setting in November 2025 to complement the RMAT designation received for ronde-cel in the 3L+ setting in April 2025.

Lyell recently acquired exclusive global rights (outside of mainland China, Hong Kong, Macau and Taiwan) to LYL273, a novel autologous guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate in development for patients with refractory metastatic colorectal cancer (mCRC) and other GCC-expressing cancers from Innovative Cellular Therapeutics. At the highest dose level studied to date, patients with mCRC treated with LYL273 in a Phase 1 clinical trial conducted in the United States achieved a 67% confirmed overall response rate (ORR) and an 83% disease control rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on local site review, with a manageable safety profile. LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release designed to improve cell expansion, immune cell infiltration and cell killing in the hostile tumor microenvironment.

"Lyell is well positioned with two next-generation CAR T-cell product candidates, each with promising clinical data. We look forward to effectively executing on both clinical programs taking full advantage of our expertise in CAR T-cell clinical development and our wholly-owned manufacturing facility capable of commercial launch," said Lynn Seely, MD, President and CEO of Lyell. "We will be presenting new ronde-cel clinical and translational data at the upcoming ASH (Free ASH Whitepaper) meeting and exposition and are focused on rapidly advancing the pivotal development of ronde-cel through our two pivotal programs: PiNACLE – H2H, which is expected to begin enrolling patients receiving treatment in the 2L setting by early 2026, and PiNACLE, our ongoing single-arm pivotal trial for patients receiving treatment in the 3L+ setting."

Third Quarter Updates and Recent Business Highlights

Lyell is advancing a pipeline of next-generation CAR T-cell product candidates targeting cancers with large unmet need and substantial patient populations. Ronde-cel is in pivotal development for patients with R/R LBCL and LYL273 is in Phase 1 clinical development for refractory mCRC. Lyell’s pipeline also includes additional preclinical programs targeting undisclosed solid tumor indications.

Ronde-cel: A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies for the treatment of LBCL

Ronde-cel is an autologous CAR T-cell product candidate with a true ‘OR’ logic gate to target B cells that express either CD19 or CD20 with full potency. It 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. Following successful End-of-Phase 1 meetings with the U.S. Food and Drug Administration (FDA), Lyell announced the initiation of two pivotal trials – PiNACLE and PiNACLE – H2H. PiNACLE is a single-arm pivotal trial that is currently underway. It is a seamless expansion of the 3L+ cohort of the Phase 1/2 trial of patients with R/R LBCL. PiNACLE – H2H is a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial for LBCL in the 2L. Enrollment in PiNACLE – H2H is expected to begin by early 2026 and until then the Phase 1/2 trial continues to enroll patients with R/R LBCL receiving treatment in the 2L setting.

The FDA has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the treatment of R/R diffuse LBCL in the 3L+ setting. RMAT provides all the benefits of the Fast Track and Breakthrough Therapy designation programs and enables increased frequency of communications with the FDA on the development of ronde-cel.

PiNACLE is a single-arm pivotal trial evaluating ronde-cel at a dose of 100 x 106 CAR T cells in patients with LBCL receiving treatment in the 3L+ setting. The trial is expected to enroll approximately 120 patients with R/R LBCL. Patients may be treated with ronde-cel in either the inpatient or outpatient setting, and there is no upper age limit for eligibility. The primary endpoint of the trial is the overall response rate, including an evaluation of duration of response.
Two abstracts highlighting new clinical and translational data from the Phase 1/2 trial of ronde-cel for the treatment of aggressive LBCL have been accepted for oral presentation at the ASH (Free ASH Whitepaper) 67th Annual Meeting and Exposition in December 2025.
Updated data from the PiNACLE trial will be presented at ASH (Free ASH Whitepaper). Data from this trial are expected to form the basis of a Biologics License Application submission to the FDA in 2027 for patients with R/R LBCL receiving treatment in the 3L+ setting.
The FDA has granted ronde-cel RMAT designation for the treatment of patients with relapsed or refractory LBCL receiving treatment in the 2L setting. RMAT designation recognizes the potential of ronde-cel to address significant unmet needs of patients with LBCL and enables an increased frequency of communications with the FDA on the development of ronde-cel.
PiNACLE – H2H is a Phase 3 head-to-head CAR T-cell therapy trial, which will evaluate ronde-cel versus an investigator’s choice of approved CD19 CAR T-cell therapies (lisocabtagene maraleucel or axicabtagene ciloleucel) in patients with aggressive LBCL receiving treatment in the 2L setting. Patients randomized to ronde-cel will be treated with a dose of 100 x 106 CAR T cells. The primary endpoint of the trial is event-free survival. The trial is expected to enroll approximately 400 patients with R/R LBCL (200 per arm). Patients may be treated with ronde-cel in either the inpatient or outpatient setting.
Clinical site initiation is underway for PiNACLE – H2H in the United States, Canada and Australia, and the first patient is expected to be enrolled by early 2026.
Lyell recently announced the formation of an expert steering committee comprised of a distinguished group of lymphoma and cell therapy experts who will collaborate with the Company on the design and conduct of PiNACLE – H2H.

LYL273: A next-generation GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release designed to improve outcomes for patients with mCRC

LYL273 is a GCC-targeted CAR T-cell therapy enhanced with CD19 CAR expression and controlled cytokine release to increase cell expansion, immune cell infiltration and cancer cell killing in the hostile tumor microenvironment. LYL273 was granted Fast Track designation for the treatment of mCRC by the FDA.

Dose-dependent clinical activity was observed in patients with refractory mCRC in a U.S. Phase 1 clinical trial.
Across both dose levels, the overall response rate was 50% (6 of 12 patients), and the disease control rate was 83%. At Dose Level 2, the highest dose tested to-date, the overall response rate was 67%, including one patient with a pathological complete response, one patient with complete reduction in tumor volume of the target lesions (100% partial response) and two additional patients with confirmed partial responses. For patients treated at Dose Level 2, the disease control rate was 83%, and the median progression-free survival was 7.8 months.
The incidence and severity of treatment-related adverse events were highest at Dose Level 2, where the most common treatment-related adverse events were cytokine release syndrome in 83% (5/6) of patients (Grade 1, 67%; Grade 2, 17%) and diarrhea in 83% (5/6) of patients (Grade 1, 33%; Grade 2, 33%; Grade 3, 17%). The median duration of diarrhea was 11 days. Immune effector cell-associated neurotoxicity syndrome occurred in 33% (2/6) of patients (Grade 2, 17%; Grade 3, 17%) and resolved rapidly with treatment. One patient experienced a dose-limiting toxicity at Dose Level 2, including Grade 3 diarrhea, Grade 4 enterocolitis and death from fungal sepsis 48 days post-infusion. No Grade 3 or higher diarrhea occurred in the last three patients treated since establishing an optimized management protocol for diarrhea, including prophylaxis.
The U.S. Phase 1 clinical trial is continuing to enroll patients to determine the recommended Phase 2 dose.
The next data update from this Phase 1 clinical trial is expected in the first half of 2026.

Preclinical Pipeline, Technologies and Manufacturing Protocols

Lyell is advancing next-generation fully-armed CAR T-cell product candidates, each including multiple technologies, designed to overcome T-cell exhaustion and the lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment.

The first IND for a fully-armed CAR T-cell product candidate with an undisclosed target for solid tumors is expected in 2026.

Third Quarter 2025 Financial Results

Lyell reported a net loss of $38.8 million for the third quarter ended September 30, 2025, compared to a net loss of $44.6 million for the same period in 2024. The $5.7 million decrease in net loss was primarily due to decreased personnel expenses, including a $2.4 million reduction in stock-based compensation expense attributable to lower headcount and the reduced value of new equity awards granted. The decrease was partially offset by a $4.0 million loss related to the put/call asset issued to certain institutional and other accredited investors as part of our July 2025 securities purchase agreement. Non‑GAAP net loss, which excludes stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities and certain non-cash investment gains and charges, decreased to $29.1 million for the third quarter ended September 30, 2025, compared to $37.1 million for the same period in 2024, primarily due to decreased personnel expenses resulting from lower headcount and lower interest income primarily driven by decreased interest rates in 2025 coupled with lower cash equivalent and marketable securities balances.

(Press release, Lyell Immunopharma, NOV 12, 2025, View Source [SID1234659840])

On November 12, 2025 Parabilis Medicines, a clinical-stage biopharmaceutical company committed to creating extraordinary medicines for people living with cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track product designation to FOG-001 for the treatment of desmoid tumors, reflecting significant unmet need and the potential of this first-in-class therapy to transform patient care. FOG-001, Parabilis’s lead investigational Helicon peptide, is the first and only direct inhibitor of the "undruggable" β-catenin:TCF interaction.

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The FDA’s Fast Track designation is intended to help facilitate the development and expedite the review of new therapies for serious conditions that address an unmet medical need. A therapy may qualify if it targets a disease with no existing treatments, or if it offers a meaningful advantage over available options – such as showing superior effectiveness, avoiding serious side effects, or decreasing toxicities that frequently cause discontinuation of treatment. Fast Track designation enables more frequent interactions with the FDA throughout development and provides eligibility for features like Rolling Review and potential Priority Review, helping promising medicines reach patients sooner.

"Obtaining Fast Track designation for FOG-001 reinforces our confidence in its potential to offer meaningful clinical benefit to patients with desmoid tumors, who today have no therapies that directly address the underlying disease biology," said Fawzi Benzaghou, M.D., Chief Medical Officer of Parabilis Medicines. "More than half of patients do not respond to current treatment options, which are also associated with high toxicities. By inhibiting the β-catenin:TCF interaction, FOG-001 has the potential to intervene at the source of disease and marks an important step forward in advancing our mission to drug the undruggable."

This designation follows preliminary data, first released at ESMO (Free ESMO Whitepaper) and to be presented this week at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting, demonstrating that FOG-001 has shown evidence of clinically meaningful antitumor activity in desmoid tumors. Desmoid tumors are rare, locally invasive soft-tissue tumors that form in the connective tissues of the body, often causing pain, limited mobility, disfigurement, and organ dysfunction. Despite its impact on quality of life, there are no FDA-approved therapies that directly target the underlying biology of the disease.

In the company’s ongoing Phase 1/2 trial, as of the mid-August 2025 data cutoff, 12 patients with desmoid tumors had been treated with FOG-001. Tumor reductions were seen in all response-evaluable patients (n=10), and an 80% objective response rate (ORR) was seen in patients with more than one post-baseline scan (n=5), per RECIST 1.1. These responses were irrespective of prior exposure to gamma secretase inhibitors, progression on gamma-secretase inhibitors, tumor location, or mutations in CTNNB1 or APC. FOG-001 also demonstrated an acceptable safety and tolerability profile, with no Grade 4/5 treatment-related adverse events or discontinuations. No high-grade gastrointestinal (GI) or skin toxicities were observed.

"The Wnt/β-catenin pathway is implicated in millions of cancer cases each year, yet remains unaddressed by any approved therapies despite decades of effort," said Mathai Mammen, M.D., Ph.D., Chairman and CEO of Parabilis Medicines. "FOG-001 demonstrates that our Helicon peptides can unlock disease biology once considered completely inaccessible – opening a new path to drug targets long thought out of reach and medicines with the potential to fundamentally transform outcomes for patients."

Beyond desmoid tumors, FOG-001 is being evaluated across a broad range of rare and common Wnt/β-catenin-driven tumor types. Clinical data presented recently at the AACR (Free AACR Whitepaper)-NCI-EORTC 2025 meeting showed FOG-001 had single-agent activity in five low-complexity tumor types where Wnt/β-catenin mutations are the primary drivers of disease – including desmoid, adamantinomatous craniopharyngioma (ACP), ameloblastoma, salivary gland cancer, and solid pseudopapillary neoplasm (SPN) – with strong scientific rationale for combination therapy in more complex cancers such as microsatellite-stable colorectal cancer (MSS CRC).

Parabilis plans to share additional FOG-001 data in 2026.

About FOG-001

FOG-001 is an investigational first-in-class competitive inhibitor of β-catenin interactions with the T-cell factor (TCF) family of transcription factors and is currently in clinical development. By directly targeting the β-catenin:TCF protein-protein interaction, FOG-001 is intended to block the Wnt signaling pathway irrespective of the various APC and β-catenin mutations that typically drive disease.

FOG-001 combines key features that distinguish it from previously reported Wnt/β-catenin pathway modulators: FOG-001 acts inside the cell where it binds directly to the key oncogenic driver β-catenin; and FOG-001 blocks the Wnt pathway at the key downstream node, disrupting the interaction between β-catenin and the TCF transcription factors, thereby abrogating the signal transmission by which Wnt pathway mutations are believed to drive oncogenesis.

FOG-001 is currently being evaluated in a first-in-human Phase 1/2 clinical trial in patients with locally advanced or metastatic solid tumors.

About the Phase 1/2 trial of FOG-001

FOG-001 is being evaluated in a first-in-human Phase 1/2 multicenter, open-label study (NCT05919264) assessing its safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity. The trial includes dose-escalation and dose-expansion phases and is testing FOG-001 both as a monotherapy and in combination with other anticancer agents in patients with advanced or metastatic solid tumors likely or known to harbor a Wnt pathway–activating mutation (WPAM).

(Press release, Parabilis Medicines, NOV 12, 2025, View Source;cateninTCF-Interaction-for-the-Treatment-of-Desmoid-Tumors [SID1234659859])

On November 12, 2025 Bayer reported the company quarterly statement for the third quarter of 2025 (Presentation, Bayer, NOV 12, 2025, View Source [SID1234661630]).

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On November 12, 2025 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported financial results for the third quarter 2025 and business updates.

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Tabelecleucel (tab-cel or Ebvallo) for Post-Transplant Lymphoproliferative Disease (PTLD)

The U.S. Food and Drug Administration (FDA) has accepted the filing of Atara’s Biologics License Application (BLA) for tabelecleucel (tab-cel) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. There are no FDA approved therapies in this treatment setting.

The BLA has been granted Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026.

Atara expects to receive an additional $40 million milestone payment from Pierre Fabre Laboratories contingent upon FDA approval of the tab-cel BLA.

In October, Atara completed the transfer of regulatory activities, including BLA sponsorship, to Pierre Fabre Laboratories. Atara will continue to support Pierre Fabre Laboratories, at Pierre Fabre Laboratories expense, with certain regulatory activities related to the BLA. Substantially all operational activities and associated costs related to tab-cel have been transitioned to Pierre Fabre Laboratories.

Corporate Updates

Strategic Alternatives Evaluation: As previously communicated, Atara continues to actively explore and assess potential strategic alternatives with the goal of maximizing shareholder value.

Organizational Restructuring: In October 2025, Atara announced a reduction in its workforce that impacted approximately 29% of its current employees, retaining approximately 15 employees essential to executing on the Company’s strategic priorities.

Financial Update:

Third Quarter 2025 Financial Results:

Cash, cash equivalents and short-term investments as of September 30, 2025, totaled $13.7 million, as compared to $22.3 million as of June 30, 2025.
Net cash used in operating activities was $9.8 million for the third quarter 2025, as compared to $4.0 million in the same period in 2024. Net cash used in operating activities increased by $5.8 million year-over-year, primarily driven by a decrease in cash receipts from Pierre Fabre in the third quarter 2025 after the BLA acceptance milestone and a sale of tab-cel intermediates inventory were completed in the same period in 2024, this was partially offset by a decrease in operating expenses in the third quarter 2025.
Atara reported net loss of $4.3 million, or $0.32 per share for the third quarter 2025 as compared to $21.9 million or $2.93 per share for the same period in 2024.
Total revenues were $3.5 million for the third quarter 2025, as compared to $40.2 million for the same period in 2024. Total revenues decreased by $36.7 million year-over-year, primarily due to the accelerated recognition of deferred revenue and additional upfront and milestone payments received in the same period 2024 as a result of the A&R Commercialization Agreement, effective December 2023. In addition, the decrease is due to the accelerated recognition of deferred revenue in the first and second quarters 2025 following the transition of manufacturing, development and safety responsibilities to Pierre Fabre Laboratories.
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $1.3 million for the third quarter 2025, as compared to $7.6 million for the same period in 2024.
Research and development expenses were $2.9 million for the third quarter 2025, as compared to $43.9 million for the same period in 2024.
Research and development expenses include $0.3 million of non-cash stock-based compensation expenses for the third quarter 2025, as compared to $2.9 million for the same period in 2024.
General and administrative expenses were $4.0 million for the third quarter 2025, as compared to $10.4 million for the same period in 2024.
General and administrative expenses include $0.9 million of non-cash stock-based compensation expenses for the third quarter 2025, as compared to $3.5 million for the same period in 2024.
2025 Outlook and Cash Runway:

Under its commercialization agreement with Pierre Fabre Medicament, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA. In addition, Atara will be eligible to receive double-digit tiered royalties as a percentage of net sales and milestones related to commercial sales of EBVALLO.
We anticipate the full-year 2025 operating expenses will decrease by at least 60% compared to 2024, driven by the transition of substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories as well as the implementation of operational efficiencies in the first half of the year.
Atara projects that cash, cash equivalents and short-term investments as of September 30, 2025, combined with the net proceeds of the milestone payment upon tab-cel BLA approval under its commercialization agreement with Pierre Fabre Medicament, will provide significant cash runway and flexibility for the company to execute on its strategic priorities.

(Press release, Atara Biotherapeutics, NOV 12, 2025, View Source [SID1234659805])

On November 12, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported its participation in the following investor conference:

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Jefferies Global Healthcare Conference
November 19, 2025
3:30 p.m. GMT / 10:30 a.m. ET / 7:30 a.m. PT

A live audio webcast will be available in the Investors section of Kura’s website at View Source, with an archived replay available following the event.

(Press release, Kura Oncology, NOV 12, 2025, View Source [SID1234659821])