On November 12, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported financial results for the third quarter ended September 30, 2025, and provided a business update. The Company reported continued clinical progress across both its WEE1 and ATR inhibitor programs and has cash runway into the fourth quarter of 2026.

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"We are pleased with the continued progress in our development programs, as the emerging data on both of our clinical assets demonstrate evidence of activity," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "For APR-1051, our WEE1 kinase inhibitor, we’re encouraged by early signs of anti-tumor activity to date in the ongoing ACESOT-1051 trial, including 3 out of 4 patients with stable disease in the 100 mg once daily cohort. We have recently advanced into the 150 mg once daily cohort as dose escalation in this trial continues. For ATR-119, identifying the recommended Phase 2 dose for the once daily (QD) dosing provides a solid foundation for next-stage development, and we are now considering potential combination strategies, with radiation or checkpoint inhibitors, that could expand its clinical impact. These developments reinforce Aprea’s differentiated DDR approach and our commitment to helping patients with value creating clinical catalysts anticipated in 2026."

Key Business Updates and Potential Upcoming Key Milestones

ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051

APR-1051 is a potent and selective small molecule WEE1 inhibitor designed to potentially solve tolerability challenges of the WEE1 class and has the potential to achieve improved clinical activity than other programs currently in development. APR-1051 is being advanced as a monotherapy in biomarker-defined cancers likely to respond to WEE1 inhibition. Among these, cancers over-expressing Cyclin E represent a high unmet medical need. Patients with Cyclin E over-expression have poor prognosis and, currently, lack effective therapies options.
APR-1051 is currently evaluated in the ongoing Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051). Results from Dose Level 6 (100 mg once daily), show that 3 out of 4 patients achieved stable disease, per RECIST v1.1 in heavily pretreated gastrointestinal and gynecologic malignancies. Disease stabilization was observed in patients with FBXW7, CCNE1, and KRASG12V + TP53 alterations, molecular profiles known to drive replication stress and WEE1 dependency.
Following successful clearance of the 100 mg cohort, dose escalation has progressed to Dose Level 7 (150 mg once daily) with the goal of identifying doses that maximize therapeutic benefit while maintaining an acceptable safety profile. APR-1051 was manageable with mostly Grade 1 or 2 adverse events, which were mainly gastrointestinal events and fatigue.
A poster titled Early safety and efficacy of APR-1051, a novel WEE1 inhibitor, in patients with cancer-associated gene alterations: Updated data from ACESOT-1051 Phase 1 trial was presented on October 24, 2025at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). This poster summarizes preliminary results from the trial with a cutoff date of September 17, 2025. A copy is available on the Aprea corporate website here.
Pending additional data, future studies of ACESOT-1051 may evaluate APR-1051 in combination with checkpoint inhibitors to address unmet medical needs across distinct patient populations.
For more information, refer to ClinicalTrials.gov NCT06260514.
ABOYA-119: Ongoing Clinical Trial Evaluating ATR inhibitor, ATRN-119

ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed and developed to be used in patients with tumors harboring mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. These patients often have a poor prognosis and currently lack effective therapeutics options.
ATRN-119 is being evaluated in the open-label Phase 1/2a clinical trial (ABOYA-119) as monotherapy in patients with advanced solid tumors having at least one mutation in a defined panel of DDR-related genes. As of September 8, 2025, 43 patients with advanced solid tumors have been enrolled.
Based on results to date, Aprea has determined the recommended Phase 2 dose (RP2D) to be 1,100 mg for the once daily dosing for ATRN-119.
Following RP2D determination Aprea is strategically pausing further enrollment in both once daily and twice daily monotherapy dosing arms of the ABOYA-119 trial to consider combination studies aimed at maximizing therapeutic benefits. Aprea is currently in discussions with leading academic centers to explore combining ATRN-119 with radiation in patients with HPV+ head and neck cancer, an indication where synergistic anti-tumor effects have been observed in preclinical data. Additional investigator-led studies evaluating ATRN-119 in combination with I/O agents and antibody-drug conjugates are also being explored.
A poster titled Updated data from ABOYA-119: A phase 1/2a trial of ATRN-119, a novel macrocyclic ATR inhibitor, in patients with advanced solid tumors harboring DNA damage trial was presented on October 24, 2025 at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). This poster summarizes preliminary results from the trial with a cutoff date of September 8, 2025. A copy can be found here.
For more information on ABOYA-119, please refer to clinicaltrials.gov NCT04905914.
Select Financial Results for the Third quarter Ended September 30, 2025

As of September 30, 2025, the Company reported cash and cash equivalents of $13.7 million compared to $22.8 million as of December 31, 2024. The Company believes its cash and cash equivalents as of September 30, 2025, will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the fourth quarter of 2026.
For the third quarter ended September 30, 2025, the Company reported an operating loss of $3.1 million, compared to an operating loss of $4.1 million in the third quarter of 2024.
Research and Development (R&D) expenses were $1.6 million for the quarter ended September 30, 2025, compared to $2.8 million for the third quarter of 2024. The decrease in R&D expenses was primarily related to higher expenses in 2024 related to study start up activities in preparation for enrollment of the first patient into ACESOT-105, our Phase 1 dose-escalation study of APR-1051, and lower expenses in 2025 related to the ABOYA-119 clinical trial to evaluate ATRN-119, our clinical-stage oral small molecule inhibitor of ATR.
General and Administrative (G&A) expenses were $1.5 million for the quarter ended September 30, 2025, compared to $1.6 million for the third quarter of 2024. The decrease in G&A expenses was primarily related to a decrease in insurance costs.
The Company reported a net loss of $3.0 million ($0.47 per basic share) on approximately 6.4 million weighted average common shares outstanding for the quarter ended September 30, 2025, compared to a net loss of $3.8 million ($0.64 per basic share) on approximately 5.9 million weighted average common shares outstanding for the comparable period in 2024.

(Press release, Aprea, NOV 12, 2025, View Source [SID1234659804])

On November 12, 2025 Immuneering Corporation (Nasdaq: IMRX) a clinical-stage oncology company focused on keeping cancer patients alive and helping them thrive, reported financial results for the third quarter ended September 30, 2025, and provided business and clinical updates.

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"The third quarter was truly transformational for Immuneering. We announced extraordinary overall survival data from our ongoing Phase 2a trial of atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer and raised $225 million of cumulative financing on the strength of the data. I’m excited to say that the company is now funded into 2029 and, importantly, through the topline readout of our planned pivotal Phase 3 program in pancreatic cancer," said Ben Zeskind, Ph.D., CEO of Immuneering. "Today, we are also thrilled to share two remarkable examples of patients treated with atebimetinib in combination with FOLFIRINOX, one with a complete response, and another who had responded so well that they were able to pursue radiation and surgery with curative intent. Importantly, these patients are not among the ones we discussed in September. Looking ahead, we are excited to share updated survival data from our study of atebimetinib + mGnP in first-line pancreatic cancer patients in the first half of next year, and to begin dosing patients in our Phase 3 study of atebimetinib + mGnP by mid-next year. In summary, I have never been more excited about our company’s future, and our potential to help cancer patients live longer and feel better."

Corporate Highlights

Reported Extraordinary 86% Overall Survival at 9 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP: In September, the Company announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients (N=34), with 9 months median follow up. Immuneering reported an extraordinary 86% overall survival (OS) observed at 9 months. Atebimetinib (320mg dosed once-daily) + mGnP was reported to demonstrate a favorable tolerability profile, with only two categories of adverse events observed at the Grade 3 level in more than 10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy).

Closed $175 Million Underwritten Public Offering and Concurrent $25 Million Private Placement to Sanofi: In September, the Company closed an underwritten public offering of 18,959,914 shares of its Class A common stock at an offering price of $9.23 per share. The gross proceeds from the public offering were approximately $175 million, before deducting underwriting discounts and commissions and offering expenses payable by Immuneering. The Company also announced that Sanofi purchased 2,708,559 shares of Immuneering’s Class A common stock at a purchase price of $9.23 per share, for gross proceeds of approximately $25 million before deducting placement agent discounts and commissions and placement expenses payable by Immuneering, in a separate private placement transaction that closed concurrently with the public offering.

Closed $25 Million Private Placement: In August, the Company announced that it had entered into a definitive securities purchase agreement for a private placement of securities to top-tier institutional and other accredited investors that resulted in up front gross proceeds to the Company of approximately $25 million, before deducting fees and expenses.

Announced Clinical Supply Agreement with Lilly to Evaluate Atebimetinib in Combination with Olomorasib: In August, the Company announced a clinical supply agreement with Eli Lilly and Company for its second-generation KRAS G12C inhibitor, olomorasib. The supply agreement intends to support the evaluation of Immuneering’s lead product candidate, atebimetinib, in combination with olomorasib in a planned Phase 2a clinical trial in patients with locally advanced or metastatic KRAS G12c-mutant non-small cell lung cancer (NSCLC) who have progressed on prior therapy. In February 2025, Immuneering announced a clinical trial agreement with Regeneron Pharmaceuticals similarly intended to evaluate atebimetinib in combination with the anti-PD-1 therapy Libtayo in a planned clinical trial in patients with advanced non-small cell lung cancer.

Granted U.S. Composition of Matter Patent for Atebimetinib: In July, the Company announced the United States Patent and Trademark Office (USPTO) granted the Company a composition of matter patent for atebimetinib. U.S. Patent No. 12,351,566, titled: "MEK Inhibitors and Therapeutic Uses Thereof", that includes claims to atebimetinib’s composition of matter. The patent’s term, which includes a patent term adjustment, is currently expected to expire in August 2042. The patent may also be eligible for patent term extension to recover a portion of the time required to fulfill regulatory approval requirements.

New Case Study of a Patient with Complete Response: A 71-year-old female patient with metastatic pancreatic cancer is being treated with atebimetinib in combination with FOLFIRINOX in the first-line setting in an ongoing Phase 2a study. The patient has been on treatment for approximately five months. During that time the patient’s target lesion, located in the liver, reduced steadily over the course of three scans to the point of being undetectable, for an unconfirmed complete response. The patient remains on treatment to date, feels extremely well, and has experienced improved quality of life and stable weight.

The investigator commented "It is very unusual to see a complete response with chemotherapy alone in a non-BRCA-mutated adenocarcinoma patient like this one. I believe atebimetinib has made a real difference here."

New Case Study of a Patient with Excellent Response Warranting Treatment with Curative Intent:
Dr. Gregory Botta, a medical oncologist who specializes in treating solid tumor cancers of the gastrointestinal system at the University of California San Diego (UCSD), described a 61-year-old female patient with metastatic pancreatic cancer treated with atebimetinib in combination with FOLFIRINOX in the first-line setting in an ongoing Phase 2a study. The treatment resulted in greater than 56% reduction in the primary tumor after 7 months to the point that treatment with radiation and surgery with curative intent was possible. The patient remains on atebimetinib adjuvant therapy and continues to do well with great quality of life and stable weight approximately 14 months after starting treatment. Dr. Botta commented "Rarely do metastatic pancreatic cancer patients improve to the point that surgery with curative intent is a possibility. I believe atebimetinib helped us convert this patient to a surgical candidate with curative intent – an outcome that I have rarely seen with chemotherapy alone – and today the patient has no radiological evidence of new disease."
"These case studies add to the growing body of evidence suggesting atebimetinib’s ability to produce transformative outcomes for cancer patients, including those with metastatic pancreatic cancer, and lend further robustness to the data we announced in September from a separate group of patients treated with atebimetinib in combination with mGnP chemotherapy," said Dr. Igor Matushansky, Chief Medical Officer of Immuneering.

Near-Term Milestone Expectations

Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including to:

Q4 2025: Receive feedback from regulatory agencies and continue preparations to begin dosing patients in the pivotal trial of atebimetinib + mGnP
Q2 2026: Report updated circulating tumor DNA data on acquired alterations at a major scientific meeting
1H 2026: Report updated survival data from first-line pancreatic cancer patients treated with atebimetinib + mGnP, potentially at a major medical meeting
Mid-2026: Dose first patient in pivotal Phase 3 trial of atebimetinib in combination with mGnP in first-line pancreatic cancer
2H 2026: Dose first patient in trial of atebimetinib in combination with Libtayo in non-small cell lung cancer
Third Quarter 2025 Financial Highlights

Cash Position: Cash, and cash equivalents as of September 30, 2025 were $227.6 million, compared with $36.1 million as of December 31, 2024.

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $10.9 million, compared with $11.3 million for the third quarter of 2024. The decrease in R&D expenses was primarily attributable to decreases in clinical spend related to the IMM-6-415 program and decreases in personnel costs to support ongoing research and development activities, partially offset by higher clinical costs related to the Company’s lead atebimetinib program and spend related to other preclinical programs.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2025 were $4.5 million, compared with $4.0 million for the third quarter of 2024. The increase in G&A expenses was primarily attributable to increased public filing costs associated with the Company’s various financing efforts.

Net Loss: Net loss attributable to common stockholders was $15.0 million, or $0.38 per share, for the third quarter ended September 30, 2025, compared to $14.6 million, or $0.49 per share, for the third quarter ended September 30, 2024.

Financial Guidance

Based on cash, and cash equivalents as of September 30, 2025, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into 2029.

Conference Call

Immuneering will host a conference call and live webcast today, November 12, 2025 at 4:30 pm ET. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 in the U.S. or (646) 307-1963 for other locations and reference conference ID 7742025, or from the webcast link in the investors section of the company’s website: View Source A webcast replay will be available in the investor relations section on the company’s website for 90 days following completion of the call.

(Press release, Immuneering, NOV 12, 2025, View Source [SID1234659820])

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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