On November 6, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the third quarter ended September 30, 2025, and provided a review of recent program and corporate developments.

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"We are incredibly proud of the progress across our entire pipeline this quarter, most notably around our NDA submission for bitopertin in EPP at the end of September and subsequent receipt of the CNPV," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "Achieving this milestone is a strong testament to our team’s commitment to execution and dedication to bringing a potential new treatment option to the EPP patient community. We continue to work with the Agency on their review of our application, and we are furthering our commercial infrastructure in preparation for a potential launch."

"Beyond bitopertin, our broader pipeline is progressing well, as we expect new data from the Phase 2 trial of DISC-0974 in MF anemia by the end of the year and data from studies of DISC-3405 in PV and SCD next year. With a strong balance sheet providing cash runway into 2029, we are well-positioned to prepare for the anticipated launch of bitopertin and ultimately advancing towards our goal of delivering new treatment options to patients suffering from hematological diseases."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

Submitted NDA for bitopertin in EPP seeking priority review and accelerated approval with reduction in protoporphyrin IX (PPIX) as the surrogate endpoint for approval supported by clinical results from BEACON and AURORA Phase 2 trials
Received the CNPV, which is designed to shorten the NDA review process to 1-2 months from NDA acceptance
Accelerating activities to support a potential US approval and launch in late 2025 or early 2026
Progressing confirmatory Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Initial data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) to be presented at ASH (Free ASH Whitepaper) Annual Meeting in December, with topline data expected in 2026
Data from recently completed multiple-dose cohorts of Phase 1b study of DISC-0974 in patients with anemia of NDD-CKD to be presented at ASN Kidney Week
DISC-0974 was generally well-tolerated with substantial decreases in hepcidin, increases in iron, and improvements in markers of erythropoiesis
Meaningful hemoglobin increases observed in only a subset of patients were in part driven by those with higher baseline erythropoietin (EPO) levels
Disc is assessing options for the program based on full analysis of the data
Phase 2 study in patients with inflammatory bowel disease (IBD) and anemia anticipated to begin in Q1 2026
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Progressing ongoing Phase 2 study of DISC-3405 in patients with PV with initial data expected in 2026
Initiated Phase 1b study of DISC-3405 in patients with SCD in October 2025 with initial data expected in 2026
Third Quarter 2025 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $615.9 million as of September 30, 2025. In October 2025, Disc completed a public offering with net proceeds of approximately $211 million, extending cash runway into 2029.
Research and Development Expenses: R&D expenses were $50.3 million for the three months ended September 30, 2025, as compared to $24.7 million for the three months ended September 30, 2024. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 program, and increased headcount, as well as a payment of a $10.0 million milestone upon first administration to a patient in the Phase 2 trial of DISC-3405.
Selling, General and Administrative Expenses: SG&A expenses were $17.4 million for the three months ended September 30, 2025, as compared to $8.2 million for the three months ended September 30, 2024. The increase in SG&A expenses was primarily due to increased headcount including establishing infrastructure to support potential commercialization.
Net Loss: Net loss was $62.3 million for the three months ended September 30, 2025, as compared to $26.6 million for the three months ended September 30, 2024. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

(Press release, Disc Medicine, NOV 6, 2025, View Source [SID1234659567])

On November 6, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported third quarter 2025 financial results and provided a business update.

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"CytomX continued to execute against its pipeline priorities this quarter, highlighted by robust Phase 1 expansion enrollment for CX-2051. We remain on track for a CX-2051 Phase 1 data update in Q1 2026. Looking ahead to 2026, CX-2051 is well positioned as a first-in-class EpCAM-directed, topoisomerase-1 ADC designed to address the high unmet need in CRC and a wide range of other EpCAM-expressing indications. CytomX’s top priority is to advance CX-2051 towards a potential registrational study in advanced, late-line CRC. Additionally, we continue to plan for focused investments to further unlock the potential of CX-2051, including moving into earlier lines of CRC therapy and additional EpCAM positive cancers," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

Dr. McCarthy continued "We are also pleased with the dose escalation progress for our PROBODY interferon alpha-2b, CX-801, and look forward to presenting encouraging initial biomarker data at SITC (Free SITC Whitepaper) which underscore this potent masked cytokine’s therapeutic potential in combination with checkpoint inhibitors in advanced melanoma."

Q3 2025 Pipeline Program Updates:

CX-2051 (EpCAM PROBODY Topo-1 ADC)

CX-2051 Phase 1 dose expansions across the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W) are ongoing.
In Q3 2025, dose expansion enrollment continued with the goal of supporting a potential registrational study of CX-2051 monotherapy in advanced CRC.
Phase 1 study enrollment is projected to reach approximately 100 patients by the planned CX-2051 Phase 1 update in Q1 2026.
A Phase 1b CX-2051 combination study with bevacizumab in CRC is expected to start in Q1 2026, data from which is intended to inform potential late-phase development in earlier lines of CRC therapy.
Evaluation ongoing of multiple non-CRC, EpCAM-expressing tumor indications for potential future CX-2051 development.
CX-801 (PROBODY Interferon alpha-2b)

Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting
CX-801 monotherapy biomarker data in advanced melanoma patients to be presented that support CX-801’s mechanism of action and the ongoing combination study with KEYTRUDA (pembrolizumab).
CX-801 monotherapy has been well tolerated at doses exceeding the approved dose of unmasked IFNα2b.1
Gene expression analysis of pre- and post-treatment patient tumor biopsies demonstrated consistently increased expression of interferon-stimulated genes.
Patients demonstrated evidence of T-cell and NK cell activation and upregulation of immune checkpoint genes, including PD-1 and PD-L1.
Evidence of sustained elevation of CXCL10 in the tumor but not the blood was observed, suggesting preferential CX-801 activity in the tumor versus the periphery.
PK analysis also demonstrated dose-proportional exposure of CX-801, which remained predominantly in its intact (masked) form in circulation.
The CX-801 Phase 1 study is ongoing with a focus in advanced melanoma. CX-801 monotherapy dose escalation has reached the fourth dose level.
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Dose escalation of CX-801 in combination with KEYTRUDA is currently enrolling the 2nd dose level.
Initial clinical data for CX-801 in the combination with KEYTRUDA in advanced melanoma is anticipated in 2026.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Corporate and Financial:

Corporate:
In October 2025, announced the appointment of Rachael Lester, MBA as Senior Vice President, Chief Business Officer.
Financial:
CytomX ended the third quarter of 2025 with $143.6 million of cash, cash equivalents and investments with expected cash runway to the second quarter of 2027.
Research Pipeline and Collaborations:
CytomX has research collaborations with Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna. Multiple drug discovery programs continue across our research collaborations with a focus on bispecific immunotherapies, including T-cell engagers.
At SITC (Free SITC Whitepaper) 2025, preclinical data will be presented for CX-908, a dually masked PROBODY T-cell Engager targeting CDH3 and CD3. CX-908 potently induced tumor regressions in established breast and lung cancer xenograft tumor models and demonstrated a 100-fold improvement in tolerability, including significantly reduced cytokine release vs. an unmasked CDH3xCD3 molecule.

Third Quarter 2025 Financial Results:

Cash, cash equivalents and investments totaled $143.6 million as of September 30, 2025, compared to $158.1 million as of June 30, 2025.

Total revenue was $6.0 million for the quarter ended September 30, 2025, compared to $33.4 million for the quarter ended September 30, 2024. The decrease in revenue was driven primarily by the completion of our performance obligations in the Bristol Myers Squibb collaboration and a decrease in Moderna activities due to Moderna budget considerations.

Total operating expense in the third quarter of 2025 was $21.7 million compared to $29.3 million in the third quarter of 2024, a decrease of $7.6 million.

Research and development expenses were $15.3 million for the three months ended September 30, 2025, a decrease of $6.1 million compared to the corresponding period of 2024. Reduced research and development expenses were primarily due to a reduction in CX-904 spend due to program de-prioritization in Q1 2025, reduced research expenses following the Q1 2025 restructuring, and lower CX-2051 manufacturing expenses which was partially offset by the increase in CX-2051 clinical spend.

General and administrative expenses were $6.4 million for the three months ended September 30, 2025, a decrease of $1.5 million compared to the corresponding period of 2024. The decrease in general and administrative expenses was primarily driven by personnel costs as well as patent and legal expenses.

(Press release, CytomX Therapeutics, NOV 6, 2025, View Source [SID1234659566])

On November 6, 2025 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported its financial and operating results for the third quarter ended September 30, 2025.

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"We made good progress advancing our clinical studies in PCNSL, CLL, and AML this quarter. We continue to enroll PCNSL patients in the TakeAim Lymphoma study in both the BTKi-experienced and BTKi-naïve cohorts to enable accelerated approval filings in the US and EU. We are presenting three posters at the SNO annual meeting later this month, two in PCNSL and one in SCNSL. We are presenting at the ASH (Free ASH Whitepaper) annual meeting in December with initial data from the ongoing frontline AML triplet study evaluating different dosing regimens of emavusertib, venetoclax, and azacitidine. And, finally, we have filed the protocol with the FDA for our Phase 2 study of emavusertib + BTKi in CLL, we are working to activate clinical sites, and we expect to enroll our first patient in late Q4 or early Q1, with data expected at the ASH (Free ASH Whitepaper) annual meeting in December 2026. I am very pleased with the progress we have made across multiple ongoing studies in PCNSL, CLL, and AML," said James Dentzer, President and Chief Executive Officer.

Operational Highlights

NHL/CLL

Curis will report clinical data in Primary CNS Lymphoma (PCNSL) and Secondary CNS Lymphoma (SCNSL) in three presentations at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) on November 19-23:

PCNSL

Rapid Oral Presentation + Poster
Dr. Christian Grommes, Memorial Sloan Kettering Cancer Center, NY, NY
Analysis of Genetic Mutation Profile and CNS Pharmacokinetics in Relapsed/Refractory Primary CNS Lymphoma Patients Responding to Novel Emavusertib (IRAK4i) and BTKi Combination

PCNSL

Poster Presentation
Dr. Lakshmi Nayak, Dana-Farber Cancer Institute, Boston, MA
Preliminary Safety and Efficacy of Emavusertib (CA-4948) in Combination with Ibrutinib in Relapsed/Refractory Primary Central Nervous System Lymphoma Patients

SCNSL

Poster Presentation
Dr. Cecilia A. Merrigan, Mayo Clinic, Rochester, MN
Promising Efficacy Signal in Secondary CNS Lymphoma Patients Treated with Emavusertib and Ibrutinib
Curis continued to enroll relapsed/refractory (R/R) PCSNL patients in the Company’s TakeAim Lymphoma study which, as a result of discussions with the EMA and FDA, is intended to support filings for accelerated approval in PCNSL in the US and Europe. Emavusertib has been granted orphan drug designation by both the FDA and EMA in PCNSL.

Curis is initiating a Phase 2 clinical study of emavusertib in combination with a BTKi in patients with Chronic Lymphocytic Leukemia (CLL), with dosing of the first patient expected in late Q4 or early Q1. The goal of combining emavusertib with a BTKi is to improve upon the current standard of care (BTKi) with its limitations of partial responses and the need for chronic, life-long therapy. The combination of emavusertib with a BTKi has the potential to enable patients to achieve complete remission or undetectable minimal residual disease (uMRD) and the potential for time-limited treatment, which would be a paradigm shift in the management of CLL.
Leukemia

Curis will be presenting initial clinical data from the ongoing frontline AML triplet study in a poster presentation at the 67th ASH (Free ASH Whitepaper) Annual Meeting in December:

AML

Poster Presentation
Dr. Christina Papayannidi,
IRCCS Azienda Ospedaliero Universitaria di Bologna
Preliminary pharmacokinetic and MRD results from AML patients treated with 7- and 14-day dosing schedule of emavusertib added to combination therapy with azacitidine and venetoclax
The AML triplet study is evaluating the addition of emavusertib to the combination of azacitidine and venetoclax (aza-ven) in AML patients who have achieved complete remission on aza-ven but remain MRD positive (MRD+). The first two cohorts in the study evaluate patients who received emavusertib for 7 or 14 days in a 28-day cycle, in addition to their azacitidine and venetoclax treatment. The abstract, published on November 3, 2025, showed data with a July 2, 2025 data cut-off for 4 patients in the 7-day cohort and 6 patients in the 14-day cohort:

MRD conversion (positive to undetectable) was observed in 4 of 8 patients (50%)
1 additional patient achieved a 40% reduction in MRD from baseline as of data cut-off
No patients who remained MRD+ progressed on study.
Two dose-limiting toxicities (CPK increase and neutropenia) were observed in the 14-day cohort and both resolved
Solid Tumors

Curis will be presenting initial clinical data from a Phase 1 Investigator Sponsored Study (IST) evaluating emavusertib in combination with gemcitabine and nab-paclitaxel in metastatic or unresectable pancreatic ductal adenocarcinoma at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium on January 8-10, 2026:

PDAC

Poster Presentation
Dr. Patrick Grierson,
Siteman Cancer Center, Washington University in St Louis
A phase I trial of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in metastatic or unresectable pancreatic ductal adenocarcinoma (PDAC)
Corporate

Completed a registered direct offering and concurrent private placement extending cash runway into 2026.
Upcoming Presentations and Conferences

Updated PCNSL and SCNSL data will be reported in poster presentations at the 30th Annual Meeting of the Society for Neuro-Oncology on November 19-23, 2026

Initial clinical data in the frontline AML triplet study of emavusertib with azacitidine and venetoclax will be reported in a poster presentation at the 67th ASH (Free ASH Whitepaper) Annual Meeting on December 6-9, 2025

Initial clinical data from an Investigator Sponsored Study (IST) in pancreatic ductal adenocarcinoma (PDAC) will be reported at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium on January 8-10, 2026
Third Quarter 2025 Financial Results

For the third quarter of 2025, Curis reported a net loss of $7.7 million or $0.49 per share on both a basic and diluted basis as compared to $10.1 million or $1.70 per share on both a basic and diluted basis, for the same period in 2024. Curis reported a net loss of $26.9 million or $2.19 per share on both a basic and diluted basis, for the nine months ended September 30, 2025, as compared to a net loss of $33.8 million or $5.77 per share on both a basic and diluted basis for the same period in 2024.

Revenues were $3.2 million for third quarter of 2025, as compared to $2.9 million for the same period in 2024. Revenues were $8.3 million for the nine months ended September 30, 2025, as compared to $7.6 million for the same period in 2024. Revenues consist of royalty revenues from Genentech/Roche’s sales of Erivedge.

Research and development expenses were $6.4 million for the third quarter of 2025, as compared to $9.7 million for the same period in 2024. The decrease was primarily attributable to lower clinical, employee related, manufacturing, research, and consulting costs. Research and development expenses were $22.4 million for the nine months ended September 30, 2025, as compared to $29.6 million for the same period in 2024.

General and administrative expenses were $3.7 million for the third quarter of 2025, as compared to $3.8 million for the same period in 2024. The decrease was primarily attributable to lower employee related costs. General and administrative expenses were $11.2 million for the nine months ended September 30, 2025, as compared to $13.4 million for the same period in 2024.

Other expense was $0.8 million for the third quarter of 2025, as compared to other income of $0.5 million for the same period in 2024. The decrease was primarily attributable to an increase in the expense related to the sale of future royalties and a decrease in interest income. Other expense was $1.6 million for the nine months ended September 30, 2025, as compared to other income of $1.8 million for the same period in 2024.

Curis’s cash and cash equivalents totaled $9.1 million as of September 30, 2025, and the Company had approximately 12.7 million shares of common stock outstanding. We believe that our existing cash and cash equivalents, should enable us to fund our existing operations into the first quarter of 2026.

Conference Call and Webcast Information

Curis management will host a conference call today, November 6, 2025, at 4:30 p.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-800-836-8184 from the United States or 1-646-357-8785 from other locations. To access the webcast login here shortly before 4:30 p.m. ET. The webcast can also be accessed on the Curis website at the Events and Presentations section of the Investors page.

(Press release, Curis, NOV 6, 2025, View Source [SID1234659565])

On November 6, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company accelerating potential high-impact therapies in autoimmune diseases and cancer, reported an update on recent and anticipated business highlights and announced its financial results for the third quarter ended September 30, 2025.

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"Cullinan is strategically focusing resources and development efforts on select, high-conviction clinical stage programs. We are well-positioned to further concentrate resources on CLN-978, a CD19xCD3 bispecific T cell engager, and we plan to share initial clinical data in autoimmune diseases in the first half of 2026. We are also particularly encouraged by the emerging efficacy profile of CLN-049, our FLT3xCD3 bispecific T cell engager, and we look forward to unveiling important clinical data in an oral presentation at the upcoming 2025 ASH (Free ASH Whitepaper) Annual Meeting in December. We believe the differentiated mechanism of CLN-049 supports its potential to address a broad population of AML patients regardless of mutational status, including those with poor prognostic features," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics.

"Additionally, following a positive pre-NDA meeting with the FDA in October, our partner Taiho plans to initiate a rolling submission of an NDA for zipalertinib in relapsed EGFR ex20ins NSCLC by year-end and expects to complete enrollment of the frontline study REZILIENT3 in the first half of 2026. Finally, after reviewing emerging clinical data, we have decided not to pursue further development of CLN-619 and CLN-617. Notably, our core pipeline is now focused on T cell engagers applied to well-validated targets with transformative potential in immunology and oncology. This focused pipeline extends our cash runway into 2029 and provides us ample financial resources to deliver meaningful value-driving catalysts across our programs in 2026 and beyond."

Portfolio Highlights

Immunology

•
CLN-978 (CD19xCD3 bispecific T cell engager): Systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren’s disease (SjD).
o
The Phase 1 OUTRACE Program is enrolling and treating patients across the OUTRACE SLE, OUTRACE RA and OUTRACE SjD Studies. The Company plans to share initial safety and B cell depletion data in SLE and RA in the first half of 2026.
o
The Company was issued a key composition of matter patent by the United States Patent and Trademark Office, which is expected to extend patent protection until at least 2042, excluding possible patent term extension.
•
Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
o
Genrix Bio, from whom Cullinan licensed velinotamig in June 2025, plans to initiate a Phase 1 study in China in patients with autoimmune diseases by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
Oncology

•
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
Following a positive Type B pre-NDA meeting with the U.S. Food and Drug Administration in October, Taiho plans to initiate a rolling submission of an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026.
o
The Company shared updated efficacy and safety data demonstrating responses in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC.
o
Taiho shared initial data from the REZILIENT2 cohort demonstrating the clinical activity of zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC.
o
Taiho also shared initial data from the REZILIENT2 cohort demonstrating intracranial responses with zipalertinib in patients with active brain metastases at the ESMO (Free ESMO Whitepaper) Congress 2025.

•
CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
o
Enrollment continues in the Phase 1 study in patients with relapsed/refractory AML or MDS. The Company recently shared clinical data in a published ASH (Free ASH Whitepaper) abstract and updated results will be shared in an oral presentation at the 2025 ASH (Free ASH Whitepaper) Annual Meeting on December 8, 2025. CLN-049 demonstrated promising anti-leukemic activity, including a ~30% CRc rate at clinically active target doses, in a heavily pretreated population of patients, regardless of FLT3 mutational status.
o
Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.
Third Quarter 2025 Financial Results

•
Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $475.5 million as of September 30, 2025. Cullinan expects its cash resources to provide runway into 2029 under its new operating plan.
•
R&D Expenses: Research and development expenses were $42.0 million for the third quarter of 2025, compared to $35.5 million for the same period in 2024.
•
G&A Expenses: General and administrative expenses were $13.6 million for the third quarter of 2025, compared to $13.3 million for the same period in 2024.
•
Net Loss: Net loss attributable to Cullinan was $50.6 million for the third quarter of 2025, compared to $40.6 million for the same period in 2024.

(Press release, Cullinan Oncology, NOV 6, 2025, View Source [SID1234659564])

On November 6, 2025 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, and ImmunoScape, Pte. Ltd, a biotechnology company developing next-generation T cell receptor (TCR)-based therapies in oncology, reported that they have entered into a collaboration and license agreement to advance a novel in vivo approach to cell therapy for the treatment of solid tumors. Under the agreement, ImmunoScape will develop a novel Seed-and-Boost immunotherapy that combines Cue Biopharma’s clinically-validated Immuno-STAT T-cell engagers, the CUE-100 series, with ImmunoScape’s proprietary TCRs. The combination therapy is designed to overcome core limitations of existing cell therapies with the potential for establishing a breakthrough standard of care with superior anti-tumor activity, durable T cell persistence and product scalability.

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With this Seed-and-Boost approach to immunotherapy, a minimal starting dose of ImmunoScape’s tumor-specific TCR-Ts are administered to the patient (Seed) followed by the administration of Cue Biopharma’s TCR matched IL-2 Immuno-STAT molecules (Boost). TCR-selective engagement is designed to enable targeted expansion and activation in the patient while avoiding systemic immune activation and the off-the-shelf Immuno-STAT dosing to allow for precise in vivo modulation of the tumor-specific T cell response to enhance efficacy, persistence and tumor infiltration while mitigating T cell exhaustion. By requiring only small starting numbers of engineered T cells, this strategy simplifies manufacturing and aims to deliver deeper and durable clinical efficacy for patients along with improved tolerability and quality of life. This promising breakthrough approach is supported by a comprehensive preclinical data package from both companies.

The CUE-100 series is a novel class of injectable biologics that leverage the specificity of a TCR, enabling selective engagement and activation of targeted disease-specific T cells. The core protein framework of the Immuno-STAT molecules facilitates engagement with the TCR, fostering TCR signaling while concurrently delivering Interleukin-2 (IL-2) as the key second costimulatory molecule for selective T cell activation and expansion. The Phase 1 clinical datasets generated from the CUE-100 series programs have demonstrated clinical activity in several metastatic cancers without the significant toxicities that are often caused by traditional immune-activating IL-2 delivery.

ImmunoScape has developed an extensive library of highly potent TCRs against a diverse panel of shared tumor-specific targets binding to the world’s most prevalent HLA alleles. By utilizing these proprietary TCRs in combination with the CUE-100 series, it is anticipated that the potential of cell therapy to provide durable and effective anti-tumor effects in solid tumors may become a reality with this Seed-and-Boost approach.

"We believe this strategic collaboration with ImmunoScape represents a significant development for treating solid tumors with immunotherapy and creating potential value for our shareholders," said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. "It positions the Company to focus on our autoimmune disease programs and continue to advance the Immuno-STAT platform for oncology with our partners at ImmunoScape."

"ImmunoScape is excited to partner with Cue Biopharma to pioneer this novel immunotherapy against solid tumors and potentially provide patients with a promising treatment option," said Michael Fehlings, chief executive officer of ImmunoScape. "Based on our extensive preclinical work, we believe this Seed- and-Boost approach will transform T cell therapy for long-term efficacy against a range of solid tumors while avoiding the deleterious side effects of broad immune activation. We aim to transform patients’ lives by enabling superior cell therapy and streamlining the patient journey."

Pursuant to the terms of the collaboration, Cue Biopharma is entitled to receive an upfront total payment of $15 million, $10 million in Q4 2025 and $5 million in November of 2026, as well as a 40% equity stake in ImmunoScape. In addition, Cue Biopharma is also eligible for high-single-digit royalty payments on net sales. For further details regarding the terms of the collaboration and license agreement, please refer to the Current Report on Form 8-K filed today by Cue Biopharma.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-major histocompatibility complex (pMHC) molecules along with rationally engineered interleukin 2 (IL-2) molecules. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

(Press release, Cue Biopharma, NOV 6, 2025, View Source [SID1234659563])