On November 14, 2025 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, reported financial results for the third quarter of 2025 and recent business highlights.

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"We remain keenly focused on our mission to develop novel, immune-modulatory, off-the-shelf cancer therapies for the treatment of multiple types of tumors including melanoma, lung, and head and neck cancer," said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. "Although the IOB-013 study narrowly missed statistical significance on the primary PFS endpoint, the results of the study support the mechanism of action of our therapeutic cancer vaccines and, we believe, have significantly de-risked the program. We look forward to discussing the next Phase 3 study design for Cylembio with the FDA in December and remain committed to bringing Cylembio to cancer patients seeking alternative treatment options as quickly as possible."

Recent Business Highlights

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The company presented topline results of its Phase 3 pivotal trial (IOB-013/KN-D18) evaluating the company’s lead investigational vaccine, Cylembio (imsapepimut and etimupepimut, adjuvanted), in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of advanced melanoma in an oral presentation at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress. The trial evaluated Cylembio in combination with pembrolizumab vs. pembrolizumab alone as a first-line treatment in 407 patients with unresectable or metastatic (advanced) melanoma. In the study, Cylembio plus pembrolizumab demonstrated a clinically relevant improvement in progression free survival (PFS) compared to pembrolizumab alone, which was also observed in virtually all subgroups, but the trial narrowly missed statistical significance.

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The company has a meeting with the United States (US) Food and Drug Administration (FDA) scheduled in December to align on the design of a potential new Phase 3 registrational trial for the treatment of advanced melanoma.

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The company also presented a poster at ESMO (Free ESMO Whitepaper) of final data from the Phase 2 basket trial (IOB-022/KN-D38) of IO102-IO103 plus pembrolizumab for 1L treatment of advanced non-small cell lung cancer (NSCLC) and recurrent/metastatic squamous cell carcinoma of head and neck (SCCHN) highlighting encouraging landmark PFS and overall survival (OS) rates.

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The company presented two posters at the SITC (Free SITC Whitepaper) annual meeting with pre-clinical data for two additional T-win vaccine candidates. Data presented in a poster for its next therapeutic vaccine candidate expected to enter clinical development, IO112 targeting arginase 1, demonstrated anti-tumor activity with dynamic changes in the tumor microenvironment (TME) driven by the vaccine-targeted modulation of immunosuppressive myeloid cells, including tumor-associated macrophages (TAMs). Data presented in the poster for an additional candidate, IO170 targeting Transforming Growth Factor (TGF)-ß, demonstrated induction of immune responses that could inhibit tumor growth and reduce lung metastasis.

Investor Conferences Participation

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Jefferies Global Healthcare Conference in London: Mai-Britt Zocca, PhD, President and CEO, will give a company presentation beginning at 3:00 PM GMT on November 18, 2025.

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Piper Sandler 37th Annual Piper Sandler Healthcare Conference: Mai-Britt Zocca, PhD, President and CEO, and Amy Sullivan, CFO, will participate in a fireside chat beginning at 3:00 PM ET on December 3, 2025.

The webcasts for these two upcoming conferences will be available from the Investors section of the company’s website at View Source

Third Quarter 2025 Financial Results

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Total operating expenses for the three months ended September 30, 2025, were $19.4 million, compared to $26.5 million for the three months ended September 30, 2024.

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Research and development expenses were $13.7 million for the three months ended September 30, 2025, compared to $20.2 million for the three months ended September 30, 2024. The company recognized $0.6 million in research and development equity-based compensation for the three months ended September 30, 2025 and 2024, respectively.

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General and administrative expenses were $5.6 million for the three months ended September 30, 2025, compared to $6.3 million for the three months ended September 30, 2024. The company recognized $0.9 million in general and administrative equity-based compensation for the three months ended September 30, 2025 and $1.0 million for the three months ended September 30, 2024.

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Cash and cash equivalents as of September 30, 2025 were $30.7 million, compared to $60.0 million at December 31, 2024. During the three months ended September 30, 2025, the company increased cash, cash equivalents and restricted cash by $2.5 million primarily due to the draw down of €12.5 million in gross proceeds from our Tranche B loan with the European Investment Bank on July 4, 2025 and net proceeds of $6.6 million from the issuance of common stock in connection with our at-the-market program. The company now expects that it will have sufficient cash to run the company through the first quarter of 2026.

About Cylembio

Cylembio (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo- adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the Phase 3 trial was completed rapidly by December 2023 with topline results from this trial reported in the third quarter of 2025. Enrollment in the two ongoing company-sponsored Phase 2 clinical trials is now complete.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio.

Cylembio is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the US and Canada).

About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial

IOB-013/KN-D18 (ClinicalTrials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression-free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) or recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) at sites in the United States, Spain, and the United Kingdom. IO Biotech is sponsoring the Phase 2 trial and Merck is supplying pembrolizumab.

(Press release, IO Biotech, NOV 14, 2025, View Source [SID1234659972])

On November 14, 2025 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company developing next-generation T cell-based therapies, reported corporate updates and financial results for the third quarter ended September 30, 2025.

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"Marker entered the second half of 2025 with strong clinical momentum as we continue to advance our lead program, MT-601, in patients with relapsed or refractory B-cell lymphoma," said Juan Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "The most recent update from our Phase 1 APOLLO study showed a 66% objective response rate including 50% complete responses, in heavily pre-treated NHL patients. These data, together with a favorable safety profile, reinforce the potential of MT-601 to meet the critical needs of patients who have exhausted multiple lines of therapy, including CAR-T cell therapies and bispecific antibodies. We’re encouraged by the durability of responses and plan to share an additional update in the first half of 2026."

Dr. Vera continued, "We also achieved a number of key milestones in this quarter, including treating the first patient in our Off-the-Shelf (OTS) program and entering a strategic manufacturing collaboration with Cellipont to scale up production of MT-601. In parallel, we have strengthened our balance sheet by raising approximately $10 million through our ATM facility, extending our cash runway well into 2026. Looking ahead, we are focused on enrolling patients in the MT-601 dose expansion cohort to build on our promising observations from our APOLLO study. Having executed on the priorities we set at the beginning of the year we are entering the final stretch of 2025 with strong operational footing and a clear clinical focus."

PROGRAM UPDATES & OPERATIONAL HIGHLIGHTS

MT-601 (Lymphoma)

· Positive clinical data from the Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) showed a 66% (8 out of 12) objective response rate and 50% (6 out of 12) complete response rate in relapsed NHL patients, including those previously treated with CAR-T cell therapies and bispecific antibodies (Press Release, August 26, 2025).

· Responses were durable with five NHL patients maintaining response for ≥6 months, including three with ≥12 months (range 3-24 months).

· Favorable safety profile with no dose-limiting toxicities (DLTs) or immune effector cell–associated neurotoxicity (ICANS) observed at any dose level in the dose escalation cohort.

· Dose expansion cohort underway, evaluating MT-601 at highest dose level (400×106 cells) in patients with Diffuse Large B Cell Lymphoma (DLBCL) who have relapsed after or are ineligible for CAR-T cell therapy.

· Additional clinical data are expected in the first half of 2026.

MT-601 (Pancreatic Cancer)

· Marker was previously awarded $2.0 million from the NIH and $9.5 million from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the development of MT-601 in metastatic pancreatic cancer.

· Clinical program launch is anticipated in the first half of 2026.

Off-the-Shelf Program (Acute Myeloid Leukemia or Myelodysplastic Syndrome)

· Marker announced first patient treated in Phase 1 RAPID study (clinicaltrials.gov Identifier: NCT06552416) evaluating MT-401 as an Off-the-Shelf (OTS) product (Press Release, October 6, 2025).

· Treatment with MT-401-OTS was well tolerated, consistent with the favorable safety profile previously reported for MAR-T cells.

· The OTS program is investigating MAR-T cells in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) with the potential for future expansion to other indications.

· The Company previously secured non-dilutive funding from NIH, FDA and CPRIT to support the OTS program.

Corporate Updates

· Marker entered a current good manufacturing practice (cGMP) manufacturing agreement with Cellipont Bioservices to scale up the production of MT-601 for the APOLLO study. This partnership supports clinical supply and lays the ground for a potential pivotal trial and commercial readiness (Press Release, June 17, 2025).

· Data from the Phase 1 APOLLO study will be presented in two posters at the 67th ASH (Free ASH Whitepaper) Annual Meeting and Exposition, held from December 6-9, 2025, in Orlando, Florida (Press Release, November 3, 2025).

· Appointed Kathryn Penkus Corzo, R.Ph., MBA to the Company’s Board of Directors, effective November 1, 2025 (Press Release, November 5, 2025).

· Marker raised approximately $10 million through its ATM Agreement, extending the Company’s runway well into 2026.

THIRD QUARTER 2025 FINANCIAL HIGHLIGHTS

Cash Position and Guidance: At September 30, 2025, Marker had cash and cash equivalents of $17.6 million and restricted cash of $1.4 million. The Company believes that its existing cash, cash equivalents and restricted cash will fund its operating expenses through the third quarter of 2026, assuming no additional grant funds are received, either from new grants or from existing awarded grants.

R&D Expenses: Research and development expenses were $2.3 million for the quarter ended September 30, 2025, compared to $3.5 million for the quarter ended September 30, 2024.

G&A Expenses: General and administrative expenses were $1 million for the quarter ended September 30, 2025, compared to $0.9 million for the quarter ended September 30, 2024.

Net Loss: Marker reported a net loss from continuing operations of $2.0 million for the quarter ended September 30, 2025, compared to $2.3 million for the quarter ended September 30, 2024.

About MAR-T cells

The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient’s/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.

(Press release, Marker Therapeutics, NOV 14, 2025, View Source [SID1234659974])

On November 14, 2025 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on the development of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported a business update and announced financial results for the third quarter ended September 30, 2025.

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Acquisition by Day One Biopharmaceuticals, Inc.

Yesterday, Mersana announced that it has entered into a definitive merger agreement with Day One Biopharmaceutics, Inc. (Day One), pursuant to which Day One would acquire Mersana, through a tender offer followed by a second step merger, for upfront consideration of $25.00 per share in cash plus up to an aggregate of $30.25 per share in cash potentially payable under contingent value rights (CVRs) triggered upon the achievement of certain clinical development, regulatory and commercial milestones related to Emi-Le, the company’s B7-H4-directed Dolasynthen ADC, and upon the achievement of a certain milestone pursuant to an existing Mersana collaboration to be issued in the proposed acquisition, representing a total equity value of approximately $129 million at closing and representing a total deal value of up to approximately $285 million. Closing of the transaction is subject to the satisfaction of customary closing conditions, including that a majority of Mersana’s shares of common stock are validly tendered in the tender offer and not validly withdrawn and the receipt of certain U.S. regulatory approvals, and is expected to occur by the end of January 2026.

Emiltatug Ledadotin (Emi-Le; XMT-1660)
In the ongoing Phase 1 clinical trial of Emi-Le, Mersana continues to follow patients in its two dose expansion cohorts in patients with triple-negative breast cancer, or TNBC, who have received one to four prior treatment lines in the locally advanced or metastatic setting, including at least one prior topoisomerase-1 inhibitor ADC.

Mersana is also evaluating Emi-Le in patients with adenoid cystic carcinoma type 1 (ACC-1), a population with very high unmet need, in the backfill cohorts of the dose escalation portion of the ongoing Phase 1 clinical trial. In June 2025, at ASCO (Free ASCO Whitepaper), Mersana presented interim clinical data from nine evaluable patients with ACC-1. As of October 1, 2025, Mersana has enrolled a substantially greater number of ACC-1 patients in these backfill cohorts than was presented at ASCO (Free ASCO Whitepaper). The data from ACC-1 patients enrolled in this trial continues to mature as Mersana enrolls additional patients and patients remain on treatment for longer periods. Mersana has continued to be encouraged by the responses of the patients in these backfill cohorts.

Emi-Le continues to be generally well-tolerated, and its observed safety profile remains consistent with previously disclosed data.

XMT-2056
Mersana’s Phase 1 clinical trial of XMT-2056, the company’s lead Immunosynthen ADC candidate targeting a novel HER2 epitope, is ongoing. In the third quarter of 2025, Mersana achieved and received a $15 million development milestone under its agreement with GSK plc (GSK), which has an exclusive global license option to co-develop and commercialize XMT-2056.

Collaborations
Mersana continues to support its collaborations with both Janssen Biotech, Inc. (Johnson & Johnson, Dolasynthen research collaboration) and Merck KGaA, Darmstadt, Germany (Immunosynthen research collaboration).

In the third quarter of 2025, Johnson & Johnson received clearance from the U.S. Food and Drug Administration (FDA) of an investigational new drug application for a Dolasynthen ADC developed under Mersana’s 2022 collaboration and license agreement with Johnson & Johnson. An $8.0 million development milestone is associated with the further progress of this first-in-human clinical trial pursuant to the agreement with Johnson & Johnson.

Third Quarter 2025 Financial Results and Recent Updates

Net cash used in operating activities for the third quarter of 2025 was $3.2 million, which reflects the impact of the $15 million GSK development milestone payment received.
Cash and cash equivalents as of September 30, 2025 were $56.4 million. The company continues to expect that its capital resources will be sufficient to support its current operating plan commitments into mid-2026.
Collaboration revenue for the third quarter of 2025 was $11.0 million, compared to $12.6 million for the same period in 2024. The year-over-year change was primarily related to decreased revenue recognized under the company’s collaboration and license agreements with Johnson & Johnson and Merck KGaA, Darmstadt, Germany, partially offset by increased revenue recognized under its agreement with GSK.
Research and development (R&D) expense for the third quarter of 2025 was $12.2 million, compared to $14.8 million for the same period in 2024. Included in the third quarter of 2025 R&D expense was $0.5 million in non-cash stock-based compensation expense. The year-over-year change in R&D expense was primarily related to lower headcount and related employee compensation costs, partially offset by an increase in costs related to Emi-Le and XMT-2056 clinical development activities.
General and administrative (G&A) expense for the third quarter of 2025 was $6.3 million, compared to $9.9 million during the same period in 2024. Included in the third quarter of 2025 G&A expense was $0.6 million in non-cash stock-based compensation expenses. The year-over-year change in G&A expense was primarily related to lower headcount and related employee compensation costs and a reduction in consulting and professional services fees.
Net loss for the third quarter of 2025 was $7.5 million, or $1.51 per share, compared to a net loss of $11.5 million, or $2.34 per share, for the same period in 2024.
Conference Call
Mersana’s previously scheduled conference call to discuss business updates and its financial results for the third quarter of 2025 has been cancelled.

(Press release, Mersana Therapeutics, NOV 14, 2025, View Source [SID1234659975])

On November 13, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that Sean McCarthy, D.Phil., chief executive officer and chairman, will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Thursday, November 20, 2025, at 9:00 a.m. GMT.

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A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

(Press release, CytomX Therapeutics, NOV 13, 2025, View Source [SID1234659895])

On November 13, 2025 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported additional efficacy and safety data from the Phase 1b trial of once daily ORIC-944 in combination with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC).

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"We continue to be encouraged by ORIC-944 combination data, which further demonstrate its potential as a best-in-class PRC2 inhibitor that may benefit a broad range of patients with prostate cancer," said Jacob M. Chacko, M.D., president and chief executive officer. "The tolerability and efficacy data to date provide compelling validation for the doses we’ve selected for the dose optimization portion of the Phase 1b trial. We look forward to sharing dose optimization data in 1Q 2026 ahead of initiating our first global Phase 3 registrational trial in mCRPC in the first half of next year."

ORIC-944 Phase 1b Dose Exploration Data
Patients were previously treated with a median of three prior lines of therapy, including abiraterone acetate, up to one prior line of chemotherapy, and a variety of other approved and investigational treatment regimens. This median does not include background androgen deprivation therapy or first-generation AR inhibitors that the patients may have received. Patients were treated once daily with 400 mg, 600 mg, 800 mg, or 1,200 mg of ORIC-944 in combination with 240 mg of apalutamide once daily or with 600 mg of darolutamide twice daily. PSA data for 20 patients with mCRPC includes 17 patients previously reported in May 2025. Circulating tumor DNA (ctDNA) was assessed for 17 patients with mCRPC who had available ctDNA samples and evidence of ctDNA at baseline prior to study entry. PSA response data and ctDNA data are as of September 22, 2025.

Preliminary antitumor activity analysis
PSA responses and ctDNA reductions were observed across all ORIC-944 dose levels and were also observed at comparable rates in combination with apalutamide or with darolutamide.

PSA activity

55% of patients (11/20) achieved a PSA50 response, confirmed in 40% (8/20).
20% of patients (4/20) achieved a PSA90 response (all confirmed).

ctDNA activity
ctDNA serves as a useful biomarker to predict the duration of treatment benefit and survival in prostate cancer. Detectable ctDNA at baseline is associated with poor prognosis, and non-detectable ctDNA at baseline or upon treatment is associated with longer progression-free survival and overall survival. In the Phase 1b trial, 88% of patients had detectable ctDNA at baseline (higher than precedent trials with standard of care agents in comparable mCRPC patient populations), and ORIC-944 in combination with apalutamide or with darolutamide demonstrated:

Rapid and deep ctDNA responses across a breadth of AR mutations and other gene alterations, with 76% of patients (13/17) achieving >50% ctDNA reduction.
59% of patients (10/17) achieved ctDNA clearance, which is greater than clearance rates observed in precedent trials with standard of care agents in comparable mCRPC patient populations.

Preliminary safety analysis
ORIC-944 in combination with apalutamide or with darolutamide continues to be well tolerated to date. Both combination regimens demonstrated a safety profile compatible with long-term dosing, with the vast majority of treatment-related adverse events (TRAEs) Grade 1 or 2 in severity and consistent with PRC2 and AR inhibition. As of the September 22, 2025 cutoff date, only one patient experienced a Grade 3 TRAE, and there were no Grade 4 or Grade 5 AEs attributed to ORIC-944, apalutamide or darolutamide.

Next Steps
Based on these efficacy and safety results, ORIC has selected provisional recommended Phase 2 doses (RP2Ds) of ORIC-944 to be tested in combination with the approved doses of darolutamide and apalutamide in the dose optimization portion of the Phase 1b trial: 400 mg and 600 mg once daily of ORIC-944 in combination with 600 mg twice daily of darolutamide; and 600 mg, 800 mg and 1,200 mg once daily of ORIC-944 in combination with 240 mg once daily of apalutamide. Enrollment in the dose optimization portion of the trial is ongoing, and the company plans to announce preliminary dose optimization data in 1Q 2026. Data from the dose optimization portion of the trial will inform the choice of ORIC-944 dose to advance in combination with apalutamide or with darolutamide in the first global Phase 3 registrational trial in mCRPC, which the company expects to initiate in 1H 2026.

ORIC-944 Phase 1b Trial Design
ORIC-944 is being evaluated in a Phase 1b dose optimization trial in combination with ERLEADA (apalutamide), Johnson & Johnson’s AR inhibitor, and NUBEQA (darolutamide), Bayer’s AR inhibitor, in patients with mCRPC. Patients are eligible if they have received prior treatment with an androgen receptor pathway inhibitor (ARPI) and up to one prior chemotherapy. The primary objective of the trial is to determine the recommended Phase 2 dose (RP2D), and additional objectives include safety, tolerability, pharmacokinetics, and preliminary clinical activity.

(Press release, ORIC Pharmaceuticals, NOV 13, 2025, View Source [SID1234659911])