On November 14, 2025 TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immuno-oncology company developing novel therapeutics to overcome resistance to cancer immunotherapy, reported financial results for the Company’s third quarter ended September 30, 2025, and provided a corporate update.

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"TuHURA remains highly focused on the execution of its clinical development programs, including enrollment in our Phase 3 pivotal trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in the first line treatment of patients with advanced or metastatic MCC. This accelerated, registration-directed trial, conducted under an SPA Agreement with the FDA, has the potential, if successful, to satisfy the requirements for both accelerated and regular approval without the need to conduct a post-approval confirmatory trial," stated Dr. James Bianco, President and Chief Executive Officer of TuHURA. "In parallel to advancing our late-stage development candidate IFx-2.0, we are working with experts in the treatment of AML to complete the protocol design for our Phase 2 study of TBS-2025, our VISTA inhibiting antibody, in patients with NPM1 mutated AML. We are on track to submit our proposed Phase 2 plan to FDA next month and initiate the Phase 2 randomized study in the first quarter of next year."

Dr. Bianco continued, "In addition to our clinical programs, we were excited to see validation of the scientific merit related to our discovery of the potential role of the DOR expression on Myeloid Derived Suppressor Cells (MDSCs) by being selected by the Joint Program Committees of the ASH (Free ASH Whitepaper) 2025 Annual Meeting for an oral presentation. We look forward to presenting our data demonstrating that the DOR is a potential novel target to reprogram the immune suppressing capabilities of MDSCs and tumor-associated macrophages (TAMs). Together with regulatory T cells (Tregs), these immunosuppressive cells are collectively responsible for acquired resistance to cancer immunotherapies. The DOR technology is the backbone of our program to develop first-in-class bi-specific, bi-functional immune modulating antibody drug conjugates (ADCs). TuHURA’s oral presentation at the ASH (Free ASH Whitepaper) 2025 Annual Meeting is on December 7th at 5:15pm ET."

Corporate Highlights

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Acceptance of Oral and Poster Presentations at ASH (Free ASH Whitepaper) 2025 Annual Meeting and Exposition. TuHURA announced that ASH (Free ASH Whitepaper) has accepted the following abstracts for presentation:

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Oral Presentation: Delta Opioid Receptor (DOR) Expression on Myeloid-Derived Suppressor Cells (MDSCs) Represents a Novel Target to Overcome Resistance to Immune Checkpoint Inhibitors (ICIs)

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Poster Presentation: Delta Opioid Receptor (DOR): A Novel Target for Reprogramming Tumor-Associated Macrophage (TAM) Immunosuppressive Phenotype to Overcome Acquired Resistance and Enhance the Effectiveness of Cancer Immunotherapies

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Moffitt Cancer Center Poster Presentation: Delta opioid receptor signaling modulates myeloid suppression in Myelodysplastic Syndromes

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Strengthening of TuHURA Team Through the Appointment of Dr. Michael Turner. In November 2025, Michael Turner, Ph.D. was appointed as Vice President of Immunology. Dr. Turner has over 20 years of experience in immunology and oncology, with experience at leading industry companies such as Sanofi Genzyme, Alkermes, Ventus Therapeutics and Third Harmonic Bio.

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$50 Million At-The-Market (ATM) Facility Filed. In November 2025, TuHURA became eligible to file a "shelf" registration statement on Form S-3 and entered into agreement providing for an ATM facility of up to $50 Million. TuHURA will become able to sell shares under the ATM facility when the S-3 registration statement filed on November 3, 2025 becomes effective under the rules and regulations of the SEC.

Upcoming Targeted Milestones by Program

IFx-2.0 (Innate immune agonist)

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Q2 2026: Anticipate preliminary results from Phase 1b/2a clinical trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in first line treatment for MCC of unknown primary origin (MCCUP).

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Q4 2026: Anticipate completion of enrollment in the randomized, placebo-controlled Phase 3 accelerated approval trial in first line treatment as adjunctive therapy to Keytruda in advanced or metastatic MCC.

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Q1 2027: Anticipate topline results from the Phase 3 accelerated approval trial.

TBS-2025 (VISTA inhibiting antibody)

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Q4 2025: Submission of the Phase 2 protocol and plan to the FDA for TBS-2025 in hematologic malignancies.

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Q1 2026: Initiation of a Phase 2 trial of VISTA inhibiting mAb in relapsed or refractory NPM1-mutated AML in combination with a menin inhibitor.

Lead ADC Selection

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Q1 2026: TuHURA has developed a library of potent, highly selective DOR inhibitors to be evaluated in its MDSC assays. TuHURA expects to select a lead DOR inhibitor to conjugate to TBS-2025 for testing in preclinical models.

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Q3 2026: Anticipates first proof of concept in-vivo results from its lead immune modulating ADC.

Financial Results for the Three Months and Nine Months Ended September 30, 2025

Research and development expenses were $4.9 million and $2.9 million for the three months ended September 30, 2025, and 2024, respectively.

Net cash outflows from operating activities were ($22.1) million and ($12.1) million for the nine months ended September 30, 2025, and 2024, respectively.

As of September 30, 2025, TuHURA’s total shares outstanding was approximately 51.2 million.

(Press release, TuHURA Biosciences, NOV 14, 2025, View Source [SID1234659979])

On November 14, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the third quarter 2025.

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On October 30, 2025, the Company announced that its Board of Directors determined, after extensive consideration of the Company’s development pipeline and current market conditions, to discontinue development of solnerstotug and initiate a comprehensive review of strategic alternatives aimed at maximizing shareholder value. The Company is exploring a range of strategic alternatives that may include, among other options, a sale of assets, licensing arrangements, collaborations, a sale of the Company, a business combination, a merger, or an orderly wind-down of operations.

In connection with this strategic review, the Company has implemented a workforce reduction to preserve cash, reducing its workforce by approximately 65 percent. The Company is retaining a small team of employees to assist in exploring strategic alternatives, maintaining compliance with regulatory and financial reporting requirements, and managing the orderly cessation of development activities.

Third Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $25.0 million as of September 30, 2025, as compared to $41.3 million as of December 31, 2024.

Research and Development (R&D) Expenses: R&D expenses were $2.5 million for the quarter ended September 30, 2025, compared to $4.6 million for the quarter ended September 30, 2024. The decrease in R&D expenses was primarily attributable to lower personnel and facilities costs, and reduced lab supply costs.

General and Administrative (G&A) Expenses: G&A expenses were $2.3 million for the quarter ended September 30, 2025, compared to $3.2 million for the quarter ended September 30, 2024. The decrease in G&A expense was primarily attributable to lower personnel costs.

Net Loss: Net loss was $4.6 million for the quarter ended September 30, 2025, compared to $7.3 million for the quarter ended September 30, 2024.

(Press release, Sensei Biotherapeutics, NOV 14, 2025, View Source [SID1234659978])

On November 14, 2025 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, reported financial results for the three months ended September 30, 2025, and provided a business update.

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"During the quarter, we secured the necessary funds to support the development of our CAPTN-3 technology platform through significant milestones. We plan to conduct non-GLP and GLP toxicology studies, submit an Investigational New Drug application (IND) and initiate a Phase 1 study for IM1240 in 2026. CAPTN-3 continues to produce tri-specific NK and T cell engagers with a novel, differentiated tumor-associated antigen arm. IM1240, the first tri-specific antibody from the platform, targets 5T4, and IM1305, with a TROP2 antigen-targeting arm, has recently entered the development pipeline," said Purple Biotech CEO Gil Efron. "While the versatility and applicability of the CAPTN-3 tri-specific construct are only beginning to garner attention, we believe in its synergistic, yet safe activation of both the innate and adaptive immune systems to help overcome tumor immune evasion."

Recent Clinical and Corporate Highlights:

CAPTN-3 Tri-Specific Antibody Platform

● Nominated IM1305 as the second tri-specific antibody development candidate from the CAPTN-3 platform, targeting TROP2 in addition to masked CD3 and NKG2A arms (capped-CD3xTROP2xNKG2A)

● IM1240, the first CAPTN-3 tri-specific antibody development candidate targeting 5T4 (capped-CD3x5T4xNKG2A), achieved a manufacturing and scalability milestone with a commercially viable yield.

● In collaboration with Mt. Sinai Principal Investigator Dr. Amir Horowitz, demonstrated IM1240-induced tumor cell death in patient-derived, treatment-resistant head and neck biopsies

● IM1240 is advancing toward first-in-human clinical trials, with IND submission and study initiation planned for 2026

CM24 (α-CEACAM1 monoclonal antibody)

● The biomarkers identified in the CM24 Phase 2 study will be used for patient selection in the Phase 2b study, which is subject to partnering.

● Detailed design for the next study focuses on two main objectives:

○ A separate arm testing CM24 alone in combination with standard of care to assess the contribution of each component. The second arm will test CM24 plus anti-PD1 plus standard of care. The third arm will test standard of care alone.

○ Selection of patients based on the identified biomarkers, which are expected to result in better outcomes for patients in the treatment arms.

NT219 (IRS1/2 degrader and STAT3 blocker)

● Received an intention to grant a European patent covering NT219 combinations with immunotherapies or MEK inhibitors to overcome tumor resistance

● Ongoing NT219 Phase 2 study in recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) to evaluate NT219 in combination with pembrolizumab (Keytruda) or cetuximab (Erbitux)

● The Phase 2 study is led by Dr. Antonio Jimeno, Professor and Director of the Head and Neck Cancer Program, and Principal Investigator Dr. Alice Weaver, at the University of Colorado Anschutz Medical Campus

Financial Results for the Three Months Ended September 30, 2025

Research and Development Expenses were $0.6 million for the three months ended September 30, 2025, representing a decrease of $0.8 million, or 56.4%, from $1.3 million in the same period of 2024. The decrease was primarily attributable to reduced costs associated with the CM24 Phase 2 study.

General and Administrative Expenses were $0.8 million for the three months ended September 30, 2025, consistent with the $0.8 million reported in the same period of 2024, reflecting continued cost management discipline.

Operating Loss was $1.4 million for the three months ended September 30, 2025, a decrease of $0.8 million, or 35.8 %, compared to $2.1 million in the same period of 2024, mainly due to the decrease in the CM24 Phase 2 study expenses.

Adjusted Operating Loss (as reconciled below) was $1.3 million for the three months ended September 30, 2025, a decrease of $0.7 million compared to $2.0 million in the same period of 2024, primarily due to the decrease in the CM24 Phase 2 study expenses.

Finance Income, net, was $0.1 million for the three months ended September 30, 2025, compared to $1.5 million in the same period of 2024, representing a decrease of $1.4 million, primarily attributable to a lower non-cash gain from the revaluation of outstanding warrants and issuance-related expenses.

Net Loss was $1.3 million, or $0.29 per basic and diluted ADS, for the three months ended September 30, 2025, compared to a net loss of $0.7 million, or $0.39 per basic and diluted ADS, in the same period of 2024. The year-over-year change was primarily attributable to a $0.8 million reduction in operating expenses and a $1.4 million decrease in finance income, net.

As of September 30, 2025, Purple Biotech had cash and cash equivalents and short-term deposits of $10.5 million. The Company’s cash runway is expected into the first half of 2027.

(Press release, Purple Biotech, NOV 14, 2025, View Source [SID1234659976])

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 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])