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TScan Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

On March 4, 2026 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the three months and full year ended December 31, 2025, and provided business updates.

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"The regulatory and operational progress we have made over the last several months related to our heme program is exciting. We expect the momentum to continue into the second quarter when we plan to share the initial data from patients enrolled into Cohort C in the ALLOHA study as well as initiate TScan’s first Phase 3 trial," said Gavin MacBeath, Ph.D., Chief Executive Officer. "The data we presented at ASH (Free ASH Whitepaper) in December 2025 continue to support our decision to focus the Company’s efforts on development of therapeutics for patients with heme malignancies. Additionally, the recent FDA clearance of INDs for TSC-102-A01 and TSC-102-A03 will allow us to bring our TCR-T therapies to twice as many patients who currently have limited options in the post-transplant setting."

Recent Corporate Updates: Hematologic Malignancies Program

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In December 2025, the Company presented positive updated data from the ALLOHA Phase 1 heme trial at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

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TSC-101 was well-tolerated with no dose-limiting toxicities observed.
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Treatment arm continues to demonstrate favorable relapse-free survival (HR=0.50; p=0.23) and overall survival (HR=0.61; p=0.52).
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3/3 (100%) of TSC-101-treated patients who reached two-year follow-up remained relapse-free compared to 1/4 (25%) in the control arm.

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In February 2026, the U.S. Food and Drug Administration (FDA) cleared the Company’s investigational new drug (IND) applications for TSC-102-A01 and TSC-102-A03. These TCR-T therapy candidates target CD45, a protein that is broadly expressed in heme cells but absent in non-heme tissues. TSC-102-A01 and TSC-102-A03 are allogeneic, donor-derived TCR-T therapy candidates designed to eliminate residual cancer and prevent relapse in patients with heme malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT) using either reduced intensity conditioning or myeloablative conditioning. TSC-102-A01 and TSC-102-A03 are designed to treat patients who are HLA-A*01:01- or HLA-A*03:01-positive, respectively, and are paired with donors who are negative for the HLA allele. The Company plans to initiate a Phase 1 study with these candidates in the second half of this year.

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In February 2026, TScan announced completion of enrollment in Cohort C of the Phase 1 ALLOHA trial, where patients are being dosed with TSC-101 manufactured using its commercial-ready manufacturing process.

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In February 2026, the Company presented a poster at the 2026 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR (Tandem Meetings). The poster can be found on the "Publications" page of the Company’s website at tscan.com.

Upcoming Anticipated Milestones: Heme Malignancies Program

TScan’s lead TCR-T therapy candidate, TSC-101, is designed to treat residual disease and prevent relapse in patients with heme malignancies undergoing allogeneic HCT (the ALLOHA trial, NCT05473910).

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Share early clinical data on patients treated in Cohort C of the ALLOHA study in the second quarter of 2026.
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Launch pivotal trial for TSC-101 in the second quarter of 2026.
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Share updated data on patients treated in Cohort C of the ALLOHA study in the second half of 2026.
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Initiate Phase 1 study of TSC-102-A01 and TSC-102-A03 in the second half of 2026.

Recent Corporate Updates: Early Pipeline

Solid Tumor Program:
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In November 2025, the Company announced the discontinuation of the PLEXI-T trial. Clinical data on initial patients treated in the study have been disclosed in the Company’s 2025 Form 10-K filed with the Securities and Exchange Commission on March 4, 2026.
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The Company is currently developing methods to engineer TCR-T cells in vivo to treat solid tumors.

Autoimmunity Program:

The Company is leveraging their target discovery platform to identify targets for a set of T-cell-driven autoimmune disorders and is currently developing potential treatment options.
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The Company anticipates sharing preclinical proof-of-concept data for its therapeutic approach in the second half of 2026.

Financial Results

Revenue: Revenue for the fourth quarter of 2025 was $2.6 million, compared to $0.7 million for the fourth quarter of 2024, and $10.3 million for the full-year 2025, compared to $2.8 million for the full-year 2024. The increase in both periods was primarily due to timing of research activities pursuant to the Company’s collaboration agreement with Amgen.

R&D Expenses: Research and development (R&D) expenses for the fourth quarter of 2025 were $20.0 million, compared to $29.4 million for the fourth quarter of 2024, and $114.2 million for the full-year 2025, compared to $107.4 million for the full-year 2024. The year over year increase was primarily driven by increased manufacturing and clinical activities, with the quarter over quarter decrease primarily driven by timing of manufacturing activities, as well as savings in connection with the Company’s previously announced strategy to prioritize the clinical development of its heme program. R&D expenses included non-cash stock compensation expense of $0.9 million and $1.3 million for the fourth quarter of 2025 and 2024, respectively, and $6.0 million and $4.8 million for the full-year 2025 and 2024, respectively.

G&A Expenses: General and administrative (G&A) expenses for the fourth quarter of 2025 were $6.4 million, compared to $8.0 million for the fourth quarter of 2024, and $32.0 million for the full-year 2025, compared to $30.3 million for the full-year 2024. The year-over-year increase was primarily driven by personnel costs to support business activities, with the quarter-over-quarter decrease primarily driven by savings in connection with the Company’s previously announced strategy to prioritize the clinical development of its heme program. G&A expenses included non-cash stock compensation expense of $1.1 million and $1.4 million for the fourth quarter of 2025 and 2024, respectively, and $5.7 million and $4.7 million for the full-year 2025 and 2024, respectively.

Net Loss: Net loss was $23.0 million for the fourth quarter of 2025, compared to $35.8 million for the fourth quarter of 2024, and included net interest income of $0.9 million and $2.0 million, respectively. Net loss for the full-year 2025 was $129.8 million, compared to $127.5 million for the full-year 2024, and included net interest income of $6.0 million and $8.4 million, respectively. Net loss for the fourth quarter of 2024 and full-year 2024 included a $1.1 million loss on extinguishment of debt.

Cash Position: Cash and cash equivalents as of December 31, 2025 were $152.4 million, excluding $5.0 million of restricted cash. The Company believes that its existing cash resources will be sufficient to fund its current operating plan into the second half of 2027.

Share Count: As of December 31, 2025, the Company had 56,901,623 issued and outstanding shares of common stock, consisting of 52,625,035 shares of voting common stock and 4,276,588 shares of non-voting common stock, as well as 73,011,767 outstanding pre-funded warrants to purchase shares of voting common stock at an exercise price of $0.0001 per share. Pro forma outstanding shares, inclusive of both common stock and prefunded warrants, were 129,913,390 as of December 31, 2025.

(Press release, TScan Therapeutics, MAR 4, 2026, View Source [SID1234663251])

Theolytics Awarded €8 million in Horizon Europe 2025 Grant Funding to Advance Phase 2 Study of THEO-260 in Ovarian Cancer

On March 4, 2026 Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, reported that it has been awarded, pending final negotiation, €8 million in non-dilutive grant funding from Horizon Europe 2025, the European Union’s flagship research and innovation funding programme. Horizon Europe 2025 is supporting high-impact clinical-stage projects aimed at improving patient outcomes and strengthening Europe’s scientific leadership. The grant to Theolytics will provide significant financial support to advance the company’s Phase 2 OCTOPOD-IV clinical trial evaluating THEO-260, its novel therapeutic candidate designed to address unmet needs in patients with advanced ovarian cancer.

Positioned to tackle the complex, immune-suppressed nature of advanced solid tumours, THEO-260 is an oncolytic immunotherapy designed for effective killing of both cancer cells and cancer-associated fibroblasts (CAFs), while inducing immune activation. Platinum-resistant ovarian cancer represents a prototype of a broader category of stroma-rich solid tumours for which THEO-260 is being developed.

Margaret Duffy, CSO and Co-founder of Theolytics, said, "Our collective success with this grant award reflects the extraordinary work being done by the team at Theolytics, and the calibre of our clinical and translational partner centres. The Horizon Europe award validates both the scientific rationale behind our THEO-260 programme and the huge potential of its novel oncolytic and ‘CAF-lytic’ mechanism to address a significant unmet need in stroma-rich solid cancers. By integrating advanced translational analyses into our clinical trial design, we will clinically demonstrate the differentiated mechanism of action of THEO-260 and provide key data to advance this programme and deliver true impact for cancer patients."

This highly competitive Horizon Europe 2025 award follows a rigorous grant review process and highlights the company’s innovative science, strong technical area expertise, clear clinical development plan and the opportunity for THEO-260 to address a clear unmet patient need.

The grant application was coordinated with several major partners, expert clinical and translational centres involved in the OCTOPOD-IV study and includes the Cancer Center Clínica Universidad de Navarra, Catalan Institute of Oncology in Spain; the Princess Margaret Hospital in Toronto, Canada; and The Institute of Cancer Research (ICR) in London, UK. Two thirds of the funds will be received directly by Theolytics to advance the OCTOPOD-IV Phase 2a expansion trial, and the other third will be deployed directly to the partners in support of their work on the trial.

OCTOPOD-IV (NCT06618235) is a first-in-human, multi-centre trial to assess safety, tolerability and preliminary efficacy of THEO-260 in patients with high-grade serous ovarian or endometrioid cancer. In addition, the trial is designed to determine the recommended Phase 2 dose and demonstrate THEO-260’s differentiated cancer/cancer-associated fibroblast-lytic mechanism of action in patients through comprehensive biomarker analysis.

Prof Alan Melcher, Professor of Translational Immunotherapy at The Institute of Cancer Research, London, said, "The differentiated mechanism of action – targeting the stroma and inducing immune activity in the suppressed tumour microenvironment (TME) – of this oncolytic immunotherapy THEO-260 offers the potential to provide an important new treatment option for patients with advanced solid tumours. We are pleased to support the OCTOPOD-IV study, for which the ICR will provide important translational data to assess this novel and promising approach."

Dr Antonio González, Director of the Department of Medical Oncology and Cancer Center at the Clínica Universidad de Navarra, and President of the Spanish Cooperative Group for Gynaecological Cancer Research, added, "We see many women with advanced platinum-resistant ovarian cancer, whose life expectancy is typically only a year or less. There remains a serious lack of effective treatment options for these women, and so we are hopeful that THEO-260 may bring an advance in therapy that will improve and extend the lives of our patients."

Recruitment at UK and Spanish clinical sites for OCTOPOD-IV is ongoing and will now expand into further international centres (including additional sites in Spain and Canada). A second clinical trial (OCTOPOD-IP) in the US, which will investigate intraperitoneal (IP) delivery of THEO-260 to advanced ovarian cancer patients, has also been initiated in collaboration with The University of Texas MD Anderson Cancer Center (NCT07211659).

(Press release, Theolytics, MAR 4, 2026, View Source [SID1234663250])

MannKind to Participate in Upcoming Investor Conferences

On March 4, 2026 MannKind Corporation (Nasdaq: MNKD), reported its attendance at two upcoming investor conferences, at which MannKind’s Chief Executive Officer, Michael Castagna, PharmD, and Chief Financial Officer, Chris Prentiss will participate in fireside chats and in 1×1 meetings with investors.

Leerink Partners 2026 Global Healthcare Conference in Miami
Tuesday, March 10, 3:40 p.m. ET

Barclays 28th Annual Global Healthcare Conference in Miami
Wednesday, March 11, 1:00 p.m. ET

Links to the live audio webcast of the sessions will be available on MannKind Corporation’s website at: View Source Recorded versions will also be available on the website for approximately 90 days following the conference.

(Press release, Mannkind, MAR 4, 2026, View Source [SID1234663249])

Corporate presentation

On March 4, 2026 Keros Therapeutics presented its corporate presentation.

(Presentation, Keros Therapeutics, MAR 4, 2026, View Source [SID1234663248])

INOVIO and Akeso Announce Clinical Collaboration to Advance Novel Combination Therapy for Glioblastoma (GBM)

On March 4, 2026 INOVIO (NASDAQ: INO), and Akeso, Inc. (9926.HK) ("Akeso") reported that they have entered into a clinical trial collaboration and supply agreement to evaluate INO-5412, INOVIO’s DNA immunotherapy candidate, in combination with cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, for the potential treatment of GBM. The combination therapy will be studied as a part of INSIGhT, the innovative Phase 2 adaptive platform trial sponsored by the Dana-Farber Cancer Institute and conducted with Mass General Brigham Cancer Care, Inc., which is designed to quickly and efficiently find new treatments for GBM. Dosing in the combination therapy trial is expected to begin in the second half of 2026.

INO-5412 is composed of INO-5401 and T cell immune activator INO-9012. When combined with a checkpoint blockade, targeted DNA immunotherapy has the potential to overcome the challenges of immune checkpoint therapy alone by stimulating an immune response against tumor antigens and driving T cell infiltration into the glioblastoma tumor microenvironment. In an ongoing Phase 2 trial in newly diagnosed GBM patients, INO-5401 plus INO-9012 in combination with a PD-1 checkpoint inhibitor elicited robust immune responses that potentially correlate with enhanced survival. The novel combination of INO-5412 with cadonilimab to treat GBM builds on this promising data and could potentially benefit patients by providing additional checkpoint inhibition through CTLA-4 binding.

Cadonilimab has received marketing approval in China for several indications, including first-line gastric cancer, first-line cervical cancer, and second/third-line cervical cancer, demonstrating effectiveness irrespective of PD-L1 expression status. As the world’s first approved bispecific antibody for cancer immunotherapy developed in China, its clinical value is well-established through real-world application and validation across multiple Phase 3 trials. The drug is currently involved in over 11 Phase 3/registration clinical studies. Among these are two international multicenter trials: a Phase 3 registrational trial for the first-line treatment of gastric cancer, and a Phase 2 registrational trial for the second-line treatment of liver cancer in patients who exhibit resistance to immune checkpoint inhibitors (IO).

Dr. David Reardon, Director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute and a professor at Harvard Medical School said, "The INSIGhT trial was designed to help quickly advance cutting-edge treatments for GBM, the most common and aggressive form of brain cancer for which there are few effective treatments currently available or in development. We are excited to include INOVIO and Akeso’s novel combination immunotherapy in the trial and welcome their efforts to help improve potential outcomes for patients."

Dr. Michael Sumner, INOVIO’s Chief Medical Officer, said, "This collaboration is an important step forward for our cancer immunotherapy research and we are delighted to partner with two trailblazing organizations to advance this promising candidate in our late-stage clinical pipeline. Combining INO-5412 with Akeso’s novel checkpoint modality represents an important evolution of our research in GBM, builds on our previous data showing the potential to improve patient outcomes and highlights our ongoing commitment to advancing innovative treatments for diseases with significant unmet need."

Yu (Michelle) Xia, PhD, founder, chairwoman, president, and Chief Executive Officer of Akeso, said, "We are truly excited to collaborate with INOVIO for the treatment of GBM. We are advancing cadonilimab worldwide through Akeso’s ‘in-house innovation + global partnership’ strategy to realize its breakthrough clinical benefits for patients all around the world across multiple cancer types. By collaborating with INOVIO, we aim to harness the benefit of combining INOVIO’s DNA medicine with cadonilimab’s dual checkpoint inhibition for the treatment of GBM, a particularly challenging central nervous system malignancy. We also look forward to working with one of the world’s leading cancer centers in the clinical development of the new cadonilimab and INO-5412 combination treatment for GBM."

Under the terms of the agreement, INOVIO and Akeso will provide support for the INSIGhT study, including supplying their respective therapeutic products, while the investigative sponsors will oversee the day-to-day clinical operations.

About INSIGhT
The INdividualized Screening trial of Innovative Glioblastoma Therapy (INSIGhT) is investigating novel treatments in patients with newly diagnosed GBM. INSIGhT uses a shared control arm to test multiple investigational therapies at one time, with each arm independently compared only to the control. The arm of the trial that involves the collaboration between INOVIO and Akeso will investigate the safety and efficacy of INO-5412 in combination with cadonilimab in patients with histologically confirmed intracranial glioblastoma or gliosarcoma. Dosing is expected to begin in the second half of 2026. For more information about the clinical study, see www.clinicaltrials.gov, identifier NCT02977780.

About GBM
Glioblastoma (GBM) is the most common and aggressive type of brain cancer and remains a devastating disease for both patients and caregivers. Its prognosis is extremely poor, with few therapies approved over the last 10 years. The median overall survival for patients receiving standard of care therapy is approximately 15 months in patients with an unmethylated MGMT (O-6-methylguanine-DNA methyltransferase) promoter and the median progression-free survival is approximately 4 to 6 months. The estimated annual incidence of GBM in the U.S. is 11,362 cases or 3.21 cases per 100,000 persons and the median age at diagnosis is 65 years.

About INO-5412
INO-5412 is an investigational DNA medicine that combines INO-5401 and INO-9012 into a single vial as a potentially powerful cancer immunotherapy particularly when given in combination with checkpoint inhibitors. INO-5401 plus INO-9012 has been previously investigated as a potential therapeutic treatment targeting a number of cancers, including GBM and cancers exhibiting BRCA1 and BRCA2 mutations. Data from an ongoing Phase 2 trial in newly diagnosed GBM patients, highlighted in a 2022 oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), demonstrated that INO-5401 plus INO-9012 in combination with a PD-1 checkpoint inhibitor elicited robust immune responses that potentially correlated with enhanced survival. (Reardon D. et al, ASCO (Free ASCO Whitepaper) 2022).

INO-5401 encodes for INOVIO’s SynCon antigens for hTERT, WT1, and PSMA, which are antigens The National Cancer Institute has highlighted as important targets and designated as high priorities for cancer immunotherapy development. These three antigens have been reported to be over-expressed and often mutated in a variety of human cancers, including GBM. INO-9012 encodes for IL-12, which is a T cell immune activator.

About Cadonilimab
Cadonilimab, independently developed by Akeso, is the world’s first PD-1/CTLA-4 bispecific immuno-oncology therapy. It has been approved and reimbursed in China for three indications: recurrent/metastatic cervical cancer after platinum-based chemotherapy failure, first-line gastric cancer, and first-line cervical cancer. The drug has also been investigated in over 30 clinical trials spanning more than 20 tumor types. Currently, 11 Phase III or registrational trials are ongoing, with three already having met primary endpoints. With a novel dual-targeting mechanism against PD-1 and CTLA-4, cadonilimab demonstrates superior efficacy and a favorable safety profile compared to combination therapies. It has shown strong anti-tumor activity regardless of PD-L1 status and holds breakthrough potential in IO-resistant and immunologically "cold" tumors.

(Press release, Inovio, MAR 4, 2026, View Source [SID1234663247])