On March 10, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported an update on recent and anticipated business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Cullinan Therapeutics is poised to deliver multiple value-driving catalysts across our programs throughout 2026. Strong enrollment momentum for CLN-978 positions us to deliver the first company-sponsored data for a potential best-in-class CD19 T cell engager in autoimmune diseases in the second quarter, followed by important additional data updates throughout the year. CLN-978 is the ideal therapy for immune reset, with the optimal combination of target, CD19, and modality, T cell engager, together with the convenience of subcutaneous administration. This program has the potential to transform the treatment landscape in autoimmune diseases and deliver a compelling commercial opportunity," said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

"We are also pleased to begin the year with strong momentum in our oncology portfolio. With our partner, Taiho, we have completed the second line rolling NDA submission for zipalertinib and have fully enrolled the frontline study, REZILIENT3, both important milestones as zipalertinib moves closer to being available for patients. Finally, after sharing compelling clinical data at ASH (Free ASH Whitepaper) 2025 and with U.S. FDA Fast Track Designation, we expect to rapidly advance CLN-049 to registrational development in AML."

Portfolio Highlights and 2026 Milestones

Immunology

•
CLN-978 (CD19xCD3 bispecific T cell engager): Systemic Lupus Erythematosus (SLE), Rheumatoid arthritis (RA), and Sjögren’s disease (SjD)
•
OUTRACE SLE
o
In Q2 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, as well as other biomarker data and preliminary clinical activity data.
•
OUTRACE RA
o
In Q2 2026, the Company plans to share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.
o
In Q3 2026, the Company plans to share initial repeat dosing data, including B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.
•
OUTRACE SjD
o
In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.
•
Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
o
Genrix Bio is enrolling a Phase 1 study in China in patients with autoimmune diseases, initially in patients with SLE, followed by future planned expansion into other indications and initial clinical data from the study are expected to be shared in Q4 2026. Cullinan intends to use the data generated to accelerate global clinical development. Following completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.

Oncology

•
CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
o
The Company plans to share an update from the dose escalation portion of the Phase 1 study in patients with relapsed/refractory AML or MDS in H2 2026.
o
In Q2 2026, the Company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53m AML. In Q4 2026, the Company expects to complete enrollment for dose expansion to determine the recommended Phase 2 dose (RP2D) for an expected single arm pivotal registrational trial.
o
In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML.
o
Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.

•
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
In February, Taiho completed the rolling NDA submission to the U.S. FDA seeking accelerated approval of zipalertinib for the treatment of patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based systemic chemotherapy.
o
In February, Taiho completed enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC. Taiho expects to obtain top-line results by the end of 2026.
o
Cullinan is eligible to receive $30 million and up to $100 million upon 2L and 1L U.S. regulatory approvals, respectively, and a 50/50 profit share in the U.S. moving forward.
Fourth Quarter and Full Year 2025 Financial Results

•
Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $439.0 million as of December 31, 2025. Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.

•
R&D Expenses: Research and development expenses were $42.9 million for the fourth quarter of 2025, compared to $40.5 million for the same period in 2024, and $187.4 million for the full year 2025, compared to $142.9 million for the full year 2024.
•
G&A Expenses: General and administrative expenses were $12.3 million for the fourth quarter of 2025, compared to $14.6 million for the same period in 2024, and $54.2 million for the full year 2025, compared to $54.0 million for the full year 2024.
•
Net Loss: Net loss attributable to Cullinan was $50.7 million for the fourth quarter of 2025, compared to $47.6 million for the same period in 2024, and $219.9 million for the full year 2025, compared to $167.4 million for the full year 2024.

(Press release, Cullinan Oncology, MAR 10, 2026, View Source [SID1234663416])

On March 10, 2026 EnteroBiotix, a clinical-stage biopharmaceutical company developing best-in-class microbiome therapies, reported that the investigator-initiated Phase 2a MAST trial (Intestinal Microbiota Transplant prior to Allogeneic Stem Cell Transplantation) has completed its enrolment of 50 adult patients undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT) for defined haematological malignancies. Participants receive EBX-102-02 or matched placebo prior to conditioning chemotherapy and are followed for 12 months post-transplant.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study is sponsored by Imperial College London and funded by the Medical Research Council (MRC). It is led by Co-Chief Investigators Professor Julian Marchesi and Dr Jiri Pavlu, together with haematologists across leading UK transplant centres. EnteroBiotix is supplying EBX-102-02 for use in the trial.

Profound disruption of the gut microbiome is common during allo-HSCT, and loss of microbial diversity has been associated with increased risk of infection, graft-versus-host disease (GVHD) and reduced overall survival. The MAST trial will assess whether a single dose of pre-emptive orally administered EBX-102-02 can enhance and preserve microbial diversity during the transplantation period. Exploratory outcomes evaluate clinical transplant outcomes. Topline data are expected in H1 2027.

MAST builds on EnteroBiotix’s broader clinical programme, following previously announced positive Phase 2a data in irritable bowel syndrome (IBS) and Phase 1b data in liver cirrhosis, and supports the Company’s strategy to develop full-spectrum microbiome therapeutics across major disease areas supported by a strong biological rationale.

Professor Julian Marchesi said:

"Profound disruption of the intestinal microbiome is common during allogeneic stem cell transplantation and has been strongly associated with adverse outcomes. MAST builds on prior promising work from the Imperial team utilising traditional FMT approaches and has been designed to assess whether pre-emptive microbiota restoration using EBX-102-02 can preserve microbiome diversity during the transplant period and potentially improve post-transplant outcomes. We are pleased to have completed enrolment and thank the patients and clinical teams involved."

Dr James McIlroy, Chief Executive Officer of EnteroBiotix, said:

"Completion of enrolment in MAST builds on our recent progress in IBS and cirrhosis and marks another step in evaluating the potential of EBX-102-02 across multiple indications with high unmet medical need. We are excited about the potential of our platform and technology for supporting the treatment of oncology patients. We thank the Imperial investigators for their collaboration and look forward to topline data in H1 2027."

Trial Design

MAST (NCT06355583) is a multicentre, randomised (1:1), double-blind, placebo-controlled Phase 2a trial enrolling approximately 50 adult patients undergoing allo-HSCT for certain haematological malignancies. Participants receive EBX-102-02 or matched placebo prior to initiation of conditioning chemotherapy and are followed longitudinally for 12 months after allo-HSCT.

The primary endpoint evaluates change in gut microbiota alpha diversity from baseline to post-transplant timepoints. Secondary and exploratory endpoints include safety, tolerability, clinical transplant outcomes, and translational microbiome and immune analyses.

About EBX-102-02

EBX-102-02 is EnteroBiotix’s next-generation full-spectrum investigational microbiome therapeutic, manufactured using proprietary processing technologies designed to enable safe, stable and orally delivered microbial ecosystem restoration. The product is formulated to deliver consistently high microbial diversity with a robust stability profile.

(Press release, EnteroBiotix, MAR 10, 2026, View Source [SID1234663433])

On March 10, 2026 Galecto, Inc. (Galecto or the Company) (NASDAQ: GLTO), a biotechnology company working to fundamentally redefine care for patients with blood disorders, reported its name change to Damora Therapeutics, Inc. (Damora). Effective March 10, 2026, Damora will trade on Nasdaq under the trading symbol "DMRA."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The name change follows the completion of Galecto’s previously announced acquisition of privately held Damora and a concurrent private investment of approximately $285 million in November 2025. Combined with gross proceeds of approximately $316 million from the Company’s recently closed public offering in February 2026, Damora plans to rapidly advance its pipeline of mutant calreticulin (mutCALR)-targeted therapeutics in essential thrombocythemia (ET) and myelofibrosis (MF), beginning with lead program DMR-001.

"As Damora Therapeutics, we are bringing innovative, disease-modifying medicines to patients with mutCALR-driven myeloproliferative neoplasms (MPNs), where there is high medical need and no available treatments that target the underlying cause of disease," said Sherwin Sattarzadeh, Chief Operating Officer. "With a strong operational foundation including board and executive leadership with a track record of clinical and commercial success, we are now scaling efforts to initiate clinical development of DMR-001 and rapidly advance it toward registration."

DMR-001 is an investigational monoclonal antibody therapy targeting mutCALR with best-in-class potential, demonstrated by preclinical data showing its potent inhibition of both Type 1 and Type 2 mutCALR and an extended half-life expected to enable convenient, infrequent subcutaneous dosing. The Company’s additional anti-mutCALR pipeline therapies, DMR-002 and DMR-003, enable portfolio optionality to address the full spectrum of patients with mutCALR-driven MPNs.

MPNs are a group of rare, chronic blood cancers characterized by the abnormal production of blood cells in the bone marrow. MutCALR drives uncontrolled proliferation and disease progression in 25 percent of ET and 35 percent of MF cases. There are approximately 42,000 patients in the United States living with mutCALR-driven MPNs.

Damora anticipates the following upcoming milestones across its mutCALR programs:

•
Submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) or a clinical trial application (CTA) to a regulatory authority in another country for DMR-001 in mid-2026

•
Submit an IND or CTA for DMR-002 in the second half of 2026
•
Submit an IND or CTA for DMR-003 in 2027
•
Present two clinical proof-of-concept datasets for DMR-001 beginning mid-2027

(Press release, Galecto Biotech, MAR 10, 2026, View Source [SID1234663417])

On March 10, 2026 Kainova Therapeutics ("the Company"), a key player for breakthrough treatments in immuno-oncology and inflammation, reported positive topline results from its Phase I EPRAD study evaluating DT-9081, a proprietary, oral small molecule EP4 receptor (EP4R) antagonist in patients with advanced, recurrent, and metastatic solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study, conducted across four sites in France and Belgium, met all primary objectives. Results demonstrated a favorable safety profile, robust pharmacokinetic (PK) and pharmacodynamic (PD) characteristics with dose-proportional exposure, and sustained EP4 receptor engagement across all tested doses, with early signs of anti-tumor activity.

No dose-limiting toxicities were reported at any dose level, confirming DT-9081’s clinical tolerability and validating its mechanism of action. The Phase I findings further support DT-9081’s potential to improve responses to immune checkpoint inhibitors (ICIs). Full Phase I study details are available on clinicaltrials.gov under identifier NCT05582850.

Professor Jean-Pascal Machiels, Principal Investigator of the EPRAD study, commented: "The results of the study not only validate EP4 receptor antagonism as a powerful mechanism to counteract PGE2-driven immune suppression, but also demonstrate the clinical potential of DT-9081 across a range of tumor types. Since chemotherapy and other standard treatments often trigger PGE2 production by cancer cells, restoring competence through selective EP4 inhibition offers a rational and versatile strategy to overcome resistance. It was my honor to contribute to the advancement of DT-9081 through the clinic."

Dr Jean-Marie Cuillerot, Chief Medical Officer of Kainova Therapeutics, said: "The Phase I EPRAD study generated a clear and coherent dataset that precisely characterizes DT-9081’s clinical profile. Across all dose levels, we observed consistent safety findings together with robust PK/PD readouts. The high-quality clinical and translational data obtained in this study are essential for understanding how EP4 antagonism behaves in patients with advanced solid tumors in a clinical setting."

Sean A. MacDonald, Chief Executive Officer of Kainova Therapeutics, added: "The successful completion of this Phase I study represents an important step for Kainova Therapeutics, highlighting the strength of our innovative approach to targeting the EP4 receptor to overcome tumor-induced immunosuppression. The favorable safety and early efficacy signals observed with DT-9081 provide meaningful insight into EP4 biology and its role in immuno-oncology. These findings reflect the depth of expertise within our team and reinforce the relevance of GPCR-modulating strategies in addressing complex immune pathways."

(Press release, Kainova Therapeutics, MAR 10, 2026, View Source [SID1234663434])

On March 10, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that the Phase III AMPLIFY trial (NCT06970847) has now consented in excess of the planned number of participants following strong demand for study participation at sites in the United States (US) and Australia. Consenting of new patients has stopped at all sites pending completion of remaining screening assessments and confirmation of final enrolment numbers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

AMPLIFY (64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants with Biochemical Recurrence of Prostate Cancer) is a non-randomised, single-arm, open-label, multi-centre, diagnostic clinical trial of 64Cu-SAR-bisPSMA positron emission tomography (PET) in participants with rising or detectable prostate-specific antigen (PSA) after initial definitive treatment at clinical sites across the US and Australia.

The aim of this registrational study is to investigate the diagnostic ability of 64Cu-SAR-bisPSMA PET/computed tomography (CT) to detect recurrence of prostate cancer in men with PSA levels above 0.2 ng/mL. Evaluation will be across two imaging timepoints: Day 1 (1-4 hours post-administration, same-day imaging) and Day 2 (approximately 24 hours post administration, next-day imaging).

AMPLIFY commenced in May 2025, seeking to enrol approximately 220 participants, and the first trial participant was imaged in the same month at XCancer with Dr Luke Nordquist (Omaha, NE). The data from this study will complement the Phase I/II COBRA2 and Phase II Co-PSMA3 trials. Both studies have demonstrated enhanced imaging capabilities of 64Cu-SAR-bisPSMA over standard-of-care (SOC) prostate-specific membrane antigen (PSMA) PET imaging in patients with biochemical recurrence (BCR) of prostate cancer. As a pivotal trial, the final study results from AMPLIFY are intended to provide evidence to support an application to the US Food and Drug Administration (FDA) for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in BCR of prostate cancer.

64Cu-SAR-bisPSMA is also currently being evaluated in another registrational Phase III trial, CLARIFY (NCT06056830)4, which is expected to close recruitment in CY2026. Building on the Phase I PROPELLER5 study, the objective of CLARIFY is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET across same-day and next-day imaging in detecting prostate cancer within the pelvic lymph nodes in patients who are scheduled to undergo radical prostatectomy and pelvic lymph node dissection. The CLARIFY results are intended to support an FDA approval application for 64Cu-SAR-bisPSMA in prostate cancer patients who are candidates for definitive therapy.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, "We are about to enter the realm of a select few Australian companies who have developed a drug at the benchtop of Australian science and completed an international Phase III clinical trial with that drug, taking us one step closer to commercialisation. Our team is excited to have reached this initial recruitment milestone in the AMPLIFY trial in just 9 months since we imaged our first participant in the study. This is no small feat, given we achieved this phenomenal pace of recruitment despite three SOC products already in the market, commercialised by four different companies.

"True to our commitment to the highest standards of clinical research, we recruited participants at numerous different sites across the US and Australia to ensure the trial reflected the broad patient population, real-world clinical settings and various PET cameras in which this product is intended to be used. This strategy required careful planning to allow for all participating sites to contribute to the recruitment, based on allocation of participant numbers to be enrolled per site, resulting in what we believe will be a robust and well-balanced dataset and supporting the integrity and quality of the AMPLIFY study.

"Despite the variations in the sites’ activation times, the speed of enrolment in this trial not only highlights the unmet need in the BCR space but also indicates the strong demand for 64Cu-SAR-bisPSMA from clinicians and patients seeking more effective and accurate prostate cancer detection diagnostics. With persistent outreach from participating sites to enrol more patients, clinicians and patients would rather use an unapproved product, undertaking additional demands of a clinical trial, than rely on the findings of the current SOC PSMA PET.

"To date, we have imaged approximately 600 patients with prostate cancer with 64Cu-SAR-bisPSMA, and just in the last year we scanned over 350 of them. The growing demand for better imaging is driven by so many men around the world with prostate cancer who seek accurate and timely identification of disease location and recurrence. We are committed to answering these needs of patients, clinicians and imaging facilities with a next-generation diagnostic imaging agent specifically designed to deliver significant benefits in efficacy, clinical management, quality of life and operational flexibility across the prostate cancer care pathway.

"The results on 64Cu-SAR-bisPSMA generated to date, from our initial discovery and pre-clinical work, to the recently announced Co-PSMA and the COBRA trials, constitute an extensive body of evidence against SOC, demonstrating that maximal clinical benefit of PSMA PET can be derived through the combination of the proprietary SAR-bisPSMA agent and optimised imaging timepoints facilitated by the half-life of copper-64. Achieving a two to three times improvement in lesion detection over SOC in BCR is an incredible achievement. We believe we can grow the blockbuster PSMA PET market even further with a product that has shown impressive efficacy in clinical trials coupled with many logistical and supply chain benefits. Our team will be working closely with our vendors and participating sites to advance the final data package and with regulatory authorities to get this product to patients in need as soon as possible.

"We also look forward to closing recruitment in the CLARIFY trial this year and progressing our theranostic Phase I/IIa SECuRE trial towards completion. Together with three Fast Track Designations we have for SAR-bisPSMA and positive interactions with the US FDA to date, these milestones place us closer than ever to commercialisation of this exciting agent through the entirety of the prostate cancer journey, from first detection to late-stage metastatic disease."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide6. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease.

(Press release, Clarity Pharmaceuticals, MAR 10, 2026, View Source [SID1234663360])