On March 10, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the full year ended December 31, 2025 and provided an update on its R&D pipeline and other corporate developments.

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"Since the announcement of our strategic shift in November of 2025, our team continues to operate with a clear focus on steady execution on our JAK2V617F inhibitor and KAT6 degrader programs, most recently evidenced by the timely clearance of the IND for PRT12396." stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "We continue to remain on track to have both PRT12396 and PRT13722 in clinical development this year, which will position the Company for potential key data catalysts from both of these potentially differentiated modalities in 2027."

Program Updates and Upcoming Milestones

Mutant selective JAK2V617F JH2 inhibitor program

JAK2V617F is the primary driver mutation responsible for disease progression in the majority of patients living with myeloproliferative neoplasms (MPNs). The mutation impacts approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Identifying JAK2 JH2 inhibitors that selectively target V617F+ cells has long been the goal for advancing the treatment of MPNs. Prelude has designed and identified novel allosteric inhibitors that bind into the JAK2 JH2 "deep pocket" where the V617F mutation resides. These candidates demonstrate mutant specific inhibition in multiple preclinical models of MPNs. Prelude believes this approach may have the potential to reduce mutant allele burden, slow or even reverse disease progression, and transform treatment outcomes for MPN patients.

PRT12396, Prelude’s lead, mutant-selective JAK2V617F inhibitor received IND clearance from the U.S. Food and Drug Administration, as previously announced in February 2026 and anticipates initiating a Phase 1 study in the 2nd quarter of 2026.

The Phase 1 study of PRT12396 is an open-label, multi-center study in patients with high-risk PV and intermediate and high-risk MF.

The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in November 2025.

Highly selective KAT6A oral degrader program

KAT6 is an emerging and recently validated target in the treatment of ER+ breast cancer. Prelude discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A selective degraders. The Company has selected a development candidate and remains on track to file an IND in mid-2026 with phase 1 study initiation planned in the 2nd half of 2026. Prelude believes that selectively degrading KAT6A has the potential for improved efficacy, tolerability and combinability with other agents relative to non-selective inhibitors of KAT6A/B.

The Company presented initial preclinical data supporting this hypothesis at the AACR (Free AACR Whitepaper) Annual Meeting 2025. The presentation can be found at Publications – Prelude Therapeutics.

Degrader payloads for next generation DACs

Prelude is leveraging our expertise in targeted protein degradation to discover and develop novel degrader payloads for use with next generation DACs. We have developed highly potent SMARCA2/4 and CDK9 degrader payloads optimized for efficacy, tolerability and developability when coupled to a wide range of different antibodies.

The Company has amended and expanded the scope of our existing DAC collaboration with AbCellera Biologics. This enables AbCellera to use our degrader payloads on additional undisclosed antibody targets of interest and also enables Prelude to utilize our degrader payloads in licensing arrangements with other potential partners. The Company’s payloads and corresponding payload-linkers are available for licensing to partners to expand the reach of this new technology.

We have recently published preclinical data demonstrating that next generation DACs using Prelude degrader payloads have potential for significantly better in vivo efficacy and tolerability compared to traditional cytotoxic ADCs when tested head-to-head in xenograft models. These data can be found at: Publications – Prelude Therapeutics

Mutated calreticulin (mCALR) DAC discovery program

Mutant CALR is a neoantigen presented on the cell surface of malignant myeloid cells but not normal cells and is found in approximately 25-35% of patients with MF and essential thrombocythemia (ET). Recently, a mCALR-targeted monoclonal antibody demonstrated robust clinical activity in high-risk ET patients. Prelude is exploring mCALR-targeted DACs using the Company’s proprietary degrader payloads as a differentiated approach for patients with CALR mutations. This early discovery program is wholly owned and controlled by Prelude.

The Company presented the preclinical data from the program at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress in June and the American Society of Hematology (ASH) (Free ASH Whitepaper) 67th Annual Meeting in December 2025. The presentations can be found at Publications – Prelude Therapeutics.

Upcoming Investor Conference

The Company will participate in the Citizens Life Sciences Conference taking place in Miami, FL. On Tuesday, March 10, 2026 at 3:25 PM ET, Kris Vaddi, Ph.D., Chief Executive Officer, Peggy Scherle, Ph.D., Chief Scientific Officer and Bryant Lim, Chief Financial Officer will participate in a fireside chat.

A live webcast of the fireside chat can be accessed here and on the Company’s website under Events and Presentations. The recording will be archived and available on the Company’s website for 90 days.

Full Year 2025 Financial Results 

Cash, Cash Equivalents, Restricted cash and Marketable securities:

Cash, cash equivalents, restricted cash and marketable securities as of December 31, 2025 were $106.4 million. The Company anticipates that its existing cash, cash equivalents and marketable securities will fund Prelude’s operations into the second quarter of 2027.

Research and Development (R&D) Expenses:

For the year ended December 31, 2025, R&D expense decreased to $94.3 from $118.0 million for the prior year period. Included in the R&D expense for the year ended December 31, 2025 was $6.9 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $12.1 million for year ended December 31, 2024. Along with the decrease in stock-based compensation expense, research and development expenses decreased due to a decrease in expense related to our discontinued clinical trials. Research and development expenses may fluctuate from period to period depending upon the stage of certain projects and the level of preclinical and clinical trial-related activities.

General and Administrative (G&A) Expenses:

For the year ended December 31, 2025, G&A expenses decreased to $22.4 million from $28.7 million for the prior year period. Included in general and administrative expenses for the year ended December 31, 2025, was $5.0 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $9.2 million for year ended December 31, 2024. The decrease in general and administrative expenses was primarily due to a decrease in stock-based compensation along with a decrease in employee-related expenses.

Net Loss:

For the year ended December 31, 2025, net loss was $99.5 million, or $1.29 per share compared to $127.2 million, or $1.68 per share, for the prior year period. Included in the net loss for the year ended December 31, 2025, was $11.9 million of non-cash expenses related to the impact of expensing share-based payments, including employee stock options due in part to fewer employees, as compared to $21.3 million for the same period in 2024.

(Press release, Prelude Therapeutics, MAR 10, 2026, View Source [SID1234663420])

On March 10, 2026 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that members of the management team will participate at the Stifel 2026 Virtual CNS Forum at 4:30 PM EST on March 17, 2026.

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The live webcast can be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

(Press release, Neurocrine Biosciences, MAR 10, 2026, View Source [SID1234663419])

On March 10, 2026 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that members from its executive leadership team will be attending and participating at BIO Europe Spring taking place March 23-25, 2026 in Lisbon, Portugal.

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In attendance will be Ryan Confer, President and Chief Executive Officer at Genprex and Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing at Genprex. Throughout the duration of the conference, Genprex executives will be available to conduct one-on-one meetings with industry groups to provide an overview of the Company’s gene therapies for cancer and diabetes.

For those interested in meeting with Genprex management during the conference, please request a meeting through the conference meeting portal or by contacting Investor Relations at [email protected]. BIO Europe Spring attracts a wide range of business leaders, including senior executives of leading biotech companies, business development teams from large and midsize pharmaceutical companies, investors and other industry experts. The event is expected to bring together more than 3,700 executives from biotech, pharma and finance companies to engage in more than 20,000 one-on-one meetings.

(Press release, Genprex, MAR 10, 2026, View Source [SID1234663418])

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."

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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

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Submit an IND or CTA for DMR-002 in the second half of 2026
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Submit an IND or CTA for DMR-003 in 2027
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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 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.

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"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

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CLN-978 (CD19xCD3 bispecific T cell engager): Systemic Lupus Erythematosus (SLE), Rheumatoid arthritis (RA), and Sjögren’s disease (SjD)
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OUTRACE SLE
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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.
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OUTRACE RA
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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.
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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

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CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
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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.
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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.
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In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML.
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Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.

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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
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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

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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.

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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.
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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.
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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])