On March 5, 2026 Shattuck Labs, Inc. (Shattuck or the Company) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of potential first-in-class monoclonal and bispecific DR3 blocking antibodies for the treatment of patients with inflammatory and immune-mediated diseases, reported financial results for the fourth quarter and full year ended December 31, 2025 and provided recent business highlights.

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"SL-325 is now the first DR3 blocking antibody to generate human clinical data, and we are very pleased with the progress we have made in our Phase 1 clinical trial, which is nearly complete. We look forward to sharing the data from this trial in the second quarter, and anticipate initiating our Phase 2 clinical trial in Crohn’s disease in the third quarter," said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck.
DR3 Program Development in 2025

Shattuck’s lead product candidate, SL-325, is a potentially first-in-class and best-in-mechanism DR3 blocking antibody for the treatment of Crohn’s disease, ulcerative colitis, and other inflammatory and immune-mediated diseases. Recent updates and anticipated upcoming milestones for SL-325, and Shattuck’s other DR3 blocking antibodies, include:

•The Phase 1 trial evaluating the safety, tolerability, immunogenicity, and pharmacokinetics (PK) of SL-325 in healthy volunteers is ongoing and progressing as planned, and will determine the recommended Phase 2 dose and dosing schedule.

▪Enrollment of all six single-ascending dose (SAD) cohorts is now complete, and full enrollment in the final multiple-ascending dose (MAD) cohort of the trial is expected to be completed in the second quarter of 2026.
•Shattuck expects to disclose safety and tolerability, PK, receptor occupancy, duration of receptor occupancy, and immunogenicity data from this trial in the second quarter of 2026.

•Subject to positive Phase 1 data and regulatory alignment, Shattuck expects to initiate a Phase 2 clinical trial of SL-325 in patients with Crohn’s disease in the third quarter of 2026.

•Shattuck continues to develop multiple DR3-based bispecific antibodies. Shattuck’s lead bispecific antibody has entered IND-enabling activities. This bispecific antibody was designed to inhibit both the DR3/TL1A axis and another biologically relevant target for the treatment of patients with inflammatory and immune-mediated diseases. Shattuck plans to disclose the targets of its lead bispecific product candidate, supporting preclinical data, and expected development timelines in the first half of 2026.

Appointment to Management Team

•Michael Choi, M.D., joined Shattuck Labs as Vice President of Clinical Development in November 2025. Dr. Choi brings extensive experience advancing inflammatory bowel disease programs, including as clinical lead at Morphic Therapeutic, where he led the development of MORF-057, its oral α4β7 antagonist. Earlier in his career, Dr. Choi served as Assistant Professor of Medicine at Harvard Medical School and Affiliated Faculty at the Harvard Stem Cell Institute. Dr. Choi received his medical degree from Cornell University, trained in Internal Medicine at UCSF, and completed his Gastroenterology Fellowship at Massachusetts General Hospital.

Recent Events
•Shattuck participated in the Piper Sandler 37th Annual Healthcare Conference on December 2, 2025. Dr. Schreiber presented at the conference and management participated in one-on-one meetings.
•Shattuck participated in the Evercore ISI 8th Annual HealthCONx Conference on December 3-4, 2025. Dr. Schreiber participated in a fireside chat and management participated in one-on-one meetings.
•Shattuck participated in the Piper Sandler Virtual Novel Targets in Immunology Symposium on February 12-13, 2026. Dr. Schreiber, Andrew R. Neill, Chief Financial Officer, and Michael Choi, M.D., Vice President of Clinical Development participated in a fireside chat.
•Shattuck participated in the TD Cowen 46th Annual Health Care Conference on March 2-4, 2026. Dr. Schreiber presented at the conference and management participated in one-on-one meetings.
Upcoming Events
•Shattuck plans to attend the following investor conference. Details will be included on the Events & Presentations section of the Company’s website.
•Leerink Global Healthcare Conference 2026 (Miami, FL), March 8-11, 2026. Dr. Schreiber will present at the conference and participate in one-on-one meetings.
Capital Markets Update
•In the first quarter of 2026, Shattuck sold shares of its common stock under its at-the-market offering facility for aggregate gross proceeds of $21.4 million. As a result of these sales, accounts advised by T. Rowe Price Investment Management, Inc. reported beneficial ownership of more than 10% of the Company’s outstanding common stock.
•As of February 28, 2026, cash and cash equivalents and short-term investments were approximately $94.5 million (unaudited), which includes the gross proceeds of $21.4 million from sales of Shattuck’s common stock under its at-the-market offering facility, as described above. This amount is preliminary, has not been audited or reviewed by the Company’s independent registered public accounting firm, and is subject to change upon completion of the Company’s financial closing procedures.

Fourth Quarter and Full-Year 2025 Financial Results

•Cash and Cash Equivalents and Investments: As of December 31, 2025, cash and cash equivalents and short-term investments were approximately $78.1 million, as compared to $73.0 million as of December 31, 2024.
•Research and Development (R&D) Expenses: R&D expenses were $9.1 million for the quarter ended December 31, 2025, as compared to $15.4 million for the quarter ended December 31, 2024. R&D expenses for the year ended December 31, 2025 were $35.3 million, as compared to $67.2 million for the year ended December 31, 2024. This full year decrease was a result of the discontinuation of the SL-172154 program and related workforce reductions and other pipeline compound costs, partially offset by an increase in SL-325 expenses primarily as a result of moving SL-325 into clinical development in 2025.
•General and Administrative (G&A) Expenses: G&A expenses were $4.3 million for the quarter ended December 31, 2025, as compared to $4.2 million for the quarter ended December 31, 2024. General and administrative expenses for the year ended December 31, 2025 were $17.2 million, as compared to $19.1 million for the year ended December 31, 2024. This full year decrease was primarily the result of a decrease in compensation and related benefit expenses as a result of workforce reductions in 2024 as well as a decrease in legal fees.
•Net Loss: Net loss was $12.6 million for the quarter ended December 31, 2025, or $0.12 per basic and diluted share, as compared to a net loss of $18.7 million for the quarter ended December 31, 2024, or $0.37 per basic and diluted share. Net loss for the year ended December 31, 2025 was $48.8 million, or $0.70 per basic and diluted share, as compared to $75.4 million, or $1.49 per basic and diluted share, for the year ended December 31, 2024.

Financial Guidance

As of December 31, 2025, cash and cash equivalents and short-term investments were approximately $78.1 million. Shattuck’s current cash and cash equivalents and short-term investments, including the gross proceeds from its sale of common stock under its at-the-market offering facility of $21.4 million in the first quarter of 2026, and assuming the full exercise of the outstanding common stock warrants, are expected to fund operations into 2029. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken.

About SL-325
SL-325 is a potential first-in-class Death Receptor 3 (DR3) blocking antibody designed to achieve a complete and durable blockade of the clinically validated DR3/TL1A pathway. Shattuck’s preclinical studies demonstrate high affinity binding and superior activity over TL1A antibodies, and offer a data-driven rationale for targeting the TNF receptor, DR3, versus its ligand, TL1A. SL-325 is a fully Fc-silenced, humanized immunoglobulin G monoclonal antibody with a favorable safety profile in non-human primates, currently being evaluated in a Phase 1 clinical trial.

(Press release, Shattuck Labs, MAR 5, 2026, View Source [SID1234663305])

On March 5, 2026 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported it will webcast management participation at the Barclays 28th Annual Global Healthcare Conference at 9:00 a.m. ET on Tuesday, March 10, 2026.

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The session may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A replay and transcript of the webcast will be archived on the Company’s website for at least 30 days.

(Press release, Regeneron, MAR 5, 2026, View Source [SID1234663304])

On March 5, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinicaal-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported a business update and announced full year 2025 financial results.

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"2026 is on track to be transformational for NextCure, as we set the stage to present clinical dose escalation data from the Phase 1 trial for SIM0505, in development for multiple cancers," said Michael Richman, President and CEO of NextCure. "Since acquiring the program in June of 2025, we have made rapid clinical and regulatory progress and soon expect to begin enrolling platinum resistant ovarian cancer patients in the Phase 1 dose optimization study. To accelerate the program, we plan to double the number of U.S. trial sites and expand our footprint into multiple other countries."

Business Highlights and Near-Term Milestones

SIM0505 (CDH6 ADC): Phase 1 dose escalation data expected in Q2 2026

SIM0505 is a novel ADC directed to cadherin-6 (CDH6 ADC), overexpressed in several cancers including ovarian cancer, with limited expression in healthy tissues. SIM0505 features a proprietary topoisomerase 1 inhibitor (TOPOi) payload, designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window.

● Data from the Phase 1 open-label dose escalation study is expected to be presented in the second quarter of 2026, including results from patients in the U.S. and China.
● The study (NCT06792552) is evaluating SIM0505 in patients with advanced solid tumors with a focus on gynecological cancers and an emphasis on platinum resistant ovarian cancer (PROC).
● Initiation of Phase 1 dose optimization study in ovarian cancer expected in the second quarter of 2026 with a continued focus on PROC. The Company anticipates doubling the number of trial sites in the second half of 2026, including the activation of sites in Canada and Europe, with continued study site additions in 2027.

LNCB74 (B7-H4 ADC): Ongoing enrollment in Phase 1 dose escalation

LNCB74 is a novel ADC directed to B7-H4, overexpressed in several cancers, with limited expression in healthy tissues. LNCB74 features a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload.

● Higher dose cohort enrollment initiated in the ongoing open-label Phase 1 dose escalation study (NCT06774963), following the November 2025 protocol amendment announcement. The next dose cohort will prioritize patients with high B7-H4 expression in breast and gynecological cancers, as well as the inclusion of patients with adenoid cystic carcinoma type 1.
● NextCure continues to plan to provide a trial update in the second half of 2026.

Financial Results for the Full Year Ended December 31, 2025

● Cash, cash equivalents, and marketable securities as of December 31, 2025 were $41.8 million as compared to $68.6 million as of December 31, 2024. The decrease of $26.8 million was primarily due to cash used to fund operations of $49.6 million, including $13.5 million of upfront license fees and milestone payments to Simcere Zaiming Pharmaceutical Co., Ltd. for the rights to SIM0505, partially offset by proceeds of $22.3 million from equity sales including a $21.5 million private placement of common stock in November 2025. NextCure expects current financial resources to be sufficient to fund operating expenses and capital expenditures into the first half of 2027 through proof-of-concept for SIM0505.
● Research and development expenses were $44.9 million for the full year ended December 31, 2025, as compared to $41.5 million for the full year ended December 31, 2024. The increase of $3.4 million was due to $18.5 million of license fees and milestone payments for SIM0505 partially offset by lower costs related to deprioritized programs, lower preclinical development costs and lower personnel-related costs.
● General and administrative expenses were $12.7 million for the full year ended December 31, 2025, as compared to $15.7 million for the full year ended December 31, 2024. The decrease of $3.0 million was primarily related to lower personnel costs.
● Net loss was $55.8 million for the full year ended December 31, 2025, as compared to a net loss of $55.7 million for the full year ended December 31, 2024. Net loss for the year ended December 31, 2025 was driven by higher research and development costs and lower other income of $2.3 million, partially offset by lower general and administrative costs and lower restructuring charges.

About SIM0505

SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds

exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.

About LNCB74

LNCB74 is a novel antibody drug conjugate (ADC) directed to B7-H4, featuring a proprietary tumor-selective cleavable linker and a tubulin inhibitor monomethyl auristatin E (MMAE) payload. LNCB74 is being evaluated in an open-label, Phase 1 dose escalation study for the potential treatment of advanced solid tumors. NextCure shares global co-development rights with LigaChem Biosciences, Inc. through a 50-50 cost share arrangement.

(Press release, NextCure, MAR 5, 2026, View Source [SID1234663302])

On March 5, 2026 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious medical conditions, reported its fourth quarter and full year 2025 financial and operating results and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and to provide a business update.

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"2025 was a very productive year for the Lineage team," stated Brian M. Culley, Lineage CEO. "Our mission is to pioneer the emerging field of allogeneic cell therapy outside of oncology by applying our proprietary cell manufacturing technology platform, AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), to the production and transplantation of differentiated cell types, which are intended to replace the cells which a patient has lost, or lost function of, due to various conditions. Throughout 2025, we made meaningful progress in strengthening our scientific, operational and strategic foundations, and reported notable events in support of our mission including:

Continued progress with the OpRegen cell therapy program, including achievement of the first of the $620 million of milestone payments available under our collaboration with Roche and Genentech; a milestone rooted in our manufacturing expertise and reflecting years of investment to optimize our in-house production processes.
Solidified our position as a leader in allogeneic cell process development by demonstrating success with our proprietary AlloSCOPE manufacturing platform, reporting current Good Manufacturing Practice (cGMP) production for each of two programs, from a master and working cell bank system which we expect, in its current form, should enable a production capability of millions of doses of a single-administration product, all from our in-house facility.
Entered a research collaboration with William Demant Invest A/S, intended to fund all currently planned preclinical development of our ReSonance program, demonstrating the ability of our technology platform to produce partnerable programs efficiently, rapidly and economically.
Launched a new cell therapy research initiative, with our initial focus on addressing the issue of large-scale production of undifferentiated pluripotent cells, which if successful could be evaluated for the production of islet cells to support a potential treatment of Type 1 Diabetes.
Treated the first ever chronic spinal cord injury (SCI) patient in the DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study, the third clinical study of OPC1, a study evaluating a potentially superior delivery system, designed to deliver our proprietary cells over several minutes and without the need for stopping patient ventilation during administration."
Mr. Culley continued, "2026 will be an exciting year as we advance our therapeutic candidates and pursue our long-term goal of creating a pipeline of similar cell-based assets, some of which we might choose to develop internally and some which we might seek to partner, but all based on our core technology and platform. Our priorities in 2026 will include achieving key clinical and financial milestones, advancing our manufacturing capability, and maintaining the organizational focus necessary to execute with consistency against these goals."

Select Business Highlights

RG6501 (OpRegen Cell Therapy)
Achieved the first milestone available under worldwide collaboration with Roche and Genentech, based on manufacturing and clinical advancements related to the OpRegen cell therapy program.
Positive RG6501 (OpRegen cell therapy) Phase 1/2a clinical study 36 month results featured at Clinical Trials at the Summit (CTS) 2025, suggest evidence of sustained gains in visual acuity and structural support of the retina.
Positive long-term clinical outcomes reported following a single administration of OpRegen cell therapy.
Clinical data reported at 12-, 24-, and 36-months for Cohort 4 of the Phase 1/2a study (12 patients) continues to demonstrate a consistent and durable treatment effect, with OpRegen-treated eyes exhibiting mean best corrected visual acuity (BCVA) scores above baseline at each of these timepoints in these patients with less advanced disease.
Notably, five patients who received significant coverage of OpRegen cell therapy across their geographic atrophy (GA) lesion are demonstrating long-term outcomes consistent with meaningful disease stabilization and even improvement.
Ongoing execution of Lineage’s contributions to its collaboration with Roche and Genentech. The ongoing Phase 2a GAlette Study is currently enrolling at 17 clinical sites in the U.S. and Israel.
In addition to testing other surgical parameters, Genentech currently plans to evaluate proprietary surgical delivery devices that have potential advantages over available off-the-shelf devices in the Phase 2a GAlette Study.
Ongoing efforts to further support development of OpRegen cell therapy under a separate services agreement with Genentech, signed May 2024, including: (i) activities to support the ongoing Phase 1/2a study long term follow-up and the currently enrolling Phase 2a GAlette Study; and (ii) additional technical training and materials related to our cell therapy technology platform to support commercial manufacturing strategies.
ReSonance (ANP1)
Announced research collaboration with William Demant Invest A/S (WDI) to jointly advance preclinical development of ReSonance (ANP1) over a term of three years; up to $12 million of development costs to be contributed by WDI in a collaboration which is intended to cover planned preclinical development activities, including cell manufacturing, proof-of-concept studies, translational/functional models, delivery development, outcome measures, regulatory strategy, and market analysis.
Demonstrated AlloSCOPE Platform Manufacturing Capability
Successfully completed a production run for two product candidates, each produced from a customized, two-tiered cGMP cell banking system, highlighting the application of the Lineage platform across multiple programs.
This production process utilizes a genetically-stable master cell bank created from a single, well-characterized pluripotent cell line, to generate a working cell bank, which then provides the source material for a final cell-based product candidate.
This demonstrated cGMP production process should enable the ability to produce millions of doses of a cost-effective, scalable and consistent supply of an allogeneic, cell-based product derived from a single initial cell line, that can be applied across multiple programs.
ILT1
Launched new cell therapy research initiative, inverting the risk profile of traditional cell therapy development, focused on deploying the company’s manufacturing capability to address the issue of large-scale production of undifferentiated pluripotent cells, with the initial goal of establishing a production modality that can support the entire production process through differentiation in a dynamic culturing system, which if successful could potentially solve a major hurdle to commercialization of islet cell therapy product candidates.
OPC1
First chronic SCI participant treated in the DOSED study.
First treated participant was a neurologically complete SCI injury (American Spinal Injury Association Impairment Scale [AIS] grade A), with a single neurological level of injury (NLI) from levels T1 to T10, and the novel delivery system successfully administered a one-time injection of OPC1.
No significant safety events were reported 180 days following treatment in the first chronic SCI participant.
Opened second clinical site in the DOSED study, Rancho Research Institute, in conjunction with Rancho Los Amigos National Rehabilitation Center.
Lineage resubmitted its Clinical Trial (CLIN2) grant application to support the DOSED study to the California Institute for Regenerative Medicine (CIRM) in January 2026, and CIRM continues to review Lineage’s application.
Balance Sheet Highlights

Cash, cash equivalents, and marketable securities of $55.8 million as of December 31, 2025, together with the approximate $5.4 million in proceeds from warrant exercises in March 2026, is expected to support planned operations into Q2 2028.

Fourth Quarter Operating Results

Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended December 31, 2025 were approximately $6.6 million, a net increase of $3.7 million as compared to $2.9 million for the same period in 2024. The increase was primarily driven by higher collaboration revenue recognized under our worldwide collaboration and license agreement with Roche (the "Roche Agreement") following the achievement of the first milestone, along with the new research collaboration agreement with WDI.

Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended December 31, 2025 were $13.2 million, an increase of $5.2 million as compared to $8.0 million for the same period in 2024.

R&D Expenses: R&D expenses for the three months ended December 31, 2025 were $8.2 million, an increase of $4.8 million as compared to $3.4 million for the same period in 2024. The net increase was primarily driven by $2.1 million for our OpRegen program expenses and $2.7 million for our preclinical and other undisclosed programs.

G&A Expenses: G&A expenses for the three months ended December 31, 2025 were approximately $4.8 million, an increase of $0.4 million as compared to $4.4 million for the same period in 2024. The net increase was primarily driven by personnel costs.

Loss from Operations: Loss from operations for the three months ended December 31, 2025 was $6.5 million, an increase of $1.4 million as compared to $5.1 million for the same period in 2024.

Other Income/(Expenses): Other income/(expenses) for the three months ended December 31, 2025 reflected other income of $2.2 million, compared to other income of approximately $1.9 million for the same period in 2024. The net increase was primarily driven by exchange rate fluctuations related to Lineage’s international subsidiaries and no warrant-related financing transaction costs incurred as compared to the prior year’s quarter, partially offset by the non-cash quarterly fair value remeasurement expense of the warrant liabilities.

Net Income/Loss Attributable to Lineage: The net income/loss attributable to Lineage for the three months ended December 31, 2025 was net income of $0.9 million, or $0.004 per share (basic and diluted), compared to a net loss of $3.3 million, or $0.02 per share (basic and diluted), for the same period in 2024.

Full Year Operating Results

Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the year ended December 31, 2025 were $14.6 million, a net increase of $5.1 million as compared to $9.5 million for the same period in 2024. The increase was primarily driven by higher collaboration revenue recognized under the Roche Agreement following the achievement of the first milestone, along with the new research collaboration agreement with WDI.

Operating Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended December 31, 2025 were $51.2 million, an increase of $20.2 million as compared to $31.0 million for the same period in 2024. The increase was primarily driven by $14.8 million expense recognized during the year for the loss on impairment for the intangible asset related to the VAC platform.

R&D Expenses: R&D expenses for the year ended December 31, 2025 were $17.7 million, an increase of approximately $5.2 million as compared to $12.5 million for the same period in 2024. The increase was primarily driven by $1.6 million for our OpRegen program, $0.7 million increase for our ANP1 program, $0.2 million for our OPC1 program and $2.8 million for our preclinical programs and other undisclosed programs.

G&A Expenses: G&A expenses for the year ended December 31, 2025 were $18.5 million, an increase of approximately $0.3 million as compared to $18.2 million for the same period in 2024. The net increase was primarily driven by $0.2 million in personnel costs and $0.1 million for services provided by third parties.

Loss from Operations: Loss from operations for the year ended December 31, 2025 was $36.6 million, an increase of $15.1 million as compared to $21.5 million for the same period in 2024.

Other Income/(Expenses): Other income (expenses) for the year ended December 31, 2025 reflected other expense of $32.0 million, compared to other income of $2.9 million for the same period in 2024. The net change of $34.9 million was largely attributable to the non-cash fair value remeasurement expense of the warrant liabilities of $37.9 million, primarily due to an increase in our share price as compared to the prior year period. This increase in expense was partially offset by exchange rate fluctuations related to Lineage’s international subsidiaries and lower warrant-related transaction costs incurred as compared to the prior year in connection with the November 2024 financing.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the year ended December 31, 2025 was $63.5 million, or $0.28 per share (basic and diluted), compared to a net loss of $18.6 million, or $0.09 per share (basic and diluted), for 2024. The difference was primarily driven by the non-cash fair value remeasurement of the warrant liabilities and the loss on impairment expense related to a 2019 acquisition.

Conference Call and Webcast

Interested parties may access the conference call on March 5, 2026, by dialing (888) 596-4144 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through March 12, 2026, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 3958367.

About the AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform

The AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform highlights the key attributes of Lineage’s in-house technology and describes a differentiation and production modality from which Lineage can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial cell line, conferring consistent, cost-effective, and scalable cell-based production and which can be applied across multiple programs. From our proprietary AlloSCOPE platform, we successfully completed a current Good Manufacturing Practice ("cGMP") production run from a custom, two-tiered cell banking system, featuring a genetically-stable master cell bank (MCB) created from a single, well-characterized pluripotent cell line, which generated a working cell bank (WCB), which then provided the source material for two final cell-based product candidates.

(Press release, Lineage Cell Therapeutics, MAR 5, 2026, View Source [SID1234663301])

On March 5, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported fourth quarter and full year 2025 financial results and provided a corporate update.

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"We are encouraged by the early launch trajectory of KOMZIFTI and the positive feedback from physicians, pharmacists and payers on its differentiated clinical profile," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "With a compelling combination of efficacy, safety, compatibility, and simplicity, we believe KOMZIFTI is well positioned to lead in R/R NPM1-mutated AML. In 2026, we expect multiple clinical milestones in the combination and frontline settings that could significantly broaden the opportunity for ziftomenib across the AML treatment continuum. In addition, our solid tumor programs, including ziftomenib in gastrointestinal tumors and darlifarnib in both renal cell carcinoma and KRASG12C-mutated solid tumors, continue to advance, representing a potential addressable population of more than 200,000 patients. Importantly, our strong balance sheet, bolstered by anticipated collaboration milestones, provides the capital required to reach key value-inflecting frontline Phase 3 data and advance our next wave of novel therapies."

2025 Highlights and Recent Developments

KOMZIFTI Commercial Launch

Granted full approval by the U.S Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. KOMZIFTI is the first and only once-daily, oral menin inhibitor approved for R/R NPM1-mutant (NPM1-m) AML.
Generated $2.1 million in net product revenue in the fourth quarter of 2025, based on approximately five weeks of commercial sales following November 13 approval.
Added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a Category 2A recommended treatment option for adults with R/R NPM1-m AML.
Delivered product in channel within five business days of FDA approval, triggering a $135 million milestone payment from Kyowa Kirin.
Received rapid payer coverage within the first 90 days – approximately 80% of private payers had established published coverage policies, all aligned with the label with no additional restrictions.
Added to the FDA Orange Book, with listed patents extending up to July 2044, which support long-term market exclusivity in the United States.
Advancing Ziftomenib Across the AML Treatment Continuum

Initiated pivotal KOMET-017 Phase 3 frontline trials evaluating ziftomenib in combination with intensive and non-intensive chemotherapy in patients with NPM1-m or KMT2A-rearranged (KMT2A-r) AML in the frontline setting. Received two $30 million milestone payments from Kyowa Kirin in connection with first patient dosing in each of the two Phase 3 trials.
Presented positive Phase 1a/1b KOMET-007 (NCT05735184) data at ASH (Free ASH Whitepaper) 2025 demonstrating a favorable safety profile and encouraging antileukemic activity for ziftomenib in combination with venetoclax and azacitidine (ven/aza) in newly diagnosed NPM1-m AML as well as patients with R/R NPM1-m or KMT2A-r AML.
Dosed the first patient in the FLT3 inhibitor cohort of KOMET-007 trial evaluating ziftomenib combined with quizartinib plus cytarabine and daunorubicin (7+3) induction chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD/NPM1 co-mutations.
Solid Tumor Pipeline Progress

Initiated Phase 1b dose expansion in the FIT-001 trial evaluating darlifarnib plus cabozantinib in advanced renal cell carcinoma (RCC).
Presented preclinical and preliminary clinical data at ESMO (Free ESMO Whitepaper) 2025 highlighting the potential of darlifarnib to enhance the anti-tumor activity of PI3Kα inhibitors, KRAS inhibitors, and antiangiogenic tyrosine kinase inhibitors across multiple solid tumor indications.
2026 Strategic Priorities and Anticipated Milestones

Kura expects 2026 to be a data-rich year with multiple potential value inflection points:

KOMZIFTI Commercial Execution

Establish clear differentiation in the menin inhibitor class
Deliver strong quarter-over-quarter growth in revenue and adoption
Achieve leading class share in R/R NPM1-m AML setting
Ziftomenib – Development in Frontline AML

Continue enrollment in the pivotal KOMET-017 Phase 3 trials
Present updated KOMET-007 data for ziftomenib plus 7+3 in frontline NPM1-m/KMT2A-r AML (1H 2026)
Advance enrollment of KOMET-007 cohort for ziftomenib, quizartinib, and 7+3 quadruplet combination in frontline NPM1-m/FLT3-ITD AML
Ziftomenib – Development in R/R AML

Publish data for ziftomenib plus ven/aza in R/R NPM1-m AML (1H 2026)
Present preliminary KOMET-008 data for ziftomenib and gilteritinib combination in R/R NPM1-m/FLT3-m AML (2H 2026)
Ziftomenib and Menin Inhibition – Expansion into Solid Tumors

Advance enrollment of KOMET-015 for ziftomenib and imatinib combination in gastrointestinal stromal tumors (GIST)
Progress preclinical development of a next-generation menin inhibitor for use in combination therapy for solid tumors
Darlifarnib

Present preliminary clinical data for darlifarnib plus adagrasib in KRASG12C-mutated solid tumors (1H 2026)
Present updated Phase 1a data with ~ 1 year of additional follow-up for darlifarnib plus cabozantinib in advanced RCC (2H 2026)
KO-7246 (Next-Generation Menin Inhibitor)

Advance KO-7246 into IND-enabling studies for diabetes and cardiometabolic disease
Present additional preclinical data for menin inhibitors in Type 1 and Type 2 diabetes
Fourth Quarter 2025 Financial Results

Net product revenue: $2.1 million (first five weeks of commercial sales following November 13 approval of KOMZIFTI).
Collaboration revenue: $15.2 million, compared to $53.9 million for Q4 2024, reflecting non-cash revenue recognition under the collaboration agreement with Kyowa Kirin.
R&D expenses: $64.4 million, compared to $52.3 million for Q4 2024, primarily driven by advancement of ziftomenib combination trials, including KOMET-017.
SG&A expenses: $39.1 million, compared to $24.1 million for Q4 2024, reflecting commercialization-related investments.
Net loss: $81.0 million, compared to $19.2 million for Q4 2024. Net loss includes $11.3 million in non-cash, share-based compensation expense, compared to $8.6 million for the same period in 2024.
As of December 31, 2025, Kura had $667.2 million in cash, cash equivalents and short-term investments, compared to $727.4 million as of December 31, 2024.

The Company believes that its cash, cash equivalents and short-term investments as of December 31, 2025, will be sufficient to fund its current operating plan into the fourth quarter of 2027. When combined with the anticipated $180 million in payments under the collaboration agreement with Kyowa Kirin, these resources are expected to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 frontline trial, anticipated in 2028.

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 8:00 a.m. ET / 5:00 a.m. PT today, March 5, 2026, to discuss financial results and to provide a corporate update. A live webcast and archived replay of the event will be available here or online from the Investors section of the Company’s website at www.kuraoncology.com.

(Press release, Kura Oncology, MAR 5, 2026, View Source [SID1234663300])