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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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

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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])

On March 5, 2026 Immatics N.V. (NASDAQ: IMTX, "Immatics" or the "Company"), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, reported a business update and announced financial results for the quarter and full year ended December 31, 2025.

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"Following a year of strong execution and data updates across our entire PRAME franchise, Immatics is entering 2026 with multiple high-impact milestones ahead, including advancing our PRAME cell therapy, anzu-cel, towards approval," said Harpreet Singh, Ph.D., Chief Executive Officer and Co-Founder of Immatics. "In parallel, we strive to expand our reach to more patients with our second-generation PRAME cell therapy, IMA203CD8, with meaningful data in gynecologic cancers expected this year, and with our PRAME bispecific IMA402, where we plan to report expanded clinical data supporting initiation of indication-specific expansion cohorts. In addition, we look forward to opening a new therapeutic avenue by initiating a combination study with IMA402 and IMA401, our MAGEA4/8 bispecific, in lung cancer. Above all, we remain focused on translating this positive momentum into transformative outcomes for patients with cancer."

Full Year 2025 and Subsequent Company Progress

PRAME Franchise – Cell Therapy

Anzu-cel (IMA203) PRAME Cell Therapy – First Market Entry in Advanced Melanoma
Anzu-cel (anzutresgene autoleucel), previously called IMA203, is Immatics’ lead PRAME cell therapy and is expected to be the Company’s first PRAME therapy to enter the market in advanced melanoma. The current addressable patient population for anzu-cel’s first target indications, second-line or later (2L) advanced cutaneous melanoma as well as metastatic uveal melanoma includes ~9,000 patients2.

Anzu-cel received Orphan Drug Designation as well as RMAT designation3 from the U.S. Food and Drug Administration (FDA) for the treatment of both cutaneous and uveal melanoma.

Phase 3 trial, SUPRAME, for anzu-cel (IMA203) in previously treated, advanced cutaneous melanoma

Immatics’ global, randomized, controlled, multi-center Phase 3 clinical trial, SUPRAME, is currently ongoing to evaluate the efficacy, safety and tolerability of anzu-cel PRAME cell therapy as monotherapy vs. investigator’s choice in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a PD-1 immune checkpoint inhibitor.
SUPRAME is designed to be an adequate and well-controlled clinical trial intended to generate robust data to support regulatory approval of anzu-cel as Immatics advances this PRAME cell therapy.
Primary endpoint for seeking full approval is blinded independent central review ("BICR")-assessed (RECIST v1.1) progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), safety and patient-reported outcomes measuring quality of life.
SUPRAME timelines remain unchanged. Pre-specified interim and final data analyses will be triggered upon the occurrence of a defined number of events for PFS (progressive disease or death). Interim and final analyses remain expected to be triggered in 2026 as planned, given current strong enrollment rate. As communicated previously and in line with general FDA guidance, data from the interim analysis is not intended to be published to protect the integrity of the clinical trial as long as enrollment remains ongoing.
The Company continues to expect BLA submission in the first half of 2027 and commercial launch of anzu-cel in the second half of 2027.
Patient recruitment is currently ongoing in North America and Europe.
Phase 1/2 trial for anzu-cel (IMA203) PRAME cell therapy in patients with advanced melanoma

Phase 1b data in patients with advanced melanoma were published at ASCO (Free ASCO Whitepaper) 2025 and a subset analysis in uveal melanoma was published at ESMO (Free ESMO Whitepaper) 2025, both showing favorable tolerability and strong clinical benefit of anzu-cel one-time infusion.
A Phase 2 cohort to treat approximately 30 additional metastatic uveal melanoma patients is ongoing and being conducted at select centers in the U.S. and Germany with expertise in uveal melanoma.
Data from the ongoing single-arm Phase 1b as well as Phase 2 trial in metastatic uveal melanoma are intended to support a potential label expansion for anzu-cel.
The next data update from the Phase 1/2 trial with ongoing follow-up of patients with cutaneous and uveal melanoma is planned for 2026.
Phase 1 combination trial for anzu-cel (IMA203) PRAME cell therapy and Moderna’s PRAME cell therapy enhancer, mRNA-4203, in patients with solid tumors

First patient dosed in Phase 1 dose escalation trial in 3Q 2025; the combination treatment has the potential to further enhance anti-tumor activity of anzu-cel, strengthen clinical outcomes and broaden the addressable patient population.
Each party retains full ownership of its investigational PRAME compound, and the parties fund the clinical study on a cost-sharing basis.
IMA203CD8 PRAME Cell Therapy (GEN2) – Expansion to all Advanced PRAME Cancers
IMA203CD8 is the Company’s second-generation PRAME cell therapy product candidate being developed with the goal of expanding into all advanced PRAME cancers. Given its enhanced pharmacology profile, once the target dose is reached, the Company intends to pursue the clinical development of this product candidate with a tumor-agnostic approach, starting with gynecologic cancers.

Updated Phase 1a dose escalation data presented at ESMO (Free ESMO Whitepaper)-IO 2025 Congress showed manageable tolerability as well as promising initial anti-tumor activity in PRAME-positive tumors at low median dose, including proof-of-concept data in ovarian carcinoma.
Results could support the positioning of IMA203CD8 to treat patients with PRAME cancers without post-infusion IL-2.
Immatics plans to present Phase 1a data with a focus on ovarian cancer at relevant doses at a major medical conference in the first half of 2026.
The Company is on track to complete Phase 1a dose escalation and determine recommended Phase 2 dose (RP2D) in 2026.
PRAME Franchise – Bispecifics

IMA402 PRAME Bispecific – Expansion to Earlier-Line PRAME Cancers

To expand the PRAME opportunity to earlier-line PRAME cancers, the Company is developing its off-the-shelf, next-generation, half-life extended TCR bispecific, IMA402, as a monotherapy or in combination with standard of care, with a focus on melanoma and gynecologic cancers. In addition, Immatics is exploring the potential combination of IMA402 with IMA401 MAGEA4/8 bispecific in squamous non-small cell lung cancer (sqNSCLC) and potentially other solid tumor indications.

In November 2025, Immatics announced clinical proof-of-concept for its IMA402 PRAME bispecific with updated data from the Phase 1a dose escalation trial in heavily pre-treated patients with solid tumors, including melanoma and ovarian cancer.
Immatics expects to determine the final RP2D and present a clinical data update from a larger patient population with a focus on melanoma and gynecologic cancers treated with IMA402 monotherapy or combination with an immune checkpoint inhibitor in the second half of 2026. Based thereon, the Company may seek to convert existing Phase 1b cohorts into Phase 2 trials, which may have the potential to become registration-enabling. As part of its strategy to maximize the IMA402 opportunity, the Company also plans to initiate additional Phase 1b cohorts in 2026 to determine the monotherapy and combination potential of IMA402 with immune checkpoint inhibitors and standard of care in late as well as earlier treatment lines.
Based on the initial promising activity of IMA401 in head and neck cancer and sqNSCLC, Immatics is well-positioned to assess the synergistic potential of combining two different bispecifics, IMA402 targeting PRAME and IMA401 targeting MAGEA4/8, with and without a checkpoint inhibitor. The IMA402/IMA401 combination trial in sqNSCLC is expected to commence in 2026.

IMA401 MAGEA4/8 Bispecific – Maximizing the Potential of Bispecifics Combinations

In November 2025, Immatics presented clinical proof-of-concept data from the Phase 1a dose escalation trial evaluating IMA401 MAGEA4/8 bispecific as monotherapy or in combination with an immune checkpoint inhibitor in heavily pre-treated patients with solid tumors, including head and neck cancer and sqNSCLC.
The Company plans to present updated Phase 1a data at a major medical conference in the first half of 2026.
Consistent with Immatics’ focus on advancing its PRAME franchise, the Company is exploring IMA401 in combination with IMA402, starting with sqNSCLC.

Moderna Collaboration Expansion – TCER Multiplexing Strategy

In December 2025, Moderna decided to advance the first mRNA-based TCER product candidate from the existing collaboration with Immatics into clinical development.
This TCER, in-licensed by Moderna, is directed against an undisclosed Immatics proprietary target and is encoded in Moderna’s proprietary mRNA delivery system enabling in vivo production of the TCER molecule by the patient’s own body.
This collaboration aims to generate proof-of-principle data for the in vivo production of TCER molecules, potentially supporting a broader multiplex approach targeting multiple solid tumors.
This expansion of the collaboration triggered a milestone payment of $5 million to Immatics in January 2026. Immatics will conduct the Phase 1 trial, with all associated costs fully reimbursed by Moderna.
Corporate Developments

Chief Financial Officer Appointment: On October 1, 2025, Immatics announced the appointment of Venkat Ramanan, Ph.D., as Chief Financial Officer.
Chief People Officer Appointment: On October 27, 2025, Immatics announced the appointment of Amie Krause as Chief People Officer.
Full Year 2025 Financial Results

Cash Position: Cash and cash equivalents, as well as other financial assets, total $551.4 million1 (€469.3 million) as of December 31, 2025, compared to $710.3 million1 (€604.5 million) as of December 31, 2024. The decrease is mainly due to $234.9 million (€199.9 million) operational cash usage, principally as a result of ongoing research and development activities, as well as unrealized foreign exchange translational losses of $41.8 million1 (€35.6 million), which do not impact the expected cash reach, partially offset by the net proceeds of the public offering of $117.9 million1 (€100.3 million).

Revenue: Total revenue, consisting of revenue from collaboration agreements, was $56.8 million1 (€48.3 million) for the year ended December 31, 2025, compared to $183.1 million1 (€155.8 million) for the year ended December 31, 2024. The decrease is mainly the result of the one-time non-cash revenue associated with the acceleration of deferred revenue recognized due to the termination of the IMA401 and ACTallo collaborations by Bristol Myers Squibb during the year ended December 31, 2024.

Research and Development Expenses: R&D expenses were $216.0 million1 (€183.8 million) for the year ended December 31, 2025, compared to $174.0 million1 (€148.1 million) for the year ended December 31, 2024. The increase mainly resulted from costs associated with the advancement of the product candidates in clinical trials.

General and Administrative Expenses: G&A expenses were $60.2 million1 (€51.2 million) for the year ended December 31, 2025, compared to $54.5 million1 (€46.4 million) for the year ended December 31, 2024. The increase is driven by costs associated with early commercial activities supporting the planned market launch of anzu-cel (IMA203).

Net Profit and Loss: Net loss was $230.8 million1 (€196.4 million) for the year ended December 31, 2025, compared to a net profit of $17.9 million1 (€15.2 million) for the year ended December 31, 2024. The net loss mainly resulted from lower non-cash revenue recognized from the acceleration of deferred revenue recognized due to the termination of the collaboration agreements in the year ended December 31, 2024, and higher costs associated with the planned advancement of the Company’s PRAME franchise in clinical trials.

Full financial statements can be found in our Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) on March 5, 2026, and published on the SEC website under www.sec.gov.

Upcoming Investor Conferences

Leerink Global Healthcare Conference, Miami, Florida, USA – March 8 – 11, 2026
Jefferies "Biotech by the Beach" Summit 2026, Miami, Florida, USA – March 10 – 11, 2026
To see the full list of events and presentations, visit: View Source

About PRAME
PRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and two combination therapies that target PRAME: anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific as monotherapy and in combination with an immune checkpoint inhibitor, as well as anzu-cel in combination with Moderna’s PRAME cell therapy enhancer.

(Press release, Immatics, MAR 5, 2026, View Source [SID1234663299])

On March 5, 2026 Evogene Ltd. (Nasdaq, TASE: EVGN), a pioneering company in computational chemistry specializing in the generative AI design of small molecules for the pharmaceutical and agricultural industries, reported its financial results for the fourth quarter and full year ended December 31, 2025.

Mr. Ofer Haviv, President & CEO of Evogene, stated: "During 2025, we executed a clear and decisive strategic shift. After a comprehensive review of our technology assets, target markets, and capital allocation priorities, we sharpened our focus to drive sustainable long-term value by concentrating on a single proprietary tech-engine – ChemPass AI- for small-molecule discovery and optimization. We streamlined our operations to focus on two high-impact markets: pharma and agriculture, while discontinuing non-core activities, divesting misaligned assets, resizing the organization, and aligning our business development efforts with this focused strategy. ChemPass AI’s competitive advantage combines two core strengths: generating truly novel molecules and simultaneously optimizing multiple critical parameters from the outset.

Throughout 2025, ChemPass AI was advanced through proprietary internal developments and strategic collaborations with Google Cloud. Our first collaboration delivered a foundation model trained on 38 billion structures, achieving 90% design precision, based on our calculation – approximately tripling our benchmarks for accuracy. A second collaboration, launched in February 2026, integrates AI agents via Google Cloud Vertex AI to automate workflows, reduce manual errors, and further strengthen candidate quality and commercial potential.

Evogene’s offering – our proprietary small-molecule product candidates – combines three unique powerful characteristics: novel molecules representing new and diverse chemical structures; optimized for simultaneous multi-parameters from the earliest design stages; and highly potent compounds refined through targeted experimental validation.

Our business model is built on an integrated, partnership-driven approach that supports both collaborations and the in-house advancement of proprietary candidates. Projects begin with joint strategic alignment and continue through rigorous experimental validation, with partners actively engaged at every stage and programs tailored to specific scientific and commercial objectives.

In pharma, since the second half of 2025, we have advanced multiple partnered drug discovery programs, with ChemPass AI candidates progressing into experimental testing by our partners; four collaborations have been publicly disclosed to date.

In agriculture, AgPlenus applies ChemPass AI to novel herbicide and fungicide development, supported by strategic collaborations with Bayer and Corteva and a differentiated internal pipeline, positioning us for continued growth."

Mr. Haviv continued: "As part of our focused strategy, we discontinued non-core activities, divested misaligned assets, and resized the organization. During 2025, Lavie Bio was acquired by ICL. In early 2026, Biomica licensed its lead oncology candidate, BMC128, to Lishan Pharmaceuticals. No additional activity is expected from these companies. At the same time, Evogene has retained select activities with meaningful value potential that are not at the core of our new strategy, including Casterra, and intends to continue supporting these activities until their full potential is realized.

Looking ahead, the advancement of proprietary small-molecule product candidates is at the heart of Evogene’s mission. Supported by ChemPass AI, our differentiated generative AI tech-engine, disciplined capital allocation across two high-potential markets, and strong strategic partnerships, we believe Evogene is well-positioned on a clearly defined and focused path toward sustainable long-term value creation."

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Financial Highlights:

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As part of the Company’s updated strategic plan, management implemented an organizational realignment and cost-reduction initiative. The effects of these measures are reflected in the significant decrease in operating expenses, net, which declined to approximately $13.8 million for the year ended 2025, compared to approximately $22.0 million in 2024. The impact is also evident in the fourth-quarter results, with total operating expenses, net, of approximately $3.2 million, compared to approximately $4.3 million in the corresponding period of 2024. The Company expects this reduced expense level to be sustained in future periods.

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In 2025, Lavie Bio, our subsidiary focused on agricultural biologicals, completed the sale of the majority of its operations to ICL Group Ltd. As a result of this transaction, Lavie Bio no longer maintains employees, and its operating expense level has decreased significantly. Lavie Bio anticipates distributing the majority of its remaining cash to its shareholders, including Evogene, during 2026.

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During 2025, as part of the Company’s updated strategic plan, we scaled down Biomica’s operations and research and development activities and reduced its personnel to a minimal level. In early 2026, Biomica entered into a license agreement with Lishan Pharmaceuticals for its lead oncology candidate, BMC128. Following this transaction, Biomica does not expect to conduct further material operational activities and anticipates distributing the majority of its remaining cash to its shareholders, including Evogene.

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With respect to AgPlenus, we integrated AgPlenus, our ag-chemical subsidiary, into our core operations, with the objective of maximizing the value of our ChemPass AI platform for the development of novel ag-chemical products. In alignment with the Company’s updated organizational structure, AgPlenus was resized and streamlined to reflect the revised operating model.

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During 2025, due to a significant decline in demand for castor seeds, Casterra Ag ceased its operations in Kenya, reduced its headcount and overall expense level, and is currently focusing its activities on the Brazilian market. As a result of these developments, Casterra recorded an impairment of approximately $2.2 million related to its seed inventory. This impairment is presented within Cost of Sales in the consolidated financial statements in a separate line item.

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In February 2026, we entered into a warrant inducement agreement with an existing investor providing for the immediate exercise in full of its August 2024 Series A and Series B warrants, resulting in gross proceeds to the Company of approximately $3.4 million, before deduction of placement agent fees and other offering expenses. In consideration for such exercise, the investor will receive, in a private placement, new unregistered Series A-1 and Series B-1 warrants to purchase up to an aggregate of 5,076,924 ordinary shares. The new warrants are exercisable immediately at an exercise price of $1.25 per ordinary share.

Financial reports:

Cash Position – As of December 31, 2025, Evogene held consolidated cash, cash equivalents, and short-term bank deposits of approximately $13.0 million. The consolidated cash usage during the fourth quarter of 2025 was approximately $3.0 million. Excluding Lavie Bio and Biomica, Evogene and its other subsidiaries used approximately $2.4 million in cash during the fourth quarter of 2025.

Revenues for 2025 totaled approximately $3.9 million, compared to approximately $5.6 million in the same period the previous year, reflecting a decrease of approximately $1.7 million. The decrease was primarily driven by lower revenue recognized from AgPlenus’ activity, which included one-time payment during the first quarter of 2024 and revenues recognized from the collaboration agreement with Corteva, that was completed during 2024. Revenues for the fourth quarter of 2025 were approximately $0.3 million; a decrease compared to approximately $1.5 million in the same period last year. The decrease was mainly due to reduced seed sales generated by Casterra during the fourth quarter of 2025.

Cost of Revenues for the year ending 2025 was approximately $4.1 million, compared to approximately $2.4 million in the previous year. The increase was primarily attributable to an inventory impairment of approximately $2.2 million recorded by Casterra during the fourth quarter of 2025 mainly due to its decision to cease its operations in Kenya as noted above. Cost of revenues for the fourth quarter of 2025 was $2.3 million, compared to $0.7 million in the fourth quarter of the previous year. The increase in quarterly cost of revenues was mainly driven by the same inventory impairment of Casterra as noted above.

R&D Expenses, net of non-refundable grants, for the year 2025 were approximately $8.0 million, a decrease of approximately $4.5 million compared to $12.5 million in the year 2024. The decrease was primarily due to reduced R&D expenses in Biomica, Casterra and AgPlenus. In the fourth quarter of 2025, R&D expenses were approximately $1.8 million, down from approximately $2.7 million in the same period of 2024. This decrease is mainly attributed to decreased expenses in Biomica.

Sales and Marketing Expenses for the year 2025 were approximately $1.5 million, a decrease of approximately $0.5 million compared to approximately $2.0 million in the same period last year. The decrease was mainly due to reductions in Evogene and Biomica personnel costs. Sales and marketing expenses for the fourth quarters of 2025 and 2024 were approximately $0.3 million and $0.4 million, respectively.

General and Administrative Expenses for the year 2025 decreased to approximately $4.3 million from approximately $7.0 million in the same period last year. This decrease is mainly attributable to expenses recorded during the year 2024 related to a provision for doubtful debt for one of Casterra’s seed suppliers as well as transaction costs associated with Evogene’s fundraising in August 2024. Additional decrease is attributable to a reduction in Biomica’s activities and personnel costs during 2025. General and administrative expenses for the fourth quarter of 2025 decreased to approximately $0.9 million compared to approximately $1.3 million in the same period of the previous year, primarily due to decreased expenses in Evogene and Biomica, as mentioned above.

Other Expenses, net of approximately $37 thousand were recorded in 2025 mainly due to the impairment of fixed assets associated with the reduction in Biomica’s activities, partially offset by income recognized in the first quarter of 2025 related to the accounting treatment of Evogene’s sub-lease agreement. The decision to cease Canonic’s operations in the first half of 2024 resulted in other expenses of approximately $0.5 million, primarily due to the impairment of fixed assets.

Operating Loss for 2025 was approximately $14.0 million, a significant decrease from approximately $18.8 million in the same period of the previous year, mainly due to decreased operating expenses, partially offset by the decreased revenues as mentioned above and the higher cost of revenues, mainly due to an inventory impairment of approximately $2.2 million recorded by Casterra, in the fourth quarter of 2025. The operating loss for the fourth quarter of 2025 was approximately $5.2 million, an increase from approximately $3.5 million in the same period of the previous year, primarily due to the decreased revenues and increased cost of revenues, mentioned above, partially offset by decreased operating expenses.

Financing Income, net for the year 2025 was approximately $0.6 million, compared to approximately $4.0 million in the previous year. The decrease in financing income, net was mainly associated with accounting treatment of pre-funded warrants and warrants issued in August 2024 fund raising. As a result, during the twelve months of 2025 the Company recorded financial income, net, related to pre-funded warrants and warrants of approximately $458 thousand as compared to a financial income of approximately $3.4 million in same period of 2024. Financing expenses, net, for the fourth quarter of 2025 were approximately $0.2 million, compared to financing income, net of approximately $4.5 million in the same period of the previous year. The decrease in financing income is mainly associated with accounting treatment of pre-funded warrants and warrants issued in the August 2024 fund raising as mentioned above.

Income from Discontinued Operations, net for the twelve months of 2025 was approximately $5.7 million, compared to a loss of approximately $3.2 million in the same period of 2024. For the fourth quarter of 2025, loss from discontinued operations, net was approximately $16 thousand, compared to a loss of approximately $1.0 million in the fourth quarter of the previous year. These amounts primarily reflect the financial results of Lavie Bio’s operations as well as expenses related to the development and maintenance of MicroBoost AI for Ag, which are presented as a single-line item in the consolidated statements of profit and loss. Following the sale of the majority of Lavie Bio’s assets as well as Evogene’s MicroBoost AI for Ag to ICL, the Company recognized a gain on sale of approximately $6.4 million which is also included in the income (loss) from discontinued operations, net, for the year of 2025. All prior period amounts have been reclassified to conform to this presentation.

Net loss for the twelve months of 2025 was approximately $7.8 million, compared to approximately $18.1 million in the same period last year. The $10.3 million decrease in net loss was primarily due to decreased operating expenses and an income derived from discontinued operations due to the asset sale to ICL, net, partially offset by reduced revenues, higher cost of revenues and a decreased financing income, net. The net loss for the fourth quarter of 2025 was approximately $5.4 million, compared to net loss of approximately $5 thousand in the same period last year. This increase in net loss was primarily due to decreased financial income, net, decreased revenues, and increased cost of revenues, partially offset by decreased operating expenses, as mentioned above.

(Press release, Evogene, MAR 5, 2026, View Source [SID1234663298])