On March 25, 2026 Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biotechnology company developing engineered natural killer (NK) cell therapies to treat autoimmune diseases, reported financial results for the fourth quarter and year ended December 31, 2025.

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"2025 was a year of strategic importance for Nkarta as we onboarded a clinical team with deep autoimmune experience, right-sized our workforce to be a responsible steward of investor capital, and continued to advance our CAR-NK cell therapy platform through dose escalation in the clinic," said Paul J. Hastings, Chief Executive Officer of Nkarta. "Thoughtfully leveraging our safety data, we are now dosing patients at 4 billion cells in a three-dose cycle for a total of 12 billion cells as we look to maximize the depth and durability of B-cell depletion and clinical response, positioning us to unlock the full potential of NKX019 for people living with autoimmune disease."

"We look forward to sharing a comprehensive clinical update from Ntrust-1 and Ntrust-2 later this year with the aim of presenting a meaningful data set at a medical conference. With cash projected to fund operations into 2029, we remain focused on disciplined clinical execution as we continue enrollment in our Ntrust-1 and Ntrust-2 clinical programs."

NKX019 Clinical Program Progress and Upcoming Milestones

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Enrollment continued across Ntrust-1 and Ntrust-2, our multi-center, open-label, dose-escalation clinical trials evaluating NKX019 in multiple autoimmune diseases.
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Patients are now being dosed at 4 billion cells per dose as part of ongoing dose escalation.

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Enrollment remains open in both investigator-sponsored trials of NKX019 in generalized myasthenia gravis and systemic lupus erythematosus.
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Initial clinical data from Ntrust-1 and Ntrust-2 are planned for presentation at a medical conference later this year.

Fourth Quarter and Full Year 2025 Financial Highlights

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Nkarta had cash, cash equivalents, restricted cash, and investments in marketable securities of $295.1 million as of December 31, 2025.
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Research and development (R&D) expenses were $90.4 million for the full year 2025 and $25.3 million for the fourth quarter of 2025. Non-cash stock-based compensation expense included in R&D expense was $3.2 million for the full year 2025 and $0.7 million for the fourth quarter of 2025.
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General and administrative (G&A) expenses were $31.6 million for the full year 2025 and $5.7 million for the fourth quarter of 2025. Non-cash stock-based compensation expense included in G&A expense was $5.4 million for the full year 2025 and $1.2 million for the fourth quarter of 2025.
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Net loss was $104.1 million, or $1.41 per basic and diluted share, for the full year 2025. This net loss includes non-cash charges of $14.4 million that consisted primarily of share-based compensation, right-of-use asset impairment and depreciation expenses. Net loss was $27.4 million, or $0.37 per basic and diluted share, for the fourth quarter of 2025. This net loss includes non-cash charges of $3.3 million that consisted primarily of share-based compensation and depreciation expenses.

Financial Guidance

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Nkarta expects its current cash and cash equivalents to fund its current operating plan into 2029.

About the Ntrust℠ Clinical Trials in Autoimmune Disease

Ntrust-1 (NCT06557265) and Ntrust-2 (NCT06733935) are multi-center, open label, dose escalation clinical trials in patients with autoimmune disease receiving lymphodepletion followed by CD19-targeted CAR-NK cell therapy. Both trials will assess the safety of NKX019 in people living with autoimmune diseases as well as its potential to achieve durable remission via a "reset" of the immune system through the elimination of pathogenic B cells.

The Ntrust trials are enrolling up to 12 patients per dose level per disease indication across systemic sclerosis, idiopathic inflammatory myopathy, ANCA-associated vasculitis, lupus nephritis, and primary membranous nephropathy.

In both studies, patients now receive a three-dose cycle of NKX019 on Days 0, 3, and 7 following lymphodepletion with fludarabine and cyclophosphamide or cyclophosphamide alone, if they have significant cytopenia at baseline. Leveraging the engineering of NKX019, no patients in either trial will receive supplemental cytokines or antibody-based therapeutics. This approach is designed to evaluate the single-agent activity of NKX019 and facilitate a more rapid path to regulatory approval. Patients in Ntrust-1 may also receive additional cycles, if necessary, to restore response or enable a deeper response.

About NKX019

NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed chimeric antigen receptor (CAR) for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease. Nkarta is evaluating NKX019 in multiple autoimmune conditions.

(Press release, Nkarta, MAR 25, 2026, View Source [SID1234663905])

On March 25, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Terns Pharmaceuticals, Inc. ("Terns") (Nasdaq: TERN), a clinical-stage oncology company, reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Terns for $53.00 per share in cash for an approximate equity value of $6.7 billion. This equates to approximately $5.7 billion net of acquired cash and represents an approximate premium of 31% to the 60-day and 42% to the 90-day volume-weighted average stock price on March 24, 2026.

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"The acquisition of Terns builds on our growing presence in hematology with TERN-701, a potential best-in-class candidate for the treatment of certain patients with chronic myeloid leukemia," said Robert M. Davis, chairman and chief executive officer, Merck. "This transaction further diversifies and strengthens our position in oncology as we continue to look for opportunities to broaden our portfolio into other therapeutic areas."

Terns’ lead candidate, TERN-701, is a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) currently being evaluated in the Phase 1/2 CARDINAL trial (NCT06163430) for patients with Philadelphia chromosome-positive (Ph+), chronic phase chronic myeloid leukemia (CML) previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. In March 2024, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TERN-701 for the treatment of CML.

"This acquisition reflects our team’s deep commitment to innovation in oncology and developing high impact medicines," said Amy Burroughs, chief executive officer, Terns. "By working together, we will advance TERN-701, leveraging the deep expertise and significant resources at Merck, a global biopharmaceutical leader with a proven track record of delivering cancer breakthroughs for patients who need them most. I am immensely proud of the Terns team and our work towards making a difference for people living with CML. Finally, we extend our heartfelt thanks to the investigators, patients, and community advocates whose dedication and support make the development of TERN-701 possible."

In clinical trials to date, TERN-701 has shown promising activity, with encouraging rates of major molecular response and deep molecular response observed by week 24. Importantly, this includes responses in patients with high disease burden who previously received multiple lines of therapy, including many who were treated with an allosteric TKI. The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events and discontinuations. No clinically meaningful changes in blood pressure have been observed, and rates of lipase elevation have been low.

"The first approval of a BCR::ABL1 tyrosine kinase inhibitor 25 years ago transformed the prognosis for many patients with chronic myeloid leukemia. Despite new therapeutic options, there is significant need for innovative, well-tolerated therapies with faster time to onset of molecular response leading to deeper responses and better disease control," said Dr. Dean Y. Li, president, Merck Research Laboratories. "Based on early clinical evidence, TERN-701, a novel allosteric BCR::ABL1 inhibitor, may have the potential to provide a meaningfully differentiated option for certain patients living with CML."

The transaction has been approved by both Merck’s and Terns’ Boards of Directors. Under the terms of the merger agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Terns. The acquisition is subject to a majority of Terns’ stockholders tendering their shares in a tender offer that will be initiated by a subsidiary of Merck. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to be accounted for as an asset acquisition and close in the second quarter of 2026, resulting in a charge of approximately $5.8 billion, or approximately $2.35 per share, included in both second quarter and full year 2026 GAAP and non-GAAP results.

A copy of the merger agreement for the transaction will be filed with the Securities and Exchange Commission ("SEC") and will be publicly available free of charge at the SEC’s website at www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge from Merck’s website at www.merck.com or by contacting Merck at 126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ 07065 USA, or (908) 740-4000. Copies of the documents filed with the SEC by Terns may be obtained at no charge from Terns’ website at www.ternspharma.com or by contacting Terns at 1065 East Hillsdale Blvd., Suite 100, Foster City, CA 94404 or (650) 525-5535 Ext.101.

Investor Call
Merck will hold an investor call Wednesday, March 25, 2026 at 8 a.m. EDT to discuss the proposed transaction. Journalists who wish to ask questions should contact a member of Merck’s Global Media Relations team at the conclusion of the call. Investors, journalists and the general public may access a live audio webcast of the call via this weblink.

All participants may join the call by dialing (800) 369-2154 (U.S. and Canada Toll-Free) or (517) 308-9422 and using the access code 8711041.

Advisors
Centerview Partners LLC and Jefferies LLC acted as financial advisors to Terns and Freshfields LLP acted as Terns’ legal advisor.

About TERN-701
TERN-701 is a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) designed to bind to the ABL myristoyl pocket, with a potentially best-in-disease profile that could improve upon the efficacy, safety and convenience of existing treatments for CML.

About the CARDINAL study
TERN-701 is currently being evaluated in the CARDINAL trial (NCT06163430), a global multi-center dose escalation and dose-expansion clinical trial to assess safety, tolerability and efficacy in patients with Philadelphia chromosome-positive (Ph+) chronic phase CML previously treated with at least one prior TKI and experienced treatment failure, suboptimal response, or treatment intolerance. The dose escalation portion of the CARDINAL trial completed in January 2025 with no dose limiting toxicities observed up to the maximum dose of 500mg QD. Terns initiated the dose expansion portion of the trial in April 2025 with patients randomized to one of two dose cohorts (320mg or 500mg QD) with up to 40 patients per arm. In January 2026, an additional cohort was added to the CARDINAL trial to evaluate TERN-701 500 mg QD in approximately 20 patients with BCR::ABL1 resistance mutations including T315I, M244V, F359I/C/V and others.

About chronic myeloid leukemia
Chronic myeloid leukemia (CML) is a slow growing type of blood cancer that leads to an overproduction of white blood cells that accumulate in the blood and bone marrow, disrupting the production of healthy blood cells. CML is commonly associated with the Philadelphia chromosome, a translocation between chromosomes 9 and 22 that results in constitutive activation of the BCR::ABL1 fusion protein, which fuels cancer growth.

(Press release, Merck & Co, MAR 25, 2026, View Source [SID1234663904])

On March 25, 2026 KYORIN Pharmaceutical Co., Ltd. reported that it has entered into an exclusive distribution and promotion agreement with Johnson & Johnson (the legal entity for the prescription pharmaceuticals business in Japan, operating as Janssen Pharmaceutical K.K., headquartered in Chiyoda-ku, Tokyo; President: Christopher Rieger; hereafter "J&J") on March 25, 2026, for SIRTURO (Bedaquiline; hereafter "the Product").

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The Product is currently marketed by J&J as a part of combination therapy in patients with multidrug-resistant pulmonary tuberculosis (MDR-TB). Furthermore, J&J is currently conducting Phase 2/3 clinical trials in patients with treatment-refractory Mycobacterium avium complex-lung disease (MAC-LD) to expand its approved indications.

Under this agreement, KYORIN will commence sole promotional activities for the Product from June 2026. Furthermore, upon obtaining approval for the additional indication of MAC-LD, KYORIN will receive product supply from J&J and exclusively distribute and promote the Product.

The Product is a diarylquinoline antimycobacterial drug marketed globally by J&J. It specifically inhibits ATP synthase, which is essential for the energy production of Mycobacterium tuberculosis, and exhibits antibacterial activity against both actively replicating and dormant cells. In Japan, it has been available since 2018 for the treatment of MDR-TB, with strains of Mycobacterium tuberculosis susceptible to the Product as the indicated bacterial species. As an oral medication, the standard dosage for adults is 400 mg once daily for the first two weeks, followed by 200 mg three times per week (with at least 48 hours between doses) from the third week onwards, to be taken with food. Furthermore, it is required that the Product always be used in combination with other antimycobacterial drugs.

In its medium-term business plan, "Vision 110 – Stage1 -", KYORIN aims for the "expansion of development pipeline through in-licensing", focusing on products that are expected to contribute early to business results. Under the "Franchise Customer (FC) Strategy", which concentrates resources on the specialized areas of respiratory, otolaryngology, and urology. KYORIN strives to contribute to the treatment of patients suffering from infectious diseases by adding this drug to product lineup.

The impact on business performance for the fiscal year ending March 31, 2026 is expected to be negligible.
There are no capital, personnel, or business relationships between KYORIN and J&J, and neither party is considered a related party to the other.

(Press release, Kyorin, MAR 25, 2026, View Source [SID1234663903])

On March 25, 2026 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported final clinical data from the completed Phase 2 OVATION 2 clinical trial evaluating IMNN-001 in combination with standard of care (SoC) neoadjuvant and adjuvant chemotherapy (N/ACT). The large randomized 112-patient study evaluated IMNN-001 in women with newly diagnosed advanced ovarian cancer. IMNN-001, the company’s lead drug candidate, utilizes its proprietary non-viral DNA delivery platform, TheraPlas, the only nucleic acid nanoparticle technology showing promise in treating cancer. This novel immunotherapy is designed to recruit the entirety of the immune system by enabling locoregional secretion of the powerful cancer-fighting cytokine interleukin 12 (IL-12), altering the tumor microenvironment.

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Based on prior data assessments, IMUNON previously reported a median 11.1-month increase in OS (40.5 vs. 29.4 months) in the IMNN-001 treatment arm compared to SoC chemotherapy alone. Following the most recent data assessment, the company is now reporting a median 14.7-month increase in OS (45.1 vs. 30.4 months) in women in the IMNN-001 treatment arm compared to SoC alone, demonstrating continuous improvement in OS (3.6 delta). In addition, the new IMNN-001 data showed that women treated with IMNN-001 and SoC chemotherapy plus poly ADP-ribose polymerase (PARP) inhibitors as part of maintenance therapy achieved a median increase in OS of 24.2 months (65.6 vs. 41.4 months) compared to SoC chemotherapy alone.

"It is very encouraging to see results from the OVATION 2 trial indicating that treatment with IMNN-001 was associated with an overall survival benefit of more than a year in patients treated with IMNN-001 plus chemotherapy and more than two years in women also receiving PARP inhibitors as part of maintenance therapy. These new findings are especially exciting given that there have been no meaningful advances in standard of care in ovarian cancer in the last 30 years," said Premal H. Thaker, M.D., Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, OVATION 2 Study Chair and Study Chair of Phase 3 OVATION 3 trial. "Importantly, with these new efficacy results, IMNN-001 continues to maintain a highly favorable safety and tolerability profile, further reinforcing the potential of this IL-12 immunotherapy to represent a landmark advance in treatment for women who are in desperate need of new and improved treatment options."

"With each new assessment of the findings from the OVATION 2 study, IMNN-001 has continued to show that it can improve overall survival in women with newly diagnosed advanced ovarian cancer while maintaining an advantageous safety profile," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "The strong response from our current trial investigators and the broader medical community supports our belief in the significant potential of IMNN-001 to make a meaningful difference in women’s lives. We remain focused on executing our Phase 3 trial and advancing this promising therapy to the final stage of regulatory review as quickly as possible."

The pivotal Phase 3 OVATION 3 trial is a robustly designed clinical study with the primary endpoint of OS. The trial design includes two planned interim analyses of the primary endpoint, designed to allow for an accelerated timeline for potential submission of a Biologics License Application (BLA) for full approval of IMNN-001 to the U.S. Food and Drug Administration (FDA) if the primary endpoint reaches statistical significance. OVATION 3 is currently enrolling patients at seven clinical sites with up to 43 additional sites being considered for activation. IMUNON anticipates enrolling approximately 80 patients (~20%) of the total target of 500 participants within the next year.

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel neoadjuvantly in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

(Press release, IMUNON, MAR 25, 2026, View Source [SID1234663902])

On March 25, 2026 Exicure, Inc. (Nasdaq: XCUR, the "Company") reported the following financial results for the year ended December 31, 2025.

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2025 Financial Results

Cash Position: Cash and cash equivalents were $3.7 million as of December 31, 2025, compared to $12.5 million as of December 31, 2024. Our current liquidity may not be sufficient to fund operations for the next 12 months. Additional financing will be required to support ongoing operations, continue the exploration of strategic alternatives, and pursue any alternatives that we identify.

Research and Development (R&D) Expense: Research and development expenses were $3.3 million for the year ended December 31, 2025, as compared to $0 for the year ended December 31, 2024. The increase of $3.3 million reflects R&D activities incurred following the acquisition of GPCR Therapeutics USA Inc. ("GPCR USA"), which conducts research operations. Immediately prior to closing the acquisition of GPCR USA, the Company recorded no research or development expenses.

General and Administrative (G&A) Expense: General and administrative expenses were $6.8 million for the year ended December 31, 2025, as compared to $5.4 million for the year ended December 31, 2024. The increase in G&A expense of $1.4 million was primarily driven by additional expenses associated with the acquisition and integration of GPCR USA.

Loss from sale or disposal of property and equipment: The Company recognized a $90,000 loss from GPCR USA’s sale of fixed assets.

Gain on early lease termination: As a result of the early termination of the Company’s lease for its office in Chicago, effective January 31, 2025, the Company recognized a $6.0 million gain from the reversal of the remaining liability related to this lease.

Other Income and Expense: The Company recognized a $346,000 gain in the third quarter of 2025 upon satisfying its self‑insured retention with its insurer. The Company recorded a loss of $1,553,000 related to the change in fair value of its contingent liability. The Company recognized a loss of $275,000 associated with the sale of its subsidiary, KC Creation, along with additional currency translation losses related to this foreign subsidiary.

Net Loss: The Company had a net loss of $4.9 million for the year ended December 31, 2025, compared to a net loss of $9.7 million for the year ended December 31, 2024. The decrease in net loss of $4.8 million was primarily due to the $6.0 million gain resulting from the lease liability reversal, partially offset by increased operating expenses following the acquisition of GPCR USA.

Going Concern: Management believes that the Company’s existing cash and cash equivalents is not sufficient to continue to fund operations. The Company has already engaged in significant cost reductions, and its ability to further cut costs and extend the Company’s operating runway is limited. As a result, substantial additional financing is needed in the short term to pay expenses, fund the ongoing exploration of strategic alternatives and pursue any alternatives that may be identified. The Company also needs to raise capital to fund its operations. There can be no assurance that such additional financing will be available and, if available, can be obtained on acceptable terms.

(Press release, Exicure, MAR 25, 2026, View Source [SID1234663901])