On February 26, 2026 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported financial results and business highlights for the fourth quarter and full year-ended December 31, 2025.

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Fourth Quarter and Full Year 2025 Financial Results

Total fourth quarter and full year revenue of $20.7 million and $85.2 million, respectively
HEPZATO KIT fourth quarter and full year revenue of $19.0 million and $78.8 million, respectively
CHEMOSAT fourth quarter and full year revenue of $1.7 million and $6.4 million, respectively
Gross margins of 85% for the fourth quarter and 86% for the full year
Fourth quarter net loss of $1.9 million and full year net income of $2.7 million
Non-GAAP positive adjusted EBITDA for the fourth quarter and full year of $2.4 million and $25.1 million, respectively
Repurchased 628,572 common shares for $6.0 million through December 31, 2025 under the approved $25 million Share Buyback Program
As of December 31, 2025, the Company had approximately $91.0 million of cash and short-term investments and no debt
Business Highlights

Currently 28 active centers
Approximately 140% growth in HEPZATO procedure volume in 2025 compared to 2024
Announced the publication of additional results from the FOCUS study, "Subgroup Analyses of the Phase 3 FOCUS Study of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma" in Journal of Cancer Research and Clinical Oncology
Announced the publication of results from multiple studies by independent investigators, including:
Results from the Phase 2 CHOPIN trial sponsored by Leiden University Medical Center evaluating CHEMOSAT with ipilimumab and nivolumab in metastatic uveal melanoma at the 2025 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress showing a significant improvement in one-year progression-free survival versus CHEMOSAT alone
A long-term retrospective study conducted by researchers at the University Hospital Tübingen, Germany, "Characterization of long-term survivors with liver metastases from uveal melanoma diagnosed between 2005 and 2021", in International Journal of Cancer
A long-term retrospective study conducted by researchers at the Asklepios Hospital Barmbek, Germany, "Survival Outcome After Percutaneous Hepatic Perfusion with High-Dose Melphalan for Liver-Dominant Metastatic Uveal Melanoma: A 10-Year Single-Center Experience" in Cancers
"2025 was a pivotal year in which we delivered robust procedure-volume growth, positive operating cashflow and successfully navigated temporary headwinds to stabilize the HEPZATO revenue base in the fourth quarter," said Gerard Michel, President and Chief Executive Officer of Delcath "With 28 active treatment centers now delivering therapy and compelling CHOPIN data demonstrating clear clinical benefit when PHP is sequenced with checkpoint inhibitors, we enter 2026 with strong momentum. Through continued site activations, commercial expansion, and heightened physician awareness of the CHOPIN results, we expect accelerated adoption and utilization that will drive long-term value for patients and shareholders alike."

2026 Full Year Financial Guidance

The Company’s financial outlook for fiscal year 2026:

Total CHEMOSAT and HEPZATO KIT revenue to be at least $100 million, reflecting an increase in HEPZATO KIT volume of at least 20% over 2025, and
Gross margins in the range of 84% to 87%.
Fourth Quarter and Full Year 2025 Results

Total revenue for the quarter ended December 31, 2025 was $20.7 million compared to $15.1 million for the same period in the prior year. Revenue in the quarter includes sales of $19.0 million of HEPZATO in the U.S. and $1.7 million of CHEMOSAT in Europe.

Total revenue for the year-ended December 31, 2025 was $85.2 million compared to $37.2 million for the same period in the prior year. Revenue in 2025 includes sales of $78.8 million of HEPZATO in the U.S. and $6.4 million of CHEMOSAT in Europe.

Research and development expenses for the quarter and year-ended December 31, 2025, were $9.4 million and $29.2 million, respectively compared to $2.9 million and $13.9 million for the same periods in the prior year. The increase is primarily due to costs associated with expanding the clinical team including share-based compensation expense related to an increase in headcount and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for mCRC and mBC. In 2024, these costs are primarily related to medical affairs and regulatory costs associated with the approved products.

Selling, general and administrative expenses for the quarter and year-ended December 31, 2025, were $10.5 million and $43.5 million, respectively compared to $7.0 million and $29.6 million for the same periods in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses and additional personnel on the commercial team. In addition, the increase in personnel along with higher grant date exercise prices has increased the share-based compensation expense.

Net loss for the quarter ended December 31, 2025 was $1.9 million and net income for the full year was $2.7 million, compared to net loss of $3.4 million and $26.4 million for the same periods in the prior year.

Non-GAAP positive adjusted EBITDA for the quarter and year-ended December 31, 2025 was $2.4 million and $25.1 million compared to adjusted EBITDA gain of $4.6 million and loss of $2.5 million for the same periods in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of December 31, 2025, the Company had $91.0 million in cash and investments, and no debt.

Conference Call Information

To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Thursday, February 26, 2026
Time: 8:30 AM Eastern Time

(Press release, Delcath Systems, FEB 26, 2026, View Source [SID1234663067])

On February 26, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial and operational results for the fourth quarter and full year ended December 31, 2025 and recent business highlights and provided financial guidance for the full year 2026.

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Fourth Quarter and Recent Strategic and Operational Highlights

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Secured Milestone Medicare Coverages for Breast & Lung Cancer: Received Medicare coverage approval in the fourth quarter for the surveillance of cancer recurrence in breast cancer patients, and also, received Medicare coverage for Stage I to III non-small cell lung cancer (NSCLC) in the first quarter of 2026; both are expected to be key catalysts for clinical revenue generation and market share growth in the MRD space.
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Published Landmark TRACERx Data: Highlighted data from one of the largest and most comprehensive NSCLC patient cohorts to date in the journal Cell, demonstrating the clinical importance of Personalis’ ultrasensitive MRD approach.
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Validated ctDNA Dynamics: Published VHIO data in Clinical Cancer Research titled "Broad Utility of Ultrasensitive Analysis of ctDNA Dynamics across Solid Tumors Treated with Immunotherapy," further reinforcing the clinical validity of the NeXT Personal platform in a broad array of cancer types.
Full Year 2025 Financial Results Compared with 2024

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Total Revenue: $69.6 million compared with $84.6 million.
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Clinical Momentum: Clinical test revenue of $2.0 million, more than double the $0.8 million.
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Volume Performance: Clinical test volume reached 16,233 tests, a nearly 400% increase over the 3,285 test volume in 2024.
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Core Revenue Streams: Pharma testing services and all other customers contributed $49.0 million. Revenue from enterprise sales (Natera) and population sequencing (the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP)) totaled $17.6 million. Other revenue included a $1.0 million royalty payment for the patents licensed by the Company.
Fourth Quarter 2025 Financial Results Compared with 2024

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Quarterly Revenue: $17.3 million compared with $16.8 million.
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Accelerating Volume: Delivered 6,183 clinical tests in the fourth quarter, representing a 41% sequential increase over the third quarter of 2025.

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Clinical Revenue: Clinical test revenue of $0.9 million, compared with $0.2 million.
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Core Revenue Streams: Pharma testing services and all other customers contributed $10.9 million. Revenue from enterprise sales (Natera) and population sequencing (the VA MVP) totaled approximately $4.5 million. Other revenue included a $1.0 million royalty payment for the patents licensed by the Company.
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Strong Cash Position: Ended the year with approximately $240.0 million in cash, cash equivalents, and short-term investments. This includes approximately $109.0 million in net proceeds from the Company’s At-The-Market (ATM) sales program, executed at a weighted-average price of $8.43 per share.
CEO Commentary

"Our performance in 2025 was transformative, demonstrated by 400% year-over-year clinical volume growth and pivotal Medicare coverage for breast and lung cancer," said Chris Hall, Chief Executive Officer and President. "We enter 2026 with a fortified balance sheet of approximately $240 million in cash, which allows us to expand our investments in our ‘Win-in-MRD’ strategy. While we are in the early stages of reimbursement, we are driving volume now to secure long-term market leadership. We expect 2026 to be a year of rapid commercial expansion, with clinical revenue projected to grow approximately five-fold as we operationalize our recent coverage wins."

Full Year 2026 Outlook

Personalis expects the following for the full year of 2026:

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Total company revenue in the range of $78.0 to $80.0 million.
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Clinical revenue of $10.0 to $11.0 million, including Medicare reimbursement from breast and lung cancer surveillance; clinical volume expected to be in the range of 43,000 to 45,000 tests.
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Revenue from pharma testing services and all other customers in the range of $55.0 to $56.0 million.
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Revenue from population sequencing and enterprise sales of approximately $13.0 million.
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Gross margin in the range of 15% to 20%, reflecting the strategic decision to accelerate clinical volume adoption ahead of full reimbursement coverage to establish market share.
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Net loss of approximately $105.0 million.
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Cash usage of approximately $100.0 million, driven by commercial investments to support the projected 5x clinical revenue growth.

(Press release, Personalis, FEB 26, 2026, View Source [SID1234663086])

On February 26, 2026 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the fourth quarter and year ended Dec. 31, 2025.

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"We closed out an outstanding year with a strong fourth quarter, reflecting the strength of our innovative test portfolio, disciplined execution and the dedication of the entire Castle team who continue to deliver meaningful impact for patients and clinicians every day," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We exited 2025 with clear leadership across our core dermatologic and gastrointestinal franchises, highlighted by continued momentum in TissueCypher, which achieved 86% test report growth over 2024.

"In 2025, we also delivered an important milestone with the limited access launch of AdvanceAD-Tx, which materially expanded our total addressable market and reinforced our commitment to providing clinical answers to dermatology clinicians and their patients. As we look ahead to 2026 and beyond, we believe we are well positioned to continue delivering stockholder value and capitalize on our near- and long-term opportunities, supported by continued test adoption growth for our core tests, a robust pipeline and a strong balance sheet."

Twelve Months Ended Dec. 31, 2025, Financial and Operational Highlights

Revenues were $344.2 million, compared to $332.1 million in 2024, growth of 4% over 2024. Excluding DecisionDx-SCC and IDgenetix revenue, growth of 34% over 2024. Affecting year ended Dec. 31, 2025, revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.
Revenues for our non-dermatologic tests were $127.9 million, compared to $75.1 million in 2024.
Core revenue drivers:

2025 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 37% over 2024:
DecisionDx-Melanoma test reports delivered in 2025 were 39,083, compared to 36,008 in 2024.
TissueCypher Barrett’s Esophagus test reports delivered in 2025 were 39,014, compared to 20,956 in 2024.
Additional tests:

DecisionDx-SCC test reports delivered in 2025 were 17,294, compared to 16,348 in 2024. Affecting twelve-month test report volume was the change in Medicare coverage effective April 24, 2025, and the re-focus of our commercial efforts.
MyPath Melanoma test reports delivered in 2025 were 4,288, compared to 3,909 in 2024.
DecisionDx-UM test reports delivered in 2025 were 1,769, compared to 1,699 in 2024.
Discontinued tests:

IDgenetix test reports delivered in 2025 were 3,605, compared to 17,151 in 2024. The Company discontinued its IDgenetix test offering effective May 2025.
Gross margin for 2025 was 69%, and Adjusted Gross Margin was 80%, compared to 79% and 82%, respectively, for the same periods in 2024. Affecting 2025 gross margin was the loss of revenues from DecisionDx-SCC and the one-time adjustment of an acceleration of amortization expense of approximately $20.1 million during the three months ended March 31, 2025.
Net cash provided by operations was $64.3 million, compared to $64.9 million in 2024.
Net loss for 2025, which includes non-cash stock-based compensation expense of $45.9 million, was $24.2 million, compared to net income of $18.2 million in 2024.
Net loss per share, Basic and Diluted, was $0.83 and Adjusted Net Loss per Share, Basic and Diluted, was $0.14, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.66 and $0.62, respectively, for 2024.
Adjusted EBITDA for 2025 was $44.0 million, compared to $75.0 million in 2024.
Cash, Cash Equivalents and Marketable Investment Securities

As of Dec. 31, 2025, the Company’s cash, cash equivalents and marketable investment securities totaled $299.5 million.

Fourth Quarter Ended Dec. 31, 2025, Financial and Operational Highlights

Revenues were $87.0 million, compared to $86.3 million during the same period in 2024, growth of 1% over the fourth quarter of 2024. Excluding DecisionDx-SCC and IDgenetix, revenue growth was 43% over the fourth quarter of 2024. Affecting fourth quarter 2025 revenue was the change in DecisionDx-SCC Medicare coverage effective April 24, 2025, the re-focus of our commercial efforts, as well as the discontinuation of IDgenetix in May 2025.
Revenues for our non-dermatologic tests were $38.4 million, compared to $22.5 million during the same period in 2024.
Core revenue drivers:

Fourth quarter 2025 total test reports for our core revenue drivers (DecisionDx-Melanoma, TissueCypher) increased 42% over the fourth quarter of 2024:
DecisionDx-Melanoma test reports delivered in the quarter were 10,022, compared to 8,672 in the fourth quarter of 2024.
TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 11,803, compared to 6,672 in the fourth quarter of 2024.
Additional tests:

DecisionDx-SCC test reports delivered in the quarter were 3,971, compared to 4,299 in the fourth quarter of 2024. Affecting fourth quarter test report volume was the change in Medicare coverage effective April 24, 2025, and the re-focus of our commercial efforts.
MyPath Melanoma test reports delivered in the quarter were 1,045, compared to 879 in the fourth quarter of 2024.
DecisionDx-UM test reports delivered in the quarter were 395, compared to 424 in the fourth quarter of 2024.
Gross margin was 76%, and Adjusted Gross Margin was 78%, compared to 76% and 81%, respectively, for the same periods in 2024.
Net cash provided by operations was $26.9 million, compared to $24.4 million for the same period in 2024.
Net loss, which includes non-cash stock-based compensation expense of $11.4 million, was $2.3 million, compared to net income of $9.6 million for the same period in 2024.
Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.08, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.34 and $0.32, respectively, for the same period in 2024.
Adjusted EBITDA was $11.5 million, compared to $21.3 million for the same period in 2024.
2026 Outlook

The Company anticipates generating between $340-350 million in total revenue in 2026.

Fourth Quarter and Recent Accomplishments and Highlights

Dermatology – Skin Cancer

The Company announced the publication of an independent expert consensus paper titled "31-Gene Expression Profiling for Cutaneous Melanoma: An Expert Consensus Panel," which endorsed the Company’s DecisionDx-Melanoma test. Authored by a panel of ten melanoma experts from leading academic and clinical institutions, the paper presented evidence-based recommendations supporting DecisionDx-Melanoma as a best-practice tool for guiding management decisions in patients with cutaneous melanoma (CM). The panel concluded that the test provides prognostic information independent of traditional clinicopathologic factors and can be integrated with existing staging systems to improve patient risk assessment and help optimize clinical decision-making. Drawing on a comprehensive review of 26 published studies encompassing more than 7,500 patients, the panel used a modified Delphi process to reach unanimous agreement on nine consensus statements defining the test’s role in risk stratification, sentinel lymph node biopsy (SLNB) decision making and long-term patient management. See the Company’s news release from Dec. 9, 2025, for more information.
The Company also announced new data demonstrating the clinical value of its DecisionDx-Melanoma test in improving SLNB decision making and enhancing recurrence risk prediction in patients with CM. The data was featured in two oral presentations at the 2nd European Congress on Dermato-Oncology. By combining the biologic information of a patient’s tumor with traditional staging, DecisionDx-Melanoma is designed to enhance five-year prognostic accuracy in SLN-negative patients and potentially provide additional clarity for identifying those at higher risk of recurrence. These findings support the test’s potential to help clinicians make more risk-aligned therapeutic decisions and tailor follow-up care according to a patient’s individual risk. See the Company’s news release from Nov. 14, 2025, for more information.
Gastroenterology

The Company announced the publication of a new systematic review and meta-analysis (SRMA) demonstrating that the TissueCypher Barrett’s Esophagus test provides clinically validated risk stratification for patients with Barrett’s esophagus (BE). The findings confirm that TissueCypher can outperform traditional pathology or clinical factors alone to identify patients at increased risk of developing esophageal cancer. The paper, titled "The Tissue Systems Pathology Test Predicts Risk of Progression in Patients With Barrett’s Esophagus: Systematic Review and Meta-Analysis," was published in the Journal of Clinical Gastroenterology. The analysis consolidated data from six previously published studies and found that TissueCypher consistently identifies patients at greater risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC), a key step toward enabling personalized, risk-aligned patient management aimed at preventing cancer. See the Company’s news release from Dec. 12, 2025, for more information.
Dermatology – Atopic Dermatitis

The Company announced the limited access launch of AdvanceAD-Tx, a 487-gene expression profile test designed to guide systemic treatment decision making in patients ages 12 and older with moderate-to-severe atopic dermatitis, following a presentation of the prospective, multicenter development and validation study at the 25th Annual Fall Clinical Dermatology Conference (news release), which was recently published in the Journal of the American Academy of Dermatology (JAAD) (news release). AdvanceAD-Tx is designed to identify patients with a Janus kinase inhibitor (JAKi) responder profile who are more likely to achieve an Eczema Area and Severity Index improvement of 90% (EASI-90), more quickly and with reduced flares and itch by three months, when treated with a JAKi compared to a T helper type 2 (Th2)-targeted therapy. See the Company’s news release from Nov. 11, 2025, for more information.
Uveal Melanoma

The Company announced new data from the largest prospective, multicenter study to date comparing next-generation sequencing (NGS)-based gene mutation analysis with the combination of DecisionDx-UM and Preferentially Expressed Antigen in Melanoma (PRAME) gene expression for predicting outcomes in patients with uveal melanoma (UM). The study, titled "Early Genetic Evolution of Driver Mutations in Uveal Melanoma," was conducted by the Collaborative Ocular Oncology Group (COOG) and recently published in Nature Communications. See the Company’s news release from Dec. 17, 2025, for more information.
Corporate

The Company announced that it was recognized by the Houston Chronicle as a Houston Top Workplace, which celebrates people-focused, standout workplace cultures. This marked the fifth consecutive year the Company had been ranked among the Houston metro area’s esteemed workplaces. Castle also earned three Culture Excellence awards in the areas of Employee Appreciation, Employee Well-Being and Professional Development. See the Company’s news release from Nov. 17, 2025, for more information.
Conference Call and Webcast Details

Castle Biosciences will hold a conference call on Thursday, Feb. 26, 2026, at 4:30 p.m. Eastern time to discuss its fourth quarter and full-year 2025 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until March 19, 2026.

To access the live conference call via phone, please dial 833-470-1428 from the United States, or global dial-in numbers are available here: View Source, at least 10 minutes prior to the start of the call, using the conference ID 695618.

(Press release, Castle Biosciences, FEB 26, 2026, View Source [SID1234663102])

On February 26, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a review of recent program and corporate developments.

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"We remain confident in the bitopertin program and the Phase 3 APOLLO study. We are fully committed to working closely with the FDA to position bitopertin for approval following the completion of APOLLO at the end of the year," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "At the same time, our broader pipeline continues to deliver meaningful momentum. DISC-0974 generated powerful data in MF anemia that further reinforces its potential to transform the treatment landscape and we look forward to providing additional updates later this year. We are also excited about DISC-3405 with first in-patient data in both polycythemia vera and sickle cell disease expected later this year."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)

Received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) in February 2026 related to sufficiency of evidence of association between percent change in PPIX and sunlight exposure-based endpoints
Progressing Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP, with topline data expected Q4 2026
Following completion of APOLLO, expect to submit a response to the CRL and receive an FDA decision by mid-2027
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Initial data from Phase 2 RALLY-MF trial of DISC-0974 in patients with anemia of myelofibrosis (MF) presented at ASH (Free ASH Whitepaper) Annual Meeting in December
Positive, durable benefits on hemoglobin and transfusion burden in anemia of MF across a broad range of patients
Demonstrated efficacy regardless of concomitant JAK inhibitor use, setting up for utilization across all anemic MF patients
Phase 2 study in patients with inflammatory bowel disease (IBD) and anemia initiated in Q1 2026 with initial data expected in 2027
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Progressing ongoing Phase 2 study in patients with polycythemia vera with initial data expected in 2H 2026
Initiated Phase 1b study in sickle cell disease in Q4 2025 with initial data expected in 2H 2026
Full Year 2025 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $791.2 million as of December 31, 2025, compared to $489.9 million as of December 31, 2024. The increase was largely due to net proceeds of $454.4 million from underwritten offerings in January and October 2025, partially offset by cash utilized in operating activities. We expect that our existing cash, cash equivalents, and marketable securities as of December 31, 2025 will be sufficient to fund operational plans into 2029.

Research and Development Expenses: R&D expenses were $170.6 million for the full year ended December 31, 2025, as compared to $96.7 million for the full year ended December 31, 2024. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 program, and increased headcount, as well as $23.0 million in payments related to the achievement of development milestones.

Selling, General and Administrative Expenses: SG&A expenses were $65.4 million for the full year ended December 31, 2025, as compared to $33.0 million for the full year ended December 31, 2024. The increase in SG&A expenses was primarily due to increased headcount including establishing infrastructure to support potential commercialization.
Net Loss: Net loss was $212.2 million for the full year ended December 31, 2025, as compared to $109.4 million for the full year ended December 31, 2024. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

(Press release, Disc Medicine, FEB 26, 2026, View Source [SID1234663068])

On February 26, 2026 Prokarium’s CEO, Ibs Mahmood, reported that it will be presenting at the 41st Annual EAU Congress, London, UK, 13-16th March 2026.

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Presentation information:

Presentation Title: PARADIGM 1 – A multi-center Phase 1 study evaluating the safety and clinical effect of a novel microbial immunotherapeutic (ZH9) in patients with relapsed NMIBC – A first interim review (Abstract ID: A0089)
Session Title: High-risk NMIBC: Evolving BCG–immunotherapy strategies and technical advances in TURB (Abstract Session 05)
Session Date and Time: Friday 13th March, 16:20 – 16:56

(Press release, Prokarium, FEB 26, 2026, View Source [SID1234663087])