On March 12, 2026 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a novel class of custom-built protein drugs known as DARPin therapeutics ("Molecular Partners" or the "Company"), reported its corporate highlights and audited financial results for the full year 2025, as well as the publication of its 2025 Annual Report.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are making significant progress in targeted alpha radiotherapy, as our first Radio-DARPin candidate, MP0712 targeting DLL3, enters clinical development. Early imaging and dosimetry results support the ongoing Phase 1/2a study for MP0712, which aims to address critical needs in lung cancer treatment," said Patrick Amstutz, Ph.D., CEO of Molecular Partners. He added: "We are strengthening our expertise with a strong scientific advisory board, chaired by Prof. Ken Herrmann, to support our growing Radio-DARPin pipeline, with MP0726 moving towards imaging and new candidates being selected. Our solid finances position us well for future growth."

Research & Development Highlights

MP0712 & Radio-DARPin Pipeline

The MP0712 Phase 1/2a trial has started (ClinicalTrials.gov: NCT07278479) and recruitment is open. MP0712 is the Company’s lead Radio-DARPin Therapy (RDT) targeting the tumor-associated protein delta-like ligand 3 (DLL3) and carrying the therapeutic payload 212Pb. It is being developed with Molecular Partners’ strategic partner Orano Med, a pioneer in targeted alpha therapy, for the treatment of patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. The Phase 1/2a study is a multi-center study in the US, with the objectives to assess safety and determine a recommended Phase 2 dose for MP0712. The study contains a pre-treatment imaging and dosimetry step with 203Pb-labeled MP0712. The Company expects initial clinical data from this study in 2026.

Molecular Partners and the NuMeRI team presented first patient imaging and dosimetry data on MP0712 at the 8th Theranostics World Congress (TWC) in January 2026. The data from five evaluable patients with various DLL3-expressing cancers, including small cell lung, urothelial, and other neuroendocrine cancers, were generated with MP0712 carrying the diagnostic isotope 203Pb under the leadership of Dr. Mike Sathekge as part of a Named Patient Access Program under the legal framework for compassionate care in South Africa (also referred to as Section 21 of the Medicines and Related Substances Act). The images show specific uptake as well as robust accumulation of MP0712 in tumor lesions, with limited uptake in healthy tissues, as intended, confirming the initial data on MP0712 presented at the Targeted Radiopharmaceuticals (TRP) Summit Europe 2025. MP0712 is half-life engineered to promote tumor uptake over time via the DLL3 internalization and replenishment mechanism. The biodistribution and dosimetry extrapolations are supportive of the Phase 1/2a study design and of the clinical development plans of MP0712 carrying the therapeutic isotope 212Pb for patients with small cell lung cancer (SCLC) and other DLL3-expressing neuroendocrine cancers.

The Company’s second RDT program MP0726, co-developed with Orano Med, targets mesothelin (MSLN), a tumor target overexpressed across several cancers with high unmet need, such as ovarian cancer. Molecular Partners has developed Radio-DARPins able to selectively bind to membrane-bound MSLN without being impacted by shed MSLN – a mechanism which has hampered the development of other MSLN-targeting therapeutics. The Company presented preclinical data on MP0726 at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI). The Company is planning to progress several Radio-DARPin programs towards first-in-human imaging, including MP0726.

For its growing Radio-DARPin pipeline and based on the first-in-human Radio-DARPin data presented at TWC 2026 indicating that Radio-DARPins may be suitable vectors for alpha-emitting isotopes, including 212Pb and also the longer-lived 225Ac, Molecular Partners is evaluating various radio-nuclides moving forward to tailor Radio-DARPin candidates to patient needs – matching vector and isotope properties with target and disease biology. Molecular Partners entered a non-exclusive development agreement with Eckert & Ziegler for targeted alpha radio-therapeutics, thereby enabling the potential of Radio-DARPins for a range of therapeutic isotopes, including 225Ac, and advancing the Company’s wholly owned pipeline. The Company plans to present pre-clinical data on Radio-DARPins suitability with multiple isotopes at the 3rd Global Radiopharmaceuticals Development Summit in March 2026 in Shanghai, China.

In December 2025 Molecular Partners announced the formation of a scientific advisory board (SAB) to accelerate the development of its targeted radiotherapeutics. The SAB, chaired by well-known nuclear medicine expert Prof. Ken Herrmann, will be instrumental in guiding Molecular Partners strategic direction as it transitions and evolves from early clinical validation to full clinical development of its targeted alpha radiotherapies.

Molecular Partners’ Radio-DARPins are designed as ideal vectors for precise delivery of potent alpha-emitting isotopes to tumor lesions with the potential to unlock a broad range of solid tumor targets for radiopharmaceuticals.

MP0317 (tumor-localized CD40 agonist)

An investigator-initiated, proof-of-concept Phase 2 study of MP0317 combined with standard-of-care (SoC) for the treatment of patients with advanced cholangiocarcinoma is now open with two sites activated (NCT07036380) and patient dosing ongoing. The study is a randomized, multicenter study in France and aims to recruit 75 patients (with a 2to1 design, including 50 patients in the experimental arm, and 25 in the control arm). The objective of the study is to assess the clinical benefit of MP0317 combined with SoC comprising the immunotherapy durvalumab, an anti-PD-L1 checkpoint inhibitor, plus gemcitabine-cisplatin-based chemotherapy, compared to SoC alone. The tumor microenvironment (TME) is known to play a crucial role in cholangiocarcinoma development and treatment resistance. MP0317 is hypothesized to lead to immune-mediated reshaping of the TME, thereby improving the 12-month progression-free survival rate of patients compared to those treated with SoC only.

MP0317 is designed to activate immune cells specifically within the TME by anchoring to fibroblast activation protein (FAP), which is expressed in high amounts in the stroma of various solid tumors, including cholangiocarcinoma. The Company completed a Phase 1 dose-escalation study of MP0317 in patients with advanced solid tumors in 2024 (NCT05098405; 46 patients treated across 9 dose levels). Comprehensive biomarker analyses from this trial showed tumor-localized CD40 activation and remodeling of the TME. CD40 is an attractive target for cancer immunotherapy due to its strong immune-stimulatory activity. Molecular Partners believes that MP0317’s tumor-localized approach has the potential to deliver superior efficacy with fewer side effects compared to systemic CD40 agonists.

MP0533 (multispecific T cell engager)

MP0533 is currently being evaluated in a Phase 1/2a clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome/AML (NCT05673057).

Data presented at the 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting showed that densified dosing appears tolerable, and leads to markedly improved serum exposure in cycle 1, along with antitumor activity, in particular in patients with low bone marrow blast count at baseline. Cohort 10 is currently dosing patients and an update on this study is expected in H1 2026.

Molecular Partners plans to support the exploration of MP0533 in combination, both in patients with relapsed/refractory disease as well as in front-line, and has been approached by several consortia expressing interest in conducting such studies. The Company is actively engaging with key opinion leaders and regulators to shape the next phase of development, and anticipates updating the clinical plan for MP0533 in H1 2026.

MP0533 is a novel tetra-specific T cell-engaging DARPin designed for selective and broad killing of AML cells in a mutation-agnostic manner. MP0533’s mode of action enables T cell-mediated killing of AML cells – which commonly co-express at least two of the three targeted antigens (CD33, CD123, CD70) – while preserving a therapeutic window that minimizes damage to healthy cells, which normally express one or none of the targets.

Switch-DARPin Platform (next-generation immune cell engagers)

Molecular Partners designed a logic-gated Switch-DARPin T-cell engager (TCE) to achieve conditional tumor-localized immune activation targeting MSLN and epithelial cell adhesion molecule (EpCAM), which are highly co-expressed in ovarian cancer and other solid tumors. The Switch-DARPin TCE is designed to unmask the CD3-engaging DARPin ("Switch" on) and to activate T cells only upon binding to both MSLN and EpCAM. Co-engagement of CD2 leads to sustained T-cell activation and cytotoxic capacity, enabling the development of potent TCEs with an improved therapeutic window. This Switch-DARPin is half-life extended through a Fc domain, which broadens the Company’s capabilities in half-life engineering modalities.

Based on the encouraging pre-clinical data presented at the 2025 Annual Meetings of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), the Company intends to nominate a lead Switch-DARPin candidate for development in H1 2026 and will provide an update on the program at AACR (Free AACR Whitepaper) 2026.

Corporate Governance & Leadership Highlights

Molecular Partners appointed Martin Steegmaier, Ph.D., as Chief Scientific Officer (CSO) and member of its Executive Committee, effective October 1, 2025. Martin brings a wealth of experience in oncology drug development, having previously contributed to the advancement of several innovative cancer therapies at major biotech and pharmaceutical companies.

In 2025 Molecular Partners performed a strategic review of its operations and headcount, with the objectives of increased efficiency in the organization and to sharpen the focus on advancing its clinical assets.

In April 2025, all motions proposed by the Board of Directors at the Annual General Meeting were approved by the shareholders of the Company by a wide majority.

2025 Financial Highlights

In the financial year ended December 31, 2025, Molecular Partners recognized no revenue (2024: CHF 5.0 million) and incurred total operating expenses of CHF 58.1 million (2024: CHF 66.2 million). This led to an operating loss of CHF 58.1 million for 2025 (2024: Operating loss of CHF 61.2 million).

The net financial loss recorded in 2025 was CHF 3.5 million, compared to a net financial gain of CHF 7.2 million in 2024. This resulted in a 2025 net loss of CHF 61.7 million (2024: Net result of CHF 54.0 million).

The net cash used in operating activities in 2025 was CHF 51.3 million (2024: Net cash used in operating activities CHF 59.2 million). Including short-term time deposits, the cash and cash equivalents position decreased by CHF 56.3 million as compared to year-end 2024, to CHF 93.1 million as of December 31, 2025 (December 31, 2024: CHF 149.4 million). Total shareholders’ equity stood at CHF 80.3 million as of December 31, 2025, a decrease of CHF 61.3 million (December 31, 2024: CHF 141.6 million).

The Company’s cash and cash equivalents and short-term time deposits were CHF 93.1 million as of December 31, 2025, and based on current operating assumptions, will be sufficient to fund its operating expenses and capital expenditure requirements until 2028.

The Company’s balance sheet remained debt-free as of December 31, 2025. As of December 31, 2025, the Company employed 134.0 FTE (full-time equivalents). About 81% of the employees are employed in R&D-related functions.

Key figures as of December 31, 2025

Key Financials (CHF million, except per share, FTE data) FY 2025 FY 2024 Change
Total revenues and other income — 5.0 (5.0 )
R&D expenses (40.2 ) (48.6 ) 8.4
SG&A expenses (15.2 ) (17.6 ) 2.4
Restructuring expenses (2.7 ) — (2.7 )
Total operating expenses (incl depr. & amort.) (58.1 ) (66.2 ) 7.9
Operating result (58.1 ) (61.2 ) 3.1
Net finance result (3.5 ) 7.2 (10.7 )
Net result (61.7 ) (54.0 ) (7.6 )
Basic net result per share (in CHF) (1.65 ) (1.59 ) 0.30
Net cash (used in) from operating activities (51.3 ) (59.2 ) 7.9
Cash & cash equivalents (incl. short-term time deposits) 93.1 149.4 (56.3 )
Total shareholders’ equity 80.3 141.6 (61.3 )
Number of total FTE 134.0 158.5 (24.5 )

Financial outlook 2026

For the full year 2026, at constant exchange rates, the Company expects total operating expenses of CHF 45-55 million, of which around CHF 6 million will be non-cash effective costs for share-based payments, IFRS pension accounting and depreciation.

Documentation

This press release, the Company’s Annual Report on Form 20-F for the year ended December 31, 2025 to be filed with the U.S. Securities and Exchange Commission (SEC), and the Company’s annual report 2025 will be made available through www.molecularpartners.com under the investor section after 10.00 pm CET (4.00 pm EST) on March 12, 2026.

Financial calendar

April 14, 2026 Annual General Meeting
May 12, 2026 Interim Management Statement Q1 2026
August 25, 2026 Half-year results 2026 (unaudited)
October 29, 2026 Interim Management Statement Q3 2026

The latest timing of the above events can always be viewed on the investor section of the website.

(Press release, Molecular Partners, MAR 12, 2026, View Source [SID1234663511])

On March 12, 2026 Gyre Therapeutics (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, reported financial results for the fourth quarter and full year ended December 31, 2025 and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"2026 is expected to be a pivotal regulatory year for Gyre as we advance Hydronidone toward conditional approval in China following our alignment with China’s CDE," said Ping Zhang, Executive Chairman and Interim Chief Executive Officer of Gyre Therapeutics. "Our planned NDA submission in the first half of 2026 underscores the strength of our Phase 3 data and the constructive progress achieved through regulatory engagement. In addition, we have completed enrollment in our 52-week Phase 3 pirfenidone trial in pneumoconiosis, further strengthening our late-stage respiratory portfolio. We have also incorporated the complete Phase 2 and Phase 3 clinical data from our CHB-associated liver fibrosis program into our U.S. development strategy and expect to submit an IND application in 2026 for MASH-associated liver fibrosis. Finally, we recently announced an agreement to acquire Cullgen, a company with a robust pipeline of degraders, targeting inflammatory diseases and cancers, as well as U.S.-based drug discovery and development capabilities. Collectively, these achievements support the continued advancement of our differentiated pipeline across both China and the United States."

Fourth Quarter 2025 Business Highlights and Upcoming Milestones

Commercial Portfolio

ETUARY (pirfenidone): Generated $106.1 million in sales of ETUARY for the full year ended December 31, 2025, compared to $105.0 million for the same period in 2024.
Etorel (nintedanib ethanesulfonate soft capsules): Launched in June 2025 and generated $4.6 million in sales for the full year ended December 31, 2025.
Contiva (avatrombopag maleate tablets): Launched in March 2025 and generated $5.5 million in sales for the full year ended December 31, 2025.
Pipeline Development Updates

Hydronidone:

In November 2025, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals) presented positive Phase 3 trial results evaluating Hydronidone for the treatment of liver fibrosis in chronic hepatitis B (CHB)-associated liver fibrosis at The Liver Meeting 2025, the annual meeting of the American Association of the Study of Liver Diseases. The abstract was selected as a Poster of Distinction.
Following the Phase 3 trial results, Gyre Pharmaceuticals completed a Pre-NDA meeting with China’s CDE. Based on the discussions, the CDE indicated that the existing Phase 3 clinical data support a conditional approval filing and potential priority review eligibility, subject to formal acceptance and approval. The Company plans to submit an NDA for conditional approval in the first half of 2026.
In the United States, Gyre Therapeutics plans to conduct a hepatic impairment study under its active U.S. IND application to inform dose selection and enrollment criteria in patients with reduced hepatic function, supporting the Company’s broader U.S. development strategy.
Gyre Therapeutics remains on track to submit an IND application in 2026 with the U.S. Food & Drug Administration for Hydronidone in MASH-associated liver fibrosis, and, subject to IND clearance, initiate a Phase 2 clinical trial.
Pirfenidone:

In the third quarter of 2025, Gyre Pharmaceuticals completed patient enrollment in its 52-week Phase 3 clinical trial evaluating pirfenidone for the treatment of PD. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 272 patients across 18 clinical research centers in China and is designed to assess the efficacy and safety of 52 weeks of pirfenidone treatment in patients with this chronic occupational lung disease characterized by progressive pulmonary fibrosis. The final patient is expected to complete the trial in the third quarter of 2026.
Following approval in March 2025 from China’s National Medical Products Association’s (NMPA) for a clinical trial evaluating pirfenidone in oncology-related pulmonary complications, Gyre Pharmaceuticals plans to initiate an adaptive Phase 2/3 trial in the first half of 2026 in China. This trial will evaluate pirfenidone for radiation-induced lung injury (RILI), including cases complicated by immune-related pneumonitis, at leading oncology centers.
Corporate Updates:

In March 2026, Gyre announced an agreement to acquire Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and degrader antibody conjugate therapies, in an all-stock transaction valued at approximately $300 million. Following the closing of the acquisition, expected in the second quarter of 2026, the new combined entity is expected to be a fully integrated biopharmaceutical company with U.S.- and China-based capabilities spanning from discovery to manufacturing and commercialization and covering multiple therapeutic areas, including inflammatory diseases, cancers, and pain.
Financial Results

Cash Position

As of December 31, 2025, Gyre had cash, cash equivalents, short-term and long-term bank deposits of $75.9 million.

Financial Results for the Three Months Ended December 31, 2025

Revenues: Revenues for the three months ended December 31, 2025 were $37.2 million, compared to $27.9 million for the same period in 2024, representing an increase of $9.3 million, or 33.3% year-over-year. The growth was driven by $1.5 million in Etorel sales and $2.5 million in Contiva sales, as well as a $5.5 million increase in ETUARY sales, partially offset by a $0.2 million decrease in generic drug revenue. The increase in ETUARY sales reflects strengthened commercial execution and the reallocation of marketing resources during the second half of 2025.
Cost of Revenues: For the three months ended December 31, 2025, cost of revenues was $1.7 million, compared to $1.2 million for the same period in 2024. The $0.5 million increase was primarily driven by a $0.4 million increase in stock-based compensation expense, and a $0.1 million increase in cost of sales of Etorel and Contiva.
Selling and Marketing Expense: Selling and marketing expense for the three months ended December 31, 2025 was $23.8 million, compared to $16.9 million for the same period in 2024, representing an increase of $6.9 million, or 40.8% year-over-year. The increase was primarily attributable to expanded commercial activities, including a $2.9 million increase in personnel costs driven by higher sales headcount and commissions, a $2.2 million increase in stock-based compensation expense, a $1.7 million increase in conference and promotional activities, and a $0.1 million increase in travel and other expenses.
Research and Development Expense: For the three months ended December 31, 2025, research and development expense was $4.8 million, compared to $3.7 million for the same period in 2024. The $1.1 million increase was primarily driven by a $0.6 million increase in facilities, depreciation and other expenses, attributable mainly to professional and consulting fees incurred in connection with research and development operations, a $0.3 million increase in pre-clinical research costs, a $0.2 million increase in clinical trial costs and a $0.3 million increase in staff costs which included $0.2 million in stock-based compensation expenses, partially offset by a $0.3 million decrease in materials and utilities expenses.
General and Administrative Expense: For the three months ended December 31, 2025, general and administrative expense was $6.7 million, compared to $5.5 million for the same period in 2024. The $1.2 million increase was primarily driven by a $1.2 million increase in stock-based compensation expense and a $0.8 million increase in functional and administrative department’s personnel expense, partially offset by a $0.6 million decrease in professional service expense, a $0.1 million decrease in depreciation and amortization expense and a $0.1 million decrease in miscellaneous expense.
Income from Operations: For the three months ended December 31, 2025, income from operations was $0.1 million, compared to $0.7 million income from operations for the same period in 2024. The $0.6 million decrease in income from operations was driven primarily by a $9.9 million increase in total operating expenses, partially offset by a $9.3 million increase in revenue.
Net (Loss) Income: For the three months ended December 31, 2025, net loss was $1.4 million, compared to $0.6 million net income for the same period in 2024. The $2.0 million decrease was driven primarily by an increase in income tax expense of $1.1 million, an increase in operating expenses of $9.9 million and a decrease in other income of $0.3 million, partially offset by an increase in revenue of $9.3 million.
Non-GAAP Adjusted Net Income: For the three months ended December 31, 2025, non-GAAP adjusted net income was $4.3 million, compared to $1.1 million for the same period in 2024. The $3.2 million increase was primarily driven by an increase in revenue of $9.3 million partially offset by the increase in operating expenses of $5.8 million and an decrease in other income of $0.3 million.
Financial Results for the Full Year Ended December 31, 2025

Revenues: Revenues for the full year ended December 31, 2025 were $116.6 million, compared to $105.8 million for the same period in 2024, representing an increase of $10.8 million, or 10.2% year-over-year. The growth was driven by $5.5 million in Contiva sales and $4.6 million in Etorel sales, along with a $1.1 million increase in ETUARY sales, partially offset by a $0.4 million decline in generic drug revenue.

Sales of Contiva and Etorel, which commenced commercialization in March 2025 and June 2025, respectively, were primarily driven by the targeted allocation of commercial and marketing resources to support their respective launches during the first half of 2025. The increase in ETUARY sales reflects a strategic realignment of marketing efforts in the third quarter of 2025 to optimize product mix and address evolving market dynamics.
Cost of Revenues: For the full year ended December 31, 2025, cost of revenues was $5.4 million, compared to $3.9 million for the same period in 2024. The $1.5 million increase was primarily driven by a $0.8 million increase in ETUARY’s cost, due to higher plant, property and equipment depreciation from a plant renovation completed in the second half of 2024, a $0.6 million increase in the cost of Contiva and Etorel, in line with the corresponding increase in their sales, and a $0.5 million increase in stock-based compensation expense. These factors were partially offset by a $0.4 million decrease in costs related to generic drugs due to the decrease in sales.
Selling and Marketing Expense: For the full year ended December 31, 2025, selling and marketing expense was $65.2 million, compared to $57.5 million for the same period in 2024. This $7.7 million increase was primarily driven by a $2.5 million increase in conference expenses and promotional expenses, attributable to the launch of additional promotional campaigns in the current year—particularly for the Company’s new products, a $2.6 million increase in staff costs, which was driven by expanded headcount and higher sales commissions, consistent with the corresponding growth in revenue, a $2.3 million increase in stock-based compensation expense and a $0.3 million increase in traveling and other expense.
Research and Development Expense: For the full year ended December 31, 2025, research and development expense was $13.7 million, compared to $12.0 million for the same period in 2024. The $1.7 million increase was attributable to a $1.0 million increase in clinical trial costs, primarily as a result of data analysis costs for Hydronidone, PD and RILI, a $0.4 million increase in staff costs, which included $0.2 million in stock-based compensation expense, a $0.5 million increase in facilities, depreciation and other expenses, attributable mainly to professional and consulting fees incurred in connection with research and development operations, and a $0.4 million increase in pre-clinical research expenses. These expense increases were partially offset by a $0.6 million decrease in materials and utilities expenses.
General and Administrative Expense: For the full year ended December 31, 2025, general and administrative expense was $20.8 million, compared to $16.1 million for the same period in 2024. This $4.7 million increase was primarily driven by a $3.3 million increase in stock-based compensation expense, a $1.3 million increase in functional and administrative department’s personnel expense, and a $0.9 million increase in miscellaneous expense. These cost increases were partially offset by a $0.8 million decrease in professional service expenses.
Income from Operations: For the full year ended December 31, 2025, income from operations was $11.5 million, compared to $16.2 million in income for the same period in 2024. The $4.7 million decrease in income from operations was driven primarily by a $15.5 million increase in total operating expenses, partially offset by a $10.8 million increase in revenue.
Net Income: For the full year ended December 31, 2025, net income was $9.9 million, compared to $17.9 million net income for the same period in 2024. This $8.0 million decrease was driven primarily by the increase in operating expenses of $15.5 million and decrease in change in fair value of warrant liability of $4.5 million, partially offset by an increase in revenue of $10.8 million, an increase in other income of $0.4 million, and a decrease in income tax expense of $0.8 million.
Non-GAAP Adjusted Net Income: For the full year ended December 31, 2025, non-GAAP adjusted net income was $18.9 million, compared to $16.9 million for the same period in 2024. The increase was primarily driven by an increase in revenue of $10.8 million and an increase in other income of $0.4 million partially offset by an increase in operating expenses of $9.2 million.
Full Year 2026 Financial Guidance

For the full year 2026, the Company expects to generate revenues of $100.5 million to $111.0 million, representing a decline of approximately 13.8% to 4.8% compared to 2025.

The Company anticipates that 2026 will be a transition period, during which it plans to prioritize regulatory activities, including preparation for the planned NDA submission of Hydronidone.

In addition, given uncertainties associated with the National Centralized Drug Procurement program and evolving market dynamics, the Company expects to moderate promotional activities for Contiva and Etorel.

Please note the following regarding the total revenue guidance:

Guidance assumes a constant foreign currency exchange rate.
Guidance assumes no significant economic disruption or downturn.

(Press release, Gyre Therapeutics, MAR 12, 2026, View Source [SID1234663527])

On March 12, 2026 Circle Pharma, Inc., a clinical-stage biopharmaceutical company pioneering next-generation targeted macrocycle therapeutics for cancer, reported publication of research in the Journal of Medicinal Chemistry titled, "Orally Bioavailable Cyclin A/B RxL Inhibitors: Optimization of a Novel Class of Macrocyclic Peptides That Target E2F-High and G1-S-Checkpoint-Compromised Cancers." The paper is included in the journal’s special issue on Peptide Therapeutics.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The publication builds on the company’s August 2025 Journal of Medicinal Chemistry paper titled, "Discovery of Cell-Permeable Macrocyclic Cyclin A/B RxL Inhibitors that Demonstrate Antitumor Activity," which described the first cell-permeable macrocyclic cyclin A/B RxL inhibitors and provided initial in vivo proof-of-concept efficacy.

"This publication demonstrates the capability of our MXMO macrocycle platform to bring forward orally bioavailable macrocycles against therapeutic targets that have been refractory to small molecule chemistry," said James Aggen, Ph.D., vice president of medicinal chemistry at Circle Pharma. "Our earlier work established that the cyclin A/B hydrophobic patch was druggable with macrocycles. This new research demonstrates these molecules can be delivered orally with compelling in vivo activity."

Cyclins A and B regulate cell cycle progression by recruiting substrates through an RxL-mediated interaction. In cancers characterized by RB1 loss or elevated E2F activity – including nearly all small-cell lung cancers – this pathway becomes dysregulated, driving uncontrolled tumor growth. Rather than inhibiting CDK catalytic activity, Circle Pharma’s approach disrupts the protein-protein interactions between cyclins A and B and their RxL-containing substrates, selectively killing E2F-high tumor cells.

CID-078, Circle Pharma’s oral cyclin A/B RxL inhibitor is currently being evaluated in a multi-center Phase 1 clinical trial in patients with advanced solid tumors (NCT06577987).

(Press release, Circle Pharma, MAR 12, 2026, View Source [SID1234663493])

On March 12, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, reported financial results for the fourth quarter and year ended December 31, 2025 and provides an overview of recent and upcoming business highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Our team remains highly focused on achieving our 2026 targets," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Specifically, our top priority goals are CNSide commercial scale-up and REYOBIQ pivotal trial readiness; we also are looking aggressively for ways to over achieve where possible."

Q4 2025 AND RECENT HIGHLIGHTS

Corporate

Completed an upsized public offering generating $15 million in gross proceeds, extending the Company’s projected cash runway and supporting CNSide commercialization and advancement of two ongoing Phase 2 clinical programs
REYOBIQ Development

Secured American Medical Association Category III CPT reimbursement code for convection-enhanced delivery with REYOBIQ, unlocking market access and growth potential of REYOBIQ therapy in recurrent glioblastoma and pediatric brain cancer
Incorporating constructive Type B meeting feedback from the FDA to help accelerate clinical development timelines and facilitate submission of application for the approval of REYOBIQ for patients with leptomeningeal metastases (LM)
Highlighted three REYOBIQ clinical data presentations at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO), building upon body of real world clinical experience with REYOBIQ in both primary and metastatic CNS cancers that continue to show promising safety profile and signs of efficacy
CNSide CSF Assay Platform

Expanded CNSide laboratory licensing to 49 of 50 U.S. states, having recently added Pennsylvania and California; enables access to CNSide Tumor Cell Enumeration (TCE) test to approximately 95% of the U.S. population
Continued to expand the CNSide Diagnostics team to support national test adoption
Announced second of planned national coverage agreements with Humana effective October 29, 2025. Combined with UnitedHealthcare national coverage agreement, CNSide CSF laboratory test policy coverage now reaches approximately 67 million people throughout the U.S.
Full Year 2025 FINANCIAL RESULTS

The Company’s cash and investments balance was $13.1 million on December 31, 2025 compared to $3.6 million on December 31, 2024
Recognized $5.2 million in grant revenue in the year ending December 31, 2025 and $5.8 million for the year ending December 31, 2024, which in both periods represents CPRIT’s share of the costs incurred for the advancement of our REYOBIQ development for the treatment of patients with LM
Total operating loss for the year ending December 31, 2025 was $15.3 million versus $14.7 million for the year ending December 31, 2024, with the increase primarily attributed to expansion of the CNSide operations team
Net loss for the year ending December 31, 2025 was $22.4 million, or $(0.29) per basic share versus $13.0 million, or $(1.95) per basic share, for the year ending December 31, 2024. The change in the net loss for the year ended December 31 was primarily due to change in fair value of derivative instruments from the Q1 2025 financings
Anticipated MILESTONES and OUTLOOK for 2026

REYOBIQ clinical program:

Define optimal dose/interval for REYOBIQ in the ReSPECT-LM Phase 2 trial; anticipate reporting data in Q3 2026
Completing enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma and conduct an End of Phase meeting with FDA with the goal of aligning on pivotal trial design. Data expected in Q4 2026
Complete commercial manufacturing scale up for REYOBIQ
Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial
The Company expects research and development expenditures to increase in 2026 compared to 2025, due to increased costs for the ReSPECT-LM clinical trial, manufacturing scale up for REYOBIQ commercial and approval trial drug availability, and initial patient enrollments in the ReSPECT-PBC clinical trial, together with expansion of CNSide research and development teams.

CNSide commercial roll out:

Expand U.S. commercial payer coverage to >150 million covered lives
Secure Medicare coverage pathway
Achieve > 1,250 annualized test orders
Launch additional CSF tumor characterization assays to expand the CNSide platform
The Company expects general and administrative expenditures to increase in 2026 as compared to 2025 due to expanded CNSide commercial operations team (including sales, customer service and laboratory operations), such that the goal is for CNSide Diagnostics to breakeven by 2027.

About Leptomeningeal metastases (LM)
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, MAR 12, 2026, View Source [SID1234663512])

On March 12, 2026 20/20 BioLabs (Nasdaq: AIDX), an early market entrant in cutting-edge, AI powered laboratory-based blood tests for the early detection and prevention of cancers and chronic diseases, reported an update on its patented protein tumor marker (PTM) based, machine learning (ML) derived multi-cancer early detection (MCED) methodology in the wake of several recent studies suggesting the expected value of this approach for earlier stage detection compared to stand-alone circulating tumor DNA (ctDNA) based MCEDs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

As population-scale cancer screening studies continue to generate trial data and real-world evidence, the medical community, consumers, investment community, and scientific experts are increasingly focused on which MCEDs and biomarker modalities are best suited to detect cancers early enough to meaningfully change patient outcomes. Results reported in February 2026 from a large-scale ctDNA-based MCED study conducted in the U.K. has prompted broader discussion about the biological limitations of circulating tumor DNA as first-line screening tests for early-stage disease.

Generally, for MCED tests to be clinically meaningful, they must detect cancer early enough to change outcomes. Among other things, this requires biomarkers that are present and detectable before tumors shed sufficient DNA into the bloodstream. Circulating tumor DNA (ctDNA)-based tests, while valuable in detecting advanced disease, face a fundamental biological constraint: in early-stage cancers, where tumor burden is low, DNA shedding is often intermittent or absent. As a result, ctDNA signals may only become reliably detectable after disease has progressed beyond the window of greatest clinical impact.

"The U.K. trial confirms that MCED blood testing can meaningfully shift the stage of cancer diagnosis. However, it also underscores that detecting the earliest cancers remains a fundamental biological challenge for ctDNA-based tests, as cancer biology does not begin with DNA fragment release in the bloodstream," said Michael Lebowitz, Ph.D., Chief Scientific Officer of 20/20 BioLabs. "A scalable future for population screening will likely combine technologies, with sensitive protein biomarkers identifying risk earlier and genomic assays providing confirmatory precision."

Studies published by 20/20 Biolabs and several independent research groups in the U.S. and Asia over the past 10 months add to the growing body of evidence that our company’s patented multi-cancer testing approach may help overcome many of the limitations of ctDNA for earlier stage detection:

In May 2025 20/20 Biolabs presented data on the sensitivity of its OneTest for Cancer (Premium version) at the annual meeting of the U.S. National Cancer Institute’s (NCI) Early Detection Research Network (EDRN), demonstrating detection rates for early-stage cancers as high as 50% for some tumor types — including pancreatic and ovarian cancers — from a pre-diagnostic (asymptomatic) population using a blinded cohort supplied by the NCI. (EDRN Poster May 2025)
Additional support for using protein tumor markers comes from a large, multicenter validation study published in Nature’s Precision Oncology in October 2025, which evaluated an AI enhanced blood test integrating seven well established protein tumor markers (6 of which are part of OneTest) across more than 15,000 participants from seven centers in three countries (USA, China, and Brazil). The study demonstrated consistent cancer signal detection across diverse populations, with measurable sensitivity even in Stage I disease and progressively higher detection rates as cancers advanced.
In a blinded validation study published in November 2025, investigators at MD Anderson Cancer Center reported that a protein based multicancer test—with most of the same biomarkers measured in OneTest (Standard version)—identified nearly 90% of early stage lung cancers and flagged multiple other cancers a median of 12–21 months prior to diagnosis, supporting the sensitivity of protein tumor markers during early oncogenesis.

These recent reports build upon hundreds of studies over several decades showing the sensitivity of PTMs for early-stage detection of many different tumor types, especially following repeat (serial) testing. This evolving evidence reinforces the scientific and commercial rationale for large scale screening first with its protein biomarker-based OneTest for Cancer test prior to considering the more costly ctDNA tests or advanced imaging platforms.

"Given the higher sensitivity of protein-based tests for Stage I and II cancers, a tiered approach in which protein-based tests like OneTest serve as the initial screening step makes sense," suggests Dr. Lebowitz. "Individuals identified by protein-based tests to be at mild risk can then be directed into ctDNA-based testing within a 3–6-month window, when ctDNA signals are more likely to be present. We believe those deemed at higher risk by protein–based tests are likely better served by moving directly to imaging studies. This tiered, or multi-step, approach is likely to yield the best outcomes and the lowest costs."

Results from the ctDNA MCED trails in the U.K. come shortly after Congress passed legislation in February 2026 to create a pathway for Medicare coverage of MCEDs beginning in 2028.

"The reimbursement opportunity created by the new legislation is an important step forward for cancer screening access," said Jonathan Cohen, CEO of 20/20 BioLabs. "As coverage decisions are made, we believe the science supports a broader view of MCED — one that includes protein-based technologies that have demonstrated meaningful early-stage detection. We are committed to continuing to build the evidence base and to working with policymakers, regulators, and payers to ensure that the most meaningful and cost-effective screening tools are readily available to Americans."

(Press release, 20/20 GeneSystems, MAR 12, 2026, View Source [SID1234663528])