Antengene Announces 2025 Full-Year Results: First TCE Out-licensing Validates Platform Value and Marks Inflection Point Towards 2026 Profitability

On March 20, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) reported its full-year results for the period ending December 31, 2025, and provided an update on recent business highlights and strategic progress.

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Dr. Jay Mei, Antengene’s Founder, Chairman, and CEO, commented, "Over 2025 and prior years, Antengene has built a solid foundation for long-term growth, including a robust late-stage clinical pipeline, the proprietary AnTenGager T-cell engager (TCE) platform, and the commercialization of XPOVIO, which is generating revenue across 10 APAC markets. As we enter into 2026, we are beginning to translate this foundation into tangible value creation. Our recent global licensing agreement with UCB for ATG-201 (CD19×CD3 TCE) represents the first out-licensing transaction for the company and the AnTenGager platform, validating its global competitiveness and marks a clear inflection point for Antengene. Antengene will receive USD 80 million (comprised of an initial upfront payment of USD 60 million and additional near-term milestone payments of USD 20 million), and is eligible to receive more than USD 1.1 billion in success-based development, regulatory and sales milestones, along with tiered royalties on future net sales.

At the same time, our late-stage clinical programs continue to advance. ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]) has demonstrated strong efficacy and best-in-class safety in gastric cancer and other CLDN18.2+ solid tumors, with frontline combination studies in gastric cancer underway, positioning upcoming data as a potential key value inflection point. The company plans to initiate a pivotal Phase III monotherapy trial in gastric cancer in 2026, with enrollment starting in the second half of 2026. ATG-037 (oral CD73 small molecule inhibitor) has shown encouraging efficacy in checkpoint inhibitor (CPI) resistant tumors in combination with anti-PD-1 therapy and is well positioned for combination use with next-generation CPIs such as PD-1×VEGF bispecific antibodies. Together, these programs represent important future value drivers as they approach key clinical milestones. In parallel, the AnTenGager TCE platform will remain open for global collaboration, enabling continued licensing and partnership opportunities. These collaborations represent a new and important revenue stream for the company, with the potential to generate multiple revenue streams through upfront payments, development and regulatory milestones, and potential royalties.

Looking ahead, we will continue to advance our clinical pipeline with disciplined cost control while expanding our innovation capabilities across new and emerging scientific platforms. With multiple novel modalities in development, we believe we are well positioned to further strengthen our R&D engine and support sustainable long-term growth."

【Business Updates】

1. AnTenGager TCE Platform

TCE platform with steric hindrance masking technology: AnTenGager is Antengene’s proprietary, second-generation TCE platform featuring "2+1" bivalent binding for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform’s broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has discovered multiple investigational programs:
ATG-201 (CD19 x CD3 TCE): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed on the AnTenGager TCE platform for the treatment of B cell related autoimmune diseases. Antengene has entered into a global license agreement with UCB for ATG-201. The company plans to submit the IND application for ATG-201 in the first quarter of 2026, and will transfer subsequent clinical development to UCB upon the completion of the first-in-human (Phase I) clinical trial. In return of the license rights granted to UCB, Antengene will receive an upfront and near term milestone payment of USD 80 million (comprised of an initial upfront payment of USD 60 million and additional near-term milestone payments of USD 20 million upon satisfaction of certain conditions) and would be eligible to receive future success-based development and commercial milestone payments of over USD 1.1 billion, as well as tiered royalties on future net sales.
ATG-106 (CDH6 x CD3 TCE): A global first-in-class CDH6 x CD3 targeted TCE being developed for the treatment of ovarian cancer and kidney cancer. The Company plans to submit an IND application for ATG-106 in the second quarter of 2027.
ATG-112 (ALPPL2 x CD3 TCE): A global first-in-class ALPPL2 x CD3 targeted TCE being developed for the treatment of gynecological tumors, digestive system malignancies, bladder cancer and NSCLC. The Company plans to submit an IND application for ATG-112 in the second quarter of 2027.
Additional TCE programs for solid tumors: Antengene plans to submit an IND application for ATG-110 (LY6G6D × CD3 TCE) in the first half of 2027 for the treatment of microsatellite-stable colorectal cancer. In addition, ATG-115 (an undisclosed bispecific antibody) and two undisclosed trispecific antibody programs are currently in preclinical development.

2. Key Clinical Programs

ATG-022 (CLDN18.2 Antibody-Drug Conjugate)
Data from the Phase II CLINCH study: ATG-022 has demonstrated potent anti-tumor activity across all levels of CLDN18.2 expression and maintained a favorable safety profile, with the incidence of Grade 3 or higher treatment-related adverse events (TRAEs) standing at only 19.4%, suggesting promising potential for frontline combination therapy. Meanwhile, ATG-022 has also shown positive efficacy in patients with non-gastrointestinal tumors, and the Company expects further expansion of its therapeutic indications to treatable patient populations beyond gastrointestinal cancers (for detailed data, please refer to the Company’s press release issued in January 2026 at View Source). The Company expects to release the latest clinical data of ATG-022 in the second quarter of 2026.
Advancing clinical development across 1L to 3L gastric cancer: Antengene is currently conducting the Phase II CLINCH study and the Phase Ib/II CLINCH-2 study of ATG-022 in Mainland of China and Australia. The Company continues to advance the clinical development of ATG-022 across different lines of gastric cancer treatment, including first-line therapy in combination with checkpoint inhibitors (CPIs) and chemotherapy (CAPOX/FOLFOX); second-line therapy in combination with CPIs; and third-line therapy as monotherapy, covering patients with varying levels of CLDN18.2 expression. In addition, the CLINCH study of ATG-022 includes a basket trial cohort evaluating multiple tumor types, with the majority of patients continuing to receive treatment.
ATG-037 (Oral CD73 Small Molecule Inhibitor)
Data from the Phase Ib/II STAMINA study: Following the initiation of a global clinical collaboration with MSD, Antengene is evaluating ATG-037 in combination with the anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with checkpoint inhibitor (CPI)-resistant melanoma and non-small cell lung cancer (NSCLC). These findings suggest that ATG-037 has clinically meaningful therapeutic potential in multiple tumor types, particularly in patients who are CPI-resistant (for detailed data, please refer to the Company’s press release issued in November 2025 at View Source). The Company expects to release the latest clinical data of ATG-037 in the fourth quarter of 2026.
Clinical development pathways: existing data show that ATG-037 holds enormous therapeutic potential for the treatment of first-line or CPI-resistant melanoma, with promising potential for expansion into other tumor types. Antengene’s clinical development roadmap for ATG-037 has four main components: 1. combination with CPI for the treatment of CPI-resistant unresectable and metastatic melanoma (second-line treatment); 2. combination with CPI for the first-line treatment of unresectable or metastatic melanoma; 3. combination with CPI for the treatment of CPI-resistant unresectable or metastatic NSCLC (second-line treatment); 4. active expansion into other CPI-resistant tumor types supported by the encouraging proof-of-concept data; 5. explore potential combinations with next-generation CPIs such as PD-1×VEGF bispecific antibody.
Combination with PD-1/VEGF Bispecific Antibody: Antengene has entered into a clinical collaboration agreement with Junshi Biosciences to evaluate the synergistic therapeutic potential of Antengene’s ATG-037 in combination with Junshi Biosciences’ JS207, a recombinant humanized anti-PD-1/VEGF bispecific antibody, in patients with solid tumors in Mainland of China. The combination therapy of ATG-037 and JS207 may constitute a potential "triple-axis" strategy. With the potential to deepen responses while maintaining a favorable safety profile, the combination of ATG-037 with JS207 may further improve the durability of benefit and may translate into improved overall survival (OS).
3. Next Generation ADCs and Other Novel Programs

ATG-125 (B7-H3 × PD-L1 bispecific ADC): ATG-125 is an "IO + ADC" dual-function molecule targeting B7-H3 and PD-L1, integrating the direct cytotoxic activity of an ADC with the durable immune activation of IO therapies. By simultaneously blocking B7-H3- and PD-L1-mediated immunosuppressive signaling, ATG-125 effectively activates T cells and induces immunological memory. Preclinical studies demonstrate that the bispecific ADC delivers superior in vivo efficacy compared with single-target B7-H3-ADC or PD-L1-ADC approaches. The Company plans to submit an IND application for ATG-125 in the second quarter of 2027.
ATG-207 (αCD3-TGF-β Bispecific Fusion Protein): ATG-207 is a globally first-in-class αCD3-TGF-β bispecific fusion protein being developed for the treatment of T cell–mediated autoimmune diseases. The Company plans to present preclinical data for ATG-207 for the first time at an international scientific conference in 2026.
4. Commercialized Product

Mainland of China: In July 2025, XPOVIO received approval for its third indication in the Mainland of China, bringing a new treatment option to patients with multiple myeloma (MM) who have received at least one prior therapy. Among the three approved indications of XPOVIO, two have already been included in China’s National Reimbursement Drug List (NRDL), including XPOVIO monotherapy for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and XPOVIO in combination with dexamethasone for the treatment of R/R MM.
Taiwan Market: In February 2025, XPOVIO received national reimbursement approval in Taiwan market, making it the fifth APAC market to secure reimbursement coverage after mainland of China, South Korea, Australia, and Singapore.
Hong Kong, China:In December 2025, XPOVIO received approval for two additional indications in Hong Kong, China for the treatment of MM and R/R DLBCL.
South Korea: In March 2026, XPOVIO received national reimbursement approval for its second indication in South Korea for the treatment of MM.
ASEAN Markets: In March 2025, XPOVIO was approved in Indonesia. To date, XPOVIO has been approved for multiple indications in ten countries and regions across the APAC region. In December 2025, XPOVIO received approval for its third indication in Malaysia for the treatment of DLBCL.
【Highlights of Financial Results】

1. Strong Cash Reserves Securing the Execution of Long-Term Strategies
As of the end of the reporting period, the company held RMB 734 million in cash and bank balances, which is sufficient to support existing key programs to the proof-of-clinical-concept stage, securing the execution of the company’s long-term strategies. Antengene will receive USD 80 million (comprised of an initial upfront payment of USD 60 million and additional near-term milestone payments of USD 20 million), and is eligible to receive more than USD 1.1 billion in success-based development, regulatory and sales milestones, along with tiered royalties on future net sales, providing strong momentum for our future R&D and sustainable growth.

To learn more about the 2025 full-year results, please see the full announcement in the "Investor Relations" section on the company’s website.

(Press release, Antengene, MAR 20, 2026, View Source [SID1234663794])

Cardiff Oncology to Host Key Opinion Leader Discussion Focusing on First-Line RAS-mutated Metastatic Colorectal Cancer

On March 20, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported that the Company will host a key opinion leader (KOL) webinar to discuss the emergent treatment landscape in first-line RAS-mutated metastatic colorectal cancer (mCRC). The webinar will take place on Wednesday, March 25th, 2026, at 4:30 p.m. ET.

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The webinar will feature KOLs Scott Kopetz, M.D., Ph.D., FACP and Heinz-Josef Lenz, M.D., who will join Mani Mohindru, PhD, interim Chief Executive Officer, to discuss onvansertib’s existing clinical data and its potential as a novel therapeutic approach in the management of mCRC.

About the KOLs

Scott Kopetz, M.D., Ph.D., FACP, is a Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center and an internationally recognized leader in colorectal cancer research and translational oncology. Dr. Kopetz’s work has helped establish new treatment approaches for molecularly defined colorectal cancers, including therapies targeting BRAF-mutated metastatic disease. He serves in multiple national leadership roles supporting gastrointestinal cancer research and clinical trial development and has led numerous Phase I–III clinical studies focused on improving outcomes for patients with GI malignancies. His research integrates molecular profiling and translational science to advance precision medicine strategies and overcome treatment resistance in colorectal cancer.

Heinz Josef-Lenz, M.D., is a University Professor of Medicine, Population and Public Health Sciences and Cancer Biology; Professor of Medicine and Preventive Medicine of USC. He serves as Co-Leader of the Gastrointestinal Cancers Program and Co-Director of the USC Center for Cancer Drug Development. Dr. Lenz’s research focuses on molecular mechanisms of cancer development, drug resistance, and biomarker-driven treatment approaches in gastrointestinal cancers, including colorectal cancer. He has authored numerous peer-reviewed publications and holds leadership roles across national oncology research initiatives, including service on National Cancer Institute committees and cooperative clinical trial groups guiding translational and clinical research in GI oncology.

KOL Webinar Information

Interested parties can register for and access the live webcast by visiting the "Events" section of the Cardiff Oncology website. The webcast replay will be available after the conclusion of the discussion.

(Press release, Cardiff Oncology, MAR 20, 2026, View Source [SID1234663795])

SELLAS Life Sciences Reports Full Year 2025 Financial Results and Provides Corporate Update

On March 19, 2026 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported financial results for the full year ended December 31, 2025, and provided a corporate update.

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"Based upon continued progress in our GPS and SLS009 clinical programs in AML, we believe 2026 is shaping up to be a pivotal year for SELLAS," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "We are advancing toward the final analysis of our Phase 3 REGAL trial evaluating GPS in AML patients who have achieved complete remission following second-line salvage therapy. Once we reach the required pre-specified 80th event, which will be announced, we will proceed with the necessary procedures towards database lock completion, statistical analysis, unblinding, and disclosure of topline results. If positive, REGAL could position GPS as a first- and best-in-class immunotherapeutic option in this AML population and serve as a significant value-inflection point for SELLAS."

Dr. Stergiou continued, "We also continue to make significant progress in our SLS009 clinical program for AML. Following the positive Phase 2 results of SLS009 in r/r AML presented at ASH (Free ASH Whitepaper), particularly in high-risk molecular subtypes, we have now dosed the first patient in the expansion cohort, which is evaluating SLS009 in newly diagnosed, first-line AML patients. Additionally, our preclinical data presented at ESMO (Free ESMO Whitepaper) in T-PLL demonstrated a statistically significant survival benefit of SLS009 both as monotherapy and in combination with venetoclax in a patient-derived xenograft model, further supporting the breadth of the CKD9 inhibition strategy. With a catalyst rich outlook, continued clinical execution, our strongest financial position in history and expansion into earlier treatment settings, we look forward to an important year ahead."

Recent Corporate Highlights:

European Collaboration to Advance SLS009 Clinical Program: In January 2026, SELLAS entered into a strategic collaboration with IMPACT-AML to expand SLS009 clinical program in Europe. Under the agreement, IMPACT-AML’s STREAM clinical network will conduct a study of SLS009 in combination with AZA/VEN in newly diagnosed AML patients. The enrollment of approximately 40 patients in Europe is anticipated in Q2 2026.

Phase 3 REGAL Trial of GPS: On December 29, 2025, the Company provided an update on the pivotal Phase 3 REGAL trial, announcing that a total of 72 events had been recorded as of December 26, 2025, with the study remaining fully blinded. After reaching the required pre-specified 80th event, customary database lock and blinded data review procedures must be completed before statistical analysis, unblinding, and disclosure of topline results. Because the final analysis is event-driven, the timing of studies with overall survival as an endpoint can vary; SELLAS will announce the 80th event when it occurs.

Phase 2 SLS009 in r/r AML: On December 7, 2025, the Company announced that clinical data from its ongoing Phase 2 study of SLS009, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with r/r AML with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment were presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2025. SLS009 in combination with AZA/VEN demonstrated clinically meaningful activity in patients with R/R AML-MR, and among the 35 evaluable patients, the overall response rate (CR/Cri/MLFS) was 46%, including 29% achieving CR/CRi. Patients harboring ASXL1 or TP53 mutations achieved response rates of 48% and 57%, respectively. The median overall survival (mOS) was exceedingly higher than the expected 2.6 months in this R/R AML patient population, and in the least pretreated cohort, mOS reached 8.9 months. Across all cohorts, patients with one prior line of therapy experienced the greatest benefit, with a 58% response rate and mOS not yet reached. No dose-limiting toxicities (DLTs) or treatment-related deaths were observed, and the combination was well tolerated.

Expansion of SLS009 into Earlier-Line AML Treatment: Following the encouraging Phase 2 results of SLS009 in r/r AML particularly in patients with high-risk molecular subtypes, the Company has expanded the development program into earlier lines of therapy. After receiving constructive feedback from the FDA, SELLAS dosed the first patient in an 80-patient trial in newly diagnosed AML patients as well as those who become refractory early to AZA/VEN treatment which we established through our extensive transcriptomics, genomics, and proteomics models.

Preclinical Data on SLS009 in AML at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper): The data shows that SLS009 induces apoptosis in AML cell lines, including those harboring high-risk ASXL1 and TP53 mutations. Pharmacodynamic changes were observed as early as 8 hours after treatment and became more pronounced over time, with reductions in MCL-1 and survivin, correlating with increased apoptosis. The poster, entitled, "Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels in AML cell lines" will be presented on April 21, 2026.

Preclinical Data on SLS009 in T-PLL Presented at ESMO (Free ESMO Whitepaper) 2025: In October 2025, preclinical data demonstrating statistically significant survival benefit of SLS009 were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Berlin, Germany. The results showed that SLS009, as a monotherapy and in combination with VEN, significantly prolonged survival compared to VEN alone in an in vivo patient-derived xenograft model of T-cell prolymphocytic leukemia (T-PLL). These findings further support the therapeutic potential of SLS009 to improve outcomes across multiple hematologic malignancies.

Virtual R&D Day on Advancing Novel Therapies in AML: On October 29, 2025, SELLAS hosted a virtual R&D Day on "Advancing Novel Therapies in Acute Myeloid Leukemia (AML)" featuring key opinion leaders and Company management. The event provided a detailed review of the Company’s ongoing Phase 3 REGAL trial of GPS and the SLS009 program, underscoring each therapy’s potential to address multiple stages of disease progression along the AML treatment continuum. To access a replay of the R&D Day, please click here.

Received $67.2 Million in Gross Proceeds from Warrant Exercises in 2025: In September and October 2025, SELLAS received a total of approximately $54.6 million in gross proceeds from the immediate exercise of existing warrants, including $23.6 million from warrants issued in January 2025 and $31.0 million from warrants issued in March and August 2024. An additional $12.6 million in proceeds was received during 2025 from the exercise of other previously outstanding warrants.

Received Additional $42.6 Million in Proceeds from Warrant Exercises in Q1 2026: Subsequent to December 31, 2025, the Company received an additional $42.6 million in proceeds from the exercise of previously outstanding warrants. These additional proceeds bolster the reported $71.8 million cash and cash equivalents as of December 31, 2025, and provide the Company with the strongest financial position in its history.

Financial Results for the Full Year 2025:

Research and Development Expenses: Research and development expenses for the year ended December 31, 2025, were $16.0 million, compared to $19.1 million for the year ended December 31, 2024. The decrease was primarily due to decreases in clinical trial expenses and clinical and regulatory consulting costs, which were primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024.

General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2025, were $12.3 million, as compared to $12.4 million for the year ended December 31, 2024. The decrease was primarily attributable to a decrease in personnel related expenses.

Net Loss: The net loss was $26.9 million for the year ended December 31, 2025, or a basic and diluted loss per share of $0.25, as compared to a net loss of $30.9 million for the year ended December 31, 2024, or a basic and diluted loss per share of $0.50.

Cash Position: As of December 31, 2025, cash and cash equivalents totaled approximately $71.8 million. Subsequent to December 31, 2025, the Company received an additional $42.6 million in proceeds from the exercise of previously outstanding warrants.

(Press release, Sellas Life Sciences, MAR 19, 2026, View Source [SID1234663755])

Acrivon Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights

On March 19, 2026 Acrivon Therapeutics, Inc. ("Acrivon" or "Acrivon Therapeutics") (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, reported financial results for the fourth quarter and full year ended December 31, 2025 and reviewed recent business highlights.

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"It’s an exciting time for the company as we build on strong maturing data and clinical momentum," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. "Our compelling data from ACR-368 in EC was well received at the ESGO Congress, reinforced by powerful commentary from world-renowned key opinion leaders at our live webcast, after the late-breaking oral presentation by Dr. Konstantinopoulos from the Dana- Farber Cancer Institute. Serous EC represents a particularly significant unmet need with a mortality rate resulting in 40-50% of all EC deaths. Through our rapidly maturing data, we are strategically generating multiple opportunities towards potential registration for ACR-368, including our announcement today of a fourth arm to our study to investigate ACR-368 monotherapy in biomarker-unselected serous EC subjects. Elsewhere in our pipeline, ACR-2316 has already shown promising clinical activity in lung cancer, underscoring the potential of its differentiated mechanism of action. Finally, we continue to build our pipeline with our next development candidate, ACR-6840, and new programs, reflecting our sustained AP3-driven innovation and commitment to long-term value creation."

Recent Highlights

ACR-368: CHK1 / CHK2 Inhibitor

Clinical data from the ongoing, registrational-intent ACR-368 Phase 2b trial was presented in a late-breaking oral presentation at the European Society of Gynecological Oncology (ESGO) Annual Congress by Dr. Panagiotis (Panos) Konstantinopoulos, M.D., Ph.D., from the Dana-Farber Cancer Institute
Consistent with higher BM levels in serous versus non-serous EC, an interim analysis across both OncoSignature-positive (BM+) and BM- serous EC subjects showed a cORR of 52% (N = 23) versus 22% (N = 37) in non-serous EC subjects; all subjects in this analysis received up to two prior lines of therapy (LoT), including chemotherapy and anti-PD-1
Based on this, Arm 3 was initiated in late 2025 to generate prospective data of ACR-368 with ULDG sensitization in all-comer (no pre-treatment biopsy or biomarker stratification) serous EC subjects with ≤2 prior LoT and is actively enrolling and dosing patients in the US, with 4 major EU countries on track to be activated by end of Q1 further accelerating enrollment through the addition of more than 20 EU sites
Following Dr. Konstantinopoulos’ presentation, the company hosted a KOL panel at ESGO, during which KOL experts expressed strong enthusiasm for ACR-368 and discussed the promising clinical data, emphasizing the high unmet need and potential impact for patients suffering from serous EC.
Building on promising clinical data and observed biomarker upregulation in serous EC, the company announced today that it plans to initiate a fourth cohort (Arm 4) in the ongoing ACR-368 Phase 2b study in the first half of 2026. This arm will enroll all-comer (BM-unselected) serous EC subjects, similar to Arm 3, but subjects will be treated with ACR-368 monotherapy and otherwise identical inclusion criteria to Arm 3.
Company also announced today that it has completed the exploratory Arm 2 of the study which treated BM- EC subjects with ≤3 prior LoT using ACR-368 with ULDG sensitization. Objectives of this arm were achieved, supporting that ULDG may contribute to ACR-368 efficacy in BM- subjects with a favorable tolerability profile.
ACR-2316: WEE1 / PKMYT1 Inhibitor

Initial data from the Phase 1 monotherapy dose-escalation trial showed a favorable tolerability profile and demonstrated clinical activity with tumor shrinkage, notably including partial responses and strong disease control in small cell lung cancer (SCLC) and squamous non-small cell lung cancer (NSCLC), tumor types predicted sensitive by AP3 not previously shown sensitive to WEE1 or PKMYT1 inhibitors in development

ACR-6840: Oral CDK11 Inhibitor

Nominated as internally-discovered development candidate from company’s AP3-driven cell cycle program

Strengthened Precision Medicine Therapeutics Capabilities

Launched wholly-owned and operated Clinical Laboratory Improvement Amendment (CLIA) certified laboratory with full license to conduct patient sample testing and develop companion diagnostics

Anticipated Upcoming Milestones

ACR-368 Ongoing Registrational-Intent Phase 2b Study

Achieve CTA approval in EU for the ongoing (US) registrational intent serous EC all-comer Arm 3 (ACR-368 + ULDG) by Q1 2026
Initial clinical data from Arm 3 and additional update on Arm 1 of the ACR-368 Phase 2b trial in mid-2026
Initiate enrollment for the registrational intent serous EC all-comer Arm 4 (ACR-368) in the US in first half of 2026
Achieve readiness for Phase 3 confirmatory trial for ACR-368 in combination with PD-1 therapy by mid-2026
Complete enrollment (up to N = 90 subjects) in the registrational intent serous EC all-comer Arm 3 (ACR-368 + ULDG) in Q4 2026

Broader Pipeline

Additional ACR-2316 Phase 1 clinical data for weekly and bi-weekly dosing regimens and transition into dose expansion in AP3-identified tumor types in 2026
Submit IND filing to the FDA for ACR-6840 in Q4 2026
Initiate additional internal programs utilizing the AP3 platform in 2026

Fourth Quarter and Full Year 2025 Financial Results

Net loss for the quarter and full year ended December 31, 2025 was $19.0 million and $77.9 million, respectively. This compares to a net loss of $22.8 million and $80.6 million, respectively for the same periods in 2024.

Research and development expenses were $14.7 million for the quarter ended December 31, 2025, and $60.0 million for the full year 2025, compared to $18.6 million and $64.0 million, respectively, for the same periods in 2024. The difference was significantly driven by fewer milestones scheduled and incurred in the current period, as well as the prioritization of endometrial cancer in the ACR-368 clinical trial.

General and administrative expenses were $5.4 million for the quarter ended December 31, 2025, and $24.1 million for the full year 2025, compared to $6.3 million and $25.2 million, respectively, for the same periods in 2024. The difference was primarily due to a decrease in personnel costs, inclusive of non-cash stock compensation expense.

As of December 31, 2025, the company had cash, cash equivalents and investments of $118.6 million, which is expected to fund operating expenses and capital expenditure requirements into the second quarter of 2027.

(Press release, Acrivon Therapeutics, MAR 19, 2026, View Source [SID1234663773])

TG Therapeutics Secures an Additional $500 Million in Non-Dilutive Capital from Blue Owl and Expands Share Repurchase Program to $300 Million

On March 19, 2026 TG Therapeutics, Inc. ("TG" or "the Company"), (NASDAQ: TGTX), reported that it has entered into a new five-year, $750 million senior secured credit facility with funds managed by Blue Owl Capital ("Blue Owl"). As part of the transaction, the Company will repay its outstanding $250 million senior secured credit facility, resulting in a net raise of $500 million in non-dilutive capital. The new facility also provides for up to an additional $250 million of incremental capital, for a total facility size of up to $1 billion, available at the mutual discretion of TG and Blue Owl.

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In connection with the new facility, the Company’s Board of Directors authorized an increase to its share repurchase program from $100 million to $300 million. As of March 18, 2026, the Company has repurchased approximately $38 million of common stock under the existing share repurchase program at an average price of $28.98 per share.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, "We are pleased to announce this expanded credit facility with funds managed by Blue Owl, which significantly enhances our financial position with increased scale and improved terms compared to our prior facility. This financing builds on our cash flow positive business and provides substantial non-dilutive capital to support opportunistic share repurchases and business development, while continuing to invest in the growth of BRIUMVI and advancement of our pipeline." Weiss continued, "The expansion of our share repurchase program underscores our confidence in our business and our commitment to delivering long-term shareholder value. We appreciate Blue Owl’s continued relationship and support."

"TG Therapeutics continues to demonstrate strong commercial execution with BRIUMVI and a disciplined approach to growth," said Sandip Agarwala, Managing Director and Head of Life Sciences at Blue Owl. "We are pleased to deepen our relationship with TG through this expanded facility and support the Company as it continues to advance its strategic initiatives."

Additional details regarding the credit facility will be filed with the Securities and Exchange Commission on Form 8-K.

ABOUT BRIUMVI (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in several countries outside of the U.S. for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:

Active Hepatitis B Virus infection
A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.

Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.

Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. JCV infection resulting in PML has been observed in patients treated with anti-CD20 antibodies, including BRIUMVI, and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy, until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Liver Injury: Clinically significant liver injury, without findings of viral hepatitis, has been reported in the postmarketing setting in patients treated with anti-CD20 B-cell depleting therapies approved for the treatment of MS, including BRIUMVI. Signs of liver injury, including markedly elevated serum hepatic enzymes with elevated total bilirubin, have occurred from weeks to months after administration.

Patients treated with BRIUMVI found to have an alanine aminotransaminase (ALT) or aspartate aminotransferase (AST) greater than 3x the upper limit of normal (ULN) with serum total bilirubin greater than 2x ULN are potentially at risk for severe drug-induced liver injury.

Obtain liver function tests prior to initiating treatment with BRIUMVI, and monitor for signs and symptoms of any hepatic injury during treatment. Measure serum aminotransferases, alkaline phosphatase, and bilirubin levels promptly in patients who report symptoms that may indicate liver injury, including new or worsening fatigue, anorexia, nausea, vomiting, right upper abdominal discomfort, dark urine, or jaundice. If liver injury is present and an alternative etiology is not identified, discontinue BRIUMVI.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.

(Press release, TG Therapeutics, MAR 19, 2026, View Source [SID1234663756])