City of Hope Developed a Foundational Map of Tumor Cells for Personalized Brain Cancer Treatments




City of Hope Developed a Foundational Map of Tumor Cells for Personalized Brain Cancer Treatments

Scientists developed a new framework to improve the ability of doctors to use precision medicine to identify therapeutic targets and potentially spotlight ways to prevent disease recurrence

LOS ANGELES–(BUSINESS WIRE)–City of Hope^®, one of the largest and most advanced cancer research and treatment organizations in the U.S. with its National Medical Center named top 5 in the nation for cancer by U.S. News & World Report, co-led the first study to demonstrate that characterizing genetic material near chromosomes forecasts how mutated, cancer-causing genes reengineer DNA and alter the tumor microenvironment. The leading-edge brain cancer research provides foundational knowledge that one day will improve the practice of precision medicine and allow oncologists to deliver more personalized therapies to cancer patients.

Tiny DNA molecules outside of chromosomes were once disregarded, but in the past decade research has revealed that these circles called extrachromosomal DNA, or ecDNA, fuel cancer by breaking the laws of biology.

“Our study offers new insights into the interplay between different ecDNA. Importantly, when there is a prevalence of ecDNA and cancer-causing ingredients like the EGFR protein or tumor protein p53, the tumor microenvironment becomes hypoxic. It falls into a state of reduced oxygen, which has been linked to cancer progression, resistance to therapy and poor clinical outcomes,” said David Craig, Ph.D., professor and chair of the Department of Integrative Translational Sciences at City of Hope and co-corresponding author of a study published today in Nature Communications.

Spatial transcriptomics (measuring and mapping of DNA activity) combined with genomic data can help identify groups of cells within a tumor that share a common ancestor but have acquired additional mutations. How they are distributed spatially informs the understanding of tumor evolution. The new translational science data underpins City of Hope’s precision medicine research, which applies innovation to create better outcomes with fewer side effects for more patients. City of Hope aspires to cure more cancer patients.

City of Hope researchers led a team that performed bulk RNA sequencing, tumor/normal DNA sequencing and spatial transcriptomics in a small sample of gliomas — tumors that develop in the brain or spinal cord. Through varied experiments and validation cohorts, they were able to identify common and distinct characteristics of the tumor microenvironment, developing an integrated analysis framework that can be leveraged by others.

“While our paper solely evaluated different types of brain cancers, the spatial transcriptomic principles and genome sequencing techniques we outlined will one day enable physicians to provide more personalized therapies for cancer patients,” said Gabriel Zada, M.D., a neurosurgeon with Keck Medicine of USC, professor of neurological surgery and physiology and neuroscience at the Keck School of Medicine of USC, co-director of the USC Brain Tumor Center and co-corresponding study author. “Cancer and its treatment is not one-size-fits-all. Understanding the molecular activity of ecDNA near inheritable and non-inheritable cells provides deep insights into potential therapeutic targets and risk of cancer recurrence.”

The researchers demonstrated that ecDNA drives rapid cancer cell (oncogene) proliferation outside of chromosomes, the thread-like structures inside the cell nucleus that houses DNA and RNA. EcDNA contributes to the development of gliomas, genetic instability and distinct tumor cell populations within a single tumor, making cancer more difficult to eliminate.

The dynamic nature of ecDNA may be what enables cancer cells to adapt and reprogram their genomes, driving tumor progression in response to changes in their microenvironment, including changes resulting from therapies.

“We have now demonstrated how cancer cells dynamically reprogram their own genome to control and respond to the tumor microenvironment. By uncovering these mechanisms, we are paving the way for more precise and effective treatments tailored to the unique biology of each patient,” Dr. Craig said.

The Nature Communications study entitled “Resolving Subclonal Genomic Heterogeneity in Gliomas by Integrating Spatial Transcriptomics with Loss of Heterozygosity and Extrachromosomal DNA Analysis” was supported by the National Center for Advancing Translational Science of the U.S. National Institutes of Health (KL2TR001854).

About City of Hope

City of Hope’s mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope^TM. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn.

Contacts

Letisia Marquez

626-476-7593

lemarquez@coh.org

MaaT Pharma Presents Updated Positive Data in Early Access Program for Xervyteg® at the EHA Congress Validating High Efficacy Observed in Pivotal ARES Study in Acute Graft-versus-Host Disease




MaaT Pharma Presents Updated Positive Data in Early Access Program for Xervyteg® at the EHA Congress Validating High Efficacy Observed in Pivotal ARES Study in Acute Graft-versus-Host Disease

• Oral presentation highlights updated data in Early Access Program (EAP) for 173 patients with acute Graft-vs-Host Disease (aGvHD) treated with Xervyteg^®
• Independent dataset from EAP reinforces the findings from the pivotal ARES trial and has also been included in the EMA Marketing Authorization Application submitted on June 2^nd, 2025
• EAP for Xervyteg^® in aGvHD is currently running in 11 countries* providing expanded access to patients with high unmet medical needs

LYON, France–(BUSINESS WIRE)–$MAAT #Cancer–Regulatory News:

MaaT Pharma (EURONEXT: MAAT – the “Company”), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies^TM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, today announced that Professor Mohamad Mohty, Professor of Hematology and Head of the Hematology and Cellular Therapy Department at Saint-Antoine Hospital and Sorbonne University, will present updated data for Xervyteg^® (MaaT013) in treating acute Graft-versus-Host Disease (aGvHD) under the Early Access Program (EAP) at the European Hematology Association (EHA) Annual Congress 2025. This independent EAP dataset further supports the efficacy and safety profile of Xervyteg^® previously shown in the pivotal ARES trial. It also confirms the breakthrough potential of Xervyteg^® for aGvHD patients with limited treatment options and it also serves as supportive data within the Marketing Authorization Application (MAA) recently submitted to the European Medicines Agency (EMA).

Key highlights:

• aGvHD is a major cause of morbidity and mortality following allogeneic hematopoietic stem cell transplantation. The patients (N=173) treated in EAP previously failed 1 to 6 aGvHD systemic treatment lines and most had grade III (49%) or IV (38%) aGvHD. The real-world data presented underscores the favorable safety profile of Xervyteg^® the strong and durable responses, translating into increased overall survival:

• Gastrointestinal Overall Response Rate (GI-ORR) of 53% at D28, with Complete Response (CR) observed in 30% of patients; all-organ Overall Response Rate (ORR) was 50% with 26% CR.

• Response is maintained at D56 indicating a long-term disease control with a GI-ORR of 47% and an ORR considering all organs of 46%.

• Overall Survival (OS) in all patients was 55% at 6 months, 48% at 12 months, 44% at 24 months.

• Xervyteg^® displayed a good overall safety profile in the EAP population.

• OS was significantly higher in patients who responded to Xervyteg^® (MaaT013) compared to non-responders (69% versus 25% at 12 months, and 61% versus 25% at 24 months).

• Median survival in all patients was 312 days. In responder patients, median survival was 834 days vs 69 days in non-responders.

A subset of patients (n=70) failing both steroid resistant (SR) and ruxolitinib resistant (RR) and thus resembling the cohort enrolled in the pivotal Phase 3 ARES trial (NCT04769895), exhibited a significant and consistent efficacy profile:

• At both Day 28 and Day 56, Xervyteg^® demonstrated durable efficacy in SR/RR aGvHD patients, with GI-ORRs of 57% and Complete Response (CR) observed in 44% of patients at D28 and 51% at D56. All-organs ORR was 54% with 41% CR at D28, and 55% with 48% CR at D56.

• OS was 55% at 6 months, 51% at 12 months, 40% at 24 months.

• OS was significantly higher in patients who responded to Xervyteg^® compared to non-responders (77% versus 14% at 12 months, and 59% versus 14% at 24 months).

• Median survival in all 70 patients was 445 days. In responder patients, median survival was 834 days vs 53 days in non-responders.

The complete data may be found here.

“The consistency between the real-world Early Access Program data and our pivotal ARES trial underscores Xervyteg^®’s clinical benefit for patients with severe, treatment-resistant aGvHD,” said Dr. Gianfranco Pittari, PhD, Chief Medical Officer at MaaT Pharma. “This is particularly meaningful for clinicians and patients, as it confirms the potential of microbiome therapies to deliver long-term survival benefits in a population with historically poor outcomes.”

In comparison, historical data from Abedin et al. 2021 demonstrated that in a similar population of patients, i.e. third-line aGvHD patients receiving additional treatment after ruxolitinib failure, the median survival was only 28 days.

“Among patients who responded by Day 28, the majority achieved a complete resolution of aGvHD symptoms — a strong predictor of sustained disease control over time. The overall safety profile is favorable in this high-risk patient population,” outlines Professor Mohty, Professor of Hematology and Head of the Hematology and Cellular Therapy Department at Saint-Antoine Hospital and Sorbonne University.

Details of the Oral Presentation:

• Title: Pooled Fecal Allogeneic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from the Early Access Program in Europe
• Abstract number: S260
• Presenting Author: Mohamad Mohty, Professor of Hematology and Head of the Hematology and Cellular Therapy Department at Saint-Antoine Hospital and Sorbonne University
• Session title: s424 Stem cell transplantation – Session 2
• Date & Time: 13/06/2025 (17:00 – 17:15 CEST) – Brown Hall 3

MaaT Pharma also presented a poster on the design of its ongoing Phase 2b trial (PHOEBUS) evaluating MaaT033 to enhance overall survival in allo-HSCT. This international, multi-center trial (NCT05762211) is the largest randomized controlled study to date of a microbiome-based therapy in oncology, enrolling up to 387 patients across 60 sites.

—

About MaaT Pharma

MaaT Pharma is a leading, late-stage clinical company focused on developing innovative gut microbiome-driven therapies to modulate the immune system and enhance cancer patient survival. Supported by a talented team committed to making a difference for patients worldwide, the Company was founded in 2014 and is based in Lyon, France. As a pioneer, MaaT Pharma is leading the way in bringing the first microbiome-driven immunomodulator in oncology. Using its proprietary pooling and co-cultivation technologies, MaaT Pharma develops high diversity, standardized drug candidates, aiming at extending life of cancer patients. MaaT Pharma has been listed on Euronext Paris (ticker: MAAT) since 2021.

Forward-looking Statements

All statements other than statements of historical fact included in this press release about future events are subject to (i) change without notice and (ii) factors beyond the Company’s control. These statements may include, without limitation, any statements preceded by, followed by, or including words such as “target,” “believe,” “expect,” “aim”, “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements are subject to inherent risks and uncertainties beyond the Company’s control that could cause the Company’s actual results or performance to be materially different from the expected results or performance expressed or implied by such forward-looking statements.

* France, Austria, Belgium, Canada, Germany, Italy, Lebanon, Spain, Sweden, Switzerland & USA

Contacts

MaaT Pharma – Investor Relations

Guilhaume DEBROAS, Ph.D.

Head of Investor Relations

+33 6 16 48 92 50

invest@maat-pharma.com

Rx Communications Group – U.S. Investor Relations

Michael Miller

Managing Director

+1-917-633-6086

mmiller@rxir.com

MaaT Pharma – Media Relations

Pauline RICHAUD

Senior PR & Corporate Communications Manager

+33 6 14 06 45 92

media@maat-pharma.com

Catalytic Agency – U.S. Media Relations

Heather Shea

Media relations for MaaT Pharma

+1 617-286-2013

heather.shea@catalyticagency.com

Innate Pharma Highlights Preclinical Antitumor Activity of IPH6501 in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma at the 2025 European Hematology Association (EHA) Congress




Innate Pharma Highlights Preclinical Antitumor Activity of IPH6501 in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma at the 2025 European Hematology Association (EHA) Congress

• Preclinical data from IPH6501, Innate’s proprietary ANKET^® targeting CD20, demonstrating potent antitumor activity in vitro on patient-derived samples from Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL), will be presented
• Preclinical in vivo models support enhanced antitumor efficacy for the combination of IPH6501 with R-CHOP, the standard of care in untreated DLBCL and FL patients
• IPH6501 is currently under investigation in a Phase 1/2 clinical study in relapsed and/or refractory (R/R) CD20+ B-cell non-Hodgkin lymphoma

MARSEILLE, France–(BUSINESS WIRE)–#ANKET–Regulatory News:

Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the presentation of preclinical data for IPH6501, its proprietary ANKET^® targeting CD20 currently under investigation in a Phase 1/2 study in relapsed and/or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) (NCT06088654), at the European Hematology Association (EHA) Congress 2025, taking place June 12-15 in Milan, Italy.

R-CHOP is an established standard of care for treatment-naïve patients with diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL), two subtypes of B-NHL. The treatment landscape continues to evolve with novel approaches including T cell engagers, antibody-drug conjugates, their combination with standard of care therapies, and CAR-T cells. Yet, there remains an unmet medical need for patients ineligible, refractory to, or relapsing from these therapies.

In preclinical in vitro models, IPH6501 demonstrated potent NK cell proliferation and tumor cell killing activity in DLBCL and FL patient samples, supporting its therapeutic potential in these indications. In preclinical in vivo xenografted mouse tumor models, IPH6501 showed strong activity in a rituximab-resistant model — even in the presence of rituximab highlighting their combination potential. Additionally, when combined with R-CHOP, IPH6501 showed enhanced antitumor efficacy, leading to tumor eradication that was maintained after treatment discontinuation. These findings underscore the potential of IPH6501 in improving standard-of-care R-CHOP treatment in previously untreated DLBCL and FL patients and support further evaluation of additional combination strategies in B-NHL.

“Patients with R/R DLBCL and FL continue to face significant unmet medical needs. The encouraging activity observed in preclinical models with IPH6501, including in rituximab-resistant settings, suggests its potential to offer new treatment options for B-cell non-Hodgkin lymphoma. The enhanced antitumor activity in combination with R-CHOP could support further investigation in untreated patients. These findings support further clinical development aimed at improving outcomes in this challenging patient population,” commented Dr Sonia Quaratino, Chief Medical Officer of Innate Pharma.

The poster will be available in the publication section of Innate Pharma’s website.

Abstract details

Antitumor characterization of IPH6501, a novel il2v-armed tetraspecific NK cell engager targeting CD20 B cells, in DLBCL and FL patient samples, and in preclinical combination with R-CHOP
Abstract Code: PS2004

Session: Poster session 2

Session Date/Time: Saturday, June 14, 2025, 18:30 – 19:30 CEST

About ANKET^®

ANKET^® (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About IPH6501

IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not the alpha subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule. This unique multispecific design provides targeted proliferation and activation signals to NK cells, promoting their cytotoxic activity against CD20 expressing malignant cells.

IPH6501 has shown better antitumor efficacy compared to approved benchmark antibodies in preclinical tumor models (Demaria, EHA 2023, Carrette, SITC 2024, Demaria et al, Science Immunology 2024).

IPH6501 is currently being evaluated in a Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with relapsed and/or refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma.

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET^® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs).

Innate’s portfolio includes several ANKET^® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer.

Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com. Follow us on LinkedIn and X.

Information about Innate Pharma shares

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:

Investors

Innate Pharma
Henry Wheeler

Tel.: +33 (0)4 84 90 32 88

Henry.wheeler@innate-pharma.fr

Media Relations

NewCap
Arthur Rouillé

Tel.: +33 (0)1 44 71 00 15

innate@newcap.eu

Data of InnoCare’s Robust Hemato-Oncology Pipelines Presented at the European Hematology Association (EHA) 2025 Congress




Data of InnoCare’s Robust Hemato-Oncology Pipelines Presented at the European Hematology Association (EHA) 2025 Congress

BEIJING–(BUSINESS WIRE)–Latest data of InnoCare’s (HKEX: 09969; SSE: 688428) robust oncology pipelines were presented at the ongoing European Hematology Association (EHA) 2025 Congress.

Poster Presentation:

1. First Presentation of Efficacy and Safety Data for First-Line Treatment of CLL/SLL with BCL2 Inhibitor Mesutoclax in Combination with BTK Inhibitor Orelabrutinib (Abstract No.: PS1567)

The study showed that mesutoclax (100 and 125 mg) in combination with orelabrutinib was safe and well tolerated in patients with treatment naïve (TN) CLL/SLL. Substantial efficacy was observed, with early high undetectable MRD (uMRD) rate.

42 patients with TN CLL/SLL were enrolled (mesutoclax 100 mg, n=21; 125 mg, n=21). The fixed-duration treatment of mesutoclax in combination with orelabrutinib is expected to deliver deeper remissions for TN CLL/SLL patients. In all patients, the overall response rate (ORR) was 97.6%.

At week 24 of the combination therapy, in the 125 mg dose cohort, the overall response rate (ORR) was 100%, the complete remission rate (CRR) was 23.8%, the CRR in target lesions was 57.1%, and the peripheral blood (PB) uMRD rate was 48%. In the 100 mg mesutoclax dose cohort, the ORR was 95.2%, the CRR was 19.0%, the CRR in target lesions was 42.9%, and the PB uMRD rate was 19%. With the extension of the duration of treatment, the therapeutic efficacy is expected to be further improved.

All patients are still on treatment. No disease progression or death occurred, and no adverse events leading to discontinuation of treatment were reported.

Due to its favorable efficacy and safety profile, a registrational Phase III clinical study of mesutoclax (125 mg once daily) in combination with orelabrutinib for the treatment of TN CLL/SLL patients has been initiated, with patient enrollment being accelerated.

2. Orelabrutinib Combined with Bendamustine-Rituximab or Obinutuzumab followed by Orelabrutinib Maintenance in Untreated Marginal Zone Lymphoma (OPTIMIZE): A Multicenter, Single-Arm, Phase II Study (Abstract No.: PF898)

The absence of a standard first-line treatment for marginal zone lymphoma (MZL) have inspired the exploration of novel regimens. In recent years, Bruton’s tyrosine kinase inhibitors (BTKis) have demonstrated durable responses with a favorable benefit-risk profile across all MZL subtypes in the relapsed/refractory setting. Orelabrutinib is a novel BTK inhibitor with higher selectivity and fewer off-target than other BTK inhibitors. Orelabrutinib combined with bendamustine-rituximab or obinutuzumab followed by orelabrutinib maintenance was effective and well-tolerated in untreated patients with MZL.

The majority of patients presented with MALT lymphoma and had Ann Arbor stage II-IV disease. At the end of induction treatment, the overall response rate (ORR) was 100.0% among all enrolled patients. At the data cutoff, the median progression-free survival (PFS) and overall survival (OS) remained immature. No BTK inhibitor-related adverse events (AEs), such as atrial fibrillation or bleeding, were observed.

3. The Rationality, Efficacy and Safety of Orelabrutinib plus Obinutuzumab (O2) in Systemic Treatment-naïve Marginal Zone Lymphoma: A Prospective Cohort Study (Abstract No.: PS1902)

The Orelabrutinib plus Obinutuzumab regimen had well rationality and demonstrated promising efficacy.

Across the entire study and during the period of induction therapy, the best objective response rate (ORR) was 100%. 3 patients who achieved partial response (PR) after the induction therapy subsequently achieved complete response (CR) in the maintenance period. The 18-month progression-free survival (PFS) and overall survival (OS) rates were both 100%.

4. Ultra-low Dose Radiotherapy Combined with Orelabrutinib Improves the Complete Response Rate of Treatment for Localized Ocular Adnexal Extranodal Marginal Zone B-cell Lymphoma (Abstract No.: PS1901)

The combination of ultra-low dose radiotherapy and orelabrutinib in the treatment of ocular adnexal extranodal marginal zone lymphoma (OA-EMZL) not only improves the effectiveness of treatment but also significantly reduces the toxic effects of radiotherapy, providing a new approach for the treatment of localized OA-EMZL.

Of all the 17 patients who completed treatment, 16 patients achieved complete response (CR) and one patient achieved a partial response. Additionally, the lesions in the patients still undergoing treatment have shrunk compared to before treatment.

5. Orelabrutinib plus Bendamustine-Rituximab (OBR) versus Bendamustine-Rituximab (BR) in Transplant-ineligible, Intermediate- to High-risk Mantle Cell Lymphoma (MCL) (Abstract No.: PS1969)

This open-label, randomized, multi-center study aims to compare the efficacy and safety of Orelabrutinib plus Bendamustine-Rituximab versus Bendamustine-Rituximab in transplant-ineligible, intermediate- to high-risk mantle cell lymphoma (MCL) patients. Early data suggest that Orelabrutinib plus Bendamustine-Rituximab could reduce disease progression events compared to Bendamustine-Rituximab in high-risk MCL. Updated outcomes on efficacy, safety, and biomarker analysis will be reported.

6. Pomalidomide, Rituximab, Orelabrutinib, and MiniCHOP-like (PRO-miniCHOP) in Elderly Patients with Newly Diagnosed Diffuse Large B-cell Lymphoma: Updated Results from a Phase II Study (Abstract No.: PF950)

The results further support Pomalidomide, Rituximab, Orelabrutinib, and MiniCHOP-like (PRO-miniCHOP) as a potential treatment option for elderly patients with diffuse large B-cell lymphoma (DLBCL), demonstrating promising efficacy and acceptable safety, especially for those who responded to the Pomalidomide-Rituximab-Orelabrutinib (PRO) induction therapy.

A total of 32 patients were enrolled in this study, of whom 26 patients completed ≥3 cycles of the PRO-miniCHOP, resulting in a complete response rate (CRR) of 65.4% and overall response rate (ORR) of 100.0%. Among the 21 patients who completed the full 6-cycle therapy with PRO-miniCHOP, both the CRR and ORR were 95.2%. At a median follow-up of 15.6 months, the median progression-free survival (PFS) and overall survival (OS) had not yet been reached, with the 2-year PFS and OS rates being 94.7% and 100.0%, respectively.

7. Orelabrutinib Addition to R-CHOP-like Regimen Adapted to Response in Treatment-Naïve Non-GCB DLBCL: Update Results of Orient Study (Abstract No.: PS1943)

In non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL) patients who responded to orelabrutinib plus rituximab (OR) induction, orelabrutinib plus R-CHOP-like (OR-CHOP) exhibited favorable antitumor activity and manageable safety. Update results further support the orelabrutinib plus R-CHOP-like therapy as an option in this disease.

At end of 6-cycle orelabrutinib plus R-CHOP-like, response (all 100%) was independent of double-expressing lymphoma (DEL), extranodal involvement (EI), and Lymphgen subtypes. No off-target-related cardiac toxicities occurred.

8. Primary Efficacy and Safety of First-line R-MTO Regimen (Rituximab, Methotrexate, Thiotepa, and Orelabrutinib) followed by Autologous Hematopoietic Stem Cell Transplantation in PCNSL (Abstract No.: PF966)

The Rituximab, Methotrexate, Thiotepa, and Orelabrutinib (R-MTO) induction treatment has demonstrated notable efficacy in achieving higher response rate among patients with newly diagnosed primary central nervous system lymphoma (PCNSL), with a manageable safety profile.

At the data cutoff, all patients had completed four cycles of induction therapy, and the complete response (CR) rate and overall response rate (ORR) were 93.34% and 96.67%, respectively. The 12-month progression-free survival (PFS) and overall survival (OS) rates were 82.26% and 85.33%, respectively.

9. Orelabrutinib, Rituximab Combined with High-Dose Methotrexate as Induction Therapy in Newly Diagnosed Primary Central Nervous System Lymphoma (Abstract No.: PS1917)

This study demonstrated the promising efficacy of the Orelabrutinib, Rituximab Combined with High-Dose Methotrexate induction regimen in newly diagnosed primary central nervous system lymphoma (PCNSL), with encouraging response rates and durable progression-free survival (PFS). The regimen also showed promising overall survival (OS) trends, highlighting its potential as an effective treatment. Treatment-related adverse events (TRAEs) were manageable, and no severe BTK inhibitor-related off-target toxicities (e.g., atrial fibrillation/flutter) were observed. These findings suggest that the Orelabrutinib, Rituximab Combined with High-Dose Methotrexate regimen is a well-tolerated and effective therapeutic option for PCNSL.

Except the above poster presentations, more than 10 studies were also selected as poster presentations or online publications at the meeting. For more detailed clinical data, please refer to EHA website.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

Contacts

Media
Chunhua Lu

86-10-66609879

chunhua.lu@innocarepharma.com

Investors
86-10-66609999

ir@innocarepharma.com

SINOVAC’s Board of Directors Issues a Letter to Shareholders Outlining Clear Pathway to Restore Fairness and Deliver Value to All Shareholders




SINOVAC’s Board of Directors Issues a Letter to Shareholders Outlining Clear Pathway to Restore Fairness and Deliver Value to All Shareholders

Intends to file definitive proxy materials in the coming days

BEIJING–(BUSINESS WIRE)–Sinovac Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it intends to file its definitive proxy materials in the coming days with the Securities and Exchange Commission (SEC) for the Special Meeting of Shareholders to be held on Wednesday, July 9, 2025 at 8:00 a.m. China Standard Time (Tuesday, July 8, 2025 at 8:00 p.m. Atlantic Standard Time). Valid shareholders of record as of the close of business on May 19, 2025 are entitled to vote at the meeting.

SINOVAC’s Board of Directors (the “SINOVAC Board”) also issued a letter to shareholders. The full text of the letter follows:

Dear SINOVAC Shareholder,

We are at a critical juncture for SINOVAC and, as a valued shareholder in the Company, you face an important decision at the upcoming Special Meeting of Shareholders.

A dissenting investor group led by Advantech/Prime Success (“Prime Success”) and Vivo Capital (together known as the “Dissenting Investor Group”) has launched a hostile attempt to remove the SINOVAC Board. Prime Success and Vivo Capital are not legitimate shareholders of the Company. Their ownership is the result of an invalid private investment in public equity (“PIPE”), which is in the process of being unwound.

The PIPE transaction was authorized by an illegitimate former board, which lost its seats at the February 2018 Annual General Meeting and failed to accept the outcome despite a clear shareholder vote. The UK Privy Council, in an unappealable ruling in January 2025, deemed this board to be an “Imposter Board”. Yet, during the years when the Imposter Board refused to vacate office, they distributed nearly US$2 billion in dividends to themselves, while distributing nothing to the valid shareholders of SINOVAC (including 1Globe Capital and OrbiMed). Additionally, the Dissenting Investor Group and Imposter Board collaborated to buy out SINOVAC at just US$7.00 per share, below market price, which was rejected by 1Globe Capital, the largest minority shareholder.

Since the Dissenting Investor Group knows they are not legitimate shareholders, they have requested the Special Shareholder Meeting through SAIF Partners to replace the SINOVAC Board with their own slate of nominees (the “Dissident Slate”).

We urge you not to be distracted by the Dissenting Investor Group’s hostile actions and false claims, nor to believe their sudden support of the dividend we declared, their empty promises to distribute more cash to you in the future, or the false allegations against the SINOVAC Board in their recent letter dated June 10, 2025. As we detailed in our April 29 letter, the Dissenting Investor Group’s self-serving actions blatantly interfere with the fair governance of our Company and pose a direct threat to the value of your investment and the future of SINOVAC.

The Dissenting Investor Group’s goal is clear: to protect the ill-gotten gains they stripped from SINOVAC subsidiaries over the past seven years and reinstate a complacent and complicit board that will allow them to continue such behavior and profit alongside.

The past actions of the Imposter Board – specifically, the invalid poison pill adopted in 2018 – directly caused the NASDAQ trading halt and the subsequent resignation of the Company’s former independent auditor. The Dissenting Investor Group and the Imposter Board have prioritized their own financial interests over those of all SINOVAC shareholders, while simultaneously undermining shareholder value and corporate governance and creating challenges that the SINOVAC Board is now working expeditiously to resolve.

At the Special Meeting of Shareholders, you will have a chance to send a clear message to the Dissenting Investor Group: SINOVAC will no longer be held captive to their self-dealing. We are moving forward, not backward. The rightful SINOVAC Board – reconstituted in February 2025 and led by respected and recognized industry leaders following seven years of legal efforts begun in 2018 by 1Globe Capital, SINOVAC’s single largest shareholder – is steadfast in its commitment to act in the best interests of ALL investors.

Importantly, the SINOVAC Board is fully aligned with the interests of common shareholders. 1Globe Capital and OrbiMed will vote their collective stake in SINOVAC AGAINST the Dissenting Investor Group’s misguided proposals.

Dr. Chiang Li, Chairman of the SINOVAC Board, despite being nominated to the Dissident Slate, unequivocally stands with the SINOVAC Board and firmly opposes the Dissenting Investor Group’s proposals at the Special Meeting of Shareholders. As the founder and Chairman of 1Globe Capital, Dr. Li’s track record over the past eight years speaks volumes about his unwavering commitment to governance, fairness, and shareholder value – including defending against multiple attempts by the Dissenting Investor Group at undervalued privatizations (US$7.00/share) and other transactions dilutive to SINOVAC shareholders, as well as personally financing the litigation that resulted in the non-appealable Privy Council ruling.

SINOVAC’s Board is focused on making shareholders whole, following years of self-serving practices by the Imposter Board, by:

• Paying valid, rightful shareholders the previously declared US$55.00 dividend that the SINOVAC Board initiated immediately after being installed as a corrective step in returning an appropriate share of distributions to the Company’s common shareholders.
  

• Creating the opportunity for future additional dividends to be paid from our operating subsidiaries to catch up ALL SINOVAC common shareholders with the Dissenting Investor Group.
  

• Ensuring fair and equitable treatment of SINOVAC shareholders going forward, making distributions at the SINOVAC parent level and not just via operating subsidiaries directed by the Dissenting Investor Group.
  

• Accelerating the resumption of trading on NASDAQ and potentially other exchanges to maximize shareholders’ investment return.
  

• Protecting the best interests of and maximizing value for ALL valid shareholders.
  
  

In contrast, the Dissident Slate, which includes several members of the Imposter Board, will continue the Dissenting Investor Group’s track record of self-serving actions by:

• Protecting their own ill-gotten gains made from the unauthorized PIPE investment and illegitimate convertible debt with our subsidiary, which diluted the ownership of and stole multi-billions of dollars from rightful SINOVAC shareholders and violated governance standards.

• Stripping value from SINOVAC shareholders while attempting to delay and interfere with your special dividend through multiple lawsuits and intimidation tactics.

• Pressuring SINOVAC to misappropriate the Company’s cash for investment into venture capital funds affiliated with the Dissenting Investor Group, prioritizing their own financial interests over the Company’s operational needs and the best interests of shareholders.

• Propagating false claims to undermine the SINOVAC Board’s efforts to make shareholders whole through dividends, maintain the Company’s NASDAQ listing and resume trading.

• Preventing the rightful SINOVAC Board from carrying out its fiduciary duties to you by refusing to accept the final and non-appealable Privy Council judgment and dragging the Company into a barrage of unnecessary litigation.

• Calling a Special Shareholder Meeting, which is just one prong in a multifaceted strategy aimed at continuing to operate SINOVAC solely for the benefit of a few favored shareholders at the expense of all valid shareholders.

Actions Speak Louder Than Words: The SINOVAC Board Has Already Announced a Special Cash Dividend to Shareholders and a Commitment to Further Dividends

The SINOVAC Board has taken decisive steps to make shareholders whole by restoring fairness, integrity, and value to SINOVAC’s rightful shareholders after years of unfair practices under the Dissenting Investor Group-controlled Imposter Board. These steps include:

• US$55.00 Per Share Special Dividend: In April 2025, after years of no allocation of the distributions enjoyed by the Dissenting Investor Group being made to SINOVAC common shareholders, the SINOVAC Board announced a special cash dividend of US$55.00 per common share, an initial corrective step to return value to you. We are working diligently to ensure this payout is completed on or about July 9, 2025, despite the Dissenting Investor Group’s lawfare, interference, threats and delay tactics, including via the Special Meeting of Shareholders.

• New Dividend Commitment: The SINOVAC Board intends to pay out a pro rata portion of dividends to all SINOVAC shareholders to make you whole with dividends already taken out of the Company at the subsidiary level by the Dissenting Investor Group-controlled subsidiary shareholders, most of whom are affiliated with the Imposter Board. Details, including amount per share, will be announced in the near future.

• Additional US$11.00 Per Share Dividend Redistribution: Upon cancellation of the unauthorized and fraudulent PIPE shares that were issued to Prime Success and Vivo Capital in 2018, the SINOVAC Board intends to redistribute the PIPE share portion of the US$55.00 per share dividend to all valid SINOVAC shareholders. The Dissenting Investor Group has already taken over US$800 million in dividends between 2021 and 2024 – all at the expense of valid SINOVAC shareholders who received nothing.
  

The SINOVAC Board is Committed to Creating Sustainable Value

In addition to distributing significant dividends to all SINOVAC shareholders, the SINOVAC Board is focused on:

• Resolving NASDAQ Compliance and Auditor Issues: The SINOVAC Board is actively addressing past governance failures and working to restore NASDAQ compliance and hire an independent auditor as part of its efforts to resume trading of SINOVAC shares.

• Executing a Global Growth Strategy: We are formulating long-term growth strategies to expand SINOVAC’s business in China and globally, leveraging our position as a leading provider of vaccine products.

• Exploring a Dual Listing: Considering the geopolitical environment for U.S.-listed Chinese companies, the SINOVAC Board is also looking into the feasibility of an additional listing in Hong Kong.
  

A Destructive Future Awaits Under the Dissident Slate

We urge you – do not trust recent comments by Prime Success and Vivo Capital regarding their sudden embrace of dividends. How convenient is it that after years in which they lined their own pockets while you received nothing, they now are in support of dividends for all? These misleading comments are clearly an effort to further swindle shareholders and loot SINOVAC. And don’t just take our word for it – refer to the Company’s 2023 20-F, issued under the Imposter Board in April 2024, right after they granted the Dissenting Investor Group over US$800 million in dividends from SINOVAC’s operating subsidiary:

“We have never declared or paid any dividends, nor do we have any present plan to pay any cash dividends on Sinovac Antigua’s shares in the foreseeable future. We currently intend to retain most, if not all, of our available funds and any future earnings to operate and expand our business.” (emphasis added)

Here’s what you can expect if the Dissident Slate is elected at the upcoming Special Meeting of Shareholders:

• Significant Risk that the US$55.00 Per Share Dividend Will Be Cancelled or Delayed Indefinitely: While they may be publicly supporting the US$55.00 dividend that we initiated, the reality is the Dissenting Investor Group has been attempting to block dividend payment through lawsuits and intimidation tactics. This includes intimidating our dividend payments agent to not facilitate your rightful dividend distribution. Several lawsuits have also been filed against SINOVAC Board members and their affiliates following the special dividend declaration.

• No US$11.00 Per Share Dividend Redistribution: If the Dissident Slate gains control, the PIPE shares will not be cancelled and the additional US$11.00 per share redistribution will not be made to SINOVAC’s rightful shareholders and all future dividends will be diluted.

• Privatization Risks at Below Market Value: The Imposter Board has a well-documented history of attempting to privatize SINOVAC at undervalued prices, which short-changes you once again. In 2017, it sought to privatize the Company at prices below market value, employing tactics such as unlawful poison pills to block competing bids and entrench its control. If the Dissident Slate gains power, there is a serious risk of a renewed privatization effort that could once again undervalue your shares and force a sale at a price far below SINOVAC’s true value.

• Continued Self-Serving Actions: Under the Dissenting Investor Group’s control, the Imposter Board approved numerous unauthorized transactions that have diluted and consistently undermined the interests of SINOVAC’s rightful shareholders. This includes investing US$15 million in convertible debt for a 15% stake in our subsidiary, Sinovac Life Sciences Co. Ltd. (“SLS”) – the operating entity primarily responsible for the CoronaVac vaccine – immediately prior to the vaccine’s emergency use authorization in China. The Company did not need this US$15 million convertible debt. Six months later another investor paid US$515 million (34 times more) for an equivalent 15% stake in SLS – valuing SLS at over US$3.4 billion.

• Ongoing Conflicts of Interest: Additionally, the Imposter Board committed to invest RMB1 billion (~US$139 million) of SINOVAC cash into a fund managed by Vivo Capital, where Shan Fu is a Managing Partner – creating a clear conflict of interest. SINOVAC has already invested approximately US$100 million into Vivo Capital funds. If elected, you should expect the Dissident Slate to continue this favored treatment of the Dissenting Investor Group at the expense of all valid shareholders.

• Continued Mismanagement and Governance Failures: The Imposter Board’s actions, including the invalid poison pill, directly caused the NASDAQ trading halt in February 2019, trapping your investment during a time of immense growth and opportunity for SINOVAC. The Imposter Board’s financial mismanagement also led to a material weakness in SINOVAC’s internal controls, as disclosed by the Company’s former independent auditor, Grant Thornton Zhitong Certified Public Accountants LLP (“Grant Thornton”), and Grant Thornton’s subsequent resignation in 2025, which is expected to further delay resumption of NASDAQ trading.

• Continued Erroneous Claims and Misinformation: As part of its coordinated and multifaceted effort to regain control, the Dissenting Investor Group has attempted to rewrite history and made blatantly false claims about the resignation of Grant Thornton in an attempt to mislead shareholders. In reality, Grant Thornton clearly stated its resignation was not the result of any disagreement with the current SINOVAC Board; the auditor resigned because, following the Privy Council’s ruling that the former Board were “Imposters”, Grant Thornton could not rely on representations about the Company’s financials in 2021, 2022, and 2023.
  

We cannot allow this pattern to continue.

Your Vote Will Be Important

This vote will be about the future of SINOVAC, your receipt of your make whole dividend payments in the near-term, and the long-term value of your investment. We look forward to sharing more details about the Dissenting Investor Group’s misguided proposals in our proxy materials, which we intend to file in the coming days.

Your vote will be critical to ensuring that SINOVAC remains on the path to stability, growth, and value creation for all shareholders.

Moving Forward Together

The SINOVAC Board is committed to restoring trust, fairness, and value for all shareholders. We are taking the necessary steps to correct the injustices of the past, investigate conflicts of interest, defend against the Dissenting Investor Group’s hostile actions, and position SINOVAC for a brighter tomorrow. We thank you for your continued confidence and support as we work to protect your investment and the future of SINOVAC.

Together, we can ensure that SINOVAC remains in the hands of leaders who are dedicated to acting in your best interests.

Sincerely,

The SINOVAC Board of Directors

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of vaccines that protect against human infectious diseases.

SINOVAC’s product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected Hand-Foot-Mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, etc.

The COVID-19 vaccine, CoronaVac^®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive^®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive^®, is an innovative vaccine under “Category 1 Preventative Biological Products” and commercialized in China in 2016. In 2022, SINOVAC’s Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.

SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1^®, which has supplied the Chinese government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu^®, to the Chinese government stockpiling program.

SINOVAC continually dedicates itself to new vaccine R&D, with more combination vaccine products in its pipeline, and constantly explores global market opportunities. SINOVAC plans to conduct more extensive and in-depth trade and cooperation with additional countries, and business and industry organizations.

Important Additional Information and Where to Find It

In connection with SINOVAC’s Special Meeting, SINOVAC will file with the U.S. Securities and Exchange Commission (“SEC”) and mail to shareholders of record entitled to vote at the Special Meeting a proxy statement and other documents, including a WHITE proxy card. SHAREHOLDERS ARE ENCOURAGED TO READ THE PROXY STATEMENT AND ALL OTHER RELEVANT DOCUMENTS WHEN FILED WITH THE SEC AND WHEN THEY BECOME AVAILABLE BECAUSE THOSE DOCUMENTS WILL CONTAIN IMPORTANT INFORMATION. When filed with the SEC, the proxy statement and WHITE proxy card will also be mailed to shareholders of record. Investors and other interested parties will be able to obtain the documents free of charge at the SEC’s website, www.sec.gov, or from SINOVAC at its website: https://www.sinovac.com/en-us/Investors/sec_filings. You may also obtain copies of SINOVAC’s proxy statement and other documents, free of charge, by contacting SINOVAC’s Investor Relations Department at ir@sinovac.com. Other information regarding potential participants in any such proxy solicitation will be filed by SINOVAC.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions, including the Company’s statements related to the Compliance Plan, and timing and actions taken to regain compliance with Nasdaq listing rules. Such statements are based upon the Company’s current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, including without limitation risks, uncertainties and factors related to the timing of engaging independent auditors and completion of the audits of required fiscal periods, completion and filing of the 2024 Annual Report, the Compliance Plan, and actions taken to regain compliance with the Nasdaq listing rules, all of which are difficult to predict and many of which are beyond the Company’s control, which may cause the Company’s actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

Contacts

Investor and Media Contacts
FGS Global

Sinovac@fgsglobal.com

Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet




Phase 3 Data for Incyte’s Retifanlimab (Zynyz®) in Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC) Published in The Lancet

• POD1UM-303/InterAACT 2 is the first and largest global Phase 3 trial evaluating a PD-1 inhibitor in combination with chemotherapy for the treatment of patients with advanced SCAC not previously treated with systemic chemotherapy

• The trial met its primary endpoint; treatment with retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel) resulted in clinically meaningful improvements in progression-free survival and overall survival

• In May 2025, the U.S. Food and Drug Administration (FDA) approved Zynyz^® (retifanlimab-dlwr) in combination with carboplatin and paclitaxel and as a single agent for the treatment of advanced SCAC; submissions to other global regulatory agencies are also under review

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte (Nasdaq:INCY) today announced that primary results from the Phase 3 POD1UM-303/InterAACT 2 trial of retifanlimab (Zynyz^®), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), in combination with carboplatin and paclitaxel (platinum-based chemotherapy) in adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal cancer (SCAC) who have not been previously treated with systemic chemotherapy, were published in The Lancet.¹

“The publication of the POD1UM-303/InterAACT 2 trial in The Lancet is a testament to the strength of the data generated for retifanlimab in patients with inoperable locally recurrent or metastatic SCAC, a disease which until recently had seen limited innovation for decades,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “SCAC can be a devastating disease, and patients often have a poor prognosis. These data supported the U.S. Food and Drug Administration (FDA) approval of Zynyz^® (retifanlimab-dlwr) in May 2025, providing U.S. patients the first and only first-line treatment for inoperable locally recurrent or metastatic SCAC.”

The POD1UM-303/InterAACT2 trial results, which were also featured at a Presidential Symposium on Practice-Changing Trials at the European Society for Medical Oncology (ESMO) in 2024, showed that the study met its primary endpoint by demonstrating a statistically significant improvement in progression-free survival (PFS) in patients with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy, as assessed by blinded independent central review (BICR) using RECIST v1.1.² Adding retifanlimab to carboplatin and paclitaxel resulted in a clinically meaningful 37% reduction in the risk of progression or death (Hazard Ratio [HR]: 0.63; 95% Confidence Interval [CI] (0.47, 0.84); P=0.0006).² Patients in the retifanlimab and chemotherapy combination group achieved a median PFS of 9.3 months compared to 7.4 months for patients in the placebo combination group.²

New data published today in The Lancet show that in patients treated with retifanlimab plus chemotherapy:¹

• A consistent benefit in PFS in favor of retifanlimab plus chemotherapy was observed for all pre-defined subgroups with sufficient patients for comparison.
• A clinically meaningful 6-month difference in overall survival (OS) was observed at the interim analysis (29.2 months in the retifanlimab plus carboplatin and paclitaxel group vs 23.0 months in the placebo plus carboplatin and paclitaxel group). Interim OS results were not statistically significant, and patients continue to be followed for the final key secondary OS analysis.
• The overall response rate (ORR) to treatment was improved by the addition of retifanlimab to the chemotherapy (55.8% in the retifanlimab plus carboplatin and paclitaxel group vs 44.2% in the placebo plus carboplatin and paclitaxel group) and the median duration of response was approximately doubled (14 months in the retifanlimab plus carboplatin and paclitaxel group vs 7.2 months in the placebo plus carboplatin and paclitaxel group) when compared to placebo.

As reported in The Lancet, no new safety signals were observed in POD1UM-303/InterAACT2, and safety was consistent with chemotherapy plus checkpoint inhibitor regimens. Serious and Grade 3 or worse adverse events were more frequent in the retifanlimab plus carboplatin and paclitaxel group compared with placebo plus carboplatin and paclitaxel group (47.4% vs 38.8% and 83.1% vs 75.0%, respectively). The most common Grade ≥3 adverse events were neutropenia (35.1% for retifanlimab plus carboplatin and paclitaxel vs 29.6% for placebo plus carboplatin and paclitaxel) and anemia (19.5% vs 20.4%). Despite the higher rate of serious, Grade 3 or worse, and fatal adverse events with retifanlimab plus carboplatin and paclitaxel than placebo plus carboplatin–paclitaxel, these toxicities were manageable with standard measures and carboplatin and paclitaxel delivery was not compromised.

The publication, entitled “Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial,” can be found online here.

“The incidence of SCAC is increasing by approximately 3% annually, driven mainly by endemic human papillomavirus (HPV infection). With no approved treatments available for advanced cases until recently, it is crucial to develop effective therapies for this orphan disease,” said Sheela Rao, M.D., Consultant Medical Oncologist, The Royal Marsden National Health Service Foundation Trust.

In May 2025, the FDA approved Zynyz^® (retifanlimab-dlwr) in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic SCAC. In addition, the FDA granted approval for Zynyz as a single agent for the treatment of adult patients with locally recurrent or with metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy. Incyte has also submitted a Type II variation Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for retifanlimab in advanced SCAC and in March 2025 submitted and received acceptance of a Japanese New Drug Application (J-NDA) by the Pharmaceuticals and Medical Devices Agency (PMDA) for retifanlimab in advanced SCAC.

About Squamous Cell Carcinoma of the Anal Canal (SCAC)

SCAC is the most common type of anal cancer, making up 85% of cases.³ It is a rare disease for which the incidence is increasing approximately 3% per year.⁴ About 90% of cases are associated with human papillomavirus (HPV) infection—the number one risk factor for anal cancer.⁵ HIV is an important amplifier of anal cancer, as people with HIV are 25 to 35 times more likely to develop it.^6,7 Anal cancer shares many of the same symptoms as non-cancerous conditions, such as hemorrhoids—including pain, itching, a lump or mass and changes in bowel movements—and as a result can go undetected leading to the majority of patients presenting with locally advanced disease.^8,9 More information about SCAC is available by visiting www.analcancer.com.

About POD1UM

The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-303, POD1UM-202 and several other Phase 1, 2 and 3 studies for patients with solid tumors, including a registration-directed trial evaluating retifanlimab in combination with platinum-based chemotherapy for patients with non-small cell lung cancer.

About POD1UM-303/InterAACT 2

POD1UM-303/InterAACT 2 (NCT04472429) is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study evaluating retifanlimab or placebo in combination with platinum-based chemotherapy (carboplatin and paclitaxel) in adult patients with inoperable locally recurrent or metastatic SCAC who have not been previously treated with systemic chemotherapy.

During the blinded portion of the study, patients, including those with well-controlled HIV infection, were randomized 1:1 to receive retifanlimab 500 mg intravenously or placebo during each 28-day cycle for up to 6 months in combination with standard therapy of carboplatin and paclitaxel, followed by retifanlimab or placebo monotherapy for up to 1-year total treatment in the absence of disease progression or unacceptable toxicity. Crossover to retifanlimab monotherapy was allowed for patients assigned to placebo upon verification of progression by blinded independent central review (BICR).

The primary endpoint was progression-free survival (PFS) as determined by BICR using RECIST v1.1. The key secondary endpoint was overall survival (OS). Other secondary endpoints include objective response rate (ORR), duration of response (DOR), disease control rate (DCR) by BICR, safety and pharmacokinetics.

For more information about the study, please visit https://clinicaltrials.gov/study/NCT04472429.

About Zynyz^® (retifanlimab-dlwr)

Zynyz^® (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

Zynyz is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Zynyz is marketed by Incyte in the United States. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a registered trademark of Incyte.

Important Safety Information

What is the most important information I should know about Zynyz?

Zynyz is a medicine that may treat certain types of cancers by working with your immune system. Zynyz can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your doctor right away if you develop any new or worsening signs or symptoms, including:

Lung problems: cough, shortness of breath, chest pain

Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdomen) pain or tenderness

Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal

Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, loss of appetite

Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Zynyz. Call or see your doctor right away for any new or worsening signs or symptoms, which may include:

• chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• persistent or severe muscle pain or weakness, muscle cramps
• low red blood cells, bruising

Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain.

Rejection of a transplanted organ or tissue. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ or tissue transplant that you have had.

Complications, including graft-versus-host disease, in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Zynyz. Your doctor will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during your treatment. Your doctor may treat you with corticosteroid or hormone replacement medicines and may also need to delay or completely stop treatment if you have severe side effects.

Before you receive Zynyz, tell your doctor about all of your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant or tissue transplant, including corneal transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. Zynyz can harm your unborn baby

Females who are able to become pregnant:

• Your doctor should do a pregnancy test before you start treatment.
• You should use an effective method of birth control during your treatment and for 4 months after your last dose. Talk to your doctor about birth control methods that you can use during this time.
• Tell your doctor right away if you become pregnant or think you may be pregnant during treatment.
• are breastfeeding or plan to breastfeed. It is not known if Zynyz passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Zynyz when given with the chemotherapy medicines carboplatin and paclitaxel in people with SCAC include tiredness, numbness, pain, tingling, or burning in your hands or feet; nausea; hair loss; diarrhea; muscle and bone pain; constipation; bleeding; rash; vomiting; decreased appetite; itching; stomach-area pain.

The most common side effects of Zynyz when used alone in people with SCAC include tiredness, muscle and bone pain, diarrhea, infection, rectal or genital-area pain, bleeding, urinary tract infection (UTI), rash, nausea, loss of appetite, constipation, stomach-area pain, shortness of breath, fever, vomiting, cough, itching, low levels of thyroid hormone, headache, decreased weight.

The most common side effects of Zynyz when used alone in people with MCC include tiredness, muscle and bone pain, itching, diarrhea, rash, fever, nausea.

These are not all the possible side effects of Zynyz. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.

General information about the safe and effective use of Zynyz

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about Zynyz, talk with your doctor. You can ask your doctor for information about Zynyz that is written for health professionals.

Please see the full Prescribing Information, including the Medication Guide, for Zynyz.

You may also report side effects to the FDA http://www.fda.gov/medwatch or to Incyte Corporation at 1-855-463-3463.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and when Zynyz might provide a successful treatment option for patients with SCAC, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on Incyte‘s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by FDA or other regulatory authorities; Incyte‘s dependence on its relationships with its collaboration partners; the efficacy or safety of Incyte‘s products and the products of Incyte‘s collaboration partners; the acceptance of Incyte‘s products and the products of Incyte‘s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte‘s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended March 31, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.

Contacts

Media
media@incyte.com

Investors
ir@incyte.com

Quince Therapeutics Announces Pricing of Up to $22 Million Private Placement of Securities




Quince Therapeutics Announces Pricing of Up to $22 Million Private Placement of Securities

Financing to provide $11.5 million in upfront proceeds with up to an additional $10.4 million of proceeds assuming exercise in full of the warrants

Financing priced at a premium to last close

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–$QNCX #biotech–Quince Therapeutics, Inc. (Nasdaq: QNCX) (“Quince” or the “Company”), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today announced that it has entered into a securities purchase agreement with certain institutional and accredited investors to purchase shares of its common stock (or pre-funded warrants in lieu thereof), and accompanying common warrants (“Warrants”) that is expected to result in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million if the accompanying common warrants are exercised in full for cash, before deducting placement agent fees and other private placement expenses.

The private placement is being led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince’s senior management.

Quince intends to use the net proceeds of this offering for working capital and general corporate purposes, including funding the ongoing enrollment of the Company’s pivotal Phase 3 NEAT (Neurological Effects of eDSP on Subjects with A–T; NCT06193200/IEDAT-04-2022) clinical trial in Ataxia-Telangiectasia (A-T), research and development expenses, general and administrative expenses and capital expenditures. The net upfront proceeds from the private placement, combined with Quince’s current cash, cash equivalents, and short-term investments are expected to fund the Company’s operations into the second quarter of 2026, or the second half of 2026 if the Warrants are exercised in full for cash.

At the closing, the Company will issue to the investors an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), along with accompanying Warrants to purchase an aggregate of 8,671,928 shares of common stock (or pre-funded warrants in lieu thereof), at a combined purchase price of $1.325 per share (or $1.324 per pre-funded warrant) and accompanying Warrant (representing a 10% premium over the $1.20 closing price per share of the Company’s common stock). The accompanying Warrants have an exercise price of $1.20 per share and will become exercisable immediately. The Warrants will expire five years from the date of issuance. The private placement is expected to close during the week of June 16, 2025, subject to the satisfaction of customary closing conditions.

Citizens Capital Markets is acting as the lead placement agent for the private placement. Maxim Group LLC and Brookline Capital Markets, a division of Arcadia Securities, LLC, are acting as co-placement agents for the private placement.

The securities to be issued in connection with the private placement described above are being offered in a private placement and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdictions’ securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

This news release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Quince Therapeutics

Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com.

Forward-looking Statements

Statements made in this news release that are not statements of historical or current facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this news release regarding the expected closing of the private placement; the receipt of additional gross proceeds if the accompanying common warrants are exercised in full; the achievement of positive clinical trial results and approval of the eDSP by the FDA; the company’s intended use of the proceeds from the private placement; the company’s expectation that the net proceeds from the closing of the private placement, combined with its current cash, cash equivalents and marketable securities, will fund its operating and capital expenditures into the second quarter of 2026, or the second half of 2026, assuming all warrants are exercised for cash; and the company’s strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks and uncertainties related to: cost, timing, progress and results of the pivotal Phase 3 NEAT clinical trial in A-T indication and potential future trials in other indications; the company’s ability to obtain FDA approval and successfully commercialize its product candidate; the satisfaction of customary closing conditions related to the proposed private placement and the impact of general economic, industry or political conditions in the United States or internationally, the current or evolving effects of macroeconomic conditions, on Quince’s business operations and activities. There can be no assurance that the company will be able to complete the proposed private placement on acceptable terms, or at all. Quince’s actual results, performance, or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including the risks discussed under the heading “Risk Factors” discussed under the caption “Item 1A. Risk Factors” in Part I of Quince’s most recent Annual Report on Form 10-K or any updates discussed under the caption “Item 1A. Risk Factors” in Part II of its Quarterly Reports on Form 10-Q and in the company’s other filings with the SEC. Quince undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as required by law.

Contacts

Media & Investor Contact:
Stacy Roughan

Quince Therapeutics, Inc.

Vice President, Corporate Communications & Investor Relations

ir@quincetx.com

BeOne Medicines to Host Investor R&D Day Webcast on June 26, 2025




BeOne Medicines to Host Investor R&D Day Webcast on June 26, 2025

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne–BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that it will host an Investor R&D Day in New York City and via webcast on June 26, 2025 at 8:30 am ET. John V. Oyler, Co-Founder, Chairman, and CEO of BeOne, along with the Company’s leadership team and distinguished key opinion leaders, will provide an update on BeOne’s extensive global innovation pipeline and platforms, including new assets, targets and clinical data, and will share insights on the Company’s vision, differentiated capabilities, and value creation drivers.

Live webcast of this event can be accessed from the investors section of the Company’s website at http://ir.beonemedicines.com/, https://hkexir. beonemedicines.com/, https://sseir. beonemedicines.com/. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the Company’s website.

About BeOne Medicines

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements

This presentation may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne’s plans, commitments, aspirations and goals related to BeOne’s medicines and drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors which are discussed in the section entitled “Risk Factors” in BeiGene’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”) as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this presentation is as of the date presented, and BeiGene undertakes no duty to update such information unless required by law.

Contacts

Investors:
Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media:
Kyle Blankenship

+1 667-351-5176

media@beonemed.com

Clinical and Pre-Clinical Data on the Novel Barriolide, EP395 (glasmacinal), Published in Three Articles in Pulmonary Pharmacology and Therapeutics




Clinical and Pre-Clinical Data on the Novel Barriolide, EP395 (glasmacinal), Published in Three Articles in Pulmonary Pharmacology and Therapeutics

REYKJAVIK, Iceland–(BUSINESS WIRE)–EpiEndo Pharmaceuticals (‘EpiEndo’ or the ‘Company’), a clinical-stage biopharmaceutical company developing a new class of oral anti-inflammatory drugs which enhance the host defence response to inhaled pathogens, has had three articles published in peer-reviewed journal, Pulmonary Pharmacology and Therapeutics.

These publications describe the potential for EpiEndo’s lead asset EP395, also known as ‘glasmacinal’, to be of therapeutic benefit in the treatment of COPD and support its continued clinical development. The article “Effect of EP395, a novel anti-inflammatory macrolide, in an inhaled lipopolysaccharide challenge model in healthy volunteers: a randomised controlled trial” reports that EP395 enhances the host defence response to inhaled LPS whilst reducing pro-inflammatory mediators. The paper was co-authored with investigators from Fraunhofer Institute for Toxicology and Experimental Medicine who conducted the study.

The second article, “Effects of EP395, a novel macrolide, on acute neutrophilic airway inflammation” describes preclinical data that demonstrate EP395 has comparable inhibitory effects on acute neutrophilic airway inflammation to azithromycin, which is used chronically off-label for its immunomodulatory properties to reduce COPD exacerbations.

Finally, “A novel macrolide, EP395, with reduced antibacterial activity and an enhancing effect on respiratory epithelial barrier” reports that EP395 has negligible antibiotic activity and enhances the barrier function of the respiratory epithelium.

Maria Bech, CEO of EpiEndo Pharmaceticals commented:

“It is great to see the publication of this clinical and pre-clinical research in a peer-reviewed journal, highlighting the efficacy we are seeing with glasmacinal in neutrophilic inflammation.

“The anti-inflammatory effects of glasmacinal are comparable to those seen with azithromycin preclinically, but without anti-microbial activity. The clinical LPS study shows that EP395 enhances the host defence response to inhaled challenge, supporting our hypothesis that glasmacinal could be effective in reducing exacerbations in COPD but without developing anti-microbial resistance.

“We continue to develop glasmacinal as a potential new oral treatment option for COPD patients, aiming to bring additional therapeutic options to patients with chronic respiratory diseases.”

Professor Clive Page, Emeritus Professor of Pharmacology, King’s College London and Chairman of EpiEndo Pharmaceutical’s Scientific Advisory Board added:

“These exciting new data demonstrate glasmacinal’s effect on neutrophilic inflammation both in a clinical study and in established non-clinical models of airways disease. These novel findings, coupled with data presented at ERS in 2024 on EP395’s anti-inflammatory effect on eosinophilic inflammation (caused by allergens), demonstrate the broad anti-inflammatory activity of this drug that has the potential to provide a novel, groundbreaking approach to treat patients with COPD, irrespective of their type of inflammation.”

About EpiEndo Pharmaceuticals (www.epiendo.com)

EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to chronic respiratory diseases that focuses on the role of epithelial function in various inflammatory disorders.

EpiEndo’s new class of orally available macrolides, with reduced antimicrobial resistance (AMR) potential, known as ‘Barriolides™’, show promise as first-in-class therapeutics for chronic respiratory diseases as well as other inflammatory indications. EpiEndo’s lead asset, glasmacinal, was the first Barriolide™ to enter clinical trials, for chronic obstructive pulmonary disease (COPD).

Glasmacinal aims to be a first on-market oral treatment which is anti-inflammatory and enhances the host defense response to inhaled pathogens such as viruses, bacteria & pollution.​ Therefore, glasmacinal has the potential to become an impactful treatment in reducing exacerbations in patients with COPD.

According to the WHO, COPD is the third leading cause of death globally, and the global economic burden of COPD is projected to cost $4.8 trillion by 2030.

Contacts

EpiEndo Pharmaceuticals:
Maria Bech, CEO

+354 454 0090

Vigo Consulting (media relations):

Rozi Morris

+44 20 7390 0230

epiendo@vigoconsulting.com

3D Investment Partners: Leading Proxy Advisory Firm Glass Lewis Recommends Toho Holdings Shareholders Vote “AGAINST” the Reappointment of CEO Hiromi Edahiro at the Company’s June 2025 AGM




3D Investment Partners: Leading Proxy Advisory Firm Glass Lewis Recommends Toho Holdings Shareholders Vote “AGAINST” the Reappointment of CEO Hiromi Edahiro at the Company’s June 2025 AGM

Glass Lewis Highlights “Relevant and Substantiated Concerns Regarding Toho Holdings’ Governance Practices,” Especially the Company’s Response to the Nihon University Incident

Believes Shareholders Should Expect “Stronger Accountability and Leadership at the Highest Levels” and Advises Shareholders to Vote Against the Reappointment of CEO Hiromi Edahiro in order to “Express Their Concerns and Dissatisfaction”

TOKYO–(BUSINESS WIRE)–3D Investment Partners Pte. Ltd., the investment manager of 3D Opportunity Master Fund (“3D” or “we”), today announced that Glass, Lewis & Co. (“Glass Lewis”), a leading independent provider of proxy research and voting recommendations for the institutional investor community, has recommended that shareholders of Toho Holdings Co., Ltd. (“Toho HD” or the “Company”) (TOKYO: 8129) vote “AGAINST” the reappointment of Representative Director, President, CEO and CFO Hiromi Edahiro (“Mr. Edahiro”) at the Company’s 77th Annual General Meeting of Shareholders (the “AGM”), scheduled to be held on June 27, 2025.

In its report, Glass Lewis recognized that 3D “raises relevant and substantiated concerns regarding Toho Holdings’ governance practices” and concluded that shareholders should vote against the reappointment of Mr. Edahiro.

In reaching its conclusion, Glass Lewis highlighted Toho HD’s fraudulent scheme related to Nihon University Hospital (the “Nihon University Incident”) and found that the incident – which was “characterized by limited disclosure and unclear accountability” – warranted “further scrutiny.”

Furthermore, Glass Lewis criticized Toho HD’s response to the Nihon University Incident particularly; they analyze that this incident suggested “gaps in the Company’s risk awareness and disclosure governance framework.” Glass Lewis noted that:

• “[T]he Company’s involvement in transactions perceived as questionable might have merited a more proactive and transparent response. From the standpoint of risk oversight and shareholder communication, an internal investigation followed by a timely explanation would likely have been more appropriate.”

• “[T]he Company’s first formal disclosure [of the Nihon University Incident] was issued only in response to 3D’s public statements ahead of this shareholder meeting. In our view, this reactive approach appears misaligned with generally accepted expectations for corporate transparency. The rationale cited—that disclosure was delayed to protect the Company’s reputation—may in fact have had the opposite effect, potentially exacerbating reputational risks.”

3D completely agrees with Glass Lewis that shareholders should expect “stronger accountability and leadership at the highest levels.” 3D strongly believes that addressing Toho HD’s serious governance and compliance failures is essential to enhance the Company’s corporate value sustainably, and that substantive change must start at the top of the organization.

3D therefore encourages Toho HD shareholders to vote AGAINST Mr. Edahiro at the Company’s upcoming AGM.

Note: The passages in quotation marks (“”) are direct quotes excerpted by 3D from Glass Lewis’ report. The portions in brackets ([ ]) have been added by 3D for additional clarity/context. Permission to use these quotes from Glass Lewis was neither explicitly sought nor obtained.

About 3D Investment Partners Pte. Ltd.

3D Investment Partners Pte. Ltd. is an independent Singapore-based Japan focused value investing fund manager founded in 2015. 3D Investment Partners Pte. Ltd. focuses on partnering with management[s] who share its investment philosophy of medium- to long-term value creation through compound capital growth and a common objective of achieving long-term returns.

Disclaimer

This press release, including annexes is provided for informational purposes only and does not constitute an offer to purchase or sell any security or investment product, nor does it constitute professional or investment advice. This press release should not be relied on by any person for any purpose and is not, and should not be construed as investment, financial, legal, tax or other advice.

3D Investment Partners Pte. Ltd. and its affiliates and related persons (“3DIP”) of either believe that the current market price of Toho HD does not reflect its intrinsic value. 3DIP acquired beneficial and/or economic interests based on its own idea that Toho HD securities have been undervalued and provide an attractive investment opportunity and may in the future beneficially own, and/or have an economic interest in, Toho HD securities. 3DIP intends to review its investments in Toho HD on a continuing basis and, depending upon various factors including, without limitation, Toho HD’s financial position and strategic direction, the outcome of any discussions with Toho HD, overall market conditions, other investment opportunities available to 3DIP, and the availability of Toho HD securities at prices that would make the purchase or sale of Toho HD securities desirable, 3DIP may, from time to time (in the open market or in private transactions), buy, sell, cover, hedge, or otherwise change the form or substance of any of its investments (including the investment in Toho HD securities) to any degree in any manner permitted by any applicable law, and expressly disclaims any obligation to notify others of any such changes.

3DIP provides no representation or warranty, either expressed or implied, in relation to the accuracy, completeness, or reliability of the information contained herein (including content or quotes from news coverage or other third-party public sources (“Third-Party Materials”)), nor is it intended to be a complete statement or summary of the securities, markets, or developments referred to herein. 3DIP expressly disclaims any responsibility or liability for any loss whatsoever arising from any use of, or reliance on, this press release or its contents as a whole or in part by any person, or otherwise whatsoever arising in connection with this press release. 3DIP hereby expressly disclaims any obligation to update or provide additional information regarding the contents of this press release or to correct any inaccuracies in the information contained in this press release.

3DIP disclaims any intention or agreement to be treated as a joint holder (kyodo hoyu sha) under the Financial Instruments and Exchange Act of Japan, a closely related party (missetsu kankei sha) under the Foreign Exchange and Foreign Trade Act with other shareholders, or receiving any power or permission to represent other shareholders in relation to the exercise of their voting rights, and has no intention to solicit, encourage, induce or require any person to cause other shareholders to represent such voting rights.

3DIP does not have the intention to make a proposal, directly or through other shareholders of Toho HD, to transfer or abolish the business or assets of Toho HD and/or Toho HD group companies at the general shareholders meeting of Toho HD. 3DIP does not have the intention or purpose to engage in any conduct which constricts the continuing and stable implementation of business of Toho HD and/or Toho HD group companies.

This press release may include Third-Party Materials. Permission to quote from Third-Party Materials in this press release may neither have been sought nor obtained. The content of the Third-Party Materials has not been independently verified by 3DIP and does not necessarily represent the views of 3DIP. The authors and/or publishers of the Third-Party Materials are independent of, and may have different views to 3DIP. Quoting Third-Party Materials in this press release does not imply that 3DIP endorses or concurs with any part of the content of the Third-Party Materials or that any of the authors or publishers of the Third-Party Materials endorses or concurs with any views which have been expressed by 3DIP on the relevant subject matter. The Third-Party Materials may not be representative of all relevant news coverage or views expressed by other third parties on the stated issues.

In respect of information that has been prepared by 3DIP (and not otherwise attributed to any other party) and which appears in the English language version of this press release, in the event of any inconsistency between the English language version and the Japanese language version of this press release, the meaning of the Japanese language version shall prevail unless otherwise expressly indicated.

Contacts

KRIK (PR Agent)

Koshida: +81-70-8793-3990

Sugiyama: +81-70-8793-3989