Zymeworks Presents Initial Clinical Data from the Phase 1 trial of ZW191, an Antibody-Drug Conjugate Targeting Folate Receptor-⍺ at AACR-NCI-EORTC Conference




Zymeworks Presents Initial Clinical Data from the Phase 1 trial of ZW191, an Antibody-Drug Conjugate Targeting Folate Receptor-⍺ at AACR-NCI-EORTC Conference

• Preliminary efficacy data, combined with a tolerable safety profile, reinforce the potential of ZW191 in patients with advanced solid tumors, including ovarian, endometrial, and non-small cell lung cancer
• 64% overall response rate in gynecological cancers at doses ≥6.4mg/kg
• Responses observed at all doses evaluated at 3.2mg/kg and above demonstrating wide therapeutic index of Zymeworks’ novel antibody-drug conjugate platform
• Dose optimization of ZW191 in ovarian cancer to initiate in 4Q-2025
• Investor and analyst call to be held today at 3:30 pm Eastern Time (ET)

VANCOUVER, British Columbia, Oct. 23, 2025 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced preliminary results from a Phase 1 study evaluating ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-alpha (FR⍺), at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics, being held October 22-26, 2025, in Boston, MA.

“These first clinical data from our Phase 1 study of ZW191 provide early validation of our innovative approach to designing novel ADCs, through combining a unique antibody design with our proprietary payload, ZD06519,” said Sabeen Mekan, MD, Senior Vice President of Clinical Development of Zymeworks. “We are encouraged by the early signs of anti-tumor activity and favorable safety profile in a heavily pretreated population, which supports best-in-class potential and strengthens our confidence in this approach. With dose optimization planned to begin in the fourth quarter of this year and additional candidates such as ZW251 advancing in development, we remain focused on delivering meaningful new treatment options for patients with challenging cancers.”

Key Findings

As of September 10, 2025, the study enrolled 41 patients from doses 1.6 to 11.2 mg/kg (which was ongoing as of this date) in a heavily pretreated patient population of platinum resistant ovarian cancer, metastatic endometrial cancer, and metastatic non-small cell lung cancer who were enrolled regardless of FR⍺ expression levels. The majority of patients (85%) remain on study treatment.

• ZW191 exhibited promising preliminary anti-tumor activity:
  • For all response-evaluable participants (n=27) across dose levels, objective response rate (ORR) was 44%; across doses of 6.4 mg/kg to 9.6 mg/kg, ORR was 53%.
  • For response-evaluable gynecological cancer participants (n=24) across dose levels, ORR was 50%; across doses of 6.4 mg/kg to 9.6 mg/kg, ORR was 64%.
  • Responses were observed beginning at the 3.2 mg/kg dose and in tumors with low/negative levels of FRα expression.

• ZW191 demonstrated a manageable safety profile, with low rates of dose modifications, dose delays, and Grade ≥3 treatment-related adverse events (AE).
  • • No serious treatment-related AEs, discontinuations due to AEs, or deaths were reported.
    • The most common ≥ Grade 3 treatment-related AEs were anemia (10%), neutropenia (5%) and thrombocytopenia (5%).

• • These data represent a broad therapeutic window for ZW191 and provide the rationale for further investigation in advanced solid tumors.

Since this data-cut, 11.2 mg/kg has been determined as the maximum tolerated dose and based on safety, efficacy, and pharmacokinetic data, two dose levels – 6.4 mg/kg and 9.6 mg/kg – have been selected for dose optimization, with approximately 30 patients planned in each cohort. This next stage of development is designed to further evaluate ZW191’s clinical activity and safety to inform a registrational strategy.

“It is rewarding to see the scientific promise behind ZW191, including its novel antibody and payload technology, begin to translate into meaningful observations in the clinic,” said Patricia LoRusso, DO, PhD (hc), FAACR and lead author. “These early efficacy and safety findings represent an important step in exploring new treatment strategies for patients with advanced, aggressive cancers and I look forward to observing ZW191’s continued progress.”

Presentation Details

• Title: Preliminary Results From a Phase 1 First-in-Human Multicenter Open-Label Study Of ZW191, a Folate Receptor α–Targeting Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
• Session: Poster Session A
• Date/Time: Thursday, October 23, 2025 at 12:30-4:00 pm ET

Investor & Analyst Call
A live webcast will be held today at 3:30 pm ET with lead author Patricia LoRusso, DO, PhD (hc), FAACR and Zymeworks senior management to discuss the data presented. Dial-in details and webcast replay available on Zymeworks’ website at https://ir.zymeworks.com/events-and-presentations.

About ZW191
ZW191 is an ADC engineered to target a protein called folate receptor-⍺ (FR⍺), found in ~75% of high-grade serous ovarian carcinomas¹ and ~70% of lung adenocarcinomas². ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells.

About Zymeworks Inc.
Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat conditions such as cancer, inflammation, and autoimmune disease. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited, granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab has received accelerated approval from the U.S. FDA, conditional approval from the NMPA in China, and conditional marketing authorization from the European Commission for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. It is the first and only dual HER2-targeted bispecific antibody approved for this indication in the U.S., Europe, and China. Zanidatamab is also being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with multiple HER2-expressing cancers. Zymeworks is rapidly advancing a robust pipeline of wholly-owned product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. A Phase 1 study for ZW191 is actively recruiting and ZW251 is expected to enter clinical trials in 2025. In addition to Zymeworks’ pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.

Cautionary Note Regarding Forward-Looking Statements
This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to Zymeworks’ data presentations and key findings; the timing and status of ongoing and future studies and the release of data; the potential therapeutic effects of and commercial potential of Zymeworks’ product candidates; Zymeworks’ preclinical pipeline; plans for product candidates’ next stages of development; the ability to advance product candidates into later stages of development and the timing of such advancement; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “anticipate”, “potential”, “will”, “on track”, “continue”, “progress” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty and new policies implemented under the current administration, including executive orders, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of pandemics and other health crises on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; clinical trials and any future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca).

Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.

Investor inquiries:
Shrinal Inamdar
Senior Director, Investor Relations
(604) 678-1388
ir@zymeworks.com

Media inquiries:
Diana Papove
Senior Director, Corporate Communications
(604) 678-1388
media@zymeworks.com

¹ Köbel, M., Madore, J., Ramus, S. et al., Br J Cancer 111, 2297–2307 (2014).
² O’Shannessy DJ, et al., Oncotarget. 2012 Apr; 3(4):414-25.

ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference




ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference

-Two poster presentations showcase best- and first-in-class potential of ALX2004, a novel, antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors

-Robust body of preclinical data supports ALX2004 differentiation in EGFR-ADC class and continued evaluation in first-in-human trial

–Initial safety data from ongoing ALX2004 Phase 1 trial anticipated in the first half of 2026

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2025 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today presented preclinical data and the trial design for the ongoing Phase 1 clinical trial for its ADC candidate, ALX2004, in two poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22 – 26, 2025 in Boston, Massachusetts. ALX2004-01 is a first-in-human study to evaluate the safety, tolerability, and preliminary efficacy of ALX2004 in patients with advanced or metastatic solid tumors that are known to express EGFR.

“Our preclinical findings have shown potent anti-tumor activity and a favorable toxicity profile supporting our advancement of ALX2004 into the clinic,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Given that toxicity challenges of earlier generation ADCs have limited the therapeutic window in the treatment of EGFR-expressing solid tumors; we are encouraged by our preclinical data that this unique molecule, ALX2004 could potentially overcome these limitations. Enrollment in this trial began in August and continues to be on track to allow us to deliver initial safety data in the first half of next year. We are pleased to present extensive preclinical data supporting ALX2004’s potential to break new ground in ADC innovation in the EGFR-targeting class at the AACR-NCI-EORTC Conference.”

The Company’s first ADC, ALX2004, is the result of a rigorous internal drug design process. Developed in house by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is designed to optimize all mechanisms of ADC cancer killing while maximizing the therapeutic window. ALX2004 uses a matuzumab-derived EGFR antibody selected to minimize off tumor skin toxicity and maximize therapeutic window, with a binding epitope distinct from U.S. Food and Drug Administration approved EGFR antibodies. Additionally, ALX2004 has a proprietary linker-payload and Top1i payload engineered to offer improved linker stability for on-target delivery of payload and enhanced bystander effect.

ALX2004 is currently being evaluated in a first-in-human, open-label multicenter study in participants with advanced or metastatic select EGFR-expressing solid tumors. The design of this Phase 1 clinical trial (NCT07085091) will also be presented at the meeting.

Details for ALX Oncology’s poster presentations are as follows:

Title: ALX2004, A Novel Anti-EGFR Topoisomerase I Inhibitor Antibody-Drug Conjugate for the Treatment of EGFR-Expressing Solid Tumors
Presenter: Marja Vrljic, Ph.D., Vice President, Antibody Technologies, ALX Oncology
Abstract: #A119
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

Title: A Phase 1, First-in-Human, Open-Label Multicenter Study to Evaluate ALX2004, Antibody-Drug Conjugate Targeting EGFR, in Patients With Advanced or Metastatic Select Solid Tumors (ALX2004-01)
Abstract: LB-A004
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
ewebb@alxoncology.com

Media Contact:
Audra Friis, Sam Brown Healthcare Communications
audrafriis@sambrown.com
(917) 519-9577

ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference




ALX Oncology Announces Preclinical Data and Phase 1 Trial-in-Progress Presentations of ALX2004, a Novel EGFR-Targeted ADC, at 2025 AACR-NCI-EORTC Conference

-Two poster presentations showcase best- and first-in-class potential of ALX2004, a novel, antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors

-Robust body of preclinical data supports ALX2004 differentiation in EGFR-ADC class and continued evaluation in first-in-human trial

–Initial safety data from ongoing ALX2004 Phase 1 trial anticipated in the first half of 2026

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2025 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology” or the “Company”) (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today presented preclinical data and the trial design for the ongoing Phase 1 clinical trial for its ADC candidate, ALX2004, in two poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22 – 26, 2025 in Boston, Massachusetts. ALX2004-01 is a first-in-human study to evaluate the safety, tolerability, and preliminary efficacy of ALX2004 in patients with advanced or metastatic solid tumors that are known to express EGFR.

“Our preclinical findings have shown potent anti-tumor activity and a favorable toxicity profile supporting our advancement of ALX2004 into the clinic,” said Jason Lettmann, Chief Executive Officer at ALX Oncology. “Given that toxicity challenges of earlier generation ADCs have limited the therapeutic window in the treatment of EGFR-expressing solid tumors; we are encouraged by our preclinical data that this unique molecule, ALX2004 could potentially overcome these limitations. Enrollment in this trial began in August and continues to be on track to allow us to deliver initial safety data in the first half of next year. We are pleased to present extensive preclinical data supporting ALX2004’s potential to break new ground in ADC innovation in the EGFR-targeting class at the AACR-NCI-EORTC Conference.”

The Company’s first ADC, ALX2004, is the result of a rigorous internal drug design process. Developed in house by ALX Oncology’s protein engineers utilizing the Company’s proprietary topoisomerase I inhibitor (Top1i) payload and linker payload platform, ALX2004 is designed to optimize all mechanisms of ADC cancer killing while maximizing the therapeutic window. ALX2004 uses a matuzumab-derived EGFR antibody selected to minimize off tumor skin toxicity and maximize therapeutic window, with a binding epitope distinct from U.S. Food and Drug Administration approved EGFR antibodies. Additionally, ALX2004 has a proprietary linker-payload and Top1i payload engineered to offer improved linker stability for on-target delivery of payload and enhanced bystander effect.

ALX2004 is currently being evaluated in a first-in-human, open-label multicenter study in participants with advanced or metastatic select EGFR-expressing solid tumors. The design of this Phase 1 clinical trial (NCT07085091) will also be presented at the meeting.

Details for ALX Oncology’s poster presentations are as follows:

Title: ALX2004, A Novel Anti-EGFR Topoisomerase I Inhibitor Antibody-Drug Conjugate for the Treatment of EGFR-Expressing Solid Tumors
Presenter: Marja Vrljic, Ph.D., Vice President, Antibody Technologies, ALX Oncology
Abstract: #A119
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

Title: A Phase 1, First-in-Human, Open-Label Multicenter Study to Evaluate ALX2004, Antibody-Drug Conjugate Targeting EGFR, in Patients With Advanced or Metastatic Select Solid Tumors (ALX2004-01)
Abstract: LB-A004
Date and Time: Thursday, October 23, 12:30-4:00 p.m. ET
Session: Poster Session A
Location: Hynes Convention Center, Level 2, Exhibit Hall D

About ALX Oncology
ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and entered the clinic in a Phase 1 trial in August 2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objects of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Relations Contact:
Elhan Webb, CFA, IR Consultant
ewebb@alxoncology.com

Media Contact:
Audra Friis, Sam Brown Healthcare Communications
audrafriis@sambrown.com
(917) 519-9577

eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery




eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery

Princeton, NJ, Oct. 23, 2025 (GLOBE NEWSWIRE) — eteraflex connects and CliniExperts have announced a strategic partnership that unites their complementary expertise in clinical research, regulatory strategy, and technology integration under a single, scalable service platform.

eteraflex connects & cliniexperts group

The alliance combines eteraflex connects leadership in scientific program management, data analytics, and client engagement with CliniExperts’ being one of the premier regulatory service provider, clinical trial management excellence, and medical affairs capabilities. Together, they will deliver comprehensive end-to-end solutions for pharmaceutical, biotechnology, and medical device innovators — from regulatory strategy, Clinical Development support, through regulatory submission and post-approval support.

Operating from offices in Princeton, NJ (Headquarters) and Canton, MA, with Global Capability Centers in Hyderabad, Chennai, New Delhi, and Bengaluru, the unified organization now employs over 300 plus professionals and consultants. This expanded infrastructure provides clients with a globally synchronized framework that ensures scientific rigor, regulatory precision, and operational efficiency across markets.

This partnership represents a defining evolution for both organizations and the life sciences ecosystem we serve,” said Santhosh RK, Managing Partner, eteraflex connects. “By integrating CliniExperts’ regulatory and clinical operations excellence with our technology-driven service model, we are building a platform that delivers measurable acceleration, compliance confidence, and data integrity for every client program.”

Dr. Ashwini Kumar, CEO, CliniExperts Group, added, “Our combined strengths enable our clients to access complete clinical development and regulatory pathways through one unified partner. Supported by our unmatched Clinical Operation Skills, Globally compliant EDC platform and analytics, we deliver transparent, efficient, and outcome-focused solutions from first patient to final submission and from IND to securing Marketing Authorization.”

The strategic partnership brings together proven capabilities across:

• Clinical Operations – Full-service trial management for Drugs, Biologics, and Medical Devices across all phases.
• Regulatory Strategy and Submissions – Comprehensive global submissions, licensing, and post-market support.
• Biostatistics and Data Management – Integrated data handling with validated systems and analytics frameworks.
• Functional Service Provider (FSP) Delivery – Scalable and optimized workforce management enabled through HeliX, ensuring predictable performance and cost control.
• Technology-Enhanced Delivery – Unified digital ecosystem using globally compliant EDC platforms for real-time data management, quality assurance, and analytical oversight.

The alliance will be guided by a Joint Strategic Board responsible for governance, innovation strategy, and operational harmonization across global regions. The Board will ensure continued alignment with international compliance standards and the highest levels of ethical and scientific integrity.

By uniting technology leadership, regulatory experience, and execution excellence, eteraflex connects and CliniExperts are creating a single global operations that delivers consistent, compliant, and accelerated outcomes for clients seeking to bring new therapies, devices, and innovations to market.

About eteraflex connects LLC
eteraflex connects is a U.S.-based life sciences consulting providing integrated program management, biostatistics, CSA and regulatory services to biotechnology and medical device innovators. With over 18 years of operational heritage and technology-driven capabilities, eteraflex connects operates from Princeton, NJ (HQ), Canton, MA, and Global Capability Centers in Hyderabad and Chennai, India.

About CliniExperts
CliniExperts Group of companies is a leading regulatory and clinical research organization established in 2009, providing end-to-end services across Drugs, Biologics, Medical Devices, and Consumer Health. With ISO 9001 and ISO 27001 certifications and a track record of over 65 successful studies, and more than 10,000 product approvals across various regions from different regulatory bodies , CliniExperts operates from Delhi , Bengaluru in India and delivering regulatory and clinical solutions with global compliance excellence.

Media Contact
Communications Office
eteraflex connects LLC
Email: media@eteraflexconnects.com
Phone: +1 (609) 506-1555
Website: www.eteraflexconnects.com

eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery




eteraflex connects and CliniExperts Announce Global Alliance to Redefine Clinical Research and Regulatory Services Delivery

Princeton, NJ, Oct. 23, 2025 (GLOBE NEWSWIRE) — eteraflex connects and CliniExperts have announced a strategic partnership that unites their complementary expertise in clinical research, regulatory strategy, and technology integration under a single, scalable service platform.

eteraflex connects & cliniexperts group

The alliance combines eteraflex connects leadership in scientific program management, data analytics, and client engagement with CliniExperts’ being one of the premier regulatory service provider, clinical trial management excellence, and medical affairs capabilities. Together, they will deliver comprehensive end-to-end solutions for pharmaceutical, biotechnology, and medical device innovators — from regulatory strategy, Clinical Development support, through regulatory submission and post-approval support.

Operating from offices in Princeton, NJ (Headquarters) and Canton, MA, with Global Capability Centers in Hyderabad, Chennai, New Delhi, and Bengaluru, the unified organization now employs over 300 plus professionals and consultants. This expanded infrastructure provides clients with a globally synchronized framework that ensures scientific rigor, regulatory precision, and operational efficiency across markets.

This partnership represents a defining evolution for both organizations and the life sciences ecosystem we serve,” said Santhosh RK, Managing Partner, eteraflex connects. “By integrating CliniExperts’ regulatory and clinical operations excellence with our technology-driven service model, we are building a platform that delivers measurable acceleration, compliance confidence, and data integrity for every client program.”

Dr. Ashwini Kumar, CEO, CliniExperts Group, added, “Our combined strengths enable our clients to access complete clinical development and regulatory pathways through one unified partner. Supported by our unmatched Clinical Operation Skills, Globally compliant EDC platform and analytics, we deliver transparent, efficient, and outcome-focused solutions from first patient to final submission and from IND to securing Marketing Authorization.”

The strategic partnership brings together proven capabilities across:

• Clinical Operations – Full-service trial management for Drugs, Biologics, and Medical Devices across all phases.
• Regulatory Strategy and Submissions – Comprehensive global submissions, licensing, and post-market support.
• Biostatistics and Data Management – Integrated data handling with validated systems and analytics frameworks.
• Functional Service Provider (FSP) Delivery – Scalable and optimized workforce management enabled through HeliX, ensuring predictable performance and cost control.
• Technology-Enhanced Delivery – Unified digital ecosystem using globally compliant EDC platforms for real-time data management, quality assurance, and analytical oversight.

The alliance will be guided by a Joint Strategic Board responsible for governance, innovation strategy, and operational harmonization across global regions. The Board will ensure continued alignment with international compliance standards and the highest levels of ethical and scientific integrity.

By uniting technology leadership, regulatory experience, and execution excellence, eteraflex connects and CliniExperts are creating a single global operations that delivers consistent, compliant, and accelerated outcomes for clients seeking to bring new therapies, devices, and innovations to market.

About eteraflex connects LLC
eteraflex connects is a U.S.-based life sciences consulting providing integrated program management, biostatistics, CSA and regulatory services to biotechnology and medical device innovators. With over 18 years of operational heritage and technology-driven capabilities, eteraflex connects operates from Princeton, NJ (HQ), Canton, MA, and Global Capability Centers in Hyderabad and Chennai, India.

About CliniExperts
CliniExperts Group of companies is a leading regulatory and clinical research organization established in 2009, providing end-to-end services across Drugs, Biologics, Medical Devices, and Consumer Health. With ISO 9001 and ISO 27001 certifications and a track record of over 65 successful studies, and more than 10,000 product approvals across various regions from different regulatory bodies , CliniExperts operates from Delhi , Bengaluru in India and delivering regulatory and clinical solutions with global compliance excellence.

Media Contact
Communications Office
eteraflex connects LLC
Email: media@eteraflexconnects.com
Phone: +1 (609) 506-1555
Website: www.eteraflexconnects.com

With Med4Cure, EUROAPI accelerates pharmaceutical innovation at the service of health sovereignty




With Med4Cure, EUROAPI accelerates pharmaceutical innovation at the service of health sovereignty

The project launch event, held at the Vertolaye site, brought together State officials, elected representatives, and several project partners to accelerate pharmaceutical innovation in Europe

Paris – October 23, 2025 – EUROAPI officially launched its innovation programs today as part of the Health IPCEI (Important Project of Common European Interest), a European initiative aimed at strengthening pharmaceutical sovereignty. This project, called “Med4Cure,” is supported by the European Commission. The inaugural event took place at the EUROAPI Vertolaye (Puy-de-Dôme) site in the presence of State representatives, local elected officials, and public and private partners involved in the project.

The project led by EUROAPI initially involves start-ups such as Abolis (expert in biotechnology), Alysophil (specialized in AI) and Crysttal (expert in cryo-micronization), the leader in process systems and solutions for the pharmaceutical industry De Dietrich and several academic institutions: the i-CLeHS laboratory of Chimie ParisTech – PSL University, the CARMeN Institute of INSA Rouen, the CEISAM laboratory of Nantes Université and Toulouse INP. EUROAPI has identified around 40 potential partners and will finalize its consortium as developments progress.

“EUROAPI is proud to bring together a unique collaborative ecosystem of start-ups, med-sized companies, and renowned academic teams to develop the pharmaceutical solutions of tomorrow,” said David Seignolle, Chief Executive Officer of EUROAPI. “Thanks to IPCEI and its open innovation framework, we will boost our R&D capacity by launching three pioneering programs that will strengthen the sustainable production of active ingredients in Europe, benefiting patients and local communities.”

“With France 2030, the State is proud to support the innovative projects carried out by EUROAPI and its partners and is fulfilling its ambition to secure the supply of essential medicines for our fellow citizens,” said Bruno Bonnell, General Secretary for Investment in charge of France 2030. “By developing competitive, sustainable and integrated production of active ingredients, Med4Cure is a major driver of health sovereignty for France and Europe.”

“I welcome this project, which shows the role of State services in supporting industrial innovation and boosting the vitality of the region by creating new partnership opportunities,” said Joël Mathurin, prefect of Puy-de-Dôme. “Together, we have also strengthened the environmental management of the Vertolaye site, notably through improved planning of technological risks and a more sustainable use of water resources.”

In June 2024, EUROAPI was selected by the European Commission as one of the 13 companies eligible to share up to 1 billion euros in total public funding under the Health IPCEI. In France, a contractual agreement was signed in July 2025 between the State and EUROAPI providing up to 140 million euros in public aid under the France 2030 investment plan to support the company’s three innovation programs.

Three areas of innovation to strengthen pharmaceutical sovereignty
Med4Cure provides co-financing for EUROAPI R&D activities, from research to industrial feasibility studies, focusing on three strategic priorities:

• Corticosteroids (Vertolaye site): development of cutting-edge processes and technologies to enhance the production of molecules used in the treatment of allergic and immune diseases. The global market for EUROAPI was estimated at 657 million euros in 2024¹. 
• Nanocrystals (Vertolaye site): improving the bioavailability of molecules and opening up new therapeutic applications to support innovation in existing and future drugs.
• Macrolide antibiotics (Saint-Aubin-lès-Elbeuf site): project to relocate the production of a key intermediate in the manufacture of macrolides.

About EUROAPI
EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.

Taking action for health by enabling access to essential therapies inspires our 3,270 employees every day. With strong research and development capabilities and five manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris (ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn.

About the France 2030 investment plan
France 2030 is unprecedented in its scale: €54 billion is being invested so that our businesses, our schools, our universities and our research organizations fully succeed with their transitions in these strategic sectors. The challenge is to enable them to respond in a competitive way to the world’s future ecological and attractiveness challenges, and to showcase the future champions of our sectors of excellence. France 2030 is defined by two overarching objectives, which will see 50% of expenses given over to the decarbonization of the economy, and 50% to emerging key players, those at the forefront of innovation, without neglecting the environment (in the sense of the “Do No Significant Harm” principle).

France 2030 is being implemented collectively: designed and deployed in consultation with economic, academic, local and European key players to establish strategic guidelines and decisive action. Project holders are invited to submit their entries via the current application process, which is a demanding and selective one, to benefit from state support.

France 2030 is being led by the French General Secretariat for Investment, in charge of France 2030, on behalf of the Prime Minister, and in partnership with the relevant government ministries.

France 2030 is being implemented by the French National Research Agency (ANR), the French Agency for Ecological Transition (ADEME), Bpifrance and the Caisse des Dépôts et consignation (CDC).

More information : france2030.gouv.fr | @SGPI_avenir

Forward-Looking Statements
Certain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the Group’s current and future strategy, financial and non-financial future results and the environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 “Risk factors” of the Universal Registration Document filed with the French Financial Markets Authority (Autorité des marchés financiers, AMF) on April 1, 2025. These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based.

1 Source: company estimate based on IQVIA data.

Attachment

• EUROAPI – Press release – October 23, 2025

With Med4Cure, EUROAPI accelerates pharmaceutical innovation at the service of health sovereignty




With Med4Cure, EUROAPI accelerates pharmaceutical innovation at the service of health sovereignty

The project launch event, held at the Vertolaye site, brought together State officials, elected representatives, and several project partners to accelerate pharmaceutical innovation in Europe

Paris – October 23, 2025 – EUROAPI officially launched its innovation programs today as part of the Health IPCEI (Important Project of Common European Interest), a European initiative aimed at strengthening pharmaceutical sovereignty. This project, called “Med4Cure,” is supported by the European Commission. The inaugural event took place at the EUROAPI Vertolaye (Puy-de-Dôme) site in the presence of State representatives, local elected officials, and public and private partners involved in the project.

The project led by EUROAPI initially involves start-ups such as Abolis (expert in biotechnology), Alysophil (specialized in AI) and Crysttal (expert in cryo-micronization), the leader in process systems and solutions for the pharmaceutical industry De Dietrich and several academic institutions: the i-CLeHS laboratory of Chimie ParisTech – PSL University, the CARMeN Institute of INSA Rouen, the CEISAM laboratory of Nantes Université and Toulouse INP. EUROAPI has identified around 40 potential partners and will finalize its consortium as developments progress.

“EUROAPI is proud to bring together a unique collaborative ecosystem of start-ups, med-sized companies, and renowned academic teams to develop the pharmaceutical solutions of tomorrow,” said David Seignolle, Chief Executive Officer of EUROAPI. “Thanks to IPCEI and its open innovation framework, we will boost our R&D capacity by launching three pioneering programs that will strengthen the sustainable production of active ingredients in Europe, benefiting patients and local communities.”

“With France 2030, the State is proud to support the innovative projects carried out by EUROAPI and its partners and is fulfilling its ambition to secure the supply of essential medicines for our fellow citizens,” said Bruno Bonnell, General Secretary for Investment in charge of France 2030. “By developing competitive, sustainable and integrated production of active ingredients, Med4Cure is a major driver of health sovereignty for France and Europe.”

“I welcome this project, which shows the role of State services in supporting industrial innovation and boosting the vitality of the region by creating new partnership opportunities,” said Joël Mathurin, prefect of Puy-de-Dôme. “Together, we have also strengthened the environmental management of the Vertolaye site, notably through improved planning of technological risks and a more sustainable use of water resources.”

In June 2024, EUROAPI was selected by the European Commission as one of the 13 companies eligible to share up to 1 billion euros in total public funding under the Health IPCEI. In France, a contractual agreement was signed in July 2025 between the State and EUROAPI providing up to 140 million euros in public aid under the France 2030 investment plan to support the company’s three innovation programs.

Three areas of innovation to strengthen pharmaceutical sovereignty
Med4Cure provides co-financing for EUROAPI R&D activities, from research to industrial feasibility studies, focusing on three strategic priorities:

• Corticosteroids (Vertolaye site): development of cutting-edge processes and technologies to enhance the production of molecules used in the treatment of allergic and immune diseases. The global market for EUROAPI was estimated at 657 million euros in 2024¹. 
• Nanocrystals (Vertolaye site): improving the bioavailability of molecules and opening up new therapeutic applications to support innovation in existing and future drugs.
• Macrolide antibiotics (Saint-Aubin-lès-Elbeuf site): project to relocate the production of a key intermediate in the manufacture of macrolides.

About EUROAPI
EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.

Taking action for health by enabling access to essential therapies inspires our 3,270 employees every day. With strong research and development capabilities and five manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries. EUROAPI is listed on Euronext Paris (ISIN: FR0014008VX5; ticker: EAPI). Find out more at www.euroapi.com and follow us on LinkedIn.

About the France 2030 investment plan
France 2030 is unprecedented in its scale: €54 billion is being invested so that our businesses, our schools, our universities and our research organizations fully succeed with their transitions in these strategic sectors. The challenge is to enable them to respond in a competitive way to the world’s future ecological and attractiveness challenges, and to showcase the future champions of our sectors of excellence. France 2030 is defined by two overarching objectives, which will see 50% of expenses given over to the decarbonization of the economy, and 50% to emerging key players, those at the forefront of innovation, without neglecting the environment (in the sense of the “Do No Significant Harm” principle).

France 2030 is being implemented collectively: designed and deployed in consultation with economic, academic, local and European key players to establish strategic guidelines and decisive action. Project holders are invited to submit their entries via the current application process, which is a demanding and selective one, to benefit from state support.

France 2030 is being led by the French General Secretariat for Investment, in charge of France 2030, on behalf of the Prime Minister, and in partnership with the relevant government ministries.

France 2030 is being implemented by the French National Research Agency (ANR), the French Agency for Ecological Transition (ADEME), Bpifrance and the Caisse des Dépôts et consignation (CDC).

More information : france2030.gouv.fr | @SGPI_avenir

Forward-Looking Statements
Certain information contained in this press release is forward looking and not historical data. These forward-looking statements are based on opinions, projections and current assumptions including, but not limited to, assumptions concerning the Group’s current and future strategy, financial and non-financial future results and the environment in which the Group operates, as well as events, operations, future services or product development and potential. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Forward looking statements and information do not constitute guarantees of future performances, and are subject to known or unknown risks, uncertainties and other factors, a large number of which are difficult to predict and generally outside the control of the Group, which could cause actual results, performances or achievements, or the results of the sector or other events, to differ materially from those described or suggested by these forward-looking statements. These risks and uncertainties include those that are indicated and detailed in Chapter 3 “Risk factors” of the Universal Registration Document filed with the French Financial Markets Authority (Autorité des marchés financiers, AMF) on April 1, 2025. These forward-looking statements are given only as of the date of this press release and the Group expressly declines any obligation or commitment to publish updates or corrections of the forward-looking statements included in this press release in order to reflect any change affecting the forecasts or events, conditions or circumstances on which these forward-looking statements are based.

1 Source: company estimate based on IQVIA data.

Attachment

• EUROAPI – Press release – October 23, 2025

Guerbet : Revenue at September 30, 2025. Return to growth in Q3 2025. Confirmation of all financial targets for 2025.




Guerbet : Revenue at September 30, 2025. Return to growth in Q3 2025. Confirmation of all financial targets for 2025.

Revenue at September 30, 2025

Return to growth in Q3 2025

• 9-month revenue: €586.5 million, down 2.8% at CER¹ and on a like-for-like basis², largely due to the fall in activity in France
• An increase in Q3 of 2.6% at CER and on a like-for-like basis, underpinned by the acceleration of Elucirem^TM sales and good momentum on Lipiodol^®

Confirmation of all financial targets for 2025

Villepinte, October 23, 2025, 5.45 p.m.: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for the first nine months of 2025.

At September 30, 2025, Group sales totaled €586.5 million, representing a decrease of 5.5%. At constant exchange rates (CER)¹, sales fell by 3.1%, incorporating a negative foreign exchange effect of €14.6 million, mainly due to the depreciation of the currencies of Latin America and Asia. At CER and on a like-for-like basis², sales decreased by 2.8%.

This reflects a steady sequential improvement throughout the year: after falling by 7.1% in the first quarter and 3.9% in the second quarter, Guerbet saw a resumption of growth in the third quarter to +2.6% at CER and on a like-for-like basis. This acceleration, which is in line with the Group’s forecast, is expected to continue in the fourth quarter of 2025.

*Divested businesses: Accurate and urology

In the EMEA region, revenue came to €255.8 million at September 30, 2025, down 2.3% at CER and on a like-for-like basis. These first nine months were negatively affected by sales in France and difficulty in winning back the market share lost during the switch from single dose to larger vials, following the supply chain reform. In the third quarter alone, revenue rose by 10.2% at CER and on a like-for-like basis (+25.7% excluding France), benefiting from the performance of indirect sales (distributors).

In the Americas, revenue came to €176.5 million at September 30, 2025, down 2.2% at CER and on a like-for-like basis; the solid increase in volumes only partially offset the pressure on prices linked to the increased weight of distributors in the customer mix. In the third quarter of 2025, the fall in revenue (-5.7% at CER and on a like-for-like basis) can be explained in particular by a weaker performance in Latin America following the technical incident at our Raleigh plant.

In Asia, revenue totaled €152.4 million at September 30, 2025, down 4.3% at CER and on a like-for-like basis, linked to the loss of a customer by our distributor in Vietnam and the discontinuation of deliveries to one of our distributors in South Korea. In the third quarter alone, the trend was positive (+1.5%), driven by strong sales in Japan.

*Divested businesses: Accurate and urology

In Diagnostic Imaging, revenue totaled €508.0 million at September 30, 2025, down 4.0% at CER and on a like-for-like basis, with a return to growth in the third quarter alone (+1.7%).

• 9-month sales of the IRM division were up 2.0% at CER and on a like-for-like basis, incorporating an increase of 9.6% in the third quarter, driven by an acceleration in the ramp-up of Elucirem^TM in both the United States and Europe.
• 9-month sales of the X-ray division were down 7.3% at CER and on a like-for-like basis (-2.4% in the third quarter), linked to the fall in volumes for Xenetix^® and Optiray^®, mainly due to activity in France.

In Interventional Imaging, sales reached €76.7 million in the first nine months of the year, representing an increase at CER and on a like-for-like basis of 6.0%, of which +8.8% in the third quarter alone. This performance was fueled by the solid trajectory of Lipiodol® (volumes and prices), particularly in vascular embolization.

Confirmation of financial targets for 2025

At the end of this third quarter marked by a return to growth, Guerbet is confident it will see an acceleration in the fourth quarter of 2025. This will be supported by the continued ramp-up of Elucirem^TM, expectations of a further acceleration for Lipiodol^® (vascular embolization, Go Direct in China), and positive momentum in indirect sales in several countries in Latin America, Europe and Asia.

In this context, Guerbet confirms all of the financial targets announced on September 15th. For 2025, the Group anticipates a slight decline in revenue at CER and on a like-for-like basis of around -1%, together with a restated EBITDA margin³ of between 12-13%. Free cash flow, meanwhile, is still expected to be slightly negative for the year.

Next event:

2025 full-year sales
February 5, 2026, after market close

About Guerbet

At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for 98 years, with more than 2,905 employees worldwide, we continuously innovate and devote 9% of our revenue to Research and Development in four centers in France and the United States. Guerbet (GBT) is listed in compartment B of Euronext Paris and generated revenue of €841m in 2024. For more information, please visit www.guerbet.com.

Forward-looking statements

Certain information contained in this press release is not historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts and assumptions including, without limitation, assumptions regarding the Group’s current and future strategy and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties and other factors, which may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly in these forward-looking statements.

These forward-looking statements are only valid as of the date of this press release and the Group expressly disclaims any obligation or commitment to issue an update or revision of the forward-looking statements contained in this press release to reflect changes in the assumptions, events, conditions or circumstances on which such forward-looking statements are based. Forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and generally beyond the control of the Group.

These risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, future clinical data and analyses, including post-marketing analyses, decisions by regulatory authorities, such as the Food and Drug Administration or the European Medicines Agency, whether or not to approve, and when, the application for a drug, process or biological product for one of these candidate products, as well as their labeling decisions and other factors that may affect the availability or commercial potential of these candidate products. A detailed description of the risks and uncertainties related to the Group’s activities can be found in chapter 4.8 “Risk factors” of the Group’s Universal Registration Document registered by the AMF under number D.25-0220 on April 3, 2025, available on the Group’s website (www.guerbet.com).

1 At constant exchange rates: the impact of exchange rates was eliminated by recalculating sales for the period based on the exchange rates used for the previous financial year.
2 Excluding the urology and Accurate businesses, which were sold in July 2024 and January 2025 respectively.
3 Excluding non-recurring costs related to the optimization of the operational framework and changes to the sales model.

Contacts:

Guerbet    
Christine Allard, SVP Public Affairs and Corporate Communications +33 6 30 11 57 82 / christine.allard@guerbet.com

Seitosei.Actifin                                                                               
Marianne Py, Financial Communication + 33 6 85 52 76 93 / marianne.py@seitosei-actifin.com
Anne-Claire Taton, Press +33 6 02 12 25 18 / anne-claire.taton@seitosei-actifin.com

Attachment

• 2025 1023 CP GBT CA T3 VDef EN 02

Solana Company (NASDAQ: HSDT) Strengthens Treasury Strategy with Helius, Anchorage Digital and Twinstake Staking Services




Solana Company (NASDAQ: HSDT) Strengthens Treasury Strategy with Helius, Anchorage Digital and Twinstake Staking Services

NEWTOWN, Pa., Oct. 23, 2025 (GLOBE NEWSWIRE) — Solana Company (NASDAQ: HSDT or the “Company”) announced that it has entered into agreements with Helius and Twinstake (each, a “Provider,” and collectively, the “Providers”), related to non-custodial staking services. The Company is also staking its SOL holdings directly from qualified custody at Anchorage Digital Bank.

The Providers have developed non-custodial staking and restaking solutions that allow users to delegate, stake, and/or restake their digital assets to earn rewards. Pursuant to the agreements, the Providers will make their platforms available to the Company and provide the Company with certain services, which include staking, voting with staked tokens, and reporting with regard to the staked tokens.

“This marks an important next step in executing our digital asset treasury strategy,” said Joseph Chee, Executive Chairman of HSDT and Chairman of Summer Capital. “By staking with industry leaders like Helius and Twinstake, we are strengthening the operational backbone of our SOL holdings while contributing to the resilience and decentralization of the Solana ecosystem. Both providers rank among the top 25 validators on the Solana network by total SOL staked, signaling their established track record and strong confidence within the community.”

Cosmo Jiang, General Partner at Pantera Capital and Board Observer at HSDT, added: “These partnerships position HSDT to maximize on-chain yield in a secure, compliant and scalable manner. Partnering with top-tier validators trusted by the broader Solana community reinforces our focus on institutional-grade execution and network alignment. As Solana continues to lead in performance and adoption, we see staking as both a core part of our return generation strategy and a reinforcement of our commitment to the network’s long-term growth.”

Helius, the leading Solana validator with over 13 million SOL staked, offers institutional-grade staking services and operates SOC 2 Type II-compliant infrastructure, ensuring optimal uptime, performance and security. Twinstake and Anchorage Digital bring complementary strengths in regulated and enterprise-level staking, expanding the Company’s exposure to the broader Solana validator ecosystem.

“Crypto is connecting the internet of value,” said Mert Mumtaz, Co-founder and CEO of Helius. “Solana today is the only blockchain network with the scale to onboard all of the world’s capital markets, microtransactions, and AI payments. Together with the Solana Company, we’re accelerating institutional adoption of Solana, and building the future of the world’s trading terminal.”

Solana has historically been the fastest-growing blockchain, leading the industry in transaction revenue, and processing more than 3,500 transactions per second. The network is also the most widely adopted, with an average of around 3.7 million daily active wallets and surpassing 23 billion transactions year-to-date. SOL is financially productive by design, offering a ~7% native staking yield, whereas assets like BTC are non-yield-bearing.

As an independent treasury company, HSDT’s mission is to support the growth and security of tokenized networks by serving as a long-term holder of $SOL, in addition to continuing the development of its neurotech and medical device operations.

Forward Looking Statements

This press release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended. This press release also includes express and implied forward-looking statements regarding the Company’s current expectations, estimates, opinions and beliefs that are not historical facts. Such forward-looking statements may be identified by words such as “believes,” “expects,” “endeavors,” “anticipates,” “intends,” “plans,” “estimates,” “projects,” “should” and “objective” and the negative and variations of such words and similar words. These statements are made on the basis of current knowledge and, by their nature, involve numerous assumptions and uncertainties. Nothing set forth herein should be regarded as a representation, warranty or prediction that we will achieve or are likely to achieve any particular future result. Actual results may differ materially from those indicated in the forward-looking statements because the realization of those results is subject to many risks and uncertainties, including the risk that we may fail to realize the anticipated benefits of the private placement, including the ability of the Company to execute on its digital asset treasury strategy, as well as risks related to economic conditions, fluctuations in the market price of SOL, and the evolving regulatory environment, as well as other factors. Forward-looking statements contained in this press release are made as of the date of this press release, and the Company undertakes no duty to update such information except as required under applicable law.

About Solana Company

Solana Company (NASDAQ: HSDT) is a listed digital asset treasury dedicated to acquiring Solana (SOL), created in partnership with Pantera and Summer Capital. Focused on maximizing SOL per share by leveraging capital markets opportunities and onchain activity, Solana Company offers public market investors optimal exposure to Solana’s secular growth. https://www.solanacompany.co/

For additional information, follow us on:

https://x.com/Solana_Company
https://www.linkedin.com/company/helius-solana-company/