Exelixis Announces Zanzalintinib in Combination with an Immune Checkpoint Inhibitor Improved Overall Survival in STELLAR-303 Phase 3 Pivotal Trial in Patients with Metastatic Colorectal Cancer




Exelixis Announces Zanzalintinib in Combination with an Immune Checkpoint Inhibitor Improved Overall Survival in STELLAR-303 Phase 3 Pivotal Trial in Patients with Metastatic Colorectal Cancer

– Zanzalintinib in combination with atezolizumab demonstrated a statistically significant reduction in risk of death versus regorafenib in intent-to-treat population –

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced positive topline results from the STELLAR-303 phase 3 pivotal trial in which zanzalintinib in combination with atezolizumab (Tecentriq^®) demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intent-to-treat (ITT) population of patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (CRC). These topline findings are from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial. The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases, NLM).

The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified.

The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment.

“The STELLAR-303 results, which showed a survival benefit with the combination of zanzalintinib and atezolizumab versus regorafenib across all randomized patients with previously treated metastatic colorectal cancer, marks an important first milestone for our zanzalintinib pivotal development program,” said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “We look forward to discussing the findings with regulatory authorities and presenting the detailed results at an upcoming medical conference.”

Secondary endpoints of STELLAR-303 include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. Exelixis plans to submit detailed results of STELLAR-303 for presentation at an upcoming medical conference.

About STELLAR-303

STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized 901 patients 1:1 to either zanzalintinib (100 mg) in combination with atezolizumab or regorafenib. The study includes patients with previously treated non-MSI-high metastatic CRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. Presence of liver metastases at baseline for all enrolled patients was determined by investigator assessment. Secondary endpoints include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov.

About Zanzalintinib

Zanzalintinib is a third-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis and resistance to multiple therapies, including immune checkpoint inhibitors. With zanzalintinib, Exelixis sought to build upon its extensive experience with the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. Zanzalintinib is currently being developed for the treatment of advanced solid tumors, including colorectal cancer, kidney cancer, head and neck cancer and neuroendocrine tumors.

Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.

About CRC

CRC is the third most common cancer and the second leading cause of cancer-related deaths in the U.S.¹ Approximately 154,000 new cases will be diagnosed in the U.S. with around 53,000 expected deaths from the disease in 2025.¹ CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.² Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is just 16.2%.² The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.³

About Exelixis

Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX^® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit www.exelixis.com, follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the therapeutic potential of the combination of zanzalintinib in combination with atezolizumab to improve overall survival in patients with metastatic CRC; Exelixis’ plans to discuss the trial data from STELLAR-303 with regulatory authorities and to present detailed findings at an upcoming medical conference; and Exelixis’ scientific pursuit to create transformational treatments that give more patients hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the availability of data at the referenced times; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating zanzalintinib; Exelixis’ dependence on third-party vendors for the development, manufacture and supply of zanzalintinib; Exelixis’ ability to protect its intellectual property rights; market competition; changes in economic and business conditions; and other factors affecting Exelixis and its development programs detailed from time to time under the caption “Risk Factors” in Exelixis’ most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis’ future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo and CABOMETYX are registered U.S. trademarks of Exelixis.

TECENTRIQ is a registered U.S. trademark of Genentech, a member of the Roche Group.

___________________________

¹ Key Statistics for Colorectal Cancer. ACS website. Available at: https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html. Accessed June 2025.

² Cancer Stat Facts: Colorectal Cancer. SEER website. Available at: https://seer.cancer.gov/statfacts/html/colorect.html. Accessed June 2025.

³ Ros J, Salva F, Dopazo C, et al. Liver transplantation in metastatic colorectal cancer: are we ready for it? Br J Cancer. May 2023;128(10):1797-1806.

Contacts

Investors Contact:
Susan Hubbard
EVP, Public Affairs and

Investor Relations
Exelixis, Inc.
650-837-8194
shubbard@exelixis.com

Media Contact:
Stekki Millman
Senior Director, Public Affairs
Exelixis, Inc.
650-837-7187
smillman@exelixis.com

Prime Success Issues Statement on New York State Court Decision Confirming Our Rights as Sinovac Shareholders – Including Right to Vote at Upcoming Special Meeting




Prime Success Issues Statement on New York State Court Decision Confirming Our Rights as Sinovac Shareholders – Including Right to Vote at Upcoming Special Meeting

Corrects the Record Following Latest Attempt By the 1Globe Activist Board to Distort Reality in Transparent Attempt to Mislead Shareholders

Notes That on Friday Antiguan Judge Denied the 1Globe Activist Board’s Attempt to Immediately Prevent Prime Success From Voting Sinovac Shares – Which the Board Failed to Disclose to Shareholders

HONG KONG–(BUSINESS WIRE)–Prime Success L.P., (together with its affiliates, “Prime Success” or “we”), a significant shareholder of Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”) with ownership of approximately 8% of the Company’s outstanding shares, today issued a statement in response to the decision by the United States District Court for the Southern District of New York on Friday, June 20, 2025.

Prime Success stated:

“The New York court ruling confirms what we have consistently stated: Prime Success has been a major owner of registered, valid shares of Sinovac for seven years and it has undisputed rights as such – including the right to vote with other shareholders to boot 1Globe and OrbiMed out of power. We requested an injunction in self-defense in response to the litigation initiated by the 1Globe Activist Board to prevent us from voting our shares. The 1Globe Activist Board also threatened to resort to self-help measures to keep us from voting. The court’s decision was based on the premises that the 1Globe Activist Board currently has no basis to deny our rights as shareholders and that the dispute is currently in arbitration in Hong Kong, and unless those change no injunctive relief is required. The court expects the 1Globe Activist Board to act lawfully and not deprive us of our shareholder rights, and for the Antiguan court to uphold the obligation to send appropriate matters to arbitration, as required by treaty obligations. Importantly, this is why the ruling was without prejudice – we have the right to go back to the New York court if at any point the 1Globe Activist Board refuses to recognize our clear legal status as voting shareholders.

Also on Friday in a separate hearing in Antigua, the court rejected the 1Globe Activist Board’s attempt to invalidate the shares Prime Success and Vivo legally acquired from their PIPE investment – an $86 million equity investment made to support SINOVAC when it was in dire need of capital. There will now be a subsequent hearing at the end of June to decide the appropriate next step on this case – which we continue to believe is mandatory arbitration in the Hong Kong International Arbitration Centre (“HKIAC”) under Hong Kong law. Tellingly, the 1Globe Activist Board declined to disclose this development to shareholders in its June 21 press release – likely because it was not favorable to them.

Shareholders should realize at this stage that the alarming public statements issued by the 1Globe Activist Board are self-serving distortions of reality. Their characterizations are inaccurate, and especially their claim that Prime Success tried “to interfere with the payment of the US$55.00 per common share special cash dividend declared by the current SINOVAC Board.” Prime Success has been demanding the distribution of dividends and never tried to block it.

Importantly, Prime Success reminds shareholders of the following:

• We support the fair distribution of dividends as soon as possible to all SINOVAC shareholders – the delay in dividend payments resulted from actions taken by the 1Globe Activist Board. The fact is that the SAIF slate’s highly qualified nominees are better-suited to continue paying dividends and achieve a resumption of trading as soon as possible.
• Without Prime Success and Vivo’s PIPE investment, Sinovac’s core success would not have been possible. Our investment was a critical turning point for Sinovac, allowing for the distribution of all COVID vaccine doses, providing crucial medical treatment and putting Sinovac on a path to significant long-term growth, and came at a time when other funding options were not available to the Company.
• The 1Globe Activist Board cannot be trusted to act in the best interests of Sinovac or its shareholders. Shareholders deserve a refreshed, forward-looking Board committed to sound governance, ending wasteful litigation, recruiting a new auditor, and getting Sinovac’s NASDAQ trading halt lifted. To date, the 1Globe Activist Board has not communicated any concrete intention or documented any steps taken to resume share trading on NASDAQ as soon as possible.

Prime Success is directly aligned with shareholders and believes that the slate of directors proposed by SAIF Partners IV L.P., (“SAIF Partners”) is essential for a renewed focus on durable value creation that will pave the way for Sinovac to move forward – ending the toxic pattern of infighting and litigation instigated by the 1Globe Activist Board.

Your vote at the Special Meeting can make this important change happen.

We urge all shareholders vote the GOLD proxy card in support of the SAIF nominees and choose the leadership that will best secure our Company’s success in the years to come.”

About Prime Success, L.P.

Prime Success is an investment vehicle established by Advantech Capital specifically to invest in Sinovac and Sinovac Life Sciences; Advantech Capital is a private equity fund established in 2016 with a focus on innovation-driven growth opportunities in China.

Contacts

Media Contact
Longacre Square Partners

advantech@longacresquare.com

GE HealthCare drives innovation in theranostics with latest technological advances




GE HealthCare drives innovation in theranostics with latest technological advances

• GE HealthCare is helping advance clinical and operational excellence in theranostics and molecular imaging through a comprehensive portfolio of AI-powered imaging technologies, radiopharmaceuticals, cyclotrons, chemistry systems, and workflow-optimizing software—designed to support personalized, data-driven care across the entire patient journey.
• At #SNMMI25, the company is proud to introduce LesionID™ Pro with automated zero-click pre-processing,ⁱ which aims to help physicians minimize manual segmentation required to access patient-specific insights that can play a key role in delivering precision care with confidence.

CHICAGO–(BUSINESS WIRE)–At this year’s Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, GE HealthCare is spotlighting the future of precision care with its innovative portfolio of theranostics-enabling solutions designed to help drive clinical and operational excellence. Making its debut, GE HealthCare’s MIM Software introduces LesionID Pro with automated zero-click pre-processingⁱ – an AI-powered innovation to help aid physician decision making and therapy response monitoring.

With cancer accounting for over 10 million deaths globally each year,ⁱⁱ the rise of precision care – particularly theranostics – is offering new hope to patients. By combining advanced diagnostic imaging and radiopharmaceuticals with targeted therapies, theranostics enables a personalized, patient-centric approach that may help improve disease detection, treatment accuracy, and overall quality of life.

“Precision care is the future of oncology—and theranostics is at the heart of that future. The integration of advanced imaging and AI-powered software is accelerating the adoption of theranostics in clinical practice,” shares Shyam Srinivas, MD, PhD, Chief of Nuclear Medicine, Associate Clinical Professor, Department of Radiological Sciences, University of California, Irvine. “With tools like GE HealthCare’s Omni Legend, StarGuide, and MIM software at our disposal, we now have the ability to visualize disease with great clarity, quantify tumor burden efficiently, and make fast, informed decisions. These advancements are not only helping enhance diagnostic accuracy and therapy monitoring but are also opening the door to dosimetry—ultimately helping improve outcomes for our patients. This is precision care in action, and it’s making a real difference in patients’ lives.”

Central to the practice of theranostics is molecular imaging, such as positron emission tomography (PET) and single photon emission computed tomography (SPECT), which provides detailed, patient-specific insights to guide and monitor treatment. However, accessing these insights – like whole-body tumor burden, which represents the total amount of cancer is in the body – has traditionally required time-consuming manual analysis, resulting in clinical and operational challenges.

In response, GE HealthCare’s MIM Software is introducing LesionID Pro with automated zero-click pre-processing,ⁱ designed with AI-powered automation to help physicians access reliable whole-body tumor burden statistics without having to spend hours manually segmenting lesions, removing normal physiologic uptake, and registering multiple patient images for comparison.

In addition to turning manual pre-processing into a zero-click experience, this new version of LesionID Pro comes with significant algorithm improvements that provide physicians with a precise whole-body tumor volume to review and finalize. Intuitive, user-friendly tools were intentionally designed with input from leading theranostics practitioners with the ultimate goal of making whole-body tumor burden analysis a practical clinical reality and help shorten physicians’ time-to-report.

“At GE HealthCare, we are dedicated to providing clinicians the precision care tools needed for the adoption and practice of theranostics,” shares Jean-Luc Procaccini, President & CEO, Molecular Imaging & Computed Tomography, GE HealthCare. “We designed our portfolio of precision care solutions to evolve with healthcare system needs and help support a patient’s entire care journey – from the imaging equipment needed for a noninvasive look at a patient’s anatomy and treatment monitoring, to novel radiopharmaceuticals used to diagnose and monitor disease and the systems required to produce them, to the software optimized to enable data-driven decision-making. In the hands of clinicians, these tools help advance the global practice of personalized medicine and help improve patient outcomes.”

Also on display at #SNMMI25, as part of GE HealthCare’s comprehensive portfolio of theranostics-enabling solutions for clinical and operational excellence, are the following innovations:

• MINItrace Magni,ⁱⁱⁱ GE HealthCare’s newest cyclotron technology, designed with a small footprint (about the size of a commercial refrigerator) and the goal of providing an easy-to-site, easy-to-install solution for the reliable, in-house production of commercial PET tracers and radiometals, including Gallium-68, used in diagnostic imaging to support personalized care plans. Adoption of such easy-to-site, easy-to-install technology may help enhance the capabilities of the healthcare system but also grant clinicians the ability to offer a variety of tracers to their patients and encourage the practice of precision care locally, helping fuel inhouse Theranostics capabilities.
• Omni Legend is a performance-focused PET/CT designed to evolve and help meet growing healthcare system demands by enabling clinicians to reduce dose by up to 40%^iv while maintaining exceptional image quality. Supportive of the diagnostic portion of theranostics, the system continues to gain in popularity, representing the company’s fastest-ever-selling PET/CT.^v
• StarGuide is a digital SPECT/CT with a 12 CZT detector design that delivers high-quality 3D images and short scan times. Optimized for certain theranostic procedures, the system is designed to help clinicians pinpoint the size, shape, and position of lesions and monitor therapy with exceptional precision. Its flexibility in patient scanning and workflow efficiencies also support high patient throughput and help reduce complexity. For oncology patients, especially those in pain, short scans can help enhance comfort and overall experience.
• Aurora is an advanced dual-head SPECT/CT designed with excellent diagnostic capabilities^vi and streamline workflows, offering clinicians excellent image quality and operational efficiency. Its CT has a 40 mm detector – twice the detector coverage compared to CTs of other hybrid systems^vii – with the ability to reduce the dose up to 82%,^viii support accurate quantitation, and help clinicians make the personalized care decisions that are at the heart of theranostics.
• Theranostics Pathway Manager Tile is an easy-to-use application, available on GE HealthCare’s Command Center software, that is designed to simplify the time-consuming task of coordinating the theranostics care pathway. It does so by tracking patient readiness for therapy, eliminating the need for manual data gathering across disparate systems (e.g., labs, scheduling, ordering, spreadsheets), and providing a unified, up-to-date view of each patient’s treatment journey. Oregon Health & Science University will be an early adopter.

“Every day counts when it comes to cancer care. The latest theranostics solutions will help our care teams more quickly and easily keep tabs on patient readiness and reduce patient coordination time—freeing up more time for clinicians to focus on direct patient care,” says Erik Mittra, M.D., Ph.D., professor of diagnostic radiology in the at Oregon Health & Science University.

Altogether, GE HealthCare has the unique ability to provide solutions along every step of the theranostics care pathway. Our integrated portfolio of solutions provides clinicians with the isotopes, imaging, informatics, and molecular imaging agents necessary for the practice and advancement of precision care.

For more information on GE HealthCare’s innovative portfolio of theranostics-enabling solutions, please visit gehealthcare.com. SNMMI show attendees are also encouraged stop by the company’s booth (#638 and #1023) at New Orleans Ernest N. Morial Convention Center in New Orleans, Louisiana from June 21-24.

About GE HealthCare Technologies Inc.

GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits.

GE HealthCare is proud to be among 2025 Fortune World’s Most Admired Companies™.

Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information.

ⁱ LesionID Pro with automated zero-click pre-processing is 510(k)-pending with the U.S. FDA. Not CE Marked and not licensed in accordance with Canadian law. Not available for sale in the United States, Europe, Canada, or any other region.

ⁱⁱ Cancer. World Health Organization. Published February 3, 2022. https://www.who.int./news-room/fact-sheets/detail/cancer. Accessed March 2, 2023.

ⁱⁱⁱ Technology in development that represents ongoing research and development efforts. These technologies are not products and may never become products. Not CE marked.

^iv Omni Legend 21cm as compared to Discovery MI Gen1 20cm. As demonstrated in phantom testing.

^v Based on orders data of GE HealthCare PET/CT systems since 2010.

^vi Compared to NM/CT 870 DR.

^vii As compared to NM/CT 870 DR with Optima 540 CT.

^{viii a} ASiR-V reduces dose by 50% to 82% relative to FBP at the same image quality (Image quality as defined by low contrast detectability).

^{viii b} In clinical practice, the use of ASiR‐V may reduce CT patient dose depending on the clinical task, patient size, anatomical location, and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task. Low Contrast Detectability (LCD), Image Noise, Spatial Resolution and Artifact were assessed using reference factory protocols comparing ASiR‐V and FBP. The LCD was measured using 0.625 mm slices and tested for both head and body modes using the MITA CT IQ Phantom (CCT183, The Phantom Laboratory), using a model observer method.

Contacts

GE HealthCare Media Contact:
Margaret Steinhafel

M +1 608 381 8829

margaret.steinhafel@gehealthcare.com

SINOVAC Board of Directors Prevails Against Advantech/Prime’s New York Lawsuit




SINOVAC Board of Directors Prevails Against Advantech/Prime’s New York Lawsuit

New York Court Denies Advantech/Prime’s Petition for Emergency Injunctive Relief

Clears Legal Hurdle for Dividend Paying Agent to Payout the Special Cash Dividend of US$55.00 Per Common Share on July 7, 2025

BEIJING–(BUSINESS WIRE)–SINOVAC Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced it has prevailed against Advantech/Prime Success’ (“Advantech/Prime”) Petition for Emergency Injunctive Relief in the U.S. District Court for the Southern District of New York.

The result in the New York court represents another failure in the campaign by Advantech/Prime in coordination with Vivo Capital (together known as the “Dissenting Investor Group”) to wrest control of SINOVAC from its recently installed, lawfully-elected Board of Directors (the “current SINOVAC Board”) in accordance with the Privy Council order and Antiguan Law, and to interfere with the payment of the US$55.00 per common share special cash dividend declared by the current SINOVAC Board.

Following the New York court’s ruling, the current SINOVAC Board is free to pursue its legal action in Antigua seeking to cancel the PIPE shares invalidly issued to the Dissenting Investor Group by the former illegitimate board (the “Imposter Former Board”). If the current SINOVAC Board succeeds in legal proceedings on the PIPE shares, it has announced its intention to redistribute an additional US$11.00 per common share to SINOVAC’s valid shareholders.

Dr. Chiang Li, Chairman of the SINOVAC Board, commented, “We will continue our mission to restore fairness and deliver value to all valid SINOVAC shareholders, starting with paying the $55.00 per share special cash dividend as soon as July 7, 2025.”

The Dissenting Investor Group’s self-serving, multi-pronged lawfare strategy against SINOVAC has one goal: to prevent all valid SINOVAC common shareholders from receiving any dividend payments unless the Dissenting Investor Group receives an allocation for their invalid PIPE shares, despite the fact that they have already received over US$1 billion in dividends from a SINOVAC operating subsidiary. The current SINOVAC Board has set aside in escrow the pro rata portion of dividends for the PIPE shares — funds the Dissenting Investor Group could receive if the legal proceedings they initiated rule in their favor. The current SINOVAC Board is fighting back – and winning. We feel certain that we will prevail against any further legal action by the Dissenting Investor Group and look forward to ensuring all valid shareholders receive their fair share.

Your Vote is Important

Your vote on or before July 8 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 urge you to keep SINOVAC’s Board in place and vote on the WHITE proxy card “AGAINST” Proposal 1 to remove the current Board and “AGAINST” Proposal 2 to appoint the Reconstituted Imposter Board Slate. Your vote is critical to ensuring that SINOVAC remains on the path to stability, growth, and value creation for all shareholders.

DISCARD any items you received asking you to vote for the Reconstituted Imposter Former Board Slate. If you have already voted for the Reconstituted Imposter Former Board Slate, you can subsequently revoke it by using the WHITE proxy card or WHITE voting instruction form to vote. Only your latest-dated vote will count!

If you have questions about how your vote can be counted, please contact our proxy solicitor, Georgeson LLC, toll free at (844) 568-1506 in the U.S. and (646) 543-1968 outside the U.S. or via email at SinovacSpecialMeeting@georgeson.com.

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 has filed with the U.S. Securities and Exchange Commission (“SEC”) and mailed to shareholders of record entitled to vote at the Special Meeting a definitive 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. 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 definitive proxy statement and other documents, free of charge, by contacting SINOVAC’s Investor Relations Department at ir@sinovac.com.

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. Such statements are based upon current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond the Company’s or Board’s control, which may cause 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 and Board do 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 Contact
FGS Global

Sinovac@fgsglobal.com

Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030: 18 Multispecific Antibodies Approved Globally with Strong Market Performance – ResearchAndMarkets.com




Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030: 18 Multispecific Antibodies Approved Globally with Strong Market Performance – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Global Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030” report has been added to ResearchAndMarkets.com’s offering.

Global Multispecific Antibodies Market, Drug Sales, Dosage, Price & Clinical Trials Insight 2030 Report Highlights:

• Global Multispecific Antibodies Market Opportunity By 2030: > USD 50 Billion
• Global Multispecific Antibodies Market Sales In 2024: > USD 12 Billion
• Number Of Approved Multispecific Antibodies: 18
• Global & Regional Trends Insight
• Approved Antibodies Global, Regional, Annual & Quarterly Sales Insight
• Approved Antibodies Dosage & Pricing Insight
• Comprehensive Insight On All Antibodies In Clinical Trials By Company, Country, Indication & Phase
• Number Of Multispecific Antibodies: In Clinical Trials: > 700

Multispecific antibodies market globally has been one of the most energetic and fast growing sectors in the biopharmaceutical business as a result of therapeutic breakthroughs and growing acceptance of their ability to treat complicated pathologies by targeting multiple pathways simultaneously. As of May 2025, 18 multispecific antibodies have gained regulatory approval globally, all of which are bispecific constructs, a monumental milestone in the history of targeted therapeutics.

This expanding portfolio boasts trailblazing drugs like Blincyto, the first bispecific antibody to gain approval, and Hemlibra, which was the first bispecific antibody to be approved for a non-cancer indication. The latest entrant to this therapeutic pipeline is Regeneron’s Lynozyfic, which received marketing approval in April 2025 for the treatment of multiple myeloma, with evidence of ongoing momentum in the segment.

The range of approved multispecific antibodies mirrors the flexibility of this therapeutic modality across various disease indications and patient bases. Rybrevant is another key breakthrough as the first bispecific antibody for a solid tumor, whereas China based Akeso’s Cadonilimab is especially noteworthy for being solely approved bispecific antibody intended to target two immune checkpoints at once and becoming the first China developed bispecific antibody to gain regulatory approval. This regional variation in development emphasizes the world nature of innovation in this sector, with input from both mature pharmaceutical markets and developing biotechnology centers.

The regulatory environment is still changing at a rapid pace, with further approvals expected in the near future. The FDA is also evaluating marketing applications for Odronextamab and Linvoseltamab, both of which have already received approval in the EU for follicular lymphoma and diffuse large B-cell lymphoma, and multiple myeloma, respectively. Such transatlantic regulatory advancements reflect the growing acceptability and trust in multispecific antibody technologies by global regulatory bodies.

Market performance has been extremely strong, with global multispecific antibodies market sales in 2024 amounting to over US$ 12.6 Billion, followed by first quarter 2025 sales of over US$ 3.46 Billion. The US is the largest contributor to these sales, highlighting the maturity and acceptance of the market in this prime geography. Roche’s mature products, Hemlibra and Vabysmo, lead the market share, with over half of total sales, emphasizing the value of first mover benefit and effective market entry strategies in this competitive market.

The pipeline for development is an even more daunting picture, with more than 900 multispecific antibodies already in various stages of development. Oncology is leading this pipeline, both due to the traditional priority of multispecific antibody development and due to the large unmet medical needs in cancer treatment. However, pipeline diversity is not confined to oncology alone with promising candidates being identified in autoimmune and inflammatory diseases and neurological disorders as well, indicating an expanding therapeutic horizon that has the potential to dramatically expand market opportunities.

Major industry players behind this innovation are well established pharma giants like Amgen, AstraZeneca, Genentech, and Regeneron, as well as new biotech firms like ABL Bio, Harbour BioMed, Innovent Biologics, Merus, and Zymeworks. This combination of well established and new players provides a vibrant competitive landscape that ensures ongoing innovation and technological progress.

Strategic alliances continue to influence the development of the market, such as in the April 2025 alliance of Boehringer Ingelheim and Cue Biopharma for the development of CUE-501, a bispecific candidate that attacks pathogenic B cells via virus-specific memory T cells. The alliance, involving a US$ 12 Million upfront payment and possible milestone payments of up to US$ 345 Million, illustrates the high financial investment that companies are undertaking to drive multispecific antibody technologies, specifically in autoimmune indications where existing treatments are still inadequate.

Regulatory encouragement of innovation continues to be robust, with the FDA’s April 2025 fast track designation of ISB 2001, an Ichnos Glenmark Innovation investigational trispecific T-cell engager for relapsed or refractory multiple myeloma, reflecting ongoing regulatory enthusiasm for moving multispecific antibody technologies forward that treat important unmet medical needs.

As a result of these ongoing innovations, the global multispecific antibody market is expected to grow rapidly and is on track to become one of the most important segments within the pharmaceutical industry.

Key Topics Covered:

1. Introduction to Next Generation Multispecific Antibodies

2. Next Generation Multispecific Antibody Current Clinical Development & Future Commercialization Outlook

2.1 Current Market Overview

2.2 Future Commercialization Opportunity

2.3 Collaborations, License Agreements, Investments & Acquisitions

2.4 Next Generation Multispecific Antibody Proprietary Technologies By Company

3. Next Generation Multispecific Antibody Clinical Trends by Indication

3.1 Cancer

3.2 Hematological Disorders

3.3 Microbial Infections

3.4 Autoimmune & Inflammatory Disorders

3.5 Ocular Diseases

4. Next Generation Multispecific Antibody Clinical Development & Market Trends by Region

4.1 US

4.2 EU

4.3 China

4.4 UK

4.5 Japan

4.6 Australia

4.7 South Korea

4.8 Canada

5. Approved Multispecific Antibodies – Clinical Overview, Pricing & Dosage Insight

5.1 Overview

5.2 Clinical Overview, Pricing & Dosage Insight

6. Approved Multispecific Antibodies – Sales Insight (2020 – Q1’2025)

7. Global Multispecific Antibodies Clinical Trials Overview

8. Global Bispecific Antibodies Clinical Trials By Company, Indication & Phase

8.1 Research

8.2 Preclinical

8.3 Phase-I

8.4 Phase-I/II

8.5 Phase-II

8.6 Phase-II/III

8.7 Phase-III

8.8 Preregistration

8.9 Registered

9. Marketed Bispecific Antibodies Clinical Insight By Company, Country & Indication

10. Global Trispecific Antibodies Clinical Trials Insight By Company, Country, Indication & Phase

10.1 Research

10.2 Preclinical

10.3 Phase I

10.4 Phase I/II

10.5 Phase II/III

11. Tetraspecific Antibodies Clinical Trials Insight By Company, Country, Indication & Phase

11.1 Preclinical

11.2 Phase I

11.3 Phase I/II

11.4 Phase II

12. Competitive Landscape

• AbbVie
• ABL Bio
• Abzyme Therapeutics
• Affimed Therapeutics
• Akeso Biopharma
• Alligator Bioscience
• Amgen
• Antibody Therapeutics
• APITBIO
• Astellas Pharma
• AstraZeneca
• Aptevo Therapeutics
• BioAtla
• Biocytogen Pharmaceuticals
• Biosion
• EpimAb Biotherapeutics
• FutureGen Biopharmaceutical
• Genentech
• Genmab
• Genor Biopharma
• Gensun Biopharma
• Harbour BioMed
• IGM Biosciences
• I-MAB Biopharma
• ImmuneOnco Biopharma
• ImmunoPrecise Antibodies
• Innate Pharma
• Innovent Biologics
• Invenra
• Johnson & Johnson
• Kenjockety Biotechnology
• LaNova Medicines Limited
• Light Chain Bioscience
• Linton Pharm
• Lyvgen Biopharma
• MacroGenics
• Merck
• Merus
• ModeX Therapeutics (OPKO Health)
• Molecular Partners
• NovaRock Biotherapeutics
• Numab
• OPKO Health
• Pfizer
• Regeneron Pharmaceuticals
• Revitope
• Roche
• Sanofi
• Sichuan Baili Pharmaceutical
• SystImmune
• Virtuoso Therapeutics
• Xencor
• Y-Biologics
• Zhejiang Shimai Pharmaceutical
• Zymeworks

For more information about this report visit https://www.researchandmarkets.com/r/ylbp0t

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SINOVAC Board of Directors Provides Update on Special Dividend Payment and Commitment to Delivering Value to All Shareholders




SINOVAC Board of Directors Provides Update on Special Dividend Payment and Commitment to Delivering Value to All Shareholders

Accelerates payment of previously announced special cash dividend of US$55.00 per common share

Decides to declare second special cash dividend of US$19.00 per common share

Intends to declare third special cash dividend between US$20.00 – US$50.00 per common share

Adopts new dividend policy to regularly return cash to shareholders

BEIJING–(BUSINESS WIRE)–The Board of Directors of SINOVAC Biotech Ltd. (NASDAQ: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced several important decisions to deliver sustainable value to shareholders and strengthen the Company’s governance framework.

Currently, a dissenting investor group led by Advantech/Prime Success and Vivo Capital (together known as the “Dissenting Investor Group”) and certain former illegitimate board (the “Imposter Board”) members are attempting to distract SINOVAC shareholders with lawsuits, false claims and empty promises as part of a hostile attempt to remove the SINOVAC Board – which was recently installed by the Privy Council order and in accordance with Antiguan law – with the goal to move SINOVAC backward and continue to entrench themselves. In contrast, the SINOVAC Board is taking clear actions to restore fairness and deliver value to ALL SINOVAC shareholders.

Key Updates and Commitments

1. Acceleration of Special Dividend Payment:
   
   The SINOVAC Board has authorized Audit Committee Chair Sven H. Borho to accelerate the payment of the previously announced special dividend of US$55.00 per common share, which it now expects to be paid on or about July 7, 2025, in advance of the Special Shareholder Meeting (“SSM”), subject to compliance with and approval by NASDAQ and the outcome of the Advantech/Prime Success lawsuit recently filed in New York.

   Contrary to claims by the Dissenting Investor Group, the date of the SSM on July 8 was driven by when SAIF filed the requisition for the meeting, and per Antiguan law, the SSM has to be held by July 8 unless SAIF agrees to resend their request. The SINOVAC Board has asked SAIF to reissue the request so that the SSM can be delayed until after July 9, but received no reply. Nevertheless, since establishing the date for the SSM, the Board has been working to accelerate the payment of the special dividend, demonstrating our commitment to restoring fairness. Yet the SINOVAC Board has encountered frequent interference by the Dissenting Investor Group, including the new lawsuit filed by Advantech/Prime Success on June 12.

   The SINOVAC Board’s acceleration of this payment is to ensure that, regardless of the outcome of the SSM, all valid shareholders will receive the special dividend payment as an initial corrective step in ensuring fair and equitable distributions of dividends to all SINOVAC shareholders.

2. Decision to Declare an Additional Dividend:
   In its April 1 announcement, the SINOVAC Board stated its intention to make additional distributions to shareholders as part of its effort to catch up common shareholders with distributions that were paid out to subsidiary shareholders (primarily the Dissenting Investor Group). The SINOVAC Board has since learned that the Company’s operating subsidiary, Sinovac Life Sciences Co., Ltd. (“SLS”), continued issuing additional dividends to its minority shareholders in the second half of 2024 while the Company was still under the control of the Imposter Board, with SINOVAC’s valid shareholders receiving nothing. Thus, the current SINOVAC Board has decided to declare a second special cash dividend after the SSM of US$19.00 per common share. If the legal proceedings on PIPE shares conclude with cancellation of PIPE shares, the valid SINOVAC shareholders will receive an additional US$3.73 per common share.

3. Adoption of a New Dividend Policy:
   The SINOVAC Board has adopted a policy regarding the regular payment of dividends out of surplus cash above the amount needed to properly capitalize the Company and fund its operations. Based on a preliminary analysis, the SINOVAC Board believes this amount is between US$20.00 – US$50.00 per common share that could be distributed to SINOVAC shareholders in the future.

   This policy is another step the SINOVAC Board is taking to make common shareholders whole and restore fairness and equity for all valid shareholders who were previously excluded from distributions. The Imposter Board allowed SLS to distribute over US$2 billion in dividends to minority shareholders but determined not to distribute a fair share to the valid common shareholders of SINOVAC. Under the current SINOVAC Board, this practice will stop – if there are distributions made at the subsidiary level, we will ensure they will be fairly distributed to all SINOVAC shareholders.

4. Commitment to an Annual Meeting in Q2 of 2026:
   
   The current SINOVAC Board directors are focused on completing the SSM and fighting for fairness for ALL shareholders, in furtherance of the Company’s best interests. Following the SSM, the SINOVAC Board will immediately turn towards improving SINOVAC’s corporate governance. To that end, the SINOVAC Board is committed to holding an annual meeting of shareholders in the second quarter of 2026. Ahead of this meeting, the SINOVAC Board will introduce additional director nominees for election, ensuring the full slate has the combined skills, qualifications, and experience to best serve and oversee the Company’s strategy and operations, with the integrity and fiduciary commitment to fairly represent and make decisions in the best interests of the Company, while duly considering the interests of all SINOVAC shareholders. The slate is expected to include one or more representatives from SINOVAC’s management team, ensuring that the SINOVAC Board and management remain aligned on the Company’s long-term strategic goals.

5. Exploration of Other Listing Venues:
   
   The SINOVAC Board also authorized the formal exploration of a future listing of SINOVAC shares on The Stock Exchange of Hong Kong and potentially other exchanges in order to stimulate liquidity, mitigate geopolitical risk, and maximize long term shareholder value.

Your Vote Will be Important

As previously announced, the Company intends to imminently file its definitive proxy materials 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.

Your vote on or before July 9 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.

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

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

Investors and Media
FGS Global

Sinovac@fgsglobal.com

X-Atlas/Orion: Xaira Therapeutics Unveils Largest Publicly Available Genome-Wide Perturb-seq Dataset to Power Next-Generation AI for Biology




X-Atlas/Orion: Xaira Therapeutics Unveils Largest Publicly Available Genome-Wide Perturb-seq Dataset to Power Next-Generation AI for Biology

• Xaira is an integrated biotechnology company built to deliver on the promise of AI to help transform the drug discovery and development process

• The company released a preprint with details of its robust platform, Fix-Cryopreserve-ScRNAseq (FiCS) Perturb-seq, specifically designed for generating high-quality data at scale; and simultaneously provided the largest public release to date of this type of data, X-Atlas/Orion

• Xaira also reported details of its method to identify dose-dependent genetic effects within this kind of data

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Xaira Therapeutics today announced a significant leap forward in developing AI-driven virtual cell models with the release of “X-Atlas/Orion,” the largest publicly available Perturb-seq atlas. This extensive dataset was made possible by Xaira’s concurrently introduced “Fix-Cryopreserve-ScRNAseq” (FiCS) Perturb-seq platform, a highly scalable technology designed for large-scale data generation. These combined advancements are poised to accelerate the development of biological foundation models and unlock new frontiers in biological discovery and therapeutic development.

The rapid progress of single cell technology has spurred the creation of foundation models aimed at deciphering complex biological processes. While these models hold immense potential for creating AI-driven virtual cells, their advancement has been hampered by the scarcity of large-scale, high-quality perturbation data. Xaira’s FiCS Perturb-seq platform, which leverages the Chromium platform from 10x Genomics, delivers the sensitivity, scalability and reproducibility essential for generating high-quality perturbational data. Xaira’s innovative approach solves logistical challenges associated with profiling large numbers of cells, effectively captures perturbation-induced transcriptomic changes and accurately recapitulates known biological pathways and protein complexes. The X-Atlas/Orion dataset itself comprises 8 million cells, targeting all human protein-coding genes, with deep sequencing of over 16,000 unique molecular identifiers (UMIs) per cell, allowing for the discovery of biological phenotypes from a wide range of genetic perturbations.

“This industrialized platform and the Orion dataset will empower scientists to build more predictive models of complex biology,” said Ci Chu, vice president of early discovery at Xaira and senior author of the preprint. “We believe this will help us better understand disease biology and discover drug targets.”

One of the most significant advances is Xaira’s method to detect dose-dependent genetic effects, a more refined way of understanding how gene activity changes with the intensity of a given intervention. Traditionally, scientists viewed Perturb-seq gene knockdowns as an “on” or “off” switch. The Xaira scientists showed that the amount of single guide RNA (sgRNA) detected in each cell can be used to measure how strongly a gene is suppressed, offering a much more detailed picture of genetic function. This methodology offers a refined framework to enhance the predictive power and biological insight of future causal models by incorporating perturbation strength as a continuous variable.

“This platform provides the scale and quality needed to model how cells respond across conditions, which is a crucial step toward training the first generation of virtual cell models,” said Bo Wang, SVP and head of biomedical AI for Xaira Therapeutics. “With this foundation, we’re better equipped to uncover disease mechanisms and design smarter therapies.”

This publication caps a landmark year for Xaira since its launch in April 2024. In October 2024, Dr. David Baker, Xaira co-founder, received the Nobel Prize in Chemistry alongside Drs. Demis Hassabis and John Jumper of Google DeepMind for pioneering AI-driven advancements in protein structure prediction and novel protein design. The Xaira team is working to advance these models while developing new methods that can connect the world of biological targets and engineered molecules to the human experience of disease.

Access the Dataset:

X-Atlas/Orion is now publicly available here: https://doi.org/10.25452/figshare.plus.29190726

Read the Preprint:

FiCS Perturb-seq and X-Atlas/Orion publication: https://www.biorxiv.org/content/10.1101/2025.06.11.659105v1

About Xaira Therapeutics

Xaira Therapeutics is an integrated biotechnology company driving advances in artificial intelligence to learn the language of life and transform how we treat disease. The company seeks to rethink the drug discovery and development process from end-to-end by bringing together leading talent across three core areas: machine learning research to better understand biology, expansive data generation to power new models, and robust therapeutic product development to treat disease. Xaira is headquartered in the San Francisco Bay Area.

Contacts

press@xaira.com

ChoiceSpine™ Announces Launch of ChoiceSpine™ App for Surgical Use with eCential Robotics Op.n™ Robotic and Navigation Platform




ChoiceSpine™ Announces Launch of ChoiceSpine™ App for Surgical Use with eCential Robotics Op.n™ Robotic and Navigation Platform

KNOXVILLE, Tenn. & FRANKLIN, Tenn.–(BUSINESS WIRE)–#ChoiceSpine–ChoiceSpine LLC, a privately-held U.S. spinal implant company, in collaboration with eCential Robotics, a leading innovator in surgical robotics, proudly announces the launch of the ChoiceSpine™ application (App) for surgical use on the eCential Op.n™ robotic and navigation platform.

This milestone represents a significant leap forward in spine surgery, integrating advanced navigation and robotic-assisted technology to support both open and minimally invasive spine procedures. The ChoiceSpine™ application will function on the Op.n™ platform, working in tandem with ChoiceSpine’s core spine portfolio. This includes the following ChoiceSpine Navigation-enabled instrumentation:

• Thunderbolt™ MIS Pedicle Screw System
• Thunderbolt™ Extended Tab MIS Pedicle Screw System
• Lancer™ Open Pedicle Screw System

The Op.n™ platform enhances the precision of implant placement and reduces radiation exposure while improving procedural efficiency.

Steve Ainsworth, Ph.D., ChoiceSpine’s Co-President, said, “Robotics has become a significant competitive advantage in modern healthcare, and we are thrilled to expand our presence in this space through our collaboration with eCential Robotics. By combining the advanced capabilities of the eCential Robotics platform with our comprehensive spinal implant portfolio, we are setting a new standard in spine surgery.

“This strategic partnership enables us to deliver innovative solutions that enhance patient outcomes and improve procedural efficiency. It exemplifies our commitment to bringing technically superior spinal devices to the market—and doing Spine the Right Way℠.”

“We are excited to see our APP ecosystem growing, delivering on our vision to provide procedural option choices for surgeons while minimizing the capital investment cost for medical facilities,” commented Clement Vidal, CEO of Surgical Robotics.

The release of the new ChoiceSpine App marks another significant milestone for eCential Robotics in democratizing access to spinal Robotic surgery.

About eCential Robotics

Founded by Stéphane Lavallée and part of the Grenoble Haventure network, eCential Robotics is a French and US-based company specializing in surgical robotics. Powered by a unique OPEN ecosystem fueled by APPS, it has developed an implant-agnostic, modular multi-technology, and scalable robotic and navigation platform aiming to increase robotic capabilities, enable decentralized innovation through third-party development, and give surgeons and hospitals maximal control over their clinical, technological, and capital investment strategy. With over 100 patents and seven trademarks, and thanks to multiple partnerships established with implant manufacturers, tech companies, research labs, and surgeons, eCential Robotics is positioned as a leader in the fast-growing surgical robotics market and aspires to become the world leader in open robotic platforms.

Please visit http://www.ecential-robotics.com and follow us on LinkedIn (eCential Robotics).

About ChoiceSpine

ChoiceSpine LLC is a privately held spinal device company located in Knoxville, TN, and is owned by Altus Capital Partners. ChoiceSpine prides itself on providing excellent products that aim to improve people’s lives through a positive customer experience. Here at ChoiceSpine, we offer a variety of surgeon-focused product lines designed to be safe, efficient, and easy to use. By focusing on a collaborative team approach with physicians and industry partners, ChoiceSpine continues to deliver upon product commitments, maintain cutting-edge research and development, and bring technically superior products to the forefront of the spinal implant industry. For more information, please visit www.choicespine.com.

Contacts

Media contact
Matthieu VILLE

matthieu.ville@ecential-robotics.com

Benjamin COLAS

Investor relations

benjamin.colas@ecential-robotics.com

Media contact

Ron Moore

Sr. Director of Marketing

865-246-3333

rmoore@choicespine.com

Zetagen Therapeutics Announces Peer-reviewed Publication of In-Vivo Dose Optimization Findings for ZetaMast™ (Zeta-MBC-005) for Triple Negative Breast Cancer Liver Metastases




Zetagen Therapeutics Announces Peer-reviewed Publication of In-Vivo Dose Optimization Findings for ZetaMast™ (Zeta-MBC-005) for Triple Negative Breast Cancer Liver Metastases

(Patients with disseminated metastatic disease from breast cancer are likely to have liver involvement in >50% of cases at some point during disease progression. These patients have poor prognosis; and, when treated with the standard of care systemic therapy they have a median survival of <9-months.)

• Zetagen identifies two concentrations of ZetaMast™ (Zeta-MBC-005) which were most effective in treating metastatic triple negative breast cancer (TNBC) in the liver
• ZetaMast™ (Zeta-MBC-005) exhibits significant decrease in tumor volume (4-fold) vs. control Doxorubicin
• ZetaMast™ (Zeta-MBC-005) demonstrates a 3.9-fold increase in survival rate over control Doxorubicin with no lung or brain metastases.

SYRACUSE, N.Y.–(BUSINESS WIRE)–Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company developing first-of-its-kind targeted therapies for primary and metastatic breast cancer, announced today the peer-reviewed publication in PLOS-One of their dose optimization in-vivo study results of ZetaMast™ (Zeta-MBC-005).

Zetagen identified two concentrations of ZetaMast™ (Zeta-MBC-005) which demonstrated superior effectiveness, reduction in tumor burden, and increased survival rate over control Doxorubicin.

“Patients with disseminated metastatic breast cancer involving the liver, face a poor prognosis and new approaches are urgently needed,” stated Debasish Tripathy, MD, Professor and Chairman, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. “Although some therapies have been designed for direct administration for liver metastases, they have not demonstrated efficacy in significantly improving survival. ZetaMast™ is an innovative therapeutic approach that has demonstrated systemic biological effects potentially extending beyond liver metastases in preclinical models, offering promising potential to enhance outcomes in this setting.”

ZetaMast™ (Zeta-MBC-005) Increased Survival in a Mouse Xenograft Liver Metastases Model. The 4T1, TNBC cell line, tagged with luc2 luciferase (4T1-luc2), was implanted directly into the liver of BALB/c mice. Seven days after tumor inoculation, mice were treated with various concentrations via a single administration of ZetaMast™ (Zeta-MBC-005) (30-, 60-, 120-, 180-, 240-, or 480-μg) in combination with 5-mg/kg doxorubicin. Mice in the Control group received 5 mg/kg of doxorubicin and the ZetaMast™ (Zeta-MBC-005) carrier without Zetagen’s small molecule, administered every 72-hours.

ZetaMast™ (Zeta-MBC-005) has the ability to deliver Zetagen’s small molecules intratumorally as well as other therapies, avoiding off-target side effects.

“Effective locoregional therapies are likely the key to reducing breast cancer mortality for patients with disseminated metastatic disease and increasing 5-year survival above 31%. If treatments like ZetaMast™ (Zeta-MBC-005) can be given when and where needed, increasing the duration of overall tumor control, which may be enough to tip the balance towards a favorable impact on survival,” stated Bryan S. Margulies, MS, Ph.D., CSO of Zetagen.

To view the ZetaMAST™ (Zeta-MBC-005) dose optimization study results go to https://doi.org/10.1371/journal.pone.0323621.

About ZetaMAST™ (Zeta-MBC-005)

ZetaMast™ (Zeta-MBC-005) is a proprietary drug eluting carrier designed for locoregional administration, controlled release of two small molecules in the treatment of multifocal, unresectable, liver metastases from breast cancer with the potential to increase survival rates.

The USPTO has granted Zetagen a “Composition of Matter” patent for ZetaMast™ (Zeta-MBC-005), and Zetagen has also submitted a filing to the FDA for Orphan Drug Designation.

Zetagen is finalizing preparations for an FDA IND submission this fall, with a Phase 1b clinical trial set to commence early 2026.

About Zetagen Therapeutics

Zetagen has three novel drugs in development, ZetaMet™ (Zeta-BC-003), for the treatment of metastatic breast cancer to bone, ZetaMast™ (Zeta-MBC-005) for breast cancer liver metastases (BCLM), and (NEW) ZetaPrime™ (Zeta-PBC-007) for the treatment of primary HR+ breast cancer, all with inspiring results. To learn more, visit www.zetagen.com.

The FDA has acknowledged Zetagen’s innovative research with multiple Breakthrough Designations, notably ZetaMet™ (Zeta-BC-003). Under FDA and Health Canada (HC) approval through the Expanded Access (Compassionate Use) programs, Zetagen has treated eight patients with ZetaMet™ (Zeta-BC-003), with results featured in several peer-reviewed journals. Furthermore, Zetagen has completed enrollment for its Phase 2a open-label clinical trial focused on treating metastatic breast cancer in the spine.

Zetagen Upcoming Events

Zetagen will attend the 2025 San Antonio Breast Cancer Symposium (SABCS).

Forward-Looking Statements

This press release contains certain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions. Source: Zetagen Therapeutics, Inc.

Contacts

Investor Inquiries:
Zetagen Therapeutics, Inc.

Email: InvestorRelations@zetagen.com

Biocytogen Responds to Harbour BioMed’s Patent Claims: RenNano® is an Independently Developed Platform with Distinct Innovation and Full Legal Standing




Biocytogen Responds to Harbour BioMed’s Patent Claims: RenNano® is an Independently Developed Platform with Distinct Innovation and Full Legal Standing

BEIJING–(BUSINESS WIRE)–In response to Harbour BioMed’s recent press release regarding a procedural development in their ongoing legal claim, Biocytogen issues the following statement:

Biocytogen stands by its core values of independent innovation, respect for intellectual property, and a commitment to fair competition. The RenNano® platform is the result of independent, original R&D, based on Biocytogen’s proprietary genome editing technologies. Its technical principles, design strategy, and IP scope are fundamentally different from the patents in dispute.

120 vs. 9 – A Significant Technical Divide of RenNano® Platform; Biocytogen Will Resolutely Take Legal Actions to Protect Its Rights

The RenNano® platform employs a large-fragment knock-in strategy that incorporates over 120 human V genes in situ, enabling a complete and functional human heavy chain antibody repertoire. In stark contrast, Harbour BioMed’s HCAb platform introduces only 9 V genes through a small-fragment transgenic approach. This key difference reflects not only divergent technical strategies but also the depth, innovation, and translational potential of Biocytogen’s antibody discovery platforms.

The decision referenced in Harbour BioMed’s PR involves a procedural ruling on jurisdiction only and does not address the substance of the patent infringement case. Furthermore, the CNIPA’s affirmation of patent validity is a routine administrative process that does not imply infringement. The underlying lawsuit has not yet entered the trial phase.

Biocytogen is currently evaluating all legal options and will resolutely defend its IP rights and scientific reputation. The RenNano® platform has been fully validated and is supported by a robust portfolio of domestic and international patents, clearly documenting its originality and independence.

We remain confident in:

• The technical integrity and legal foundation of the RenNano® platform;
• The non-infringement of any third-party IP;
• Our continued leadership in antibody discovery and therapeutic innovation.

According to public records, the Chinese patent related to Harbour BioMed’s HCAb platform is set to expire on July 22, 2025, further underscoring the short-sighted nature of any speculative claims. Regardless, Biocytogen will continue to uphold its rights, ensure business continuity, and deliver transformative technologies for global partners and patients.

Any misleading allegations or speculative narratives will not deter our team from advancing the RenMice® platform series with world-class innovation and delivering on our mission to accelerate therapeutic discovery.

Key Technical Differences Between Biocytogen’s RenNano® Platform and Harbour BioMed’s HCAb Platform

• Biocytogen RenNano® Platform: Uses large-fragment knock-in technology to replace mouse genes with over 120 human V genes in situ, resulting in a full and functional human heavy chain variable region genomic repertoire.
• Harbour BioMed HCAb Platform: Introduces only 9 V genes using small-fragment transgenic approaches.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMab™/ RenLite®/ RenNano®/ RenTCR-mimic™ ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >1,000,000 fully human antibody sequences against over 1000 targets for worldwide collaboration. As of December 31, 2024, approximately 200 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and over 50 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco, San Diego), and Germany (Heidelberg). For more information, please visit http://en.biocytogen.com.cn.

Contacts

Biocytogen Contacts
Antibody platform and assets: BD-Licensing@biocytogen.com
Preclinical models and services: info@biocytogen.com
Media: marketing@biocytogen.com