Forte Biosciences Announces Pricing of $75 Million Public Offering




Forte Biosciences Announces Pricing of $75 Million Public Offering

DALLAS–(BUSINESS WIRE)–Forte Biosciences, Inc. (Nasdaq: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced the pricing of a public offering of 5,630,450 shares of its common stock at a price to the public of $12.00 per share and, in lieu of common stock to certain investors who so chose, pre-funded warrants to purchase up to 619,606 shares of common stock at a price to the public of $11.999 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.001 per share exercise price for each pre-funded warrant. In addition, Forte has granted the underwriters a 30-day option to purchase up to an additional 937,508 shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants are being offered by Forte.

The gross proceeds from the offering are expected to be approximately $75 million before deducting underwriting discounts and commissions and other offering expenses. The offering is expected to close on or about June 26, 2025, subject to satisfaction of customary closing conditions.

Forte intends to use the net proceeds of the offering for working capital and other general corporate purposes, which includes funding clinical and preclinical development of its product candidate and other research activities.

TD Cowen, Evercore ISI, Guggenheim Securities and Chardan are acting as joint book-running managers for the offering. Lucid Capital Markets and Brookline Capital Markets, a division of Arcadia Securities, LLC are acting as co-managers for the offering.

The offering is being made pursuant to a Registration Statement on Form S-3 (File No. 333-286226), including a base prospectus, previously filed with and declared effective by the SEC. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC. A final prospectus supplement and accompanying prospectus relating to the offering will also be filed with the SEC. These documents can be accessed for free through the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus relating to the offering, when available, may also be obtained from TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846 or by email at TD.ECM_Prospectus@tdsecurities.com, Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888)-474-0200, or by email at ecm.prospectus@evercore.com, Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com, and Chardan Capital Markets, LLC, One Pennsylvania Plaza, Suite 4800, New York, NY 10119.

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

About Forte

Forte Biosciences, Inc. is a clinical-stage biopharmaceutical company that is advancing FB102, which is a proprietary anti-CD122 monoclonal antibody therapeutic candidate with potentially broad autoimmune and autoimmune-related indications.

Forward Looking Statements

Forte cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the Forte’s current beliefs and expectations. Forward-looking statements include statements regarding the completion and timing of the offering and the anticipated use of proceeds from the offering. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: whether or not Forte will be able to raise capital through the sale of securities or consummate the offering; the final terms of the offering; the satisfaction of customary closing conditions; prevailing market conditions; general economic and market conditions as well as geopolitical developments; and other risks. Additional risks, uncertainties, and other information affecting Forte’s business and operating results are contained in Forte’s Quarterly Report on Form 10-Q filed on May 15, 2025, and in its other filings with the Securities and Exchange Commission. All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Forte undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Source: Forte Biosciences, Inc.

Contacts

Forte Biosciences, Inc.

investors@fortebiorx.com

Ono Pharmaceutical and Vertex Announce Strategic Agreement to Develop and Commercialize Povetacicept in Japan and South Korea




Ono Pharmaceutical and Vertex Announce Strategic Agreement to Develop and Commercialize Povetacicept in Japan and South Korea

• Ono and Vertex have entered into an exclusive collaboration and license agreement for povetacicept in Japan and South Korea
• Povetacicept is a therapeutic in development for multiple serious B cell-mediated diseases including IgA nephropathy and primary membranous nephropathy
• Povetacicept is a recombinant fusion protein and a dual antagonist of the BAFF and APRIL cytokines

OSAKA, Japan & BOSTON–(BUSINESS WIRE)–Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) and Vertex Pharmaceuticals Incorporated (Headquarters: Boston, MA, U.S.; CEO: Reshma Kewalramani, M.D.; “Vertex”) today announced an exclusive collaboration and license agreement for the development and commercialization of Vertex’s povetacicept in Japan and South Korea.

Povetacicept is a recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines with best-in-class potential being studied for the treatment of immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN) and other serious B cell-mediated diseases.

Under the terms of the agreement, Ono will pay Vertex an upfront payment, as well as certain regulatory and commercial milestone payments and tiered royalties. Ono will utilize its extensive development expertise to help advance Vertex’s clinical trials for povetacicept and will be responsible for obtaining marketing authorizations in Japan and South Korea. Following approval, Ono will be solely responsible for commercializing povetacicept in these regions. The agreement includes povetacicept for both IgAN and pMN, with the potential to add other indications.

“Vertex has a strong track record of developing innovative therapies for serious diseases. Through this strategic partnership, we can strengthen our late-stage pipeline in the immunology field, which is a key focus area for Ono,” said Toichi Takino, Representative Director, President and Chief Operating Officer of Ono. “We look forward to collaborating with Vertex to provide this new therapeutic option for patients with IgAN and other autoimmune diseases in Japan and South Korea, and to maximize the value of this treatment.”

“Ono is a proven leader in Japan and South Korea, bringing established local relationships, infrastructure, and nephrology expertise that make them a perfect partner for Vertex as we look to deliver povetacicept to the thousands of potential patients in these countries,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “We are very pleased to partner with Ono and look forward to close collaboration as we continue to advance this potentially best-in-class treatment for IgAN, pMN and other serious B cell-mediated diseases.”

About Povetacicept

Povetacicept is a recombinant fusion protein therapeutic and a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation, and/or survival of B cells, T cells, and innate immune cells. Based upon an engineered TACI (transmembrane activator and calcium modulator ligand interactor) domain, povetacicept has higher binding affinity and greater potency in preclinical studies versus other inhibitors of BAFF and/or APRIL alone and has demonstrated potential best-in-class efficacy in a clinical trial in patients with IgA nephropathy and primary membranous nephropathy. Povetacicept is also in development for multiple serious B cell-mediated diseases including other autoimmune kidney diseases and autoimmune cytopenias.

About IgA Nephropathy (IgAN)

IgAN is a serious, progressive, life-threatening, B cell-mediated chronic kidney disease that is the most common cause of primary (idiopathic) glomerulonephritis, affecting approximately 300,000 people in the United States and Europe. It is estimated that there are approximately 33,000 diagnosed patients in Japan. IgAN results from deposition of circulating immune complexes consisting of immunoglobulins and galactose-deficient immunoglobulin A (Gd-IgA1) in the renal glomerular mesangium, triggering kidney injury and fibrosis. Up to 72% of adult IgAN patients progress to end-stage renal disease within 20 years. There are no approved therapies that specifically target the underlying cause of IgAN.

About Primary Membranous Nephropathy (pMN)

Primary membranous nephropathy is a serious, progressive, life-threatening B cell-mediated chronic kidney disease affecting people worldwide, with approximately 150,000 people diagnosed in the U.S. and Europe. It is estimated that there are approximately 6,000 diagnosed patients with pMN in Japan. pMN is a rare glomerular disease that occurs when the body generates an abnormal immune response, including autoantibodies, against proteins that are part of the kidney. Autoantibodies trigger damage and inflammation, especially within the glomeruli (the parts of the kidney that filter blood), impairing the kidneys’ ability to properly filter waste and fluid, eventually causing progressive loss of kidney function. There are no approved therapies that specifically target the underlying cause of pMN.

About RAINIER

RAINIER is a global Phase 3 pivotal trial of povetacicept 80 mg vs. placebo on top of standard of care in approximately 480 people with IgAN. The study is designed to have a pre-planned interim analysis evaluating urine protein to creatinine ratio (UPCR) for the povetacicept arm versus placebo after a certain number of patients reach 36 weeks of treatment. If positive, the interim analysis may serve as the basis for Vertex to seek accelerated approval in the U.S. Final analysis will occur at two years of treatment, with a primary endpoint of total eGFR slope through Week 104.

The Phase 3 clinical trial is underway in multiple regions, including the U.S., EU and Asia. Specifically, Japanese and South Korean regulatory authorities have approved the Clinical Trial Application (CTA) for RAINIER, where the Phase 3 trial is underway.

About RUBY-3

RUBY-3 is an ongoing, multiple ascending dose, multi-cohort, open label, Phase 1/2 basket study of povetacicept in autoimmune glomerulonephritis, including IgAN, primary membranous nephropathy, lupus nephritis, and ANCA-associated vasculitis with glomerulonephritis where povetacicept is being administered subcutaneously for up to 104 weeks.

About Ono Pharmaceutical Co., Ltd

Ono Pharmaceutical Co., Ltd. delivers innovative therapies for patients worldwide. Upholding its philosophy of “Dedicated to the Fight against Disease and Pain,” Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care. For more information, please visit the company’s website at https://www.ono-pharma.com/en.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 15 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.

Ono Forward-Looking Statements

In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of the company. These statements are based on current assumptions and beliefs in light of the information currently available and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in the business environment in the pharmaceutical market and amendments to relevant laws and regulations, (ii) disruptions to product supply due to stagnation or delays in production caused by natural disasters, fires, etc., (iii) the possibility that sales activities for new and existing products may not achieve the expected results, (iv) the emergence of new side effects in post-marketing drugs, and (v) infringements of intellectual property rights by third parties. Information about pharmaceutical products included in this press release is not intended to constitute an advertisement or medical advice.

Vertex Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Reshma Kewalramani M.D., and Toichi Takino, in this press release, and statements about the terms of and expectations for Vertex’s collaboration with Ono, statements about potential benefits and results that may be achieved through the collaboration, statements regarding the future activities of the parties pursuant to the collaboration, including Ono’s help to advance clinical trials and Ono’s responsibility to obtain marketing authorizations in Japan and South Korea and to commercialize povetacicept in the regions, statements regarding upfront and milestone payments, and potential royalties on future products, and statements about Vertex’s plans and expectations for the RAINIER and RUBY-3 clinical trials and potential plans to seek accelerated approval in the U.S. based on interim analysis from the RAINIER trial. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that the anticipated benefits and potential of the collaboration between Vertex and Ono may not be achieved on the anticipated timeline, or at all, that data may not support further development of the therapies subject to the collaboration due to safety, efficacy, or other reasons, and other risks listed under the heading “Risk Factors” in Vertex’s annual report filed with the Securities and Exchange Commission (SEC) and available through Vertex’s website at www.vrtx.com and on the SEC’s website at www.sec.gov. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

Contacts

Ono Pharmaceutical Co., Ltd.
Corporate Communications

public_relations@ono-pharma.com

For more information:

Vertex Pharmaceuticals Incorporated
Investors:
InvestorInfo@vrtx.com

Media:
mediainfo@vrtx.com
or

International: +44 20 3204 5275

or

U.S.: 617-341-6992

or

Heather Nichols: +1 617-839-3607

Vertex and Ono Pharmaceutical Announce Strategic Agreement to Develop and Commercialize Povetacicept in Japan and South Korea




Vertex and Ono Pharmaceutical Announce Strategic Agreement to Develop and Commercialize Povetacicept in Japan and South Korea

– Exclusive collaboration and license agreement for povetacicept in these countries –

– Ono will leverage its deep expertise in clinical development and commercialization for chronic kidney disease in Japan and South Korea to accelerate advancement of povetacicept for patients with IgA nephropathy and primary membranous nephropathy –

BOSTON & OSAKA, Japan–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Ono Pharmaceutical Co., Ltd. (OTCMKTS: OPHLY) today announced an exclusive collaboration and license agreement for the development and commercialization of Vertex’s povetacicept in Japan and South Korea. Povetacicept is a recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines with best-in-class potential being studied for the treatment of immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN) and other B cell-mediated diseases.

Under the terms of the agreement, Vertex will receive an upfront payment, as well as certain regulatory and commercial milestone payments and tiered royalties. Ono will utilize its extensive development expertise to help advance Vertex’s clinical trials for povetacicept and will be responsible for obtaining marketing authorizations in Japan and South Korea. Following approval, Ono will be solely responsible for commercializing povetacicept in these regions. The agreement includes povetacicept for both IgAN and pMN, with the potential to add other indications.

“Ono is a proven leader in Japan and South Korea, bringing established local relationships, infrastructure and nephrology expertise that make them a perfect partner for Vertex as we look to deliver povetacicept to the thousands of potential patients in these countries,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “We are very pleased to partner with Ono and look forward to close collaboration as we continue to advance this potentially best-in-class treatment for IgAN, pMN and other serious B cell-mediated diseases.”

“Vertex has a strong track record of developing innovative therapies for serious diseases. Through this strategic partnership, we can strengthen our late-stage pipeline in the immunology field, which is a key focus area for Ono,” said Toichi Takino, Representative Director, President and Chief Operating Officer of Ono. “We look forward to collaborating with Vertex to provide this new therapeutic option for patients with IgAN and other autoimmune diseases in Japan and South Korea, and to maximize the value of this treatment.”

About Povetacicept

Povetacicept is a recombinant fusion protein therapeutic and a dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, which play key roles in pathogenesis of multiple autoimmune diseases via their roles in the activation, differentiation and/or survival of B cells, T cells and innate immune cells. Based upon an engineered TACI (transmembrane activator and calcium modulator ligand interactor) domain, povetacicept has higher binding affinity and greater potency in preclinical studies versus other inhibitors of BAFF and/or APRIL alone and has demonstrated potential best-in-class efficacy in a clinical trial in patients with IgA nephropathy and primary membranous nephropathy. Povetacicept is also in development for multiple serious B cell-mediated diseases including other autoimmune kidney diseases and autoimmune cytopenias.

About IgA Nephropathy (IgAN)

IgAN is a serious, progressive, life-threatening, B cell-mediated chronic kidney disease that is the most common cause of primary (idiopathic) glomerulonephritis, affecting approximately 300,000 people in the United States and Europe. It is estimated that there are approximately 33,000 diagnosed patients in Japan. IgAN results from deposition of circulating immune complexes consisting of immunoglobulins and galactose-deficient immunoglobulin A (Gd-IgA1) in the renal glomerular mesangium, triggering kidney injury and fibrosis. Up to 72% of adult IgAN patients progress to end-stage renal disease within 20 years. There are no approved therapies that specifically target the underlying cause of IgAN.

About Primary Membranous Nephropathy (pMN)

Primary membranous nephropathy is a serious, progressive, life-threatening B cell-mediated chronic kidney disease affecting people worldwide, with approximately 150,000 people diagnosed in the U.S. and Europe. It is estimated that there are approximately 6,000 diagnosed patients with pMN in Japan. pMN is a rare glomerular disease that occurs when the body generates an abnormal immune response, including autoantibodies, against proteins that are part of the kidney. Autoantibodies trigger damage and inflammation, especially within the glomeruli (the parts of the kidney that filter blood), impairing the kidneys’ ability to properly filter waste and fluid, eventually causing progressive loss of kidney function. There are no approved therapies that specifically target the underlying cause of pMN.

About RAINIER

RAINIER is a global Phase 3 pivotal trial of povetacicept 80 mg vs. placebo on top of standard of care in approximately 480 people with IgAN. The study is designed to have a pre-planned interim analysis evaluating urine protein to creatinine ratio (UPCR) for the povetacicept arm versus placebo after a certain number of patients reach 36 weeks of treatment. If positive, the interim analysis may serve as the basis for Vertex to seek accelerated approval in the U.S. Final analysis will occur at two years of treatment, with a primary endpoint of total eGFR slope through Week 104.

The Phase 3 clinical trial is underway in multiple regions, including the U.S., EU and Asia. Specifically, Japanese and South Korean regulatory authorities have approved the Clinical Trial Application (CTA) for RAINIER, where the Phase 3 trial is underway.

About RUBY-3

RUBY-3 is an ongoing, multiple ascending dose, multi-cohort, open label, Phase 1/2 basket study of povetacicept in autoimmune glomerulonephritis, including IgAN, primary membranous nephropathy, lupus nephritis and ANCA-associated vasculitis with glomerulonephritis where povetacicept is being administered subcutaneously for up to 104 weeks.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 15 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.

About Ono Pharmaceutical Co., Ltd

Ono Pharmaceutical Co., Ltd. delivers innovative therapies for patients worldwide. Upholding its philosophy of “Dedicated to the Fight against Disease and Pain,” Ono targets areas with unmet medical needs including oncology, immunology, and neurology, and fosters partnerships with academic and biotech organizations to accelerate drug discovery. Through its affiliate, Deciphera Pharmaceuticals, Ono is accelerating clinical development and commercial operations in the US and Europe to drive global business expansion and further its commitment to patient care. For more information, please visit the company’s website at https://www.ono-pharma.com/en.

Vertex Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Reshma Kewalramani M.D., and Toichi Takino, in this press release, and statements about the terms of and expectations for Vertex’s collaboration with Ono, statements about potential benefits and results that may be achieved through the collaboration, statements regarding the future activities of the parties pursuant to the collaboration, including Ono’s help to advance clinical trials and Ono’s responsibility to obtain marketing authorizations in Japan and South Korea and to commercialize povetacicept in the regions, statements regarding upfront and milestone payments, and potential royalties on future products, and statements about Vertex’s plans and expectations for the RAINIER and RUBY-3 clinical trials and potential plans to seek accelerated approval in the U.S. based on interim analysis from the RAINIER trial. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that the anticipated benefits and potential of the collaboration between Vertex and Ono may not be achieved on the anticipated timeline, or at all, that data may not support further development of the therapies subject to the collaboration due to safety, efficacy, or other reasons, and other risks listed under the heading “Risk Factors” in Vertex’s annual report filed with the Securities and Exchange Commission (SEC) and available through Vertex’s website at www.vrtx.com and on the SEC’s website at www.sec.gov. You should not place undue reliance on these statements. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

Ono Forward-Looking Statements

In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of the company. These statements are based on current assumptions and beliefs in light of the information currently available and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in the business environment in the pharmaceutical market and amendments to relevant laws and regulations, (ii) disruptions to product supply due to stagnation or delays in production caused by natural disasters, fires, etc., (iii) the possibility that sales activities for new and existing products may not achieve the expected results, (iv) the emergence of new side effects in post-marketing drugs, and (v) infringements of intellectual property rights by third parties. Information about pharmaceutical products included in this press release is not intended to constitute an advertisement or medical advice.

Contacts

Vertex Pharmaceuticals Incorporated
Investors:
InvestorInfo@vrtx.com

Media:
mediainfo@vrtx.com
or

International: +44 20 3204 5275

or

U.S.: 617-341-6992

or

Heather Nichols: +1 617-839-3607

Ono Pharmaceutical Co., Ltd.
Corporate Communications
public_relations@ono-pharma.com

NEL Animal Cardiovascular Center Achieves World’s First Surgical Correction of Complex VSD in Canine Patient




NEL Animal Cardiovascular Center Achieves World’s First Surgical Correction of Complex VSD in Canine Patient

ANYANG, South Korea–(BUSINESS WIRE)–#Canine—NEL Animal Cardiovascular Center, a private 24-hour animal hospital in South Korea, said that its cardiac surgery team has successfully performed the world’s first surgical correction of a complex ventricular septal defect (VSD) in a canine patient.

This veterinary milestone is highly significant, as it marks the first such case not only in Korea but also globally, with no previous reports of successful surgical treatment for complex VSDs.

The patient was diagnosed with a unique form of VSD—a single, continuous defect extending from the perimembranous to the subarterial region (Perimembranous VSD extending into subarterial region). Given that there had been no prior successful surgical cases even for typical VSDs in veterinary medicine, this breakthrough greatly expands the possibilities for surgical treatment of congenital heart disease in Korea’s veterinary cardiac surgery field.

Over the past year, NEL’s cardiac surgery team has gained experience through more than 50 open-heart surgeries using cardiopulmonary bypass. Based on this expertise, the team developed a thorough surgical plan. During the procedure, the complex VSD involving both membranous and subarterial regions was confirmed. The team performed incisions in the right atrium and pulmonary artery, successfully closing the defect with a bovine pericardial patch.

Immediately after surgery, the left-to-right shunt was completely resolved, and the risk of progressive regurgitation due to aortic valve prolapse was eliminated. The patient’s cardiac function recovered to near-normal levels, and the long-term prognosis is considered highly favorable.

Subarterial VSDs are particularly dangerous due to the risk of aortic valve prolapse and severe regurgitation, making early surgical intervention crucial. The success of this surgery offers new hope for animals with congenital heart defects, demonstrating the potential for a surgical cure.

Dr. Tae-Heum Um, Director of NEL Animal Cardiovascular Center, stated,

“Although this was a complex defect, thorough discussion and preparation among our medical team led to a successful outcome. We will continue our efforts so that more animals with congenital heart disease can lead healthy and normal lives.”

NEL Animal Cardiovascular Center is preparing an academic analysis and official report on this case, and sincerely hopes that this achievement contributes to the advancement of veterinary cardiac surgery not only in Korea, but also across Asia.

Contacts

NEL Animal Cardiovascular Center

Yoon il-yong

+82-31-421-7579

heart@thenel.org

New Data Show Delve Bio’s Metagenomic Testing Delivers Broader, Deeper Pathogen Identification Compared to Traditional Testing




New Data Show Delve Bio’s Metagenomic Testing Delivers Broader, Deeper Pathogen Identification Compared to Traditional Testing

Data Presented at the 2025 American Society for Microbiology Microbe Conference

BOSTON–(BUSINESS WIRE)–#biotech—Delve Bio, a pioneer in metagenomic next-generation sequencing (mNGS) for infectious diseases, today announced data presented at the American Society for Microbiology (ASM) Microbe conference in Los Angeles showing the impact of metagenomic sequencing for transforming infectious disease diagnostics by offering advances compared to traditional microbiological testing.

Among the data presented at the meeting is a comparison of Delve’s metagenomic cerebrospinal fluid (CSF) test, Delve Detect CSF, compared to a traditional PCR-based meningitis/encephalitis (ME) panel. The study reanalyzed samples from a diverse patient cohort previously tested using the ME panel. The data showed that mNGS can be used in conjunction with microbiological testing to increase diagnostic yield by identifying pathogens that are not detectable with traditional, pathogen-specific panel testing. The inclusion of mNGS tests like Delve Detect, which has a 48-hour turnaround time, can shorten time to diagnosis, enabling clinicians to initiate targeted therapies sooner.

“This study showed substantial agreement between Delve Detect and a syndromic PCR panel. But importantly, Delve Detect also identified pathogens that were not included on the PCR panel and would have been missed as causes of a patient’s infection if mNGS were not included in the diagnostic workup,” said Benjamin Bradley, M.D., Ph.D., medical director of virology and molecular infectious diseases at ARUP Laboratories. “This study supports including mNGS in the diagnostic workup for patients with complex central nervous system infections.”

The study included 122 samples — 47 positive and 75 negative. Analysis showed that in comparison with the ME panel, Delve Detect CSF demonstrated approximately 10% higher positivity rate (48% vs. 38%), with an additive diagnostic yield of 24%. This added yield included detection of multiple co-infections, 16 unique organisms not included in the ME panel, and positive detections in 19 samples (25%) that were negative by the ME panel. Additionally, in samples that were negative by both tests, Delve Detect CSF showed high agreement (95%) with the ME panel, supporting the negative predictive value of mNGS.

The company’s full presence at ASM Microbe 2025 includes:

• Delve’s chief medical officer Steve Miller, M.D., Ph.D. hosted A New Era: Metagenomic Sequencing for Comprehensive Pathogen Detection, exploring real world evidence, clinical cases and considerations for laboratory teams implementing mNGS.
• Presentation of a case report in a feature poster, Using Metagenomic Sequencing to Diagnose a Novel Moraxella CNS Shunt Infection in a Culture-Negative Case
• Presentation of data comparing the company’s mNGS CSF test, Delve Detect, to a widely used, PCR meningitis/encephalitis panel as part of the session Assessing the Clinical Impact of Next-Generation Sequencing: Where Are We Now?

“These presentations at ASM highlight the transformation underway in infectious disease diagnostics. Delve Bio’s metagenomic sequencing technology enables clinicians to identify the cause of serious central nervous system infections when existing methods do not deliver a diagnosis and speed is critical,” said Brad Murray, chief executive officer of Delve Bio. “We’re working to make this technology more widely available to neurologists, infectious disease physicians and laboratory teams so they can get patients the answers they need.”

Conference attendees are also invited to visit Delve Bio at booth #1440 to learn more about the company’s metagenomic platform, including Delve Detect and its proprietary bioinformatics platform Delve Decide.

Delve Detect is Delve Bio’s flagship metagenomic testing service, providing comprehensive pathogen detection with a 48-hour turnaround time after sample receipt and including access to Delve’s Clinical Microbial Sequencing Board, an on-call team of infectious disease experts who review results in clinical context.

About Delve Bio, Inc.

Delve Bio is a metagenomic next-generation sequencing (mNGS) company that empowers laboratories and clinicians with the insights they need to confidently diagnose routine and rare infectious diseases, thereby minimizing the impact of harmful pathogens on humanity. By leveraging its unbiased, pathogen-agnostic mNGS platform, Delve Bio is able to identify a wide range of pathogens with a single test. Founded by world leaders in genomics and infectious disease Drs. Charles Chiu, Joe DeRisi, Michael Wilson, Pardis Sabeti, and Matthew Meyerson, the company is backed by top institutional investors including Perceptive Xontogeny Venture Fund II, Section 32, and GV, along with leading individual investors. For more information, visit www.delve.bio.

Contacts

Company Contact

Amy Wong

Senior Director of Marketing and Business Development, Delve Bio

Email: media@delve.bio

Media Contact

Julie McKeough

42 North for Delve Bio

Email: julie@consult42north.com

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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