Eviden-built JUPITER Supercomputer Hits Exascale Milestone According to the TOP500, a First in Europe




Eviden-built JUPITER Supercomputer Hits Exascale Milestone According to the TOP500, a First in Europe

Paris, France – November 17, 2025 – Eviden, the Atos Group product brand leading in advanced computing, announces today the rankings of its 58 Eviden-built systems¹ in the TOP500 and Green500, official listings of the world’s most powerful and most energy-efficient supercomputers.

Amongst the 58 Eviden-built systems listed in the TOP500, JUPITER, through its Booster partition, remains the 4^th most powerful supercomputer in the world and Europe’s 1^st, marking a historic milestone as Europe’s first system to officially break the symbolic ExaFlop barrier – one billion billion calculations per second.

Eviden also leads the Green500 for the fourth edition in a row, claiming the top three spots with its Eviden-built systems KAIROS (CALMIP), ROMEO (URCA), and the Levante GPU extension (DKRZ) – and with JUPITER being recognized as the most energy-efficient of all existing exascale-class supercomputers.

These achievements underscore Eviden’s unwavering commitment to innovation, performance, and sustainability—accelerating the adoption of AI and large-scale simulation for science, research, and technological progress.

JUPITER breaks the Exascale barrier, a historic milestone

Developed by the Jülich Supercomputing Centre (JSC) in collaboration with the EuroHPC Joint Undertaking (EuroHPC JU) and procured by EuroHPC, JUPITER is Europe’s first exascale computer to reach that gigantic level of performance, enabling groundbreaking AI training and scientific simulations in fields like climate, energy, medicine, and materials research. It has already powered over 100 projects, achieving milestones such as simulating a universal quantum computer with 50 qubits and modeling the entire Earth system at one-kilometer resolution.

Ranked 4^th worldwide in the TOP500 and 1^st in Europe, JUPITER Booster partition is also recognized by the Green500 as the most energy-efficient supercomputer amongst all exascale-class systems. With 63 GigaFlops per watt, JUPITER Booster partition demonstrates the best performance-per-watt ratio, ensuring lower energy consumption, compared to its exascale competitors, assuming all systems are scaled to the same 1 ExaFlop performance.

Built in record time with sustainable design, JUPITER sets global efficiency standards and forms the core of the JUPITER AI Factory, soon offering secure access to AI models for research, start-ups, and industry.

Eviden leads the Green500 for the fourth edition in a row

Eviden has taken the lead in sustainable high-performance computing, claiming the top three positions in the Green500 ranking with KAIROS (#1 at 73 GFlops/Watt), ROMEO (#2 at 70 GFlops/Watt), and Levante GPU extension (#3 at 69 GFlops/Watt). This ranking matters as GFlops per Watt measures how many calculations a system performs for every unit of energy consumed, with a higher GFlop/Watt indicating lower energy consumption and costs. This success is the result of years of innovation, especially with Eviden’s patented fifth-generation Direct Liquid Cooling, expertise in HPC applications, and smart software like Argos for real-time energy optimization. As AI and HPC demands soar, Eviden sets the benchmark for sustainable growth.

Bruno Lecointe, VP, global head of HPC, HPC-AI and Quantum Computing at Eviden, Atos Group said “Breaking the symbolic 1 ExaFlop ceiling, building the most energy-efficient Exascale supercomputer and leading the Green500 with the top three positions is a defining and proud moment for the Eviden teams. These results demonstrate that the future of computing is not only about scale and speed, but also about responsibility, delivering unprecedented power while minimizing environmental impact. As demand for AI and HPC accelerates globally, we remain committed to driving innovation that combines performance and efficiency, shaping a more sustainable digital future for science, industry, and society.”

***

About Eviden

Eviden is the Atos Group brand for hardware and software products with c. € 1 billion in revenue, operating in 36 countries and comprising four business units: advanced computing, cybersecurity products, mission-critical systems and vision AI. As a next-generation technology leader, Eviden offers a unique combination of hardware and software technologies for businesses, public sector and defense organizations and research institutions, helping them to create value out of their data. Bringing together more than 4,500 world-class talents and holding more than 2,100 patents, Eviden provides a strong portfolio of innovative and eco-efficient solutions in AI, computing, security, data and applications.

About Atos Group

Atos Group is a global leader in digital transformation with c. 67,000 employees and annual revenue of c. €10 billion, operating in 61 countries under two brands — Atos for services and Eviden for products. European number one in cybersecurity, cloud and high performance computing, Atos Group is committed to a secure and decarbonized future and provides tailored AI-powered, end-to-end solutions for all industries. Atos Group is the brand under which Atos SE (Societas Europaea) operates. Atos SE is listed on Euronext Paris.

The purpose of Atos Group is to help design the future of the information space. Its expertise and services support the development of knowledge, education and research in a multicultural approach and contribute to the development of scientific and technological excellence. Across the world, the Group enables its customers and employees, and members of societies at large to live, work and develop sustainably, in a safe and secure information space.

Press contact

Constance Arnoux – constance.arnoux@eviden.com – +33 6 44 12 16 35

1 This figure includes all 57 systems listed in the TOP500 under the “Eviden” brand, as well as the Gefion system of the Danish Centre for AI Innovation (DCAI), built by Eviden powered by NVIDIA

Clover Health to Participate in Upcoming 2025 Citi Global Healthcare Conference




Clover Health to Participate in Upcoming 2025 Citi Global Healthcare Conference

WILMINGTON, Del., Nov. 17, 2025 (GLOBE NEWSWIRE) — Clover Health Investments, Corp. (Nasdaq: CLOV) (“Clover,” “Clover Health” or the “Company”), today announced that its Chief Financial Officer, Peter Kuipers, will present at the 2025 Citi Global Healthcare Conference on Thursday, December 4, 2025, at 11:15 a.m. Eastern Time.

A live webcast and replay of the presentation will be accessible on Clover Health’s investor relations website at https://investors.cloverhealth.com/.

About Clover Health:
Clover Health (Nasdaq: CLOV) is a physician enablement technology company committed to bringing access to great healthcare to everyone on Medicare. This includes a focus on seniors who have historically lacked access to affordable, high-quality healthcare. Our strategy is powered by our software platform, Clover Assistant, which is designed to aggregate patient data from across the healthcare ecosystem to support clinical decision-making and improve health outcomes through the early identification and management of chronic disease. For our members, we provide PPO and HMO Medicare Advantage plans in several states, with a differentiated focus on our flagship wide-network, high-choice PPO plans. For healthcare providers outside Clover Health’s Medicare Advantage plan, we extend the benefits of our data-driven technology platform to a wider audience via our subsidiary, Counterpart Health, and aim to enable enhanced patient outcomes and reduced healthcare costs on a nationwide scale. Clover Health has published data demonstrating the technology’s impact on Medication Adherence, Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, and in Underserved Populations as well as the earlier identification and management of Diabetes and Chronic Kidney Disease.

Investor Relations:
Ryan Schmidt
investors@cloverhealth.com

Press Inquiries:
press@cloverhealth.com

Results of Pivotal ApproaCH Trial of TransCon® CNP (Navepegritide) in Children with Achondroplasia Published in JAMA Pediatrics




Results of Pivotal ApproaCH Trial of TransCon® CNP (Navepegritide) in Children with Achondroplasia Published in JAMA Pediatrics

COPENHAGEN, Denmark, Nov. 17, 2025 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today announced that pivotal Week 52 results from its randomized double-blind, placebo-controlled ApproaCH Trial of investigational once-weekly TransCon^® CNP (navepegritide) in children with achondroplasia have been published in JAMA Pediatrics, a journal of the American Medical Association. In the publication, titled “Once-Weekly Navepegritide in Children with Achondroplasia: The ApproaCH Randomized Clinical Trial,” the authors report that treatment with TransCon CNP led to significantly higher annualized growth velocity (AGV) at Week 52 compared to placebo (primary endpoint), as well as improved lower-limb alignment and body proportionality and positive changes in health-related quality of life, with a safety and tolerability profile similar to placebo. The abstract can be accessed on the JAMA Pediatrics website.

“Children randomized to navepegritide had significantly better growth and improvements in important health outcomes compared with placebo,” said Ravi Savarirayan, MBBS, M.D., Group Leader of Molecular Therapies at Murdoch Children’s Research Institute in Melbourne, Australia. “These findings show that navepegritide is a promising potential new treatment option to reduce the medical burden of this condition, with once-weekly dosing and a low rate of injection site reactions.”

“To help guide their healthcare decision, families want information beyond changes in height to understand how an intervention may affect the potential medical challenges of achondroplasia,” said Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America. “Including these endpoints in blinded, controlled studies, as done in ApproaCH begins to fill that gap, and our community looks forward to seeing more research to deepen understanding in these areas.”

TransCon CNP (navepegritide) is an investigational prodrug of C-type natriuretic peptide (CNP) administered once weekly, designed for continuous inhibition of the overactive FGFR3 pathway in achondroplasia by providing continuous exposure of active CNP to receptors on tissues throughout the body.

ApproaCH was a randomized, double-blind, placebo-controlled trial evaluating TransCon CNP in 84 children with achondroplasia ages 2-11, randomized 2:1 to receive TransCon CNP at the 100 μg/kg/week dose or placebo in the 52-week double-blind period, followed by an open-label extension through Week 104.

In addition to the key primary endpoint of annualized growth velocity (AGV) superior to placebo, favorable impacts on body proportionality and leg bowing were reported at Week 52. These analyses showed treatment with TransCon CNP decreased upper-to-lower body segment ratio from baseline to Week 52 and improved tibial-femoral angle (TFA), mechanical axis deviation (MAD), and fibula-to-tibia length ratio from baseline to Week 52 compared to placebo.

In the trial, treatment with TransCon CNP resulted in numerical improvements in health-related quality of life compared to placebo, as measured across several Achondroplasia Child Experience Measure (ACEM) domains. The benefits of TransCon CNP were achieved without accelerating bone age or negatively affecting spinal curvature. In the trial, TransCon CNP demonstrated a safety and tolerability profile similar to placebo, with the majority of adverse events (AEs) mild or moderate. Injection site reaction rates were low, and no observed symptomatic hypotension or bone fractures were reported.

“Across our development programs for TransCon CNP, we strive to demonstrate benefits that the achondroplasia community have told us are important to them,” said Aimee Shu, M.D., Executive Vice President of Endocrine & Rare Disease Medical Science and Chief Medical Officer at Ascendis Pharma. “We are therefore especially pleased to see these overall results of our pivotal trial for TransCon CNP, including results that go beyond linear growth, published in this prestigious journal.”

TransCon CNP as a potential treatment for children with achondroplasia is under Priority Review by the U.S. Food & Drug Administration (Prescription Drug User Fee Act target date November 30, 2025) and is also under review by the European Medicines Agency.

About Achondroplasia
Achondroplasia is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3 (FGFR3) variant that leads to an imbalance in the effects of the FGFR3 and CNP signaling pathways, estimated to affect more than 250,000 individuals worldwide. While historically considered a bone growth disorder, the FGFR3 variant seen in achondroplasia is expressed in tissues throughout the body, causing serious muscular, neurological, and cardiorespiratory complications in addition to skeletal dysplasia. Medical complications of achondroplasia vary across different stages of life. Throughout infancy and childhood, observed complications include spinal abnormalities, enlarged brain ventricles, impaired muscle strength and stamina, hearing deficits and chronic ear infections, upper airway obstructions, sleep-disordered breathing, hip problems, leg bowing, and chronic pain; many of these persist or worsen in adulthood. These medical complications can have detrimental effects on quality of life, physical functioning, and psychosocial function. Individuals with achondroplasia often require multiple surgeries and procedures to alleviate the condition’s many complications.

About Ascendis Pharma A/S
Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the potential of TransCon CNP (navepegritide) as a new treatment option and its potential to reduce medical burden; (ii) the Prescription Drug User Fee Act target date; (iii) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients; and (iv) Ascendis’ application of its TransCon technologies to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; and the impact of international economic, political, legal, compliance, social and business factors, including tariffs and trade policies. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. © November 2025 Ascendis Pharma A/S.

Invivyd Announces Proposed Public Offering of Common Stock




Invivyd Announces Proposed Public Offering of Common Stock

NEW HAVEN, Conn., Nov. 17, 2025 (GLOBE NEWSWIRE) — Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Invivyd intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the shares of Invivyd common stock sold in the public offering at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by Invivyd. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Cantor is acting as sole book-running manager for the offering.

Invivyd intends to use the net proceeds that it will receive from the offering, together with its existing cash and cash equivalents, for commercial preparedness for the potential launch of VYD2311, continued research and development related to its pipeline programs such as respiratory syncytial virus (RSV) and measles, continued advancement of the Spike Protein Elimination and Recovery (SPEAR) Study Group efforts related to assessing the effects of monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome, and for working capital and other general corporate purposes.

The securities described above are being offered by Invivyd pursuant to a shelf registration statement on Form S-3 (File No. 333-267643) filed with the U.S. Securities and Exchange Commission (SEC) on September 28, 2022 and declared effective by the SEC on October 5, 2022.

The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022; or by e-mail at prospectus@cantor.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

About Invivyd

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.

Trademarks are the property of their respective owners.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the timing, anticipated terms and success of the proposed offering, as well as the anticipated use of the net proceeds from the proposed offering. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Invivyd’s actual results to be materially different than those expressed in or implied by Invivyd’s forward-looking statements. For Invivyd, this includes satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, political uncertainties, stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy, and the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market. Other factors that may cause Invivyd’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the preliminary prospectus supplement relating to the offering to be filed with the SEC, in Invivyd’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed with the SEC, and in Invivyd’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

Contacts:

Media Relations
(781) 208-0160
media@invivyd.com

Investor Relations
(781) 208-1747
investors@invivyd.com

Results of Pivotal ApproaCH Trial of TransCon® CNP (Navepegritide) in Children with Achondroplasia Published in JAMA Pediatrics




Results of Pivotal ApproaCH Trial of TransCon® CNP (Navepegritide) in Children with Achondroplasia Published in JAMA Pediatrics

COPENHAGEN, Denmark, Nov. 17, 2025 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today announced that pivotal Week 52 results from its randomized double-blind, placebo-controlled ApproaCH Trial of investigational once-weekly TransCon^® CNP (navepegritide) in children with achondroplasia have been published in JAMA Pediatrics, a journal of the American Medical Association. In the publication, titled “Once-Weekly Navepegritide in Children with Achondroplasia: The ApproaCH Randomized Clinical Trial,” the authors report that treatment with TransCon CNP led to significantly higher annualized growth velocity (AGV) at Week 52 compared to placebo (primary endpoint), as well as improved lower-limb alignment and body proportionality and positive changes in health-related quality of life, with a safety and tolerability profile similar to placebo. The abstract can be accessed on the JAMA Pediatrics website.

“Children randomized to navepegritide had significantly better growth and improvements in important health outcomes compared with placebo,” said Ravi Savarirayan, MBBS, M.D., Group Leader of Molecular Therapies at Murdoch Children’s Research Institute in Melbourne, Australia. “These findings show that navepegritide is a promising potential new treatment option to reduce the medical burden of this condition, with once-weekly dosing and a low rate of injection site reactions.”

“To help guide their healthcare decision, families want information beyond changes in height to understand how an intervention may affect the potential medical challenges of achondroplasia,” said Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America. “Including these endpoints in blinded, controlled studies, as done in ApproaCH begins to fill that gap, and our community looks forward to seeing more research to deepen understanding in these areas.”

TransCon CNP (navepegritide) is an investigational prodrug of C-type natriuretic peptide (CNP) administered once weekly, designed for continuous inhibition of the overactive FGFR3 pathway in achondroplasia by providing continuous exposure of active CNP to receptors on tissues throughout the body.

ApproaCH was a randomized, double-blind, placebo-controlled trial evaluating TransCon CNP in 84 children with achondroplasia ages 2-11, randomized 2:1 to receive TransCon CNP at the 100 μg/kg/week dose or placebo in the 52-week double-blind period, followed by an open-label extension through Week 104.

In addition to the key primary endpoint of annualized growth velocity (AGV) superior to placebo, favorable impacts on body proportionality and leg bowing were reported at Week 52. These analyses showed treatment with TransCon CNP decreased upper-to-lower body segment ratio from baseline to Week 52 and improved tibial-femoral angle (TFA), mechanical axis deviation (MAD), and fibula-to-tibia length ratio from baseline to Week 52 compared to placebo.

In the trial, treatment with TransCon CNP resulted in numerical improvements in health-related quality of life compared to placebo, as measured across several Achondroplasia Child Experience Measure (ACEM) domains. The benefits of TransCon CNP were achieved without accelerating bone age or negatively affecting spinal curvature. In the trial, TransCon CNP demonstrated a safety and tolerability profile similar to placebo, with the majority of adverse events (AEs) mild or moderate. Injection site reaction rates were low, and no observed symptomatic hypotension or bone fractures were reported.

“Across our development programs for TransCon CNP, we strive to demonstrate benefits that the achondroplasia community have told us are important to them,” said Aimee Shu, M.D., Executive Vice President of Endocrine & Rare Disease Medical Science and Chief Medical Officer at Ascendis Pharma. “We are therefore especially pleased to see these overall results of our pivotal trial for TransCon CNP, including results that go beyond linear growth, published in this prestigious journal.”

TransCon CNP as a potential treatment for children with achondroplasia is under Priority Review by the U.S. Food & Drug Administration (Prescription Drug User Fee Act target date November 30, 2025) and is also under review by the European Medicines Agency.

About Achondroplasia
Achondroplasia is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3 (FGFR3) variant that leads to an imbalance in the effects of the FGFR3 and CNP signaling pathways, estimated to affect more than 250,000 individuals worldwide. While historically considered a bone growth disorder, the FGFR3 variant seen in achondroplasia is expressed in tissues throughout the body, causing serious muscular, neurological, and cardiorespiratory complications in addition to skeletal dysplasia. Medical complications of achondroplasia vary across different stages of life. Throughout infancy and childhood, observed complications include spinal abnormalities, enlarged brain ventricles, impaired muscle strength and stamina, hearing deficits and chronic ear infections, upper airway obstructions, sleep-disordered breathing, hip problems, leg bowing, and chronic pain; many of these persist or worsen in adulthood. These medical complications can have detrimental effects on quality of life, physical functioning, and psychosocial function. Individuals with achondroplasia often require multiple surgeries and procedures to alleviate the condition’s many complications.

About Ascendis Pharma A/S
Ascendis Pharma is a global biopharmaceutical company focused on applying our innovative TransCon technology platform to make a meaningful difference for patients. Guided by our core values of Patients, Science, and Passion, and following our algorithm for product innovation, we apply TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more.

Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) the potential of TransCon CNP (navepegritide) as a new treatment option and its potential to reduce medical burden; (ii) the Prescription Drug User Fee Act target date; (iii) Ascendis’ ability to apply its TransCon technology platform to make a meaningful difference for patients; and (iv) Ascendis’ application of its TransCon technologies to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: dependence on third party manufacturers, distributors and service providers for Ascendis’ products and product candidates; unforeseen safety or efficacy results in Ascendis’ development programs or on-market products; unforeseen expenses related to commercialization of any approved Ascendis products; unforeseen expenses related to Ascendis’ development programs; unforeseen selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; Ascendis’ ability to obtain additional funding, if needed, to support its business activities; and the impact of international economic, political, legal, compliance, social and business factors, including tariffs and trade policies. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on February 12, 2025, and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law.

Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, and TransCon are trademarks owned by the Ascendis Pharma group. © November 2025 Ascendis Pharma A/S.

Invivyd Announces Proposed Public Offering of Common Stock




Invivyd Announces Proposed Public Offering of Common Stock

NEW HAVEN, Conn., Nov. 17, 2025 (GLOBE NEWSWIRE) — Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Invivyd intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the shares of Invivyd common stock sold in the public offering at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by Invivyd. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Cantor is acting as sole book-running manager for the offering.

Invivyd intends to use the net proceeds that it will receive from the offering, together with its existing cash and cash equivalents, for commercial preparedness for the potential launch of VYD2311, continued research and development related to its pipeline programs such as respiratory syncytial virus (RSV) and measles, continued advancement of the Spike Protein Elimination and Recovery (SPEAR) Study Group efforts related to assessing the effects of monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome, and for working capital and other general corporate purposes.

The securities described above are being offered by Invivyd pursuant to a shelf registration statement on Form S-3 (File No. 333-267643) filed with the U.S. Securities and Exchange Commission (SEC) on September 28, 2022 and declared effective by the SEC on October 5, 2022.

The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022; or by e-mail at prospectus@cantor.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

About Invivyd

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.

Trademarks are the property of their respective owners.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the timing, anticipated terms and success of the proposed offering, as well as the anticipated use of the net proceeds from the proposed offering. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Invivyd’s actual results to be materially different than those expressed in or implied by Invivyd’s forward-looking statements. For Invivyd, this includes satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, political uncertainties, stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy, and the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market. Other factors that may cause Invivyd’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the preliminary prospectus supplement relating to the offering to be filed with the SEC, in Invivyd’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed with the SEC, and in Invivyd’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

Contacts:

Media Relations
(781) 208-0160
media@invivyd.com

Investor Relations
(781) 208-1747
investors@invivyd.com

Kraig Biocraft Laboratories Fulfilling Order for Customized Spider Silk Application from Leading Performance Sports Brand




Kraig Biocraft Laboratories Fulfilling Order for Customized Spider Silk Application from Leading Performance Sports Brand

Company to deliver spider silk yarns for elite-tier athletic application

ANN ARBOR, Mich., Nov. 17, 2025 (GLOBE NEWSWIRE) — Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) (“Company” or “Kraig Labs”), a world leader in spider silk technology*, today announced that it is fulfilling an order for spider silk from a globally recognized performance sports apparel brand as part of a confidential pilot development program.

This project will incorporate the Company’s next-generation recombinant spider silk into a cutting-edge application targeted at the highest tier of performance apparel. While specific project details remain protected, Kraig Labs can confirm that the program is designed for one of the most demanding and innovation-focused segments of the athletic market.

This customer’s market leadership, engineering sophistication, and reputation for excellence in performance apparel made them the ideal choice for this initial pilot engagement. Their market leadership and commitment to innovation is the reason Kraig Labs selected to fulfill this request from among the numerous recent inbound inquiries it received.

The Company is now processing a portion of its recombinant spider silk inventory into yarns tailored to the precise specifications provided by the customer’s development team. Delivery of these specialized materials is expected before the end of the first quarter.

As a focused pilot program, this order calls for a small, purpose-built quantity of spider silk designed explicitly for this highly specialized application. Even at this limited scale, the project provides a powerful platform for demonstrating the performance capabilities and commercial potential of the Company’s specialized spider silk technology within a premier performance environment.

“This collaboration underscores the growing recognition of our material’s potential in high-value, high-performance applications,” said Kim Thompson, Kraig Labs’ Founder and CEO. “We are excited to support this project and a customer whose commitment to innovation aligns with our own. We look forward to showcasing what our spider silk can deliver at the elite level of apparel design and performance.”

Kraig Labs will share additional updates as appropriate and consistent with the confidentiality terms of the agreement.

For the latest updates on Kraig Labs and its pioneering spider silk technologies, visit www.kraiglabs.com.

For details about other recent Kraig Labs advancements, please watch the Company’s investor conference at www.kraiglabs.com/videos or on the Company’s YouTube Channel https://www.youtube.com/@kraigbiocraftlaboratories2270.

To view the most recent news from Kraig Labs and/or to sign up for Company alerts, please go to www.KraigLabs.com/news   

* For a description of our historical leadership in this technology, please follow this link https://www.kraiglabs.com/world-leader/

About Kraig Biocraft Laboratories, Inc.

Kraig Biocraft Laboratories, Inc. (www.KraigLabs.com), a reporting biotechnology company is the leading developer of genetically engineered spider silk-based fiber technologies.

The Company has achieved a series of scientific breakthroughs in the area of spider silk technology with implications for the global textile industry.

Cautionary Statement Regarding Forward Looking Information

Statements in this press release about the Company’s future and expectations other than historical facts are “forward-looking statements.” These statements are made on the basis of management’s current views and assumptions. As a result, there can be no assurance that management’s expectations will necessarily come to pass. These forward-looking statements generally can be identified by phrases such as “believes,” “plans,” “expects,” “anticipates,” “foresees,” “estimated,” “hopes,” “if,” “develops,” “researching,” “research,” “pilot,” “potential,” “could” or other words or phrases of similar import. Forward looking statements include descriptions of the Company’s business strategy, outlook, objectives, plans, intentions and goals. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements. This press release does not constitute an offer to sell or the solicitation of an offer to buy any security.

Ben Hansel, Hansel Capital, Inc.

(720) 288-8495

ir@KraigLabs.com

Protext Mobility, Inc. (OTC: TXTM) Announces Strategic TruLeaf Partnership & Next-Level Innovation




Protext Mobility, Inc. (OTC: TXTM) Announces Strategic TruLeaf Partnership & Next-Level Innovation

FORT LAUDERDALE, Fla., Nov. 17, 2025 (GLOBE NEWSWIRE) — Protext Mobility, Inc. (OTC: TXTM) (“Protext” or the “Company”) is proud to announce a strategic Letter of Intent (LOI) with TruLeaf, marking a pivotal moment in the company’s growth and mission. This partnership not only accelerates technology adoption and market expansion but also opens the door to innovative financial applications leveraging CBD-based assets.

Highlights:

• TruLeaf provides strategic support, including product samples, initial inventory shipments, infrastructure support, and operational resources.
• Perfect synergy: TruLeaf’s nanotechnology enhances TXTM’s kettle technology, significantly increasing bioavailability. Products are cheaper, faster-acting, and more effective, benefiting patients worldwide.
• TruLeaf’s natural CBD FECO without THC, combined with Farm Bill compliance, provides a regulatory and competitive advantage.
• The resulting API (active pharmaceutical ingredient) and mg quantities of CBD can be treated as real-world assets (RWA) on the company’s balance sheet, recognized under IFRS/GAAP as income/gain, strengthening net profit without cash outflow.
• These assets could potentially support the creation of a stablecoin, enabling future staking, investment, or liquidity applications — a true financial innovation benefiting all shareholders.
• This partnership is aligned with TXTM Tribe Mission: raising all boats by improving patient outcomes, advancing global healing, and creating shareholder value.

Strategic Rationale

1. Technological Synergy & Bioavailability
   • TruLeaf’s nanotechnology complements TXTM’s kettle technology.
   • Dramatically increases bioavailability, improving effectiveness and speed of action for patients.
   • Reduces production costs, enhancing shareholder value.
   • Supports the mission of global healing and patient wellbeing.
2. Regulatory & Competitive Advantage
   • THC-free CBD FECO aligns with Farm Bill compliance.
   • Provides a clear market differentiation and competitive edge.
3. Financial Strengthening & Asset Potential
   • CBD API is a real-world asset (RWA) recognized under IFRS/GAAP as income/gain.
   • Strengthens balance sheet, net profit, and potential share price.
   • RWA could support innovative stablecoin creation or staking mechanisms, creating new financial opportunities for the company and shareholders.
4. Market Validation & Mission Impact
   • TruLeaf’s support is a vote of confidence from a successful, established partner.
   • Accelerates growth, operational scaling, and market entry.
   • Delivers meaningful impact for patients and the TXTM Tribe Mission: “raising all boats.”

Dylon Du Plooy, CEO, mentioned:

“This is a landmark moment for TXTM. TruLeaf’s nanotechnology enhances our kettle technology, dramatically increasing bioavailability, making our products more effective, faster, and more affordable for patients. The resulting API is a real-world asset on our balance sheet, recognized as income/gain, and has the potential to support stablecoin creation for staking or investment — a transformative financial innovation. Combined with THC-free CBD FECO and Farm Bill compliance, we now have a regulatory and competitive advantage. This partnership accelerates growth, strengthens our market position, and aligns perfectly with the TXTM Tribe Mission: raising all boats, for shareholders, patients, and global healing.”

About Protext Mobility, Inc. (OTC: TXTM)

Protext Mobility is focused on the research, testing, and development of highly bioavailable, nanotechnology-based botanical formulations for nutraceutical and pharmaceutical applications. Through proprietary live plant extraction technologies, the company aims to advance plant-based therapeutics that address wellness and health needs globally.

Investor & Media Contact:
Dylon Du Plooy – dylon@rsammd.co.za
Dr. J – exportintl@aol.com

Follow Us:
X (Twitter): https://x.com/ProtextP

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws. Actual results may differ materially due to market conditions, foreign exchange fluctuations, operational execution, regulatory requirements, and other risks detailed in the Company’s filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements.

Neocis Unveils Next-Generation AI-Powered Robotic System for Dental Implants




Neocis Unveils Next-Generation AI-Powered Robotic System for Dental Implants

Yomi® S and YomiPlan® AI Platform Now FDA-Cleared, Offering Unprecedented Precision, Efficiency, and Access for Dentists and Patients

MIAMI, Nov. 17, 2025 (GLOBE NEWSWIRE) — Neocis^®, the pioneer behind the first and only U.S. FDA-cleared robotic system for dental implant surgery, today announced the launch and FDA approval of its next-generation robotic platform: Yomi S. The new system, powered by advanced AI software YomiPlan, redefines what’s possible in dental surgery—delivering surgical precision, streamlined workflows, and high-quality patient outcomes.

Designed for maximum efficiency and minimal invasiveness, Yomi S can now be operated by a single practitioner via foot pedal and touchscreen—freeing up staff resources and making robotic-assisted implant surgery more accessible to general dentists. The system features a smaller footprint, enhanced dexterity, better visibility, and a new AI-powered planning suite that automates complex preoperative tasks.

Unlocking Growth for Dentists, Better Outcomes for Patients
Nearly 200 million Americans are missing at least one tooth, and one-third of adults over 65 need full-arch replacement. Traditional implant surgery is often time-consuming and costly, limiting patient access. Yomi S changes that.

For dentists, the Yomi S platform creates new opportunities to expand practice offerings and drive revenue:

• Single-Operator Workflow: Enhanced automation allows one clinician to manage the procedure, reducing operational overhead.
• YomiPlan AI: Proprietary machine learning algorithms automate segmentation of critical anatomy (e.g., nerves, sinuses) from CBCT scans, dramatically speeding up the planning phase.
• Versatile Use Cases: In addition to implants, Yomi S unlocks new applications that will vastly expand the market opportunity beyond dental implants.
• Compliant and Secure: YomiPlan meets the latest FDA standards for cybersecurity and medical software, ensuring safety in connected clinical environments.

“Yomi S simplifies procedures thanks to excellent robotic range of motion, extended reach, touchscreen, and voice commands, while maintaining superior accuracy,” says Dr. Jay Neugarten, DDS, MD, FACS. “I approach each patient with the same care I would give my mother. With the capabilities of Yomi S, I am committed to providing exceptional quality treatment that every patient deserves.”

Making Minimally Invasive, Same-Day Implants a Reality

Patients benefit significantly from Yomi S’s minimally invasive, flapless approach. By reducing incisions and surgical time, the system helps shorten recovery periods and reduce discomfort.

With real-time AI-guided navigation through the entire implant planning, imaging and surgical process, Yomi S supports safer implant procedures—automatically highlighting dental nerves and other vital structures, much like lane-assist features in modern vehicles.

“Yomi was totally painless and it’s more precise than a human being would be. I’ve had an implant before on the other side with a different doctor and without this technology – and this one was so much easier,” said Yomi patient Anders Brag. “The results were terrific and I really didn’t feel anything afterwards – and in my prior experience I had pain.”

“Yomi S isn’t just groundbreaking for dental robotics; it sets a new standard for robotic surgery in general. With ease of use as the primary focus, Yomi S enables every dental practice to integrate robotics into their workflow” said Alon Mozes, founder and CEO of Neocis. “We’ve combined robotic precision with an intuitive, surgeon-friendly design to make implant surgery faster and more accessible than ever before. Yomi has nearly completed 100,000 osteotomies, and we’re excited to accelerate growth with Yomi S to deliver the best care to patients everywhere.”

About Yomi
The Yomi robotic system is a computerized robotic navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoloplasty) of the mandible and/or maxilla. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

Since 2016, Yomi has been helping clinicians around the country plan and place dental implants with a high level of precision and efficiency, so they can operate with confidence, expand their practices, and deliver an excellent patient experience. The platform has assisted in the placement of nearly 100,000 implants.

About Neocis
Neocis is transforming dental surgery with robotics. The company collaborates closely with leading clinicians to develop innovative technologies that help advance patient care and improve quality of life. Based in Miami, Neocis is venture-backed with funding from Mirae Asset Financial Group, NVentures, Intuitive Ventures, DFJ Growth, Mithril Capital Management, Norwest Venture Partners, Vivo Capital, Section 32, and surgical robotics pioneer Fred Moll. For more information, visit neocis.com.

Contact
For more information, please contact the Neocis media relations team at info@neocis.com.

Raphael Pharmaceutical Announces Filing of Provisional Patent Application for the Treatment of Neutrophil-Dominant Autoimmune Diseases, Including Rheumatoid Arthritis (RA)




Raphael Pharmaceutical Announces Filing of Provisional Patent Application for the Treatment of Neutrophil-Dominant Autoimmune Diseases, Including Rheumatoid Arthritis (RA)

NEW YORK, Nov. 17, 2025 (GLOBE NEWSWIRE) — Raphael Pharmaceutical Inc. (“Raphael Pharmaceutical” or the “Company”) (OTCQB: RAPH), a clinical-stage biotechnology company developing an innovative research platform based on cannabinoids free of THC and CBD, today announced the filing of a provisional patent application with the United States Patent and Trademark Office.

The application covers the use of the Company’s highly purified cannabinoid-based technology platform in the treatment of neutrophil-dominant autoimmune diseases, including its lead product candidate for rheumatoid arthritis (RA), as well as psoriatic arthritis, inflammatory bowel disease, systemic lupus erythematosus with neutrophil involvement, and gout.

Raphael previously announced positive proof-of-concept clinical study results for its cannabinoid-based formula for the management of RA. The study was successfully completed in the United States under Institutional Review Board (“IRB”) approval and in compliance with U.S. Food and Drug Administration (“FDA”) regulations. No adverse effects were reported throughout the trial.

The provisional patent application, titled, “Raphael Pharmaceutical, Inc. / Rambam MedTech Formula for Treating Neutrophil-Dominant Autoimmune Diseases (including RA)” (No. 63/911,729), was filed jointly with the Medical Cannabis Research and Innovation Center (MCRIC) at Rambam Health Care Campus – one of the world’s leading university hospitals.

Raphael and Rambam have collaborated under a sponsored research agreement signed in 2019, granting Raphael exclusive access to Rambam’s world-class cannabinoid research and development program, led by Dr. Igal Louria-Hayon, who serves as both Chief Technology Officer (CTO) of Raphael and Head of the Medical Cannabis Research and Innovation Center at Rambam Health Care Campus.

Dr. Louria-Hayon is a global expert in cannabinoid research and cell-to-cell communication.  

“The filing of this provisional patent application represents a major milestone for Raphael and our partner Rambam,” said Shlomi Pilo, President and CEO of Raphael Pharmaceutical. “It is a critical step forward in protecting our innovative cannabinoid-based technology platform and moving toward the initial launch of our commercial product “RaphaWell,” which is designed for targeted, orally accessible delivery to patients within the RA community in the U.S.”

Dr. Louria-Hayon added, “Based on our research to date, we believe Raphael Pharmaceutical’s proprietary formula has the potential to offer a safe and cost-effective option that significantly reduces inflammation, and severe symptoms for millions of people suffering from rheumatoid arthritis.   As reflected in the scope of the provisional patent, we also believe this highly purified cannabinoid platform may have broader applications in other chronic inflammatory conditions.”

Key Findings from the Proof-of-Concept Clinical Study

Raphael Pharmaceutical utilizes a highly purified cannabinoid formulation derived from the hemp plant, entirely free of psychoactive cannabis components, with exceptional anti-inflammatory potential.

The formulation is administered orally and demonstrated no side effects.

It is designed to interact with the human endocannabinoid system by activating cannabinoid receptors expressed on immune cells.

In 2025, the Company announced positive Proof-of-Concept clinical results for the use of its cannabinoid-based formula in the treatment of RA.

The eight-week IRB-approved study conducted in the United States showed significant improvements in pain, sleep quality, and overall well-being, which became evident as early as week four and persisted through the end of the trial.

This included a reduction in DAS28 scores from high disease activity to moderate disease severity.

About Raphael Pharmaceutical Inc.

Raphael Pharmaceutical Inc. (“Raphael”) (OTCQB: RAPH) is a clinical-stage biotechnology company focused on developing an innovative research platform based on THC-free and CBD-free cannabinoids for the treatment of inflammatory diseases.   The Company’s lead product candidate, RaphaWell, is a highly purified non-psychoactive cannabinoid formulation developed for targeted, orally accessible delivery to patients, designed specifically for the treatment of rheumatoid arthritis, with no reported side effects.

For more information, please visit: https://www.raphaelpharmaceutical.com/

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.   These statements are based on current expectations, assumptions, and projections about the Company’s business and are not guarantees of future performance.   Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those expressed or implied herein.   Additional information about the risks facing the Company’s business is available in its most recent Annual Report on Form 10-K and subsequent filings on Forms 10-Q and 8-K with the U.S. Securities and Exchange Commission (SEC).   Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.

Investor Contact:

The Equity Group        
Devin Sullivan
Managing Director                
T: (212) 836-9608        
dsullivan@theequitygroup.com

Conor Rodriguez
Associate        
T: (212) 836-9628        
crodriguez@theequitygroup.com