Citryll Presents Positive Data from Phase I Study of CIT-013 in Rheumatoid Arthritis at ACR Convergence 2025




Citryll Presents Positive Data from Phase I Study of CIT-013 in Rheumatoid Arthritis at ACR Convergence 2025

CITRYLL PRESENTS POSITIVE DATA FROM PHASE I STUDY OF CIT-013 IN RHEUMATOID ARTHRITIS AT ACR CONVERGENCE 2025

• Phase I trial data in rheumatoid arthritis patients demonstrates favorable safety, encouraging clinical activity, and robust biomarker responses
• Data provides strong validation for the advancement of CIT-013 into Phase IIa studies

Oss, Netherlands – 27 October 2025 – Citryll, a biotech company pioneering a transformative approach to treating immune-mediated inflammatory diseases by targeting Extracellular Traps (ETs), has shared positive data from its first-in-human Phase I clinical trial of CIT-013 in participants with rheumatoid arthritis (RA) and healthy volunteers, as well as data from preclinical studies in three posters at the American College of Rheumatology (ACR) Convergence 2025, currently underway in Chicago.

The featured poster highlights findings from Citryll’s Phase I clinical trial of CIT-013 in participants with RA and healthy volunteers, which demonstrated that CIT-013 was generally well tolerated across all participants, with no serious treatment-related events reported. Importantly, clinically meaningful reductions in disease activity were seen in all active RA participants treated with CIT-013.

Two additional posters provided details from preclinical studies supporting the clinical program. The first outlines the use of radiolabelled CIT-013 as an imaging tool, with data indicating CIT-013 is a targeted therapy which accumulates specifically in inflamed tissue. The second evaluates calprotectin as a biomarker of disease activity, with a correlation seen between treatment response and serum calprotectin levels, supporting its use as a biomarker in RA.

Maarten Kraan, Chief Medical Officer of Citryll, commented, “Together, this data provides a compelling picture of CIT-013’s potential as a first-in-class therapeutic targeting ETs for the treatment of RA and other immune-mediated diseases. We are encouraged by the favorable safety and early efficacy signals observed in our Phase I study, validating our decision to advance CIT-013 through to Phase IIa studies. Additionally, the expanding body of translational evidence supports ET inhibition as a potential treatment option in autoimmune and inflammatory disease, strengthening our confidence in the ongoing clinical development program.”

A Phase IIa study – Citydream – is currently underway in RA, with an additional Phase IIa trial in hidradenitis suppurativa expected to start later this year.

POSTER DETAILS

Poster 1: Phase I Trial in Participants with Rheumatoid Arthritis and Healthy Volunteers with CIT-013, a First in Class NETosis Inhibitor
Date: 26 October 2025
Session: Rheumatoid Arthritis – Treatment Poster I
Abstract Number: 0493

Poster 2: Calprotectin Serum Levels: a potential neutrophil activation biomarker to monitor treatment response in Rheumatoid Arthritis
Date: 26 October 2025
Session: Rheumatoid Arthritis – Diagnosis, Manifestations, and Outcomes Poster I
Abstract Number: 0431

Poster 3: Radiolabelled anti-citrullinated histone antibody CIT-013 as a tool to visualize NET-rich inflamed joints in a collagen induced arthritic mouse model
Date: 27 October 2025
Session: Innate Immunity Poster
Abstract Number: 0928

-ENDS-

About CIT-013

CIT-013 is Citryll’s first-in-class monoclonal antibody targeting Extracellular Traps (ETs), a key driver of inflammation in RA and other immune-mediated diseases, which has yet to be addressed therapeutically. It has a unique dual mechanism of action, which enhances the clearance of existing ETs and inhibits the formation of new ETs. CIT-013 is highly selective for its epitope, minimizing off-target effects and representing a potentially transformative therapeutic strategy, going beyond individual pathway management and symptom treatment.

About Citryll

Citryll is pioneering a transformative approach to treating inflammatory diseases by targeting Extracellular Traps (ETs), a fundamental component of the inflammatory process that has yet to be addressed therapeutically.

Citryll is developing the first ET-targeting therapy and potentially creating a new class of therapeutics with broad applications across immune-mediated inflammatory diseases.

Our lead asset, CIT-013, is a first-in-class monoclonal antibody with a unique dual mechanism of action: it enhances the clearance of existing ETs and inhibits the formation of new ETs.

By addressing this key driver of inflammation, CIT-013 has the potential to offer a differentiated and comprehensive treatment option for conditions such as rheumatoid arthritis and hidradenitis suppurativa, where current therapies often fall short of providing adequate disease control.

Contacts

Citryll
Sjoerd van Gorp, COO / CFO
Email: info@citryll.com

Citryll Media Contacts
ICR Healthcare
Amber Fennell, Stephanie Cuthbert, Lucy Featherstone
Email: citryll@icrinc.com

World’s First Multi-Omics LLM, Promising to Decode the Language of Human Biology Showcasing in Global Health Exhibition, Riyadh




World’s First Multi-Omics LLM, Promising to Decode the Language of Human Biology Showcasing in Global Health Exhibition, Riyadh

PanOmiQ’s foundational model trained on multi-Omics data breakthrough FPGA-powered deployment addresses data sovereignty challenge, ultrafast AI-driven multi-omics analysis on premises, redefining speed and accuracy in precision medicine

DUBAI, United Arab Emirates, Oct. 27, 2025 (GLOBE NEWSWIRE) — For the first time, the human body’s most complex data—the intricate conversations between our genes, proteins, and metabolites—can be understood not as isolated signals, but as a coherent language. Today, BioAro Inc. announces a historic leap in artificial intelligence: the world’s first large language model (LLM) built on unified multi-omics data. This core ‘The BioIntelligence™’ powers its flagship platform, PanOmiQ™, which will be showcased at the Global Health Exhibition – Riyadh, offering a new paradigm where biology is not just measured, but truly understood.

The central failure of modern medicine is fragmentation. We drown in data—genomic snapshots, proteomic profiles, metabolomic readouts—but lack the translator to make sense of their collective story. This siloed approach keeps the origins of complex diseases like cancer and diabetes locked away, delaying cures and personalizing care.

PanOmiQ™ shatters these siloes. Its multi-omics LLM, trained on the complete lexicon of human biology, deciphers the subtle, non-linear interactions that define health and disease. It doesn’t just analyze data points; it interprets the biological narrative, uncovering root causes and predictive insights with a speed and clarity previously unimaginable.

“We have moved from counting words to understanding poetry—the poetry written in the language of our own cells,” said Dr. Anmol Kapoor, Founder and CEO of BioAro. “The core of a new health ecosystem is ‘The BioIntelligence™’. It transforms disconnected data into a coherent dialogue between patients and their own biology, finally making proactive, predictable health a practical reality.”

A Sovereign Fortress for the Most Personal Data

Recognizing that the most sensitive data—our genetic blueprint—demands the highest security, BioAro engineered PanOmiQ™ for on-premises deployment. Leveraging a powerful fusion of FPGA acceleration and GPU computing, the platform operates as a self-contained intelligence unit within a hospital or lab’s own walls.

• Your Data Never Leaves: In an era of cloud vulnerabilities, PanOmiQ™ guarantees absolute data sovereignty. It ensures full compliance with GDPR, HIPAA, and local regulations, keeping the world’s most personal information securely on-site.
• Speed Where It Matters Most: By processing data at the edge, the platform eliminates the critical delays of cloud uploads. What takes weeks with traditional, disconnected tools, PanOmiQ™ achieves in hours, through parallel processing and accelerating time-to-treatment and discovery.
• Genuinely Certified Accuracy: The platform has achieved 100% accuracy in CAP proficiency testing, ensuring that its revolutionary speed is matched by unwavering reliability using standard guidelines.

The BioIntelligence™ Ecosystem: A Unified Front for Healthcare

Powered by the core multi-omics LLM, The BioIntelligence™ fuels a suite of specialized tools that work in concert:

• Genelio™: This is where the magic of the LLM becomes personal. Genelio™ allows individuals to have a natural, chat-based conversation with their own genomic and health data. Users can ask questions like “Why do I have a higher risk for heart disease?” or “What does this genetic variant mean for my children?” and receive clear, conversational answers drawn directly from their unique biological profile, making complex science accessible and empowering.
• PanAUM™: An AI-powered in silico drug discovery environment that predicts molecular interactions and accelerates the identification of therapeutic candidates.
• BioLIMS™: A next-generation end-to-end lab system that seamlessly feeds structured data into the analytic engine.
• BioELR™: Connects wearables, sensors, and health apps to provide real-time, AI-driven insights for chronic disease management and preventive care.

Introducing the Axion™ – The BioIntelligence Series

To power this ecosystem at scale, Axion™ Series — a proprietary family of intelligent hardware systems designed to deliver on-premises, FPGA-accelerated, and sovereign AI computation for healthcare and research environments.

The Axion™ line — Core, Ultra, and Supreme — enables hospitals, research institutes, and national health programs to deploy technology seamlessly, with each tier tailored for varying operational and data processing needs.

Together, Axion™ and PanOmiQ™ redefine speed, sovereignty, and scalability — ensuring that the future of medicine can operate anywhere, securely and intelligently.

“For the UAE and the wider Gulf region, which prioritizes both technological leadership and data sovereignty, this is a transformative solution,” said Bader Al-Marzooqi, a leading Emirati health-tech investor. “BioAro isn’t just importing technology; they are delivering a sovereign capability that aligns with our national vision for a secure, innovative, and proactive healthcare future. It empowers our clinicians and protects our citizens’ data simultaneously.”

Showcasing at Global Health Exhibition – Riyadh

At the Global Health Exhibition in Riyadh, BioAro will demonstrate the power of ecosystem — featuring a live conversation with Genelio™, and real-time multi-omics analysis through PanOmiQ™.

“We are not just launching a product; we are igniting a movement — from reactive guesswork to proactive, intelligent health,” said Dr. Kapoor. “The future of medicine speaks the language of life itself, and we are proud to give it a voice in Riyadh.”

About BioAro Inc.
BioAro Inc. is a Canada-based software and biotechnology company building the future of intelligent, sovereign health. Its mission is to unify biology and data science through The Bio Intelligence™, bridging the gap between complex molecular information and actionable, personalized health insights.

Media Contact:
Mohini
Email: mohini@bioaro.com
Phone: +1-403-250-2221

For more information, please visit: www.PanOmiQ.com | www.BioAro.com

Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/83d816d2-5608-4ef8-a36f-bf9d55cda525
https://www.globenewswire.com/NewsRoom/AttachmentNg/18aa3fb2-b13e-4a25-a7cb-4557cba39e89

Genenta Announces Pricing of $15.0 Million Registered Direct Offering of American Depositary Shares




Genenta Announces Pricing of $15.0 Million Registered Direct Offering of American Depositary Shares

MILAN and NEW YORK, Oct. 27, 2025 (GLOBE NEWSWIRE) — Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology, today announced that it has entered into a securities purchase agreement with institutional investors to purchase 4,285,715 American Depositary Shares (“ADSs”) at an offering price of $3.50 per ADS, for gross proceeds of approximately $15.0 million, before deducting placement agent fees and other estimated offering expenses. All of the securities in the offering were sold by Genenta, and no warrants or other derivative securities were issued in connection with this offering.

Maxim Group LLC is acting as lead placement agent for the offering, and Rodman & Renshaw LLC is acting as co-placement agent for the offering.

Genenta intends to use the net proceeds from the offering for working capital and general corporate purposes. The offering is expected to close on or about October 28, 2025, subject to the satisfaction of customary closing conditions.

The securities described above are being offered pursuant to a shelf registration statement on Form F-3 (File No. 333-271901) previously filed with the U.S. Securities and Exchange Commission (“SEC”) and declared effective on May 24, 2023. A prospectus supplement relating to the securities to be issued in the offering will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or by contacting Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Syndicate Department, or via email at syndicate@maximgrp.com or by telephone at (212) 895-3745., or from Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540-4414, or by email at info@rodm.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 Genenta Science
Genenta Science (Nasdaq: GNTA) is a clinical stage immuno-oncology company developing a proprietary hematopoietic stem cells therapy for the treatment of a variety of solid tumor cancers. Genenta’s first in class product candidate is Temferon™, which is designed to allow the expression of immune-therapeutic payloads within the tumor microenvironment by bone marrow derived myeloid cells and enable a durable and targeted response. Genenta has completed the Phase 1 trial for newly diagnosed Glioblastoma Multiforme (GBM) patients with an unmethylated MGMT gene promoter, which suggests the potential reprogramming of the tumor microenvironment and inhibiting of myeloid induced tolerance, while allowing the induction of T cell responses, potentially breaking immune tolerance. Genenta has initiated a Phase 1/2a metastatic Renal Cell Carcinoma study that will also include a combination with immune checkpoint inhibitors. Genenta’s treatments are designed as one-time monotherapies, but with the additional potential, when used in combination, to significantly enhance the efficacy of other approved therapeutics.

Forward-Looking Statements
Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Genenta’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the expected completion, timing and size of the offering, Genenta’s intended use of the proceeds from the offering, the funding provided by the recently acquired Mandatory Convertible Bond, the completion and timing of Genenta’s ongoing Phase 1/2a clinical trial for newly diagnosed GBM patients with uMGMT-GBM, its clinical trial for metastatic RCC or any related studies, as well as Genenta’s ability to fund its research and development plans. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Genenta’s Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of the date of this announcement, and Genenta undertakes no duty to update such information except as required under applicable law. This press release discusses product candidates that are under preclinical or clinical evaluation and that have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. Until finalized in a clinical study report, clinical trial data presented herein remain subject to adjustment as a result of clinical site audits and other review processes. No representation is made as to the safety or effectiveness of these product candidates or the use for which such product candidates are being studied. Temferon™ is an investigational product candidate for which the effectiveness and safety have not been established. In addition, Temferon™ is not approved for use in any jurisdiction.

Genenta Science Media
Tiziana Pollio, Mobile: +39 348 23 15 143
E-mail: tiziana.pollio@genenta.com

Health Canada Grants Authorization for “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease




Health Canada Grants Authorization for “LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease

In Canada, lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes and who have confirmed amyloid pathology

TOKYO and CAMBRIDGE, Mass., Oct. 26, 2025 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI^®” (lecanemab) for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes and who have confirmed amyloid pathology. LEQEMBI is the first treatment for early AD that targets an underlying cause of the disease, to be authorized in Canada.

LEQEMBI selectively binds to soluble Aβ aggregates (protofibrils**), as well as insoluble Aβ aggregates (fibrils) which are a major component of Aβ plaques, thereby reducing both Aβ protofibrils and Aβ plaques in the brain. LEQEMBI is the first approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with AD. LEQEMBI is also approved in 51 countries and regions including Japan,¹ the United States,² Europe,³ China,⁴ South Korea,⁵ Taiwan,⁶ and SaudiArabia,⁷ and applications have been filed in 9 countries.

The approval of LEQEMBI is based on the large global Phase 3 Clarity AD study. In the Clarity AD study, LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results.^8,9 LEQEMBI has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Eisai plans to submit clinical assessment data captured from participants in real-world clinical practice.

AD is the most common form of dementia, accounting for 60 to 80% of all cases.¹⁰ As of January 1, 2025, it is estimated there are more than 771,000 patients with dementia in Canada, which is expected to increase to approximately 1 million in 2030 and over 1.7 million in 2050.¹¹ In addition, annual care provided by family and friends for those with dementia is equivalent to 290,000 full-time jobs, which is expected to increase to 690,000 full-time jobs in 2050.¹¹

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. In Canada, Eisai Limited will distribute the product and conduct information provision activities. Eisai and Biogen are committed to working together with healthcare professionals and other stakeholders towards the early treatment of AD.

* Apolipoprotein E is a protein involved in the metabolism of lipid in humans. It is implicated in AD. People with only one (heterozygous) or no copy (non-carriers) of the ApoE ε4 gene are less likely to experience ARIA than people with two ApoE ε4 copies (homozygous).¹²
** Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.¹³ Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.¹⁴

Notes to Editors

1.  About lecanemab (generic name, brand name: LEQEMBI^®)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

LEQEMBI’s approvals in these countries was based on Phase 3 data from Eisai’s, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results.^8,9 The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). In the Clarity AD clinical trial, treatment with LEQEMBI reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo. The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with LEQEMBI and 1.66 with placebo (difference, −0.45; 95% confidence interval [CI], −0.67 to −0.23; P<0.001). In addition, the secondary endpoint from the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL), which measures information provided by people caring for patients with AD, noted a statistically significant benefit of 37% compared to placebo. The adjusted mean change from baseline at 18 months in the ADCS-MCI-ADL score was −3.5 in the LEQEMBI group and −5.5 in the placebo group (difference, 2.0; 95% CI, 1.2 to 2.8; P<0.001). The ADCS MCI-ADL assesses the ability of patients to function independently, including being able to dress, feed themselves and participate in community activities. The most common adverse events (>10%) in the LEQEMBI group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

LEQEMBI is approved in 51 countries and regions including Japan,¹ the United States,² Europe,³ China,⁴ South Korea,⁵ Taiwan,⁶ and SaudiArabia,⁷ and applications have been filed in 9 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in the U.S. and China, and others, and applications have been filed in 5 countries and regions.

LEQEMBI’s approvals in these countries was based on Phase 3 data from Eisai’s, global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB).^8,12 The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In September 2025, the rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with LEQEMBI IQLIK was also initiated.

Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

2.  About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

3.  About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.

4.  About Eisai Co., Ltd.
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai, Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on X (global and U.S), LinkedIn (for global, U.S. and EMEA) and Facebook (global).

5.   About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (LEQEMBI); the potential benefits, safety and efficacy of LEQEMBI; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer’s disease; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including  lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements. 

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements. 

References

1. Reuters. 2023. Japan approves Alzheimer’s treatment Leqembi by Eisai and Biogen. Last accessed: July 2025.
2. U.S. Food and Drug Administration. 2023. FDA Converts Novel Alzheimer’s Disease Treatment to Traditional Approval. Last accessed: July 2025.
3. Reuters. 2025. EU authorizes Eisai-Biogen’s drug for early Alzheimer’s treatment. Last accessed: October 2025.
4. The Pharma Letter. 2024. Brief – Alzheimer drug Leqembi now approved in China. Last accessed: July 2025.
5. Pharmaceutical Technology. 2024. South Korea’s MFDS approves Eisai-Biogen’s LEQEMBI for Alzheimer’s. Last accessed: July 2025.
6. Taiwan Food and Drug Administration Assessment Report. http://bit.ly/454Oawe. Last accessed: July 2025.
7. Saudi Food & DrugAuthority. 2025. SFDA Approves the Registration of “Leqembi” as the First Alzheimer’s Treatment in Saudi Arabia. Last accessed: August 2025.
8. Eisai presents full results of lecanemab Phase 3 confirmatory Clarity AD study for early Alzheimer’s disease at Clinical Trials on Alzheimer’s Disease (CTAD) conference. Available at: https://www.eisai.co.jp/news/2022/news202285.html
9. van Dyck, H., et al. Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. 2023;388:9-21. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.
10. Alzheimer Society of Canada “What is Alzheimer’s disease?”. Available at: https://alzheimer.ca/en/about-dementia/what-alzheimers-disease Last accessed: June 2025.
11. Alzheimer Society of Canada “Dementia numbers in Canada”. Available at: https://alzheimer.ca/en/about-dementia/what-dementia/dementia-numbers-canada Last accessed: June 2025.
12. van Dyck, C.H., et al. Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. 2023;388:9-21. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.
13. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
14. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.

Vivani Medical, Inc. Announces Pricing of Common Stock Offering




Vivani Medical, Inc. Announces Pricing of Common Stock Offering

ALAMEDA, Calif., Oct. 26, 2025 (GLOBE NEWSWIRE) — Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing miniature, ultra long-acting drug implants, today announced the pricing of a best efforts registered direct offering of 6,000,000 shares of its common stock at an offering price of $1.62 per share and concurrent private placement of 3,703,703 shares of its common stock at an offering price of $1.62 per share purchased by Gregg Williams, the Chairman of the Company’s board of directors. The registered offering and the private placement were priced “at-the-market” under the rules and regulations of The Nasdaq Stock Market LLC. The gross proceeds to the Company from the registered offering and private placement are expected to be approximately $15.7 million, before deducting placement agent fees and estimated offering expenses. The registered offering and private placement are expected to close on or about October 28, 2025, subject to the satisfaction of customary closing conditions.

The Company intends to use the net proceeds from the registered offering and private placement to fund ongoing research and clinical development of the Company’s product candidates, as well as for working capital and general corporate purposes.

ThinkEquity is acting as sole placement agent for the registered direct offering.

The securities in the registered direct offering were offered and will be issued pursuant to a shelf registration statement on Form S-3 (File No. 333-278869), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 22, 2024 and declared effective on May 3, 2024. The offering will be made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

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

About Vivani Medical, Inc:

Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for metabolic diseases including obesity and type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately 50%, including those taking daily pills. For more information, please visit: www.vivani.com.

Forward-Looking Statements:

This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that are used in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development thereof, Vivani’s plans with respect to Cortigent and its technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani’s current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani’s control. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation, risks that the spin-off will not be completed in a timely manner or at all; risks of failure to satisfy any conditions to the spin-off; risks of failure of the spin-off to qualify for non-recognition of gain or loss for U.S. federal income tax purposes; uncertainty of whether the anticipated benefits of the spin-off can be achieved; risks of unexpected costs or delays; and risks and uncertainties associated with the development and commercialization of products and product candidates that may impact or alter anticipated business plans, strategies and objectives. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to market conditions and the ability of Cortigent to complete its spin-off, Cortigent’s history of losses and its ability to access additional capital or otherwise fund its business and advance its product candidates and pre-clinical programs. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. There may be additional risks that the Company or Cortigent consider immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 31, 2025, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law.

For Investor Relations Inquiries:

Company Contact:
Donald Dwyer
Chief Business Officer
info@vivani.com
(415) 506-8462

Investor Relations Contact:
Jami Taylor
Investor Relations Advisor
investors@vivani.com
(415) 506-8462

Media Contact:
Sean Leous
ICR Healthcare
Sean.Leous@ICRHealthcare.com
(646) 866-4012

MapLight Therapeutics Announces Pricing of Initial Public Offering




MapLight Therapeutics Announces Pricing of Initial Public Offering

SAN FRANCISCO and BOSTON, Oct. 26, 2025 (GLOBE NEWSWIRE) — MapLight Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders, today announced the pricing of its initial public offering of 14,750,000 shares of common stock at an initial public offering price of $17.00 per share. In addition, MapLight has granted the underwriters a 30-day option to purchase up to an additional 2,212,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

In addition to the shares sold in the initial public offering, MapLight announced a concurrent sale of 476,707 shares of common stock at the initial public offering price per share in a private placement to affiliates of Goldman Sachs & Co. LLC, including certain investment funds managed by Goldman Sachs & Co. LLC. The sale of the shares of common stock in the private placement will not be registered under the Securities Act of 1933, as amended (the “Securities Act”). The gross proceeds to MapLight from the initial public offering and the concurrent private placement, without giving effect to the underwriters’ option to purchase additional shares and before deducting underwriting discounts and commissions and offering expenses, are expected to be $258.9 million. All of the shares of common stock are being offered by MapLight.

The shares are expected to begin trading on the Nasdaq Global Market on October 27, 2025 under the symbol “MPLT.” The offering is expected to close on October 28, 2025, subject to customary closing conditions.

Morgan Stanley, Jefferies, Leerink Partners and Stifel are acting as joint book-running managers for the offering.

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission, and became automatically effective on October 25, 2025 pursuant to Section 8(a) of the Securities Act. The offering of the shares is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by email at syndprospectus@stifel.com.

The concurrent private placement is also scheduled to close on October 28, 2025, subject to the satisfaction of customary closing conditions. The closing of the private placement is contingent and conditioned upon consummation of the initial public offering. However, the closing of the initial public offering is not contingent on the consummation of the concurrent private placement.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

About MapLight

MapLight Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients suffering from debilitating central nervous system disorders. The company was founded by globally recognized leaders in psychiatry and neuroscience research to address the lack of circuit-specific pharmacotherapies available for patients. MapLight’s lead product candidate, ML-007C-MA, is an oral, extended-release, fixed-dose combination of an investigational M1/M4 muscarinic agonist, ML-007, co-formulated with a peripherally acting anticholinergic. ML-007C-MA is currently being evaluated in Phase 2 clinical trials for the treatment of schizophrenia and Alzheimer’s disease psychosis.

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding MapLight’s expectations regarding the commencement of trading of its shares on the Nasdaq Global Market, the completion and timing of the closing of the offering and the concurrent private placement and the anticipated gross proceeds from the offering and the concurrent private placement. Forward-looking statements are based on MapLight’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include risks and uncertainties related to the satisfaction of customary closing conditions and the completion of the offering and the private placement, and the risks inherent in biopharmaceutical product development and clinical trials. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the offering to be filed with the Securities and Exchange Commission. Forward-looking statements contained in this press release are made as of this date, and MapLight undertakes no duty to update such information except as required under applicable law.

For investor inquiries: investors@maplightrx.com 

For media inquiries: media@maplightrx.com 

New Global Coalition Launches to Address the Hidden Threat of RSV in Adults




New Global Coalition Launches to Address the Hidden Threat of RSV in Adults

VIENNA, Austria, Oct. 26, 2025 (GLOBE NEWSWIRE) — A new global coalition, the RSV Alliance, has been launched to raise awareness about the risks of respiratory syncytial virus (RSV) infections, with a focus on aging populations and individuals with underlying health conditions.

With core members including leading advocacy organizations the International Federation on Ageing (IFA) and the Global Allergy and Airways Patient Platform (GAAPP), alongside GSK, and with the European Scientific Working Group on Influenza (ESWI) providing scientific oversight, the RSV Alliance seeks to drive education, advocacy, and collaboration to improve prevention and care for those most vulnerable to RSV.

RSV is often thought to primarily affect infants and young children, but it also poses a serious and underrecognized risk to older adults with certain underlying conditions. “As a person with controlled asthma, I was not aware of the impact an RSV infection could have on my lungs,” said Gundula Koblmiller. She continued, “It took me several weeks to regain full confidence in my lung health again and months to be sure I had overcome the RSV infection.”

According to the U.S. Centers for Disease Control and Prevention (CDC), RSV causes an estimated 110,000 to 180,000 hospitalizations annually among adults aged 50 and older in the United States, with the highest burden among those aged 75 and older, individuals with chronic heart or lung disease, weakened immune systems, or those living in long-term care facilities¹. According to a 2024 study published in The Lancet Infectious Diseases, respiratory syncytial virus (RSV) was responsible for an estimated 118,000 deaths globally in 2019, with the highest burden occurring among infants and older adults².

“RSV is often underestimated in older adults and those with underlying conditions,” said Tonya Winders, CEO of the Global Allergy and Airways Patient Platform. “Through the RSV Alliance, we hope to elevate understanding, drive prevention strategies, and ensure that those at risk have access to the resources and care they need.”

Despite its impact, awareness of RSV among adults remains low. The RSV Alliance aims to close this gap by supporting global initiatives, promoting patient and healthcare professional education, and strengthening advocacy efforts to advance prevention and policy change.

The Alliance will mark its public launch during RSV Awareness Week, November 3–7. More information, including educational resources and ways to get involved, will be available soon at www.gaapp.org.

About the RSV Alliance

The RSV Alliance is a coalition between GAAPP, IFA, GSK, and ESWI dedicated to raising awareness, education, and advocacy around respiratory syncytial virus infections, particularly for aging populations and those with chronic health conditions. With funding from GSK, and managed by GAAPP, the RSV Alliance brings together patient advocacy, scientific expertise, and global collaboration to improve prevention and care.

About GAAPP

The Global Allergy & Airways Patient Platform (GAAPP) is an umbrella organization founded in 2009 to bring a collective patient voice to the global conversation on atopic, allergy, and airway diseases. Today, the organization comprises more than 188 patient organizations that advocate for global policy and access to care for over 800 million people living with these conditions.

References

1. Centers for Disease Control and Prevention. RSV in Older Adults and Adults with Chronic Medical Conditions. Updated 2024. https://www.cdc.gov/rsv/adults/index.html 
2. The Lancet.  Global, regional, and national incidence and mortality burden of non-COVID-19 lower respiratory infections and aetiologies, 1990–2021: a systematic analysis from the Global Burden of Disease Study 2021 – The Lancet Infectious Diseases.https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(24)00176-2/fulltext#supplementary-material

CONTACT: Contact
Stephanie Williams
swilliams@gaapp.org

New Data at American College of Gastroenterology Annual Meeting Show TissueCypher® Provides Actionable Risk Insights that Influence Clinical Management and Prompt Risk-Aligned Intervention in Barrett’s Esophagus




New Data at American College of Gastroenterology Annual Meeting Show TissueCypher® Provides Actionable Risk Insights that Influence Clinical Management and Prompt Risk-Aligned Intervention in Barrett’s Esophagus

Research on TissueCypher by Horvath et al. honored with a Presidential Poster Award from the ACG Abstract Selection Committee, a distinction awarded to only 5-7% of abstracts for research deemed high quality, novel or unique

FRIENDSWOOD, Texas, Oct. 26, 2025 (GLOBE NEWSWIRE) — Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data demonstrating that its TissueCypher^® Barrett’s Esophagus test can provide risk insights beyond pathology alone, influencing clinical management to support earlier intervention for those at higher risk of progression to esophageal cancer and potentially reducing unnecessary procedures for those at lower risk. The research will be presented in three posters at the American College of Gastroenterology (ACG) 2025 Annual Scientific Meeting, taking place Oct. 27–29, 2025, in Phoenix, Arizona, including one selected for a Presidential Poster Award.

“Our findings being presented at ACG highlight how difficult it can be to accurately assess progression risk in patients with Barrett’s esophagus when relying on pathology alone,” said Edward Horvath, M.D., board-certified gastroenterologist at Gastro Health West Boynton in Boynton Beach, Florida. “By identifying patients at higher risk who may otherwise be missed, the TissueCypher test provides objective, individualized risk information that supports more personalized decisions around surveillance and intervention, helping clinicians act sooner to potentially reduce the risk of progression to esophageal cancer.”

More than 6,400 scientific abstracts will be presented during ACG 2025. Only a small percentage of these received a Presidential Poster Award, recognizing high quality, novel, unique or interesting research, including the abstract by Horvath et al. highlighted below.* Two additional posters on TissueCypher will also be presented (all times Pacific Daylight Time).

P0689: The Tissue Systems Pathology Test (TSP-9) Informs Management of Patients That Are Indefinite for Dysplasia to Predict Missed Prevalent Neoplasia

• Presenting Author: Ronen Arai, M.D., Gastro Health North Broward, Coral Springs, Florida
• Date: Sunday, Oct. 26
• Time: 3:30-7:00 p.m.; author available to answer questions from 5:15-6:30 p.m.
• Summary: Pathologists may issue a finding of indefinite for dysplasia (IND) when active inflammation makes it unclear whether dysplasia or early neoplasia is present. Although guidelines recommend repeat endoscopy in three to six months after high-dose proton pump inhibitor (PPI) therapy, patients with IND remain at increased risk of progression to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC). New data from two case studies show that TissueCypher returned high-risk results corresponding to five-year probabilities of progression to HGD/EAC of 34% and 62%, respectively, exceeding the published rates of progression from HGD to EAC (33% over five years). These results prompted the use of advanced imaging and/or earlier follow-up, leading to detection of HGD in one patient and HGD and intramucosal cancer in another, enabling timely and more aggressive intervention. These findings illustrate how TissueCypher can deliver clinically valuable insights that support more risk-aligned management of patients with IND to reduce the risk of mortality from EAC.

ACG Presidential Poster Award Winner*
P4977: High-risk Tissue Systems Pathology Test (TSP-9) Results Enable Risk-aligned Management of Patients With Presumed Clinically Low-Risk Non-Dysplastic Barrett’s Esophagus

• Presenting Author: Edward Horvath, M.D., Gastro Health West Boynton, Boynton Beach, Florida
• Date: Tuesday, Oct. 28
• Time: 10:30 a.m.-4 p.m.; author available to answer questions from 1-2:15 p.m.
• Summary: Patients with non-dysplastic Barrett’s esophagus (NDBE) are considered at low risk for progression to HGD/EAC under current guidelines, which recommend surveillance every three to five years. Despite this classification, patients with NDBE can still progress to HGD or EAC within that interval. New data from two case studies show that TissueCypher identified patients with NDBE at high-risk of progression to HGD/EAC, with five-year probabilities of 43% and 45%, respectively, exceeding the published rates of progression from HGD to EAC (33% over five years). Guided by these results, clinicians recommended earlier intervention with endoscopic eradication therapy, and both patients were subsequently confirmed to have progressed to low grade dysplasia (LGD). These findings support the role of TissueCypher in providing individualized risk stratification to help inform more risk-aligned decision making and potentially earlier interventions to help prevent disease progression at an early, treatable stage.

P4930: Impact of Spatialomics Utilization on the Management of Non-Dysplastic Barrett’s Esophagus in a Rural Community

• Presenting Author: Stephen Thai, M.S., Texas Medical Center, The Colony, Texas
• Date: Tuesday, Oct. 28
• Time: 10:30 a.m.-4 p.m.; author available to answer questions from 1-2:15 p.m.
• Summary: In a rural Texas study of 114 patients with NDBE, TissueCypher stratified patients into low, intermediate and high-risk groups. Seven patients identified as intermediate- or high-risk by the TissueCypher test received ablation therapy, while 99 low-risk patients had their surveillance interval safely extended from two to three years to five years. Overall, the test influenced clinical management in 93% of cases, supporting its potential to help ensure timely intervention for higher-risk patients while reducing unnecessary procedures and burden for lower-risk patients.

All posters are available on the ACG 2025 website and in an online issue of The American Journal of Gastroenterology. For more information on TissueCypher, visit Castle at booth 358.

About TissueCypher Barrett’s Esophagus Test
The TissueCypher Barrett’s Esophagus test is Castle’s precision medicine test designed to predict future development of HGD and/or EAC in patients with Barrett’s esophagus (BE). The TissueCypher Barrett’s Esophagus test is indicated for use in patients with endoscopic biopsy confirmed BE that is graded NDBE, IND, or LGD; its clinical performance has been supported by 14 peer-reviewed publications of BE progressor patients with leading clinical centers around the world. The test received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022.

About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors.

Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus and uveal melanoma. Additionally, the Company has active research and development programs for tests in these and other diseases with high clinical need, including its test in development to help guide treatment decisions for patients with moderate-to-severe atopic dermatitis. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn, Facebook, X and Instagram. 

DecisionDx-Melanoma, DecisionDx-CMSeq, i31-SLNB, i31-ROR, DecisionDx-SCC, MyPath Melanoma, TissueCypher, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: TissueCypher’s ability to provide risk insights beyond pathology alone and enable more personalized surveillance and treatment strategies for BE patients that may help prevent cancer including , supporting earlier intervention for those at higher risk for progression to esophageal cancer, reducing unnecessary procedures for those at lower risk of progression, and supporting risk-aligned management of patients with a finding of indefinite for dysplasia. The words “believe,” “can” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, each as filed with the SEC, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

Investor Contact:
Camilla Zuckero
czuckero@castlebiosciences.com

Media Contact:
Allison Marshall
amarshall@castlebiosciences.com

Source: Castle Biosciences, Inc.

Novartis agrees to acquire Avidity Biosciences, an innovator in RNA therapeutics, strengthening its late-stage neuroscience pipeline




Novartis agrees to acquire Avidity Biosciences, an innovator in RNA therapeutics, strengthening its late-stage neuroscience pipeline

Ad hoc announcement pursuant to Art. 53 LR

• Transaction strengthens neuroscience franchise for Novartis with three late-stage programs that address genetic neuromuscular diseases
• Advances the Novartis xRNA strategy by adding a scientifically robust, muscle-directed, Antibody Oligonucleotide Conjugates (AOCs™) platform and first-in-disease pipeline
• Expected to unlock multi-billion-dollar opportunities with planned product launches before 2030
• Raises expected 2024-2029 sales CAGR for Novartis from +5% to +6%, and bolsters mid-single digit long-term growth
• As part of the agreement, Avidity will separate its early-stage precision cardiology programs into a new company (“SpinCo”) prior to closing
• Consideration totals USD 12bn in cash; closing expected in H1 2026 subject to completion of the separation of SpinCo from Avidity and other customary closing conditions

Basel, October 26, 2025 – Novartis today announced that it has entered into an agreement to acquire Avidity Biosciences, Inc. (Nasdaq: RNA), a San Diego-based, biopharmaceutical company focused on a new class of therapeutics enabling RNA delivery to muscle. The acquisition will follow the separation of Avidity’s early-stage precision cardiology programs.

Avidity is committed to delivering a new class of pioneering RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™) for serious, genetic neuromuscular diseases. The proposed acquisition will bring Avidity’s late-stage neuroscience programs into Novartis and provide Novartis access to a differentiated RNA-targeting delivery platform. These programs are expected to advance the company’s neuroscience strategy and complement the current pipeline with potential first-in-class therapeutic candidates that address the genetic drivers of muscle-damaging conditions.

“Avidity’s pioneering AOC platform for RNA therapeutics ​and its late-stage assets bolster our commitment to delivering innovative, targeted and potentially first-in-class medicines to treat devastating, progressive neuromuscular diseases,” said Vas Narasimhan, CEO of Novartis. “The Avidity team has built robust programs with industry-leading delivery of RNA therapeutics to muscle tissue. We look forward to developing these programs to meaningfully change the trajectory of diseases for patients.”

The proposed acquisition raises the expected 2024-2029 sales CAGR for Novartis from +5% to +6% CAGR, representing a significant opportunity to deliver substantial shareholder returns over time.

Accelerating innovative RNA science and AOC therapies for patients with neuromuscular disease
The proposed acquisition aligns with the long-term neuroscience strategy of Novartis, expanding the company’s pipeline with potential near-term launches in genetically defined diseases with high unmet need. The Avidity programs feature potential first-in-class, late-stage disease-modifying therapies in myotonic dystrophy type 1 (DM1), a rare progressive neuromuscular disorder with a poor prognosis and no disease-modifying therapies; facioscapulohumeral muscular dystrophy (FSHD), a rare hereditary disorder causing relentless loss of muscle function and progressive disability; and Duchenne muscular dystrophy (DMD), a severe, early-onset disease marked by progressive muscle damage and reduced life expectancy.

The proposed acquisition is expected to create an industry-leading pipeline, building on the Novartis expertise in spinal muscular atrophy and commercialization capabilities in genetic neuromuscular diseases. Avidity aims to deliver meaningful patient benefits by addressing root genetic causes, restoring muscle function, and potentially slowing disease progression. Its AOC platform combines the tissue specificity of monoclonal antibodies with the precision of oligonucleotides, enabling targeted delivery to previously hard-to-reach muscle cells. AOCs carry disease-specific, oligonucleotide payloads intended to correct underlying genetic mechanisms and enable targeted, disease-modifying therapies with the potential to have significant impact on patient lives.

Transaction details
Under the terms of the transactions, which have been unanimously approved by the Boards of Directors of both companies, Novartis, through a merger with a newly formed indirect wholly owned subsidiary, will acquire all outstanding shares of Avidity. Pursuant to the terms of the merger agreement, holders of Avidity common stock will receive USD 72.00 per share in cash at closing, representing a premium of 46% to the closing share price on October 24, 2025, and valuing the company at approximately USD 12bn on a fully diluted basis and representing an enterprise value of approximately USD 11bn at the expected closing date.

Prior to the closing of the merger, Avidity will transfer to SpinCo, a wholly owned subsidiary of Avidity, the early-stage precision cardiology programs and collaborations of Avidity. The transfer includes certain Avidity assets whose transfer will trigger a right of first negotiation with an existing collaboration partner of Avidity. Holders of Avidity common stock will receive (1) a distribution of one share of SpinCo for every ten shares of Avidity they hold and/or (2) a pro rata cash distribution of the proceeds received by Avidity prior to the closing if certain SpinCo assets are, or SpinCo itself is, sold to a third party.

The acquisition by Novartis of Avidity is subject to the completion of a spin-off or a sale of SpinCo and other customary closing conditions, including the receipt of regulatory approvals and the approval of Avidity stockholders. The companies expect the merger to close in the first half of 2026. Until closing, Novartis and Avidity will continue to operate as separate and independent companies.

Novartis Investor Call
Novartis will host a conference call for investors to discuss the transaction on October 27, 2025 at 1 pm CET. Details can be found at https://www.novartis.com/investors/event-calendar.

About Avidity Biosciences
Avidity Biosciences, Inc., is a biopharmaceutical company developing Antibody Oligonucleotide Conjugates (AOCs™) to treat serious diseases, with an initial focus on rare neuromuscular genetic disorders such as DM1, FSHD, and DMD. Avidity’s proprietary platform is designed to achieve targeted delivery of RNA therapeutics to muscle tissue via TfR1 mAb, enabling modulation of disease-causing genetic mechanisms. Avidity integrates patient perspectives into development and is advancing pivotal studies, including HARBOR™, FORTITUDE™ and EXPLORE44, supported by a robust translational and biomarker framework. The company also pursues programs in precision cardiology and immunology through internal discovery and partnerships.

About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide. 

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. 

Additional information and Where to Find It
In connection with the spin-off and the merger (the “Transactions”), Novartis, Avidity and SpinCo intend to file relevant documents with the Securities and Exchange Commission (the “SEC”), including a preliminary and definitive proxy statement to be filed by Avidity. The definitive proxy statement and proxy card will be delivered to the stockholders of Avidity in advance of the special meeting relating to the Transactions. This document is not a substitute for the proxy statement or any other document that may be filed by Avidity with the SEC. AVIDITY’S STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY EACH OF NOVARTIS AND AVIDITY WITH THE SEC IN CONNECTION WITH THE TRANSACTIONS OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS AND THE PARTIES TO THE TRANSACTIONS. Investors and security holders will be able to obtain a free copy of the proxy statement and such other documents containing important information about Novartis and Avidity, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. Novartis and Avidity make available free of charge at the Novartis website at www.novartis.com/investors/financial-data/sec-filings and Avidity’s website at investors.aviditybiosciences.com/sec-filings, respectively, copies of documents they file with, or furnish to, the SEC.

Participants in the Solicitation
This press release does not constitute a solicitation of a proxy. Novartis, Avidity and their respective directors, executive officers and certain employees may be deemed to be participants in the solicitation of proxies from the stockholders of Avidity in connection with the Transactions. Information regarding the special interests of these directors and executive officers in the Transactions will be included in the definitive proxy statement referred to above. Security holders may also obtain information regarding the names, affiliations and interests of the Novartis directors and executive officers in the Novartis Annual Report on Form 20-F for the fiscal year ended December 31, 2024, which was filed with the SEC on January 31, 2025. Security holders may obtain information regarding the names, affiliations and interests of Avidity’s directors and executive officers in Avidity’s definitive proxy statement on Schedule 14A, which was filed with the SEC on April 29, 2025. To the extent the holdings of Avidity’s securities by Avidity’s directors and executive officers have changed since the amounts set forth in Avidity’s definitive proxy statement for its 2025 annual meeting of stockholders, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov, the Novartis website at https://www.novartis.com and Avidity’s website at https://aviditybiosciences.com. The contents of the websites referenced above are not deemed to be incorporated by reference into the proxy statement.

No Offer or Solicitation
This press release is for informational purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements that are “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” “on track” or similar terms, or by express or implied discussions regarding the proposed acquisition of Avidity and Avidity’s related spin-off, the expected timetable for completing each of the proposed Transactions, the composition of the assets and liabilities to be held by SpinCo and Avidity following the spin-off, the management team for SpinCo and its cash balance, potential marketing approvals, new indications or labeling for Avidity’s product candidates, Avidity’s platform and preclinical assets, or potential future revenues from Avidity’s product candidates. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Avidity’s investigational products will be submitted or approved for sale or for any additional indications or labeling in any market or at any particular time, or that Avidity’s approach to the discovery and development of product candidates based on its AOC™ platform will produce any products of commercial value. There can be no guarantee that the conditions to the closing of the Transactions will be satisfied on the expected timetable or at all or that the expected benefits or synergies from the Transactions will be achieved in the expected timeframe, or at all. In particular, expectations regarding Avidity, SpinCo, or the Transactions could be affected by, among other things, the timing of the satisfaction of customary closing conditions, including the receipt of regulatory approvals and the approval of Avidity’s stockholders, on acceptable terms or at all; risks and costs related to the implementation of the separation of SpinCo, including the ability to complete the separation in the anticipated timeframe, or at all, and any changes to the configuration of the businesses included in the separation if implemented; the sale of certain of SpinCo’s assets pursuant to a third party right of first negotiation; the risk that competing offers or acquisition proposals will be made; the effects of disruption from the Transactions and the impact of the announcement and pendency of the Transactions on Novartis and/or Avidity’s businesses, including their relationships with employees, business partners or governmental entities; the risk that the Transactions may be more expensive to complete than anticipated; the risk that stockholder litigation in connection with the Transactions may result in significant costs of defense, indemnification and liability; a diversion of management’s attention from ongoing business operations and opportunities as a result of the Transactions or otherwise; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; and the risks and factors referred to in Novartis AG’s most recent Annual Report on Form 20-F for the year ended December 31, 2024, Avidity’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, and any subsequent filings made by either party with the SEC, available on the SEC’s website at www.sec.gov. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise, except to the extent required by law.

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Fate Therapeutics Presents New Clinical Data at ACR Convergence 2025 Demonstrating Immune Remodeling and Durable Responses in Patients with Systemic Lupus Erythematosus Treated with FT819 Off-the-Shelf CAR T-Cell Therapy




Fate Therapeutics Presents New Clinical Data at ACR Convergence 2025 Demonstrating Immune Remodeling and Durable Responses in Patients with Systemic Lupus Erythematosus Treated with FT819 Off-the-Shelf CAR T-Cell Therapy

As of a September 25, 2025 data cut-off-date, 10 patients with treatment-refractory, moderate-to-severe Systemic Lupus Erythematosus (SLE) were treated with a single dose of FT819 with less-intensive or no conditioning chemotherapy

Favorable safety profile with no dose-limiting toxicities supports plan to enable same-day discharge post FT819 treatment broadening patient accessibility

All patients surpassing a 3-month post-treatment time point (n=5) showed significant reductions in the SLE Disease Activity Index (SLEDAI-2K) score and Physician’s Global Assessment (PGA)

SLE patients with lupus nephritis (LN) surpassing a 3-month post-treatment time point (n=2) achieved complete renal response (CRR) at 6 months; first patient continues in drug-free Definition of Remission in SLE (DORIS) at 15 months follow-up

Cumulative clinical dataset provides clear evidence for rapid CD19+ B cell depletion and immune remodeling toward a naïve and less pathogenic B-cell repertoire

SAN DIEGO, Oct. 26, 2025 (GLOBE NEWSWIRE) — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today announced new and updated data from the first 10 patients dosed with FT819 in a Phase 1 clinical trial for the treatment of moderate-to-severe systemic lupus erythematosus (SLE) at the American College of Rheumatology (ACR) Convergence 2025 in Chicago.

“This promising initial clinical data demonstrates that FT819 can deliver transformative outcomes in patients with moderate-to-severe SLE, particularly with reduced or no conditioning chemotherapy,” said Bob Valamehr, Ph.D., M.B.A., President and Chief Executive Officer of Fate Therapeutics. “Having shown meaningful and durable clinical activity, a safety profile enabling plans for same-day discharge, and robust enrollment from the first four enrolling clinical sites, we expect accelerated patient enrollment as additional sites join the study. With many more sites now participating, we aim to promptly complete our Phase 1 trial. In addition, under our RMAT designation, we continue to engage with the FDA on a registrational study design with the goal of initiating a pivotal study next year. We are making great progress on our mission to make FT819 available on-demand, in a true off-the-shelf and cost-effective manner, with the potential to help patients suffering with SLE and other autoimmune diseases.”

New and Updated Clinical Data Summary

The Company is currently conducting a multi-center, Phase 1 clinical trial of FT819, its off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate, for the treatment of patients with moderate-to-severe SLE, including lupus nephritis and extrarenal lupus (NCT06308978). The study is designed to evaluate the safety, pharmacokinetics, and activity of a single dose of FT819 administered to patients with active refractory lupus with either (i) a less-intensive conditioning regimen (Regimen A; fludarabine (flu)-free conditioning consisting of either cyclophosphamide alone or bendamustine alone), or (ii) a conditioning-free regimen to patients on standard-of-care maintenance therapy (Regimen B). As of the data cut-off date of September 25, 2025, 10 patients (8 on Regimen A, 2 on Regimen B) have been treated with FT819, providing the following key insights:

Less-intensive Conditioning Regimen

• Active Lupus Nephritis. Five patients with active refractory lupus nephritis (prior therapies range between 7 and 8, with all patients having received prior B-cell targeted therapy; baseline SLE Disease Activity Index (SLEDAI-2K) ranging between 8 and 20) were treated with a single dose of FT819 in the less-intensive conditioning regimen. As of the data cut-off date, two patients who were treated at dose level 1 (DL1, 360 million cells) had surpassed the 3-month evaluation timepoint and exhibited significant reductions of 16 and 12 points, respectively, in SLEDAI-2K from baseline and importantly, Urine Protein-to-Creatinine ratio (UPCr) reduction to < 0.5 mg/mg at 6 months. The patient who exhibited a 16 point SLEDAI-2K reduction discontinued steroids and achieved DORIS (definition of remission in SLE) and complete renal response (CRR) at 6 months and remains in steroid-free DORIS and CRR at the 15-month follow-up. The second patient exhibited a 12 point reduction in SLEDAI-2K and achieved CRR at 6 months; however, this patient subsequently experienced a disease flare and at the 12-month evaluation timepoint is under consideration for retreatment with FT819.   
• Extrarenal Lupus. Three patients with active moderate-to-severe extrarenal lupus (prior therapies ranging between 3 and 10; baseline SLEDAI-2K ranging between 14 and 18) were treated with a single dose of FT819 in the less-intensive conditioning regimen. As of the data cut-off date, two patients had surpassed the 3-month evaluation timepoint. Both patients were treated at dose level 2 (DL2, 900 million cells). The first patient exhibited a significant reduction of SLEDAI-2K from 18 to 10 at one-month post-treatment; however, this patient was restarted on anifrolumab two months after treatment with FT819, which the patient had been on for the previous 3 years. SLEDAI-2K score and PGA continued to improve thereafter, and DORIS was achieved at 6 months post-treatment with FT819. Notably, these results were not previously achieved for this patient with treatment with combination therapy that included anifrolumab prior to starting treatment with FT819. The second patient also demonstrated significant reduction in SLEDAI-2K score to 6 from a baseline of 16, a meaningful reduction of PGA to 0.4 from a baseline of 2.2 and dramatically improved FACIT score at the 3-month evaluation timepoint.

Conditioning-free Regimen

• Add-on to Maintenance Therapy. Two patients were treated with a single dose of FT819 at 360 million cells in the conditioning-free regimen as an add-on to mycophenolate mofetil maintenance therapy (one patient with extrarenal lupus with prior therapies = 5, baseline SLEDAI-2K = 8; and a second patient with lupus nephritis prior therapies = 8, baseline SLEDAI-2K = 17). As of the data cut-off date, the patient with extrarenal lupus had surpassed the 3-month evaluation timepoint and achieved low lupus disease activity state (LLDAS) by 3 months from FT819 administration, which was maintained at the most recent follow-up at 9 months. The patient also experienced meaningful reductions in SLEDAI-2K to 2 from 8 at baseline and in PGA to 0.5 from 2 at baseline, with steroids that were tapered to less than 5 mg / day.

Safety

• In more than 60 patients treated with FT819 across autoimmune disease and oncology, favorable safety profile continues to be observed with low incidence of low-grade cytokine release syndrome (CRS), no events of immune effector cell-associated neurotoxicity (ICANS), and no events of graft-versus-host disease (GvHD). Specifically, in the 8 safety-evaluable patients treated with FT819 for SLE with at least one month follow-up as of the data cut-off date:
  • there have been no events of ICANS, no events of GvHD, and 3 patients who experienced low-grade CRS (Grade 2 in maximum severity in 1 patient, Grade 1 in maximum severity in 2 patients);
  • no dose-limiting toxicities were observed in any patient; and
  • all patients were discharged following a short-duration of hospitalization post infusion of FT819, supporting the potential for outpatient administration and same-day discharge.

Translational

• In patients treated with less-intensive conditioning chemotherapy, rapid and sustained CD19+ B cell depletion was observed, positively correlating with dose escalation. Upon return of the B cell compartment, naïve B cell emergence beyond baseline levels was observed, suggestive of an immune reset and correlative to reduction in disease burden.
• In patients treated without conditioning chemotherapy, a meaningful reduction in CD19+ B cells was also observed, alongside reduction in expanded B-cell clones and remodeling of the B cell compartment that correlated with improvement in disease activity scores.
• These observations underscore the unique ability of FT819 to remodel the B-cell repertoire toward a more naïve and less pathogenic state without the need for intensive conditioning chemotherapy. The mechanistic remodeling of the B cell compartment supports immune restoration as a driver of clinical remission, reinforcing transformative potential of FT819 in autoimmune disease treatment.

Program Expansion and Outlook

The Company has initiated independent dose-expansion cohorts in anti-neutrophilic cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). In addition, the Company is actively engaged under its Regenerative Medicine Advanced Therapy (RMAT) designation with the U.S. Food and Drug Administration (FDA) to align on a registrational study design with the goal to initiate a pivotal study in 2026. The Company currently has approximately 600 cryopreserved drug product bags of FT819 in inventory available for treatment of patients.

Below are links to the Company Presentations at the 2025 ACR Convergence:

Sunday, October 26, 2025

Poster Presentation | Abstract #0663
iPSC-Derived, Off-the-Shelf anti-CD19 CAR T cells Deliver Improved Clinical Outcomes in Lupus with Reduced or No Conditioning Chemotherapy
Session Title: Systemic Lupus Erythematosus – Treatment Poster I
Session Time: 11:30AM – 1:30PM ET

Monday, October 27, 2025

Poster Presentation | Abstract #1270
Increasing Participation in the FT819 Cell Therapy Trial Amongst People Living with Lupus: A Focus Group Study
Session Title: Patient Outcomes, Preferences, & Attitudes Poster II
Session Time: 11:30AM – 1:30PM ET

Tuesday, October 28, 2025

Poster Presentation | Abstract #2454
Longitudinal Analysis of B cell Remodeling in Systemic Lupus Erythematosus Following iPSC-derived CAR T-cell Therapy
Session Title: Systemic Lupus Erythematosus – Treatment Poster III
Session Time: 11:30AM – 1:30PM ET

About Fate Therapeutics’ iPSC Product Platform
Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the safety and therapeutic potential of the Company’s product candidates, including FT819, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, including the Company’s plans to complete IND-enabling studies and to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, and the Company’s clinical and product development strategy. These and any other forward-looking statements in this release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), and the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:
Christina Tartaglia
Precision AQ
212.362.1200
christina.tartaglia@precisionaq.com