Author: Ravi Shankar

New solution links in-store purchase activity to persistent identities, helping merchants recognize previously unknown shoppers

CHICAGO, Oct. 21, 2026 (GLOBE NEWSWIRE) — TransUnion (NYSE: TRU) today announced the launch of Transaction Matching, a solution that connects transaction activity to persistent, privacy-conscious customer identities. The offering leverages Fiserv’s Unknown Shopper solution to help merchants recognize previously unidentified shoppers, including loyalty members who paid with a new card, or shoppers who paid using tap-to-pay or mobile wallet.

Merchants can then enrich pseudonymized customer profiles with demographic and lifestyle insights to better understand purchasing behavior and deliver more relevant offers.

“Transaction Matching helps merchants recognize more of the customers they already serve,” said Brian Silver, EVP of Global Marketing Solutions at TransUnion. “By connecting transaction activity with pseudonymized customer profiles, merchants can reduce duplicate records, better understand the customer journey and apply those insights across advertising, analytics and measurement.”

This is the first collaboration under TransUnion’s broader Transaction Matching solution, giving merchants a new way to unlock the value of customers who have traditionally been overlooked. It empowers merchants and brands to:

• Bring unknown shoppers into focus: Connect previously unidentified in-store transactions to persistent customer identities.

• Separate new customers from repeat customers: Identify returning customers who use a different payment card and measure new-customer acquisition more accurately.

• Enrich customer profiles: Add demographic and lifestyle insights to help improve customer analysis and engagement.

• Reduce payment method blind spots: Associate different card-based payment methods, inclusive of debit and credit card dip and swipe, tap-to-pay, and mobile wallet, with a single customer profile.

“Before partnering with TransUnion and Fiserv, a new credit card could look like a new customer, even when it belonged to a loyalty member,” explained Alisa Stewart, Director of Customer Relationship Management at Red Lobster. “Now we can easily distinguish new customers from returning guests and combine behavioral and demographic insights to better understand and engage them.”

Connecting customer intelligence across commerce and advertising
The collaboration connects complementary transaction and identity capabilities across the advertising and commerce ecosystems. This gives merchants a more complete view of customer activity while maintaining privacy-conscious controls.

“Many merchants have an incomplete view of their customers because transactions can appear disconnected across cards and payment methods,” said Prasanna Dhore, Chief Data Officer at Fiserv. “By working with TransUnion, we’re helping brands like Red Lobster recognize more of the customers already transacting with them, distinguish new customers and turn those insights into smarter marketing and growth decisions.” 

To learn more about TransUnion’s Marketing Solutions, click here.

About TransUnion (NYSE: TRU)
TransUnion is a global information and insights company with over 13,000 associates operating in more than 30 countries. We make trust possible by ensuring each person is reliably represented in the marketplace. We do this with a Tru™ picture of each person: an actionable view of consumers, stewarded with care. Through our acquisitions and technology investments, we have developed innovative solutions that extend beyond our strong foundation in core credit into areas such as marketing, fraud, risk and advanced analytics. As a result, consumers and businesses can transact with confidence and achieve great things. We call this Information for Good® — and it leads to economic opportunity, great experiences and personal empowerment for millions of people around the world.
http://www.transunion.com/business

Contact	Dave Blumberg TransUnion
E-mail	david.blumberg@transunion.com
Telephone	312-972-6646

Miv-cel reversed disability and achieved durable efficacy across all primary and secondary endpoints through one year, with nearly all patients remaining off chronic immunotherapies 

Deep B-cell depletion demonstrated with a single dose supports the potential for broad immune reset enabled by miv-cel’s unique construct

Consistent, well-tolerated safety profile with no high-grade CRS or ICANS, and no cases of IEC-HS in one-year follow-up

Data further strengthens SPS BLA package and supports potential for miv-cel to be the first approved therapy in SPS and first approved CAR T-cell therapy for autoimmune diseases

EMERYVILLE, Calif., Oct. 21, 2026 (GLOBE NEWSWIRE) — Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical immunology company pioneering transformative therapies for people with neurologic autoimmune diseases, today announced the full one-year data set from KYSA-8, its registrational trial of miv-cel (mivocabtagene autoleucel, KYV-101) in patients with stiff person syndrome (SPS). The data will be presented today at MS Toronto 2026, the joint ACTRIMS-ECTRIMS meeting.

“The totality of the one-year durability data from the KYSA-8 trial is very encouraging and suggests miv-cel has the potential to fundamentally change how we treat stiff person syndrome, a progressive, disabling disease with no approved therapies,” said Amanda Piquet, M.D., FAAN, Director of Autoimmune Neurology at the University of Colorado Anschutz School of Medicine, Céline Dion Foundation Endowed Chair, and lead investigator of the KYSA-8 trial. “The positive primary endpoint results, together with the secondary and exploratory endpoint data, highlight the full clinical benefit of miv-cel with a single dose. Through one year, patients experienced significant improvements across multiple measures of disease burden, including disability, mobility, stiffness, hypersensitivity, physical functioning and mental health, with a well-tolerated safety profile.”

Poster Presentation:
Title: 1-Year Analysis of KYSA-8: the Pivotal, Multicenter, Phase 2 Study of Miv-cel (Mivocabtagene Autoleucel; Formerly KYV-101) CD19 CAR T-Cell Therapy in Stiff Person Syndrome
Presenter: Amanda Piquet, M.D., FAAN, Director of Autoimmune Neurology at the University of Colorado Anschutz School of Medicine
Poster ID: P0364
Date & Time: Wed., October 21, 2026, 4:30 – 6:30 PM ET

As reported at AAN 2026, the primary endpoint and all key secondary endpoints were achieved with statistical significance in KYSA-8. The one-year durability data being presented today further strengthens these positive results.

Efficacy highlights from one-year follow-up data on 26 patients include:

• Significant improvement in the timed 25-Foot Walk (T25FW) sustained at one year (p < 0.0001): median improvement from baseline of 46% at week 16 (primary endpoint) and 49% at one year.
• At 16 weeks and one year after receiving miv-cel, 81% (21/26) and 77% (20/26) of patients achieved clinically meaningful improvement (≥20% reduction from baseline) in T25FW, respectively, demonstrating sustained benefit for the vast majority of patients.
• Over one-third of patients completed T25FW in <5 seconds, comparable to a typical time for healthy adults.
• Of the 12 patients requiring a walking aid prior to treatment, 67% (8/12) continue to not require assistance.
• 92% (24/26) of patients remained free of chronic immunotherapies for SPS.
• At one year, the trial continued to meet all secondary endpoints, with significant mean improvements from baseline in Modified Rankin Scale, Hauser Ambulation Index, Distribution-of-Stiffness and Heightened Sensitivity Scale, of -1.0 (p = .0003), -1.7 (1.38; p < .0001), -1.6 (1.75; p < .0001) and -2.8 (2.11; p < .0001), respectively.

Exploratory endpoints, including additional efficacy measures continue to support miv-cel’s differentiated clinical profile:

• In the 6-minute walk test, responses deepened over time, with the median improvement in walking distance increasing from 89 meters at the 16-week primary endpoint measurement to 119 meters at one year, a nearly 6-fold improvement over the clinical minimally important change of 20 meters.
• Sustained clinical benefit at one year in physical functioning and mental health, comparable to healthy adults, across the 36-item short form health survey.
• B-cell reconstitution was observed with sustained efficacy and antibody reduction.

Miv-cel continued to demonstrate a well-tolerated safety profile, supporting its potential for outpatient administration:

• No high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), and no cases of immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS).
• Grade 3/4 neutropenia, an expected adverse event (AE) with lymphodepletion and CAR T-cell therapies, was observed in five patients and was manageable.
• Serious treatment-related AEs occurred in three patients, all of which have fully resolved.

“This is a remarkable data set, demonstrating consistent and durable clinical benefit across primary, secondary, and exploratory endpoints, with a well-tolerated safety profile,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “These results reinforce miv-cel’s potential best-in-class clinical profile, which may meaningfully change the trajectory of stiff person syndrome with a single dose, while allowing patients to remain free of chronic immunosuppressive therapies. We look forward to bringing this transformative therapy to patients as quickly as possible.”

About KYSA-8 Registrational Clinical Trial
KYSA-8 is a single-arm registrational Phase 2 trial in which 26 adult patients with SPS, who had an inadequate response to at least one immunotherapy treatment, received a single dose of miv-cel. The primary endpoints are the change from baseline in the T25FW at 16 weeks and the incidence and severity of adverse events (AEs). Secondary endpoints measuring disability, stiffness, hypersensitivity, and mobility include the Modified Rankin Scale (mRS), Distribution-of-stiffness Index (DSI), Heightened Sensitivity Scale (HSS), and Hauser Ambulation Index (HAI), respectively.

About miv-cel (mivocabtagene autoleucel, KYV-101)
Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy with CD28 co-stimulation. It is uniquely designed for potency and tolerability with the potential to achieve deep B-cell depletion, reset the immune system, and deliver durable drug-free, disease-free remission in autoimmune diseases with a single dose. Miv-cel is under investigation for B-cell driven autoimmune diseases and is produced using a well-established, validated manufacturing process. To date, more than 100 patients have been treated with miv-cel across a range of autoimmune diseases, and the clinical data demonstrates a consistent and well-tolerated safety profile.

About Stiff Person Syndrome (SPS)
SPS is a rare, progressive neurologic autoimmune disease characterized by muscle stiffness and painful muscle spasms, impacting mobility and gait. Stiffness, rigidity, and spasms in the torso, arms, and legs lead to progressive disability causing up to 80% of patients to lose mobility, requiring walking aid assistance or wheelchair use^1-3. SPS has been shown to lead to permanent disability and increased risk of mortality³. Most patients with SPS have antibodies to glutamic acid decarboxylase 65 (GAD65) or the glycine receptor, which disrupt normal inhibitory neurotransmission, contributing to the hallmark symptoms of SPS. There are currently no FDA-approved treatments for SPS. Current treatment options include symptomatic treatments, off-label immunotherapies, such as intravenous immunoglobulin (IVIg), rituximab and plasmapheresis, as well as supportive care and physical, speech, occupational, and psychiatric therapy; however, the majority of patients have inadequate or no response to these treatment options. An estimated 6,000 patients are diagnosed with SPS in the United States^4-5.

About Kyverna Therapeutics
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a late-stage clinical immunology company pioneering differentiated therapies with curative potential for neurologic autoimmune diseases. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome (SPS) and an ongoing registrational trial for generalized myasthenia gravis (gMG).

Miv-cel has received three FDA Regenerative Medicine Advanced Therapy (RMAT) designations, in SPS, gMG, and non-active secondary progressive multiple sclerosis (naSPMS) based on compelling clinical data and significant unmet need, further reinforcing the therapy’s potential across neuroimmunology. Additionally, the Company continues to advance new innovations that broaden access and choice for patients, expanding its leadership position in the field. For more information, please visit https://kyvernatx.com.

Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: the potential for a single dose of miv-cel to provide a broad immune reset; miv-cel’s potential to fundamentally change how stiff person syndrome is treated; miv-cel’s potential outpatient administration; miv-cel’s potential best-in-class clinical profile; miv-cel’s potential to meaningfully change the trajectory of stiff person syndrome with a single dose while allowing patients to remain free of chronic immunosuppressive therapies; the potential for miv-cel to achieve deep B-cell depletion, reset the immune system, and deliver durable drug-free, disease-free remission in autoimmune diseases with a single dose or to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases; the possibility that miv-cel may be the first approved treatment for patients with SPS or the first approved CAR T-cell therapy for autoimmune diseases; Kyverna’s pipeline opportunities; and Kyverna’s potentially first-in-class neuroimmunology franchise. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions; risks related to the timing and outcome of regulatory submissions and interactions with the FDA; the ability to enroll patients in clinical trials on anticipated timelines; the possibility that topline results may change following further analysis or differ from final results; the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; and other factors discussed in the “Risk Factors” section of Kyverna’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:
Investors: InvestorRelations@kyvernatx.com
Media: media@kyvernatx.com

¹ Rakocevic G, et al. BMC Neurol. 2019;19:1.
² Dalakas MC. Nat Rev Neurol. 2024;20(10):587-601.
³ Duddy ME, Baker MR. Front Neurol Neurosci. 2009;26:147-165.
⁴ Crane PD, et al. Neurology. 2024;103(12):e210078.
⁵ Analysis of 2024 Komodo U.S. Claims Data.

VANCOUVER, British Columbia, Oct. 21, 2026 (GLOBE NEWSWIRE) — Coppernico Metals Inc. (TSX: COPR, OTCQB: CPPMF, FSE: 9I3) (“Coppernico” or the “Company”) is pleased to announce its participation in several upcoming investor conferences across North America and Europe, where Chair and CEO Ivan Bebek will highlight the Company’s corporate strategy and planned Phase 2 drill program at its flagship copper-gold Sombrero Project in Peru, as the Company advances preparations for its next phase of exploration.

Following the recent approval of its expanded Environmental Impact Assessment – Semi-detailed (“EIA-Sd”) and the execution of a drilling contract with AK Drilling International S.A., the Company is advancing the final steps required to obtain its start-of-activities authorization, the final regulatory approval required to commence drilling, while drill pad construction is already underway. The planned program will initially focus on expanding known copper-gold mineralization and testing multiple high-priority targets across the expanded permitted area.

Upcoming Investor Conferences and Presentations

Kinvestor Day 2026 Virtual Investor Conference

• Date: Thursday, October 22, 2026
• CEO Presentation: 11:40 a.m. PT / 2:40 p.m. ET
• Format: 12-minute corporate presentation followed by a live Q&A session
• Registration: Kinvestor Day 2026

Curzio One Wealth Forum

• Date: Monday, October 26, 2026
• CEO Speaking Engagement: 2:25 p.m. ET (Tavistock Ballroom C & D)
• Location: Pier Sixty-Six, Fort Lauderdale, Florida
• Format: Ivan Bebek will join Frank Curzio on stage to discuss the copper market, the growing importance of new discoveries, opportunities across the mining sector and Coppernico’s upcoming exploration plans.
• Event Website: Curzio One Wealth Forum

Red Cloud Fall Mining Showcase 2026

• Dates: October 28–29, 2026
• CEO Presentation: Thursday, October 29, at 11:20 a.m. ET (Kensington Room)
• Location: Omni King Edward Hotel, Toronto, Ontario
• Format: Corporate presentation and investor meetings
• Event Website: Red Cloud Fall Mining Showcase

Precious Metals Summit Zurich 2026

• Dates: November 9–11, 2026
• CEO Presentation: Wednesday, November 11, at 2:15 p.m. (Room 2)
• Location: Park Hyatt, Zurich, Switzerland
• Format: Corporate presentations and one-on-one meetings with institutional investors and industry participants
• Event Website: Precious Metals Summit Zurich

121 Mining Investment London

• Dates: November 23–24, 2026
• Location: Convene, 133 Houndsditch, London, United Kingdom
• Format: One-on-one meetings with institutional investors, fund managers and mining sector participants
• Event Website: 121 Mining Investment

Management will be available for meetings with investors, analysts and industry participants during the upcoming conferences. Investors interested in arranging a meeting are encouraged to contact the Company at info@coppernicometals.com.

For additional information on Coppernico’s upcoming events, please visit www.coppernicometals.com.

Technical Disclosure and Qualified Person

The scientific and technical information contained in this news release was reviewed and approved by Tim Kingsley, M.Sc., CPG, Coppernico’s Vice President of Exploration, who is a “Qualified Person” as defined in NI 43-101.

ON BEHALF OF THE BOARD OF DIRECTORS

Ivan Bebek
Chair & CEO

For further information, please contact:

Coppernico Metals Inc.
Phone: +1 778 729 0600

Email: info@coppernicometals.com    

Website: www.coppernicometals.com

Twitter: @CoppernicoMetal

LinkedIn: www.linkedin.com/company/coppernico-metals/

About Coppernico

Coppernico is a mineral exploration company focused on creating value for shareholders and stakeholders through diligent project evaluation and exploration, in pursuit of the discovery of large-scale, high-grade copper-gold deposits in the Americas. The Company’s management and technical teams have a successful track record of raising capital, discovery and the monetization of exploration successes. The Company’s objective is to become a leading advanced copper and gold explorer, and through its wholly owned Peruvian subsidiary Sombrero Minerales S.A.C., is currently focused on the Ccascabamba (previously referred to as Sombrero Main) and Nioc target areas within the Sombrero Project in Peru, its flagship project, while regularly reviewing additional premium projects to consider for acquisition.

The Sombrero Project is a land package of approximately 57,000 hectares (570 square kilometres) located in the north-western margins of the world-renowned Andahuaylas-Yauri trend in Peru. It consists of a number of prospective exploration targets characterized by copper-gold skarn and porphyry systems and precious metal epithermal systems. The Company’s NI 43-101 technical report, with an effective date of April 17, 2024, and as filed on SEDAR+ on May 23, 2024, focuses on the Ccascabamba and Nioc target areas of the Sombrero Project.

Common shares of Coppernico Metals Inc. are listed on the Toronto Stock Exchange under the symbol “COPR”, trades on the OTCQB Venture Market under symbol “CPPMF” and is quoted over the counter by certain dealers in the Unofficial Market of the Frankfurt Stock Exchange under the symbol “9I3”. More information about Coppernico can be found on the Company’s profile on SEDAR+ (www.sedarplus.ca).

Cautionary Note

No regulatory organization has approved the contents hereof.

This news release contains forward-looking statements and forward-looking information within the meaning of Canadian securities legislation (collectively, “forward-looking statements”). Forward-looking statements are often identified by terms such as “may”, “should”, “anticipate”, “expect”, “intend” and similar expressions and include, but are not limited to, statements with respect to: the Company’s preparations for Phase 2 drilling at the Sombrero Project; the timing and receipt of the final Start-of-Activities authorization; the commencement, execution and objectives of the planned drill program; the potential to expand known mineralization and make new discoveries; and participation in upcoming investor conferences. No certainty can be given that these expectations will prove to be correct and such forward-looking statements included in this news release should not be heavily relied upon. Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking statements. Readers should refer to the risks discussed in the Company’s 2025 Annual Information Form and other continuous disclosure filings with the Canadian Securities Administrators, available at www.sedarplus.ca. These factors are not, and should not be construed as being, exhaustive. Accordingly, readers should not place heavy reliance on forward-looking statements. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement. Any forward-looking information and the assumptions made with respect thereto speak only as of the date of this news release. The Company does not undertake any obligation to publicly update or revise any forward-looking information after the date of this news release to conform such information to actual results or to changes in the Company’s expectations except as otherwise required by applicable legislation.

• Final pre-MAA package submitted to MHRA on October 20, 2026
• Full MAA submission targeted for early February 2027, under a revised strategy that could bring potential UK approval forward by approximately six weeks
• U.S. BLA expected to be submitted in Q2, 2027

BOCA RATON, Fla., Oct. 21, 2026 (GLOBE NEWSWIRE) — INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a late-stage biotechnology company focused on inflammation and immunology, today announced that it has submitted its final pre-Marketing Authorisation Application (pre-MAA) package to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Ebstrocel™ (CORDStrom™), its investigational cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The company has updated its regulatory submission strategy, as faster-than-expected manufacturing progress supports a full MAA submission in early February 2027, with potential UK approval in mid-2027, subject to MHRA review.

Following MHRA feedback on the final pre-MAA package, INmune Bio plans to finalize and submit a complete application in February 2027, replacing the sequential rolling submission previously planned to begin in late 2026. Based on progress in chemistry, manufacturing and controls (CMC) and discussions with regulatory advisors, the Company believes this approach could accelerate potential UK approval by approximately six weeks compared with the previously anticipated timeline.

The Company anticipates an MHRA response within three to six months after submission, subject to application validation, agency review and any requests for additional information. Submission of the complete package is intended to support assessment of the clinical, manufacturing and quality data together.

“This is a remarkable achievement by the whole CMC team and our external regulatory advisors allowing us to accelerate the potential approval for Ebstrocel for children with RDEB,” said Mark Lowdell, Chief Scientific Officer of INmune Bio. “Our progress allows us to bring forward the anticipated timeline to commercial supply, subject to approval, for children and families waiting for treatment.”

In parallel, INmune Bio has engaged U.S. regulatory advisors with rare disease expertise to prepare and submit a Type B meeting request to the U.S. Food and Drug Administration (FDA). Subject to feedback from that meeting, the Company plans to submit a Biologics License Application (BLA) in the second quarter of 2027, seeking traditional or accelerated approval, as appropriate.

“Based on positive feedback from our regulatory consultants in the U.S, we are prioritizing our FDA application ahead of an EMA submission, building on Ebstrocel’s U.S. Orphan Drug and Rare Pediatric Disease designations,” said David Moss, Chief Executive Officer of INmune Bio. “With potential UK and U.S. approvals in 2027, we are approaching a pivotal year. Approval in either or both markets would mark a major milestone for INmune Bio and bring Ebstrocel closer to patients and families living with RDEB.”

About INmune Bio Inc.

INmune Bio Inc. is a publicly traded (NASDAQ: INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. The Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes.

INmune Bio is actively advancing two late-stage product platforms toward registrational milestones:

• CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA in 2026 and EU EMA in 2027, alongside a planned U.S. Biologics License Application (BLA) submission.
• XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform designed to selectively neutralize soluble TNF (sTNF) and reduce neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease. 

To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com.

Forward Looking Statements

The Company’s product candidates remain in clinical development stage and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including  Ebstrocel™, XPro™ and INKmune™ trial results, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™, XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.

INmune Bio Contacts: 
David Moss 
Chief Executive Officer 
(561) 710-0512 
info@inmunebio.com

Daniel Carlson 
Head of Investor Relations 
(415) 509-4590 
dcarlson@inmunebio.com

• Resubmission includes Chemistry, Manufacturing, and Controls (CMC) data from new drug product (DP) manufacturing vendor

MOUNTAIN VIEW, Calif., Oct. 21, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The NDA was resubmitted following a Complete Response Letter (CRL) received in June 2026. The FDA has deemed the OLC resubmission a Class II with a six-month review period from the resubmission date, and set a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027.

“We are pleased that the FDA has accepted the resubmission of our NDA for OLC and assigned a PDUFA date,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “This resubmission includes CMC data from a new third-party drug product manufacturing vendor. The new vendor’s facility was last inspected by the FDA in March 2024 and received ‘No Action Indicated’ status. We hope to continue working with the FDA toward potential approval of this important medication to patients with CKD on dialysis who need additional treatment options for managing hyperphosphatemia.”

The Company does not know whether the FDA will decide to conduct a pre-approval inspection of the new third-party DP vendor. Additionally, if the original third-party manufacturing vendor is inspected in the near term and finds that its facility complies with current Good Manufacturing Practice (cGMP), the Company plans to seek FDA alignment on a shorter approval timeline.

The Company resubmitted the NDA following the second CRL, which cited deficiencies previously identified at the original third-party manufacturer of the drug product, which the FDA had not been able to re-inspect during the prior submission review.

The timing and outcome of any FDA inspection of the original third-party vendor will be determined solely by the FDA.

The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, as well as CMC data. The FDA did not raise any concerns regarding OLC’s preclinical or clinical data, including safety data, included in the original NDA submission.

About Oxylanthanum Carbonate
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.¹ Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

¹Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.

About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; Unicycive’s clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; Unicycive’s dependence on third parties for manufacturing; the possibility that FDA may require inspection of any vendor prior to approval, which could delay or prevent approval of its NDA; the risk that the inspection of the original or new third-party manufacturing vendor may not occur within a timeframe that benefits its regulatory timeline, or may result in adverse findings; risks related to business interruptions, which could seriously harm its financial condition and increase its costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of its products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com

Media Contact:
Unicycive Therapeutics
media@unicycive.com 

SOURCE: Unicycive Therapeutics, Inc.

21 October 2026

LEI: 2138003QW2ZAYZODBU23

LSE Code: 3OIS

WISDOMTREE MULTI ASSET ISSUER PUBLIC LIMITED COMPANY
(a public company incorporated with limited liability in Ireland)
WISDOMTREE WTI CRUDE OIL 3X DAILY SHORT SECURITIES
ISIN: XS2819844387

PROPOSED AMENDMENT TO THE PRINCIPAL AMOUNT OF THE AFFECTED SECURITIES
MEETING OF THE ETP SECURITYHOLDERS

THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION. If you are in any doubt about what action you should take, you are recommended to consult your independent financial adviser.

NOTICE is hereby given that, pursuant to the provisions of the trust deed dated 30 November 2012 (as amended) constituting (inter alia) the WisdomTree WTI Crude Oil 3x Daily Short Securities (the “Affected Securities”) and made between (1) WisdomTree Multi Asset Issuer Public Limited Company (the “Issuer”), (2) The Law Debenture Trust Corporation p.l.c. (the “Trustee”) and (3) WisdomTree Multi Asset Management Limited (the “Manager”), a meeting of the holders of the Affected Securities (the “Affected Securities Holders”), convened by the Issuer, will be held at the offices of Apex IFS Limited in 2nd Floor, Block 5, Irish Life Centre, Abbey Street Lower, Dublin 1, D01P767, Ireland on Friday 13 November 2026 at 11 a.m. local time (the “Meeting”).

The Meeting is being held to consider certain amendments, made under the powers set out in clause 2 of schedule 7 of the master trust deed of the Affected Securities, to documentation required to effect a reduction in the principal amount of the Affected Securities from USD 0.14 to USD 0.014. This follows the price of the Affected Securities falling below 500 per cent of its current principal amount on Friday 16 October 2026 (the “Threshold Event Date”).

In a scenario where the vote does not pass, if the price then falls below 200% of the principal amount on or after 60 days from the Threshold Event Date, then a compulsory redemption event will be triggered and the Issuer will be required to compulsorily redeem all Affected Securities Holders.

In order to maintain the normal trading and operations of the Affected Securities and to avoid a compulsory redemption event being triggered, the Issuer considers that the principal amount of the Affected Securities should be reduced.

The reduction in the principal amount will not affect the price of the Affected Securities as the price is calculated by reference to the underlying index and not to the principal amount of the Affected Securities.

It is important to note that:

• The reduction of the principal amount of the Affected Securities does NOT dilute an Affected Securities Holder’s holding or reduce the value of an Affected Securities Holder’s holding.
• The reduction of the principal amount does NOT negatively impact the ability of the investor to trade the Affected Securities.
• The reduction of the principal amount does NOT affect the amount an Affected Securities Holder would, in practice, receive on redemption of the Affected Securities.

Affected Securities Holders may also access the notification, including the circular, on the website of the Issuer, at
https://www.wisdomtree.eu/en-gb/resource-library/prospectus-and-regulatory-reports#tab-2A942D42-5AA1-4008-9080-3C2DADB050A7

Holders of the Affected Securities are advised to check with any bank, securities broker or other intermediary through which they hold their Affected Securities when such intermediary would need to receive instructions from a holder of Affected Securities in order for such holder of Affected Securities to participate in the Meeting by the deadlines specified in this circular. The deadlines set by any such intermediary and each ICSD for the submission instructions will be earlier than the relevant deadlines specified in this circular.

In relation to the delivery instructions or obtaining voting certificates or otherwise making arrangements for the giving of voting instructions, in each case through the ICSDs, holders of the Affected Securities should note the particular practice and policy of the relevant ICSDs, including any earlier deadlines set by such ICSD. The deadlines set by any intermediary or by the ICSDs will be earlier than the deadlines set out in this circular.

Affected Securities Holders will be notified of the outcome of the Meeting shortly thereafter.

• VMS063 is a novel, potential first- and best-in-class monoclonal antibody investigational candidate discovered by Invivyd 
• VMS063 demonstrated potent in vitro antiviral activity against contemporary measles virus variants, and attractive biophysical properties supporting its potential utility for both treatment and prevention of measles
• Invivyd is scaling up production toward clinical development in 2027
• There are currently no FDA approved treatments for measles, leaving a major gap in the public health and medical management of measles
• The U.S. is experiencing a record-breaking number of measles cases in 2026, and a significant immunity gap has emerged, leaving millions of Americans vulnerable to measles infection and associated complications

NEW HAVEN, Conn., Oct. 21, 2026 (GLOBE NEWSWIRE) — Invivyd, Inc. (Nasdaq: IVVD) today announced the presentation of preclinical data describing its novel, potential first- and best-in-class investigational monoclonal antibody candidate VMS063 at IDWeek 2026™ in Washington, D.C. Data demonstrated highly potent in vitro antiviral activity against contemporary measles fusion protein (MeV-F) variants, supporting its potential utility for both treatment and prevention (pre/post-exposure prophylaxis) of measles.

VMS063 is a highly potent, half-life-extended, high resistance barrier measles monoclonal antibody candidate engineered via Invivyd’s proprietary antibody discovery platform to target a highly conserved protein of measles virus. VMS063 could be the first precision therapy for measles, as well as a potentially important direct immunization option to supplement, offer an alternative to, or enhance standard measles vaccination. As a potential measles prophylactic option, Invivyd intends to maximize the convenience of accessing antibody immunization versus measles virus by developing VMS063 in either intramuscular or subcutaneous forms. Invivyd has begun manufacturing scale-up toward clinical development in 2027.

“Despite continued transmission of measles globally, and a reemergence in the United States, physicians who see measles patients have long lamented that there are no targeted approved treatments for measles. More generally, there has been little, if any, innovation in how we prevent and treat measles since 1963. As we see more and more cases, it’s clear that Americans, as well as the international community, need additional prevention options for measles as well as a specific treatment,” said Michael Mina, M.D., Ph.D., Chief Medical Officer and Chief Epidemiologist of Invivyd and widely cited measles researcher.  “A molecule like VMS063 has the potential to transform the measles landscape by leveraging the extraordinary potential of monoclonal antibodies that can, with one molecule, provide both prevention and treatment to fill these gaps. We are excited to interact with the scientific and public health community at IDWeek 2026™, as well as leaders across public health more generally, and we are rapidly advancing this program toward clinical development.”

At IDWeek 2026™, Invivyd will present data describing that VMS063 binds a highly conserved epitope of the MeV-F protein, stabilizing its pre-fusion conformation, supporting a mechanism of neutralization through inhibition of membrane fusion. Invivyd characterized the properties of VMS063 including its highly potent in vitro neutralization activity against historical and contemporary MeV variants, including the highest circulating contemporary genotypes, B3 and D8, in both authentic virus and pseudovirus neutralization assays.

The United States is facing a critical measles virus inflection point in 2026, with measles incidence reaching levels not seen in decades. As of October 2026, U.S. disease burden is nearly double that seen in 2025. As pediatric and community vaccination rates dip, a significant immunity gap has emerged. More than nine million school-aged children are estimated to be unprotected against measles in the U.S. today along with many millions more adults who are immune compromised. More, as one of the most infectious viruses known to exist, and a virus uniquely capable of destroying human immunologic memory, measles has the potential to impose a substantial burden on the healthcare system as infection spreads.  

IDWeek 2026™ is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric Infectious Diseases Society (PIDS). IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2026™ takes place Oct. 21-24 at the Walter E. Washington Convention Center (801 Allen Y. Lew Place NW) in Washington, D.C. For more information, visit www.idweek.org.

About VMS063
VMS063 is a novel, highly potent, half-life-extended, high resistance barrier measles monoclonal antibody candidate engineered via Invivyd’s proprietary antibody discovery platform to target a highly conserved protein of measles virus. VMS063 targets the measles Fusion (F) protein and is designed to lock the trimeric measles Fusion protein into a pre-fusion configuration, thereby preventing cell entry, similar to approved pediatric respiratory syncytial virus (RSV) monoclonal antibodies. VMS063 could be the first precision therapy for measles, as well as a potentially important passive preventive option to supplement or enhance measles vaccination.

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

Trademarks are the property of their respective owners.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “future,” “intends,” “plans,” “potential,” “predicts,” “projects,” and “targets” or similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, plans related to the company’s measles program, and the potential of VMS063 as a novel, potential first- and best-in-class mAb candidate being developed for the treatment and prevention of measles; the potential for VMS063 to be the first precision therapy for measles and a potentially important direct immunization option to supplement, offer an alternative to, or enhance standard measles vaccination; the company’s anticipated development and clinical timeline for VMS063; expectations regarding the public health environment and potential of a molecule like VMS063 to transform the measles landscape; the company’s plans to develop VMS063 in either intramuscular or subcutaneous forms; the company’s strategies and objectives; the company’s future prospects; and other statements that are not historical fact. The company may not actually achieve the plans, intentions, or expectations disclosed in the company’s forward-looking statements, and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress, and results of the company’s discovery and preclinical development activities, including with respect to VMS063; whether or not any preclinical candidate identified by the company is determined to be suitable for clinical development; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company’s product candidates based on neutralizing activity in nonclinical studies and the assessment of other in vitro properties; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; the company’s reliance on third parties; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; changes in the regulatory environment; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies may adversely impact the development or commercial success of the company’s product candidates; changes in expected or existing competition; the company’s reliance on third parties; complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, each as filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.

Contacts:

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

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

Artea Bank (ROE1L) invites shareholders, investors, analysts and other stakeholders to join its investor webinar on the 9 months 2026 financial results and highlights. The webinar will take place on 29 October 2026 at 8:30 a.m. (EET) and will be held online in English.

The webinar will be hosted by Tomas Varenbergas, acting CEO, Paulius Daukša, acting CFO, Indrė Genytė-Pikčienė, Chief Economist, and Tautvydas Mėdžius, Chief of Staff, who will discuss the bank’s financial results for 9 months 2026 and recent developments, and take questions from participants.

Participants are encouraged to submit questions in advance to investors@artea.lt.

The 9 months 2026 results will be announced in advance on 28 October after trading hours.

How to join the webinar:

To join the webinar, please register via following link https://artea.zoomtv.lt. After successful registration You will be provided with the webinar link. The webinar will be recorded and available online for everyone at Artea website.   

Additional information:
Arnas Šukys,
Head of Investor Relations
arnas.sukys@artea.lt; +370 610 44447  

TORONTO, Oct. 21, 2026 (GLOBE NEWSWIRE) — Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL), a clinical-stage company developing potentially life-improving medicines to treat degenerative muscle diseases, today announced that management will participate in the following investor conferences in November.

Guggenheim 3rd Annual Healthcare Innovation Conference
Date: Monday, Nov. 9, 2026
Fireside Chat: 9:30 a.m. ET
Location: Boston, MA
Webcast

Jefferies Global Healthcare Conference
Date: Nov. 18-19, 2026
Location: London, United Kingdom

Members of the Satellos leadership team will be available for one-on-one investor meetings during both conferences. A replay of the fireside chat will be available in the Events & Presentations section of the Company’s website following the events.

ABOUT SATELLOS BIOSCIENCE INC.
Satellos is a clinical-stage drug development company focused on restoring natural muscle repair and regeneration in degenerative muscle diseases. Through its research, Satellos has developed forazapadin, an orally administered small molecule AAK1 inhibitor designed to address deficits in muscle repair and regeneration. Forazapadin is being evaluated as a potential disease-modifying treatment for Duchenne muscular dystrophy (DMD) in two Phase 2 clinical trials, BASECAMP in pediatric participants with DMD and TRAILHEAD in adults living with DMD. Following FDA clearance of an Investigational New Drug (IND) application, a Phase 2 clinical trial of forazapadin in adults with facioscapulohumeral muscular dystrophy (FSHD) is expected to begin in the fourth quarter of 2026. The company has identified additional muscle diseases and injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and plans to pursue these opportunities in future clinical development. For more information, visit www.satellos.com and connect with Satellos on X, LinkedIn, Facebook and Instagram.

NOTICE ON FORWARD-LOOKING STATEMENTS
This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Satellos and its business, which may include, but are not limited to, statements regarding the possibility of pursuing regulatory approval for forazapadin, including a potential accelerated approval pathway; anticipated benefits to patients from forazapadin; the enrollment in, advancement and timing of results of forazapadin through clinical trials, including the BASECAMP, TRAILHEAD and TRAVERSE clinical trials, and the timing of release of related clinical trial data; the potential of Satellos’ approach in other degenerative muscle diseases and Satellos’ plans to pursue additional muscle diseases and injury conditions in future clinical development; Satellos’ technologies and drug development plans; and Satellos’ expectation for broader use of International Nonproprietary Name in future scientific, regulatory and corporate communications. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, occurrences or developments, are “forward-looking information or statements.” Often, but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “believe”, “plan”, “expect”, “intend”, “estimate”, “anticipate”, “potential”, “prospective”, “assert” or any variations (including negative or plural variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. These statements are based on assumptions and subject to risks and uncertainties. In making forward looking statements, the Company has relied on various assumptions, including but not limited to: its ability to obtain future funding on favorable terms, if at all; obtaining positive results in its clinical trials; its ability to obtain necessary regulatory approvals; its ability to arrange for the manufacturing of its product candidates and technologies; and general business, market and economic conditions. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, risks relating to the pharmaceutical and bioscience industry (including the risks associated with preclinical and clinical trials and regulatory approvals), the research and development of therapeutics, the results of preclinical and clinical trials, general market conditions and equity markets, economic factors and management’s ability to manage and to operate the business of the Company generally, including inflation and the costs of operating a biopharma business, and those risks and uncertainties described in more detail in the “Risk Factors” section of Satellos’ Annual Information Form dated March 27, 2026, and amended and restated short form base shelf prospectus dated August 11, 2026 (each of which is located on Satellos’ SEDAR+ profile) and incorporated by reference in Satellos’ Form F-10 filed with the Securities and Exchange Commission on August 11, 2026, and in Satellos’ public filings on EDGAR (sec.gov) and SEDAR+ (sedarplus.ca). Although Satellos has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Satellos does not undertake any obligation to publicly update or revise any forward-looking statement, whether resulting from new information, future events, or otherwise.

CONTACTS
Investors: Caitlin Lowie, Vice President, Investor Relations & Communications, ir@satellos.com
Media: Emily Williams, Senior Director, Communications, media@satellos.com

• Brepocitinib 45 mg once-daily achieved statistically significant benefit compared to placebo on the primary and all key secondary endpoints for each of CLARITY-1 and CLARITY-2, the two identical Phase 3 trials comprising the CLARITY program in NIU
• Median time to treatment failure for brepocitinib patients was greater than 48 weeks in both studies, compared with ~12 weeks on placebo in each study (p<0.0001 in both studies), including 40 weeks of steroid-free treatment, setting a new bar for time to failure and steroid-sparing benefit in NIU
• Pooled across the CLARITY studies, 62% of patients on brepocitinib achieved steroid-free quiescence at Week 48, compared with 20% on placebo (p<0.0001), with similar results in each study
• Of patients that entered the CLARITY studies (pooled) with macular edema, 42% of eyes on brepocitinib achieved resolution of macular edema at Week 48, compared with 4.8% on placebo (p<0.0001), with similar results in each study
• The magnitude and breadth of benefit observed across every ranked endpoint, compared with results reported in registrational trials of existing NIU therapies, suggest brepocitinib has the potential to be the most effective systemic, non-steroid treatment option for NIU
• Safety data consistent with prior brepocitinib clinical trials; no new safety signals or findings
• Priovant intends to file a supplemental New Drug Application (sNDA) for brepocitinib for the treatment of NIU in the first half of calendar year 2027
• Roivant will host an investor call to discuss these updates today, October 21, 2026, at 8:00 a.m. ET

BASEL, Switzerland and LONDON and NEW YORK and DURHAM, N.C., Oct. 21, 2026 (GLOBE NEWSWIRE) — Roivant (Nasdaq:ROIV) and Priovant Therapeutics today announced positive results from the Phase 3 CLARITY program evaluating brepocitinib in non-infectious uveitis (NIU). Brepocitinib met the primary endpoint for both the CLARITY-1 and CLARITY-2 studies. Brepocitinib also achieved statistically significant and clinically meaningful benefit on all key secondary endpoints, including measurements of sustained steroid-free quiescence at Week 48, chorioretinal vascular leakage, resolution of macular edema and patient-reported visual functioning. These results were achieved despite a substantially more aggressive steroid taper than precedent NIU trials.

“Today marks a potential turning point for the field of uveitis and for the patients and physicians who have waited nearly a decade for a new systemic, non-steroid treatment option. The phenomenal results from the Phase 3 CLARITY program suggest that brepocitinib could meaningfully change how we treat non-infectious uveitis across multiple etiologies,” said Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Professor of Medicine (Immunology/Rheumatology), and Professor of Pediatrics (Rheumatology) at the Byers Eye Institute and Stanford University School of Medicine, President of the International Ocular Inflammation Society (IOIS), and Executive Vice President of the Foster Ocular Immunology Society (FOIS). “Even with a much faster taper of oral prednisone, patients treated with brepocitinib in CLARITY demonstrated highly differentiated benefits across the primary and all key secondary endpoints, including quiescence, resolution of macular edema and improvement in chorioretinal inflammation. This is the kind of outcome that can redefine expectations for an entire field. To see this breadth of benefit across disease control, macular edema and visual functioning is tremendously exciting for those of us who care for these patients.”

NIU, a debilitating ocular inflammation, is one of the leading causes of blindness among the working age population. Undertreated NIU can result in permanent vision loss. NIU is frequently associated with ocular pain, floaters and visual impairment across multiple domains (acuity, peripheral vision, color recognition, ability to focus on moving objects, night vision, etc.) that can interfere with everyday activities including reading the newspaper, driving, socializing, working and independent self-care. NIU is estimated to affect 70,000 to 190,000 adults in the United States.

CLARITY Study Design and Data

The CLARITY program enrolled 371 patients across two identical studies, CLARITY-1 and CLARITY-2. Patients were randomized 1:1 to once-daily brepocitinib 45 mg or placebo for a 48-week double-masked treatment period. All patients received an 8-week oral corticosteroid (OCS) regimen of 60 mg/day for 2 weeks followed by a mandatory 6-week steroid taper to zero. The primary endpoint was time to treatment failure, assessed from Week 6 through Week 48.

Time to treatment failure in CLARITY-1 and CLARITY-2 (Kaplan-Meier estimates, brepocitinib vs. placebo) is captured below:

Brepocitinib demonstrated consistent benefits on preventing treatment failure across key subgroups, including intermediate, posterior, and panuveitis; patients with and without prior TNFi experience; and multiple etiologies of uveitis, including idiopathic disease, birdshot chorioretinopathy, and sarcoidosis.

Pre-specified multiplicity controlled secondary endpoints in the CLARITY trials included sustained steroid-free quiescence, improvement in chorioretinal vascular leakage as assessed through wide-field fluorescein angiography (FA), resolution of macular edema, and improvement in patient-reported visual functioning (NEI VFQ-25 overall composite score).

Results on the primary and key secondary endpoints are captured below:

	CLARITY-1 (N=166)					CLARITY-2 (N=204)
	Brepocitinib 45 mg		Placebo		Delta*	Brepocitinib 45 mg		Placebo		Delta*
Hazard Ratio for Treatment Failure vs. Placebo (95% CI)	0.27 (0.17–0.43)		—		P<0.0001	0.22 (0.14–0.34)		—		P<0.0001
Cumulative Incidence of Treatment Failure at Week 48	35.4%		78.7%		Δ 43.3%; P<0.0001	32.4%		77.8%		Δ 45.4%; P<0.0001
Steroid-Free Quiescence in Both Eyes at Week 48	58.8%		19.8%		Δ 38.1%; P<0.0001	64.4%		19.4%		Δ 45.2%; P<0.0001
Achievement of FA Response (≥ 30% Reduction from Baseline) at Week 48 Among Eyes With FA Score > 5 at Baseline	39.4%		8.6%		Δ 31.3%; P<0.0001	54.9%		7.2%		Δ 49.8%; P<0.0001
Resolution of Macular Edema at Week 48 Among Eyes with Macular Edema at Baseline	40.4%		2.1%		Δ 33.3%; P=0.0041	42.6%		7.0%		Δ 40.1%; P=0.0002
Achievement of ≥ 5-point Improvement in NEI VFQ-25 Overall Composite Score from Baseline at Week 48, Among Subjects with Baseline ≤ 95	36.4%		13.7%		Δ 21.9%; P=0.0013	40.4%		14.1%		Δ 24.5%; P=0.0003

*Deltas account for covariates
Efficacy analyses exclude one subject who was randomized but did not receive any doses of masked study drug.

Safety and Regulatory Submissions

Brepocitinib was generally well tolerated during the treatment period. Most events were mild or moderate in severity, and only 3% of participants discontinued treatment due to an AE. The observed safety profile in the trials was consistent with the known safety profile of brepocitinib, with no new safety signals observed.

Priovant intends to file a supplemental New Drug Application (sNDA) for brepocitinib for treatment of NIU in the first half of calendar year 2027.

“The breadth and magnitude of benefit seen in the CLARITY studies position brepocitinib to potentially set a new standard for the treatment of non-infectious uveitis,” said Ben Zimmer, CEO of Priovant. “With LISRAYA now commercially available for adults with dermatomyositis, we see NIU as the potential next pillar of a leading rare disease immunology franchise. I would like to thank all of the investigators and patients who participated in the CLARITY trials, without whom this moment would not be possible.”

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. ET on Wednesday, October 21, 2026, to discuss the Phase 3 results for brepocitinib in non-infectious uveitis. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

Roivant will also host an investor day on Wednesday, December 9, 2026. To attend the event in person or by webcast, please register online using this registration link. 

About Priovant

Priovant Therapeutics is a biotechnology company dedicated to developing and commercializing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company’s commercial product, LISRAYA™ (brepocitinib) is the first and only targeted oral therapy approved for the treatment of adults with dermatomyositis. See important LISRAYA safety information, including boxed warning, at lisrayahcp.com/pi. Brepocitinib, a first-in-class TYK2/JAK1 inhibitor, also recently generated positive Phase 3 data in non-infectious uveitis (NIU). Brepocitinib is under evaluation in a Phase 3 program in cutaneous sarcoidosis, and a Phase 2b/3 program in lichen planopilaris. These potential indications have not been approved by the FDA. Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company.

About Roivant

Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com.

Roivant Forward-Looking Statements

This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product and product candidates, the availability and success of topline results from our ongoing clinical trials, the timing of potential regulatory approvals for our product and product candidates, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.

Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:
Investors
Keyur Parekh
keyur.parekh@roivant.com

Media
Stephanie Lee
stephanie.lee@roivant.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/76d0a0eb-19e9-4a8e-ad9a-3d963f8a2082