Algernon Announces Increase to Private Placement Financing to $750,000 and Close of Third Tranche




Algernon Announces Increase to Private Placement Financing to $750,000 and Close of Third Tranche

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR 
FOR DISSEMINATION IN THE UNITED STATES

VANCOUVER, British Columbia, Dec. 23, 2025 (GLOBE NEWSWIRE) — Algernon Health Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian healthcare company, announces an increase to its non-brokered private placement financing, previously announced on November 6, 2025, to $750,000 and the closing of the third tranche (the “Third Tranche”). Gross proceeds from the Third Tranche totaled CAD $352,500 from the sale of 5,035,714 units (the “Units”) at an issue price of CAD $0.07 per Unit. The closing of the Third Tranche brings the financing to a total of CAD $739,500 from the sale of 10,564,286 Units, including the closing of the first and second tranches on November 14, 2025 and November 28, 2025, respectively.

The Company did not pay any cash finder’s fees pertaining to the Third Tranche of the Offering.

The Company will use the proceeds of the Offering towards advancing its Alzheimer’s Disease (“AD”) program including the opening of its first U.S. AD clinic, general and administrative expenses and for working capital purposes.

The securities issued and issuable, described in this and the previous news release on November 6, 2025, will be subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable Canadian securities legislation.

The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and may not be offered or sold within the United States or to, or for the account or benefit of, “U.S. persons” (as such term is defined in Regulation S under the U.S. Securities Act) absent registration under the U.S. Securities Act and applicable state securities laws, or an exemption from such registration

For more information please contact:

Christopher J. Moreau
CEO
Algernon Health Inc.
604.398.4175 Ext 701
cjmoreau@algernonhealth.com

https://www.algernonhealth.com/ 

About Algernon Health  

Algernon Health is a Canadian healthcare company focused on the provision of brain optimized PET scanning services through a planned network of new clinics in North America for the early-stage detection of Alzheimer’s Disease, as well as other forms of dementia, epilepsy, neuro-oncology, and movement disorders. Algernon is also the parent company of a recently created private subsidiary called Algernon USA LLC, that will oversee all U.S. neuroimaging operations.

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to planned brain-specific neuroimaging PET scanning clinic opening timelines, planned financings in the Company and its subsidiary and the closings of additional tranches thereof, product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

Vor Bio Appoints RA Capital’s Andrew Levin, M.D., Ph.D., and Forbion’s Wouter Joustra to Board of Directors




Vor Bio Appoints RA Capital’s Andrew Levin, M.D., Ph.D., and Forbion’s Wouter Joustra to Board of Directors

BOSTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) — Vor Biopharma Inc. (Nasdaq: VOR), a clinical-stage biotechnology company dedicated to transforming the treatment of autoimmune diseases, today announced the appointment of Andrew Levin, M.D., Ph.D., Partner at RA Capital Management, and Wouter Joustra, General Partner at Forbion, to its Board of Directors. Their appointments follow the Company’s recently announced $150M PIPE financing, which included participation from both investors.

“Andrew and Wouter bring highly complementary experience in life sciences investment, financing strategy, and board-level oversight. We are delighted to welcome them to our Board at an important moment for the Company,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio. “Their perspectives will be invaluable as we advance our global Phase 3 programs and position the Company to drive long-term shareholder value.”

Dr. Levin is a Partner on the investment team at RA Capital Management, L.P., where he brings deep expertise in life sciences investing and strategic oversight to support innovative biopharma companies across all stages of development. He holds a B.S. in mechanical engineering from Princeton University, and M.D. from Harvard Medical School, and a Ph.D. in biomedical engineering from Massachusetts Institute of Technology. Dr. Levin fills the seat previously held by Sarah Reed, General Counsel at RA Capital, who resigned from the Board.

“Vor Bio is at an important inflection point, and I am excited to support the Company as it advances telitacicept through global Phase 3 development and continues to focus on disciplined capital allocation and long-term growth,” said Dr. Levin.

Mr. Joustra is a General Partner at Forbion, where he is responsible for general fund management, late stage private, cross-over and public investments.   Mr. Joustra has served on the boards of several high-growth biotech companies through successful acquisitions and currently serves on the boards of multiple public and private life sciences companies. He holds an M.Sc. in Business Administration and a B.Sc. in International Business and Management from the University of Groningen.

“Vor Bio has established an exceptionally strong foundation with telitacicept, and I look forward to contributing my experience in late-stage biotech growth and value creation as the Company scales its clinical programs,” said Mr. Joustra.

About Vor Bio

Vor Bio is a clinical-stage biotechnology company transforming the treatment of autoimmune diseases. The Company is focused on rapidly advancing telitacicept, a novel dual-target fusion protein, through Phase 3 clinical development and potential commercialization to address serious autoantibody-driven conditions worldwide.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “aim,” “anticipate,” “can,” “continue,” “could,” “design,” “enable,” “expect,” “initiate,” “intend,” “may,” “on-track,” “ongoing,” “plan,” “potential,” “should,” “target,” “update,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include Vor Bio’s statements regarding Vor Bio’s development plans for telitacicept; and other statements that are not historical fact. Vor Bio may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors. These and other risks are described in greater detail under the caption “Risk Factors” included in Vor Bio’s most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Vor Bio expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.

Media & Investor Contacts:
Carl Mauch
cmauch@vorbio.com

Sarah Spencer
investors@vorbio.com

Singlera Genomics Signs European Distribution and Research Agreement with Pure Medical for Cancer Detection Products




Singlera Genomics Signs European Distribution and Research Agreement with Pure Medical for Cancer Detection Products

LA JOLLA, Calif., Dec. 23, 2025 (GLOBE NEWSWIRE) — Singlera Genomics, a company focused on the development and application of novel DNA methylation technologies to genetic diagnosis, today announced that it has entered into a research and distribution agreement with European Union-based international medical company Pure Medical.

Singlera’s mTitan and mGuard platforms screen circulating cell-free DNA for signals associated with cancer, often before symptoms appear. The patented technology behind these platforms has been utilized to non-invasively detect methylation haplotypes from esophageal, colorectal, gastric, lung, liver, and pancreatic cancer. Under the terms of the agreement, Singlera and Pure Medical will collaborate with local universities, hospital networks, and national heathcare systems on research studies across western Europe, as well as on the commercial distribution of mTitan- and mGuard-based assays in several European countries.

“We are excited to partner with Pure Medical to focus on cancer detection and surveillance across western Europe, including colorectal and pancreatic cancer,” said Qiang Liu, COO and co-founder of Singlera Genomics. “This distribution agreement represents an important step in our European business strategy to bring inexpensive early cancer detection and monitoring to the global patient population; we hope that Singlera’s methylation products can give clinicians an important tool for faster detection, diagnosis, and treatment of cancer.”

“We are pleased to be working with Singlera Genomics,” said Maarten van Dijk, CEO of Pure Medical. “We are already engaged in research collaborations with academic and healthcare institutions across the UK and Europe, and are working toward the earliest possible commercialization of Singlera’s colorectal and pancreatic cancer products across seven EU countries. These innovative, non-invasive technologies have the potential to support earlier detection and more effective monitoring of colorectal and pancreatic cancer, and we are encouraged by what our existing engagement with healthcare systems can bring in translating this innovation into real-world clinical benefit.”

Singlera Genomics Inc. (www.singlera.com)

Singlera Genomics Inc., a globally operating enterprise specializing in non-invasive genetic diagnosis, was established in July 2014. With a presence spanning across continents, the company boasts research and development centers along with business operations worldwide. Singlera is at the forefront of innovation with its proprietary technologies in single-cell sequencing, DNA methylation, and bioinformatics, making significant strides in the global field of genomics.

Pure Medical (www.puremedical.world)

Founded in 2015, Pure Medical is an established international medical company with a strong background in genetics. The company works closely with innovative healthcare specialists, governments, and medical professionals to address both current and future healthcare challenges. Pure Medical focuses on supporting the introduction and adoption of new medical technologies within national healthcare systems. Through strategic partnerships and a commitment to innovation, Pure Medical aims to improve patient outcomes and enable more effective, accessible, and sustainable healthcare.

Media Contact
858.732.0061
info@singleragenomics.com

Sequana Medical announces execution of letter of intent to amend terms of the Kreos Loan




Sequana Medical announces execution of letter of intent to amend terms of the Kreos Loan

Ghent, Belgium, Dec. 23, 2025 (GLOBE NEWSWIRE) — Sequana Medical announces execution of letter of intent to amend terms of the Kreos Loan

PRESS RELEASE 
REGULATED INFORMATION / INSIDE INFORMATION
23 December 2025, 6:30 pm CET / 12:30 pm ET 

• Letter of intent to amend the loan from funds managed by Kreos, including an extension of the interest only period and deferral of amortization payments
• Additional runway supports ongoing alfapump commercial rollout in the U.S.

Ghent, Belgium – 23 December 2025 – Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announced that it entered into a non-binding letter of intent with Kreos Capital VII (UK) Limited (together with its affiliates, “Kreos”)¹ to agree to a number of amendments to the terms of its loan (the “Kreos Loan“), including notably that the interest only period will be extended, and amortisation repayments will be postponed until 1 May 2026, and that the first two monthly repayments of principal and interest following the new amortisation resumption date (i.e., the 1 May and 1 June payments) shall equal half of each of the monthly repayments of principal and interest for the remaining three (3) months of amortisation to the final repayment date of 1 September 2026. The amendments are subject to the entry into a final binding agreement with Kreos. As a result of converting a portion of the Kreos Loan into equity of the Company during 2025, the outstanding principal of the loan has been reduced to less than €4.5 million.

Ian Crosbie, Chief Executive Officer at Sequana Medical, commented: “We are very pleased with the ongoing support from Kreos as we continue the rollout of alfapump in the US. With these positive steps to improve our financial flexibility, we look forward to building upon our commercial momentum including the recent implants at Mount Sinai and University of Pennsylvania. As we expand our commercial activities, we grow ever more confident of the US market opportunity for alfapump, as obesity drives strong growth in recurrent and refractory ascites due to liver cirrhosis.”

For more information, please contact:

Sequana Medical
Investor relations
E: IR@sequanamedical.com
T: +44 (0) 797 342 9917

Media Relations:
Josephine Galatioto
ICR Healthcare
E: Sequana@icrhealthcare.com
T: +1 (332) 242-4388

About Sequana Medical

Sequana Medical NV is a pioneer in treating fluid overload, a serious and frequent clinical complication in patients with liver disease, heart failure and cancer. This causes major medical issues including increased mortality, repeated hospitalizations, severe pain, difficulty breathing and restricted mobility. Although diuretics are standard of care, they become ineffective, intolerable or exacerbate the problem in many patients. There are limited effective treatment options, resulting in poor clinical outcomes, high costs and a major impact on their quality of life. Sequana Medical is seeking to provide innovative treatment options for this large and growing “diuretic resistant” patient population. alfapump® and DSR® are Sequana Medical’s proprietary platforms that work with the body to treat diuretic-resistant fluid overload, and are intended to deliver major clinical and quality of life benefits for patients, while reducing costs for healthcare systems.

The Company received US FDA approval for the alfapump System for the treatment of recurrent or refractory ascites due to liver cirrhosis in December 2024, following the grant of FDA Breakthrough Device Designation in 2019. In Sequana Medical’s POSEIDON study, a landmark study across 18 centers in the US and Canada, the pivotal cohort of 40 patients implanted with the alfapump showed at 6 and 24 months post-implantation the virtual elimination of therapeutic paracentesis and an improvement in quality of life^{1, 2}.

Sequana Medical is commercializing the alfapump through a specialty commercial team initially targeting US liver transplant centers – 90 of these centers perform more than 90% of US liver transplants annually. In August 2025, CMS announced that it approved the New Technology Add-on Payment for the alfapump when performed in the hospital inpatient setting as of October 1, 2025.

Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements.³ The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is dependent on securing additional financing.

Sequana Medical is listed on the regulated market of Euronext Brussels (Ticker: SEQUA.BR) and headquartered in Ghent, Belgium. For further information, please visit www.sequanamedical.com.

Important Safety Information: For important safety information regarding the alfapump® system, see https://www.sequanamedical.com/wp-content/uploads/ISI.pdf.

The alfapump® System is currently not approved in Canada.

DSR® therapy is still in development and is currently not approved in any country. The safety and effectiveness of DSR® therapy has not been established.

Note: alfapump® and DSR® are registered trademarks.

Forward-looking statements

This press release may contain predictions, estimates or other information that might be considered forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements represent the current judgment of Sequana Medical on what the future holds, and are subject to risks and uncertainties that could cause actual results to differ materially. Sequana Medical expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

¹         BlackRock Inc. announced the completion of its acquisition of Kreos, a leading provider of growth and venture debt financing to companies in the technology and healthcare industries, on 2 August 2023

¹ alfapump system SSED (summary of safety and effectiveness) PMA 230044

² as defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q)

³ Data reported in press release of March 25, 2024; mean increase of 326% in six-hour urinary sodium excretion at 3 months follow up vs baseline, and 95% reduction of loop diuretics over same period

Attachments

• PR Kreos Amendment (ENG) (23 December 2025)
• PR Kreos Amendment (NL) (23 december 2025)

West Hollywood Orthodontist Launches Free ‘Student Airway Baseline’ Screenings After Research Links Sleep-Disordered Breathing to Academic Struggles




West Hollywood Orthodontist Launches Free ‘Student Airway Baseline’ Screenings After Research Links Sleep-Disordered Breathing to Academic Struggles

Harvard-trained orthodontist offers complimentary 15-minute airway analysis to help identify hidden causes of childhood focus problems

LOS ANGELES, Dec. 23, 2025 (GLOBE NEWSWIRE) — McComb Orthodontics, a specialty orthodontic practice serving Culver City and West Hollywood, has launched a free screening program designed to identify airway obstructions that research increasingly links to attention deficits and poor academic performance in children.

The “Student Airway Baseline” initiative offers complimentary 15-minute analyses of the orofacial structures for children ages 6 to 12. The program, which requires no referral, aims to detect signs of sleep-disordered breathing before the condition affects school performance or leads to misdiagnosis of behavioral disorders.

“Many parents hire tutors or seek medication for a child who can’t focus, not realizing the child is physically exhausted from poor sleep,” said Dr. Ryan McComb, the Harvard-trained orthodontist who leads the practice. “New research confirms that narrow palates and restricted airways don’t just affect teeth—they can deprive the developing brain of the deep, restorative sleep essential for learning and memory consolidation.”

The initiative follows mounting clinical evidence connecting airway health to cognitive development. A January 2024 systematic review and meta-analysis published in BMC Pediatrics quantified the proportion of neurobehavioral impairments attributed to sleep-disordered breathing in children and adolescents. A separate 2022 meta-analysis in Sleep Medicine Reviews reviewing 77 studies found that children with sleep-disordered breathing had significant impairments across all cognitive domains, with the largest deficits in verbal and overall intelligence.

The American Academy of Pediatrics’ September 2025 clinical report on developmental screening emphasizes the critical importance of early identification of conditions that affect mental, emotional, and behavioral health in children, noting that standardized screening helps reduce cognitive biases that can contribute to misdiagnosis.

Sleep-disordered breathing in children often goes undetected because symptoms differ from those in adults. Rather than loud snoring, affected children may exhibit restless sleep, mouth breathing, bedwetting, or daytime behaviors that mimic attention deficit hyperactivity disorder. Studies suggest that as many as one in 10 children experience some form of sleep-disordered breathing, with many cases remaining undiagnosed until problems manifest academically or behaviorally.

“We’re seeing children labeled as problem students when the real issue is that their airway is so compromised they’re operating on a fraction of the sleep their brains need,” Dr. McComb said. “A simple screening can identify structural issues that, when addressed early, may prevent years of struggle in the classroom and at home.”

The noninvasive Student Airway Baseline screening takes approximately 15 minutes and produces immediate results. Children identified with potential concerns receive detailed findings that parents can share with pediatricians or sleep specialists for further evaluation, along with potential referral to ENT specialists.

“This isn’t a dental exam—it’s a baseline measurement that gives families objective data about their child’s airway development,” Dr. McComb said. “Our goal is early identification, before grades suffer and before a child begins to see themselves as someone who can’t succeed in school.”

The complimentary screenings are available at both McComb Orthodontics locations in Culver City and West Hollywood and are open to all students in the greater Los Angeles area regardless of whether they are existing patients. Parents may schedule appointments by contacting either clinic directly or through the practice website.

About McComb Orthodontics

McComb Orthodontics is a specialty orthodontic practice with clinics in West Hollywood, and Culver City, serving families across the Westside and central Los Angeles. The West Hollywood clinic is convenient to Beverly Grove, Melrose, the Fairfax District and the Sunset Strip. The Culver City clinic serves the Culver Arts District, Palms, Mar Vista, Playa Vista and Baldwin Hills. Led by Board Certified orthodontist Ryan McComb, DMD, MS, the practice provides comprehensive care that includes growth and airway-aware evaluations, braces and clear aligners for children, teens and adults. Learn more at https://mccomborthodontics.com/

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3ce1d3a7-31ce-420c-adb4-bc075f376aa3

CONTACT: Media Contact: Alexandre@McCombortho.com 

Prenetics Enters Into Warrant Exchange Agreements With Warrant Holders, Strengthening Capital Structure




Prenetics Enters Into Warrant Exchange Agreements With Warrant Holders, Strengthening Capital Structure

CHARLOTTE, N.C., Dec. 23, 2025 (GLOBE NEWSWIRE) — Prenetics Global Limited (NASDAQ: PRE) (“Prenetics” or the “Company”), a leading health sciences company and parent of the IM8 premium health and longevity brand, today announced that it has entered into warrant exchange agreements, subject to customary closing conditions, with holders representing approximately 83.4% of its outstanding Class A and Class B warrants, pursuant to a voluntary warrant exchange program designed to simplify the Company’s capital structure and materially reduce potential future dilution.

The warrant exchange program was developed based on investor feedback and following discussions with several of the Company’s largest institutional shareholders, who expressed strong support for consolidating legacy warrant instruments into a cleaner capital structure.

Background and Participation

In connection with the Company’s prior financing in October 2025, 2,722,642 Class A ordinary shares were issued, with one Class A warrant and one Class B warrant issued for each such Class A ordinary share, for a total of 5,445,284 warrants.

As of the date of this announcement, the Company has entered into exchange agreements covering 4,539,722 of the 5,445,284 aggregate Class A and Class B warrants, representing approximately 83.4% participation.

Summary of the Warrant Exchange

Under the exchange agreements:

• One (1) Class A warrant and one (1) Class B warrant with exercise prices of $24.12 and $32.16, respectively, each with a five-year term have been exchanged for
• One (1) new Class C warrant with:
  • an exercise price of $18.00 per Class A ordinary share,
  • a two-year term commencing upon the effectiveness of a registration statement on Form F-3 registering the resale of the shares issuable upon exercise of the Class C warrants, and
  • a standard forced-redemption (call) feature.

The Company may exercise its forced-redemption right only after the registration statement on Form F-3 registering the resale of the shares issuable upon exercise of the Class C warrants is declared effective and only if the Company’s Class A ordinary shares trade at or above 120% of the exercise price (i.e., $21.60) for ten (10) consecutive trading days.

Warrant holders participated in the exchange on a voluntary basis, and identical terms were offered to all eligible warrant holders.

Impact on Capital Structure

Based on the exchange agreements, a total of approximately 4.54 million in aggregate of the Company’s outstanding Class A warrants and Class B warrants is expected to be exchanged for approximately 2.27 million Class C warrants.

After such exchange, the total number of outstanding Class A warrants, Class B warrants and Class C warrants is expected to be approximately 3.18 million in aggregate, representing a reduction of approximately 42.0% from the number of Class A and Class B warrants issued in the October 2025 financing round, and further up to 50% assuming participation in full by all holders of Class A warrants and Class B warrants.

The Company believes this reduction materially improves its long-term dilution profile, reduces warrant overhang, and enhances the investability of its ordinary shares. The Company is not undertaking this warrant exchange in connection with any financing transaction and has no plans to conduct any equity or equity-linked capital raise in the foreseeable future.

Strategic Rationale and Benefits

The Company believes this warrant exchange delivers several meaningful benefits to the Company and its shareholders, including:

• Up to 50% reduction from the number of outstanding Class A warrants and Class B warrants, materially lowering long-term dilution risk
• Substantial elimination of two deep out-of-the-money legacy classes of warrants, reducing up to 50% of the overhang on the Company’s shares that resulted from the Class A warrants and Class B warrants
• Simplification in favor of a single, unified class of warrants, improving transparency and institutional investability
• Improved alignment with shareholders, by providing a more realistic and attainable path to warrant redemption

The Company noted that its largest institutional investors, each with significant long-term investments, have participated in the exchange, reflecting strong confidence in the revised structure and its long-term benefits.

About Prenetics
Prenetics (NASDAQ: PRE) is a leading health sciences company redefining the future of health and longevity through IM8 — its flagship consumer brand co-founded with David Beckham and championed by World No. 1 tennis player Aryna Sabalenka. IM8 has achieved the fastest growth trajectory in supplement industry history, reaching $100 million+ in ARR within 11 months of launch, outpacing even leading AI startups.

About IM8
IM8 is the pinnacle of premium core nutrition, born from a collaboration between David Beckham as a co-founding partner, and an elite team of scientists spanning medical professionals, academia and space science. Combining cutting-edge science with nature’s most potent ingredients, IM8 delivers a holistic, science-backed approach to health, empowering you to live your most vibrant life. IM8’s flagship product, Daily Ultimate Essentials is an all-in-one powder supplement engineered to replace 16 different supplements in a delicious drink and is NSF Certified for Sport, non-GMO, vegan, free from common allergens, and contains no artificial flavors, colors or sweeteners. IM8 is a subsidiary of Prenetics (NASDAQ: PRE), a leading global health sciences company dedicated to advancing consumer health. To learn more about IM8, please visit www.IM8health.com.

Investor Relations Contact:
investors@prenetics.com
PRE@mzgroup.us

Angela Cheung
Investor Relations / Corporate Finance
angela.hm.cheung@prenetics.com

Forward-Looking Statements
This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company’s goals, targets, projections, outlooks, beliefs, expectations, strategy, plans, objectives of management for future operations of the Company, and growth opportunities are forward-looking statements. Our guidance (including warrant structure, numbers and timeline) reflects management’s current estimates and assumptions as of the date of this release, is subject to significant risks and uncertainties, and is not a guarantee of future performance. Actual results may differ materially. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to,” “guidance,” “outlook,” “forecast,” or other similar expressions. Forward-looking statements are based upon estimates and forecasts and reflect the views, assumptions, expectations, and opinions of the Company, which involve inherent risks and uncertainties, and therefore they should not be relied upon as being necessarily indicative of future results. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to factors beyond the Company’s control that prevent the closing and final consummation of the exchange agreements. In addition to the foregoing factors, you should also carefully consider the other risks and uncertainties described in the “Risk Factors” section of the Company’s most recent registration statement and the prospectus therein, and the other documents filed by the Company from time to time with the U.S. Securities and Exchange Commission. Unless otherwise specified, all information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

Prenetics Enters Into Warrant Exchange Agreements With Warrant Holders, Strengthening Capital Structure




Prenetics Enters Into Warrant Exchange Agreements With Warrant Holders, Strengthening Capital Structure

CHARLOTTE, N.C., Dec. 23, 2025 (GLOBE NEWSWIRE) — Prenetics Global Limited (NASDAQ: PRE) (“Prenetics” or the “Company”), a leading health sciences company and parent of the IM8 premium health and longevity brand, today announced that it has entered into warrant exchange agreements, subject to customary closing conditions, with holders representing approximately 83.4% of its outstanding Class A and Class B warrants, pursuant to a voluntary warrant exchange program designed to simplify the Company’s capital structure and materially reduce potential future dilution.

The warrant exchange program was developed based on investor feedback and following discussions with several of the Company’s largest institutional shareholders, who expressed strong support for consolidating legacy warrant instruments into a cleaner capital structure.

Background and Participation

In connection with the Company’s prior financing in October 2025, 2,722,642 Class A ordinary shares were issued, with one Class A warrant and one Class B warrant issued for each such Class A ordinary share, for a total of 5,445,284 warrants.

As of the date of this announcement, the Company has entered into exchange agreements covering 4,539,722 of the 5,445,284 aggregate Class A and Class B warrants, representing approximately 83.4% participation.

Summary of the Warrant Exchange

Under the exchange agreements:

• One (1) Class A warrant and one (1) Class B warrant with exercise prices of $24.12 and $32.16, respectively, each with a five-year term have been exchanged for
• One (1) new Class C warrant with:
  • an exercise price of $18.00 per Class A ordinary share,
  • a two-year term commencing upon the effectiveness of a registration statement on Form F-3 registering the resale of the shares issuable upon exercise of the Class C warrants, and
  • a standard forced-redemption (call) feature.

The Company may exercise its forced-redemption right only after the registration statement on Form F-3 registering the resale of the shares issuable upon exercise of the Class C warrants is declared effective and only if the Company’s Class A ordinary shares trade at or above 120% of the exercise price (i.e., $21.60) for ten (10) consecutive trading days.

Warrant holders participated in the exchange on a voluntary basis, and identical terms were offered to all eligible warrant holders.

Impact on Capital Structure

Based on the exchange agreements, a total of approximately 4.54 million in aggregate of the Company’s outstanding Class A warrants and Class B warrants is expected to be exchanged for approximately 2.27 million Class C warrants.

After such exchange, the total number of outstanding Class A warrants, Class B warrants and Class C warrants is expected to be approximately 3.18 million in aggregate, representing a reduction of approximately 42.0% from the number of Class A and Class B warrants issued in the October 2025 financing round, and further up to 50% assuming participation in full by all holders of Class A warrants and Class B warrants.

The Company believes this reduction materially improves its long-term dilution profile, reduces warrant overhang, and enhances the investability of its ordinary shares. The Company is not undertaking this warrant exchange in connection with any financing transaction and has no plans to conduct any equity or equity-linked capital raise in the foreseeable future.

Strategic Rationale and Benefits

The Company believes this warrant exchange delivers several meaningful benefits to the Company and its shareholders, including:

• Up to 50% reduction from the number of outstanding Class A warrants and Class B warrants, materially lowering long-term dilution risk
• Substantial elimination of two deep out-of-the-money legacy classes of warrants, reducing up to 50% of the overhang on the Company’s shares that resulted from the Class A warrants and Class B warrants
• Simplification in favor of a single, unified class of warrants, improving transparency and institutional investability
• Improved alignment with shareholders, by providing a more realistic and attainable path to warrant redemption

The Company noted that its largest institutional investors, each with significant long-term investments, have participated in the exchange, reflecting strong confidence in the revised structure and its long-term benefits.

About Prenetics
Prenetics (NASDAQ: PRE) is a leading health sciences company redefining the future of health and longevity through IM8 — its flagship consumer brand co-founded with David Beckham and championed by World No. 1 tennis player Aryna Sabalenka. IM8 has achieved the fastest growth trajectory in supplement industry history, reaching $100 million+ in ARR within 11 months of launch, outpacing even leading AI startups.

About IM8
IM8 is the pinnacle of premium core nutrition, born from a collaboration between David Beckham as a co-founding partner, and an elite team of scientists spanning medical professionals, academia and space science. Combining cutting-edge science with nature’s most potent ingredients, IM8 delivers a holistic, science-backed approach to health, empowering you to live your most vibrant life. IM8’s flagship product, Daily Ultimate Essentials is an all-in-one powder supplement engineered to replace 16 different supplements in a delicious drink and is NSF Certified for Sport, non-GMO, vegan, free from common allergens, and contains no artificial flavors, colors or sweeteners. IM8 is a subsidiary of Prenetics (NASDAQ: PRE), a leading global health sciences company dedicated to advancing consumer health. To learn more about IM8, please visit www.IM8health.com.

Investor Relations Contact:
investors@prenetics.com
PRE@mzgroup.us

Angela Cheung
Investor Relations / Corporate Finance
angela.hm.cheung@prenetics.com

Forward-Looking Statements
This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company’s goals, targets, projections, outlooks, beliefs, expectations, strategy, plans, objectives of management for future operations of the Company, and growth opportunities are forward-looking statements. Our guidance (including warrant structure, numbers and timeline) reflects management’s current estimates and assumptions as of the date of this release, is subject to significant risks and uncertainties, and is not a guarantee of future performance. Actual results may differ materially. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to,” “guidance,” “outlook,” “forecast,” or other similar expressions. Forward-looking statements are based upon estimates and forecasts and reflect the views, assumptions, expectations, and opinions of the Company, which involve inherent risks and uncertainties, and therefore they should not be relied upon as being necessarily indicative of future results. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to factors beyond the Company’s control that prevent the closing and final consummation of the exchange agreements. In addition to the foregoing factors, you should also carefully consider the other risks and uncertainties described in the “Risk Factors” section of the Company’s most recent registration statement and the prospectus therein, and the other documents filed by the Company from time to time with the U.S. Securities and Exchange Commission. Unless otherwise specified, all information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia




Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

• Novel treatment targets BTK through multi-immune modulation to help address the underlying causes of ITP
• Approval based on the LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other ITP symptoms
• ITP is a rare disease of complex immune dysregulation leading to lower platelet counts, bleeding, and reduced quality of life

Paris, December 23, 2025 – The European Commission has approved Wayrilz (rilzabrutinib), a novel, oral, reversible, Bruton’s tyrosine kinase (BTK) inhibitor, as a new treatment for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. This follows the positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Wayrilz can help address the underlying causes of ITP through multi-immune modulation, targeting different pathways across the immune system.

“ITP is caused by complex immune system dysregulation leading to low platelet counts, bleeding and other often overlooked symptoms that can affect both physical and mental health, significantly impacting quality of life,” said Waleed Ghanima, MD, Head of Research and a Consultant Hematologist at Østfold Hospital, Norway. “The traditional approach to disease management focuses on restoring platelet counts and reducing bleeding risk, but patients may still experience other symptoms. Wayrilz offers a new approach, targeting the underlying cause of ITP through multi-immune modulation to help address the multi-faceted burden of this disease.”

“The approval of Wayrilz in the EU for the treatment of ITP underscores Sanofi’s commitment to leveraging our knowledge of the immune system to develop innovative treatments that make a meaningful impact on people living with rare and inflammatory diseases,” said Brian Foard, Executive Vice President, Head of Specialty Care at Sanofi. “Wayrilz has a differentiated mechanism of action, enabling multi-immune modulation to address the underlying pathology of ITP, allowing patients to benefit from an advanced treatment to help manage their disease.”

The EU approval of Wayrilz is based on the pivotal LUNA 3 phase 3 study (clinical study identifier: NCT04562766), in which Wayrilz met the primary and secondary endpoints, demonstrating a positive impact on sustained platelet counts as well as other ITP symptoms.

The LUNA 3 phase 3 study, presented at the 66th American Society of Hematology Annual Meeting and Exposition, and also published in Blood, evaluated the efficacy and safety of Wayrilz compared to placebo in adults (n=202) with persistent or chronic ITP. Patients who achieved platelet count response at 12 weeks were eligible to continue the full 24-week double-blind period (64% of patients in the Wayrilz arm and 32% of patients in the placebo arm). Patients receiving Wayrilz experienced the following compared to patients receiving placebo:

• Statistically significant durable platelet response at week 25 (23% of patients in Wayrilz arm vs. 0% in placebo arm; p<0.0001) 
• Faster time to first platelet response (36 days in Wayrilz arm vs. not reached in placebo arm; p<0.0001)
• Longer duration of platelet response (least square mean of 7 weeks in Wayrilz arm vs. 0.7 weeks in placebo arm)

Patients receiving Wayrilz reported an overall 10.6-point improvement in the overall quality of life domain compared to a 2.3-point increase in the placebo arm, based on The Immune Thrombocytopenia Patient Assessment Questionnaire, a clinical tool designed to measure ITP symptoms and impacts. The results of this analysis are descriptive and were not powered for statistical significance.

The most common adverse reactions (incidence ≥10%) are diarrhea, nausea, headache, abdominal pain, and COVID-19.

Wayrilz has already been approved in the US and the United Arab Emirates (UAE), and it is currently under regulatory review for ITP in Japan and China. It received fast track and orphan drug designations (ODD) in the US for ITP, with similar orphan designations in the EU and Japan. In other indications under investigation, the US Food and Drug Administration (FDA) granted Wayrilz ODD for three additional rare diseases, including warm autoimmune hemolytic anemia (wAIHA), IgG4-related disease (IgG4-RD), and sickle cell disease (SCD). Wayrilz also received FDA fast track designation and EU orphan designation in IgG4-RD.

About the LUNA 3 study
LUNA 3 (clinical study identifier: NCT04562766) was a randomized, multicenter, phase 3 study evaluating the efficacy and safety of Wayrilz vs. placebo in adult and adolescent patients with persistent or chronic ITP. Patients received either oral Wayrilz 400 mg twice a day or placebo through a 12- to 24-week double-blind treatment period, followed by a 28-week open-label treatment period, and then a four-week safety follow-up or long-term extension period. The adolescent part of the study is ongoing. The primary endpoint for the EU is the proportion of adult participants able to achieve platelet counts at or above 50,000/μL for at least eight out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy. Secondary endpoints included time to platelet response (platelet count ≥50 x 10⁹/L or between 30 x 10⁹/L and <50 x 10⁹/L and at least doubled from baseline in absence of rescue therapy), number of weeks maintaining a specific platelet response (i.e., doubled or within range), rescue therapy use, physical fatigue score, and bleeding score as assessed by change from baseline in Idiopathic Thrombocytopenic Purpura Bleeding Scale (IBLS) assessment at Week 25.

About Wayrilz
Wayrilz (rilzabrutinib) is the first BTK inhibitor for ITP that helps address the root cause of disease through multi-immune modulation. BTK, expressed in B cells, macrophages, and other innate immune cells, plays a critical role in multiple immune-mediated disease processes and inflammatory pathways. With the application of Sanofi’s TAILORED COVALENCY^® technology, Wayrilz can selectively inhibit the BTK target. This innovative therapy is now approved for ITP in the US, in the EU, and in the UAE. Regulatory review for use in ITP is currently ongoing in China and Japan.

Wayrilz is being studied across a variety of rare diseases, including wAIHA, IgG4-RD, and SCD. These additional indications are currently under investigation and have not been approved by regulatory authorities.

About ITP
ITP is a disease of complex immune dysregulation that causes low platelet counts (<100,000/μL), resulting in a variety of bleeding symptoms and high risk of thromboembolism risk. Beyond bruising and bleeding, which can include potentially life-threatening episodes like intracranial hemorrhage, people living with ITP may experience reduced quality of life, including physical fatigue and cognitive impairment.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com

Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group.

Attachment

• Press_Release

Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia




Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

• Novel treatment targets BTK through multi-immune modulation to help address the underlying causes of ITP
• Approval based on the LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other ITP symptoms
• ITP is a rare disease of complex immune dysregulation leading to lower platelet counts, bleeding, and reduced quality of life

Paris, December 23, 2025 – The European Commission has approved Wayrilz (rilzabrutinib), a novel, oral, reversible, Bruton’s tyrosine kinase (BTK) inhibitor, as a new treatment for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. This follows the positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Wayrilz can help address the underlying causes of ITP through multi-immune modulation, targeting different pathways across the immune system.

“ITP is caused by complex immune system dysregulation leading to low platelet counts, bleeding and other often overlooked symptoms that can affect both physical and mental health, significantly impacting quality of life,” said Waleed Ghanima, MD, Head of Research and a Consultant Hematologist at Østfold Hospital, Norway. “The traditional approach to disease management focuses on restoring platelet counts and reducing bleeding risk, but patients may still experience other symptoms. Wayrilz offers a new approach, targeting the underlying cause of ITP through multi-immune modulation to help address the multi-faceted burden of this disease.”

“The approval of Wayrilz in the EU for the treatment of ITP underscores Sanofi’s commitment to leveraging our knowledge of the immune system to develop innovative treatments that make a meaningful impact on people living with rare and inflammatory diseases,” said Brian Foard, Executive Vice President, Head of Specialty Care at Sanofi. “Wayrilz has a differentiated mechanism of action, enabling multi-immune modulation to address the underlying pathology of ITP, allowing patients to benefit from an advanced treatment to help manage their disease.”

The EU approval of Wayrilz is based on the pivotal LUNA 3 phase 3 study (clinical study identifier: NCT04562766), in which Wayrilz met the primary and secondary endpoints, demonstrating a positive impact on sustained platelet counts as well as other ITP symptoms.

The LUNA 3 phase 3 study, presented at the 66th American Society of Hematology Annual Meeting and Exposition, and also published in Blood, evaluated the efficacy and safety of Wayrilz compared to placebo in adults (n=202) with persistent or chronic ITP. Patients who achieved platelet count response at 12 weeks were eligible to continue the full 24-week double-blind period (64% of patients in the Wayrilz arm and 32% of patients in the placebo arm). Patients receiving Wayrilz experienced the following compared to patients receiving placebo:

• Statistically significant durable platelet response at week 25 (23% of patients in Wayrilz arm vs. 0% in placebo arm; p<0.0001) 
• Faster time to first platelet response (36 days in Wayrilz arm vs. not reached in placebo arm; p<0.0001)
• Longer duration of platelet response (least square mean of 7 weeks in Wayrilz arm vs. 0.7 weeks in placebo arm)

Patients receiving Wayrilz reported an overall 10.6-point improvement in the overall quality of life domain compared to a 2.3-point increase in the placebo arm, based on The Immune Thrombocytopenia Patient Assessment Questionnaire, a clinical tool designed to measure ITP symptoms and impacts. The results of this analysis are descriptive and were not powered for statistical significance.

The most common adverse reactions (incidence ≥10%) are diarrhea, nausea, headache, abdominal pain, and COVID-19.

Wayrilz has already been approved in the US and the United Arab Emirates (UAE), and it is currently under regulatory review for ITP in Japan and China. It received fast track and orphan drug designations (ODD) in the US for ITP, with similar orphan designations in the EU and Japan. In other indications under investigation, the US Food and Drug Administration (FDA) granted Wayrilz ODD for three additional rare diseases, including warm autoimmune hemolytic anemia (wAIHA), IgG4-related disease (IgG4-RD), and sickle cell disease (SCD). Wayrilz also received FDA fast track designation and EU orphan designation in IgG4-RD.

About the LUNA 3 study
LUNA 3 (clinical study identifier: NCT04562766) was a randomized, multicenter, phase 3 study evaluating the efficacy and safety of Wayrilz vs. placebo in adult and adolescent patients with persistent or chronic ITP. Patients received either oral Wayrilz 400 mg twice a day or placebo through a 12- to 24-week double-blind treatment period, followed by a 28-week open-label treatment period, and then a four-week safety follow-up or long-term extension period. The adolescent part of the study is ongoing. The primary endpoint for the EU is the proportion of adult participants able to achieve platelet counts at or above 50,000/μL for at least eight out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy. Secondary endpoints included time to platelet response (platelet count ≥50 x 10⁹/L or between 30 x 10⁹/L and <50 x 10⁹/L and at least doubled from baseline in absence of rescue therapy), number of weeks maintaining a specific platelet response (i.e., doubled or within range), rescue therapy use, physical fatigue score, and bleeding score as assessed by change from baseline in Idiopathic Thrombocytopenic Purpura Bleeding Scale (IBLS) assessment at Week 25.

About Wayrilz
Wayrilz (rilzabrutinib) is the first BTK inhibitor for ITP that helps address the root cause of disease through multi-immune modulation. BTK, expressed in B cells, macrophages, and other innate immune cells, plays a critical role in multiple immune-mediated disease processes and inflammatory pathways. With the application of Sanofi’s TAILORED COVALENCY^® technology, Wayrilz can selectively inhibit the BTK target. This innovative therapy is now approved for ITP in the US, in the EU, and in the UAE. Regulatory review for use in ITP is currently ongoing in China and Japan.

Wayrilz is being studied across a variety of rare diseases, including wAIHA, IgG4-RD, and SCD. These additional indications are currently under investigation and have not been approved by regulatory authorities.

About ITP
ITP is a disease of complex immune dysregulation that causes low platelet counts (<100,000/μL), resulting in a variety of bleeding symptoms and high risk of thromboembolism risk. Beyond bruising and bleeding, which can include potentially life-threatening episodes like intracranial hemorrhage, people living with ITP may experience reduced quality of life, including physical fatigue and cognitive impairment.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com

Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group.

Attachment

• Press_Release

MannKind Shares FUROSCIX® Business Updates




MannKind Shares FUROSCIX® Business Updates

• FDA approves FUROSCIX^® for use in pediatric patients weighing 43kg or above
• USPTO issues five patents for FUROSCIX ReadyFlow^™ Autoinjector

WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) — MannKind Corporation (Nasdaq: MNKD) today announced two business updates—approval of the FUROSCIX^® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage FUROSCIX ReadyFlow^™ Autoinjector, which is currently under review by the U.S. FDA.

FUROSCIX Expanded Treatment Options for Appropriate Pediatric Patients
The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for FUROSCIX^® (furosemide) On-body Infusor, expanding the indication of this product to include pediatric patients weighing 43 kg or more. FUROSCIX was previously approved for the treatment of edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults. This additional approval fulfills all post-marketing requirements outlined in the original approval letter under the Pediatric Research Equity Act.

“We are pleased to make FUROSCIX available to the pediatric population, a highly specific patient group, offering a convenient option outside the hospital setting for those who meet the weight criteria,” said Dr. Ajay Ahuja, Chief Medical Officer of MannKind Corporation.

Five New U.S. Patents Provide Protection to FUROSCIX ReadyFlow Autoinjector
The U.S. Patent and Trademark Office (USPTO) issued five patents with claims that protect the FUROSCIX ReadyFlow Autoinjector. These patents cover the high-concentration liquid compositions of furosemide and associated methods of treatment potentially through 2040, further reinforcing MannKind’s intellectual property position around this innovative drug-device combination. The patents would be listed in the FDA’s Orange Book, if the FUROSCIX ReadyFlow Autoinjector is approved by the FDA.

The newly issued patents complement previously issued patents supporting FUROSCIX and the FUROSCIX ReadyFlow Autoinjector, creating a robust IP portfolio that is designed to protect the formulation and delivery approach for years to come.

FUROSCIX ReadyFlow Autoinjector Could Transform Care from Hours to Seconds
MannKind recently announced that the FDA accepted for review its sNDA for the FUROSCIX ReadyFlow Autoinjector for the treatment of edema in adults with CHF or CKD. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.

If approved, the FUROSCIX ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/mL) in under 10 seconds, providing a new option for patients with CHF or CKD to manage fluid buildup episodes from the convenience of their home rather than in a hospital setting. The FDA-approved FUROSCIX On-body Infusor was approved in 2022 for the treatment of edema in adult patients with chronic heart failure and, in 2025, for adult patients with chronic kidney disease in 2025.

“FUROSCIX ReadyFlow Autoinjector has the potential to redefine how patients manage fluid overload episodes,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “By delivering an IV-equivalent diuretic dose in seconds from the comfort of home, this innovation, if approved, could significantly reduce hospital visits, improve quality of life, and lower healthcare costs—creating meaningful value for patients, providers, and payers alike.”

About FUROSCIX
FUROSCIX^® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in pediatric patients who weigh at least 43 kg and adult patients with chronic heart failure or chronic kidney disease, including the nephrotic syndrome.

IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives. 

Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO₂, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.

Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.

Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.

In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.

Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.

The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Please see the full Prescribing Information (https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf) and Instructions for Use (https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf).

About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Learn more at mannkindcorp.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, including statements about a potential regulatory action date, statements regarding the potential duration of patent protection and statements regarding the potential benefits of the administration of furosemide via an autoinjector for providers, patients and payors. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that issues that develop in the review by the FDA may subject us to unanticipated delays or prevent us from obtaining marketing approval, the risk that we may be unable to protect our proprietary rights as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

FUROSCIX is a registered trademark of scPharmaceuticals, a wholly owned subsidiary of MannKind Corporation.

MANNKIND is a registered trademark of MannKind Corporation.

CONTACT: MannKind Contacts:

Media Relations:
Christie Iacangelo
(818) 292-3500
media@mnkd.com

Investor Relations:
Kate Miranda
(781) 301-6869
ir@mnkd.com