Eupraxia Pharmaceuticals Announces Closing of US$80.5 Million Public Offering Including Full Exercise of Underwriter Option




Eupraxia Pharmaceuticals Announces Closing of US$80.5 Million Public Offering Including Full Exercise of Underwriter Option

VICTORIA, British Columbia, Sept. 24, 2025 (GLOBE NEWSWIRE) — Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, is pleased to announce the successful closing of its previously announced public offering (the “Offering”) of 14,636,363 common shares of the Company (the “Common Shares”), which includes the full exercise of the option to purchase additional shares granted to the underwriters, at a price to the public of US$5.50 per Common Share for gross proceeds of approximately US$80.5 million, before deducting the underwriting commissions and estimated expenses incurred in connection with the Offering.

“This financing represents a pivotal milestone for Eupraxia, enabling us to accelerate the development of EP-104GI for eosinophilic esophagitis and advance toward our upcoming Phase 2b clinical readout, plus other key clinical and regulatory milestones,” said James Helliwell, CEO of Eupraxia. “The strong participation from leading life-science focused investors validates both our strategy and technology, and with this financing, we believe we are now capitalized into the first quarter of 2028, providing the resources and flexibility to deliver on our vision.”

Cantor and LifeSci Capital acted as joint book-running managers for the Offering. Bloom Burton also acted as co-manager for the Offering.

As previously stated, the Company intends to use the net proceeds from the Offering primarily for the continued advancement of its product pipeline, including the completion of ongoing preclinical studies and clinical trials, regulatory submissions, and associated commercial preparation and manufacturing scale-up activities. A portion of the proceeds will also be allocated to research and development of additional pipeline candidates, business development initiatives, and general corporate purposes, which may include but are not limited to employee salaries, working capital, leases for facilities, administrative expenses, and capital expenditures. The Company may also use a portion of the proceeds to expand its intellectual property portfolio and strengthen its corporate infrastructure to support future growth.

The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the “SEC”) on February 7, 2024, and the Company’s existing Canadian short form base shelf prospectus, (the “Base Prospectus”) dated February 5, 2024. A preliminary prospectus supplement and a final prospectus supplement (the “Supplement”) relating to and describing the terms of the Offering were filed with the securities commissions in all of the provinces and territories of Canada, except Quebec, and with the SEC in the United States. The Supplement and accompanying Base Prospectus contain important detailed information about the Offering.

The Supplement and accompanying Base Prospectus can be found on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Copies of the Supplement and accompanying Base Prospectus may also be obtained from Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at prospectus@cantor.com, from LifeSci Capital LLC at 1700 Broadway, 40^th Floor, New York, New York 10019, or by email at compliance@lifescicapital.com, or from Bloom Burton Securities Inc. at ecm@bloomburton.com.

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

About Eupraxia Pharmaceuticals Inc.

Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. Diffusphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs.

Notice Regarding Forward-looking Statements and Information

This news release includes forward-looking statements and forward-looking information within the meaning of applicable securities laws. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “is expected”, “expects”, “suggests”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes”, “potential” or variations (including negative and grammatical variations) of such words and phrases, or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include statements regarding the anticipated use of proceeds from the Offering; expectations around the development of EP-104GI, upcoming Phase 2b clinical trial readouts, and other clinical and regulatory milestones; expected capitalization into the first quarter of 2028; and the potential for the Company’s technology to impact the drug delivery process. Such statements and information are based on the current expectations of Eupraxia’s management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company’s ability to obtain positive results from the Company’s research and development activities, including clinical trials; and the Company’s ability to protect patents and proprietary rights. Although Eupraxia’s management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: risks and uncertainties related to the Company’s limited operating history; the Company’s novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company’s current license agreement may not provide an adequate remedy for its breach by the licensor; the Company’s technology may not be successful for its intended use; the Company’s future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company’s clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates at any stage of clinical development; the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the Company completely relies on third parties to provide supplies and inputs required for its product candidates and services; the potential impact of tariffs on the cost of the Company’s active pharmaceutical ingredients and clinical supplies of EP-104IAR and EP-104GI; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company’s ability to obtain regulatory approval in a timely manner, or at all; the impact of health pandemics or epidemics on the Company’s operations; the Company’s restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company’s common share price; and other risks and uncertainties described in more detail in Eupraxia’s public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events or otherwise.

For investor and media inquiries, please contact:
Danielle Egan, Eupraxia Pharmaceuticals Inc.
778.401.3302
degan@eupraxiapharma.com

or

Kevin Gardner, on behalf of:
Eupraxia Pharmaceuticals Inc.
617.283.2856
kgardner@lifesciadvisors.com

SOURCE Eupraxia Pharmaceuticals Inc.

Artios Receives U.S. FDA Fast Track Designation for alnodesertib in ATM-negative Metastatic Colorectal Cancer (mCRC)




Artios Receives U.S. FDA Fast Track Designation for alnodesertib in ATM-negative Metastatic Colorectal Cancer (mCRC)

• U.S. Fast Track designation underscores the strength of the alnodesertib clinical data generated to date and the high degree of unmet need in 3L mCRC

CAMBRIDGE, United Kingdom and NEW YORK, September 24, 2025 – Artios Pharma Limited (“Artios”), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response (“DDR”) in cancer, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its ATR inhibitor, alnodesertib, in combination with a low dose of chemotherapeutic agent irinotecan, for the treatment of adult patients with ATM-negative metastatic colorectal cancer (mCRC) in the third-line setting.

“The Fast Track designation for alnodesertib underscores its first-in-class potential for third-line mCRC patients with ATM-negative tumors,” said Mike Andriole, Chief Executive Officer of Artios. “Approximately 3,000 patients with ATM-negative third-line mCRC succumb to this disease annually in the United States, with no treatment options that specifically address this protein deficiency. Alnodesertib has the potential to be the first treatment specifically for this invariably lethal disease. Additionally, we are encouraged by the durable responses this program has demonstrated across other tumor types, highlighting its ability to target replication stress across a range of solid tumors.”

The designation is supported by encouraging results from the ongoing STELLA Phase 1/2a study, which is evaluating alnodesertib in combination with a low dose of irinotecan. Beyond third-line mCRC, clinical responses were observed in seven additional solid tumor types with ATM deficiency. The combination of alnodesertib plus low-dose irinotecan has a favorable safety profile to date, has been well tolerated, and has been shown to be suitable for long-term dosing.ⁱ

“Patients with third-line colorectal cancer face a dismal prognosis, with current standards of care for third-line mCRC delivering response rates in the single digits. In our studies to date, alnodesertib has demonstrated compelling clinical activity in ATM-negative patients with mCRC as well as in other heavily pretreated cancer types with high endogenous replication stress,” said Ian Smith, Chief Medical Officer of Artios. “These results, together with activity across other solid tumors, highlight alnodesertib’s potential to deliver meaningful benefit where treatment options are limited. The FDA’s Fast Track designation recognizes both the strength of our early clinical data and the urgent need for new therapies, while also providing the opportunity for enhanced interactions with the Agency.”

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of investigational drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening conditions. Product candidates with Fast Track designation are eligible for priority review and accelerated approval if relevant criteria are met. The Fast Track designation for alnodesertib was granted based on early Phase 1/2 clinical studies that are currently ongoing in the United States. The designation will enable Artios to interact early and more frequently with the FDA to discuss alnodesertib’s development path.

About Alnodesertib
Alnodesertib, formerly known as ART0380, is a potential first-in-class, orally administered, selective small molecule inhibitor of ataxia-telangiectasia and Rad3-related protein (ATR). Artios’ differentiated approach combines alnodesertib with a low dose of the chemotherapy irinotecan, targeting cancers with high endogenous replication stress, such as those with ATM protein deficiency. 

About Artios Pharma Ltd.
Artios is pioneering approaches in the DNA damage response (DDR) field through its comprehensive anti-cancer approach and the deep experience of its team of DDR drug developers. The company’s clinical-stage candidates, ATR inhibitor alnodesertib and DNA Polymerase theta (Polθ) inhibitor ART6043, as well as its pre-clinical programs, including DDRi-ADCs, are designed with differentiated pharmaceutical properties and novel biological approaches to precisely eliminate a cancer cell’s remaining survival mechanisms. Artios’ mission is to develop new classes of medicines that exploit DDR pathways with the aim of improving outcomes for patients with hard-to-treat cancers.

Visit our website at www.artios.com for more information about the company.

For more information, please contact:

Trophic Communications
Jacob Verghese or Verena Schossmann
Tel: +49 151 7441 6179
Email: artios@trophic.eu

ⁱ Artios Pharma Reports Differentiated Clinical Activity in STELLA Phase 1/2a Study for Lead Program ART0380

ITM and TerThera Sign Supply Agreement for Medical Radioisotope Terbium-161




ITM and TerThera Sign Supply Agreement for Medical Radioisotope Terbium-161

Garching / Munich, Germany, and Breda, the Netherlands, September 24, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and TerThera BV, a leading provider of GMP-grade Terbium-161, today announced a supply agreement for non-carrier-added (n.c.a.) Terbium-161 (Tb-161), a novel medical radioisotope with distinct chemical properties and emerging potential in radiopharmaceutical therapy. Under the terms of the agreement, TerThera will supply Good Manufacturing Practice (GMP)-compliant n.c.a. Tb-161 to ITM to support the development of its Terbium-based pipeline candidates, complementing ITM’s established manufacturing capabilities in cooperation with the Paul Scherrer Institute (PSI).

“Driving innovation across isotopes, targeting molecules and cancer indications keeps ITM at the forefront of the rapidly evolving radiopharmaceutical industry,” said Dr. Andrew Cavey, CEO of ITM. “We see strong potential in Terbium-161 as a critical new isotope for targeted radiopharmaceutical therapy, and our partnership with TerThera will allow us to advance its use in our pipeline. With supply of Terbium-161, we are well-positioned to harness its radiation properties to deliver meaningful advances for people living with cancer.”

Currently, Tb-161-based radiopharmaceuticals are being clinically investigated for various types of cancers. Tb-161 is gaining attention in the radiopharmaceutical field for its unique emission profile. Like Lu-177, it emits medium-range beta particles and has a similar half-life. However, Tb-161 also emits low-energy Auger and internal conversion electrons, delivering highly localized radiation that can effectively target isolated cancer cells and micro-metastases with minimal off-target effects. 

“As industry interest in Terbium-161 grows, a safe and sustainable supply of this radionuclide is crucial to support the development of new treatment options and strategies and we see this as our core mission,” added Philippe van Overeem, CEO of TerThera. “ITM is a true innovator in the dynamic radiopharmaceutical field and we look forward to supplying them with our GMP-grade Terbium-161 as they advance their pipeline candidates and make progress in bringing the benefit of this valuable isotope to patients.”

About ITM Isotope Technologies Munich SE
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply of medical radioisotopes. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com 

About TerThera
TerThera is a radionuclide production-focused company based in The Netherlands. The founders and staff of TerThera have decades of experience in the nuclear medicine industry and are highly dedicated to bringing the innovative radionuclide Terbium-161 (Tb-161) to the clinic. TerThera is building a global platform including GMP production facilities in Europe, USA and Asia to meet the growing demand for radionuclides in RLT.

ITM Contact
Corporate Communications
Kathleen Noonan/Julia Westermeir
Phone: +49 89 329 8986 1500
Email: communications@itm-radiopharma.com

Investor Relations
Ben Orzelek
Phone: +49 89 329 8986 1009
Email: investors@itm-radiopharma.com

TerThera Contact
support@terthera.com

Attachment

• 20250924_ITM and TerThera Sign Supply Agreement for Medical Radioisotope Terbium-161

CARBIOS presents its 2025 half-year results and confirms its objective to build a PET biorecycling plant, with a revised timeline.




CARBIOS presents its 2025 half-year results and confirms its objective to build a PET biorecycling plant, with a revised timeline.

• CARBIOS has reduced its operating expenses and has a strong cash position of
  €72 million as of June 30, 2025, providing a cash horizon of more than 12 months
• The Longlaville plant construction project is now supported by:
  • Major progress with public financers ADEME and the Regional Council
  • Clear interest from private investors, conditional upon the pre-sale of a significant portion of the future plant’s capacity, which has not yet been achieved
  • Recent regulatory developments that enhance the competitiveness of CARBIOS’ technology

• In this context, the resumption of the Longlaville plant construction project is expected before the end of 2025, subject to securing the necessary funding. The plant would then be commissioned in the second half of 2027.

Clermont-Ferrand (France), September 24, 2025 (08 :45 CEST). CARBIOS (Euronext Growth Paris: ALCRB), a pioneer in the development and industrialization of biological technologies aimed at reinventing the lifecycle of plastics and textiles, today announces its 2025 half-year results and confirms its objective to build a PET biorecycling plant in Longlaville, with a revised timeline.

Key highlights

1.   Financial results

Thanks to a refocused and rigorously executed cost-saving plan during the first half of 2025, the Company reports a solid cash position of €72 million as of June 30, 2025, providing a cash horizon of more than 12 months. The Group continues its efforts to reduce operational expenses.

2.   Regulatory environment developments in France

On September 7, 2025, France published a new decree under the “Environmental Code” (Article L. 541-10-3) related to financial incentives (bonus) provided for the incorporation of recycled material on products and for discourage the use of materials that hinder recycling (the “Decree”). This decree represents a powerful new lever to accelerate customer adoption of CARBIOS’ technology as it enables them to benefit from a €1,000/ton bonus for including biorecycled plastics derived from hard-to-recycle waste into sensitive-contact packaging (e.g. food packaging). CARBIOS will thus be able to supply its packaging clients, selling on the French market, with recycled PET (r-PET) with a quality equivalent to virgin PET (free of contaminants, transparent, and with excellent material properties), offering significantly superior characteristics compared to mechanically recycled products, at a comparable net price, while processing complex waste that is currently not recycled.

3.   Update on the Longlaville PET biorecycling plant

• The resumption of construction is expected before end of 2025, subject to securing the necessary additional funding.
• Pre-sales of products from the future Longlaville plant are progressing, supported by a favorable regulatory environment.
• In addition, the Company has secured a significant portion of its raw material supply and signed polymerization contracts, strengthening the industrial foundations of the project.
• Plant financing update

CARBIOS plans to finance the Longlaville plant through:

• €42.5 million in public funding, including a €30 million grant for which an agreement already has been signed with ADEME, that will allow disbursements to begin once the project resumes, and €12.5 million in regional aid, for which the European Commission has approved the chemical recycling aid scheme. The publication in the Official Journal of the European Union is expected shortly, which will remove the final barrier to receiving this aid. It is specified that these amounts have not yet been received and are therefore not included in the available cash.
• Additional funding, notably non-dilutive, is currently under discussion. Based on a detailed study of the project, many private investors, , have expressed strong interest and given agreement on principle for the required investment amounts, mainly subject to the pre-sale of a significant portion of the plant’s capacity, a level not yet reached by CARBIOS. The Company has selected two lead banks to drive this process.
• A portion of its available cash (€72 million as of June 30, 2025).

With the support of the new Decree announced in September, the Company is therefore working to further advance the pre-sale of products from the plant in order to reach a sufficient level that would secure the necessary funding for the project to resume before the end of 2025, with production expected to start in the second half of 2027.

4.   Licensing update

In parallel, the technological maturity, engineering documentation, and ongoing negotiations with various partners, allow CARBIOS to remain fully committed to the commercialization of licenses for its technology.
Vincent Kamel, Chief Executive Officer of CARBIOS: “Our well-controlled expenses and our solid cash position allows us to move forward with confidence. Recent favorable developments, both in terms of regulation and in our discussions with financial and industrial partners, provide us additional comfort about the strength of our plan. We approach this next phase with determination and confidence, driven by our clients’ recognition of the value of our technology, the soundness of our business model, and the commitment of our team.”

Condensed consolidated income statement H1 2025
(unaudited)

As of June 30, 2025, current operating income stood at (-€17.6 million), in progress of
€2.4 million compared to the (-€20 million) loss as of June 30, 2024. This improvement is mainly due to the execution of the cost reduction plan announced at the end of 2024 and revenues from ordinary activities for a cumulated total amount of €6.2 million, offset by exceptional items such as costs and provisions for the restructuring and workforce reduction (‘PSE’) plan (-€3 million), as well as financing related costs (-€0.8 million).

Apart from these exceptional one-off items, the decrease in current operating expenses related to R&D expenses, sales and marketing expenses, and general and administrative expenses.

The current operating income of (-€17.6 million) reflects the Group’s efforts to reduce expenses and ensure tight control over spending, to pursue financing discussions with public and private partners for the Longlaville plant project without liquidity pressure.

To facilitate the restart of the Longlaville project and limit the financial impact of the postponement, the Company implemented protocols with its main suppliers when the delay was announced. Nevertheless, following the non-renewal of one of these protocols and in the absence of an agreement with one supplier to date, the Company recognized, as a precautionary measure, an impairment loss of €7.3 million on one asset of the Longlaville plant, which brings back the half-year operational income to (-€24.9 million).

Net financial income of €1.4 million is mainly due to financial income from cash investments and capitalization of borrowing costs. It is down by (-€1.9 million) compared to the first half of 2024, due to lower interest rates and the level of cash investments.

The Group’s net loss for the period stood at €23.5 million at the end of June 2025, compared to €18.1 million at the end of June 2024.

Consolidated cash flow statement
(unaudited)

The Group has a cash reach of more than twelve months, based on a cash position of
€72 million as of June 30, 2025, compared to a financial reserve of €109 million as of December 31, 2024, which included €89 million in cash and €19 million in financial assets, which were reclassified as cash in the first half of 2025.

Net cash consumption amounted to €18.1 million during the period, compared to
€102.1 million for the year 2024. This cash consumption of €18.1 million includes -€20 million in payments to suppliers associated to the Longlaville project, in accordance with commitments already made when the project delay was announced, -€17.1 million of cash for current business activities, partially offset by +€19 million in financial assets reclassified as available cash.

###

About CARBIOS:
CARBIOS is a biotechnology company that develops and industrializes biological solutions to reinvent the lifecycle of plastics and textiles. Inspired by nature, CARBIOS designs enzyme-based biological processes to break down plastics, with the mission of preventing plastic and textile pollution and accelerating the transition to a circular economy. Its two innovative technologies—dedicated to PET biorecycling and PLA biodegradation—are currently scaling up to industrial and commercial levels. Its industrial demonstration plant for biorecycling has been operational since 2021, and construction of the world’s first biorecycling plant is expected to resume before the end of 2025, subject to securing the necessary additional funding. Founded in 2011 by Truffle Capital, CARBIOS has received major scientific recognition, including a cover feature in Nature and a second article published in the same journal. The company is supported by prestigious brands in the cosmetics, food, and apparel industries, aiming to improve the recyclability and circularity of their products. Nestlé Waters, PepsiCo, and Suntory Beverage & Food Europe are members of a packaging consortium founded by CARBIOS and L’Oréal. On, Patagonia, PUMA, PVH Corp., and Salomon collaborate with CARBIOS in a textile consortium. CARBIOS is part of the global community of B Corp™ certified companies that are transforming their business models to serve the common good.

Visit www.carbios.com to learn more about biotechnology for circular plastics and textiles.

LinkedIn : carbios / Instagram : insidecarbios

Information on CARBIOS shares:

ISIN Code                 FR0011648716
Ticker Code                 Euronext Growth: ALCRB
LEI:                         969500M2RCIWO4NO5F08

CARBIOS, founded in 2011 by Truffle Capital, is eligible for the PEA-PME, a government program allowing French residents investing in SMEs to benefit from income tax rebates.

Disclaimer on forward-looking statements and risk factors:
This press release contains forward-looking statements, not historical data, and should not be construed as a guarantee that the facts and data stated will occur. These forward-looking statements are based on data, assumptions and estimates considered reasonable by CARBIOS. CARBIOS operates in a competitive and rapidly evolving environment. It is therefore not in a position to anticipate all risks, uncertainties or other factors that may affect its business, their potential impact on its business or the extent to which the materialization of a risk or combination of risks could lead to results that differ significantly from those mentioned in any forward-looking statement. CARBIOS draws your attention to the fact that forward-looking statements are in no way a guarantee of its future performance and that its actual financial position, results, cash flows, its partnerships and corporate agreements, and the development of the sector in which CARBIOS operates may differ significantly from those proposed or suggested by the forward-looking statements contained in this document. In addition, even if CARBIOS’ financial position, results, cash flows, its partnerships and corporate agreements, and developments in the industry in which it operates are consistent with the forward-looking information contained in this document, such results or developments may not be a reliable indication of CARBIOS’ future results or developments. Readers are also advised to carefully consider the risk factors described in the Universal registration document filed with the French Market Authority (“AMF”), as well as in the half-year financial report available free of charge on the Company’s website. Should all or any part of these risk factors occur or others, in no case whatsoever will CARBIOS be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages. This information is given only as of the date of this press release. CARBIOS makes no commitment to publish updates to this information or on the assumptions on which it is based, except in accordance with any legal or regulatory obligation applicable to it.

For additional information, please contact:

APPENDIX

Condensed consolidated income statement H1 2025
(unaudited)

Consolidated statement of financial position
(unaudited)

Consolidated cash flow statement
(unaudited)

Attachment

• 24092025 – CARBIOS – 2025 half-year results

Burning Rock’s OncoGuide™ OncoScreen™ Plus CDx System Now Approved in Japan as a Companion Diagnostic for Capivasertib in Breast Cancer




Burning Rock’s OncoGuide™ OncoScreen™ Plus CDx System Now Approved in Japan as a Companion Diagnostic for Capivasertib in Breast Cancer

TOKYO and GUANGZHOU, China, Sept. 24, 2025 (GLOBE NEWSWIRE) — Riken Genesis Co., Ltd. (Riken Genesis) and Burning Rock Biotech Limited (NASDAQ: BNR, “Burning Rock”) today announced that the OncoGuide™ OncoScreen™ Plus CDx System based on OncoScreen™ Plus to be used as a companion diagnostic for AstraZeneca’s capivasertib has received Manufacturing and Marketing Approval from Japan’s Ministry of Health, Labour and Welfare (MHLW).

The CDx System is a combination medical device consisting of the OncoGuide™ OncoScreen™ Plus CDx Kit and the OncoGuide™ OncoScreen™ Plus CDx Analysis Program, designed to be used with a next-generation sequencer. It enables the detection of PIK3CA, AKT1, and PTEN alterations in a single test. This diagnostic tool is intended to guide treatment decisions for adult patients with unresectable or recurrent hormone-receptor (HR)-positive, HER2-negative breast cancer who have progressed following endocrine therapy and whose tumors carry one or more PIK3CA, AKT1, or PTEN gene alterations.

The approval of this CDx system supports the use for patient selection for capivasertib in combination with fulvestrant.
With the introduction of this CDx System into clinical practice, access to precision diagnostics for breast cancer patients in Japan is expected to improve, ultimately expanding therapeutic opportunities. Riken Genesis will begin preparations for insurance coverage, aiming to ensure timely and equitable access for all eligible patients.

Yusheng Han, Founder and CEO of Burning Rock, commented:
“We are delighted to collaborate with Riken Genesis to achieve the approval of the CDx System in Japan. This is a significant milestone in Burning Rock’s global strategy. Research shows that this CDx System can assist in guiding clinical treatment for breast cancer, optimizing treatment plans, and enhancing patient outcomes. We are concurrently advancing the product’s registration application in China, hoping that its approval there will benefit more breast cancer patients.”

Yuko Oi, President and CEO of Riken Genesis, commented:
“We are honored to receive our first approval for a combination medical device product in partnership with Burning Rock. This achievement represents a promising step toward expanding treatment options for breast cancer patients in Japan. We are committed to delivering this innovative diagnostic tool to patients as quickly as possible.”

Notes
1 Combination Medical Device:
A combination of two or more types of items (pharmaceuticals, medical devices or regenerative medicines) constituting a medical device to be manufactured and marketed.

2 Companion diagnostics:
Clinical testing performed to predict the efficacy and side effects of drugs before using them for treatment, particularly testing that is performed at the same time as pharmaceutical development.

About OncoGuide™ OncoScreen™ Plus CDx System

 * Guangzhou Burning Rock Dx Co., Ltd is a variable interest entity’s subsidiary of Burning Rock.

About Riken Genesis Co., Ltd.
RIKEN GENESIS, founded in October 2007, provides lab-assay services as well as products for genetic testing based on cutting-edge gene analysis technologies and bioinformatics, and has experience in the field of personalized medicine. The company provides highly reliable tests based on international quality standards, as demonstrated by its CLIA certification, being the first organization in Japan to meet this U.S. quality control standard for clinical laboratories.
For more information, please visit: https://www.rikengenesis.jp

About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of 1) NGS-based therapy selection testing for late-stage cancer patients, 2) Global pharmaceutical services on biomarker detection and companion diagnostics development, and 3) Early cancer detection which has moved beyond proof-of-concept R&D into the clinical validation stage. Burning Rock provides dedicated services to pharmaceutical partners, encompassing genomic data solutions, clinical trial solutions, precision patient recruitment, and companion diagnostics development and commercialization. Burning Rock has achieved two NMPA-approved IVD kits, four assays with CE marking, and a breakthrough device designation (BDD) received from both US FDA and China NMPA for multi-cancer detection blood test.
For more information about Burning Rock, please visit: https://www.brbiotech.com

Contact:
Tatsuro Saito
General Manager, Marketing department
Tel: +81-3-5759-6042
info2@rikengenesis.jp

Contact:
PBD@brbiotech.com
IR@brbiotech.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cb8b2cfa-f5fa-4dc5-b585-f3539f41af76

New Novartis data further support benefits of Kesimpta® in relapsing MS following switch from oral disease modifying therapies




New Novartis data further support benefits of Kesimpta® in relapsing MS following switch from oral disease modifying therapies

• ARTIOS Phase IIIb, open-label, single-arm, prospective study showed a substantial reduction in disease activity in people with relapsing multiple sclerosis (RMS) following switch to Kesimpta after breakthrough disease* on fingolimod or fumarate-based therapies¹
• Following switch to Kesimpta, over 90% of people with RMS showed no evidence of disease activity (NEDA-3) and low annualized relapse rates (ARR) were observed¹
• In the separate ALITHIOS open-label extension study, more than 90% of patients receiving first-line Kesimpta were progression-free for up to seven years, reinforcing benefit of introducing Kesimpta early²

Basel, September 24, 2025 – Novartis today announced new data from two Kesimpta^® (ofatumumab) studies in relapsing multiple sclerosis (RMS) that will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting in Barcelona, Spain, on September 24–26.

Data from the ARTIOS Phase IIIb, open-label, single-arm, prospective study showed that patients who switched to Kesimpta after breakthrough disease on fingolimod or fumarate-based therapies had a substantial reduction in disease activity, as shown by a low annualized relapse rate (ARR, 0.06 over 96 weeks)¹. The data also showed an almost complete suppression of MRI activity and over 9 out of 10 participants achieving no evidence of disease activity (NEDA-3)¹. No new safety concerns were observed following the switch to Kesimpta, irrespective of the last prior disease modifying treatment (DMT)¹.

Lead investigator Dr. Riley Bove of the University of California, San Francisco, stated, “These findings add to the growing evidence on the efficacy and safety of ofatumumab after a switch from oral DMTs. Crucially, we observed robust disease control sustained over two years in patients with RMS who did not respond well to oral DMTs.”

The separate ALITHIOS open-label extension study includes recently diagnosed (≤3 years) treatment-naïve (RDTN) people with RMS receiving first-line continuous Kesimpta². The study showed more than 90% achieved NEDA-3 at seven years². Long-term efficacy was measured by sustained low ARR and profound suppression of MRI activity as well as a favorable safety profile, with no new safety concerns, in both the overall population and RDTN patients^2,3.

“The long-term data from these studies underscore Kesimpta’s ability to deliver sustained efficacy and a consistent safety profile for people with RMS,” said Norman Putzki, M.D., Ph.D., Global Head Development, Neuroscience & Gene Therapy, Novartis. “These findings reinforce Kesimpta’s position as a therapy that empowers patients to take early control of their disease.”

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves and spinal cord⁴. MS, which affects nearly 3 million people worldwide⁵, can be characterized into four main types: clinically isolated syndrome (CIS), relapsing-remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS)⁶. The various forms of MS can be distinguished based on whether a patient experiences relapses (clearly defined acute inflammatory attacks of worsening neurological function), and/or whether they experience progression of neurologic damage and disability from the onset of the disease⁴.

About Kesimpta^® (ofatumumab)
Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with relapsing forms of multiple sclerosis (RMS). It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously^7–10. Initial doses of Kesimpta are at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional^7,8. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen¹¹. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 2015¹². Kesimpta has been approved for the treatment of relapsing forms of multiple sclerosis in over 92 countries worldwide with more than 150,000 patients treated as of August 2025^7,8,13.

Novartis in Neuroscience
At Novartis, we have been tackling neurological conditions for more than 80 years, launching transformative treatments which have made meaningful differences to millions of people worldwide now and in the future. We continue to collaborate on industry-leading treatments in multiple sclerosis, neuroimmunology, neurodegeneration and neuromuscular/rare diseases.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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

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

*In the ARTIOS Phase IIIb open-label, single-arm, prospective study, breakthrough disease activity was defined as ≥1 clinically reported relapse or ≥1 sign of MRI activity (e.g., gadolinium-enhancing T1 lesions or new or enlarging T2 lesions) while the patient was adequately using fumarate-based therapy or fingolimod prior to transitioning to ofatumumab¹.

References

1. Bove R, Langdon D, Boer I, et al. Ofatumumab Safety and Efficacy in People Living With Relapsing Multiple Sclerosis With Breakthrough Disease on Oral Fumarates or Fingolimod: ARTIOS Study. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting; September 24-26, 2025; Barcelona, Spain.
2. Bittner S, Hauser SL, Pardo G, et al. Continuous Ofatumumab Treatment Up to 7 Years Shows a Consistent Safety and Efficacy Profile in Recently Diagnosed Treatment-Naive People Living With Relapsing Multiple Sclerosis. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting; September 24-26, 2025; Barcelona, Spain.
3. Hauser SL, Bar-Or A, Cross AH, et al. Continuous Ofatumumab Treatment for Up to 7 Years Shows a Favourable Safety and Efficacy Profile in People With Relapsing Multiple Sclerosis. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2025 Annual Meeting; September 24-26, 2025; Barcelona, Spain.
4. Guthrie E. Multiple sclerosis: A primer and update. Adv Studies Pharm. 2007;4(11):313-317.
5. Portaccio E, Magyari M, Kubala Havrdova E, et al. Multiple sclerosis: emerging epidemiological trends and redefining the clinical course. Lancet Reg. Health Eur. 2024;44:100977.
6. National Multiple Sclerosis Society. Types of MS. Available from: https://www.nationalmssociety.org/understanding-ms/what-is-ms/types-of-ms Accessed August 13, 2025.
7. Kesimpta. Prescribing Information. Novartis Pharmaceuticals Corporation East Hanover. 2024. https://www.novartis.com/us-en/sites/novartis_us/files/kesimpta.pdf Accessed September 12, 2025.
8. Kesimpta. Summary of Product Characteristics. Novartis Ireland Limited. February 2025. https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf Accessed August 20, 2025.
9. Hauser SL, Kappos L, Bar-Or A, et al. The Development of Ofatumumab, a Fully Human Anti-CD20 Monoclonal Antibody for Practical Use in Relapsing Multiple Sclerosis Treatment. Neurol Ther. 2023;12(5):1491-1515.
10. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Annual Forum; February 27–29, 2020; West Palm Beach, FL, US.
11. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting 2016; September 14–17, 2016; London, UK.
12. Genmab. Press Release: Genmab announces completion of agreement to transfer remaining ofatumumab rights. December 21, 2015. Available from: https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d Accessed August 13, 2025.
13. Novartis. Data on file.

# # #

Press Release: Sanofi commits an additional $625 million to Sanofi Ventures to accelerate investment in biotech and digital health innovation




Press Release: Sanofi commits an additional $625 million to Sanofi Ventures to accelerate investment in biotech and digital health innovation

Sanofi commits an additional $625 million to Sanofi Ventures to accelerate investment in biotech and digital health innovation

• The fund will remain focused on Sanofi’s key areas of immunology, rare diseases, neurology, and vaccines, backing earlier-stage innovation and emerging opportunities that support the company’s long-term strategy
• Sanofi Ventures drives innovation through leading and participating in private financing rounds for pioneering healthcare companies

Paris, September 24, 2025. Sanofi Ventures has announced an additional $625 million multi-year capital commitment from Sanofi, increasing its total assets under management to over $1.4 billion. This new commitment to the evergreen venture fund builds on more than a decade of investing in innovative biotech and digital health companies that align with Sanofi’s long-term growth ambitions.

“This new, significant capital commitment reflects our strong belief that some of the most important medical breakthroughs begin in early-stage companies. With a proven track record of strategic wins and successful exits, Sanofi Ventures has become a powerful engine for scientific progress and strategic growth,” said Paul Hudson, Chief Executive Officer at Sanofi. “By strengthening our investment capabilities, we are accelerating our ability to bring next-generation therapies that improve people’s lives while building valuable partnerships across the healthcare ecosystem.”

Sanofi Ventures is the corporate venture capital arm of Sanofi, investing in top-tier biotech and artificial intelligence/digital health companies that focus on helping patients and transforming the practice of medicine. Since its inception in 2012, the fund has deployed over $800 million across more than 70 innovative companies in biotech and digital health. The team leads investments across all stages of the private company lifecycle, from seed to crossover, serves on boards, and participates in IPOs. Sanofi Ventures maintains a diverse, globally distributed portfolio of companies advancing innovation around the world.

“The increased capital commitment enables us to deepen our role as a leading strategic investor in breakthrough science and digital innovation. Our global portfolio spans the full company lifecycle from seed-stage through IPO participation, demonstrating the long-term value we bring to both entrepreneurs and Sanofi,” said Jason P. Hafler, PhD, Managing Director at Sanofi Ventures. “The strong performance of our fund, including three realized exits in 2024 from companies with a combined acquisition value of $3.25 billion, validates our evergreen structure and approach to identifying and supporting companies that are at the forefront of medical innovation.”

Sanofi Ventures’ expanded capital commitment comes at a time when access to early-stage funding has become more limited across the biotech sector, positioning the fund to play a crucial role in advancing healthcare innovation. By providing essential financial backing and strategic support, the fund is helping to bridge the gap for promising startups, enabling them to advance potentially life-changing therapies through key development milestones. This strategy not only strengthens Sanofi’s pipeline of future innovations but also reinforces the company’s position as a leading catalyst for breakthrough science in healthcare.

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
Felix Lauscher | +1 908 612 7239 | felix.lauscher@sanofi.com  
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | +1 617 710 3587 | tarik.elgoutni@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 statement
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 and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. 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, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, 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.

Attachment

• Press Release

Dimora PHMB Skin and Wound Cleanser – Gentle for Kids, Trusted by Parents




Dimora PHMB Skin and Wound Cleanser – Gentle for Kids, Trusted by Parents

Dimora PHMB Skin and Wound Cleanser: Gentle for Kids, Trusted by Parents

SAN FRANCISCO, Sept. 24, 2025 (GLOBE NEWSWIRE) — Dimora Medical is proud to introduce its newest innovation, the Dimora PHMB Skin and Wound Cleanser. Designed with children’s needs in mind, this product offers a gentle, odorless alternative to traditional wound cleansers. Free from stinging sensations and harsh chemical smells, it helps create a more comfortable experience for both kids and caregivers. At the heart of the cleanser is PHMB, a trusted antibacterial ingredient that effectively protects against bacteria while being mild on the skin. Safe for use on minor cuts, scrapes, and abrasions, it’s an ideal solution for everyday home wound care.

At Dimora Medical, the goal has always been simple: to make home care easy for families. With 34 years of experience in medical supplies, the team focuses on creating practical solutions that help people handle home wound care with confidence. The PHMB Skin and Wound Cleanser continues this approach. Suitable for everyday family use, and gentle enough for children over the age of three, it provides an easy, comfortable way to clean minor cuts and scrapes.

View the Details Here

A Gentle Cleanser for Life’s Little Ouches

If you’ve got young kids at home, you know that bumps, scrapes, and little cuts are just part of growing up—whether it’s a tumble at the playground, a scraped knee from running around outside, or a nick from a favorite toy. These small injuries can feel like a big deal to little ones, and sometimes just as stressful for parents. That’s why having a wound cleanser that’s both gentle and effective really matters.

Dimora PHMB Skin and Wound Cleanser was created for exactly these situations. Its key ingredient, PHMB (polyhexamethylene biguanide), is proven safe and gentle enough for children. Unlike alcohol, it doesn’t sting on contact, so kids won’t feel unnecessary pain. Its mildness is trusted worldwide—the same ingredient is used in contact lens solutions, where it touches delicate eye tissue daily. At the same time, PHMB provides fast, broad-spectrum antibacterial protection, helping prevent infection while keeping care stress-free.

Because it’s odorless, the cleanser avoids the sharp chemical smell often associated with products like hypochlorous acid. This makes wound care less intimidating, reducing children’s fear and resistance.

The precision spray nozzle adds to the ease of use. It directs a steady, gentle stream that rinses away dirt without irritating the wound, and the one-handed design makes it practical whether at home, outdoors, or on the go.

Effective Protection, Without the Sting

Treating small wounds shouldn’t have to mean choosing between comfort and protection. With Dimora PHMB Skin and Wound Cleanser, families get both. Its clinically trusted formula defends against a wide range of bacteria while staying gentle enough for children’s sensitive skin.

Unlike harsh antiseptics that sting or leave behind strong odors, this cleanser keeps the experience calm and cooperative, helping kids feel reassured and parents confident. The result is reliable wound care that fits seamlessly into everyday family routines—without the stress that often comes with treatment.

Engineered for Real-Life Family Moments

Dimora’s latest product is not just clinically sound—it’s thoughtfully adapted for real-life scenarios. Whether it’s cleaning up a scraped knee after a soccer game, rinsing a small cut from a schoolyard fall, or addressing minor abrasions during a family camping trip, the PHMB cleanser is built to be a reliable companion in every parent’s first aid kit.

The Dimora PHMB Skin and Wound Cleanser stays effective for up to eight weeks after opening, making it a practical choice for everyday use without unnecessary waste. For a limited time, it’s available at a special launch price of $17.99 (regularly $19.99), giving families an affordable way to upgrade their home first-aid kit.

Now available on Amazon and the official Dimora website, this gentle, child-friendly cleanser is a smart addition to any household. Give your family the care they deserve—order now and be ready for life’s little accidents.

A Brand Built on Simplicity, Care, and Everyday Confidence

The launch of the Dimora PHMB Skin and Wound Cleanser reflects more than just a new product—it represents the heart of Dimora’s mission: to make home care easy.

With a strong foundation in medical expertise, Dimora focuses on designing wound care solutions that are simple to use and thoughtfully built for real-life situations. From a scraped knee at home to a schoolyard tumble, the brand’s goal is to empower caregivers—especially non-professionals—to respond with confidence and compassion.

As Dimora continues to grow, its commitment remains the same: to develop versatile, effective, and family-friendly products that simplify care, reduce stress, and give caregivers more time to focus on what really matters—comfort, connection, and peace of mind.

Contact: Kim Yin, contact@winnermedical.com

Press release: Availability of the Q3 2025 Aide mémoire




Press release: Availability of the Q3 2025 Aide mémoire

Availability of the Q3 2025 Aide mémoire

Paris, France – September 24, 2025. Sanofi announced today that its Q3 2025 Aide mémoire is available on the “Investors” page of the company’s website:

Third quarter 2025 (sanofi.com)

As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group’s quarterly results. This document includes a reminder on various non-comparable items, as well as the foreign currency impact and share count. Sanofi’s second quarter 2025 results will be published on October 24, 2025. 
  

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 75 45 51 36 93| thomas.larsen@sanofi.com
Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@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

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 and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. 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, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, 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.

Attachment

• Press release

Monopar Therapeutics Inc. Announces Pricing of $135 Million Underwritten Offering of Common Stock and Pre-Funded Warrants




Monopar Therapeutics Inc. Announces Pricing of $135 Million Underwritten Offering of Common Stock and Pre-Funded Warrants

WILMETTE, Ill., Sept. 23, 2025 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (Nasdaq: MNPR) (“Monopar Therapeutics”, “Monopar”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced the pricing of an underwritten registered offering of 1,034,433 shares of its common stock at an offering price of $67.67 per share and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase 960,542 shares of common stock at the purchase price of $67.669 per pre-funded warrant, which represents the offering price per share for the common stock less a $0.001 per share exercise price.

The gross proceeds to Monopar from the offering net of the anticipated Stock Repurchase (as defined below), but before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $100 million. Monopar intends to use such remaining net proceeds from the offering for general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital.

Monopar Therapeutics intends to use up to $35 million of the proceeds from the offering to purchase shares of its common stock held by Tactic Pharma, LLC in a privately negotiated transaction at $63.6098 per share, which is the same price per share as the price at which the shares are being sold to investors in the offering, less underwriting discounts and commissions (the “Stock Repurchase”).

The offering is expected to close on or about September 25, 2025, subject to customary closing conditions.

Morgan Stanley, Leerink Partners and Barclays are acting as the lead book-running managers for the offering.

The securities in the registered offering are being offered and sold pursuant to a “shelf” registration statement on Form S-3 (File No. 333-289947), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on August 29, 2025, and declared effective on September 9, 2025. A prospectus supplement and accompanying prospectus describing the terms of the registered offering will be filed with the SEC and will be available on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the registered offering, when available, may also be obtained by contacting Morgan Stanley & Co. LLC at Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email: prospectus@morganstanley.com; Leerink Partners LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com; or Barclays Capital Inc., Attn: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at barclaysprospectus@broadridge.com.

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

About Monopar Therapeutics

Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements regarding the completion of the offering, the satisfaction of customary closing conditions related to the offering, and the anticipated use of proceeds therefrom, including the Stock Repurchase. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory process that Monopar intends to initiate related to ALXN1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; Monopar’s ability to raise sufficient funds in order for the Company to support continued preclinical, clinical, regulatory, precommercial and commercial development of its programs and to make contractual milestone payments, as well as its ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Contact:

Monopar Therapeutics Inc.
Investor Relations
Quan Vu
Chief Financial Officer
vu@monopartx.com