Disc Medicine to Participate in Upcoming Investor Conferences

Disc Medicine to Participate in Upcoming Investor Conferences




Disc Medicine to Participate in Upcoming Investor Conferences

WATERTOWN, Mass., Oct. 31, 2025 (GLOBE NEWSWIRE) — Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, announced today that company management will participate in fireside chats at three upcoming investor conferences:

  • Guggenheim Second Annual Healthcare Innovation Conference on Monday, November 10th at 4:30 p.m. ET.
  • Stifel 2025 Healthcare Conference on Thursday, November 13th at 8:40 a.m. ET.
  • Jefferies London Healthcare Conference on Wednesday, November 19th at 2:00 p.m. GMT.

Live webcasts of the fireside chats will be available through the investor relations section of the Company’s website at ir.discmedicine.com and an archived replay will be available after each event.

About Disc Medicine

Disc Medicine (NASDAQ:IRON) is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. For more information, please visit www.discmedicine.com.

Media Contact

Peg Rusconi
Deerfield Group
peg.rusconi@deerfieldgroup.com

Investor Relations Contact

Christina Tartaglia
Precision AQ
christina.tartaglia@precisionaq.com

NewGen Enters Into an Innovative Digital Assets Purchase Agreement with White Lion to Acquire up to 600,000 Solana Tokens Valued at Over $110 Million

NewGen Enters Into an Innovative Digital Assets Purchase Agreement with White Lion to Acquire up to 600,000 Solana Tokens Valued at Over $110 Million




NewGen Enters Into an Innovative Digital Assets Purchase Agreement with White Lion to Acquire up to 600,000 Solana Tokens Valued at Over $110 Million

BANGKOK, Oct. 31, 2025 (GLOBE NEWSWIRE) — NewGenIvf Group Limited (Nasdaq: NIVF) (“NewGen” or the “Company”), a tech-forward, diversified, multi-jurisdictional high-growth entity transforming industries through innovative solutions across real estate development, digital asset management and reproductive health solutions, today announced it has entered a binding term sheet with White Lion Capital LLC (“White Lion”) setting out the principal terms and conditions for a Digital Assets Purchase Agreement (the “Agreement”) with a commitment amount of 600,000 Solana (SOL) tokens.

Pursuant to the Term Sheet, NewGen will have the option, but not the obligation, to sell to White Lion shares of common stock of the Company over an initial 24-month period up to a total amount equivalent to the value of 600,000 Solana tokens. Upon a sale of shares, the Company will be compensated by White Lion in Solana tokens rather than cash. This innovative structure is designed to further the Company’s previously announced Solana treasury strategy, and reaffirms NewGen’s commitment to both the digital assets space as a whole and to Solana as a digital asset specifically.

The transactions contemplated by the Term Sheet are subject to entry into definitive agreements, and are subject to certain conditions, including a registration statement being filed immediately upon execution of the definitive agreements.

Mr. Siu Wing Fung Alfred, Founder, Chairman, and CEO of NewGen commented, “This groundbreaking agreement with White Lion represents another key development in NewGen’s evolution as a forward-thinking, diversified enterprise. By structuring this innovative arrangement to receive Solana tokens rather than traditional cash compensation, we are not only strengthening our digital asset treasury but also demonstrating our unwavering confidence in the future of blockchain technology and decentralized finance. We believe Solana’s robust ecosystem and scalable infrastructure make it an ideal cornerstone for our digital asset strategy, positioning NewGen to capitalize on the tremendous growth opportunities at the intersection of traditional industries and the digital economy.”

Nathan Yee, Managing Partner of White Lion, commented, “We believe this is more than just an investment, it’s a blueprint for the next era of capital formation. By exchanging shares for Solana tokens, we’re witnessing the convergence of blockchain and public markets.”

NewGen launched its digital asset strategy in December 2024, with an initial US$1 million investment to establish a digital asset portfolio. Since then, the Company has embraced digital assets as a core business line, establishing its Solana treasury in June 2025 and advancing innovative real-world asset (RWA) tokenization projects involving real estate and fine art. As of the date of this press release, NewGen has accumulated 13,000 Solana tokens with a total value of approximately US$2.5 million.

About NewGen
NewGenIVF Group is a tech-forward, diversified, multi-jurisdictional high-growth entity capitalizing on emerging opportunities across real estate development, digital asset innovation, and reproductive health solutions. The Company operates through three strategic business divisions that leverage cutting-edge technology and innovative solutions to drive sustainable growth and high ROI for shareholders across multiple global markets. These include “NewGenProperty”, which operates lucrative real estate development projects in the UAE’s Ras Al Khaimah Emirate; “NewGenDigital”, which serves as the Company’s digital assets and DeFi solutions arm; and “NewGenSup”, which focuses on health and longevity products and solutions. NewGen’s legacy business involves providing industry-leading IVF and assisted reproductive treatment services across Asia. With operations spanning multiple jurisdictions and a commitment to innovative, technology-enabled solutions, NewGenIVF Group is uniquely positioned to capitalize on the convergence of real estate, healthcare, and digital asset opportunities in the evolving global economy.

To learn more, visit www.newgenivf.com. The information contained on, or accessible through, NewGen’s website is not incorporated by reference into this press release, and you should not consider it a part of this press release.

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. These forward-looking statements are generally identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include but are not limited to: the potential value and benefits of the proposed Digital Assets Purchase Agreement; the Company’s ability to further its Solana treasury strategy and strengthen its digital asset holdings; the Company’s confidence in Solana and blockchain technology; and the potential for growth at the intersection of traditional industries and the digital economy. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company’s ability to enter into a definitive Digital Assets Purchase Agreement with White Lion on acceptable terms, or at all; the risk that the registration statement required to be filed with the SEC may not become effective or may be delayed; the extreme volatility in the market price of Solana (SOL) and other digital assets, which could significantly impact the value of any potential capital received by the Company and the value of its existing digital asset treasury; the Company’s decision on whether to exercise its option to sell shares, which it is not obligated to do; risks associated with the development, integrity, and maintenance of the Solana blockchain and its broader ecosystem, including potential technical vulnerabilities, security breaches, or network congestion; regulatory risks and uncertainties surrounding digital assets, securities laws, and the treatment of such transactions by regulatory bodies in the jurisdictions where the Company operates; and the Company’s inability to fully implement its broader digital asset strategy or realize the anticipated benefits from its initiatives in the blockchain and digital assets space.

You should carefully consider the foregoing factors and the other risks and uncertainties described in NewGenIvf Group’s Annual Report on Form 20-F and other documents filed or to be filed by NewGenIvf Group with the U.S. Securities and Exchange Commission (the “SEC”) from time to time, which could cause actual events and results to differ materially from those contained in the forward-looking statements. Copies of these documents are available on the SEC’s website, www.sec.gov. All information provided herein is as of the date of this press release, and the Company and NewGenIvf Group undertake no obligation to update any forward-looking statement, except as required under applicable law.

Investor Relations Contact
ICR, LLC
Robin Yang
Phone: +1 (212) 537-4406
Email: Newgenivf.IR@icrinc.com

Bavarian Nordic Awarded New Procurement Framework Contract by the European Commission to Strengthen Preparedness Against Smallpox and Mpox

Bavarian Nordic Awarded New Procurement Framework Contract by the European Commission to Strengthen Preparedness Against Smallpox and Mpox




Bavarian Nordic Awarded New Procurement Framework Contract by the European Commission to Strengthen Preparedness Against Smallpox and Mpox


  • New and larger framework contract with the European Commission’s Health Emergency Preparedness and Response Authority (HERA) replaces previous agreement and provides for up to 8 million doses of smallpox/mpox vaccine over the next four years.
  • Additional countries have joined the agreement, now providing access to the vaccine for 20 EU member states and other European countries.

COPENHAGEN, Denmark, October 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today the award of a joint procurement contract by the European Commission, through the Health Emergency Preparedness and Response Authority (HERA), enabling the EU, its member states and additional European countries1 to purchase up to 8 million doses of the Company’s MVA-BN® smallpox/mpox vaccine.

The two-year agreement, which may be extended for up to additional two years, builds on the previous agreement entered by the parties in 2022, and aims to ensure continuous access to the MVA-BN vaccine throughout Europe. In this extended agreement, the European Commission and 20 countries have confirmed their participation.

Paul Chaplin, President and CEO of Bavarian Nordic said: “We are pleased to extend our collaboration with HERA to facilitate broad access to our smallpox and mpox vaccine across the region. This agreement is a recognition of public health security as part of the resilience that the EU is building to unify against threats on a larger scale, and we are proud to be part of the endeavors to safeguard Europe’s citizens against life-threatening diseases.”

By signing the agreement, approximately 1.1 million doses have already been committed, of which supply of the first 750,000 doses are expected to occur in 2026.

Additionally, the contract contains provisions that allow contracting authorities to procure the vaccine at adjusted price for donations to low- and lower-middle-income countries in response to future outbreaks.

Final contract signature is pending expiry of the statutory 10-day standstill period.

Background
Bavarian Nordic has collaborated with the European Commission’s Health Emergency Preparedness and Response Authority (HERA) since 2022, initially supporting the European Commission’s response to the global mpox outbreak through supply of its MVA-BN vaccine. The framework agreement also allowed the European Commission and European Member States to stockpile MVA-BN as a critical medical countermeasure against a potential reemergence of smallpox.

About the smallpox/mpox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is the only non-replicating mpox vaccine approved in the U.S., Switzerland, Singapore and Mexico (marketed as JYNNEOS®), Canada (marketed as IMVAMUNE®), and the EU/EAA and United Kingdom (marketed as IMVANEX®). Originally developed as a smallpox vaccine in collaboration with the U.S. government to ensure the supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines, MVA-BN has been indicated for use in the general population in individuals considered at risk for smallpox or mpox infection.

About Bavarian Nordic
Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health preparedness and have a leading portfolio of travel vaccines. For more information, visit www.bavarian-nordic.com

Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Contact investors:
Europe: Disa Tuominen, IR Manager, detu@bavarian-nordic.com
US: Graham Morrell, Gilmartin Group, graham@gilmartinir.com, Tel: +1 781 686 9600

Contact media:
Nicole Seroff, Vice President Corporate Communications, nise@bavarian-nordic.com, Tel: +45 53 88 06 03

Company Announcement no. 35 / 2025

1 In addition to EU Member states, countries in the European Economic Area (EEA) and the Western Balkan countries are eligible to join the procurement agreement.

Attachment

Unprecedented Clinical data from the Landmark BOOSTB4 Trial to be presented at the 15th International Conference on Osteogenesis Imperfecta in Hong Kong

Unprecedented Clinical data from the Landmark BOOSTB4 Trial to be presented at the 15th International Conference on Osteogenesis Imperfecta in Hong Kong




Unprecedented Clinical data from the Landmark BOOSTB4 Trial to be presented at the 15th International Conference on Osteogenesis Imperfecta in Hong Kong

COPENHAGEN, Denmark, Oct. 31, 2025 (GLOBE NEWSWIRE) — BOOST Pharma, a clinical-stage cell biotech company focused on rare skeletal pediatric diseases, is proud to announce that new long-term data from the first-in-class BOOSTB4 stem cell therapy trial has been selected for presentation by BOOST Pharma co-founder Dr. Cecilia Götherström at the prestigious 15th International Conference on Osteogenesis Imperfecta (OI), taking place from October 29-31, 2025, in Hong Kong.

The presentation will provide two-year follow-up data from the landmark BOOSTB4 Phase I/II clinical study. Notably, the results demonstrate that more than 50% of the treated patients experienced zero bone fractures in the second year after last dose (Range 0-5). The previously reported ~70% reduction in fractures during the first year of follow-up was not only sustained but further improved, with an overall reduction of nearly 78% compared to the pre-treatment period. This indicates a durable therapeutic effect of the BT-101 stem cell therapy. These data suggest that BT-101 has the potential to be a disease-modifying cellular therapy, which may effectively prevent new bone fractures in patients with severe OI. Such a treatment could represent a significant advancement for the OI patient community, which currently lacks any approved therapy that modifies the fundamental course of the disease.

“We are excited and honored by the presentation of these groundbreaking results with the global OI and rare disease community in Hong Kong,” said Ingelise Saunders, Chairman of BOOST Pharma. “Demonstrating such a dramatic reduction in fracture rates over a two-year period marks an extraordinary milestone and supports our mission to significantly improve the lives of children born with this severe genetic disorder.”

BOOSTB4 is the world’s first clinical trial to evaluate postnatal and prenatal allogeneic stem cell therapy for OI—also known as brittle bone disease. The therapy, leveraging mesenchymal stem cells with high bone-forming capability, aims to address the genetic cause of OI, moving beyond supportive care and toward lasting, disease-modifying improvement.

About BOOST Pharma ApS

BOOST Pharma is a clinical-stage biopharmaceutical company focused on the development of novel cell therapy treatments. The company is currently developing a first-in-class therapy to treat Osteogenesis Imperfecta, a severe, inherited rare genetic disease leading to significant physical disability. BOOST Pharma is supported by Industrifonden and Karolinska Development, Sweden.

About Osteogenesis Imperfecta

Osteogenesis Imperfecta (OI), also know as Brittle Bone Disease, is a rare and devastating genetic disease, with currently no approved therapies. OI is characterized by fragile bones and reduced bone mass resulting in bones that break easily, loose joints, and weakened teeth. In severe cases, those with OI may experience hundreds of fractures in a lifetime. In addition, people with OI often suffer muscle weakness, early hearing loss, fatigue, curved bones, scoliosis, respiratory problems, and short stature, leading to significant effects on overall health and quality of life. Current treatment of OI is only supportive, focusing on minimizing fractures and maximizing mobility, but to date, there are no FDA or EU approved treatments. OI is estimated to affect 1 in 15,000 people globally.

About the BOOSTB4 Clinical Study

“Boost Brittle Bones Before Birth” (BOOSTB4) is an exploratory, open label, multiple dose, multicenter Phase I/II trial evaluating safety and efficacy of postnatal, or prenatal and postnatal administration, of allogeneic expanded human stem cells for the treatment of severe Osteogenesis Imperfecta (OI) compared with a combination of historical and untreated prospective controls. The aim is to develop a first-in-class cell therapy to reduce the severity of inherited OI in unborn and young children. The study received funding from the European Union’s Horizon 2020 Research and Innovation Program (681045) and from the Swedish Research Council (921-2014-7209) with Karolinska Institutet as study sponsor.

For further information, please contact:

Jonathan Ilicki, Board member
Email: jonathan.ilicki@industrifonden.com

Nxera’s President & CEO to Participate in a ‘Fireside Chat’ at the Jefferies London Healthcare Conference 2025

Nxera’s President & CEO to Participate in a ‘Fireside Chat’ at the Jefferies London Healthcare Conference 2025




Nxera’s President & CEO to Participate in a ‘Fireside Chat’ at the Jefferies London Healthcare Conference 2025

Tokyo, Japan and Cambridge, UK, 31 October 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces its President & CEO, Chris Cargill, will participate in a ‘Fireside Chat’ at the Jefferies London Healthcare Conference on Monday, 17 November at 12:00 p.m. GMT / 7:00 a.m. ET / 9:00 p.m. JST. During the event, Mr. Cargill will present the Company’s strategy, recent progress and expected upcoming milestones to leading global life sciences investors.

The live webcast of the ‘Fireside Chat’ will be available here.

The replay will also be available at the same link or our website (here) for 90 days post the event.

–END–

About Nxera Pharma
Nxera Pharma is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally.

We have built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high value, large and growing market and those in the broader APAC region.

Behind that, and powered by our unique NxWave™ discovery platform, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline of potentially first- and best-in-class candidates is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across obesity and metabolic disorders, neurology/neuropsychiatry and immunology and inflammation.

Nxera employs approximately 400 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565).

For more information, please visit www.nxera.life
LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma

Enquiries:

Nxera – Media and Investor Relations
Shinya Tsuzuki, VP, Head of Investor Relations
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
Maya Bennison, Communications Manager
+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life

MEDiSTRAVA (for International Media)
Mark Swallow, Frazer Hall, Erica Hollingsworth
+44 (0)203 928 6900 | Nxera@medistrava.com

Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

NANOBIOTIX Announces Strategic Royalty Monetization Agreement With Healthcare Royalty for up to $71 Million and Extends Cash Runway Toward Long-Term Growth

NANOBIOTIX Announces Strategic Royalty Monetization Agreement With Healthcare Royalty for up to $71 Million and Extends Cash Runway Toward Long-Term Growth




NANOBIOTIX Announces Strategic Royalty Monetization Agreement With Healthcare Royalty for up to $71 Million and Extends Cash Runway Toward Long-Term Growth

  • $71 million in funding would extend Nanobiotix cash visibility into early 2028
  • Transaction enables Nanobiotix development beyond key milestones in head and neck cancer and lung cancer
  • Financing establishes financial foundation toward self-sustainability and the advancement of next wave nanotherapeutic platforms for long-term growth
  • HealthCare Royalty (HCRx) will receive a capped portion of milestones and royalties on sales of JNJ-1900 (NBTXR3) payable to Nanobiotix under its global licensing agreement

PARIS and CAMBRIDGE, Mass., Oct. 31, 2025 (GLOBE NEWSWIRE) — NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced that it has entered into a royalty-based financing agreement with HealthCare Royalty (“HCRx”), providing up to $71 million in non-dilutive capital and establishing the financial foundation for self-sustainability and the advancement of next wave nanotherapeutic platforms for long-term growth.

“This non-dilutive financing reflects our commitment to preserving long-term shareholder value, while strategically aligning capital to unlock the full potential of our nanotherapeutics platforms. Importantly, this funding provides the resources to advance the company through critical potential milestones that will lead to self-sustainability and durable value creation,” said Bart van Rhijn, Chief Financial and Business Officer at Nanobiotix.

Key Terms of the Royalty Financing Agreement

  • At the closing of the agreement, Nanobiotix will receive an upfront payment of $50 million and expects to receive an additional $21 million one year post closing subject to reaching certain conditions
  • Assuming $71 million is funded, success-based1 remuneration to HCRx includes:
    • Repayment from a defined portion of royalties on the first $1 billion of net sales and a portion of certain regulatory and commercial milestone payments, subject to a cap of approximately $124 million (1.75x Multiple on Invested Capital (“MOIC”)) if repayment is completed by end of 2030, increasing to approximately $178 million (2.50x MOIC) if repayment occurs thereafter (the Return Cap figures assume $71 million is funded)
    • Following achievement of the Return Cap, a royalty-only tail period will commence, which entitles HCRx to a predefined, reduced share of royalties not to exceed $14.9 million per year; the tail period will expire 10 years following the first commercial sale of JNJ-1900 (NBTXR3) in the US
  • Payment and repayment obligations under both this royalty financing agreement with HCRx and the existing royalty agreement with the European Investment Bank (EIB) will be furnished through the transfer of receivables from the JNJ-1900 (NBTXR3) license agreement to a French law trust

“We are excited to partner with Nanobiotix at this pivotal stage of its growth” said Clarke Futch, Chairman and Chief Executive Officer at HCRx. “The differentiated nature of their physics-based approach and the compelling clinical profile of JNJ-1900 (NBTXR3) align with our mission of supporting innovative therapies that address areas of significant unmet need. This investment underscores our confidence in this first-of-its-kind approach to cancer treatment, which has the potential to redefine standards of care and establish an entirely new class of therapy.”

TD Cowen acted as sole financial advisor to Nanobiotix.

Assuming the drawdown of the second tranche one year post closing, this financing extends Nanobiotix cash runway into early 2028 subject to closing of the agreement. This extension of cash runway does not include potential milestone payments from the JNJ-1900 (NBTXR3) licensing agreement. The Company continues to expect to receive the first potential milestone payments related to clinical development in head and neck cancer (NANORAY-312) and lung cancer (CONVERGE) within this timeframe, and has thereby established the financial foundation for self-sustaining long-term growth.

About JNJ-1900 (NBTXR3)

JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018. The product candidate’s mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated across multiple solid tumor indications as a single agent or combination therapy. The program is led by NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.

About NANOBIOTIX

Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life.

Incorporated in 2003, Nanobiotix is headquartered in Paris, France and is listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. The Company has subsidiaries in Cambridge, Massachusetts (United States) amongst other locations.

Nanobiotix is the owner of more than 25 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system.

For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter

About HEALTHCARE ROYALTY

HealthCare Royalty (“HCRx”) is a leading royalty acquisition company founded in 2006 that is majority owned by KKR & Co. Inc. (NYSE: KKR).  Over two decades, the HCRx team has developed a strong track record of investing in commercial-stage and near-commercial-stage biopharmaceutical assets, committing $7+ billion in over 110 biopharmaceutical products.  With offices in New York, Stamford, San Francisco, Boston, London and Miami, HCRx continues to advance biopharmaceutical innovation by providing innovative capital solutions to counterparties.  For more information, visit https://www.hcrx.com. HEALTHCARE ROYALTY®, HEALTHCARE ROYALTY PARTNERS® and HCRx® are registered trademarks of HealthCare Royalty Management, LLC.

Disclaimer

This press release contains “forward-looking” statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the use of proceed therefrom, and the period of time through which the Company’s anticipates its financial resources will be adequate to support operations. Words such as “expects”, “intends”, “can”, “could”, “may”, “might”, “plan”, “potential”, “should” and “will” or the negative of these and similar expressions are intended to identify forward-looking statements. These forward-looking statements which are based on the Company’ management’s current expectations and assumptions and on information currently available to management. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those implied by the forward-looking statements, including risks related to Nanobiotix’s business and financial performance, which include the risk that assumptions underlying the Company’s cash runway projections are not realized. Further information on the risk factors that may affect company business and financial performance is included in Nanobiotix’s Annual Report on Form 20-F filed with the SEC on April 2, 2025 under “Item 3.D. Risk Factors”, in Nanobiotix’s 2024 universal registration document filed with the AMF on April 2, 2025 under “chapter 1.5 Risk Factors”, and subsequent filings Nanobiotix makes with the SEC and AMF from time to time, including the Half-Year Report at June 30, 2025 which are available on the SEC’s website at www.sec.gov and on the AMF’s website at www.amf.org, The forward-looking statements included in this press release speak only as of the date of this press release, and except as required by law, Nanobiotix assumes no obligation to update these forward-looking statements publicly.

Contacts

Nanobiotix  
Communications Department
Brandon Owens
VP, Communications
+1 (617) 852-4835
contact@nanobiotix.com
Investor Relations Department
Joanne Choi
VP, Investor Relations (US)
+1 (713) 609-3150
investors@nanobiotix.com 

Ricky Bhajun
Director, Investor Relations (EU)
+33 (0) 79 97 29 99
investors@nanobiotix.com

 
Media Relations  
France – HARDY
Caroline Hardy
+33 06 70 33 49 50
carolinehardy@outlook.fr   
Global – uncapped Communications
Becky Lauer
+1 (646) 286-0057
nanobiotixteam@uncappedcommunications.com
 
     

________________________________
1
The minimum repayment from Nanobiotix to HCRx would be $2.5 million in any scenario

Attachment

DXS International plc ((AQSE: DXSP) – Final Results

DXS International plc ((AQSE: DXSP) – Final Results




DXS International plc ((AQSE: DXSP) – Final Results

DXS INTERNATIONAL PLC

(AQSE: DXSP)

ANNUAL RESULTS
for the year ended 30 April 2025

The Board of DXS International plc (“the Company”), the AQSE Growth Market quoted healthcare information and digital clinical decision support systems provider, is pleased to announce its audited Final Results for the year ended 30 April 2025.

Financial highlights:

  • Revenue increased by 5% to £3,469,917 (2024: £3,308,359).
  • Core recurring revenue model remains resilient.
  • Available cash at the period end was £428,957 plus unutilised debtor drawdowns of £245,043 (2024 £469,617).
  • Loss for the year of £94,750 (2024: Loss of £4,738,686: a combination of increased amortisation of £1,020,916 and impairment of £4,378,114). The R&D tax credits were down – from £212,964 – 2024 to £80,398 -2025 – due to HMRC’s new restrictions for companies claiming R&D tax on overseas development.

Operational highlights:

  • SMART Referrals – Next-Gen, our customer-driven SMART Referral replacement for the existing DXS Point of Care solution, is now being deployed to selected GP practices for final user acceptance testing – a major milestone for the company. Combined with the anticipated renewal of the delayed NHS central funding in April 2026, this represents a significant revenue growth opportunity for 2026 /27.
  • Secondary Care – Our SMART Referral solution, customised for each specialty unit, continues to reduce referral rejections and patient waiting times. Building on this success, DXS is piloting new functionality that automatically populates specialty unit systems with referral data – eliminating manual entry and improving efficiency. Early results from the live pilot are extremely positive, creating new revenue opportunities in secondary care, with a strong return on investment potential for hospitals and speciality units.
  • Medicine Optimisation – Our ExpertCare Medicine Optimisation solution recently completed an Innovate UK funded 18-month evaluation in collaboration with Health Innovation East and the University of York. The formal evaluation, conducted by the York Health Economics Consortium (YHEC) and concluded in July 2025, demonstrated an excellent return on investment for the NHS in the management of hypertension – a key priority in Cardiovascular Disease (CVD) prevention. The Innovate programme also funded the development of a Cholesterol Module to further enhance the ExpertCare algorithm.

Post-Period

Expired Share Options have been replaced for Directors and DXS senior management, and expired Warrants have been replaced for various Advisors.

Outlook
The NHS continues to face significant pressure to reduce waiting times and address the growing challenge of CVD. Within its Ten-Year Digital Transformation Plan, the NHS has identified digital innovation and preventive care as key priorities, with targeted funding directed toward high-impact, technology-driven solutions.

David Immelman, Chief Executive of DXS, commented:

“At DXS, we understand how frustrating revenue growth delays have been for our loyal shareholders. There are however clear signs that the NHS is turning the corner with a commitment to invest in digital technology as a solution to the issues that the NHS is facing. This is why DXS management and employees have remained focused on our strategy of delivering best of breed solutions with a clear and evidenced ROI to the NHS.”

The Directors of DXS International plc accept responsibility for this announcement. This announcement contains information which, prior to its disclosure, was inside information as stipulated under Regulation 11 of the Market Abuse (Amendment) (EU Exit) Regulations 2019/310 (as amended).

Contacts :

David Immelman        01252 719800
DXS International plc
www.dxs-systems.com

AQSE Corporate Broker and Corporate Advisor
Hybridan LLP        020 3764 2341
Claire Louise Noyce

Notes to Editors

About DXS:
DXS International is a UK-based digital health technology company that develops advanced clinical decision support and medicines optimisation solutions widely used across the NHS, particularly in primary care. Its software delivers evidence-based treatment guidelines and recommendations – sourced from Clinical Commissioning Groups and other trusted NHS authorities – directly to doctors, nurses, and pharmacists within their clinical workflow. By enabling better-informed decisions at the point of care, DXS helps improve patient outcomes, enhance safety, and support the NHS in achieving its efficiency and cost-saving objectives

The following information is extracted from the DXS International plc audited accounts for the year ended 30 April 2025.

CHAIRMAN’S REPORT

The Board announces its results for the year ending 30 April 2025.

It is with ongoing enthusiasm and renewed confidence that I share this update. While continued changes to government and NHS funding programmes have continued to influence our pace of growth, DXS has remained focused on delivering outstanding service, advancing our innovative healthcare solutions, and building new commercial relationships across the NHS.

We are encouraged to see positive signs of renewed activity within the NHS, with funding and decision-making pathways beginning to reopen after a long period of constraint. This shift creates a stronger environment for growth and collaboration moving forward. GPIT Futures was originally meant to be renewed by March 2023 and was delayed until March 2024, then delayed again and has now committed to being in place by 1 April 2026.

For the year ending 30 April 2025, turnover rose by 5% to £3,469,917 (2024: £3,308,359), with a loss of £94,750 (2024: Loss of £4,738,686: a combination of increased amortisation of £1,020,916 and impairment of £4,378,114) The size of the loss reflects continued operational discipline, though it was adversely affected by a decline in allowable R&D tax credits down – from £212,964 to £80,398 – due to HMRC’s new restrictions on overseas development.

Despite these changes, DXS continues to invest in innovation, further developing our unique NHS solutions that improve outcomes for patients and healthcare professionals alike. We should note that innovation costs have been expensed this year and not capitalised as in the past. On a like for like basis, after considering the amortisation charge, the net costs were similar to the costs in 2024.

With strong foundations and growing momentum, we look ahead to the coming year with optimism and purpose.

Highlights for the Year

SMART Referrals – Next-Gen, our customer-driven SMART Referral replacement for the existing DXS Point of Care solution, is now being deployed to selected GP practices for final user acceptance testing – a major milestone for the company. Although development was delayed by around twelve months due to evolving NHS eRS requirements, new compliance standards, reporting complexities, and the temporary freeze of the NHS primary care procurement framework that is for us an important sales channel, the platform is now receiving excellent feedback from early users. With the NHS committing to a renewed funding framework scheduled for launch in April 2026 – three years later than originally planned for March 2023, delayed to March 2024 and now committed at being in place for 1 April 2026 – the company is well positioned for renewed revenue growth and broader market adoption in the year ahead. Following the NHS restructuring, around 80% of our existing NHS customers have a significant number of GP practices not yet using our SMART Referral solution. As these customers move to standardise on the SMART Referral platform, this represents a substantial revenue growth opportunity for the 2026–2027 financial year.

Secondary Care – Our SMART Referral solution, customised for each specialty unit, continues to reduce referral rejections and patient waiting times. Building on this success, DXS is piloting new functionality that automatically populates specialty unit systems with referral data – eliminating manual entry and improving efficiency. Early results from the live pilot are extremely positive, creating new revenue opportunities in secondary care with strong return on investment potential for hospitals and speciality units.

Medicine Optimisation – Our ExpertCare Medicine Optimisation solution recently completed an Innovate UK funded 18-month evaluation in collaboration with Health Innovation East and the University of York. The formal evaluation, conducted by the York Health Economics Consortium (YHEC) and concluded in July 2025, demonstrated an excellent return on investment for the NHS in the management of hypertension – a key priority in CVD prevention. The Innovate programme also funded the development of a Cholesterol Module to further enhance the ExpertCare algorithm. Building on these positive outcomes, DXS is now working with Health Innovation East to potentially roll out new projects across six Integrated Care Boards (ICBs) in the East of England, covering more than six million patients. In addition, DXS has been awarded a place on the Grow Digital Health East and West Midlands Network, an initiative designed to support commercial expansion across 13 ICBs, representing over 12 million registered patients. These developments mark an important step forward in DXS’s strategy to expand adoption of ExpertCare across the NHS and drive forward measurable health and economic benefits.

The NHS continues to face significant pressure to reduce waiting times and address the growing challenge of CVD. Within its Ten-Year Digital Transformation Plan, the NHS has identified digital innovation and preventive care as key priorities, with targeted funding directed toward high-impact, technology-driven solutions.

At DXS, however frustrating the delays have been for shareholders, management, and employees remain focused with conviction to turn delays into opportunity which we have used to build and innovate on.

Therefore, we remain committed to growing the revenue and profitability for our shareholders and thank you for your continued support.

Yours sincerely,        

Bob Sutcliffe

REPORT OF THE DIRECTORS

The directors present their annual report and the audited financial statements for the year ended 30 April 2025. The Chairman’s statement which is included in this report includes a review of the achievements of the Company, the trading performance, financial position, and trading prospects.

Directors

The directors for the year were:

  • Bob Sutcliffe – Chairman
  • David Immelman – CEO
  • Steven Bauer – COO

Principal Activities

The group’s principal activities during the period were the development and distribution of clinical decision support to General Practitioners and Primary Care Networks in the United Kingdom. The commercial side included the licensing of DXS to various ICBs (Integrated Care Boards) and the sale of e-detailing opportunities to the Pharmaceutical Industry.

The group continues to invest in research and development both locally and internationally and during this financial year has invested £705,292 (2024 – £992,828) excluding the 2025 cost of research and development time spent by the South African subsidiary for the introduction, continuation, and completion of new DXS solutions. These are targeted at providing clinicians Wider Workforce.

During the period we have repaid £103,431 on bank and third-party loans.

Financial Instruments

The Directors believe that there is no material risk arising in respect of interest rates on loans, credit, and liquidity.

Dividend

The Directors do not recommend a dividend.

Directors’ Responsibilities

The directors are responsible for preparing the annual report and financial statements for each financial year. The directors have elected to prepare the financial statements in accordance with United Kingdom Generally Accepted Accounting Practice (United Kingdom Accounting Standards and applicable law). Under company law the directors must not approve the financial statements unless they are satisfied that they give a true and fair view of the state of affairs of the Group and Company and of the profit or loss of the Group for that period. In preparing these financial statements, the directors are required to:

  • Select suitable accounting policies and apply them consistently.
  • Make judgments and accounting estimates that are reasonable and prudent.
  • State whether UK accounting principles have been followed subject to any material departures disclosed and explained in the financial statements and,
  • Prepare the financial statements on the going concern basis unless it is inappropriate to presume that the Group and Company will continue in the business.

The directors are responsible for keeping adequate accounting records that are sufficient to show and explain the Company’s transactions and disclose with reasonable accuracy at any time the financial position of the Company and enable them to ensure that the financial statements comply with the Companies Act 2006. They are also responsible for safeguarding the assets of the Company and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities.

Directors’ Responsibilities To Auditors

The directors have taken all the necessary steps that they ought to have taken as directors in order to make themselves aware of all relevant audit information and to establish that the Company’s auditors are aware of that information.

As far as the directors are aware, there is no relevant audit information of which the Company’s auditor is unaware.

Approved by the board and signed on its behalf by:

D A Immelman
Director

30 October 2025

STRATEGIC REPORT

Section 172 Report

Section 172 of the Companies Act requires that a director of the Company is managing in the best interests of all stakeholders – Customers, Employees and Shareholders.

In the spirit of above, the Directors of DXS International plc, strive to maintain a reputation for high but fair standards in the best interest of its stakeholders.

Our primary focus is on our customers and here we regard our relationships and channels of communications of paramount importance. We operate in a sensitive environment, healthcare, and as such ensure that we meet all the standards required by our customers, such as Information Governance and Clinical Safety. In addition, we comply with ISO standards which assures an overarching good governance approach to all operations.

The Board is focused on delivering value for Shareholders underpinned by motivated Employees delivering above average delivery of solutions and service to Customers. In achieving the foregoing, the Company focuses on continued innovation via a policy of research and development funded through organic investment plus capital raises, as agreed at shareholder meetings.

In our communication to Shareholders the Board is clear in terms of its short, medium, and long-term strategy and maintains an open-door approach to Shareholders seeking additional clarity on any issue. The Board releases notices on a regular basis informing Shareholders of developments in areas of business progress, non-confidential strategic decisions, and any change to company policy. Risks and opportunities are set out in this strategic review.

The Group is small and while clear management structures are in place all employees, if required, have direct access to the Executive Directors on a daily basis and, if necessary, to the Chairman. The group retains HR services to ensure the fair and equitable treatment of employees. The Company promotes a policy of promoting from within supported by training and mentorship. We encourage diverse thinking and recognise strengths and contribution to the business.

Review of the Group’s Business

The Group loss for the year is £94,750 (2024: Loss of £4,378,114 mainly due to impairment of intangible assets). The 2025 loss is primarily a result of a reduction in R&D tax – £80,398 2025 compared to £212,964 2024 – due to a change in HMRC policy of not allowing claims on development outside of the UK.

As an accredited NHS solutions provider, DXS has well-established business continuity and disaster recovery protocols in place.

We have continued the development of our new Next-Gen cloud-based system and are in the process of piloting this new version. In addition, we completed our Innovate UK grant funded trial for our ExpertCare hypertension solution with a YHEC evaluation showing excellent potential ROI for the NHS. We also completed a prototype Lipids solution and were awarded a place on the “Grow Digital Health” initiative, aimed at helping companies with innovations gain commercial traction within the NHS.

Although the NHS remains notoriously slow in adopting new technology, our sustained efforts are seeing gained awareness of our new SMART referral and CVD prevention solution which we believe will begin generating revenue in 2026 once the GPITF funding framework – already delayed by three years – is renewed which is expected in April 2026. .

Our strategy remains aligned with both the new NHS Long Term Plan and opportunities abroad.

Principal Risks and Uncertainties

The principal risk to the Company in the UK is that the NHS dramatically changes its plans or cuts its budgets. This seems unlikely, particularly with the current NHS’ stated objective for clinicians to operate using digital technologies with which our new Next-Gen and ExpertCare solutions are aligned.

Failure to achieve predicted quantities of DXS contracts, and slower development of additional revenue streams may result in revenues growing more slowly than anticipated. These may be mitigated due to existing DXS customers, with some GP practices not yet having the DXS SMART Referral solution, wanting to standardise with a single referral solution across their complete patch.

Our plans for expansion outside of the UK also mitigate this risk. Here we continue with our research and development plans to take our new ExpertCare CVD solution into international markets where improved management of CVD prevention and other long-term conditions are a top priority.

Analysis of Business During Year Ending 30 April 2025

Revenue was 5% up with a loss of (£94,750). The loss is mainly a result of decreased R&D Tax credits – £80,398 2025 compared to £212,964 2024 – due to a change in HMRC policy of not allowing claims on development outside of the UK.

Financial Metrics

  • Group Revenue of £3,469,917 (2024: £3,308,359) has increased by 5%. Definition: Total Group sales including distribution of clinical decision support to General Practitioners and the licensing of DXS to ICB’s. Group Revenue includes the sale of medicine education slots to the pharmaceutical industry.

Underlying Group loss after Tax was (£94,750). The loss is mainly a result of decreased R&D Tax credits – £80,398 2025 compared to £212,964 2024 – due to a change in HMRC policy of not allowing claims on development outside of the UK.

Depreciation and amortisation of deferred Research and Development expenditure in 2025 was £1,038 and in 2024 was £1,020,916

  • Earnings Per Share 2025 (0.01p), 2024 (0.7)p. Definition: Earnings per share is the underlying profit divided by the weighted average number of ordinary shares in issue.
  • ROE 2025 (26%) 2024 (132%). Definition: Return on Equity (ROE) is the ratio of net profit of a company to its shareholders funds. It measures the profitability of a company by expressing its net profit as a percentage of its shareholders funds which include share capital, share premium, provision for costs of share option awards and retained earnings.

Corporate Governance

We are committed to establish, maintain, and continually improve an Integrated Management System (IMS) that conforms to relevant ISO requirements.

To achieve this objective, we commit to:

  • continual improvement in our performance and services to our stakeholders.
  • Identify, assess, reduce, and eliminate hazards and risks pertaining to our business.
  • Set risk-based objectives and targets to meet applicable statutory, business, information security and service level obligations.
  • Comply with mutually agreed quality and service level requirements of our customers.
  • Develop our people and provide sufficient resources to meet our objectives and targets.

We communicate the IMS Policy to all personnel working for or on behalf of DXS to ensure that they are made aware of their individual IMS obligations.

Approved by the board and signed on its behalf by:

D A Immelman
Director

30 October 2025

FINANCIAL STATEMENTS

INCOME STATEMENT

Year ended 30 April 2025

    2025
Continuing Operations
  2024
Continuing Operations
         
    £       £    
Turnover   3,469,917   3,308,359
Cost of Sales   (479,382)   (428,212)
    _________   _________
Gross Profit   2,990,535   2,880,147
         
Grant income   132,993   136,570
Administration Costs   (3,251,011)   (2,494,510)
         
Depreciation and Amortisation        
Depreciation and Amortisation   (1,038)   (1,020,916)
Impairment     (4,378,114)
    _________   _________
    (1,038)   (5,399,030)
    _________   _________
         
Operating Loss   (128,521)   (4,876,823)
Sundry income   1,898   15
    _________   _________
    (126,623)   (4,876,808)
Interest payable and similar expenses   (48,525)   (74,842)
    _________   _________
Loss on ordinary activities before taxation   (175,148)   (4,951,650)
Tax on loss on ordinary activities   80,398   212,964
    _________   _________
Loss for the year   (94,750)   (4,738,686)
    =========   =========
Profit per share        
  • basic
  (0.1p)   (7.4p)
  • fully diluted
  (0.1p)   (7.4p)
    =========   =========

        

Statement of Other Comprehensive Income

Year ended 30 April 2025   2025
£
  2024
£
Loss for the year   (94,750)   (4,738,686)
Other comprehensive income    
Tax on components of other comprehensive income  
    _________   _________
Total comprehensive loss for the year (94,750)   (4,738,686)
    =========   =========

Statement of Financial Position

As at 30 April 2025

  Group 2025 Group 2024 Company 2025 Company 2024
Fixed Assets £ £   £   £  
Intangible Assets 1,455,000 1,455,000
Tangible Assets 1,038
Investments 535,768 507,954
  _________ _________ _________ _________
  1,455,000 1,456,038 535,768 507,954
  _________ _________ _________ _________
Current assets        
Debtors: amounts falling due within one year 486,556 1,115,272 44,507 196,024
Cash at bank and in hand 428,957 90,012 16,810 4,094
  _________ _________ _________ _________
  915,513 1,205,284 61,317 200,118
Creditors: amounts falling due within one year (908,986) (811,205) (143,674) (161,124)
  _________ _________ _________ _________
Net current assets / (liabilities) 6,527 394,079 (82,357) 38,994
  _________ _________ _________ _________
         
Total assets less current liabilities 1,461,527 1,850,117 453,411 546,948
         
Creditors:        
Amounts falling due after more than one year (285,353) (345,455) (95,939) (99,562)
Deferred income (814,542) (1,057,276)
  _________ _________ _________ _________
  361,632 447,386 357,472 447,386
  ========= ========= ========= =========
 

 

 

Capital and reserves

       
Called up share capital 211,273 211,273 211,273 211,273
Share premium 3,213,395 3,213,395 3,213,395 3,213,395
Share option reserve 15,159 11,589 15,159 11,589
Retained earnings (3,078,195) (2,988,871) (3,082,355) (2,988,871)
  _________ _________ _________ _________
Shareholders’ funds 361,632 447,386 357,472 447,386
  ========= ========= ========= =========
         

As permitted by Section 408 of the Companies Act 2006, the Income Statement of the parent company is not presented as part of these financial statements. The Company made a loss of (£98,910) (2024 – loss of (£3,145,093) for the year.

The financial statements were approved and authorized for issue by the Board on 30 October 2025.

Signed on behalf of the Board of directors

D Immelman
Director
R Sutciffe
Director

Company Registration number :        06311313

Statement Of Changes in Equity

Year ended 30 April 2025
Group

  Called -up share capital Share Premium Share Option Reserve Retained earnings Total
  £ £ £ £ £
At 30 April 2023 159,246 2,671,321 21,382 1,737,884 4,589,833
Arising from share issue net of expenses 52,027 542,074 594,101
Transfer in respect of expired options (11,931) 11,931
Cost of share options awarded 2,138 2,138
Loss for the year (4,738,686) (4,738,686)
  _________ _________ _________ _________ _________
At 30 April 2024 211,273 3,213,395 11,589 (2,988,871) 447,386
Transfer in respect of expired options (5,426) 5,426
Cost of share options and warrants awarded 8,996 8,996
Loss for the year (94,750) (94,750)
  _________ _________ ________ _________ _________
At 30 April 2025 211,273 3,213,395 15,159 (3,078,195) 361,632
  ========= ========= ========= ========= =========

Company

  Called -up share capital Share Premium Share Option Reserve Retained earnings Total
  £ £ £ £ £
At 30 April 2023 159,246 2,671,321 21,382 144,291 2,996,240
Arising from share issue net of expenses 52,027 542,074 594,101
Transfer in respect of expired options (11,931) 11,931
Cost of share options awarded 2,138 2,138
Loss for the year (3,145,093) (3,145,093)
  _________ _________ _________ _________ _________
At 30 April 2024 211,273 3,213,395 11,589 (2,988,871) 447,386
Transfer in respect of expired options (5,426) 5,426
Cost of share options and warrants awarded 8.996 8,996
Loss for the year (98,910) (98,910)
  _________ _________ ________ _________ _________
At 30 April 2025 211,273 3,213,395 15,159 (3,082,355) 357,472
  ========= ========= ========= ========= =========

The cost to the company in 2025 in respect of the share option and warrant issue was calculated at £8,996 which amount was charged to the Profit and Loss Account.

An amount of £5,426 was transferred from the Share option reserve in respect of the share options expired during the year ended 30 April 2025 to Retained Earnings.

STATEMENT OF CASH FLOWS

Year ended 30 April 2025

    Group
2025
  Group
2024

 

    £       £    
Cash flow from operating activities   247,071   323,384
Interest paid   (48,525)   (74,842)
Sundry Income   1,898   15
R&D tax credit received   195,798   326,564
    _________   _________
Net cash flow from operating activities   396,242   575,121
    _________   _________
         
Cash flow from investing activities        
Payments to acquire intangible fixed assets     (992,828)
Receipts / (Payments) to acquire tangible fixed assets     (908)
    _________   _________
   

_________

  (993,736)

_________

Financing Activities        
Share issue proceeds     630,628
Share Issue costs     (36,527)
Repayment of long term loans   (103,431)   (457,451)
Advances from directors and senior staff   46,134  
    _________   _________
    (57,297)   136,650
    _________   _________
 

 

 

       
Net increase / (decrease) in cash and cash equivalents   338,945   (281,965)
Cash and Cash equivalents at 1 May 2024   90,012   371,977
    _________   _________
Cash and Cash equivalents at 30 April 2025   428,957   90,012
    =========   =========
Cash and Cash equivalents consists of:        
Cash at bank and in hand   428,957   90,012
    =========   =========
         
         

Net Debt Reconciliation Current Debt Non Current Debt Cash Total
  £ £ £ £
At 30 April 2023 (313,486) (720,446) 371,978 (661,954)
Non – Cash Flow 374,991 374,991
Cash Flow 26,857 (281,966) (255,109)
  ________ ________ ________ ________
At 30 April 2024 (286,629) (345,455) 90,012 (542,072)
Non – cash flow 60,102 60,102
Cash Flow 209,489 338,945 548,434
  _________ _________ ________ _________
At 30 April 2025 (77,140) (285,353) 428,957 (66,464)
  ========= ========= ========= =========

NOTES TO THE FINANCIAL STATEMENTS

Year ended 30 April 2025

1     (a)   Summary of significant accounting policies

DXS International PLC is a public company limited by shares incorporated in England and Wales. The address of the registered office is given in the company information on Page 1 of these financial statements.

The group’s principal activities during the year were the development and distribution of clinical decision support to General Practitioners, Nurses and Retail Pharmacies in the United Kingdom and South Africa. The commercial side includes the licensing of DXS products to various ICB’s (Integrated Care Boards), the sale of e-detailing opportunities to the pharmaceutical industry, the UK Primary Care sector and the licencing of DXS technology to healthcare publishers.

The financial statements have been prepared in accordance with applicable accounting standards including Financial Reporting Standard 102 applicable in the UK and Republic of Ireland. The financial statements have been prepared on a going concern basis under the historical cost convention. The financial statements are prepared in sterling which is the functional currency of the company.

In the opinion of the Directors the group has sufficient funding to continue as a going concern for at least twelve months from the date of approval of the financial statements. (see note 1(m).

The significant accounting policies applied in the preparation of these financial statements are set out below. These policies have been consistently applied to all years presented unless otherwise stated.

(b)   Intangible assets

Intangible assets acquired separately from a business are capitalised at cost.

Research and development expenditure, other than specific identifiable development expenditure, is written off against profits in the year in which it is incurred. (See Note 24).

Identifiable development expenditure is capitalised to the extent that the technical, commercial and financial feasibility can be demonstrated. Developed products are for use within the NHS and other medical institutions within both the UK and internationally. The Group is already a supplier of services to the NHS.

Goodwill arising on business combinations is capitalised, classed as an asset on the balance sheet and amortised over its useful life. The period originally chosen for writing off the current goodwill was 20 years because the directors believed that this was the period of time for the benefit to be received. The Directors reviewed the anticipated future life of the goodwill during 2020. It was considered that the anticipated future life of the goodwill would not exceed 3 years from 1 May 2020. Accordingly the Net Book Value of the goodwill at 30 April 2020 was amortised over 3 years.

Intangible assets are amortised over a straight line basis over their useful lives. The useful lives of intangible assets are as follows:

Intangible type Useful life Reasons
Development expenditure 5 years from the date that the specific product is completed and sold. Period of time for benefit to be received.

Provision was made for impairment in 2024 as the recoverable amount of the asset was less than its carrying amount, based on Directors judgement of the future revenue to be derived from each product. The Directors have considered the current value of the asset and believe that no additional impairment charge is required in the current year.

In the prior year the company has completed a number of projects specifically for use by the NHS. Due to NHS Budget restraints, the often unavailability of senior NHS staff members with the authority to make decisions, the continuing changing structure of the NHS, the directors have decided that commencement of sales revenue from these products cannot be accurately predicted and accordingly have written off as “Impairment” the net book value of these products. The Directors believe that these products will be revenue producing in future years.

(c)   Tangible fixed assets

The company capitalises items purchased as Tangible Fixed Assets which have a cost in excess of £550.

Tangible fixed assets are stated at cost less accumulated depreciation.

Depreciation is provided on all tangible fixed assets at rates calculated to write off the cost , less estimated residual value, of each asset on a systematic basis over its expected useful life as follows:

Office equipment        3 – 4years straight line.

(d)   Debtors and creditors receivable/ payable within one year

Debtors and creditors with no stated interest rate and receivable or payable within one year are recorded at transaction price. Any losses arising from impairment are recognised in the profit and loss account in other administration expenses.

(e )   Loans and borrowings

Loans and borrowings are initially recognised at the transaction price including transaction costs. Subsequently they are measured at amortised cost using an effective interest rate method. If an arrangement constitutes a finance transaction it is measured at present value.

(f)   Grants

Government Grants, including non – monetary grants, shall not be recognised until there is reasonable assurance that :

(a)        the entity will comply with the conditions attached to them; and

(b)        the grants will be received.

An entity shall recognise grants either based on the performance model or the accrual model. In the current year and prior year, the Grant has been accounted for on the accrual basis over the period in which the Group recognised the related costs for which the grant is intended to compensate.

(g )   Tax

Current tax represents the amount of tax payable or receivable in respect of the taxable profit for the current or past reporting periods. It is measured at the amount expected to be paid or recovered using the tax rates and laws that have been enacted or substantively enacted by the reporting date.

(h)   Turnover and other income

Turnover is measured at the fair value of the consideration received or receivable net of VAT and trade discounts. The policy adopted for the recognition of turnover is as follows:

Sale of services and products

Turnover is from the sale of products and services to the pharmaceutical industry and the UK Primary Care sector and is recognised over the term of service contract and is apportioned on a time basis representing the delivery of the service.

(i)   Foreign currency

Foreign currency transactions are initially recognised by applying to the foreign currency amount the exchange rate between the functional currency and the foreign currency at the date of the transaction.

Monetary assets and liabilities denominated in a foreign currency at the balance sheet date are translated using the closing rate.

Foreign exchange gains or losses are recognised in the Income Statement.

(j)   Employee benefits

When employees have rendered service to the company, short term employee benefits to which the employees are entitled are recognised at the undiscounted amount expected to be paid in exchange for that service.

The company operates a defined contribution plan for the benefit of its employees. Contributions are expensed as they become payable.

(k)   Leases

Rentals payable under operating leases are charged to the income statement on a straight line basis over the period of the lease.

(l)   Share option policy

The company recognised as an expense, the fair value of share options granted over their vesting period. The fair value is calculated by applying an option pricing model.

         (m)   Key judgements and Key accounting estimates

The Key judgements or Key Accounting estimates with a material effect on the carrying value of assets and liabilities are set out below -.

Going concern

In regards to the going concern of the company, the directors have considered cash flow forecasts for the period to April 2027 which include estimates to be earned from the new Next Gen SMART Referral solution which is expected to be revenue generating from early 2026.

The renewal of the NHS central funding framework which is expected to become effective in April 2026 will enable existing NHS customers to procure the DXS SMART Referral solution for practices that do not yet have the referral solution. The renewal of the NHS framework agreement is the possibility of a price increase for the referral solution.

The successful evaluation of both the SMART Referral and ExpertCare solutions, both demonstrating strong ROI for the NHS bode well for procuring new sales for these solutions for 2026/27.

Also included are costs which, if forecasted sales are slower than anticipated, can be reduced accordingly.

Based on the foregoing, the directors consider it appropriate to adopt the going concern basis of accounting and are satisfied that there is no material uncertainty.

Research and Development Tax credit

The Research and Development tax credit received from HMRC is not a Government grant but a recognition of the costs incurred in respect of the company’s research and development and is received through an adjustment to the taxable income of the company.

Impairment

As per the NHS mandate requiring NHS accredited suppliers to continue a process of innovation, the Group has invested heavily into developing new innovative solutions to meet the NHS unmet needs. However, while there is no doubt as to the potential benefits will realise for the NHS, the slow pace at which the NHS has been, and continues to operate is frustrating. This lethargic pace has come about for a number of reasons, such as the post COVID restructuring, delays in funding renewals and more recently the GP Collective Actions which are adversely affecting times to market.

The directors have decided that commencement of sales revenue from these products cannot be accurately predicted and accordingly wrote off as “Impairment” a large portion of the cost of these products in April 2024. The Government did not provide the anticipated funding to the NHS during 2024/25 that had been expected and funds were not available for purchase of new products by the NHS, The Government has indicated that significant funds for new products will be made available in the fiscal year commencing 5 April 2025.

The Directors emphatically believe that these products will be revenue producing in future years and evidence of this, although slow, exists. The Directors believe that no further impairment provision is required in the current year.

(n)   Reduced disclosure

DXS International PLC meets the definition of a qualifying entity under FRS 102 paragraph 1.12(b) and has therefore taken advantage of the disclosure exemption in relation to the parent cash flow statement.

4DMT Announces Exclusive License Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of 4D-150 in Asia-Pacific

4DMT Announces Exclusive License Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of 4D-150 in Asia-Pacific




4DMT Announces Exclusive License Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of 4D-150 in Asia-Pacific

  • 4DMT to receive $85 million upfront cash payment and expect to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supporting global registration 
  • Up to $336 million in potential regulatory and commercial milestones and tiered double-digit royalties depending on net sales in Otsuka’s territories
  • Proceeds and cost sharing expected to support global Phase 3 clinical trial in DME and pre-commercial activities

EMERYVILLE, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced a strategic partnership with Otsuka Pharmaceutical Co., Ltd. (Otsuka) to develop and commercialize 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) in the greater Asia-Pacific (APAC) region including Japan.

The strategic partnership combines 4DMT’s expertise in AAV genetic medicine, development in retina and manufacturing with Otsuka’s strong development expertise, regulatory experience and commercial infrastructure across APAC markets. Together, the companies aim to receive 4D-150 marketing approval and commercialization in major markets globally. 4D-150 is a potentially transformative backbone therapy providing durable benefit in retinal vascular diseases such as wet AMD and DME, which are among the leading causes of blindness in the world.

Under the terms of the agreement, 4DMT will grant Otsuka exclusive rights to develop and commercialize 4D-150 for retinal vascular diseases, including wet AMD and DME, in Japan, China, Australia and other Asia-Pacific markets. Otsuka will lead all regulatory and commercialization activities in its licensed territories. 4DMT will continue to lead all Phase 3 clinical activities globally, including within the APAC region. APAC clinical sites in 4FRONT-2, the global Phase 3 study in wet AMD, are expected to open by end of year, with Japan sites expected to open in January 2026.

4DMT will receive an upfront cash payment of $85 million and expected cost sharing of at least $50 million over the next three years for global development activities. In addition, the Company is eligible for up to $336 million in potential regulatory and commercial milestone payments and tiered double-digit royalties depending on net sales in Otsuka’s territories. 4DMT retains full development and commercialization rights for 4D-150 outside the APAC region, including the U.S., Latin America and Europe.

“We are thrilled to announce this strategic partnership with Otsuka, a leading global pharmaceutical company with a strong presence in the APAC region, reflecting our shared long-term commitment to improving outcomes for patients with retinal vascular diseases,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT. “This partnership is a key pillar of our global strategy, with 4DMT continuing to lead Phase 3 clinical trial and manufacturing activities globally, in addition to pre-commercial and commercial activities outside the APAC region.”

“APAC represents a large and underserved retina market, with a high prevalence of wet AMD and DME. Navigating the region’s regulatory and patient-access complexities requires a strong local partner, and we expect Otsuka’s deep presence and expertise to accelerate both development of and access to 4D-150,” said Chris Simms, Chief Commercial Officer of 4DMT. “Partnering with Otsuka extends the global reach of 4D-150 and ensures that patients in regions with limited access to innovative therapies may ultimately benefit from its potential to deliver durable treatment burden reductions and vision preservation.”

“Otsuka has created new value that contributes to the well-being of patients in Japan and around the world through both in-house and collaborative research,” said Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. “By introducing 4D-150 to the markets in Japan, and elsewhere in Asia and Oceania, we aim to help prevent vision loss through a single, potentially lifelong administration.”

About 4D-150

4D-150 is a potential backbone therapy designed to provide multi-year, and potentially lifelong, sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection. 4D-150 utilizes our customized and evolved intravitreal AAV vector, R100, which was invented at 4DMT through our proprietary Therapeutic Vector Evolution platform. 4D-150 is being developed for wet AMD and DME which both affect millions of patients globally, with the goal of freeing patients from burdensome injections while preserving vision.

About Wet AMD

Wet AMD, or wet age-related macular degeneration, is a highly prevalent disease, with more than 4 million individuals expected to be affected in the next five years in certain major markets, including the U.S., the EU and Japan. The disease also has a high incidence, with 200,000 individuals estimated to be newly diagnosed every year in the U.S. alone. Wet AMD is a type of macular degeneration in which abnormal blood vessels grow into the macula (macular neovascularization or MNV), the central area of the retina. MNV causes swelling and edema of the retina, bleeding and scarring, leading to visual distortion and reduced visual acuity. The proliferation and leakage of abnormal blood vessels is stimulated by VEGF. This process distorts and, without treatment, can potentially destroy central vision and may progress to blindness.

About DME

DME, or diabetic macular edema, is a complication of diabetic retinopathy and is a highly prevalent disease with significant unmet medical need and poor treatment adherence. It is estimated that there are approximately one million individuals with DME in the U.S. according to published data. DME is characterized by inflammation swelling in the macula due to leakage from blood vessels, which can lead to vision loss. DME is typically treated with intravitreal anti-VEGF agents administered approximately every 4-16 weeks, although patient compliance with therapy is poor and results in high unmet medical need.

About 4DMT  

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery. 4D Molecular Therapeutics™, 4DMT™, Therapeutic Vector Evolution™, and the 4DMT logo are trademarks of 4DMT.  

All of the Company’s product candidates are in clinical or preclinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration or any other regulatory authority. No representation is made as to the safety or effectiveness of the Company’s product candidates for the therapeutic uses for which they are being studied. 

Learn more at www.4DMT.com and follow us on LinkedIn

Forward-Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding the therapeutic potential, clinical development, marketing, and commercialization of our product candidates, including 4D-150, the potential benefits of the strategic partnership with Otsuka, the amount of any potential cost sharing or milestone payments pursuant to the Company’s agreement with Otsuka, timing of opening of APAC clinical sites, and our use of proceeds. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including risks and uncertainties that are described in greater detail in the section entitled “Risk Factors” in 4D Molecular Therapeutics’ most recent Quarterly Report on Form 10-Q filed on August 11, 2025, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent 4D Molecular Therapeutics’ views only as of today and should not be relied upon as representing its views as of any subsequent date. 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. 

Contacts:

Media:
Jenn Gordon
dna Communications
Media@4DMT.com

Investors:
Julian Pei
Head of Investor Relations and Strategic Finance
Investor.Relations@4DMT.com

InnoCare Announces First Patient Dosed in Clinical Trial of Novel ADC ICP-B794 in China

InnoCare Announces First Patient Dosed in Clinical Trial of Novel ADC ICP-B794 in China




InnoCare Announces First Patient Dosed in Clinical Trial of Novel ADC ICP-B794 in China

BEIJING, Oct. 30, 2025 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in the clinical trial of its novel B7-H3 targeted ADC, ICP-B794, in China.

ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others. ICP-B794 has demonstrated superior anti-tumor activity in animal models compared with other ADCs, and exhibited significant tumor-killing effects even in large tumors.

Currently, there are no B7-H3 targeted therapies approved for marketing globally. B7-H3 is a type I transmembrane protein that is highly expressed across multiple solid tumor types. Due to its tumor-specific expression, it is considered a highly promising anti-tumor target.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, “B7-H3 is specifically expressed in a wide range of solid tumors. ICP-B794 was developed from our proprietary ADC platform, and its differentiated design offers potential to provide precise treatment options for cancer patients. We will continue to expand our portfolio with multiple ADC candidates and bring more hope to cancer patients worldwide.

The ADC platform developed by InnoCare is positioned to target hard-to-treat cancers. Through its innovated platform technology, it can achieve stronger tumor killing effects and a better safety profile when developing novel ADC drugs, which will offer better treatment option for cancer patients globally.

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

Media Investors
Chunhua Lu  
86-10-66609879 86-10-66609999
chunhua.lu@innocarepharma.com ir@innocarepharma.com

MediciNova Compounds Demonstrate Novel Therapeutic Approach for Atherosclerosis in Peer-Reviewed Publication

MediciNova Compounds Demonstrate Novel Therapeutic Approach for Atherosclerosis in Peer-Reviewed Publication




MediciNova Compounds Demonstrate Novel Therapeutic Approach for Atherosclerosis in Peer-Reviewed Publication

Study published in the Journal of Atherosclerosis and Thrombosis demonstrates tipelukast (MN-001 and its metabolite MN-002) has influence on cholesterol metabolism in patients

LA JOLLA, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) — MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), announces the publication of a new research article in the peer-reviewed Journal of Atherosclerosis and Thrombosis, the official journal of the Japan Atherosclerosis Society and the Asian Pacific Society of Atherosclerosis and Vascular Disease.

The study, titled, “Enhancement of ABCA1 and ABCG1 Expression and Cholesterol Efflux by a Metabolite of Tipelukast: A Potential Therapeutic Strategy for Atherosclerosis,” is the result of a collaboration effort between MediciNova and a leading Japanese academic research group specializing in lipid and cholesterol metabolism. The research demonstrated that MN-002, the major metabolite of Company’s investigational compound MN-001 (tipelukast), significantly enhanced cholesterol efflux in macrophages by upregulating key transport proteins ABCA1 and ABCG. These findings suggest a novel mechanism of action and potential therapeutic strategy for atherosclerosis and other metabolic disorders.

“This collaborative research provides the mechanistic insight into how MN-001 and its metabolite MN-002 may influence cholesterol and lipid metabolism. We are pleased to see these findings published in a prestigious journal and remain committed to exploring the full therapeutic potential of MN-001, an orally available small molecule with anti-inflammatory and anti-fibrotic properties. We look forward to further clinical investigation in metabolic disease, including dyslipidemia and Type 2 diabetes,” said Yuichi Iwaki, M.D., Ph.D., MediciNova President and Chief Executive Officer.

Previous clinical studies have shown that MN-001 improved serum lipid profiles in patients with Non-alcoholic fatty liver disease (NAFLD) and hypertriglyceridemia, with particularly notable effects in patients with type 2 diabetes (DM). MediciNova is currently conducting a randomized, placebo-control, double-blind Phase 2 study in hypertriglyceridemia, Type 2 DM and NAFLD patients, with enrollment nearing completion.

About MediciNova

MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

Forward-Looking Statements

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166 and MN-001. These forward-looking statements may be preceded by, followed by, or otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “estimates,” “projects,” “can,” “could,” “may,” “will,” “would,” “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166 and MN-001, and risks of raising sufficient capital when needed to fund MediciNova’s operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova’s collaborations with third parties, the availability of funds to complete product development plans and MediciNova’s ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova’s filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2024 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

INVESTOR CONTACT:

David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com