€150 million agreement between EIB and Angelini Ventures to finance European startups




€150 million agreement between EIB and Angelini Ventures to finance European startups

• This is the first agreement signed by the EIB with a corporate venture capital in the healthcare sector, and is part of the EU strategy to support the development of innovative companies across the continent.
• Angelini Ventures and the EIB will each invest €75 million in the biotechnology, medtech, and digital health sectors.

The European Investment Bank (EIB) and Angelini Ventures – Angelini Industries’ corporate venture capital fund – have signed an agreement to provide a total of €150 million in financing for European biotechnology, medtech and digital health startups. This is the first agreement the EIB has signed with a corporate venture capital in the healthcare sector, and states that Angelini Ventures and the EIB will each invest €75 million over the next six years.

Under the agreement, the EIB and Angelini plan to co-invest in a total of seven to ten European startups developing innovative solutions particularly suited for market launch, in areas such as biotechnology, medical technology and digital health.

“Initiatives like this strengthen Europe’s ability to lead technological innovation and generate tangible benefits for people, patients and businesses,” said EIB Vice-President Gelsomina Vigliotti. “Investing in biotechnology, medtech and digital health is vital, as it accelerates research, improves the quality of care, and supports the growth of companies able to bring cutting-edge solutions to market.”

Presented at the Angelini Ventures head office in Rome today, the initiative is aligned with TechEU, the EIB Group’s investment programme to strengthen the growth of innovation and technological leadership in Europe. Via TechEU, the EIB Group aims to invest €70 billion in equity, quasi-equity, loans and guarantees over the three-year period from 2025 to 2027, with the goal of mobilising €250 billion of investment in the real economy. The agreement also strengthens Angelini Ventures’ position in the sector. Founded in 2022 with €300 million from Angelini Industries (an Italian multinational in the health, industrial technology and consumer goods sectors), the company has already invested €125 million in 22 startups.

“This important agreement with the EIB enables us to bring our group’s commitment to innovation through venture capital to a European strategic context,” said Angelini Industries CEO Sergio Marullo di Condojanni. “Being chosen by the EIB for an ambitious project aiming to consolidate Europe’s role in innovation and health is an opportunity to work towards the common goal of turning researchers’ excellent ideas into products and services with a positive impact on people’s lives and the economic development of European countries.”

“The agreement with the EIB is a key step in strengthening our international presence and global vision,” explained Angelini Ventures CEO Paolo Di Giorgio. “This development path is essential to accelerating market access for talent and for innovative projects, facilitating strategic partnerships in health and offering scaling opportunities for investments and partners. These elements are fundamental to speeding up growth and creating value in the healthcare and biotechnology sector, promoting European innovation, competitiveness and social impact on an international level.”

As a first step in the new partnership, Angelini Ventures and the EIB intend to co-invest in the second financing round of Adcytherix, a French biopharmaceutical company that develops innovative ADCs (Antibody-Drug Conjugates), with the investment agreement currently being finalized. These targeted therapies combine antibodies with next-gen cytotoxic payloads, to enhance precision, reduce toxicity and address resistance to current treatments. The first round, which closed in October of this year, was led by Bpifrance through its Large Venture and InnoBio investment strategies, and co-led by Kurma Partners, Andera Partners and Angelini Ventures.

Startups in Europe and Italy

The European Commission Startup and Scale Up Strategy aims to more effectively overcome the two main obstacles that startups face as they grow: the transition from research to development and the market, and the leap from startup to established company. In this domain, the work of the European Investment Bank Group (EIB Group) with corporate venture capital companies helps to facilitate the identification and financing of innovative businesses, with the potential to accelerate the growth, scalability and competitiveness of European startups via greater availability of capital. Another goal is to stimulate a potential European initial public offering (IPO) market, which would help increase the business relevance of European stock exchanges and help to keep value generated within Europe, in Europe. This could be a particularly useful tool, given that, as the European Commission states in The EU Startup and Scaleup Strategy Choose Europe to start and scale, almost 30% of European unicorn companies moved outside the European Union between 2008 and 2021 and only 8% of global scale-ups are based in Europe.

In 2024, there were 15 000 funding rounds in the United States totalling €210 billion in investment, while there were 11 000 in Asia for a total of €70 billion. Europe, meanwhile, had 9 600 rounds with total financing of €57 billion, with the number of deals falling by 16% and total value by 8% compared to 2023.*

The United States saw a 4% increase in the number of deals and a 29% rise in total funding over the same period.

Venture capital investment in Italy in 2024 totalled €1.5 billion over 417 rounds, up 31% vs. 2023.

The Italian venture capital market is mainly focused on deeptech, software and life sciences, with €300 million invested over 62 rounds in 2024 in life sciences alone. A €12 million investment in Serenis, co-led by Angelini Ventures, was the biggest deal in the life sciences sector (and among the top five overall) in the third quarter of 2025.

*Venture capital report produced by Growth Capital and Italian Tech Alliance, in partnership with Cdp venture Capital Sgr.

Background information

The European Investment Bank (ElB) is the long-term lending institution of the European Union, owned by its Member States. Built around eight key priorities, we finance investments that contribute to EU policy objectives by bolstering climate action and the environment, digitalisation and technological innovation, security and defence, cohesion, agriculture and bioeconomy, social infrastructure, the capital markets union, and a stronger Europe in a more peaceful and prosperous world.  The EIB Group, which also includes the European Investment Fund (EIF), signed nearly €89 billion in new financing for over 900 high-impact projects in 2024, boosting Europe’s competitiveness and security. The EIB Group signed 99 operations totalling €10.98 billion in Italy in 2024, unlocking almost €37 billion of investment in the real economy. All projects financed by the EIB Group are in line with the Paris Climate Agreement, as pledged in our Climate Bank Roadmap. Almost 60% of the EIB Group’s annual financing supports projects directly contributing to climate change mitigation, adaptation, and a healthier environment. Fostering market integration and mobilising investment, the funds made available by the Group unlocked over €100 billion in new investment for Europe’s energy security in 2024 and mobilised a further €110 billion for startups and scale-ups. Around half of the EIB’s financing within the European Union is directed towards cohesion regions, where per capita income is lower than the EU average.

High-quality, up-to-date photos of EIB headquarters for media use are available here.

Angelini Ventures is an international venture capital company and part of Angelini Industries, an Italian industrial group working in health, industrial technology and consumer goods. Angelini Ventures was formed in 2022 with planned investments of €300 million, about €125 million of which have already been allocated to startups developing innovative solutions and ideas in biotechnology, medtech and digital health. It invests in innovative companies in Europe and North America that can improve patients’ life expectancy and quality of life. The company is based in Rome and has a global team of 17 professionals working in nine cities (Rome, Milan, Turin, London, Singapore, Boston, Berlin, Copenhagen,Geneva, New York, Munich, and Basel). Angelini Ventures is part of Angelini Industries’ strategy to promote innovation by combining existing capabilities and new skills to identify, finance and implement solutions that innovate on traditional healthcare models.

www.angeliniventures.com

Angelini Industries is an international industrial group founded by Francesco Angelini in Ancona in 1919. It is a robust, well-structured industrial business with around 5 600 employees that operates directly in 21 countries, generating annual revenues of €1.6 billion. Angelini Industries operates in the health, industrial technology and consumer goods sectors. Guided by the Angelini family for over 100 years, group stands out for its investment strategy focused on growth, a governance model that combines the long-term vision of family businesses with the practices of listed companies, in-depth knowledge of markets and business sectors, and a commitment to promoting sustainable growth for people, communities, ecosystems and the planet.

www.angeliniindustries.com

Press contacts

EIB: Lorenzo Squintani, l.squintani@eib.org, tel.: +39 366 57 90 312
Website: www.eib.org/press

Angelini Industries
Alessandra Favilli, Group Chief Communication Officer – press@angeliniindustries.com

Angelini Ventures
Martina Palmese, Communications Coordinator – martina.palmese@angeliniventures.com 

SEC Newgate Italia
Daniele Pinosa – daniele.pinosa@secnewgate.it – tel. +39 3357233872
Fausta Tagliarini – fausta.tagliarini@secnewgate.it – tel. +39 3476474513
Daniele Murgia – daniele.murgia@secnewgate.it – tel. +39 3384330031
Giulia Cominotti – giulia.cominotti@secnewgate.it – tel. +39 3391499949

MEDiSTRAVA (Outside of Italy)
Sylvie Berrebi, Sandi Greenwood, Mark Swallow
angeliniventures@medistrava.com

MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease




MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease

• If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds
• Would potentially provide a cost-effective and convenient option to address episodes of fluid buildup at home, benefiting patients, providers and payors
• PDUFA target action date of July 26, 2026

WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) — MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the sNDA seeking approval for FUROSCIX ReadyFlow™ Autoinjector (SCP-111), developed to deliver a subcutaneous furosemide injection in under 10 seconds as an investigational alternative to the FDA-approved FUROSCIX^® (furosemide) On-body Infusor for treatment of edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.

“The FUROSCIX ReadyFlow Autoinjector marks a key milestone in expanding patient options and improving care. By delivering treatment in under 10 seconds, the ReadyFlow Autoinjector has the potential to transform how adults with chronic heart failure or chronic kidney disease manage episodes of fluid buildup—providing faster relief, reducing hospital admissions, and lowering overall healthcare costs,” said Michael Castagna, PharmD, Chief Executive Officer at MannKind Corporation. “We are excited about the opportunity to bring this innovation forward and empower patients with greater convenience and control in their treatment journey.”

If approved, FUROSCIX ReadyFlow Autoinjector would provide a new option for patients with CHF or CKD to manage fluid buildup episodes from the convenience of their home rather than in a hospital setting. The FDA-approved FUROSCIX On-body Infusor was approved for adult patients with edema in chronic heart failure in 2022 and in chronic kidney disease in 2025. The ReadyFlow Autoinjector would reduce administration time from five hours to under 10 seconds.

The sNDA is supported by positive study results announced in August 2024. Furosemide via the ReadyFlow Autoinjector demonstrated a bioavailability of 107.3% (90% CI: 103.9 – 110.8), achieving the 90% confidence interval limit of 80 to 125 percent. Additionally, participants who utilized ReadyFlow Autoinjector had similar urine output, urinary sodium excretion and urinary potassium excretion at 6, 8, and 12 hours compared to IV furosemide, and was generally well tolerated with respect to injection site pain.

The study was an open-label, single-center, single-dose, randomized, two-way crossover study in 21 healthy volunteers, ranging in age from 45 to 80. Each subject completed the screening, baseline, treatment, and follow-up phases. Subjects were randomly assigned in a 1:1 ratio to one of two treatment sequences (IV furosemide followed by furosemide via the ReadyFlow Autoinjector, or vice versa).

About FUROSCIX

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

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

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

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

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

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

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

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

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

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

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

Learn more at mannkindcorp.com.

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

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

MANNKIND is a registered trademark of MannKind Corporation.

CONTACT: For MannKind:
Media Relations
Christie Iacangelo
Email: media@mnkd.com

Investor Relations
Email: ir@mnkd.com

NRx Pharmaceuticals (NASDAQ:NRXP) and HOPE Therapeutics to Present at NobleCon21 – Noble Capital Markets’ Twenty First Annual Emerging Growth Equity Conference




NRx Pharmaceuticals (NASDAQ:NRXP) and HOPE Therapeutics to Present at NobleCon21 – Noble Capital Markets’ Twenty First Annual Emerging Growth Equity Conference

WILMINGTON, Del., Dec. 01, 2025 (GLOBE NEWSWIRE) — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP, the “Company”, “NRx”), a clinical-stage biopharmaceutical company and HOPE Therapeutics, an interventional psychiatry network owned by NRx, today announced that its Founder, Chairman, and Chief Executive Officer, Jonathan Javitt, M.D., M.P.H will present at NobleCon21 – Noble Capital Markets’ Twenty First Annual Emerging Growth Equity Conference at Florida Atlantic University, Executive Education Complex, in Boca Raton, FL.- on Wednesday, December 3^rd at 4:30 PM EST.

The presentation will provide an update on the Company’s expanded focus following progress achieved over the past year across investigational drugs, medical devices, and interventional psychiatric therapies for suicidal depression, PTSD, and related conditions. As previously announced, the Company has begun generating clinical revenue and has made meaningful progress in drug development since its appearance at NobleCon 2024.

Interested investors and guests of the Company are welcome to attend at a discounted rate. Please register here using the discount code NRXPNOBLECON.

A high-definition video webcast of the presentation will be available the following day on the Company’s website https://ir.nrxpharma.com/events, and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website: www.nobleconference.com and on Channelchek www.channelchek.com, the investor portal created by Noble. The webcast will be archived on the company’s website, the NobleCon website, and on Channelchek.com for 90 days following the event. 

About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company focused on Neuroplastic Therapies for the treatment of central nervous system disorders, specifically suicidal depression, PTSD, anxiety, and Autism. The Company combines drug development with a best-in-class network of clinics (HOPE Therapeutics) offering medication management, Transcranial Magnetic Stimulation, and Hyperbaric Oxygen Therapy that combine to achieve rapid response and remission. NRx is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application for its preservative-free ketamine formulation and is anticipating a July 2026 launch.

About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com), a subsidiary of NRx Pharmaceuticals, is a healthcare delivery company that is building a best-in-class network of interventional psychiatry clinics to offer ketamine and other neuroplastic medications, transcranial magnetics stimulation (TMS), Hyperbaric Oxygen Therapy, and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy. HOPE is the first network in Florida to offer the AMPA One Day (ONE-D) treatment that combines TMS, physician-prescribed D-cycloserine, and lisdexamfetamine to achieve remission from treatment resistant depression.

About Noble Capital Markets, Inc.
Established in 1984, Noble Capital Markets (Noble) is an SEC / FINRA registered full-service broker-dealer offering investment/merchant banking and advisory services, with an award-winning research team, and a proprietary research distribution platform (Channelchek). Noble provides middle-market expertise to entrepreneurs, corporations, financial sponsors, and investors. In addition to its large scale in-person conference, NobleCon, Noble hosts multi-sector virtual conferences throughout the year. Over the more than 40 years, Noble has raised billions of dollars for companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com | www.nobleconference.com.

About Channelchek
Noble launched www.channelchek.com in 2018 – an investor community dedicated exclusively to emerging growth public companies and their industries. Channelchek is the first service to offer institutional-quality, FINRA-regulated research to the public, for FREE at every level without a subscription. With more than 7,000 public companies listed on the site, content includes advanced market data, equity research, videos & webcasts, and industry articles.

Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. These statements relate to future events or to the Company’s future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company’s current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company’s operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.

ProQR to Participate in 8th Annual Evercore Healthcare Conference




ProQR to Participate in 8th Annual Evercore Healthcare Conference

LEIDEN, Netherlands & CAMBRIDGE, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) — ProQR Therapeutics N.V. (Nasdaq: PRQR) (ProQR), a company dedicated to changing lives through transformative RNA therapies based on its proprietary ADAR-mediated Axiomer™ RNA editing technology platform, today announced that the Company will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on Thursday, December 4, 2025 at 8:20am ET.

Webcast details will be accessible from the “Investors & Media” section of ProQR’s website (www.proqr.com) under “Events“. Archived webcasts will be available for approximately 30 days following the presentation date.

About Axiomer^™

ProQR is pioneering a next-generation RNA base editing technology called Axiomer^™, which could potentially yield a new class of medicines for diverse types of diseases. Axiomer^™ “Editing Oligonucleotides”, or EONs, mediate single nucleotide changes to RNA in a highly specific and targeted way using molecular machinery that is present in human cells called ADAR (Adenosine Deaminase Acting on RNA). Axiomer^™ EONs are designed to recruit and direct endogenously expressed ADARs to change an Adenosine (A) to an Inosine (I) in the RNA – an Inosine is translated as a Guanosine (G) – correcting an RNA with a disease-causing mutation back to a normal (wild type) RNA, modulating protein expression, or altering a protein so that it will have a new function that helps prevent or treat disease.

About ProQR

ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA therapies. ProQR is pioneering a next-generation RNA technology called Axiomer^™, which uses a cell’s own editing machinery called ADAR to make specific single nucleotide edits in RNA to reverse a mutation or modulate protein expression and could potentially yield a new class of medicines for both rare and prevalent diseases with unmet need. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind.

Learn more about ProQR at www.proqr.com.

Forward Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “continue,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Such forward-looking statements include, but are not limited to, statements regarding our participation in this conference, statements regarding our business, technology, strategy, preclinical and clinical model data, our initial pipeline targets and the upcoming strategic priorities and milestones related thereto, the continued advancement of our lead development pipeline programs, including ongoing and planned clinical trials, expectations regarding regulatory feedback and the potential registrational pathway for AX-0810 in NTCP for cholestatic diseases, the anticipated timing of initial Phase 1 clinical data for our lead program, AX-0810, and clinical updates across multiple programs in 2025, our Axiomer^™ platform, including the continued development and advancement of our Axiomer platform, the therapeutic potential of our Axiomer RNA editing oligonucleotides and product candidates, the timing, progress and results of our preclinical studies and other development activities, including the release of data related thereto, our patent estate, including our anticipated strength and our continued investment in it, as well as the timing of our clinical development, the potential of our technologies and product candidates, the collaboration with Lilly and the intended benefits thereof, including timing for data updates, potential milestones, exercise of an option to expand targets and the receipt of an opt-in payment, our ability to selectively form new partnerships and enter into future collaborations, and our financial position and cash-runway. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Our actual results could differ materially from those expressed or implied by these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors in our filings made with the Securities and Exchange Commission, including certain sections of our most recent annual report filed on Form 20-F. These risks and uncertainties include, among others, the cost, timing and results of preclinical studies and clinical trials and other development activities by us and our collaborative partners whose operations and activities may be slowed or halted shortage and pressure on supply and logistics on the global market, economic sanctions and international tariffs; the likelihood of our preclinical and clinical programs being initiated and executed on timelines provided and reliance on our contract research organizations and predictability of timely enrollment of subjects and patients to advance our clinical trials and maintain their own operations; our reliance on contract manufacturers to supply materials for research and development and the risk of supply interruption from a contract manufacturer; the potential for future data to alter initial and preliminary results of early-stage clinical trials; the unpredictability of the duration and results of the regulatory review of applications or clearances that are necessary to initiate and continue to advance and progress our clinical programs; the ability to secure, maintain and realize the intended benefits of collaborations with partners, including the collaboration with Lilly; the possible impairment of, inability to obtain, and costs to obtain intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated in research and development; general business, operational, financial and accounting risks, and risks related to litigation and disputes with third parties; and risks related to macroeconomic conditions and market volatility resulting from global economic developments, geopolitical events and conflicts, high inflation, rising interest rates, tariffs and potential for significant changes in U.S. policies and regulatory environment. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

ProQR Therapeutics N.V.

Investor and media contact:
Sarah Kiely
ProQR Therapeutics N.V.
T: +1 617 599 6228
skiely@proqr.com
or
Investor contact:
Peter Kelleher
LifeSci Advisors
T: +1 617 430 7579
pkelleher@lifesciadvisors.com

Philips expands commercial availability of world’s first real-time AI-enabled light-based 3D navigation solution for image-guided therapy




Philips expands commercial availability of world’s first real-time AI-enabled light-based 3D navigation solution for image-guided therapy

December 1, 2025

• Commercial availability expanded across Europe and the United States
• Real-time AI-enabled 3D device visualization powered by light instead of X-ray, improving navigation in complex endovascular procedures
• LumiGuide seamlessly integrates with Azurion, Philips’ proven, world-leading image-guided therapy platform designed to drive procedural innovation across clinical domains

Amsterdam, the Netherlands and Chicago, USA – Royal Philips (NYSE: PHG, AEX: PHIA, a global leader in health technology, today announced the expanded commercial availability of LumiGuide 3D Device Guidance, the world’s first real-time AI-enabled light-based 3D navigation solution for image-guided therapy, across Europe and the United States. LumiGuide represents a breakthrough in radiation-free* navigation, allowing physicians to visualize and guide devices inside the body using light instead of continuous X-ray. Announced at RSNA 2025, the wider commercial rollout marks the next step in Philips’ long-term commitment to improving radiation safety and dose reduction in image-guided therapy.

LumiGuide seamlessly integrates with Azurion, Philips’ proven, world-leading image-guided therapy platform designed to drive procedural innovation across clinical domains. Focused on improving outcomes, efficiency, and safety, LumiGuide joins a growing suite of intelligent, AI-enabled supportive and therapeutic devices integrated on the Azurion platform – a portfolio that spans both guidance technologies and therapeutic tools – redefining how clinicians plan, guide, and perform complex procedures with greater precision and confidence.

“I have done over 160 fenestrated and branched aortic procedures with LumiGuide and have found that the system improves efficiency, reduces the procedure time, and reduces time on the fluoroscopy pedal to near zero,” said Adam W. Beck, MD, Professor and Director, Division of Vascular Surgery & Endovascular Therapy, University of Alabama at Birmingham, US.

Transforming navigation inside the body – with light instead of X-ray
LumiGuide, powered by Philips Fiber Optic RealShape (FORS) technology, is the first solution to use light to visualize the shape and position of LumiGuide wires and compatible endovascular catheters inside the body in real time and in 3D – without X-ray. By reflecting light along an optical fiber integrated into the guidewire, LumiGuide shows high-resolution, full-color images from any angle, giving physicians instant orientation during complex endovascular procedures. LumiGuide uses AI to quickly and accurately align any image with the patient’s anatomy. This technology allows clinicians to navigate with precision, while significantly reducing radiation exposure for both patients and clinical staff. Using this advanced technology, complex cases such as aortic repair procedures can be performed 37% faster and with up to 56% DAP reduction [1].

“Moving LumiGuide from limited to full commercial availability is an important milestone in expanding access to advanced image-guided therapy,” said Stacey Beske, Business Leader Image-Guided Therapy Devices at Philips.

“By bringing this light-based navigation technology to more hospitals, we’re helping clinicians treat complex vascular disease with precision and safety, while reducing radiation risk for patients and teams in the lab,” added Atul Gupta, MD, Chief Medical Officer Diagnosis & Treatment at Philips.

Proven Azurion platform
LumiGuide is the latest innovation built on Philips leadership in Image Guided Therapy and the proven Azurion platform – the foundation for procedural innovation across clinical domains. Seamlessly integrated into Azurion, LumiGuide demonstrates how Philips continues to advance minimally invasive therapies through integration of intelligent systems and devices that combine real-time insight, precision navigation, and procedural efficiency. Built on a platform that treats over 6.4 million patients each year across more than 80 countries [2], with high-quality, low-dose imaging and enhanced workflow efficiency, LumiGuide extends Philips’ commitment to making image-guided therapy safer, faster, and more effective for patients and clinical teams. Together with AI-enabled innovations such as DeviceGuide and VeriSight 3D ICE, Philips is integrating intelligence and imaging to enable the next generation of procedural precision and confidence, all within the connected Azurion environment.

Accelerating access and adoption
Following a successful limited market release in late 2023, LumiGuide will be commercially available from January 2026 in key European markets and the United States** Over the past years, LumiGuide has been used in more than 2,000 clinical procedures [2], integrated with Philips Azurion image-guided therapy platform. Building on this experience, Philips continues to invest in clinical evidence generation to help clinicians optimize the use of LumiGuide in everyday practice.

Advancing radiation safety in image-guided therapy
LumiGuide builds on Philips’ broader portfolio of innovations aimed at reducing or eliminating radiation exposure during image-guided procedures. Alongside technologies such as Azurion with ClarityIQ, DoseAware, and EchoNavigator, and complementary clinical programs like the RADIQAL trial, LumiGuide underscores Philips’ leadership in low- and no-dose interventional solutions, helping to make image-guided therapy safer, more efficient, and more sustainable.

Learn more
To learn more about Philips LumiGuide and its integration within Philips Image Guided Therapy portfolio, visit www.philips.com/lumiguide.

Also unveiled at RSNA is BlueSeal Horizon [3], a new 3.0T MRI platform featuring the world’s first helium-free 3.0T magnet and next-generation AI designed to enhance workflow efficiency and diagnostic precision.

[1] Eric J. Finnesgard, Jessica P. Simons, Douglas W. Jones, Caitlin M. Sorensen, Tammy T. Nguyen, Andres Schanzer. Initial single-center experience using Fiber Optic RealShape guidance in complex endovascular aortic repair, Journal of Vascular Surgery, November 12, 2022. https://doi.org/10.1016/j.jvs.2022.11.041.
[2] Data on file at Philips.
[3] 3.0T BlueSeal Horizon is ‘Work in Progress’ and not available in any jurisdiction. It is not for sale in the USA. Its future availability cannot be ensured. 

*While navigation with LumiGuide itself involves no radiation exposure, some clinical procedures may incorporate limited X-ray imaging for initial anatomical visualization.
** LumiGuide has FDA clearance and CE marking and will be commercially available for order in the United States and Europe starting January 2026.
*** The opinions and clinical experiences presented herein are specific to the featured topic(s), are not linked to any specific patient and are for information purposes only. The medical experience(s) derived from these topics may not be predictive of all patients.  Individual results may vary depending on a variety of patient-specific attributes and related factors.  Nothing in this presentation is intended to provide specific medical advice or to take the place of written law or regulations.

For further information, please contact:

Joost Maltha
Philips Global External Relations
Tel.: +31 6 1055816
E-mail: joost.maltha@philips.com

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people’s health and well-being through meaningful innovation. Philips’ patient- and people-centric innovation leverages advanced technology and deep clinical and consumer insights to deliver personal health solutions for consumers and professional health solutions for healthcare providers and their patients in the hospital and the home.

Headquartered in the Netherlands, the company is a leader in diagnostic imaging, ultrasound, image-guided therapy, monitoring and enterprise informatics, as well as in personal health. Philips generated 2024 sales of EUR 18 billion and employs approximately 67,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Attachment

• Philips LumiGuide 3D device guidance in use

Solid Biosciences Receives FDA Rare Pediatric Disease Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia




Solid Biosciences Receives FDA Rare Pediatric Disease Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia

– SGT-212 has been granted FDA Rare Pediatric Disease and Fast Track designations –

– SGT-212 is the only dual route gene therapy in development to treat Friedreich’s ataxia –

– FALCON Phase 1b clinical trial participant screening underway –

CHARLESTOWN, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it received Rare Pediatric Disease designation from the U.S. Food and Drug Administration (FDA) for SGT-212, the Company’s investigational gene therapy for Friedreich’s ataxia (FA). SGT-212 will deliver the full-length frataxin gene via dual routes of administration, utilizing both direct intradentate nucleus (IDN) and intravenous (IV) infusions, and was designed to promote restoration of therapeutic levels of the frataxin protein to address neurologic, cardiac and systemic clinical manifestations of FA.

Rare Pediatric Disease designation is granted by the FDA for serious and life-threatening diseases that primarily affect individuals under 18 years of age. The designation provides the Company with the potential to receive a pediatric priority review voucher (PRV), which can expedite the review for future Biologic License Applications. The PRV may be redeemed to receive priority review for another marketing application or may be sold or transferred.

Jessie Hanrahan, Ph.D., Chief Regulatory & Preclinical Operations Officer of Solid Biosciences, said, “Receiving Pediatric Rare Disease designation marks another significant milestone for our Friedreich’s ataxia program, SGT-212. Together with the Fast Track designation granted earlier this year, it recognizes our dual-route clinical approach for FALCON, our first-in-human trial, which is now screening participants, as an important first step in meeting an unmet need for FA. These designations are designed to help accelerate time to market and enhance engagement with the FDA. We look forward to continued collaboration with regulators to bring this therapy to patients as quickly as possible.”

About Rare Pediatric Disease Designation
The U.S. Food and Drug Administration Rare Pediatric Disease designation incentivizes development of therapies for serious or life-threatening rare pediatric diseases. Under this program, sponsors may qualify for a priority review voucher (PRV) upon approval that can be redeemed to receive priority review for a different product. The sponsor may also transfer or sell the voucher to another sponsor.

About SGT-212
SGT-212 is a recombinant AAV-based gene replacement therapy for Friedreich’s ataxia (FA) designed to deliver full-length human frataxin (FXN) via a dual route of administration: intradentate nucleus (IDN) infusion, using an FDA-approved, stereotactic, precision MRI-guided device, followed by an intravenous (IV) infusion to increase therapeutic FXN levels in the cerebellar dentate nuclei and in cardiomyocytes, respectively. Targeted delivery to the dentate nuclei will be confirmed in real time via gadolinium, an MRI-enhancing contrast agent. Restoration of FXN levels is expected to repair the underlying mitochondrial dysfunction in neurons and cardiomyocytes to address neurologic, cardiac and systemic manifestations of the disease.

About Friedreich’s Ataxia (FA)
FA is an inherited, life-threatening, degenerative multisystem disease caused by defects in the frataxin gene that disrupt production of the frataxin protein, a mitochondrial iron-binding protein involved in essential cellular processes, including energy production. FA is known to cause progressive nervous system damage, movement problems, and cardiac dysfunction, with cardiac complications identified as the primary cause of death. FA impacts approximately 5,000 people in the United States and 15,000 in Europe. There are currently no treatments that provide a cure or halt disease progression.

About Solid Biosciences
Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including SGT-003 for Duchenne muscular dystrophy (Duchenne), SGT-212 for Friedreich’s ataxia (FA), SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), SGT-601 for TNNT2-mediated dilated cardiomyopathy and additional fatal, genetic cardiac diseases. The Company is also focused on developing innovative libraries of genetic regulators and other enabling technologies with promising potential to significantly impact gene therapy delivery cross-industry. Solid is advancing its diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care. Patient-focused and founded by those directly impacted by Duchenne, Solid’s mission is to improve the daily lives of patients living with devastating rare diseases. For more information, please visit www.solidbio.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future expectations, plans and prospects for the company; the ability to successfully achieve and execute on the company’s goals, priorities and key clinical and preclinical milestones; strategies and expectations for the company’s SGT-003 and other programs, ; expectations for additional site activations, planned enrollment, planned regulatory interactions and the potential approval pathways for SGT-003; timing of planned clinical trials of SGT-003; t the sufficiency of the Company’s cash, cash equivalents, and available-for-sale securities to fund its operations; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the company’s ability to advance SGT-003 and other programs, capsid libraries and other enabling technologies on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies and early-stage clinical trials of the company’s product candidates; obtain, maintain or protect intellectual property rights related to its product candidates; replicate preliminary or interim data from early-stage clinicals trials in the final data of such trials; compete successfully with other companies that are seeking to develop Duchenne, FA, CPVT and other neuromuscular and cardiac treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003 and other candidates, achieve its other business objectives and continue as a going concern. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in the company’s most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof and should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so.

Solid Biosciences Investor Contact:
Nicole Anderson
Director, Investor Relations and Corporate Communications
Solid Biosciences Inc.
investors@solidbio.com

Media Contact:
Glenn Silver
FINN Partners
glenn.silver@finnpartners.com

Cocrystal Pharma to Present at the Noble Capital Markets’ 21st Emerging Growth Equity Conference




Cocrystal Pharma to Present at the Noble Capital Markets’ 21st Emerging Growth Equity Conference

BOTHELL, Wash., Dec. 01, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that James Martin, CFO and co-CEO, will present a Company overview and clinical progress update at NobleCon 21 – Noble Capital Markets 21^st Emerging Growth Equity Conference on Wednesday, December 3, 2025 at 10:00 am Eastern time. The conference is being held at the Executive Education Complex of Florida Atlantic University in Boca Raton, Florida.

Interested investors and guests of Cocrystal Pharma are welcome to attend the conference at a discounted rate. Please register here using the discount code COCPNOBLECON.

A video webcast of the Cocrystal presentation will be available on December 4, one day after the live event, on the Company’s website and archived for 90 days.

About Noble Capital Markets, Inc. 
Noble Capital Markets is a research-driven investment bank that has supported small and microcap companies since 1984. As a FINRA and SEC licensed broker dealer, Noble provides institutional-quality equity research, merchant and investment banking, and order execution services. In 2018, Noble launched Channelchek—an investor community dedicated exclusively to public small and micro-cap companies and their industries. Channelchek is the first service to offer investors free institutional-quality research without a subscription.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

Rakovina Therapeutics Announces Three-Month Q3 ended September 30, 2025 Financial Results and Provides Corporate Update




Rakovina Therapeutics Announces Three-Month Q3 ended September 30, 2025 Financial Results and Provides Corporate Update

All dollar amounts reflected in Canadian dollars unless otherwise stated.

VANCOUVER, British Columbia, Dec. 01, 2025 (GLOBE NEWSWIRE) — Rakovina Therapeutics Inc. (“Rakovina” or the “Company”) (TSX-V: RKV) (FSE: 7JO0), a biopharmaceutical company advancing cancer therapies through AI-powered drug discovery, today announced its financial results for the three months ended September 30, 2025 (“Q3 2025”), and provided an update on recent corporate developments.

Q3 2025 Financial Highlights

• Reported a net loss of $1,781,757.

• Research and development (R&D) expenses were $1,102,371, reflecting continued advancement of AI-powered drug candidates.

• General and administrative (G&A) expenses were $539,174 including investor & public relations and exchange-related fees.

• Cash and cash equivalents as at September 30, 2025 were $822,293.

“Over the past several months, Rakovina Therapeutics has delivered a series of meaningful scientific and corporate milestones that underscore the strength of our AI-enabled DDR pipeline and the growing global interest in our programs,” stated Jeffrey Bacha, Rakovina Therapeutics executive chairman. “From compelling CNS-penetrant ATR data at AACR-NCI-EORTC to multiple presentations at the Society for Neuro-Oncology Annual Meeting, together with increased visibility at leading investor and industry conferences and the advancement of strategic collaborations such as our NanoPalm joint-venture initiative, we are entering 2026 with significant momentum. These achievements not only validate the depth of our science but also position the company for the next phase of growth as we work to bring transformative therapies to patients in need.”

Recent Corporate Highlights

• On November 24, 2025, the Company announced the presentation of two scientific posters at the 2025 Society for Neuro-Oncology Annual Meeting in Honolulu, Hawaii. The posters provided updates on the Company’s ATR and PARP1 programs, including compelling preclinical data from the ATR program. Rakovina’s lead ATR compounds have now been confirmed as dual ATR/mTOR inhibitors and demonstrate properties highly relevant to treatment-resistant, PTEN-deficient solid tumors, where PTEN loss is one of the most common genetic alterations across cancers and is strongly associated with a high incidence of brain metastases.

• On November 18, 2025, the Company announced that its President & CSO, Prof. Mads Daugaard, has been invited to present and participate as a panelist at the 9th Annual DNA Damage Response (DDR) Inhibitors Summit in January 2026, where he will highlight the Company’s AI-enabled DDR drug discovery programs and ongoing preclinical progress.

• On October 27, 2025, the Company announced the presentation of new pre-clinical data at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics confirming that its AI-discovered ATR inhibitor program (kt-5000 series) achieved potent ATR inhibition and demonstrated confirmed CNS penetration — a milestone differentiator in the DDR inhibitor space.

• On September 4, 2025, the Company announced that senior management would attend the H.C. Wainwright 27th Annual Global Investment Conference (September 8–10, New York), to engage with investors and potential pharmaceutical partners to discuss the company’s AI-enabled oncology pipeline, corporate strategy, and upcoming milestones.

• On August 26, 2025, the Company announced that our president & CSO, Prof. Mads Daugaard, was invited to speak at the 13th Tuscany Retreat on Cancer Research & Apoptosis (August 23–30), highlighting Rakovina Therapeutics DDR-targeted drug discovery and development accomplishments.

• On August 12, 2025, the Company announced that Rakovina Therapeutics and NanoPalm Ltd. announced a non-binding Letter of Intent to form a joint venture to co-develop AI-discovered small-molecule oncology therapies — beginning with the dual PARP-HDAC inhibitor KT-3283 delivered via NanoPalm’s proprietary patterned lipid nanoparticle (pLNP) system — combining Rakovina’s drug candidates and validation data with NanoPalm’s nanoparticle platform, manufacturing capabilities, and support infrastructure under a Saudi Arabia-based JV with global development and commercialization rights.

• On July 28, 2025, the Company granted an aggregate of 540,000 stock options to certain directors, officers, employees, and consultants pursuant to its Long-Term Incentive Plan. Each option is exercisable at a price of $0.70 per share for a period of five years and vests in equal installments every six months over three years.

• On July 15, 2025, the Company announced that its common shares are now eligible for electronic clearing and settlement through the Depository Trust Company (DTC).

Selected Financial Results for Q3 2025:

Statement of Loss and Comprehensive Loss – Q3 Three months ended September 30

Rakovina Therapeutics’ financial statements as filed with SEDAR can be accessed from the Company’s website at: https://www.rakovinatherapeutics.com/corporate-profile/

About Rakovina Therapeutics Inc.

Rakovina Therapeutics is a biopharmaceutical research company focused on the development of innovative cancer treatments. Our work is based on unique technologies for targeting the DNA-damage response powered by Artificial Intelligence (AI) using the proprietary Deep-Docking™ and Enki™ platforms. By using AI, we can review and optimize drug candidates at a much greater pace than ever before.

The Company has established a pipeline of distinctive DNA-damage response inhibitors with the goal of advancing one or more drug candidates into human clinical trials in collaboration with pharmaceutical partners.

Further information may be found at www.rakovinatherapeutics.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

Notice Regarding Rakovina Therapeutics Forward-Looking Statements:

This release includes forward-looking statements regarding the company and its respective business, which may include, but is not limited to, statements with respect to the proposed business plan of the company and other statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans,” “is expected,” “expects,” “scheduled,” “intends,” “contemplates,” “anticipates,” “believes,” “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events, or results “may,” “could,” “would,” “might,” or “will” be taken, occur, or be achieved. Such statements are based on the current expectations of the management of the company. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the medical device industry, economic factors, regulatory factors, the equity markets generally, and risks associated with growth and competition.

Although the company has attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events, or results to differ from those anticipated, estimated, or intended. No forward-looking statement can be guaranteed, except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made, and the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. The reader is referred to the company’s most recent filings on SEDAR+ for a more complete discussion of all applicable risk factors and their potential effects, copies of which may be accessed through the company’s profile page at www.sedar.com.

For Further Information Contact:
Michelle Seltenrich, BSc, MBA
Director, Corporate Development
IR@rakovinatherapeutics.com
778-773-5432

NRG Therapeutics Announces Further Expansion with the Appointment of Paul Thompson as Chief Development Officer




NRG Therapeutics Announces Further Expansion with the Appointment of Paul Thompson as Chief Development Officer

STEVENAGE, United Kingdom, Dec. 01, 2025 (GLOBE NEWSWIRE) — NRG Therapeutics Ltd. (“NRG”), an innovative neuroscience company targeting a novel mechanism to address mitochondrial dysfunction, is pleased to announce expansion of its team with the appointment of Paul Thompson, PhD, as Chief Development Officer (CDO).

In his role at NRG, Paul will be project lead for NRG5051 which is on track to commence first-in-human studies in early 2026. NRG5051 is an oral, CNS-penetrant small molecule inhibitor of the mitochondrial permeability transition pore (mPTP) acting via a novel mechanism of action (MoA). Inhibition of the mPTP has been shown to be profoundly neuroprotective and significantly reduces neuroinflammation in pre-clinical models of amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND), and Parkinson’s. Paul will also take responsibility for all non-clinical development functions within NRG.

Paul brings over 25 years’ experience in translational research, early clinical development, and pharma R&D, with a focus predominantly on neurology. Most recently he was CSO at Mission Therapeutics for five years, responsible for delivery of clinical candidate USP30 inhibitors for renal and CNS disorders. Paul led the MTX325 USP30 inhibitor project into Phase 1 for Parkinson’s, part funded by the Michael J Fox Foundation and co-authored two manuscripts on mitochondrial dysfunction and Parkinson’s in Nature journals. Prior to Mission, he was Clinical Science Director at ONO Pharma UK, leading clinical development of multiple early phase assets across a variety of indications, and his earlier career in pharma was spent at GSK, where he transitioned from laboratory biomarker research, through experimental medicine study leadership, to leading global project teams as Director of Neurology Discovery Medicine.

Paul is currently an advisor for the Michael J Fox Foundation on its Targets to Translation programs and continues to advise neurology start-up companies in the UK. He holds an MBiochem from the University of Oxford and a PhD from UCL.

Paul’s appointment follows a number of other senior hires on the back of NRG’s £50m Series B financing bringing the team to 12 including the three founders. The new funds provide runway for completion of a Phase 2 clinical proof of concept study of NRG5051 in ALS MND, while also generating meaningful clinical data in Parkinson’s patients through a Phase 1b study.

Paul Thompson, CDO of NRG Therapeutics, said, “I am looking forward to working with the NRG Therapeutics team to drive forward NRG5051 as potentially the first disease-modifying therapeutic for sporadic ALS/MND and dementia indications such as Parkinson’s. Developing new drugs to treat neurological diseases is very challenging but I have been very encouraged by the compelling in vivo efficacy data for NRG5051 in rodent models of Parkinson’s and ALS/MND, that has validated the molecules’ novel MoA and demonstrated the therapeutic potential of NRG5051. I was also excited to see NRG5051 results in reduction in neurofilament light chain (NfL), the clinically validated fluid biomarker of neurodegeneration.”

NRG Therapeutics’ co-founder and CEO Neil Miller said, “Paul is a fantastic addition to the team, and I welcome him into NRG. His skills and expertise will enable us to efficiently progress NRG5051 through first-in-human clinical trials and into a PoC in ALS/MND, and to lay the ground for development in other indications including Parkinson’s. He joins at a pivotal time as we seek to demonstrate the therapeutic potential of NRG’s first-in-class mPTP inhibitors as disease modifying medicines for neurodegenerative diseases.”

Media enquiries (for NRG Therapeutics)
Sue Charles, Charles Consultants – +44 7968 726585 sue@charles-consultants.com

About NRG Therapeutics – https://www.nrgtherapeutics.com

NRG Therapeutics is a neuroscience drug discovery company building a pipeline of disease-modifying mitochondrial therapeutics to slow or halt the progression of neurodegenerative disorders such as Parkinson’s and amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND).

The company’s pre-clinical pipeline of small molecule assets is based on inhibiting the mitochondrial permeability transition pore (mPTP) through a novel mechanism of action. Inhibition of the mPTP has been shown to protect neurones, reduce neuroinflammation and improve motor function in pre-clinical disease models. Its lead asset, NRG5051, has completed IND-enabling studies and is on track to enter the clinic in early 2026.

Based at the Stevenage Bioscience Catalyst (SBC), UK, NRG Therapeutics is a private company with equity investment from Brandon Capital, British Business Bank, Criteria Bio Ventures, Dementia Discovery Fund, M Ventures, Novartis Venture Fund, Omega Funds and Parkinson’s UK. The company has also received awards from Innovate UK (Biomedical Catalyst Award), The Michael J. Fox Foundation, Target ALS and The ALS Association to support its innovative R&D programmes.

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Clue Unveils Our Year In Cycles: A Candid Look at How We Bled, Felt, Loved and Lived in 2025




Clue Unveils Our Year In Cycles: A Candid Look at How We Bled, Felt, Loved and Lived in 2025

• Exclusive cycle tracking data reveals 280 million days of bleeding were tracked across the globe in the last 12 months
• App users logged 34 million sex sessions and 4.4 million orgasms across 2025
• 44.6 million days of cramps were recorded, the equivalent of 122,000 years of pain if shouldered by one person
• Our Year in Cycles is an annual snapshot of hormones and health, with the aim of tackling taboo and stigma around the menstruation conversation

LONDON, Dec. 01, 2025 (GLOBE NEWSWIRE) — Clue, the #1 women-led period and cycle tracker trusted by over 100 million people worldwide, today releases Our Year In Cycles – an annual analysis of how women and people with cycles tracked their lives, bodies and emotions throughout 2025.

Based on hundreds of millions of anonymised logs made in the Clue app, this year’s edition breaks down the real rhythms behind our moods, cravings, orgasms, sleep (or lack of it), stress and the 280 million days we collectively spent bleeding – the equivalent of one person experiencing nearly 767,000 years of periods.

“Menstrual health affects over half the population, yet the cultural taboo around it has left generations without the knowledge or support they deserve,” commented Rhiannon White, CEO of Clue. “Our Year In Cycles reveals how profoundly our hormonal patterns intersect with our daily lives bringing what has been hidden into the light – not to sensationalise it, but to normalise it. By transforming millions of lived experiences into clear, accessible insights, Our Year In Cycles makes it possible for all of us to talk about hormones, pain, pleasure and wellbeing with the same openness we bring to other life topics.”

From the 280 million days of bleeding tracked, to the 44.6 million days of cramps logged, Our Year in Cycles demonstrates the world’s emotional and hormonal highs and lows through the bodies of millions of women and people with cycles.

Key Global Insights from Our Year In Cycles:

Ringing in the New Year with sex and fantasies

New Year’s Day came in hot – literally. It was the single most popular day of 2025 for high sex drive, sex, orgasms and fantasies, suggesting that Clue users kicked off the year with a surge of intimacy. Whether it’s the psychological clean-slate effect, post-party closeness or simply having a rare moment of rest and privacy, the data show that January 1st isn’t just for resolutions.

On the flip side, September 10th was reported as the year’s global ‘not tonight’ moment, as the day Clue tracked the lowest libido.

Gen Z leads the pleasure revolution

Half of all tracked orgasms in 2025 came from 18-24 year olds, establishing Gen Z as the most vocal generation when it comes to pleasure.

Gen Z also prove to be the masters of self-stimulation, accounting for more than half (58%) of all entries. In fact, Gen Z users tracked masturbation and fantasies at the highest rate, with masturbation being tracked 20% more often and fantasies 40% more often, by comparison to other age groups. Meanwhile, data show that millennials (25-34 year olds) lead the way with sex toy action.

The findings indicate that young adults are rewriting the script, turning pleasure stigma into pleasure literacy.

But pleasure isn’t logged as often as sex…

Clue users logged 34 million sex sessions and 4.4 million orgasms across 2025, highlighting that pleasure is still under-tracked and under-discussed compared with sex itself, revealing how deeply the pleasure gap is embedded in culture.

The Philippines topped the “most sex” and “most orgasms” lists, sparking new cultural questions about approaches to intimacy in different geographies.

Traditional period products still dominate despite growing appetite for reusable methods

Despite the hype around reusable period products, 2025 was still the year of the pad, used by nearly two-thirds of Clue users (63%), with tampons used by 14% comparatively. The data suggest that real-life period habits aren’t changing as fast as the headlines, with most people sticking with what feels safe, familiar and reliable. With rising concerns around tampon ingredients and contamination making global news, it’s clear that trust, not trends, is driving product choices and the shift toward reusables is more slow evolution than sudden revolution.

Period pain remains one of the most universal (and normalised) experiences

Clue users logged a staggering 44.6 million days of cramps, the equivalent of 122,000 years of pain if shouldered by one person. Cramps were the most common pain logged (35%), followed by breast tenderness (12%), lower back pain (11%) and headaches (10%). Almost one in five cramps (19%) were rated severe. The key takeaway? Menstrual pain isn’t minor. It’s massively under-recognised and it’s time the world treated it with the seriousness it deserves.

Hormones and days of the week shaped our emotional landscape – and unsurprisingly politics didn’t help…

Mood swings topped the charts over the past year, accounting for almost a fifth (17%) of all tracked feelings. The emotional peak of the year was revealed as 6th November 2024, when users worldwide recorded their saddest, angriest, and most stressed moods.

Weekly patterns painted a familiar yet striking picture: Mondays are (unsurprisingly) the gloomiest, Thursdays the most stressful, Saturdays the happiest, most energised and most creative, and Sundays the most popular day for sex. So much for a day of rest…

Sleep was scarce, with over a third waking up tired

Across millions of sleep logs, 38% recorded waking up tired, 15% struggled to fall asleep, 14% slept restlessly and 10% experienced vivid dreams – perhaps hormones, stress and modern life are a recipe for a global sleep deficit?

The good news? We’re proactive about our reproductive health

Nearly a quarter of a million OBGYN appointments were recorded throughout the year, with 18-34 year olds making up 84% of all appointments. Similarly, 18-34 year olds are 70% more likely to track STI check ups than other demographic groups – a strong sign that stigma is decreasing and sexual health checks are becoming more routine.

Dr Charis Chambers, The Period Doctor and Chief Medical Officer at Clue shared her view on the data: “When millions of people track their cycles, we gain a clearer picture of how hormones influence sleep, mood, energy, sex and pain. Our Year in Cycles isn’t just about periods, it’s about connecting the dots between our bodies and the experiences that are so often dismissed or stigmatised. Severe cramps, mood shifts, low energy, disrupted sleep are deeply common and valid. By representing real people with real data, we can help reduce shame and stigma around the menstrual health conversation.”

Clue’s data shows that cycles aren’t just about periods – they shape moods, sleep, cravings, intimacy, pain, and the rhythms of daily life. From the highs of orgasms and creativity to the lows of cramps and sleepless nights, the data turns millions of personal experiences into a collective story.

By making the invisible visible, Clue is helping to normalise conversation, break taboos, and empower women and people with cycles to understand, care for, and celebrate their bodies – every single day of the year.

Head to www.helloclue.com for more information and to download the app.

About Our Year In Cycles

Our Year In Cycles is an annual analysis including only aggregate data from Clue by Clue users over 18 years from October 2024 – October 2025.

About Clue
Clue is the #1 women-led period and cycle tracker, loved by over 100 million women and people with cycles around the world.

Beyond period tracking, Clue helps you turn your cycle into a powerful tool to help navigate your health journey by making sense of your hormones and discovering your unique patterns.

Whether you want to simply understand your cycle, try to conceive,
track your pregnancy, or navigate perimenopause, Clue is your intelligent, science-backed, data-driven health guide.

Join the movement that’s changing the future of female health, one data point at a time. Try Clue free, today.

Press
For more information about this particular press release, contact press@helloclue.com.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4533b819-ce29-4c61-8a67-132574b313bc