New Ebook Offers First-Time Biotech CEOs a Roadmap for the Decisions That Determine Company Success




New Ebook Offers First-Time Biotech CEOs a Roadmap for the Decisions That Determine Company Success

Produced by KreaMedica, in partnership with Venture Valuation and Lacerta Bio: three leading advisors to early-stage biotechs

MONTREAL, Dec. 17, 2025 (GLOBE NEWSWIRE) — Three of the biotech industry’s trusted advisory firms: KreaMedica, Venture Valuation, and Lacerta Bio, today announced the release of The First-Time Biotech CEO Playbook, a practical guide designed to help new biotech leaders avoid the predictable mistakes that derail early-stage companies.

Built from decades of combined experience working with founders, scientific leaders, investors, and global development teams, the Ebook distills the core decisions that define whether a biotech is destined for success or failure. While most first-time CEOs enter the role with strong scientific expertise, many are unprepared for the operational, financial, regulatory, and strategic decisions that ultimately determine whether their companies thrive or stall.

“Most biotech failures have little to do with the science,” said Karl-Rudolf (Rudi) Erlemann, President and CEO of KreaMedica. “They stem from avoidable decisions around hiring, funding strategy, timelines, communications, and partnerships. We built this resource to help new CEOs recognize these patterns early and navigate them with confidence.”

The playbook organizes insights across seven critical areas from building the right vision and narrative, to fundraising strategy, regulatory planning, preclinical development, and partnership decisions. Each chapter draws on the real-life experience of advisors who have supported hundreds of first-time CEOs through pivotal inflection points.

What the Playbook Covers

• Defining a compelling vision and corporate narrative
• Building purposeful networks and finding the right advisors
• Setting up early financial discipline and realistic runway planning
• Designing a practical fundraising strategy that investors respect
• Knowing when to partner, when to hold, and how to build leverage
• Aligning regulatory, preclinical, and CMC plans from day one
• Deciding what to keep in-house versus what to outsource

Whether spinning out from academia, launching from industry, or building a company around an acquired asset, new CEOs face a steep learning curve. This playbook was created to shorten it, and help founders make decisions that build resilient, investable, execution-ready companies.

The Ebook can be downloaded at: https://kreamedica.com/the-first-time-biotech-ceo-playbook/ 

About KreaMedica
KreaMedica is a collaborative drug development partner supporting biotech and pharma companies across regulatory strategy, clinical development, CMC, toxicology, and program leadership. With a seasoned global network of experts, KreaMedica helps early-stage companies de-risk development and accelerate progress toward value-creating milestones.

ARRIVE Marketing Strategies 
Kari Bennett
kari@arrivems.com
+1 720.236.7100

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BioNTX Celebrates 2025 Rising Stars Driving North Texas’ Life Science Innovation




BioNTX Celebrates 2025 Rising Stars Driving North Texas’ Life Science Innovation

Plano, Texas, Dec. 17, 2025 (GLOBE NEWSWIRE) — As 2025 comes to a close, BioNTX reflects on a year of innovation, growth, and achievement across North Texas’ life science ecosystem, highlighted by the accomplishments of the 2025 Rising Stars. These eight high-potential companies have demonstrated exceptional leadership and scientific innovation, earning recognition at BioNTX’s flagship iC³® Life Science & Healthcare Innovation Summit, culminating in the Rising Star Investor Dinner.

The Rising Stars program is a cornerstone BioNTX platform designed to elevate emerging companies by providing visibility, credibility, and direct access to investors, industry leaders, and strategic partners. More than an award, the program serves as a curated pathway that connects standout innovators to the region’s broader life science ecosystem.

The 2025 Rising Stars were first recognized on the main stage at iC³®, where they were introduced to an audience of investors, corporate leaders, researchers, and policymakers. That recognition was followed the Rising Star Investor Dinner—an intimate gathering bringing together current and past Rising Stars, and investors, for meaningful conversation, networking, and another opportunity to present their company.

“The Rising Stars program exemplifies the energy, creativity, and ambition that make our region a national leader in life sciences,” said Kathleen Otto-Rosenblum, CEO of BioNTX. “By connecting these innovators with investors and partners, we are not just recognizing their success—we are accelerating it. This platform is a catalyst for growth, collaboration, and real-world impact.”

A special thank-you goes to the evening’s fireside chat guests—Kristen Doyle, CEO of Cancer Prevention & Research Institute of Texas (CPRIT), and Eric Danielson, Managing Director and Head of Real Estate Development at NexPoint. Their insights and perspectives set a powerful tone for the event, underscoring the connectivity, shared purpose, and momentum that define North Texas’ life science ecosystem.

BioNTX also recognizes the generous support of its sponsors—Baker Tilly, Cowtown Angels, the Davis/Yost Group at Morgan Stanley, NexPoint, TechFW, and the Texas Research Quarter—whose commitment ensures that rising innovators across the region continue to be seen, supported, and elevated.

2025 BioNTX Rising Star Recipients

• EidoBio – advancing precision medicine tools to unlock new possibilities in diagnostics and treatment for women’s health
• Metaclipse Therapeutics – pioneering immune-based therapies for cancer and infectious diseases
• Moleculera Biosciences – leading the way in neuro-immune diagnostics to improve brain health and patient outcomes
• ParaNano Wound Care – developing next-generation antimicrobial nanotechnologies to fight infection and accelerate healing
• Stingray Therapeutics – driving innovation in oncology with novel approaches to modulating the immune system
• StitchLock – transforming surgical care with breakthrough wound closure technology
• SyntaxisBio – engineering advanced biologics and therapeutics with scalable, real-world applications
• Telos Biotech – redefining gene and cell therapy platforms with bold new approaches to delivery and safety

Through Rising Stars, BioNTX emphasizes investor exposure, ecosystem integration, and sustained engagement, ensuring companies are celebrated, supported, and positioned for growth. Participants gain access to curated introductions, high-profile platforms, and relationship-building opportunities that extend well beyond a single event.

BioNTX congratulates the 2025 Rising Stars and looks forward to supporting their continued growth and success in the year ahead.

About BioNTX

BioNTX is the bioscience and healthcare innovation trade organization serving the North Texas region. The organization fosters innovation and community through collaborative networking events, educational programming, professional development, market visibility, a purchasing consortium, and by being the voice for the North Texas biosciences and healthcare innovation community.

Media Contact:
Eric Moore
BioNTX
972.679.6056
emoore@biontx.org

OraSure Technologies Issues Statement Regarding Altai Capital’s Intent to Nominate Director Candidates




OraSure Technologies Issues Statement Regarding Altai Capital’s Intent to Nominate Director Candidates

No Shareholder Action Required at This Time

BETHLEHEM, Pa., Dec. 17, 2025 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (“OraSure” and “OTI”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today confirmed that Altai Capital (“Altai”) has notified the Company of its intent to nominate two candidates, including the fund’s founder, Rishi Bajaj, to stand for election to the Company’s Board of Directors (the “Board”) at its 2026 Annual Meeting of Stockholders.

The Company issued the following statement:

The OraSure Board and management team are committed to moving the Company forward with a clear focus on shareholder value creation. We maintain open and constructive dialogue with our shareholders, and members of OraSure’s Board have engaged extensively with Altai Capital in recent months, including evaluating Mr. Bajaj for potential service on the Board. Our Board ultimately determined not to appoint Mr. Bajaj to serve as a director at OraSure. Since that time, our Board has offered to make certain of our directors available to engage further, and Altai has not accepted our invitations.

OraSure maintains a strong, independent, and engaged Board. We continually assess our Board composition, and as a result our Board has undergone significant refreshment, bringing in industry perspectives and executive-level experience to provide oversight as management drives growth and value creation. Over the past three years, seven directors have departed the Board, and we have added three new, highly qualified independent directors, including the addition of accomplished healthcare investor Steven K. Boyd in October 2025. The Board also appointed John P. Kenny, who has served as a director since September 2024, as its Chair in October 2025.

OraSure is executing on a strategy to decentralize diagnostics by connecting people to healthcare wherever they are, and we are taking decisive steps to improve our performance, including:

• • Advancing our innovation roadmap to strengthen our portfolio and focus on high-growth opportunities across diagnostics and sample management solutions with a clear path to commercialization and revenue realization. Near-term milestones include anticipated FDA submissions for our Sherlock rapid molecular self-test for CT/NG¹ and Colli-Pee at-home urine collection device, as well as the launch of HEMAcollect PROTEIN blood collection tube for research use. 
  • Consolidating operations into our Pennsylvania footprint, insourcing manufacturing, and exiting unprofitable business lines to improve margins. 
  • Maintaining a healthy cash position with $216 million of cash on the balance sheet as of September 30, 2025, with no debt, and right sizing our cost structure to achieve sustainable profitability.

Reflecting our confidence in OraSure and its earnings potential as well as our ability to deliver value for all shareholders, earlier this year our Board began executing on a new $40 million share repurchase program. In addition, our Chief Executive Officer, Carrie Eglinton Manner, and Chief Financial Officer, Kenneth McGrath, adopted separate Rule 10b5-1 trading plans for purchases of the Company’s common stock.

We will continue to take actions that we believe are in the best interests of shareholders.

Upon receipt of any formal director nominations from Altai, the Nominating and Corporate Governance Committee and OraSure’s Board will review them and present the Board’s recommendations to shareholders in due course. OraSure shareholders are not required to take any action at this time.
        
Evercore is serving as financial advisor, Goodwin Procter LLP is serving as legal advisor, and Joele Frank, Wilkinson Brimmer Katcher is serving as strategic communications advisor to OraSure.

_____________________________

¹ Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG).

About OraSure Technologies, Inc. 
OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OTI improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OTI’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information, please visit www.orasure.com

Forward-Looking Statements

This press release contains certain forward-looking statements, including with respect to OraSure’s board of directors, OraSure’s business strategy, and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: our ability to satisfy customer demand; ability to reduce our spending rate, capitalize on manufacturing efficiencies and drive profitable growth; ability to market and sell our products and services, whether through our internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; significant customer concentrations that exist or may develop in the future; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; impact of replacing distributors; inventory levels at distributors and other customers; our ability to achieve its financial and strategic objectives and increase our revenues, including the ability to expand international sales and the ability to continue to reduce costs; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of our products and services; ability to achieve the anticipated benefits from the BioMedomics transaction; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to achieve and maintain sustained profitability; ability to increase our gross margins; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of our stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents, trade secrets and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms on international sales; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; cybersecurity incidents and other disruptions involving our computer systems or those of our third-party IT service providers, suppliers and customers; the impact of terrorist attacks, civil unrest, hostilities and war; and general political, business and economic conditions, including interest rates, inflationary pressures, capital market disruptions, changes in governmental agencies, international tariffs, trade protection measures, economic sanctions and economic slowdowns or recessions. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.

Important Additional Information

The OraSure intends to file a proxy statement and a white proxy card with the U.S. Securities and Exchange Commission (the “SEC”) in connection with its solicitation of proxies for the Company’s 2026 annual meeting of stockholders (the “Annual Meeting”).  STOCKHOLDERS OF THE COMPANY ARE STRONGLY ENCOURAGED TO READ SUCH PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO), THE ACCOMPANYING WHITE PROXY CARD AND ALL OTHER DOCUMENTS FILED WITH, OR FURNISHED TO, THE SEC IN CONNECTION WITH THE ANNUAL MEETING CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE ANNUAL MEETING. Stockholders will be able to obtain the Company’s proxy statement, any amendments or supplements to the proxy statement and other documents filed by the Company with the SEC at no charge at the SEC’s website at www.sec.gov. Copies will also be available at no charge at the Company’s website at https://orasure.gcs-web.com/financial-information/sec-filings.

Participant Information

The Company, each of its directors (Carrie Eglinton Manner (Chief Executive Officer), Nancy J. Gagliano, M.D., M.B.A., John P. Kenny, Lelio Marmora, Robert W. McMahon, David J. Shulkin, M.D. and Steven Kyle Boyd) and one of its executive officers in addition to Ms. Eglinton Manner (Kenneth J. McGrath, Chief Financial Officer) are deemed to be “participants” (as defined in Schedule 14A under the Securities Exchange Act of 1934, as amended) in the solicitation of proxies from the Company’s stockholders in connection with matters to be considered at the Annual Meeting. Information about the names of the Company’s directors and officers, their respective interests in the Company by security holdings or otherwise, and their respective compensation is set forth in the sections entitled “Executive Officers,” “Election of Directors,” “Compensation Discussion and Analysis,” and “Director Compensation,” and “Stock Ownership of Certain Beneficial Owners and Management” in the Company’s definitive proxy statement on Schedule 14A for the Company’s 2025 Annual Meeting of Stockholders, filed with the SEC on April 4, 2025 (available here). Supplemental information regarding the participants’ holdings of the Company’s securities can be found in SEC filings on Initial Statements of Beneficial Ownership of Securities on Form 3 or Statements of Change in Ownership on Form 4 filed with the SEC on March 27, 2025 for Mr. Kenny (available here); May 15, 2025 for, Mr. Shulkin (available here), Mr. Lelio (available here), Mr. McMahon (available here), Ms. Gagliano (available here), and Mr. Kenny (available here); June 5, 2025 for Ms. Eglinton Manner (available here); June 25, 2025 for Mr. Kenny (available here); August 4, 2025 for Mr. McMahon (available here); August 11, 2025 for Mr. McGrath (available here); September 26, 2025 for Mr. Kenny (available here); and December 2, 2025 for Mr. Boyd (available here and here) and Ms. Gagliano (available here). Such filings are also available on the Company’s website at https://orasure.gcs-web.com/financial-information/sec-filings. Updated information regarding the identity of participants, and their direct or indirect interests, by security holdings or otherwise, will be set forth in the Company’s proxy statement on Schedule 14A and other materials to be filed with the SEC in connection with the Annual Meeting.

DeLorean AI Releases New Cardiovascular AI White Paper Showing Predictive AI Can Prevent Heart Failure and Cut Costs by Up to $350,000 Per Patient




DeLorean AI Releases New Cardiovascular AI White Paper Showing Predictive AI Can Prevent Heart Failure and Cut Costs by Up to $350,000 Per Patient

Clinically validated platform delivers predictive precision, empowering clinicians with real-time visibility to reduce preventable complications and improve patient outcomes

PALM BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) — DeLorean AI has announced the release of a new white paper demonstrating that its Cardio AI platform can accurately identify patients at risk of progressing to heart failure before symptoms appear, giving providers a clinically validated tool to intervene earlier and improve outcomes. The analysis, drawn from 12 million patient records, shows DeLorean AI’s models achieve 87% sensitivity in predicting progression toward heart failure, offering payers and providers measurable outcomes that reduce avoidable care costs by as much as $250,000–$350,000 per patient annually.

“Value-based care is under enormous pressure right now, as we’ve seen with Optum renegotiating many of its contracts,” said Dr. Severence MacLaughlin, CEO and Founder of DeLorean AI. “If payers, providers, and even agencies like CMS and HHS had predictive visibility into patient deterioration before it happens, these payment structures wouldn’t break down. Predictive AI is the missing infrastructure that allows value-based care to actually work.”

Cardiovascular disease continues to drive the highest medical expenditures in the United States, costing $417.9 billion annually and contributing to more than 941,000 deaths each year. Heart failure alone can exceed $350,000 per patient in the year of diagnosis, despite being a condition with a predictable and preventable trajectory when proactive care is implemented.

DeLorean AI’s models analyze longitudinal EHR and claim data to deliver predictive precision that gives clinicians a clearer view of patient trajectories now and in the future. Findings from the white paper include:

1. Accurate identification of early deterioration from hypertension or ischemic heart disease toward heart failure with 87% sensitivity
2. Predictive insight into whether a patient’s condition will improve, worsen, or remain stable with 85–87% accuracy
3. Prediction of acute heart failure hospitalization up to 90 days in advance, supporting timely intervention
4. Provide Next Best Actions (NBAs) for licensed professionals to avert adverse events of patients predicted to have a cardiac event, keeping patients out of the hospital and decreasing costs

These clinically validated performance metrics equal or surpass those seen in peer-reviewed cardiovascular machine-learning studies, while leveraging a significantly larger dataset.

“Predictive and Interventive AI for prevention is now possible at scale,” said Dr. MacLaughlin. “By giving clinicians the power to see risk earlier and in the future, two weeks, four weeks and 8 weeks, we’re enabling hospitals to stay ahead of deterioration and provide care that’s more precise, proactive, and personalized.”

Cardio AI integrates with any EHR and keeps providers at the center of care. The platform:

1. Flags patients who may be progressing toward cardiac complications
2. Identifies deviations from ACC/AHA guideline-recommended therapies
3. Surfaces patient-specific next-best actions rooted in evidence-based medicine
4. Supports primary care physicians and cardiologists with intuitive, accessible intelligence

The white paper shows that predictive, preventative care delivers significant value for health systems, insurers, and patients. Managing individuals in pre-event stages such as hypertension (I-10) or chronic ischemic heart disease (I-25) reduces cardiac claims by $60,000–$70,000 per patient annually, while preventing heart failure altogether generates $250,000–$350,000 in savings per patient. With more than three million Americans at elevated risk, predictive intervention represents a pathway to billions in avoidable healthcare spending nationwide.

“Technology should amplify human expertise, not replace it,” said Dr. MacLaughlin. “Our platform gives clinicians the clarity and confidence to intervene earlier, reduce preventable complications, and drive better outcomes across entire populations.”

DeLorean AI’s approach centers on transparency, clinical validation, and ethical AI. The platform is built for real hospitals, real providers, and real patients, offering precision without overpromising and innovation grounded in medical science.

About DeLorean AI:

DeLorean AI is a Palm Beach-based healthtech company pioneering predictive artificial intelligence for chronic and acute disease detection. Founded by Dr. Severence MacLaughlin, DeLorean AI develops clinically validated tools that empower healthcare providers to identify at-risk patients earlier, recommend optimal interventions, and dramatically improve outcomes. The company’s platform focuses on key disease areas including cardiovascular disease, chronic kidney disease, end stage renal disease, cardiovascular disease diabetes, COPD, and depression. With seven patents in process and a proprietary model trained on over 80 million patient records, DeLorean AI delivers real-time risk stratification, suggested clinical actions, and future-state predictions, reducing costs and extending lives. As it expands from B2B partnerships to direct-to-patient engagement, DeLorean AI is redefining what’s possible in proactive, data-driven healthcare.

Media Contact:
Carolina Arguelles
inquiries@deloreanai.com

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Transparency Notification from Shareholders




Transparency Notification from Shareholders

Ghent, Belgium, Dec. 17, 2025 (GLOBE NEWSWIRE) — Transparency Notification from Shareholders
PRESS RELEASE
REGULATED INFORMATION

17 December 2025, 6:00 pm CET

Ghent, Belgium – 17 December 2025 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, announces today that it received transparency notifications in relation to the entities listed below, notifying the number of voting rights attached to the shares mentioned next to their name in the table below.

_____________
Notes:

            (1)   The total number of outstanding shares of the Company mentioned in the relevant transparency notification amounts to 71,289,225, each share giving right to one (1) vote (being 71,289,225 voting rights in total).
            (2)   On behalf of the parties mentioned in the table above, which are subject to the notification requirement, including BlackRock, Inc. (“BlackRock“) and Kreos Capital VII Aggregator ScSp (“Kreos Capital“), a parent undertaking or a controlling person informed the Company, by means of a notification dated 12 December 2025, that the shareholding of Kreos Capital (holding 2,985,668 shares and voting rights, which corresponds to 4.19% of the outstanding voting rights of the Company), crossed the threshold of 3% of the outstanding voting rights of the Company on 8 December 2025. The joint notification specifies furthermore that the full chain of controlled undertakings through which the holding is effectively held is as follows: (i) BlackRock, Inc.; (ii) BlackRock Saturn Subco, LLC; (iii) BlackRock Finance, Inc.; (iv) BlackRock Holdco 2, Inc.; (v) BlackRock Financial Management, Inc.; (vi) BlackRock International Holdings, Inc.; (vii) BR Jersey International Holdings L.P.; (viii) BlackRock Holdco 3, LLC; (ix) BlackRock Cayman 1 LP; (x) BlackRock Cayman West Bay Finco Limited; (xi) BlackRock Cayman West Bay IV Limited; (xii) BlackRock Finco UK Limited, (xiii) BlackRock Group Limited; (xiv) BlackRock Crane Limited; (xv) Kreos Capital Management Limited; (xvi) Kreos Capital Group VII Limited; (xvii) Kreos Capital Group VII LP; and (xviii) Kreos Capital VII Aggregator ScSp. The notification also states that the disclosure obligation arose due to the total holdings in voting rights for BlackRock going above 3% and that the voting rights attached to shares for BlackRock went above 3%.
            (3)   A parent undertaking or a controlling person of Société Fédérale de Participations et d’Investissement SA / Federale Participatie- en Investeringsmaatschappij NV (“SFPIM“), Belfius Banque SA (“Belfius Bank“) and Belfius Insurance SA (“Belfius Insurance“), informed the Company, by means of a notification dated 16 December 2025, that on 5 December 2025, the aggregate shareholding of SFPIM (holding 1,885,806 shares and voting rights, which corresponds to 2.65% of the outstanding voting rights of the Company) and Belfius Insurance (holding 1,399,328 shares and voting rights, which corresponds to 1.96% of the outstanding voting rights of the Company) crossed below the threshold of 5% of the outstanding voting rights of the Company and now stands at 4.61%. The joint notification specifies furthermore that SFPIM is the parent company of Belfius Bank (ex Dexia Banque SA), which in its turn is the parent company of Belfius Insurance. The notification also states that SFPI-FPIM acts in its own name, but on behalf of the Belgian State and that it is owned for 100% by the Belgian State.

This announcement is made in accordance with Article 14 of the Belgian Act of 2 May 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions.

To access a copy of the aforementioned transparency notification, reference is made to Sequana Medical’s website (https://www.sequanamedical.com/investors/shareholder-information/).

Pursuant to the Belgian Transparency Act and the articles of association of the Company, a notification to the Company and the Belgian Financial Services and Markets Authority (FSMA) is required by all natural and legal persons in each case where the percentage of voting rights attached to the securities held by such persons in the Company reaches, exceeds or falls below the threshold of 3%, 5%, 10%, and every subsequent multiple of 5%, of the total number of voting rights in the Company.

For more information, please contact:

Sequana Medical

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

About Sequana Medical

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

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

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

Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements³. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is dependent on securing additional financing.

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

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

The alfapump® System is currently not approved in Canada.

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

Note: alfapump® and DSR® are registered trademarks.

Forward-looking statements

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

¹ Alfapump system SSED (summary of safety and effectiveness) PMA 230044.
² As defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q).

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

Attachments

• Sequana Medical — Press Release (ENG) (17 December 2025)
• Sequana Medical — Press Release (NL) (17 December 2025)

Singlera Genomics announces research collaboration with the University of Pittsburgh to advance pancreatic cancer early detection




Singlera Genomics announces research collaboration with the University of Pittsburgh to advance pancreatic cancer early detection

LA JOLLA, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) — Singlera Genomics, a company focused on the application of novel DNA methylation technologies to genetic diagnosis, with their partner Breakthrough Genomics, a leader in the clinical analysis of genomic data and early cancer diagnostics, today announced a research collaboration with the University of Pittsburgh (Pitt) to advance the preclinical evaluation of Singlera and Breakthrough’s BT-Reveal™ Early Pancreatic Cancer Test.

This advanced blood test uses Singlera’s mTitan platform to screen circulating cell-free DNA for signals associated with cancer, often before symptoms appear. The patented DNA methylation technology behind the mTitan platform has previously been utilized to non-invasively detect methylation haplotypes from esophageal, colorectal, gastric, lung, liver, and pancreatic cancer; the BT-Reveal™ laboratory developed test received the FDA’s coveted Breakthrough Device Designation and is currently available for high-risk patients through Breakthrough Genomics which operates a CAP and CLIA-certified clinical lab in Southern California.

“We are excited to partner with the top pancreatic cancer researchers in the field to study the efficacy and impact of pancreatic cancer screening in high-risk populations,” said Qiang Liu, COO and co-founder of Singlera Genomics. “This preclinical study with Pitt is an important step towards a full large-scale FDA longitudinal study; we hope that the BT-Reveal test based on Singlera’s advanced methylation technology can give clinicians an important tool to allow faster screening and treatment of high-risk patients.”

November was Pancreatic Cancer Awareness Month, a time to recognize the multidisciplinary efforts working towards combatting this devastating disease. Singlera Genomics and Breakthrough Genomics are proud to contribute to the efforts of practitioners, scientists, and patient groups around the world in this important mission.

Singlera Genomics Inc. (www.singlera.com)

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

Media Contact
Alan Fung, Singlera Genomics
858.732.0061
alan.fung@singleragenomics.com

Zelluna Reaches Major Milestone and Submits Clinical Trial Application in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101), the World’s First MAGE-A4-Targeting TCR-NK Cell Therapy for Solid Tumours




Zelluna Reaches Major Milestone and Submits Clinical Trial Application in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101), the World’s First MAGE-A4-Targeting TCR-NK Cell Therapy for Solid Tumours

• On track for initial clinical data in mid-2026
• Marks a pivotal step toward scalable, accessible, off-the-shelf cell therapies for solid tumours

Oslo, Norway, 17 December 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic off-the-shelf cell therapies for cancer, today announced the submission of its Clinical Trial Application (CTA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1, the Company’s lead candidate.

The CTA submission marks Zelluna’s transition from preclinical to clinical development and represents the successful delivery of all key milestones communicated for 2025:

• Manufacturing process locked (April 2025)
• Preclinical data package completed and key data published (December 2025)
• GMP clinical batch produced and quality-tested (December 2025)
• Clinical Trial Application submitted to the UK MHRA (December 2025)

ZI-MA4-1 is a novel cell therapy that combines two powerful cancer fighting mechanisms: precise solid tumour targeting of T cell receptors (TCRs) with the potent and broad cancer killing ability of Natural Killer (NK) cells. ZI-MA4-1 targets MAGE-A4, a protein found in many solid cancers including lung, ovarian, head and neck and sarcomas.  

“Submitting our first CTA is a transformational moment for Zelluna,” said Namir Hassan, Chief Executive Officer of Zelluna. “ZI-MA4-1 will be the first MAGE-A4-targeting TCR-NK cell therapy to enter clinical testing globally and represents the culmination of rigorous scientific, non-clinical, CMC and regulatory work. Reaching this major milestone is a testament to the unwavering dedication and talent of the Zelluna team past and present, the guidance of our board, and the commitment of our investors. I am immensely proud of our team for delivering on the commitments we set out to achieve this year. We now enter the most important phase of our journey – demonstrating the potential of TCR-NK therapies for solid cancer patients.”

Zelluna’s CTA submission comes as off-the-shelf cell therapies are gaining significant traction across industry and investors, reflecting a broader shift toward scalable, accessible cell therapy solutions.  

The UK MHRA was selected for its strong track record in advanced therapy approvals and its collaborative early-phase regulatory pathways, providing an efficient and supportive environment for pioneering modalities such as TCR-NK therapies.

About the ZIMA-101 trial: 

The Phase I clinical trial will evaluate ZI-MA4-1 in patients with advanced solid tumours including ovarian cancer, head-and-neck cancer, squamous non-small-cell lung cancer, and synovial sarcoma. The study will assess safety, tolerability and early signs of efficacy with initial data expected mid-2026 (subject to regulatory approval).

The trial will be led by Prof. Fiona Thistlethwaite at The Christie NHS Foundation Trust (Manchester, UK) with participation from Dr. Andrew Furness at The Royal Marsden (London, UK), both world leading centres for oncology and early-phase cell therapy clinical research.

“This is an exciting moment, the submission of the CTA is a huge step towards bringing the ZIMA-101 study into the clinic, ” said Prof. Thistlethwaite, Medical Oncology Consultant within the Experimental Cancer Medicines Team, Clinical Lead for the Advanced Immunotherapy and Cell Therapy Team, The Christie, and Chief Investigator for the ZIMA-101 trial. “I am optimistic that combining the broad tumour-recognition and innate killing activity of NK cells with a tumour antigen directed TCR will provide us with the step-change that we need in the solid tumour setting to provide the required level of tumour potency whilst avoiding tumour escape.”

ZI-MA4-1 has broad intellectual property coverage, including a landmark granted patent providing dominant protection for Zelluna over the entire TCR-NK field.

About Zelluna ASA
Zelluna ASA (OSE: ZLNA) is a pioneering allogeneic ‘off-the-shelf’ T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of solid cancers. The company’s platform combines the innate killing power of NK cells with precise  solid tumour targeting of TCRs, designed to address the limitations of current cell therapies in solid tumours. The company’s lead candidate, ZI-MA4-1, is the worlds-first MAGE-A4 targeting TCR-NK therapy expected to enter clinical trials in 2026. Zelluna is headquartered at the Oslo Cancer Cluster innovation Park in Oslo, Norway and is listed on the Oslo Stock Exchange under the ticker ZLNA.

For further information, please contact:

Namir Hassan, CEO, Zelluna ASA
Email: namir.hassan@zelluna.com
Phone: +44 7720 687608

Anders Tuv, Chairman, Zelluna ASA
Email: at@radforsk.no
Phone: +47 982 06 826

International media:
Frazer Hall/Mark Swallow – MEDiSTRAVA
Email: zelluna@medistrava.com

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Geir Christian Melen, Finance Director of Zelluna ASA, on 17 December 2025 at 17.23 CET.

Peptinovo Biopharma in Collaboration with Chemelectiva Announces Breakthrough Manufacturing Innovation for Targeted Chemotherapy




Peptinovo Biopharma in Collaboration with Chemelectiva Announces Breakthrough Manufacturing Innovation for Targeted Chemotherapy

First-of-its-kind semi-synthetic vitamin E product enables scalable, FDA-compliant production of Peptinovo’s proprietary cancer prodrugs

ANN ARBOR, Mich., Dec. 17, 2025 (GLOBE NEWSWIRE) — Peptinovo Biopharma, an Ann Arbor–based biotechnology company pioneering targeted cancer therapies through its proprietary PALM™ nanotechnology, today announced a major manufacturing and intellectual property milestone achieved in collaboration with Chemelectiva S.r.l., an Italian specialty pharmaceutical chemistry company. The breakthrough significantly advances Peptinovo’s proprietary prodrug platform for targeted chemotherapy delivery.

Through the collaboration, Peptinovo and Chemelectiva developed and scaled a first-of-its-kind semi-synthetic vitamin E compound that is central to Peptinovo’s technology. The innovation enables FDA-compliant manufacturing at commercial scale, overcoming the limitations of naturally sourced materials and strengthening the platform’s path from clinical development to commercialization. Peptinovo is nearing clinical trials.

“This innovation began with a fundamental challenge,” said Steve Tokarz, CEO of Peptinovo Biopharma. “We needed a reliable, scalable way to manufacture a critical vitamin E–based linker at the heart of our prodrug platform. By creating this chemistry from the ground up with Chemelectiva, we unlocked a defensible, FDA-approvable process that meaningfully advances targeted chemotherapy delivery for patients.”

Placing Peptinovo in the Evolution of Targeted Chemotherapy

Over the past decade, antibody-drug conjugates (ADCs) have represented a major advance in cancer treatment by attaching potent chemotherapy agents to antibodies that recognize specific tumor markers. While ADCs have improved targeting for certain cancers, their complexity, manufacturing challenges, and dependence on specific antigens limit their applicability across tumor types.

Peptinovo’s approach builds on the same goal – delivering chemotherapy more precisely – while using a non-antibody, small-molecule prodrug strategy designed for broader applicability and scalable manufacturing.

A prodrug is an inactive or less active compound that the body converts into its active drug form through metabolic processes. Peptinovo’s platform uses a vitamin E–based linker to temporarily deactivate standard chemotherapeutic agents, allowing them to circulate safely until they reach cancer cells, where the drug is reactivated once inside the cell. This approach preserves therapeutic efficacy while reducing or eliminating many of the side effects associated with conventional chemotherapy.

Unlike antibody-drug conjugates, Peptinovo’s linker chemistry is a simple chemical construct using a single carbon and a single oxygen bond which can be applied to more than 60% of known chemotherapeutic agents as well as new chemotherapies that were once too toxic for patient treatment – significantly expanding its potential across cancer types and indications.

The breakthrough was made possible by Chemelectiva’s development of a novel, patented synthetic route for the vitamin E compound, chemistry that did not previously exist at pharmaceutical manufacturing scale.

“No one had successfully developed a semi-synthetic version of this compound suitable for pharmaceutical production,” Chemelectiva Founder and CEO Graziano Castaldi said. “We designed and patented new synthesis pathways that allow Peptinovo to access this critical molecule at the quality, scale, and cost required for clinical and future commercial use.”

The collaboration, which began in 2021, resulted in patented manufacturing technologies that now form a core component of Peptinovo’s intellectual property portfolio and support both current clinical programs and future pipeline expansion.

“Innovation doesn’t stop at discovery,” Glenn Meyer, Peptinovo Head of Product Development, said. “Manufacturability, scalability, and intellectual property are essential to translating science into real-world impact. This milestone strengthens Peptinovo’s platform and accelerates our ability to deliver better cancer treatments to patients.”

About Peptinovo Biopharma

Peptinovo Biopharma is a privately held biotechnology company based in Ann Arbor, Michigan, developing next-generation targeted nanomedicines to enhance the treatment of cancer. Its proprietary PALM™ technology delivers proven chemotherapies directly to tumors while reducing toxicity to healthy tissues, aiming to improve outcomes and quality of life for patients. The company has raised $16.8M to date and is raising additional funds in its current Series A round to expand development of its platform. Peptinovo is reaching a significant inflection point at a very attractive valuation. For more information, go to the company’s Reg CF investor portal. For more information, visit www.peptinovo.com.

Peptinovo Investor Relations Contact
Steve Tokarz
steve.tokarz@peptinovo.com

Peptinovo Media Contact
Katie Merx
katiemerx@gmail.com
+1 313.510.5090

Transparency Notification from Shareholders




Transparency Notification from Shareholders

Ghent, Belgium, Dec. 17, 2025 (GLOBE NEWSWIRE) — Transparency Notification from Shareholders
PRESS RELEASE
REGULATED INFORMATION

17 December 2025, 6:00 pm CET

Ghent, Belgium – 17 December 2025 – Sequana Medical NV (Euronext Brussels: SEQUA) (the “Company” or “Sequana Medical“), a pioneer in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, announces today that it received transparency notifications in relation to the entities listed below, notifying the number of voting rights attached to the shares mentioned next to their name in the table below.

_____________
Notes:

            (1)   The total number of outstanding shares of the Company mentioned in the relevant transparency notification amounts to 71,289,225, each share giving right to one (1) vote (being 71,289,225 voting rights in total).
            (2)   On behalf of the parties mentioned in the table above, which are subject to the notification requirement, including BlackRock, Inc. (“BlackRock“) and Kreos Capital VII Aggregator ScSp (“Kreos Capital“), a parent undertaking or a controlling person informed the Company, by means of a notification dated 12 December 2025, that the shareholding of Kreos Capital (holding 2,985,668 shares and voting rights, which corresponds to 4.19% of the outstanding voting rights of the Company), crossed the threshold of 3% of the outstanding voting rights of the Company on 8 December 2025. The joint notification specifies furthermore that the full chain of controlled undertakings through which the holding is effectively held is as follows: (i) BlackRock, Inc.; (ii) BlackRock Saturn Subco, LLC; (iii) BlackRock Finance, Inc.; (iv) BlackRock Holdco 2, Inc.; (v) BlackRock Financial Management, Inc.; (vi) BlackRock International Holdings, Inc.; (vii) BR Jersey International Holdings L.P.; (viii) BlackRock Holdco 3, LLC; (ix) BlackRock Cayman 1 LP; (x) BlackRock Cayman West Bay Finco Limited; (xi) BlackRock Cayman West Bay IV Limited; (xii) BlackRock Finco UK Limited, (xiii) BlackRock Group Limited; (xiv) BlackRock Crane Limited; (xv) Kreos Capital Management Limited; (xvi) Kreos Capital Group VII Limited; (xvii) Kreos Capital Group VII LP; and (xviii) Kreos Capital VII Aggregator ScSp. The notification also states that the disclosure obligation arose due to the total holdings in voting rights for BlackRock going above 3% and that the voting rights attached to shares for BlackRock went above 3%.
            (3)   A parent undertaking or a controlling person of Société Fédérale de Participations et d’Investissement SA / Federale Participatie- en Investeringsmaatschappij NV (“SFPIM“), Belfius Banque SA (“Belfius Bank“) and Belfius Insurance SA (“Belfius Insurance“), informed the Company, by means of a notification dated 16 December 2025, that on 5 December 2025, the aggregate shareholding of SFPIM (holding 1,885,806 shares and voting rights, which corresponds to 2.65% of the outstanding voting rights of the Company) and Belfius Insurance (holding 1,399,328 shares and voting rights, which corresponds to 1.96% of the outstanding voting rights of the Company) crossed below the threshold of 5% of the outstanding voting rights of the Company and now stands at 4.61%. The joint notification specifies furthermore that SFPIM is the parent company of Belfius Bank (ex Dexia Banque SA), which in its turn is the parent company of Belfius Insurance. The notification also states that SFPI-FPIM acts in its own name, but on behalf of the Belgian State and that it is owned for 100% by the Belgian State.

This announcement is made in accordance with Article 14 of the Belgian Act of 2 May 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions.

To access a copy of the aforementioned transparency notification, reference is made to Sequana Medical’s website (https://www.sequanamedical.com/investors/shareholder-information/).

Pursuant to the Belgian Transparency Act and the articles of association of the Company, a notification to the Company and the Belgian Financial Services and Markets Authority (FSMA) is required by all natural and legal persons in each case where the percentage of voting rights attached to the securities held by such persons in the Company reaches, exceeds or falls below the threshold of 3%, 5%, 10%, and every subsequent multiple of 5%, of the total number of voting rights in the Company.

For more information, please contact:

Sequana Medical

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

About Sequana Medical

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

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

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

Results of the Company’s RED DESERT and SAHARA proof-of-concept studies in heart failure published in European Journal of Heart Failure in April 2024 support DSR’s mechanism of action as breaking the vicious cycle of cardiorenal syndrome. All three patients from the non-randomized cohort of MOJAVE, a US randomized controlled multi-center Phase 1/2a clinical study, have been successfully treated with DSR, resulting in a dramatic improvement in diuretic response and virtual elimination of loop diuretic requirements³. The independent Data Safety Monitoring Board approved the start of the randomized MOJAVE cohort of up to a further 30 patients, which is dependent on securing additional financing.

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

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

The alfapump® System is currently not approved in Canada.

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

Note: alfapump® and DSR® are registered trademarks.

Forward-looking statements

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

¹ Alfapump system SSED (summary of safety and effectiveness) PMA 230044.
² As defined by subjective physical health (assessed by SF-36 PCS) and ascites symptoms (assessed by Ascites Q).

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

Attachments

• Sequana Medical — Press Release (ENG) (17 December 2025)
• Sequana Medical — Press Release (NL) (17 December 2025)

Singlera Genomics announces research collaboration with the University of Pittsburgh to advance pancreatic cancer early detection




Singlera Genomics announces research collaboration with the University of Pittsburgh to advance pancreatic cancer early detection

LA JOLLA, Calif., Dec. 17, 2025 (GLOBE NEWSWIRE) — Singlera Genomics, a company focused on the application of novel DNA methylation technologies to genetic diagnosis, with their partner Breakthrough Genomics, a leader in the clinical analysis of genomic data and early cancer diagnostics, today announced a research collaboration with the University of Pittsburgh (Pitt) to advance the preclinical evaluation of Singlera and Breakthrough’s BT-Reveal™ Early Pancreatic Cancer Test.

This advanced blood test uses Singlera’s mTitan platform to screen circulating cell-free DNA for signals associated with cancer, often before symptoms appear. The patented DNA methylation technology behind the mTitan platform has previously been utilized to non-invasively detect methylation haplotypes from esophageal, colorectal, gastric, lung, liver, and pancreatic cancer; the BT-Reveal™ laboratory developed test received the FDA’s coveted Breakthrough Device Designation and is currently available for high-risk patients through Breakthrough Genomics which operates a CAP and CLIA-certified clinical lab in Southern California.

“We are excited to partner with the top pancreatic cancer researchers in the field to study the efficacy and impact of pancreatic cancer screening in high-risk populations,” said Qiang Liu, COO and co-founder of Singlera Genomics. “This preclinical study with Pitt is an important step towards a full large-scale FDA longitudinal study; we hope that the BT-Reveal test based on Singlera’s advanced methylation technology can give clinicians an important tool to allow faster screening and treatment of high-risk patients.”

November was Pancreatic Cancer Awareness Month, a time to recognize the multidisciplinary efforts working towards combatting this devastating disease. Singlera Genomics and Breakthrough Genomics are proud to contribute to the efforts of practitioners, scientists, and patient groups around the world in this important mission.

Singlera Genomics Inc. (www.singlera.com)

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

Media Contact
Alan Fung, Singlera Genomics
858.732.0061
alan.fung@singleragenomics.com