PolyPid to Present Its Positive Phase 3 SHIELD II Topline Results at the 2025 American College of Surgeons Clinical Congress

PolyPid to Present Its Positive Phase 3 SHIELD II Topline Results at the 2025 American College of Surgeons Clinical Congress




PolyPid to Present Its Positive Phase 3 SHIELD II Topline Results at the 2025 American College of Surgeons Clinical Congress

The Company will present the reported topline results from its phase 3 SHIELD II trial at one of the world’s leading surgical conferences

PETACH TIKVA, Israel, Sept. 30, 2025 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that Dr. Shmuel Sharoni will present the topline results from the Company’s successful Phase 3 SHIELD II trial of D-PLEX₁₀₀ at the upcoming 2025 American College of Surgeons (ACS) Clinical Congress in Chicago, IL.

Dr. Shmuel Sharoni will deliver a presentation titled “Efficacy Of A Novel Local Prolonged-release Incisional Doxycycline On Surgical Site Infection Prophylaxis In Abdominal Colorectal Surgery: The Shield II Phase 3 Randomized Clinical Trial,” during the high-impact clinical trials session on Sunday, October 5, 2025, at 11:30 AM CT.

Conference Details:

  • 2025 ACS Clinical Congress; October 4–7, McCormick Place, Chicago, IL
  • Presentation Date: Sunday, October 5, 2025, at 11:30 AM CT
  • Session: SF109 “High Impact Clinical Trials and Studies”

The PolyPid management team will be available for meetings during the conference. For more information or to schedule a meeting, please contact IR@Polypid.com.

About SHIELD II

The SHIELD II Phase 3 trial was a prospective, multinational, randomized, double-blind study that successfully met its primary and all key secondary efficacy endpoints. The trial demonstrated that D-PLEX₁₀₀, when administered alongside standard of care, achieved a 38% reduction (p<0.005) in the combined endpoint of surgical site infections, reinterventions, or mortality compared to standard of care alone. Additionally, the trial showed a 58% reduction (p<0.005) in the rate of surgical site infections in the D-PLEX₁₀₀ treatment arm.

About PolyPid
PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. Following positive phase 3 results, New Drug Application (NDA) submission of D-PLEX₁₀₀, PolyPid’s lead product candidate, for the prevention of abdominal colorectal surgical site infections, is expected in early 2026. In addition, the Company has an innovative pipeline in oncology, obesity and diabetes.

For additional Company information, please visit http://www.polypid.com and follow us on Twitter (X) and LinkedIn.

Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the presentation of SHIELD II trial results at the upcoming conference, the planned NDA submission for D-PLEX₁₀₀ and timing thereof. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed on February 26, 2025. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. PolyPid is not responsible for the contents of third-party websites.

Company Contact:
PolyPid Ltd. 
Ori Warshavsky
908-858-5995
IR@Polypid.com

Investor Relations Contact:
Arx Investor Relations
North American Equities Desk
polypid@arxhq.com

Viromed Medical AG launches in vivo and ex vivo study with cold plasma on living lungs

Viromed Medical AG

/ Key word(s): Miscellaneous

Viromed Medical AG launches in vivo and ex vivo study with cold plasma on living lungs

30.09.2025 / 11:47 CET/CEST

The issuer is solely responsible for the content of this announcement.


PRESS RELEASE

Viromed Medical AG launches in vivo and ex vivo study with cold plasma on living lungs

Rellingen, September 30, 2025 – Viromed Medical AG (“Viromed”; ISIN: DE000A3MQR65), a medical technology company and pioneer of cold plasma technology, announces the start of a comprehensive in vivo and ex vivo study on living lungs. The in vivo and ex vivo tests are part of the ongoing study on the treatment of ventilator-associated pneumonia (VAP) using cold atmospheric plasma and are being conducted in collaboration with Hannover Medical School (MHH).

Prof. Dr. Hortense Slevogt, scientific director of the study at Hannover Medical School, emphasizes: “The results so far are groundbreaking. If the use of cold atmospheric plasma also proves safe in living lung tissue, it could potentially revolutionize the treatment of ventilated patients.”

Uwe Perbandt, CEO of Viromed Medical AG, explains: “Our study is the first of its kind and is one of the most comprehensive in the field of pulmonology worldwide. This gives us a significant competitive advantage. Our goal is to use cold plasma therapy to significantly reduce mortality from VAP and all bacterial or viral lung infections worldwide.“

Building on promising in vitro results, which showed 100% effectiveness of cold plasma technology against MRSA without damaging human lung tissue, the study is now entering its decisive next phase. For the first time, the interaction between the respiratory epithelium, bacterial infection, and cold plasma therapy will be investigated under realistic conditions—Viromed is thus closing a significant gap in international medical research.

The detailed results of the in vivo and ex vivo study will be published in a fast-track paper.

Viromed Medical AG is a pioneer in the field of cold plasma technology. With proprietary technologies, globally unique cell culture models, and close collaboration with leading university centers and research institutes, the company has a significant research and development advantage over its competitors.

 

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

Contact Viromed

E-Mail: kontakt@viromed-medical.de
 

Press contact

E-mail: viromed@kirchhoff.de


30.09.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.eqs-news.com


Language: English
Company: Viromed Medical AG
Hauptstraße 105
25462 Rellingen
Germany
E-mail: kontakt@viromed-medical.de
Internet: https://www.viromed-medical-ag.de/
ISIN: DE000A3MQR65
WKN: A3MQR6
Listed: Regulated Unofficial Market in Berlin, Dusseldorf, Frankfurt, Hamburg, Tradegate Exchange
EQS News ID: 2205908

 
End of News EQS News Service

2205908  30.09.2025 CET/CEST

VectorBuilder Wins Two IMAPAC Awards, Cementing Leadership in Gene Therapy and CDMO Innovation

VectorBuilder Wins Two IMAPAC Awards, Cementing Leadership in Gene Therapy and CDMO Innovation




VectorBuilder Wins Two IMAPAC Awards, Cementing Leadership in Gene Therapy and CDMO Innovation

CHICAGO–(BUSINESS WIRE)–#BioTechNewsVectorBuilder, a global leader in the gene delivery space, has won two prestigious awards at the Asia-Pacific Cell and Gene Therapy Excellence Awards 2025 (APCGTEA) and the Asia-Pacific Biologics CDMO Excellence Awards 2025 (APBCEA), hosted by IMAPAC.


  • Best Cell & Gene Therapy Supplier Award – AAV Vector Manufacturing
  • Best Gene Therapy CDMO – Asia-Pacific

VectorBuilder pioneers cutting-edge innovation for AAV gene delivery, with a one-stop solution supporting programs from research to early discovery to clinical development. Its proprietary technology platforms have enabled robust production of tens of thousands of custom AAV vectors for researchers and drug developers worldwide. Leveraging its expansive suite of AAV preclinical services, including a comprehensive capsid evolution platform, biodistribution profiling, and the bespoke cliniVecTM consultation service, VectorBuilder empowers its partners to accelerate and streamline their cell and gene therapy development. The company’s innovative AAV IP portfolio features novel AAV capsids, miniVecTM and MuteFreeTM AAV backbones, and novel promoters, positioning VectorBuilder at the forefront of next-generation AAV innovations.

Offering a variety of systems that meet diverse needs, VectorBuilder is a full-service CDMO offering end-to-end solutions from development to production, having developed extensive expertise in process and analytical development for the manufacturing of GMP-grade gene therapy vectors. Operating several state-of-the-art facilities, VectorBuilder has supported many customers with the GMP manufacturing of plasmid DNA, viral vectors, IVT RNA, and LNP encapsulation. The highly experienced team has successfully provided plasmids, lentiviral vectors, and AAV vectors for their customers’ IND and IIT studies in the US and Asia. These recognitions add to a growing list of accolades for VectorBuilder, including the Bio-Industrial Innovation of the Year Award from BioTech Breakthrough (November 2024) and the CDMO Leadership Award from Outsourced Pharma and Life Science Connect (May 2025). Together, these honors reinforce VectorBuilder’s impact on the global CGT industry.

“We are honored to receive two IMAPAC awards at the same time, affirming the value of our commitment to innovation,” said Dr. Bruce Lahn, founder and Chief Scientist of VectorBuilder. “We will continue to advance gene delivery technologies and collaborate globally to enable breakthrough therapies and contribute to better human health.”

For more information, please visit www.vectorbuilder.com.

About VectorBuilder

VectorBuilder is a global leader in gene delivery technologies. As a trusted partner in thousands of labs and biotech/pharma companies around the world, VectorBuilder is a one-stop shop for the design, development, and optimization of gene delivery solutions from basic research to clinical applications. Its award-winning Vector Design Studio is a transformative innovation that allows researchers to easily design and order custom vectors online, freeing them from the tedious work of cloning and packaging vectors in the lab. The global company boasts high-throughput vector production capacity, vast vector and component inventories, one-on-one CRO solutions that include advanced AAV capsid engineering capabilities, and state-of-the-art GMP manufacturing facilities. With leading R&D and CDMO capacity, the VectorBuilder team strives to provide the most effective gene delivery solutions and develop new innovative tools for life sciences research and genetic medicine.

Contacts

Media Inquiries
Sarah Shkargi

sarah@tnsmediacomms.com

Dogecoin Cash Inc. (OTCQB:DOGP) Announces Special Distribution of DogeCoin Cash (MEMECOIN:DOG) to Shareholders

Dogecoin Cash Inc. (OTCQB:DOGP) Announces Special Distribution of DogeCoin Cash (MEMECOIN:DOG) to Shareholders




Dogecoin Cash Inc. (OTCQB:DOGP) Announces Special Distribution of DogeCoin Cash (MEMECOIN:DOG) to Shareholders

MESQUITE, NV, Sept. 30, 2025 (GLOBE NEWSWIRE) —

Mesquite, NV  — Dogecoin Cash Inc. (OTCQB:DOGP) today announced that its Board of Directors has approved a special distribution of DogeCoin Cash (MEMECOIN:DOG) to shareholders of record as of December 15, 2025. The pro rata distribution will be payable on December 22, 2025.

Each shareholder of record will receive one DogeCoin Cash (MEMECOIN:DOG) for every share of Dogecoin Cash Inc. (OTCQB:DOGP) common stock held. In total, approximately 150 million DogeCoin Cash (MEMECOIN:DOG) will be distributed.

The distribution will be affected through certificates with assigned CUSIPs or equivalent book-entry positions, which shareholders may redeem through the Company’s wholly owned subsidiary, DogeSPAC LLC. Shareholders who wish to redeem will be able to do so by following instructions provided separately by the Company.

“This special distribution underscores our commitment to delivering value directly to our shareholders,” said David Tobias, CEO of Dogecoin Cash Inc. “By structuring this as a direct allocation, every shareholder has the opportunity to benefit equally.”

Additional details, including redemption instructions and FAQs, will be provided to shareholders prior to the payment date and will be available on the Company’s investor relations website. No immediate action is required by shareholders in connection with this corporate action. Shareholders will only be required to take further steps if and when they choose to redeem their certificates into digital assets, and only after payment or consideration, if applicable, has been received. Any such redemption is voluntary, subject to applicable terms and conditions, and may involve additional risks and requirements. Additional details, including redemption instructions and FAQs, will be provided to shareholders prior to the payment date and will be available on the Company’s investor relations website.

In recent years, meme coins have evolved from novelty tokens into a recognized segment of the digital asset market. Industry reports suggest that the total meme coin market capitalization recently surpassed approximately USD 77 billion, representing a measurable portion of the broader crypto sector.

Some market research indicates that the meme coin market could grow from about USD 68.5 billion in 2024 to as much as USD 925.2 billion by 2035, which would imply a compounded annual growth rate (CAGR) of roughly 26.7%. Other analyses suggest that the global meme-coin development market (the sector focused on building, launching, and supporting meme coins) could expand from about USD 40 million in 2024 to nearly USD 296 million by 2031 (CAGR ~27.8%).

These projections are inherently uncertain and depend on multiple factors such as digital-asset adoption, regulatory frameworks, and investor sentiment. Meme coins and other digital assets remain highly speculative, involve substantial risks, and may lose significant value. Nonetheless, increased trading activity, social-media engagement, and the rise of meme coin launch platforms reflect growing interest from segments of the digital-finance community.

About Dogecoin Cash, Inc. (OTCQB: DOGP)

Dogecoin Cash Inc. (OTCQB: DOGP) is a publicly traded company that owns and operates PrestoDoctor, (www.prestodoctor.com), a trusted leader in medical cannabis telemedicine. DOGP also focuses on blockchain innovation and developing blockchain-based infrastructure and digital asset initiatives. Its subsidiary, MEME Coins Inc., currently holds DOG tokens as its sole digital asset and is  an emerging platform focused on meme based cryptocurrency innovation, token utility, and social crypto applications. DOGP holds the first patented cannabis strain, Ecuadorian Sativa aka “CTA”, and a patented cannabis lozenge for treatment of hypertension 
Investor & Media Contact
Dogecoin Cash, Inc.
Info@dogecoincashinc.com

Forward-Looking Statements Disclaimer

This communication may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements are based on current expectations, estimates, forecasts, and assumptions, and involve risks and uncertainties that could cause actual outcomes to differ materially from those anticipated. Words such as “may,” “could,” “expect,” “anticipate,” “project,” “estimate,” “believe,” “intend,” “forecast,” or similar expressions are intended to identify forward-looking statements.

These statements are not guarantees of future performance and are subject to risks and uncertainties, including but not limited to regulatory developments, market volatility, adoption trends, technological changes, and other factors beyond the Company’s control. Investors should not place undue reliance on forward-looking statements, which speak only as of the date made. The Company undertakes no obligation to update or revise forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Upstream Bio Presents Data Showing Structural and Mechanistic Drivers of Verekitug’s Potent Pharmacodynamic Activity and Differentiated Clinical Profile at European Respiratory Society Congress

Upstream Bio Presents Data Showing Structural and Mechanistic Drivers of Verekitug’s Potent Pharmacodynamic Activity and Differentiated Clinical Profile at European Respiratory Society Congress




Upstream Bio Presents Data Showing Structural and Mechanistic Drivers of Verekitug’s Potent Pharmacodynamic Activity and Differentiated Clinical Profile at European Respiratory Society Congress

– Data show verekitug prevents TSLP binding to the TSLP receptor by occupying ligand binding sites –

– Additionally, findings show that verekitug outcompetes TSLP in the presence of preformed heterodimeric receptor complexes –

– Data support the potential of verekitug’s unique mechanism of action to achieve a differentiated therapeutic effect across a broad range of TSLP-driven severe respiratory diseases –

WALTHAM, Mass., Sept. 30, 2025 (GLOBE NEWSWIRE) — Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today presented structural and mechanistic data showing verekitug’s potent pharmacodynamic activity through its unique approach of targeting the thymic stromal lymphopoietin (TSLP) receptor. Data were presented at the European Respiratory Society (ERS) Congress being held September 27 – October 1, 2025, in Amsterdam, Netherlands.

“We continue to deepen our understanding of verekitug’s unique TSLP receptor-targeting mechanism and its role in driving the rapid and durable effects that have been demonstrated to date,” said Aaron Deykin, MD, Chief Medical Officer and Head of R&D of Upstream Bio. “In the clinic, we are also now beginning to see that the potency driven by this mechanism of action can translate into a differentiated clinical profile with our recently reported Phase 2 top-line clinical data in patients with chronic rhinosinusitis with nasal polyps where verekitug delivered statistically significant and clinically meaningful effects on multiple endpoints when administered only once every 12 weeks. We look forward to continuing to build the clinical dataset for verekitug with Phase 2 top-line data in severe asthma anticipated in the first quarter of 2026.”

Preclinical and clinical data to date demonstrate verekitug’s highly potent inhibition of the TSLP receptor. In clinical trials, verekitug has demonstrated rapid, substantial, and sustained TSLP receptor inhibition for up to 24 weeks after the last dose. This unique mechanism of action may translate to a differentiated clinical profile with less frequent dosing as compared to currently approved biologic therapies.

Mechanistic studies were performed to elucidate drivers of this high magnitude of effect seen with verekitug’s TSLP receptor inhibition. Data presented are summarized as follows:

  • With high affinity binding (KD < 1 pM) to the TSLP receptor, verekitug outcompetes TSLP binding to the TSLP receptor even in the presence of preformed heterodimeric receptor complexes, inhibiting TSLP:TSLP receptor interaction.
  • The high-resolution crystal structure reveals that verekitug binds and occupies most of the TSLP binding sites on the TSLP receptor.
  • Semi-mechanistic pharmacokinetic/pharmacodynamic (PK/PD) models indicate that lower abundance and slower turnover of the TSLP receptor compared to the TSLP ligand may drive the greater potency of verekitug, observed in vitro and across clinical datasets, compared to published data for tezepelumab.
  • These findings provide a mechanistic explanation for the empirically observed greater potency of targeting the TSLP receptor with verekitug as compared with targeting the TSLP ligand.

A digital version of the presentation can be found on the Publications section of the Upstream Bio website.

About TSLP and TSLP Receptor Blockade
Thymic stromal lymphopoietin (TSLP) is a cytokine that is a key driver of the inflammatory response in major allergic and inflammatory diseases, such as asthma, where disruption of TSLP signaling has been clinically validated as an effective therapeutic strategy.

TSLP activation is one of the first events in the inflammatory cascade stimulated by allergens, viruses and other triggers, initiating the activation of downstream targets such as IL-4, IL-5, IL-13, IL-17 and IgE. Because TSLP is a target upstream in the inflammatory cascade, blocking the TSLP receptor presents an opportunity for a single treatment to impact the drivers of multiple pathological inflammatory processes across a broad set of diseases.

About Verekitug
Verekitug is a novel recombinant fully human immunoglobulin G1 (IgG1) monoclonal antibody that binds to the TSLP receptor and inhibits proinflammatory signaling initiated by TSLP. It is the only known monoclonal antibody currently in clinical development that targets and inhibits the TSLP receptor. Verekitug has advanced into three separate global, placebo-controlled, randomized Phase 2 clinical trials including the recently completed VIBRANT trial (NCT06164704) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), which demonstrated that verekitug, dosed at 100 mg once every 12 weeks, met both the primary and secondary endpoints at Week 24 and was generally well tolerated. Two additional ongoing clinical trials include the VALIANT trial (NCT06196879) in patients with severe asthma and the VENTURE trial (NCT06981078) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Additionally, in May 2025, Upstream Bio initiated the VALOUR trial (NCT06966479), a long-term extension study in eligible participants with severe asthma who completed the VALIANT Phase 2 clinical trial.

In preclinical studies, verekitug demonstrated high occupancy of the TSLP receptor and potent inhibition of TSLP signaling. Additionally, verekitug inhibited cytokine production from both CD4+ T cells and ILC2 cells and completely suppressed skin allergic reactions in a non-human primate model, suggesting that it may be effective against multiple types of inflammation.

Three Phase 1 clinical trials have been completed for verekitug, including a Phase 1 single-ascending dose (SAD) clinical trial and a Phase 1b multiple-ascending dose (MAD) clinical trial. In these trials, verekitug was well tolerated, had no clinically meaningful immunogenicity, and showed a predictable and consistent pharmacokinetic profile and high subcutaneous bioavailability. In patients with asthma, verekitug led to >50% reductions in fractional exhaled nitric oxide (FeNO) and blood eosinophils that were rapid and sustained for up to 24 weeks after the last dose in the Phase 1b MAD trial.

About Upstream Bio
Upstream Bio is a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. Upstream Bio is developing verekitug, the only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin (TSLP), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. Upstream Bio has advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma and chronic obstructive pulmonary disease (COPD). Upstream Bio’s team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. To learn more, please visit www.upstreambio.com.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “predict,” “project,” “seeks,” “should,” “target,” “will” and variations of these words or similar expressions. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding: the clinical development of verekitug for the treatment of severe asthma, CRSwNP and COPD, including the initiation, timing, progress and results of ongoing and planned clinical trials; expectations for future discussions with regulatory authorities and the potential of the endpoints of the Company’s clinical trials to produce data that could support submissions for product approval; expectations regarding the differentiation, safety, efficacy or tolerability of verekitug; expectations regarding the translation of PK/PD modeling data of verekitug to clinical effects; and assessments comparing non-head-to-head clinical data of verekitug to published data for tezepelumab. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release 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. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to: Upstream Bio’s ability to advance verekitug through clinical development, and to obtain regulatory approval of and ultimately commercialize verekitug on the expected timeline, if at all; the initiation, timing, progress and results of clinical trials; Upstream Bio’s ability to fund its development activities and achieve development goals; Upstream Bio’s dependence on third parties to conduct clinical trials and manufacture verekitug, and commercialize verekitug, if approved; Upstream Bio’s ability to attract, hire and retain key personnel, and protect its intellectual property; Upstream Bio’s financial condition and need for substantial additional funds in order to complete development activities and commercialize verekitug, if approved; regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; Upstream Bio’s competitors and industry; and other risks and uncertainties described in greater detail under the caption “Risk Factors” in Upstream Bio’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the SEC. Any forward-looking statements represent Upstream Bio’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Upstream Bio explicitly disclaims any obligation or undertaking to update any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based except to the extent required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor and Media Contact:
Meggan Buckwell
Director, Corporate Communications and Investor Relations
ir@upstreambio.com

MSInsight Joins PREDI-LYNCH Project to Advance Non-Invasive Cancer Detection in Lynch Syndrome — Aligning With Hereditary Cancer Awareness Week

MSInsight Joins PREDI-LYNCH Project to Advance Non-Invasive Cancer Detection in Lynch Syndrome — Aligning With Hereditary Cancer Awareness Week




MSInsight Joins PREDI-LYNCH Project to Advance Non-Invasive Cancer Detection in Lynch Syndrome — Aligning With Hereditary Cancer Awareness Week

Press Release

Paris, September 2025 – MSInsight, a French precision oncology start-up, is proud to announce its participation in PREDI-LYNCH*, a six-year Horizon Europe consortium led by Oslo University Hospital. This ambitious project seeks to develop validated, non-invasive liquid biopsy tests to improve early cancer detection in people with Lynch syndrome (LS), one of the most common hereditary cancer syndromes.

The project launched in May 2025, and MSInsight is now pleased to share its role as a partner during Hereditary Cancer Awareness Week, underscoring the importance of raising awareness and building solutions for families at genetic risk of cancer.

Lynch Syndrome: A Major Unmet Need

Lynch syndrome is caused by inherited mutations in DNA mismatch repair (MMR) genes and greatly increases the lifetime risk of cancer (Dominguez-Valentin et al., 2019). People with this condition face a 50–80% chance of developing colorectal cancer, along with higher risks of endometrial, ovarian, gastric, and urinary tract cancers. The exact risk depends on which gene is affected: MLH1 and MSH2 mutations carry the highest risk, while MSH6 and PMS2 mutations are associated with lower—though still significant—risk (Dominguez-Valentin et al., 2019).

LS is responsible for an estimated 2-4% of all colorectal cancers in general, increasing to about 5% in studies that perform universal germline testing (Abu-Ghazaleh et al., 2022; Dinh et al., 2011). Improving early detection for LS carriers is thus both a preventive strategy and a path to improving survival across major cancer types.

Epidemiological modelling suggests that about 1 in 440 individuals of European ancestry carry LS-associated mutations. When applied to population estimates, this translates to approximately 2 million carriers in Europe. Yet only ~5% of these individuals are under active surveillance (PREDI-LYNCH estimates). This diagnostic gap underscores a profound public health challenge: despite the high lifetime risks, most carriers remain undiagnosed, untreated, or without appropriate monitoring.

About the PREDI-LYNCH Project

Approved by the European Commission in May 2025 with a total budget of €13.6 million, PREDI-LYNCH is a six-year (2025–2031) Horizon Europe initiative coordinated by Oslo University Hospital (OUS) and Pr. Mev Dominguez. The project brings together 28 leading institutions across 16 European countries to:

  • Develop non-invasive liquid biopsy tests for the detection of colorectal, endometrial, and urothelial cancers in LS carriers.
  • Validate biomarkers through multi-center trials, ensuring clinical robustness across diverse European healthcare systems.
  • Integrate AI-based analytics to improve biomarker discovery, prediction, and longitudinal monitoring.
  • Assess socio-economic and ethical aspects, ensuring new technologies are accessible, cost-effective, and patient-centered.

According to OUS, the project is motivated by the fact that current surveillance methods for LS patients (such as regular colonoscopies) are invasive, burdensome, and inconsistently followed. By shifting toward non-invasive tools like liquid biopsies, PREDI-LYNCH seeks to improve compliance, reduce delays in diagnosis, and ultimately save lives (OUS Research, 2025).

MSInsight’s Role: Leveraging MSIcare in PREDI-LYNCH

MSInsight contributes its expertise in microsatellite instability (MSI) diagnostics—a hallmark of Lynch syndrome–associated cancers—working closely with French partners at Inserm, Sorbonne University and La Pitié-Salpétrière Hospital. The company’s flagship solution, MSIcare, applies next-generation sequencing (NGS) and artificial intelligence algorithms to improve MSI detection accuracy (Ratovomanana et al., 2021).

While MSI testing is already a cornerstone of treatment selection in oncology—particularly for determining eligibility for immunotherapy—current diagnostic tools remain limited. Published studies have shown that traditional approaches can misclassify MSI status, with potentially serious consequences for patients (André et al., 2024).

By integrating MSIcare into the PREDI-LYNCH project, MSInsight will support the development of liquid-biopsy-based MSI detection, allowing non-invasive cancer prediction and surveillance in LS carriers. This work will build on the platform’s proven accuracy in tumor tissue samples and extend it into liquid-based diagnostics.

A Timely Commitment: Hereditary Cancer Awareness Week

The timing of MSInsight’s announcement reflects a broader commitment to public awareness. Hereditary Cancer Awareness Week draws attention to the millions of families worldwide living with inherited cancer risks. For LS carriers, awareness is often the first step to life-saving interventions, including surveillance, early detection, and preventive therapies.

In addition to our work on Lynch syndrome, we are committed to advancing the diagnosis of children affected by CMMRD (Constitutional Mismatch Repair Deficiency), an ultra-rare hereditary cancer syndrome with an estimated incidence of 1 in 1,000,000 births. CMMRD dramatically increases the risk of multiple, aggressive tumors at a very young age. This initiative is conducted in collaboration with Inserm, Sorbonne University, and Paris Hospitals. Improving early and accurate detection of CMMRD is essential to enable appropriate surveillance, timely care, and ultimately better outcomes for these children.

About MSInsight

Founded in Paris in 2022, MSInsight is a precision oncology start-up focused on improving cancer care through advanced diagnostics. The company builds on two decades of academic research from the “Microsatellite Instability and Cancer” team at Sorbonne University and Inserm, led by Prof. Alex Duval, a global expert in MSI. MSInsight’s flagship platform, MSIcare, integrates bioinformatics, artificial intelligence, and NGS to deliver accurate MSI/dMMR detection. Already clinically validated in tumor tissue, MSIcare is being expanded to blood-based applications, enabling non-invasive diagnostics that can transform cancer care. The company has been recognized as a winner of the 25th i-Lab Innovation Competition in France and collaborates with leading laboratories across Europe and the United States to validate and scale its technology.By combining cutting-edge science with a patient-focused mission, MSInsight is helping to redefine diagnostics in both sporadic and hereditary cancer contexts.

* PREDI-LYNCH project has received funding from the European Union’Horizon Europe research and innovation programme under grant agreement N°101213916.

Press Contacts:

MSInsight, Arnaud Cutivet ac@msinsight.tech & Sydney Normand sn@msinsight.tech


References

Abu-Ghazaleh et al. (2022), Genes, 13(2), 315.

Dinh, T. A et al. (2011), Cancer Prevention Research, 4(1), 9–22.

Dominguez-Valentin, M., et al. (2019), Journal of Clinical Oncology, 38(2), 136–147.

OUS Research. (2025, May 15). PREDI-LYNCH: Validated non-invasive liquid biopsy tests for cancer PREDIction in LYNCH Syndrome. Oslo University Hospital. https://www.ous-research.no/home/ous/news/26143

Ratovomanana, T., et al. (2021), Gastroenterology, 160(4), 1404–1417.

André, T. et al. (2024), New England Journal of Medicine, 391 (21), 2014-2026

Attachments

Pulselight appoints Sir Jonathan Van-Tam as an Advisor

Pulselight appoints Sir Jonathan Van-Tam as an Advisor




Pulselight appoints Sir Jonathan Van-Tam as an Advisor

Sir Jonathan Van-Tam joins Pulselight to support its mission to transform the UK health system by reducing waiting lists, driving efficiencies and improving patient outcomes

LONDON, Sept. 30, 2025 (GLOBE NEWSWIRE) — Pulselight, a data analytics company that has developed software AI products capable of transforming the UK health system, today announces the appointment of Sir Jonathan Van-Tam MBE, FMedSci, as an Advisor, effective immediately.

Sir Jonathan will use his extensive experience in HM Government, academia and across the health industry to strengthen Pulselight’s offering to support the NHS with maximising resources, preventing ill-health caused by obesity, tackling health inequalities and the shift of care into the community.

As the Government sharpens its focus on technology and data as drivers of NHS transformation, Sir Jonathan will leverage his deep expertise in advising how companies can deliver and communicate value across the health system. His insights will guide the company’s efforts to showcase its breadth of applications across various care settings. Sir Jonathan’s experience working at the forefront of UK health policy will help shape the company’s efforts to support the Government and NHS on addressing the country’s most urgent public health challenges.

Sir Jonathan served as Deputy Chief Medical Officer to HM Government from 2017 to 2022, playing a central role in shaping the UK’s response to the COVID-19 pandemic. Over the course of his career, he has led major global health initiatives in partnership with the World Health Organization and Public Health England, focusing on pandemic preparedness and response. His extensive experience in the pharmaceutical industry includes senior leadership roles at SmithKline Beecham (now part of GSK), Roche, and Aventis Pasteur MSD (now part of Sanofi). A distinguished academic, Sir Jonathan is a former Pro-Vice Chancellor of the University of Nottingham and currently works as an independent consultant in the biopharmaceutical sector.

Irene Manautou, Founder and CEO at Pulselight, said: “We are thrilled to welcome Sir Jonathan as an Advisor. His appointment is an important milestone in Pulselight’s UK growth as we look to bring the proven success of our AI-driven solutions from the US to support the NHS. With his unique expertise at the intersection of government, healthcare and innovation, Sir Jonathan will help us demonstrate how Pulselight’s technology can play a central role in reducing waiting lists, improving patient outcomes and enabling a more efficient health system.”

Sir Jonathan Van-Tam, Advisor at Pulselight, said: “Pulselight brings a powerful and truly bespoke solution to UK healthcare at a pivotal moment as the Government accelerates its technology-enabled strategy to reduce waiting lists and improve patient outcomes. I look forward to working with the team and showcasing the power of Pulselight’s analytics ecosystem to make sure it delivers real and lasting benefits for patients and the health service throughout the UK.”

For further information, please contact:

Pulselight (Team@Pulselight.com)

Irene Manautou

For Media Enquiries:

5654 & Company (Pulselight@5654.co.uk)

Matthew Neal, Partner

Charlotte Dawson, Associate Director

NOTES TO EDITORS

Sir Jonathan Van-Tam has joined Pulselight as an Advisor on a part-time basis.

Pulselight – a data analytics company – has developed analytical products capable of transforming the health system.

Already delivering results in the US, Pulselight’s technologies maximise resources, deliver preventive health care, tackle health inequalities, and empower community health workers.

For more information, please visit: https://www.pulselight.com/

Tagomics Publishes a New Approach to Genome-Wide Epigenomic Profiling

Tagomics Publishes a New Approach to Genome-Wide Epigenomic Profiling




Tagomics Publishes a New Approach to Genome-Wide Epigenomic Profiling

  • Study published in ‘Cell Reports Methods’ demonstrates the strength of Tagomics’ platform for epigenomic biomarker discovery and applications in liquid biopsy
  • Activace platform enables targeted, genome-wide profiling of unmethylated DNA regions, providing a comprehensive view of the epigenome that can be scaled to the study of large patient cohorts

CAMBRIDGE, England–(BUSINESS WIRE)–Tagomics Ltd., a pioneering biomarker discovery and diagnostics company, today announced the publication of a peer-reviewed study in Cell Reports Methods, underpinning its epigenomic profiling technology, Active-Seq, the basis of Tagomics’ Activace™ platform. The paper, titled ‘Genome-wide profiling of unmodified DNA using methyltransferase-directed tagging and enrichment’, built on research from the University of Birmingham, describes Tagomics’ enzymatic approach to epigenomic profiling that targets unmethylated DNA for enrichment, and its application to biomarker identification and disease profiling in colorectal cancer patients.


Current gold standard approaches for assessing genome-wide DNA methylation levels are poorly suited to the challenge of working in liquid biopsy (blood) samples, limiting the performance of cell-free DNA based diagnostic tests. Addressing these limitations, the paper describes Active-Seq (Azide Click Tagging for In Vitro Epigenomic sequencing), a base conversion-free methodology that does not alter the underlying DNA sequence and provides a scalable and comprehensive solution for the discovery of novel biomarkers in liquid biopsy samples. Activace, built on the Active-Seq technology, is a streamlined workflow that incorporates sequencing library preparation with enrichment of unmethylated DNA. The workflow is compatible with low DNA input quantities, down to one nanogram, and has been optimised for the analysis of DNA methylation in cfDNA derived from liquid biopsy samples.

The published paper demonstrates application of Active-Seq for the detection of abnormal DNA methylation signals in a cohort of colorectal cancer patients, identifying thousands of hypomethylated and hypermethylated regions in tumour-derived tissue, both of which are associated with cancer. The study lays the groundwork for application of the approach to the deconvolution of the tissue of origin of cell-free DNA in blood, improving detection and characterisation of disease.

Dr Robert Neely, CSO and co-founder of Tagomics said: “This paper is an important milestone for Tagomics, demonstrating the groundbreaking technology that underpins our Activace and Interlace platforms. We show that our platform enables the sensitive detection of unmethylated genomic regions, which are key markers for DNA tissue of origin. We’re excited about the insight this is providing into the biology of cell-free DNA and are looking forward to seeing new applications for the platform in cancer diagnostics and patient safety monitoring for therapeutics.”

For more information about Tagomics, please visit: https://tagomics.com/

Contacts

Media Contact:
Francesca Wallace

Email: francesca.wallace@zymecommunications.com

PL BioScience Announces Conferences Attendance

PL BioScience GmbH

/ Key word(s): Conference

PL BioScience Announces Conferences Attendance

30.09.2025 / 09:15 CET/CEST

The issuer is solely responsible for the content of this announcement.


PL BioScience Announces Conferences Attendance

 

Aachen, Germany, September 30, 2025 – PL BioScience GmbH, a German life science company specializing in the production and development of Human Platelet Lysate (HPL) for cell expansion, today announced its participation in six life sciences conferences this fall.

Meet our management team and marketing colleagues at one of the upcoming conferences:

 

Festival of Biologics
September 30 – October 2 in Basel, Switzerland
Anna Kolkmann (Sales Manager) and Maria Noronha (Marketing Specialist) will be present
Booth: 501C
Scheduling meetings is possible through the Terrapinn Event App

 

BioJapan
October 8 – 10 in Yokohama, Japan
Jungsoo Park (VP Marketing & Sales) and Kana Miyakubi (Sales Account Manager) will be present
Booth: B-68 at the EU-Japan Centre for Industrial Cooperation Pavilion

 

Innovative Therapies Days 2025
October 9 – 10 in Besançon, France
Silver Sponsor of the conference
Cécilia Mesa (Sales Manager) will be present and exhibit a poster
Booth: 6
Scheduling meetings is possible through the B2Match platform

 

CPHI Frankfurt 2025
October 28 – 30 in Frankfurt, Germany
Hatim Hemeda (CEO & Co-Founder), Christian Wilkes (CFO & Co-Founder) and Jungsoo Park will be present
Booth: 4S115
Scheduling meetings and contacting are possible through the CPHI Event Planner App

 

BIO-EUROPE 2025
November 3 – 5 in Vienna, Austria
Hatim Hemeda and Christian Wilkes will be present
Scheduling meetings through the partneringONE system

 

Cell 2025
November 11 – 12 in London, United Kingdom
Network & Programme Sponsors
Silke Isenhardt (Field Application Scientist) and Maria Noronha (Marketing Specialist) will be present and exhibit a poster
Booth: 54
Contact will be possible through the event app from November

 

 

About PL BioScience:

PL BioScience GmbH, a life science company located in Aachen, Germany, specializes in the production and development of Human Platelet Lysate (HPL). The company has pioneered proprietary technology to produce fully artificial HPL, allowing for a fully lab-made, scalable supply of HPL. PL BioScience currently offers a comprehensive portfolio of donor-derived, natural HPL products tailored for a range of applications – the ELAREMTM platform. From academic and preclinical research to cell therapy and biopharmaceutical manufacturing, ELAREM™ ensures seamless translations of regenerative medicine breakthroughs – from the lab to patients in need. PL BioScience is the only company worldwide holding a patent for the gamma-irradiation of HPL, covering the manufacturing process for ELAREM™ Ultimate-FD PLUS.

For more information on PL BioScience and the ELAREM™ platform, visit: https://www.pl-bioscience.com/

 

Contact:
Dr. Hatim Hemeda, CEO
PL BioScience GmbH
+49(0)24195719-100
info@pl-bioscience.com

 

Media contact:
MC Services AG
Raimund Gabriel, Dr. Regina Lutz
+49 (0)89 210 228 0

 

U.S.: Catherine Featherston
+1-203-444-4393
E-Mail: plbioscience@mc-services.eu


30.09.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Language: English
Company: PL BioScience GmbH
Auf der Hüls 184-186
52068 Aachen
Germany
E-mail: info@pl-bioscience.com
Internet: www.pl-bioscience.com
EQS News ID: 2205624

 
End of News EQS News Service

2205624  30.09.2025 CET/CEST

WINREVAIR™ (sotatercept-csrk) Reduced the Risk of Clinical Worsening Events by 76% Compared to Placebo in Patients Recently Diagnosed With PAH on Background Therapy in Phase 3 HYPERION Trial

WINREVAIR™ (sotatercept-csrk) Reduced the Risk of Clinical Worsening Events by 76% Compared to Placebo in Patients Recently Diagnosed With PAH on Background Therapy in Phase 3 HYPERION Trial




WINREVAIR™ (sotatercept-csrk) Reduced the Risk of Clinical Worsening Events by 76% Compared to Placebo in Patients Recently Diagnosed With PAH on Background Therapy in Phase 3 HYPERION Trial

Results showed the benefits of early initiation of WINREVAIR within the first year after PAH diagnosis

HYPERION results were presented today at ERS 2025 and simultaneously published in the New England Journal of Medicine

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 HYPERION trial evaluating WINREVAIR™ (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) II or III at intermediate or high risk of disease progression. In the study, WINREVAIR reduced the risk of clinical worsening events by 76% (hazard ratio [HR] 0.24 [95% confidence interval [CI], 0.14 to 0.41]; p<0.0001) as measured by a composite endpoint of all-cause death, the need for non-planned PAH-related hospitalization ≥24 hours, atrial septostomy, lung transplantation or PAH deterioration. HYPERION included participants who were within their first year of diagnosis (median seven months and as early as one month), with over 70% of trial participants on double background therapy. In the pivotal Phase 3 study, STELLAR, participants were WHO Group 1, FC II or III at baseline and had an average disease duration of 8.8 years from PAH diagnosis to screening. The safety profile of WINREVAIR was generally consistent with that observed in previous trials. Results from the study were presented today at the 2025 European Respiratory Society (ERS) Congress and simultaneously published in the New England Journal of Medicine.


In HYPERION, there was an early and sustained separation in the Kaplan-Meier curves with treatment benefit observed within six weeks of randomization. Patients on placebo plus background standard of care therapy experienced accumulation of clinical worsening events. Results showed that 10.6% (n=17/160) of patients treated with WINREVAIR compared to 36.9% (n=59/160) in the placebo group experienced at least one clinical worsening event. The treatment effect was consistent across all prespecified subgroups treated with WINREVAIR, including patients with idiopathic PAH, those with connective tissue disease, those on double background therapy, those on triple background therapy and those at intermediate or intermediate-low risk by REVEAL Lite 2 and COMPERA 2.0 risk tools, respectively.

“PAH is a rare condition that can progress quickly making diagnosis and early treatment critically important,” said Dr. Vallerie McLaughlin**, Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director, Pulmonary Hypertension Program, University of Michigan in Ann Arbor. “The patients with PAH enrolled in HYPERION were early in their treatment journey, had co-morbidities and were older, which reflects the type of patients we are diagnosing in a contemporary real-world setting. I am encouraged by the compelling results of the HYPERION study demonstrating that initiation of WINREVAIR on top of background therapy within the first year of diagnosis significantly reduces the risk of clinical worsening events compared to placebo.”

“These positive results from HYPERION expand on the body of clinical evidence for WINREVAIR, now including PAH patients within their first year of diagnosis, including those earlier in their treatment journey,” said Dr. Joerg Koglin, senior vice president, head of general and specialty medicine, global clinical development, Merck Research Laboratories. “The totality of WINREVAIR data to date continues to reinforce our confidence in its practice-changing potential. We thank the study participants and investigators for their contributions to this important study.”

The safety profile of WINREVAIR in HYPERION was generally consistent with that observed in previous studies. The median duration of follow-up was longer in those receiving WINREVAIR (14.6 months) compared with those receiving placebo (11.5 months). Adverse events occurred in 89.4% versus 90.0% and serious adverse events in 24.4% versus 28.1% of participants in the WINREVAIR and placebo groups, respectively.

WINREVAIR demonstrated statistically significant improvements in two secondary endpoints, including multicomponent improvement and maintenance or achievement of a low REVEAL Lite 2 score. Results showed that 29.4% of patients treated with WINREVAIR met all three criteria of multicomponent improvement (improvement in 6MWD, improvement or maintenance/achievement of NT-proBNP, and improvement in WHO FC or maintenance of WHO FC II) versus 14.6% treated with placebo. An additional secondary endpoint demonstrated 60.1% of patients treated with WINREVAIR maintained or achieved a low REVEAL LITE 2 score (≤5) relative to baseline at Week 24 compared to 47.9% treated with placebo. WINREVAIR did not show statistical significance in achieving or maintaining low risk for a simplified French risk score (SFRS). Subsequent secondary endpoints showed numerical improvements in the WINREVAIR arm (including NT-proBNP, WHO class and 6MWD), but were not formally tested due to the prespecified hierarchical testing strategy.

Earlier this year, the HYPERION trial was stopped early based on a review of the totality of data from the WINREVAIR clinical program at that time, and all patients were offered the opportunity to receive WINREVAIR through the SOTERIA open-label extension study. HYPERION is the third Phase 3 study of WINREVAIR to demonstrate significant efficacy in adults with PAH. The first was the Phase 3 STELLAR study previously presented at ACC.23, followed by the Phase 3 ZENITH study presented at ACC.25. Results from HYPERION will be submitted to regulatory authorities around the world. WINREVAIR is currently approved in more than 54 countries based on the results from the STELLAR study.

*World Health Organization

**Dr. McLaughlin is a member of the adult sotatercept steering committee, an investigator in the ZENITH and HYPERION studies and a paid consultant to Merck.

About HYPERION

The HYPERION study (NCT04811092) is a global, double-blind, placebo-controlled clinical trial to evaluate WINREVAIR when added to background PAH therapy in newly diagnosed intermediate or high-risk PAH patients. Participants who enrolled in the study had a diagnosis of symptomatic PAH (WHO Group 1, classified as FC II [21.3%; 68/320 participants] or III [78.8%; 252/320 participants] within 12 months of study screening. Two patients had a protocol deviation with a time since the diagnosis of PAH of more than 1 year (442 days in one patient in the sotatercept group; 397 days in one patient in the placebo group). Eligible participants had a confirmed diagnosis of PAH in any of the following subtypes: idiopathic PAH (59.4%; 190/320), heritable PAH (5.9%; 19/320), PAH associated with connective tissue diseases (CTD) (30.3%; 97/320), drug- or toxin-induced PAH (2.5%; 8/320), or PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair (1.9%; 6/320), and those at intermediate or intermediate-low risk by REVEAL Lite 2 and COMPERA 2.0 risk tools, respectively. The study excluded patients with PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH, pulmonary veno occlusive disease, and pulmonary capillary hemangiomatosis.

The study enrolled 320 study participants over the age of 18, who were randomized in a 1:1 ratio to receive either WINREVAIR or placebo, both on top of background therapy. Participants were at an intermediate to high risk of disease progression and on stable doses of double (72.2%; 231/320 participants) or triple (27.8%; 89/320 participants) background PAH therapies for at least 90 days prior to screening. A majority (83.4%; 267/320 participants) were not on prostacyclin-infusion therapy.

The primary composite outcome measure is TTCW as measured by first confirmed morbidity or mortality event. Clinical worsening events are defined as all-cause death, non-planned PAH worsening-related hospitalization of ≥ 24 hours, atrial septostomy, lung transplantation, and deterioration in six-minute walk test from baseline combined with at least one of the following changes: worsening of WHO FC from baseline, signs/symptoms of increased right heart failure, addition of a background PAH therapy or change in the background PAH therapy delivery route to parenteral.

Secondary outcome measures were assessed relative to baseline at Week 24: proportion of participants achieving multicomponent improvement (consisting of improvement in 6MWD, improvement in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level and improvement in WHO FC or maintenance of WHO FC II) as well as additional measures.

About WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg

WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics.

WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

Selected Safety Information for WINREVAIR in the U.S.

WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required.

WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required.

In clinical studies, serious bleeding (eg, gastrointestinal, intracranial hemorrhage) was reported in 4% of patients taking WINREVAIR and 1% of patients taking placebo. Patients with serious bleeding were more likely to be on prostacyclin background therapy and/or antithrombotic agents, or have low platelet counts. Advise patients about signs and symptoms of blood loss. Do not administer WINREVAIR if the patient is experiencing serious bleeding.

WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment.

Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility.

The most common adverse reactions occurring in the phase 3 clinical trial (≥10% for WINREVAIR and at least 5% more than placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%), rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea (15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs 3.1%).

Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose.

About PAH

Pulmonary arterial hypertension (PAH) is a rare, progressive and life-threatening blood vessel disorder characterized by the constriction of small pulmonary arteries and elevated blood pressure in the pulmonary circulation. Approximately 90,000 people worldwide are living with PAH. The disease progresses rapidly for many patients. PAH results in significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. The five-year mortality rate for patients with PAH is approximately 43%.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for WINREVAIR (sotatercept-csrk) at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_pi.pdf, Patient Information for WINREVAIR at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ppi.pdf, and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at https://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ifu_1-vial_2-vial_kits.pdf.

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Courtney Ronaldo

(908) 442-5695

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Ayn Wisler

(917) 691-6218