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.
Archive at www.eqs-news.com


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

Endeavor BioMedicines Announces Publication of Positive Data from Phase 2a Trial in The Lancet Respiratory Medicine Evaluating taladegib (ENV-101) in Individuals with Idiopathic Pulmonary Fibrosis

Endeavor BioMedicines Announces Publication of Positive Data from Phase 2a Trial in The Lancet Respiratory Medicine Evaluating taladegib (ENV-101) in Individuals with Idiopathic Pulmonary Fibrosis




Endeavor BioMedicines Announces Publication of Positive Data from Phase 2a Trial in The Lancet Respiratory Medicine Evaluating taladegib (ENV-101) in Individuals with Idiopathic Pulmonary Fibrosis

Treatment with taladegib demonstrated improved lung function from baseline, increased total lung capacity and reversed key measures of lung fibrosis in patients with idiopathic pulmonary fibrosis

Data also presented today in ALERT session at European Respiratory Society (ERS) Congress 2025

SAN DIEGO–(BUSINESS WIRE)–Endeavor BioMedicines (“Endeavor”), a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases, today announced that The Lancet Respiratory Medicine has published results from a Phase 2a trial evaluating the safety and efficacy of taladegib (ENV-101) in patients with idiopathic pulmonary fibrosis (IPF). Data from the Phase 2a trial were also featured in an ALERT (Abstracts Leading to Evolution in Respiratory Medicine Trials) session at the 2025 ERS Congress in Amsterdam — a special forum highlighting high-impact, practice-changing clinical trials in respiratory medicine.




The proof-of-concept clinical trial demonstrated that treatment with taladegib improved lung function from baseline, increased total lung capacity and reversed key measures of lung fibrosis in patients with idiopathic pulmonary fibrosis. Taladegib also demonstrated a favorable safety and tolerability profile. There were no treatment-related serious adverse events, treatment-related ≥grade 3 adverse events, or clinically meaningful safety findings.

“Patients living with idiopathic pulmonary fibrosis face a relentless and life-altering disease that affects not only their health but every aspect of daily life,” said Toby M. Maher, M.D., Ph.D., Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles. “We are encouraged by the totality of the clinical data for taladegib, as we observed not only significant improvements from baseline in FVC measured by spirometry, but also a significant increase in total lung capacity and reductions from baseline in key measures of fibrosis as measured by CT imaging. These encouraging results, published in The Lancet Respiratory Medicine and presented today during the ERS ALERT session, represent meaningful progress toward the goal of delivering an effective treatment for patients living with IPF.”

The randomized, double-blind, placebo-controlled Phase 2a clinical trial evaluated the safety and efficacy of taladegib vs. placebo in 41 patients with confirmed IPF who were treated for 12 weeks. The trial was conducted at 16 clinical sites in Australia, Canada, Malaysia, Mexico and South Korea for patients with IPF older than 40 years of age who were not on background standard of care. Patients were randomized to 200 mg of taladegib or placebo administered once daily orally for 12 weeks with a 6-week follow-up. The primary endpoint was safety as assessed by the incidence and severity of clinical laboratory abnormalities, change from baseline in vital sign measurements, oxygen saturation, frequency and severity of adverse events, and number of hospitalizations during the study. Secondary endpoints included change from baseline in forced vital capacity (FVC), time to progression (defined as either an absolute decline of ≥10% in percent predicted FVC from baseline to week 12 or death) and dyspnea score on the UCSD SOBQ. Exploratory endpoints included measures of fibrosis assessed by high-resolution computed tomography (HRCT).

Key published findings from the taladegib Phase 2a clinical trial include:

  • There were no serious adverse events or ≥grade 3 adverse events considered related to taladegib, and no deaths occurred during the trial.
  • The most common taladegib-related adverse events were Grade 1 or Grade 2 and included alterations in taste, hair loss/thinning and muscle spasms.
  • Patients who received taladegib experienced a statistically significant improvement in lung function assessed via spirometry through the 12 weeks of treatment.

    • The between-group difference from baseline to week 12 in percent predicted forced vital capacity (FVC) significantly favored taladegib (3.95%; 95% confidence interval [CI], 0.31% to 7.60%; p=0.035) with a mean change from baseline of 1.9% in the taladegib arm vs -1.3% for placebo.
    • By week 6, both percent predicted FVC and mean FVC (mL) exhibited an increase from baseline in the taladegib treatment group and a decrease in the placebo group that continued until the study drug was discontinued at week 12.
  • Patients who received taladegib experienced improvement across several measures assessed by quantitative analysis of lung fibrosis on High Resolution Computed Tomography (HRCT) including in total lung capacity (TLC), percent quantitative total interstitial lung disease (%QILD), percent quantitative lung fibrosis (%QLF), and percent quantitative ground glass (%QGG).

    • Improvements were seen in TLC, %QILD, %QLF and %QGG for the taladegib treatment group, while these measures of disease remained stable or worsened for the placebo group.
    • The mean change from baseline to week 12 in TLC improved significantly for the taladegib group (206.67 mL; 95% CI, 82.63 to 330.70 mL) but decreased for the placebo group (–55.58 mL; 95% CI, –170.71 to 59.55 mL) resulting in a significant between-group change from baseline to week 12 in TLC of 257.0 mL (95% CI, 86.8 to 427.2 mL; p=0.004).
    • An improvement from baseline to week 12 was also seen for %QILD for the taladegib group but not for the placebo group, and there was a significant between-group difference in change from baseline to week 12 (p=0.047) with mean change from baseline of -9.4% and 1.1% in the taladegib and placebo groups, respectively.

“We are honored that the results of our Phase 2a trial have been published in The Lancet Respiratory Medicine, one of the world’s most respected and top-tier medical journals, and also selected as an ALERT presentation at ERS. This recognition is a testament to the dedication of our scientific and clinical teams, the investigators, and most importantly, the patients who participated in the trial,” said John Hood, Ph.D., Co-Founder, CEO and Chairman, Endeavor BioMedicines. “Our team remains committed to advancing taladegib with our current Phase 2b WHISTLE-PF trial, which is on track and expected to be completed in 2026.”

About Idiopathic Pulmonary Fibrosis

IPF is a chronic, progressive lung disease that affects more than 150,000 adults in the United States. Although the exact cause of IPF is unknown, various environmental factors can deliver repeated injuries to lung cells that trigger abnormal wound-healing processes and life-threatening lung scarring. IPF is a chronic disease with limited treatment options and a very poor prognosis: the average life expectancy is only three to five years after diagnosis.

About Taladegib

Endeavor BioMedicines’ investigational medicine taladegib (ENV-101) is a Hedgehog signaling pathway inhibitor. By binding to and inhibiting a key receptor in the Hedgehog pathway, taladegib eliminates the myofibroblasts that cause fibrosis. This may resolve the excessive wound-healing process seen in pulmonary fibrosis, improving lung volume and function.

About Endeavor BioMedicines

Endeavor BioMedicines is a clinical-stage biotechnology company developing medicines with the potential to deliver transformational clinical benefits to patients with life-threatening diseases. Endeavor’s lead candidate, taladegib (ENV-101), is an inhibitor of the Hedgehog signaling pathway in development for fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). More information is available at www.endeavorbiomedicines.com and on LinkedIn or X.

Contacts

Media:
Audra Friis
Sam Brown, Inc.

917-519-9577

audrafriis@sambrown.com

ReproNovo Announces Clinical Trial Approval Notice for RPN-001 in China

ReproNovo SA

/ Key word(s): Miscellaneous

ReproNovo Announces Clinical Trial Approval Notice for RPN-001 in China

30.09.2025 / 07:00 CET/CEST

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


REPRONOVO ANNOUNCES CLINICAL TRIAL APPROVAL NOTICE FOR RPN-001 IN CHINA

  • The approval enables initiation of RPN-001 Phase 1 trial in China
     
  • Key regulatory milestone in the global development of RPN‑001
     

Lausanne, Switzerland and Copenhagen, Denmark, September 30, 2025 – ReproNovo, a company dedicated to developing innovative treatments for reproductive medicine and women’s health, today announced that China’s National Medical Products Administration (NMPA) has issued a clinical trial approval notice for RPN-001 (leflutrozole). This approval enables the initiation of a Phase 1 trial in China, marking a key regulatory milestone in the global development of RPN‑001 as a potential treatment for male infertility associated with low serum testosterone.

“Entering China with our first approved clinical study marks a meaningful geographic expansion for ReproNovo,” said Joan-Carles Arce, MD, PhD, Chief Scientific & Medical Officer of ReproNovo. “With this approval, we will soon have active clinical programs in the U.S. and China, two of the world’s largest healthcare markets, which reinforces our commitment to global development in reproductive medicine.”

RPN-001 is being studied to show improvements in testicular function and promotion of sperm production (spermatogenesis). The latest approval in China aligns with ReproNovo’s global development strategy and follows recent progress in the U.S., where a Phase 2 trial is underway.

“We are committed to expanding access to innovative therapies where few treatment options currently exist,” said Jean Duvall, Chief Executive Officer of ReproNovo. “With clinical activities now advancing in both the U.S. and China, we are building the foundation for a truly global approach to reproductive medicine and women’s health innovation.”
 

ABOUT REPRONOVO:
ReproNovo is a cutting-edge biopharmaceutical company developing innovative solutions to address critical gaps in reproductive medicine and women’s health. Our team is composed of proven experts with deep experience in reproductive medicine, drug development, regulatory affairs and business development who have throughout their careers successfully brought multiple therapies to market. Lead clinical compound, RPN-001 (leflutrozole), is being developed to treat male infertility. RPN-002 (nolasiban) is a first-in-disease and first-in-class molecular entity being developed to manage adenomyosis and increase the probability of embryo implantation in women undergoing assisted reproductive technology (ART) treatments. Both assets are Phase 2 ready. ReproNovo is financed by Jeito Capital, AXA IM Alts, founding investor M Ventures, Ysios Capital and ALSA Ventures. Headquartered in Lausanne, Switzerland, the company has its primary development team in Copenhagen, Denmark and an additional development site in Barcelona, Spain. For more information, visit the Company’s website at www.repronovo.com or follow us on LinkedIn.
 

ABOUT RPN-001 (leflutrozole):
RPN-001 is a novel orally administered compound being developed for the treatment of infertility in men with low serum testosterone. The small molecule inhibits the enzyme aromatase, suppressing testosterone conversion to estradiol, thereby normalizing testosterone levels. Low testosterone levels are becoming more prevalent, even in younger men, highlighting the urgent demand for new treatments. RPN-001 is currently being evaluated in a U.S. Phase 2 trial (https://clinicaltrials.gov/study/NCT06993155?term=Leflutrozole&rank=1). ReproNovo has an exclusive global license agreement with Mereo BioPharma for the development and commercialization of leflutrozole.
 

CONTACT INFORMATION:
ReproNovo
Rue de Langallerie 11
1003 Lausanne, Switzerland
info@repronovo.com
 

MEDIA CONTACT:
MC Services AG
Brittney Sojeva
repronovo@mc-services.eu
+49 211 529 252 14


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


2205250  30.09.2025 CET/CEST

Data show Roche’s sixth-generation Troponin T test offers a new level of accuracy critical for diagnosing heart attacks

Data show Roche’s sixth-generation Troponin T test offers a new level of accuracy critical for diagnosing heart attacks




Data show Roche’s sixth-generation Troponin T test offers a new level of accuracy critical for diagnosing heart attacks

  • Recently granted CE Mark, the novel test delivers improved sensitivity and accuracy for faster and more reliable diagnosis in emergencies.
  • The test helps clinicians quickly identify heart attack and rule out non-cardiac causes, ensuring patients receive the care they need at the earliest opportunity.
  • The global TSIX clinical study involved more than 13,000 participants, validating performance across a diverse population that reflects real-world healthcare settings.1,2

Basel, 30 September 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced the primary results from the TSIX Study Program, which evaluated the performance of its new sixth-generation high-sensitivity Troponin T test for diagnosing heart attacks. Presented at the European Society for Emergency Medicine (EUSEM) 20252 and the European Society of Cardiology (ESC) 20251, the study results showed that the Elecsys® Troponin T hs Gen 6 test was able to identify acute myocardial infarction (AMI), or heart attack, and identify those not having an AMI, with a high level of precision.2,3 This supports the efficient triage of patients arriving at the emergency department, ensuring healthcare resources can be focused where they are needed most. This data announcement follows the recent CE Mark approval for the test.

As one of the top three reasons for emergency care visits,4 chest pain creates significant anxiety and uncertainty for patients whilst putting pressure on healthcare services. Yet only one in every ten patients who presents with symptoms will actually be experiencing a heart attack.5 With 49% of emergency departments in Europe reporting overcrowding on a frequent basis,6 the ability to quickly and reliably identify those patients who are suffering from AMI, and to rule out those who are not, is crucial in ensuring the best possible outcomes for patients.

“Coronary artery disease continues to place an immense strain on global health systems, particularly in emergency care, where cases of chest pain are among the most challenging presentations to evaluate,” said Matt Sause, CEO of Roche Diagnostics. “Our new test enables clinicians to detect even the smallest elevations in troponin levels – a critical biomarker for heart attack – with high confidence. This ensures that in a situation when every second counts, patients receive the life-saving care they need at the earliest opportunity, and emergency services can prioritise resources to deliver care effectively to those in urgent need.”

About Roche Diagnostics’ commitment to heart health
With a 30-year legacy in troponin innovation, Roche was the first company in the world to introduce high-sensitivity troponin tests. And Roche’s troponin test was the first to receive FDA approval. Building on this legacy, the novel test is the first in a series of anticipated approvals for Roche, reflecting the company’s vision for the future of coronary artery disease (CAD) management. This includes a portfolio of innovative tests that enable consistent and precise biomarker measurements to be reliably compared across healthcare settings. It also includes future acute coronary syndrome (ACS) offerings that will combine next-generation digital algorithms, biomarkers, near-patient care devices, and laboratory analysers.

About the TSIX Study Program
Forming the basis for regulatory approval, the comprehensive TSIX study program recruited a total of over 13,000 individuals.1,4 It is the first global clinical study program of its kind to be performed in the use of troponin testing, involving patients in the US, China, Japan and the EU, and reflects Roche’s ambition to work towards more standardised care across the world.

The REF-TSIX study was designed to establish the standard upper reference limits (URLs) for troponin levels in the blood.1 These limits represent the highest expected concentration of troponin in a healthy population, providing the benchmarks used to diagnose myocardial infraction. The study prospectively collected plasma and serum samples from a diverse global population to ensure the assay’s accuracy across different demographics and healthcare settings. Data presented at European Society of Cardiology congress 2025 showed a 99th percentile URLs of 27 ng/L for the overall population and sex-specific URLs of 18 ng/L for females and 32 ng/L for males.1 These findings confirm the test’s consistency and accuracy, meeting the highest benchmarks for clinical diagnostics as recommended by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC).7

To validate the clinical performance of the newly established URLs, the prospective, international, multicenter, longitudinal cohort study PERFORM-TSIX enrolled 5,631 patients across 50 sites,2,4 presenting to emergency departments with symptoms of ACS. Up to five samples were collected at intervals after presentation at the emergency department, to provide a detailed assessment of the test’s performance across time points.4

The study data demonstrated that the assay was highly effective at detecting heart attacks, meeting its primary endpoint using the universal 99th percentile URL at three hours post emergency department presentation.3 Moreover, the study data showed that 56.6% of patients were able to be discharged in the first hours after presentation with a negative predictive value of 99.7%, underlining its excellent clinical performance.2,4

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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

All trademarks used or mentioned in this release are protected by law.

References
[1] Daniels LB et al. Establishing reference values in healthy participants for a next generation cardiac troponin T high-sensitivity assay – the REF-TSIX global reference study. Presented at European Society of Cardiology Congress. 2025 August
[2] Peacock WF et al. Primary results of PERFORM-TSIX, a prospective, international, observational, longitudinal cohort study evaluating clinical performance of the next generation cardiac troponin T high-sensitivity Gen 6 assay in acute coronary syndrome myocardial infarction. Presented at European Society of Emergency Medicine September 2025
[3] F. Hoffmann-La Roche Ltd. Elecsys® Troponin T hs Gen 6 Method Sheet. (v.2.0). 2025
[4] Audrey J. Weiss, Ph.D., and H. Joanna Jiang, Ph.D., Agency for Healthcare Research and Quality, Most Frequent Reasons for Emergency Department Visits, 2018. Available at: https://hcup-us.ahrq.gov/reports/statbriefs/sb286-ED-Frequent-Conditions-2018.jsp
[5] Fanaroff AC, Rymer JA, Goldstein SA, Simel DL, Newby LK. Does This Patient With Chest Pain Have Acute Coronary Syndrome?: The Rational Clinical Examination Systematic Review. JAMA. 2015 Nov 10;314(18):1955-65. doi: 10.1001/jama.2015.12735. PMID: 26547467.
[6] Velt KB, Cnossen M, Rood PPM, Steyerberg EW, Polinder S, Lingsma HF; CENTER-TBI investigators. Emergency department overcrowding: a survey among European neurotrauma centres. Emerg Med J. 2018 Jul;35(7):447-448. doi: 10.1136/emermed-2017-206796. Epub 2018 Mar 21. PMID: 29563151.
[7] Aakre, K. M., Saenger, A. K., Body, R., Collinson, P., Hammarsten, O., Jaffe, A. S., … & Apple, F. S. (2022). Analytical considerations in deriving 99th percentile upper reference limits for high-sensitivity cardiac troponin assays: educational recommendations from the IFCC committee on clinical application of cardiac bio-markers. Clinical chemistry, 68(8), 1022-1030.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD
Phone: +41 79 407 72 58
Sileia Urech
Phone: +41 79 935 81 48
Nathalie Altermatt
Phone: +41 79 771 05 25
Lorena Corfas
Phone: +41 79 568 24 95
Simon Goldsborough
Phone: +44 797 32 72 915
Karsten Kleine
Phone: +41 79 461 86 83
Kirti Pandey
Phone: +49 172 6367262
Yvette Petillon
Phone: +41 79 961 92 50
Dr Rebekka Schnell
Phone: +41 79 205 27 03
 

Roche Investor Relations

Dr Bruno Eschli
Phone: +41 61 68-75284
e-mail: bruno.eschli@roche.com
Dr Sabine Borngräber
Phone: +41 61 68-88027
e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost
Phone: +41 61 68-84814
e-mail: birgit.masjost@roche.com
 

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

 

Attachment

Valneva Reports 95% Seroresponse Four Years After Single Shot of Chikungunya Vaccine IXCHIQ®

Valneva Reports 95% Seroresponse Four Years After Single Shot of Chikungunya Vaccine IXCHIQ®




Valneva Reports 95% Seroresponse Four Years After Single Shot of Chikungunya Vaccine IXCHIQ®

  • Long-lasting antibody persistence was comparable in older (65+) and younger adults
  • Long-term antibody persistence is a key competitive advantage for a vaccine targeting unpredictable outbreak diseases like chikungunya

Saint-Herblain (France), September 30, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data four years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®. The results are in line with Valneva’s expectations for this vaccine, confirming a strong and long-lasting antibody persistence across all age groups investigated. The four-year persistence data are in line with previous persistence data1, 2,3, further highlighting a key advantage of the vaccine.

Among the 254 healthy adults still followed in the trial, 95% maintained neutralizing antibody titers well above the seroresponse threshold4 four years after the single-dose vaccination. Persistence of antibodies in older adults (age 65+) was comparable to younger adults (18-64 years of age) in terms of geometric mean titers (GMTs) and seroresponse rates (SRRs).

Trial VLA1553-303, which has received funding support from the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union’s (EU) Horizon Europe program, also collected long-term safety data up to two years, including Adverse Event of Special Interest (AESI) from the preceding trial and any new-onset Serious Adverse Events (SAEs). No safety concerns were reported or identified and no AESI were ongoing at the time of participant enrollment in the trial. Per trial protocol, antibody persistence is planned to be collected up to ten years after vaccination.

Juan Carlos Jaramillo M.D., Chief Medical Officer of Valneva, said, “We are very encouraged by these four-year data, which further reinforce IXCHIQ®‘s unique profile and its ability to generate a robust, durable antibody response in both younger and older adults with just a single dose. Whether you are a traveler, live in an endemic area, or face an outbreak situation, the prospect of long-term protection from a mosquito-borne disease with a single vaccination is highly valuable, especially in Low- and Middle-Income Countries ((LMICs) where vaccine access is often limited.”

Valneva is focused on expanding the vaccine’s access. The Company expanded its partnership with CEPI in 20245 to support broader access to the vaccine in LMICs and, within the framework of this agreement, announced an exclusive license agreement with the Serum Institute of India (SII) to enable supply of the vaccine in Asia6.

About Chikungunya
Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years.7
In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas.8 Between 2013 and 2023, more than 3.7 million cases were reported in the Americas9 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.10

About Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at www.valneva.com.

Valneva Investor and Media Contacts
Laetitia Bachelot-Fontaine
VP Global Communications & European Investor Relations
M +33 (0)6 4516 7099
laetitia.bachelot-fontaine@valneva.com        

Joshua Drumm, Ph.D.
VP Global Investor Relations
M +001 917 815 4520
joshua.drumm@valneva.com

Forward-Looking Statements

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.  


1 Valneva Reports Positive 12-Month Antibody Persistence Data for Single-Shot Chikungunya Vaccine Candidate – Valneva
2 Valneva Reports Positive 24-Month Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® – Valneva; McMahon et al., J TJ Travel Med. 2024 Mar 1;31(2):taad156.doi: 10.1093/jtm/taad156
3 Valneva Reports Positive Three-Year Antibody Persistence Data for its Single-Shot Chikungunya Vaccine IXCHIQ® – Valneva
4 A neutralizing antibody titer of ≥150 determined by µPRNT50, i.e. the antibody level agreed with regulators as endpoint under the accelerated approval pathway.
5 CEPI Expands Partnership with Valneva with a $41.3 Million Grant to Support Broader Access to the World’s First Chikungunya Vaccine – Valneva
6 Valneva Successfully Expands Access to Asia for its Chikungunya Vaccine with Serum Institute of India – Valneva
7 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf
8 https://cmr.asm.org/content/31/1/e00104-16
9 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.
10 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int)

Attachment

Addex Therapeutics Reports 2025 Half Year and Second Quarter Financial Results and Provides Corporate Update

Addex Therapeutics Reports 2025 Half Year and Second Quarter Financial Results and Provides Corporate Update




Addex Therapeutics Reports 2025 Half Year and Second Quarter Financial Results and Provides Corporate Update

  • Cash position of CHF 2.3 million at end of H1 2025
  • GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity in disease models
  • Regained rights to phase 2 mGlu2 PAM asset, ADX71149
  • Indivior advanced GABAB PAM substance use disorders program successfully through IND enabling studies
  • Entered option agreement with Sinntaxis for exclusive license to intellectual property covering the use of mGlu5 NAM in brain injury recovery
  • Invested in Stalicla SA, confirming commitment to advancing innovative treatments for CNS disorders

Ad Hoc Announcement Pursuant to Art. 53 LR

Geneva, Switzerland, September 30, 2025 Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today reported its half-year and second quarter financial results for the periods ended June 30, 2025, and provided a corporate update.

“We have seen great progress in the first six months of 2025, both in terms of drug candidate development and achieving business milestones. In particular, progress continues well and on track with our GABAB PAM drug candidate in chronic cough. We also presented positive data from the cough program, achieved in multiple preclinical models, at the prestigious American Cough conference. We also regained rights to our Phase 2 mGlu2 PAM asset, ADX71149, for which we are evaluating next steps for the program internally,” said Tim Dyer, CEO of Addex. “Solidifying our position to use mGlu5 NAMs in brain injury, we entered an option agreement with Sinntaxis to gain access to additional intellectual property in the field. Our plan is to explore further the clinical activity of dipraglurant in this indication. Our partner, Indivior, has advanced its GABAB PAM clinical candidate through IND enabling studies, providing additional validation of our allosteric modulation approach. We also led a financing in Stalicla, a Swiss company pioneering a precision medicine approach for neurodevelopmental and neuropsychiatric disorders. Following the spin-out of Neurosterix last year, this investment continues to underscore our commitment to advancing innovative treatments for CNS disorders.”

Operating Highlights: 

  • GABAB PAM chronic cough candidate demonstrated robust anti-tussive activity in multiple models of disease
  • Regained rights to phase 2 mGlu2 PAM asset, ADX71149
  • Indivior advanced its GABAB PAM program for substance use disorders successfully through IND enabling studies
  • Entered option agreement with Sinntaxis for exclusive license to intellectual property covering use of mGlu5 NAM in brain injury recovery
  • Invested in Stalicla, continuing strategic commitment to advancing innovative treatments for CNS

Key H1 2025 Financial Data

CHF’ thousands Q2 25 Q2 24 Change H1 25 H1 24 Change
Income 36 115 (79) 107 350 (243)
R&D expenses (234) (339) 105 (391) (584) 193
G&A expenses (535) (675) 140 (1,056) (1,453) 397
Total operating loss (733) (899) 166 (1,340) (1,687) 347
Finance result, net 6 (27) 33 (13) 26 (39)
Share of net loss of associates (1,232) (531) (701) (2,079) (531) (1,548)
Net loss from continuing operations (1,959) (1,457) (502) (3,432) (2,192) (1,240)
Net profit from discontinued operations 118 14,335 (14,217) 118 11,983 (11,865)
Net profit or (loss) for the period (1,841) 12,878 (14,719) (3,314) 9,791 (13,105)
Basic and diluted net loss per share:            
From continuing operations (0.02) (0.01) (0.01) (0.03) (0.02) (0.01)
From discontinued operations 0.00 0.14 (0.14) 0.00 0.12 (0.12)
Total basic and diluted net loss per share (0.02) 0.13 (0.15) (0.03) 0.10 (0.13)
Net increase / (decrease) in cash during the period (524) 2,160 (2,684) (1,041) (77) (964)
Cash and cash equivalents as of June 30 2,301 3,788 (1,487) 2,301 3,788 (1,487)
Shareholders’ equity 7,213 12,651 (5,438) 7,213 12,651 (5,438)

Financial Summary:
Income decreased by CHF 0.2 million during the six-month period ended June 30, 2025 compared to the same period ended June 30, 2024, primarily due to the completion of the R&D collaboration phase of our agreement with Indivior.

R&D expenses decreased by CHF 0.2 million during the six-month period ended June 30, 2025 compared to the same period ended June 30, 2024, primarily due to lower GABAB PAM outsourced R&D expenses related to our R&D collaboration agreement with Indivior.

G&A expenses decreased by CHF 0.4 million during the six-month period ended June 30, 2025 compared to the same period ended June 30, 2024, primarily due to reduced legal fees.

The net result decreased by CHF 13.1 million during the six-month period ended June 30, 2025 compared to the same period ended June 30, 2024, primarily due to gross proceeds of CHF 14.0 million from the sale of a part of our business executed on April 2, 2024 and recognized as discontinued operations. During the same period ended June 30, 2025, the net loss from continuing operations increased by CHF 1.2 million primarily due to an increased share of loss from the investment in Neurosterix US Holdings accounted for using the equity method since April 2, 2024. 

Basic and diluted loss per share amounted to CHF 0.03 per share for the six-month period ended June 30, 2025 compared to a basic and diluted profit per share of CHF 0.10 for the same period ended June 30, 2024.

Cash and cash equivalents decreased to CHF 2.3 million at June 30, 2025, compared to CHF 3.8 million at June 30, 2024. The decrease of CHF 1.5 million between June 30, 2025 and June 31, 2024 is primarily due to operating activities.

Half-Year 2025 Consolidated Financial Statements:
The Half-Year 2025 financial report can be found on the Company’s website in the investor/download section here.

Conference Call Details:
A conference call will be held tomorrow on October 1, 2025, at 16:00 CEST (15:00 BST / 10:00 EDT / 07:00 PDT) to review the financial results. Tim Dyer, Chief Executive Officer and Mikhail Kalinichev, Head of Translational Science will deliver a brief presentation followed by a Q&A session.

Joining the Conference Call:

  1. Participants are required to register in advance of the conference using the link provided below. Upon registering, each participant will be provided with Participant Dial-in numbers, and a unique Personal PIN.
  2. In the 10 minutes prior to the call’s start time, participants will need to use the conference access information provided in the e-mail received at the point of registering. Participants may also use the call me feature instead of dialing the nearest dial in number.

Webcast registration URL:

https://edge.media-server.com/mmc/p/vh6nhzwt

Conference call registration URL:

https://register-conf.media-server.com/register/BI403a5726888046a6a0645698cc9fdaec

About Addex Therapeutics

Addex Therapeutics is a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders. Addex’s lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in brain injury recovery, including post-stroke and traumatic brain injury recovery. Addex’s partner, Indivior, has selected a GABAB PAM drug candidate for development in substance use disorders and has successfully completed IND enabling studies. Addex is advancing an independent GABAB PAM program for chronic cough. Addex holds a 20% equity interest in a private spin out company, Neurosterix LLC, which is advancing a portfolio of allosteric modulator programs, including M4 PAM for schizophrenia, mGlu7 NAM for mood disorders and mGlu2 NAM for mild neurocognitive disorders. In addition, Addex has invested in Stalicla, a private Swiss company pioneering a precision medicine approach for neurodevelopmental and neuropsychiatric disorders. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol “ADXN” on each exchange. For more information, visit www.addextherapeutics.com
  
Contacts: 

Tim Dyer 
Chief Executive Officer 
Telephone: +41 22 884 15 55 
PR@addextherapeutics.com 
Mike Sinclair 
Partner, Halsin Partners 
+44 (0)7968 022075 
msinclair@halsin.com 

Addex Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F, prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

Kuros Biosciences debuts commercial launch of MagnetOs MIS Delivery System at SMISS 2025

Kuros Biosciences debuts commercial launch of MagnetOs MIS Delivery System at SMISS 2025




Kuros Biosciences debuts commercial launch of MagnetOs MIS Delivery System at SMISS 2025

Kuros Biosciences debuts commercial launch of MagnetOs MIS Delivery System at SMISS 2025

Schlieren (Zürich), Switzerland – September 30, 2025 – Kuros Biosciences (“Kuros” or the “Company”), a leader in innovative biologic technologies, today announced the full commercial launch of the MagnetOs™ MIS Delivery System. Purpose-built for Minimally Invasive Surgical (MIS) procedures, the system is designed to meet every surgeon’s need in bone graft delivery. It will be showcased at the Kuros booth and featured in a podium presentation at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Meeting on October 3, 2025, in Las Vegas, Nevada.

MagnetOs MIS sets a new standard in minimally invasive surgery as the only bone graft delivery system that is sterile, prefilled, free of human tissue, and with a mechanism of action backed by Level I clinical evidence.1,2 MagnetOs MIS ensures surgeons no longer need to compromise, meeting all critical needs for minimally invasive bone grafting:

  • Always ready when you are – single-use, sterile, and prefilled, available off the shelf with no refrigeration or thawing required1
  • Faster efficiency – graft placement three times faster than traditional funnel-based delivery methods3
  • Engineered for optimal handling – enabling easy, controlled, and precise graft placement in hard-to-reach spaces

Built on the proven science of MagnetOs and its proprietary NeedleGrip™ submicron surface technology to harness the immune system to stimulate bone formation, the MIS system is designed to maximize speed and efficiency in the operating room.4-6

Dr. Matthew Maserati, neurosurgeon at WellSpan Neurosurgery in Chambersburg, PA, will be presenting his experience with the MagnetOs MIS Delivery System at SMISS on October 3, 2025, from 9:12-9:18am in the DaVinci Ballroom. “Kuros Biosciences has delivered an elegant solution that makes MIS graft placement efficient and reliable, without compromise. I was impressed with how seamlessly the system performed and the confidence it provided in delivering MagnetOs precisely into confined spaces.” – Dr. Maserati.

Chris Fair, CEO of Kuros Biosciences, commented: “The launch of MagnetOs MIS is more than a product milestone – it reflects our vision to redefine what’s possible in spine surgery. By combining efficiency, precision, and the strength of Level I clinical evidence, we’re setting a new standard for minimally invasive care. At Kuros, our mission is to empower surgeons with innovations that don’t just keep pace with the future of surgery but help shape it.”

To learn more about the new MagnetOs MIS Delivery System, visit: www.kurosbio.com/spine/mis.

For further information, please contact:
Kuros Biosciences AG

Alexandre Müller Daniel Geiger
Investor Relations Chief Financial Officer
Tel +41 43 268 32 31 Tel +41 44 733 47 41
IR@kurosbio.com daniel.geiger@kurosbio.com

        

About MagnetOs MIS Delivery System
The MIS system is supported by robust published clinical evidence for MagnetOs in cases where minimally invasive procedures and surgical site accessibility is crucial. In a retrospective study, MagnetOs achieved a 94.4% fusion rate across 36 levels treated in patients undergoing MIS and open transforaminal lumbar interbody fusions (TLIF), where the majority of patients had comorbidities such as obesity, smoking, diabetes, or a previous spine surgery.7 These results build on previously published Level I prospective, randomized, controlled human clinical data demonstrating that MagnetOs achieved nearly twice the fusion rate of autograft in posterolateral fusion (79% vs. 47%).2

About MagnetOs
Growing bone with MagnetOsTM gives surgeons confidence where it matters most – delivering predictable fusion outcomes.2 In a Level I human clinical study published in Spine, MagnetOs achieved nearly twice the fusion rate (79% vs. 47%) of autograft in posterolateral fusions (PLFs).2 Among active smokers – who made up 1 in 5 patients – the fusion difference between MagnetOs and autograft was even more dramatic.*†2,8 MagnetOs grows bone on its own thanks to NeedleGripTM – a proprietary submicron surface technology that harnesses the immune system to stimulate bone growth, without added cells or growth factors.§4-6 Ready-to-use, easy to mold, and reliably staying put, MagnetOs carries no intrinsic risk of human tissue-related disease transmission and is FDA cleared for use throughout the spine, including interbody procedures.1,9-13

Indications Statement
Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings, and precautions.

About Kuros Biosciences
Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic technologies. With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company’s first commercial product, MagnetOsTM, is a unique advanced bone graft that has already been used across five continents. For more information on the company, its products and pipeline, visit kurosbio.com.

Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

* 19 of initial 100 patients were active smokers.
† Radiographic fusion data of the smoker subgroup were not statistically analyzed as a subgroup and were not included in the peer-reviewed publication of the study.2
Results from in vitro or in vivo laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please visit kurosbio.com. 
§ MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft. 
MagnetOs must also be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. MagnetOs Flex Matrix must be hydrated with BMA & mixed with autograft in posterolateral spine & intervertebral disc space. MagnetOs Granules must be hydrated with blood in the intervertebral disc space.

  1. Instructions for Use (IFU) MagnetOs MIS (US).
  2. Stempels, et al. Spine. 2024;49(19):1323-1331.
  3. Data on file. MagnetOs MIS.
  4. Van Dijk, et al. eCM. 2021;41:756-73.
  5. Van Dijk, et al. J Immunol Regen Med. 2023;19:100070.
  6. Duan, et al. eCM. 2019;37:60-73.
  7. Davis, J. et al. Orthopedic Review. 2025.
  8. Van Dijk, LA. 24th SGS Annual Meeting (Swiss Society of Spinal Surgery). Basel, Switzerland. Aug 2024.
  9. Data on file. MagnetOs Putty and MagnetOs Easypack Putty.
  10. Instructions for Use (IFU) MagnetOs Granules (US).
  11. Instructions for Use (IFU) MagnetOs Putty (US).
  12. Instructions for Use (IFU) MagnetOs Easypack Putty (US).
  13. Instructions for Use (IFU) MagnetOs Flex Matrix (US).

Attachment

Nxera Pharma to Receive US$10 Million Milestone Payment from AbbVie under Collaboration Targeting Neurological Diseases

Nxera Pharma to Receive US$10 Million Milestone Payment from AbbVie under Collaboration Targeting Neurological Diseases




Nxera Pharma to Receive US$10 Million Milestone Payment from AbbVie under Collaboration Targeting Neurological Diseases

Tokyo, Japan and Cambridge and London, UK, 30 September 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces that it has reached a second important R&D milestone under its multi-target discovery collaboration with AbbVie focused on neurological diseases, resulting in a payment of US$10 million to Nxera.

Nxera and AbbVie entered this multi-target collaboration in 2022 to leverage Nxera’s NxWave™ platform to discover novel medicines targeting G protein-coupled receptors (GPCRs) associated with neurological disease. This current milestone relates to the identification of validated and differentiated ‘hit’ molecules against a neurology target.

Under the terms of the agreement, Nxera is eligible to receive up to US$40 million in near-term research milestones, as well as further potential option, development and commercial milestones totalling up to US$1.2 billion, plus tiered royalties on global sales. This is the second milestone received in this collaboration, following the first milestone which was achieved in June 2024.

Dr. Matt Barnes, Chief Scientific Officer and President of Nxera Pharma UK, said: “Reaching this second milestone highlights the continued productivity of our collaboration with AbbVie, and reflects the remarkable work of our teams in applying our NxWave™ platform to discover and advance novel molecules that modulate neurological disease targets. We are very proud of the progress achieved so far and look forward to continuing our work towards impactful new therapies for patients.”

The milestone payment will be recognized in the third quarter of 2025.

–END–

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

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

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

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

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

Enquiries:

Media and Investor Relations
Shinya Tsuzuki, VP, Head of Investor Relations
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
Maya Bennison, Communications Manager
+81 (0)3 5962 5718 | +44 (0)1223 949390 |IR@Nxera.life

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

Forward-looking statements

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

Nxera Pharma to Receive US$10 Million Milestone Payment from AbbVie under Collaboration Targeting Neurological Diseases

Nxera Pharma to Receive US$10 Million Milestone Payment from AbbVie under Collaboration Targeting Neurological Diseases




Nxera Pharma to Receive US$10 Million Milestone Payment from AbbVie under Collaboration Targeting Neurological Diseases

Tokyo, Japan and Cambridge and London, UK, 30 September 2025 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces that it has reached a second important R&D milestone under its multi-target discovery collaboration with AbbVie focused on neurological diseases, resulting in a payment of US$10 million to Nxera.

Nxera and AbbVie entered this multi-target collaboration in 2022 to leverage Nxera’s NxWave™ platform to discover novel medicines targeting G protein-coupled receptors (GPCRs) associated with neurological disease. This current milestone relates to the identification of validated and differentiated ‘hit’ molecules against a neurology target.

Under the terms of the agreement, Nxera is eligible to receive up to US$40 million in near-term research milestones, as well as further potential option, development and commercial milestones totalling up to US$1.2 billion, plus tiered royalties on global sales. This is the second milestone received in this collaboration, following the first milestone which was achieved in June 2024.

Dr. Matt Barnes, Chief Scientific Officer and President of Nxera Pharma UK, said: “Reaching this second milestone highlights the continued productivity of our collaboration with AbbVie, and reflects the remarkable work of our teams in applying our NxWave™ platform to discover and advance novel molecules that modulate neurological disease targets. We are very proud of the progress achieved so far and look forward to continuing our work towards impactful new therapies for patients.”

The milestone payment will be recognized in the third quarter of 2025.

–END–

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

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

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

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

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

Enquiries:

Media and Investor Relations
Shinya Tsuzuki, VP, Head of Investor Relations
Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
Maya Bennison, Communications Manager
+81 (0)3 5962 5718 | +44 (0)1223 949390 |IR@Nxera.life

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

Forward-looking statements

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